Ohio Administrative Code 3701:1 — Department of Health | Radiation Control

Chapter 3701:1-37 Physical Protection Program

Ohio Adm.Code 3701:1-37-01 Definitions.

Terms defined in rule 3701:1-38-01 of the Administrative Code shall have the same meaning when used in this chapter except terms redefined within a given rule for use within that rule only. Additionally, the following terms as used in this chapter are defined as follows:

(A) "Access control" means a system for allowing only approved individuals to have unescorted access to the security zone and for ensuring that all other individuals are subject to escorted access.

(B) "Aggregated" means accessible by the breach of a single physical barrier that would allow access to radioactive material in any form, including any devices that contain the radioactive material, when the total activity equals or exceeds a category two quantity of radioactive material.

(C) "Approved individual" means an individual whom the licensee has determined to be trustworthy and reliable for unescorted access in accordance with rules 3701:1-37-07 to 3701:1-37-13 of the Administrative Code and who has completed the training required by paragraph (C) of rule 3701:1-37-15 of the Administrative Code.

(D) "Background investigation" means the investigation conducted by a licensee or applicant to support the determination of trustworthiness and reliability.

(E) "Carrier" means a person engaged in the transportation of passengers or property by land or water as a common, contract, or private carrier, or by civil aircraft.

(F) "Category one quantity of radioactive material" means a quantity of radioactive material meeting or exceeding the category one threshold in table 1 of appendix A to this rule. This is determined by calculating the ratio of the total activity of each radionuclide to the category one threshold for that radionuclide and adding the ratios together. If the sum is equal to or exceeds one, the quantity would be considered a category one quantity. Category one quantities of radioactive material do not include the radioactive material contained in any fuel assembly, subassembly, fuel rod, or fuel pellet.

(G) "Category two quantity of radioactive material" means a quantity of radioactive material meeting or exceeding the category two threshold but less than the category one threshold in table 1 of appendix A to this rule. This is determined by calculating the ratio of the total activity of each radionuclide to the category two threshold for that radionuclide and adding the ratios together. If the sum is equal to or exceeds one, the quantity would be considered a category two quantity. Category two quantities of radioactive material do not include the radioactive material contained in any fuel assembly, subassembly, fuel rod, or fuel pellet.

(H) "Commission" means the U.S. nuclear regulatory commission or its duly authorized representatives.

(I) "Diversion" means the unauthorized movement of radioactive material subject to this chapter to a location different from the material's authorized destination inside or outside of the site at which the material is used or stored.

(J) "Escorted access" means accompaniment while in a security zone by an approved individual who maintains continuous direct visual surveillance at all times over an individual who is not approved for unescorted access.

(K) "Fingerprint orders" means the orders issued by the U.S. nuclear regulatory commission or the legally binding requirements issued by agreement states that require fingerprints and criminal history records checks for individuals with unescorted access to category one and category two quantities of radioactive material or safeguards information-modified handling.

(L) "Government agency" means any executive department, commission, independent establishment, corporation, wholly or partly owned by the United States of America which is an instrumentality of the United States, or any board, bureau, division, service, office, officer, authority, administration, or other establishment in the executive branch of the government.

(M) "License issuing authority" means the licensing agency that issued the license, i.e. the U.S. nuclear regulatory commission or the appropriate agency of an agreement state.

(N) "Local law enforcement agency" or "LLEA" means a public or private organization that has been approved by a federal, state, or local government to carry firearms and make arrests, and is authorized and has the capability to provide an armed response in the jurisdiction where the licensed category one or category two quantity of radioactive material is used, stored, or transported.

(O) "Mobile device" means a piece of equipment containing licensed radioactive material that is either mounted on wheels or casters, or otherwise equipped for moving without a need for disassembly or dismounting; or designed to be hand carried. Mobile devices do not include stationary equipment installed in a fixed location.

(P) "Movement control center" means an operations center that is remote from transport activity and that maintains position information on the movement of radioactive material, receives reports of attempted attacks or thefts, provides a means for reporting these and other problems to appropriate agencies and can request and coordinate appropriate aid.

(Q) "No-later-than arrival time" means the date and time that the shipping licensee and receiving licensee have established as the time at which an investigation will be initiated if the shipment has not arrived at the receiving facility. The no-later-than-arrival time may not be more than six hours after the estimated arrival time for shipments of category two quantities of radioactive material.

(R) "Reviewing official" means the individual who shall make the trustworthiness and reliability determination of an individual to determine whether the individual may have, or continue to have, unescorted access to the category one or category two quantities of radioactive materials that are possessed by the licensee.

(S) "Sabotage" means deliberate damage, with malevolent intent, to a category one or category two quantity of radioactive material, a device that contains a category one or category two quantity of radioactive material, or the components of the security system.

(T) "Safe haven" means a readily recognizable and readily accessible site at which security is present or from which, in the event of an emergency, the transport crew can notify and wait for the local law enforcement authorities.

(U) "Security zone" means any temporary or permanent area determined and established by the licensee for the physical protection of category one or category two quantities of radioactive material.

(V) "State" means a state of the United States, the District of Columbia, the Commonwealth of Puerto Rico, the Virgin Islands, Guam, American Samoa, and the Commonwealth of the Northern Mariana Islands.

(W) "Telemetric position monitoring system" means a data transfer system that captures information by instrumentation and/or measuring devices about the location and status of a transport vehicle or package between the departure and destination locations.

(X) "Trustworthiness and reliability" are characteristics of an individual considered dependable in judgment, character, and performance, such that unescorted access to category one or category two quantities of radioactive material by that individual does not constitute an unreasonable risk to the public health and safety or security. A determination of trustworthiness and reliability for this purpose is based upon the results from a background investigation.

(Y) "Unescorted access" means solitary access to an aggregated category one or category two quantity of radioactive material or the devices that contain the material.

(Z) "United States", when used in a geographical sense, includes Puerto Rico and all territories and possessions of the United States.

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Last updated November 19, 2025 at 7:33 AM

History

• Effective: May 15, 2023
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-38-01

(A) As used in this chapter and all other rules promulgated pursuant to Chapter 3748. of the Revised Code:

(1) "A₁" means the maximum activity of special form radioactive material permitted in a type A package. These values are listed in rule 3701:1-50-25 of the Administrative Code, or may be derived in accordance with the procedure prescribed in rule 3701:1-50-25 of the Administrative Code.

(2) "A₂" means the maximum activity of radioactive material, other than special form, low specific activity and surface contaminated object material, permitted in a type A package. These values are listed in rule 3701:1-50-25 of the Administrative Code, or may be derived in accordance with the procedure prescribed in rule 3701:1-50-25 of the Administrative Code.

(3) "Absorbed dose" means the energy imparted by ionizing radiation per unit mass of irradiated material. The units of absorbed dose are the gray, or Gy, and the rad.

(4) "Accelerator or charged particle accelerator" means any of a class of radiation generating equipment designed to electronically accelerate atomic or sub-atomic particles for subsequent bombardment of targets.

(5) "Accelerator-produced radioactive material" means any material made radioactive by a particle accelerator.

(6) "Activity" means the rate of disintegration or transformation or decay of radioactive material. The units of activity are the becquerel, or Bq, and the curie, or Ci.

(7) "Address of use" means the building or buildings that are identified on the license or registration and where the source of radiation may be received, used, prepared, or stored, except for temporary job sites.

(8) "Administrative controls" means mechanisms used to protect health and minimize damage to life and property through the use of written policies, procedures, instructions, training, observation of work practices, and related compliance audits.

(9) "Administrative monetary penalty" means a monetary penalty assessed by the director under section 3748.05 of the Revised Code and in compliance with rules adopted thereunder, to emphasize the need for lasting remedial action and to deter future violations.

(10) "Adult" means an individual eighteen or more years of age.

(11) "Agreement state" means any state with which the United States nuclear regulatory commission or the atomic energy commission has entered into an effective agreement under subsection 274B of the Atomic Energy Act of 1954, 68 Stat. 919, 42 U.S.C. 2021, as amended (1978). Non-agreement state means any other state.

(12) "Airborne radioactive material" means radioactive material dispersed in the air in the form of dusts, fumes, particulates, mists, vapors, or gases.

(13) "Airborne radioactivity area" means a room, enclosure, or area in which airborne radioactive materials, composed wholly or partly of licensed material, exist in concentrations:

(a) In excess of the derived air concentrations (DACs) specified in appendix C to rule 3701:1-38-12 of the Administrative Code, or

(b) To such a degree that an individual present in the area without respiratory protective equipment could exceed, during the hours an individual is present in a week, an intake of 0.6 per cent of the annual limit on intake or twelve DAC-hours.

(14) "Air-purifying respirator" means a respirator with an air-purifying filter, cartridge, or canister that removes specific air contaminants by passing ambient air through the air-purifying element.

(15) "ALARA" or "as low as is reasonably achievable" means every reasonable effort to maintain exposures to radiation as far below the dose limits as is practical consistent with the purpose for which the licensed or registered activity is undertaken, taking into account the state of technology, the economics of improvements in relation to benefits to the public health and safety, and other societal and socioeconomic considerations, and in relation to utilization of nuclear energy and licensed materials and registered activities in the public interest.

(16) "Alert" means events may occur, are in progress, or have occurred that could lead to a release of radioactive material but that the release is not expected to require a response by off-site response organizations to protect persons off-site.

(17) "Annual limit on intake" or "ALI" means the derived limit for the amount of radioactive material taken into the body of an adult worker by inhalation or ingestion in a year. ALI is the smaller value of intake of a given radionuclide in a year by the reference man that would result in a committed effective dose equivalent of 0.05 sievert (five rem) or a committed dose equivalent of 0.5 sievert (fifty rem) to any individual organ or tissue. ALI values for intake by ingestion and by inhalation of selected radionuclides are given in appendix C to rule 3701:1-38-12 of the Administrative Code.

(18) "Annually" means either

(a) At intervals not to exceed one year; or

(b) Once per year, at about the same time each year, plus or minus one month.

(19) "Area of use" means a portion of an address of use that has been set aside for the purpose of receiving, preparing, using, or storing sources of radiation.

(20) "Assigned protection factor" or "APF" means the expected workplace level of respiratory protection that would be provided by a properly functioning respirator or a class of respirators to properly fitted and trained users. Operationally, the inhaled concentration can be estimated by dividing the ambient airborne concentration by the APF.

(21) "Atmosphere-supplying respirator" means a respirator that supplies the respirator user with breathing air from a source independent of the ambient atmosphere, and includes supplied air respirators, or SARs, and self-contained breathing apparatus, or SCBA, units.

(22) "Atomic energy commission" or "AEC" means the federal agency created by the Atomic Energy Act of 1954, 68 Stat. 919, 42 U.S.C. 2011, as amended (1964), and was the predecessor agency to the current United States nuclear regulatory commission.

(23) "Background radiation" means radiation from cosmic sources; naturally occurring radioactive materials, including radon, except as a decay product of source or special nuclear material, and global fallout as it exists in the environment from the testing of nuclear explosive devices or from past nuclear accidents such as Chernobyl that contribute to background radiation and are not under the control of the licensee. "Background radiation" does not include radiation from radioactive materials regulated by the department.

(24) "Becquerel" or "Bq" means the SI unit of activity. One becquerel is equal to one disintegration per second.

(25) "Bioassay" or "radiobioassay" means the determination of kinds, quantities or concentrations, and, in some cases, the locations of radioactive material in the human body, whether by direct measurement, in vivo counting, or by analysis and evaluation of materials excreted or removed from the human body.

(26) "Byproduct material" means

(a) Any radioactive material, except special nuclear material, yielded in or made radioactive by exposure to the radiation incident to the process of producing or utilizing special nuclear materials; or

(b) The tailings or wastes produced by the extraction or concentration of uranium or thorium from any ore processed primarily for its source material content, including discrete surface wastes resulting from solution extraction processes. Underground ore bodies depleted by such solution extraction do not constitute byproduct material within the definition.

(27) "Chelating agent" means a chemical compound or mixture that enhances the removal of radioactive material from the body, water or similar applications. Typical chelating agents include amine polycarboxylic acids such as EDTA or DTPA; hydroxy-carboxylic acids; and polycarboxylic acids such as citric acid, carbolic acid, and gluconic acid.

(28) "Chiropractor" means an individual licensed by the state of Ohio to practice chiropractic medicine pursuant to Chapter 4734. of the Revised Code.

(29) "Class" or "lung class" or "inhalation class" means a classification scheme for inhaled material according to its rate of clearance from the pulmonary region of the lung. Materials are classified as D, W, or Y, which applies to a range of clearance half-times: for class D, days, of less than ten days, for class W, weeks, from ten to one hundred days, and for class Y, years, of greater than one hundred days.

(30) "Collective dose" means the sum of the individual doses received in a given period of time by a specified population from exposure to a specified source of radiation.

(31) "Commencement of construction" means taking any action defined as "construction" or any other activity at the site of a facility subject to the rules promulgated pursuant to Chapter 3748. of the Revised Code that has a reasonable nexus to radiological health and safety.

(32) "Committed dose equivalent" or "H_T,50" means the dose equivalent to organs or tissues of reference, T, that will be received from an intake of radioactive material by an individual during the fifty year period following the intake.

(33) "Committed effective dose equivalent" or "H_E,50" means the sum of the products of the weighting factors applicable to each of the body organs or tissues, W_T, that are irradiated and the committed dose equivalent to each of these organs or tissues (H_{E, 50} = W_TH_T,50).

(34) "Consortium" means an association of medical use licensees and a PET radionuclide production facility in the same geographical area that jointly own or share in the operation and maintenance cost of the PET radionuclide production facility that produces PET radionuclides for use in producing radioactive drugs within the consortium for noncommercial distributions among its associated members for medical use. The PET radionuclide production facility within the consortium must be located at an educational institution or a medical facility.

(35) "Constraint" or "dose constraint" means a value above which specified licensee actions are required.

(36) "Construction" means the installation of foundations, or in-place assembly, erection, fabrication, or testing for any structure, system, or component of a facility or activity subject to the rules promulgated pursuant to Chapter 3748. of the Revised Code that are related to radiological safety or security. The term "construction" does not include:

(a) Changes for temporary use of the land for public recreational purposes;

(b) Site exploration, including necessary borings to determine foundation conditions or other preconstruction monitoring to establish background information related to the suitability of the site, the environmental impacts of construction or operation, or the protection of environmental values;

(c) Preparation of the site for construction of the facility, including clearing of the site, grading, installation of drainage, erosion and other environmental mitigation measures, and construction of temporary roads and borrow areas;

(d) Erection of fences and other access control measures that are not related to the safe use of, or security of, radiological materials subject to the rules promulgated pursuant to Chapter 3748. of the Revised Code;

(e) Excavation;

(f) Erection of support buildings (e.g. construction equipment storage sheds, warehouse and shop facilities, utilities, concrete mixing plants, docking and unloading facilities, and office buildings) for use in connection with the construction of the facility;

(g) Building of service facilities (e.g. paved roads, parking lots, railroad spurs, exterior utility and lighting systems, potable water systems, sanitary sewerage treatment facilities, and transmission lines);

(h) Procurement or fabrication of components or portions of the proposed facility occurring at other than the final, in-place location at the facility; or

(i) Taking any other action that has no reasonable nexus to radiological health and safety.

(37) "Controlled area" means an area, outside of a restricted area but inside the site boundary, access to which can be limited by the licensee or registrant for any reason.

(38) "Critical group" means the group of individuals reasonably expected to receive the greatest exposure to residual radioactivity for any applicable set of circumstances.

(39) "Curie" or "Ci" means a unit of activity. One curie equals 3.7 x 10¹⁰ disintegrations per second equals 3.7 x 10¹⁰ becquerels equals 2.22 x 10¹² disintegrations per minute.

(40) "Cyclotron" means a particle accelerator in which the charged particles travel in an outward spiral or circular path. A cyclotron accelerates charged particles at energies usually in excess of ten megaelectron volts and is commonly used for production of short half-life radionuclides for medical use.

(41) "Declared pregnant woman" means a woman who has voluntarily informed the licensee or registrant, in writing, of her pregnancy and the estimated date of conception. The declaration remains in effect until the declared pregnant woman withdraws the declaration in writing or is no longer pregnant.

(42) "Decommission" means to safely remove any licensed operation from service and reduce residual radioactivity to a level that permits release of the licensee's property for unrestricted use and termination of the license.

(43) "Dedicated check source" means a radioactive source that is used to assure the consistent performance of a radiation detection or measurement device over several months or years.

(44) "Deep dose equivalent" or "H_d" applies to external whole body exposure, and means the dose equivalent at a tissue depth of one centimeter, one thousand milligram per square centimeter.

(45) "Demand respirator" means an atmosphere-supplying respirator that admits breathing air to the facepiece only when a negative pressure is created inside the facepiece by inhalation.

(46) "Dentist" means an individual licensed by the state of Ohio to practice dentistry under Chapter 4715. of the Revised Code.

(47) "Department" means the Ohio department of health.

(48) "Depleted uranium" means uranium containing less uranium-235 than the naturally occurring distribution of uranium isotopes.

(49) "Derived air concentration" or "DAC" means the concentration of a given radionuclide in air which, if breathed by the reference man for a working year of two thousand hours under conditions of light work, results in an intake of one ALI. The condition of light work is inhaling 1.2 cubic meters of air per hour for two thousand hours in a year. DAC values are given in appendix C to rule 3701:1-38-12 of the Administrative Code.

(50) "Derived air concentration-hour or DAC-hour" means the product of the concentration of radioactive material in air, which is expressed as a fraction or multiple of the derived air concentration for each radionuclide, and the time of exposure to that radionuclide, in hours. A licensee or registrant may take two thousand DAC-hours to represent one ALI, equivalent to a committed effective dose equivalent of 0.05 Sv (five rem).

(51) "Direct reading dosimeter" means a device that measures radiation dose that does not require another device to read the measured radiation dose. Examples of direct reading dosimeters include pocket dosimeters and electronic dosimeters.

(52) "Director" means the director of health or a designee or authorized representative of the director.

(53) "Discipline" means a branch of knowledge or of teaching.

(54) "Discrete source" means a radionuclide that has been processed so that its concentration within a material has been purposely increased for use for commercial, medical, or research activities.

(55) "Disposable respirator" means a respirator for which maintenance is not intended and that is designed to be discarded after excessive breathing resistance, sorbent exhaustion, physical damage, or end-of service-life renders it unsuitable for use. Examples of this type of respirator are a disposable half-mask respirator or a disposable escape-only self-contained breathing apparatus.

(56) "Dose" or "radiation dose" is a generic term that means absorbed dose, dose equivalent, effective dose equivalent, committed effective dose equivalent, or total effective dose equivalent as defined in other paragraphs of this rule.

(57) "Dose equivalent" or "H_T" means the product of the absorbed dose in tissue, quality factor, and all other necessary modifying factors at the location of interest. The units of dose equivalent are the sievert and rem.

(58) "Dose limits" or "limits" means the permissible upper bounds of radiation doses established in accordance with these regulations but excludes background radiation and medical exposure.

(59) "Dosimetry processor" means a person that processes and evaluates individual monitoring devices in order to determine the radiation dose delivered to the monitoring devices.

(60) "Effective dose equivalent" or "H_E" means the sum of the products of the dose equivalent to each organ or tissue, H_T, and the weighting factor, W_T, applicable to each of the body organs or tissues that are irradiated: (H_E = ∑W_TH_T).

(61) "Embryo" or "fetus" means the developing human organism from conception until time of birth.

(62) "Engineering controls" means mechanisms used to protect health and minimize damage to life and property through engineering specifications, design, and construction of the product or facility including all of the security and safety features. This includes, but is not limited to, auxiliary security and safety features such as additional external shielding, barriers, and operational interlocks with associated processes.

(63) "Entrance" or "access point" means any opening through which an individual or extremity of an individual could gain access to radiation areas or to licensed radioactive materials or registered radiation generating equipment. This includes entry or exit portals of sufficient size to permit human entry, irrespective of their intended use.

(64) "Explosive material" means any chemical compound, mixture or device which produces a substantial instantaneous release of gas and heat spontaneously or by contact with sparks or flame.

(65) "Exposure" means being exposed to sources of ionizing radiation.

(66) "External dose" means that portion of the dose equivalent received from radiation sources outside the body.

(67) "Extremity" means hand, elbow, arm below the elbow, foot, knee, or leg below the knee.

(68) "Eye dose equivalent" means the same as lens dose equivalent.

(69) "Facility" means all buildings, equipment, structures and other stationary items that, in addition to the meaning defined in division (H) of section 3748.01 of the Revised Code, are:

(a) Located on a single site or on contiguous or adjacent sites and are operated by the same person and have common corporate or business interests; or

(b) Portions of a building or structure which are operated by the same person and have common corporate or business interests.

(70) "Filtering facepiece" or "dust mask" means a negative pressure particulate respirator with a filter as an integral part of the facepiece or with the entire facepiece composed of the filtering medium, not equipped with elastomeric sealing surfaces and adjustable straps.

(71) "Fissile material" means the radionuclides uranium-233, uranium-235, plutonium-239, and plutonium-241, or any combination of these radionuclides. Fissile material means the fissile nuclides themselves, not material containing fissile nuclides. Unirradiated natural uranium and depleted uranium and natural uranium or depleted uranium that has been irradiated in thermal reactors only, are not included in this definition. Certain exclusions from fissile material controls are provided in rule 3701:1-50-13 of the Administrative Code.

(72) "Fit factor" means quantitative estimate of the fit of a particular respirator to a specific individual, and typically estimates the ratio of the concentration of a substance in ambient air to its concentration inside the respirator when worn.

(73) "Fit test" means the use of a protocol to qualitatively or quantitatively evaluate the fit of a respirator on an individual.

(74) "Generally applicable environmental radiation standards" means standards issued by the United States environmental protection agency under the authority of the Atomic Energy Act of 1954, 68 Stat. 919, 42 U.S.C. 2011, as amended (2005), that impose limits on radiation exposures or levels, or concentrations or quantities of radioactive material, in the general environment outside the boundaries of locations under the control of persons possessing or using radioactive material.

(75) "Gray" or "Gy" means the SI unit of absorbed dose. One gray is equal to an absorbed dose of one joule per kilogram (one hundred rads).

(76) "Handle" means receive, possess, use, store, transfer, install, service, or dispose of sources of radiation unless possession is solely for the purpose of transportation.

(77) "Handler" means a facility that handles sources of radiation unless possession is solely for the purpose of transportation.

(78) "Hazardous waste" means those wastes designated as hazardous by rule 3745-51-03 of the Administrative Code.

(79) "Helmet" means a rigid respiratory inlet covering that also provides head protection against impact and penetration.

(80) "High radiation area" means an area, accessible to individuals, in which radiation levels from radiation sources external to the body could result in an individual receiving a dose equivalent in excess of one millisievert (0.1 rem) in one hour at thirty centimeters from the radiation source or thirty centimeters from any surface that the radiation penetrates.

(81) "Hood" means a respiratory inlet covering that completely covers the head and neck and may also cover portions of the shoulders and torso.

(82) "Individual" means any human being.

(83) "Individual monitoring" means

(a) The assessment of dose equivalent by the use of devices designed to be worn by an individual;

(b) The assessment of committed effective dose equivalent by bioassay or by determination of the time-weighted air concentrations to which an individual has been exposed, i.e. DAC-hours; or

(c) The assessment of dose equivalent by the use of survey data.

(84) "Individual monitoring devices" means devices designed to be worn by a single individual for the assessment of dose equivalent such as film badges; thermoluminescent dosimeters; optically stimulated luminescent dosimeters; pocket ionization chambers; and personal air sampling devices.

(85) "Industrial radiography" means the examination of the structure of materials by nondestructive methods, utilizing sealed sources of radioactive material or radiation-generating equipment.

(86) "Internal dose" means that portion of the dose equivalent received from radioactive material taken into the body.

(87) "Irradiator" means a facility that uses radioactive sealed sources for the irradiation of objects or materials and in which radiation dose rates exceeding five grays (five hundred rads) per hour exist at one meter from the sealed radioactive source in air or water, as applicable for the irradiator type, but does not include irradiators in which both the sealed source and the area subject to irradiation are contained within a device and are not accessible to personnel.

(88) "Lens dose equivalent" or "eye dose equivalent" means the external exposure of the lens of the eye and is taken as the dose equivalent at a tissue depth of 0.3 centimeters; i.e. three hundred milligrams per square centimeter.

(89) "License" means a license issued by the nuclear regulatory commission, the director, or another agreement state in accordance with rules adopted by those organizations.

(90) "Licensee" means a person to whom a license is issued.

(91) "Licensed activity" means an activity authorized by a radioactive material license which is essential to achieving the purpose for which the license was issued or amended.

(92) "Licensed material" means radioactive material received, possessed, used, transferred or disposed of under a general or specific license.

(93) "Loose-fitting facepiece" means a respiratory inlet covering that is designed to form a partial seal with the face.

(94) "Lost or missing licensed source of radiation" means a licensed source of radiation whose location is unknown. It includes material that has been shipped but has not reached its destination and whose location cannot be readily traced in the transportation system.

(95) "Low-level radioactive waste" or "LLRW," also "low-level waste," or "LLW" means radioactive waste which is not high-level radioactive waste, spent nuclear fuel, NARM, or byproduct material as defined in section 11 E. (2) of the Atomic Energy Act of 1954 68 Stat. 919, 42 U.S.C. 2011, as amended (2005), but is radioactive material that the United States nuclear regulatory commission classifies as low-level radioactive waste.

(96) "Low specific activity material" or "LSA" means radioactive material with limited specific activity which is nonfissile or is excepted under rule 3701:1-50-13 of the Administrative Code, and which satisfies the descriptions and limits set forth below. Shielding materials surrounding the LSA material may not be considered in determining the estimated average specific activity of the package contents. LSA must be in one of three groups:

(a) LSA - I.

(i) Uranium and thorium ores, concentrates of uranium and thorium ores, and other ores containing naturally occurring radioactive radionuclides that are intended to be processed for the use of these radionuclides;

(ii) Natural uranium, depleted uranium, natural thorium or their compounds or mixtures, provided they are unirradiated and in solid or liquid form;

(iii) Radioactive material other than fissile material, for which the A₂ value is unlimited; or

(iv) Other radioactive material in which the activity is distributed throughout and the estimated average specific activity does not exceed thirty times the value for exempt material activity concentration determined in accordance with rule 3701:1-50-25 of the Administrative Code.

(b) LSA-II.

(i) Water with tritium concentration up to 0.8 terabecquerels per liter (twenty curies per liter); or

(ii) Other material in which the activity is distributed throughout and the estimated average specific activity does not exceed ( 10^-4 A₂) per gram for solids and gases, and (10^-5 A₂) per gram for liquids.

(c) LSA-III. Solids (e.g., consolidated wastes, activated materials), excluding powders, that satisfy the requirements of 10 C.F.R. 71.77 (as in effect on the effective date of this rule), in which:

(i) The radioactive material is distributed throughout a solid or a collection of solid objects, or is essentially uniformly distributed in a solid compact binding agent (such as concrete, bitumen, ceramic, etc.);

(ii) The radioactive material is relatively insoluble, or it is intrinsically contained in a relatively insoluble material, so that even under loss of packaging, the loss of radioactive material per package by leaching, when placed in water for seven days, would not exceed (0.1 x A₂); and

(iii) The estimated average specific activity of the solid, excluding any shielding material, does not exceed (0.002 x A₂) per gram.

(97) "Management" means the chief executive officer or other individual having the authority to manage, direct, or administer the licensee's activities, or those persons' delegate or delegates.

(98) "Medical institution" means an organization in which more than one medical discipline is practiced.

(99) "Medical use" means the intentional internal or external administration of radioactive material or the radiation therefrom to patients or human research subjects under the supervision of an authorized user.

(100) "Member of the public" means any individual except when that individual is receiving an occupational dose.

(101) "Minor" means an individual less than eighteen years of age.

(102) "Monitoring" or "radiation monitoring" or "radiation protection monitoring" means the measurement of radiation levels, concentrations, surface area concentrations or quantities of radioactive material and the use of the results of these measurements to evaluate potential exposures and doses.

(103) "NARM" or "naturally occurring or accelerator-produced radioactive material" means naturally occurring or accelerator-produced radioactive material, including naturally occurring material that is technologically enhanced, and those nuclides that are generated in a charged particle accelerator, but does not include source material, byproduct material, or special nuclear material.

(104) "NARM licensing state" means any state with regulations equivalent to the suggested state regulations for control of radiation relating to, and an effective program for, the regulatory control of NARM and which has been granted final designation by the conference of radiation control program directors, inc.

(105) "Nationally tracked source" means a sealed source containing a quantity equal to or greater than "Category 1" or "Category 2" levels of any radioactive material listed in the appendix to rule 3701:1-38-25 of the Administrative Code. In this context a sealed source is defined as radioactive material that is sealed in a capsule or closely bonded, in a solid form and which is not exempt from regulatory control. It does not mean material encapsulated solely for disposal, or nuclear material contained in any fuel assembly, subassembly, fuel rod, or fuel pellet. "Category 1" nationally tracked sources are those containing radioactive material at a quantity equal to or greater than the "Category 1" threshold. "Category 2" nationally tracked sources are those containing radioactive material at a quantity equal to or greater than the "Category 2" threshold but less than the "Category 1" threshold.

(106) "Negative pressure respirator" or "tight fitting respirator" means a respirator in which the air pressure inside the facepiece is negative during inhalation with respect to the ambient air pressure outside the respirator.

(107) "Nonstochastic effect" or "deterministic effect" means health effects, the severity of which varies with the dose and for which a threshold is believed to exist. Radiation-induced cataract formation is an example of a nonstochastic effect.

(108) "NORM" or "naturally occurring radioactive material" means any nuclide that is radioactive in its natural physical state, but does not include source material, byproduct material, or special nuclear material.

(109) "Normal form radioactive material" means radioactive material that has not been demonstrated to qualify as special form radioactive material.

(110) "Nuclear regulatory commission" means the federal agency established by Title II of the Energy Reorganization Act of 1974, 88 Stat. 1233, 42 U.S.C.A. 5801, as amended (2005), comprising the members of the commission and all offices, employees, and representatives authorized to act in any case or matter related to licensing and related regulatory function previously assigned to the AEC.

(111) "Occupational dose" means the dose received by an individual in the course of employment in which the individual's assigned duties involve exposure to radiation or radioactive material from licensed and unlicensed sources of radiation, whether in the possession of the licensee or other person. Occupational dose does not include doses received from background radiation, from any medical administration the individual has received, from exposures to individuals administered radioactive materials and released in accordance with rule 3701:1-58-30 of the Administrative Code or equivalent United States nuclear regulatory commission or agreement state regulations, from voluntary participation in medical research programs, or as a member of the public.

(112) "Package" means the packaging together with its radioactive contents as presented for transport.

(a) Fissile material package or type AF package, type BF package, type B(U)F package, or type B(M)F package means a fissile material packaging together with its fissile material contents.

(b) Type A package means a type A packaging together with its radioactive contents. A type A package is defined and must comply with the United States department of transportation regulations in 49 C.F.R. 173 (as in effect on the effective date of this rule).

(c) Type B package means a type B packaging together with its radioactive contents. On approval, a type B package design is designated by the United States nuclear regulatory commission as B(U) unless the package has a maximum normal operating pressure of more than seven hundred kilopascals (one hundred pounds per square inch) gauge or a pressure relief device that would allow the release of radioactive material to the environment under the tests specified in 10 C.F.R. 71.73 (hypothetical accident conditions) (as in effect on the effective date of this rule), in which case it will receive a designation B(M). B(U) refers to the need for unilateral approval of international shipments; B(M) refers to the need for multilateral approval of international shipments. There is no distinction made in how packages with these designations may be used in domestic transportation. To determine their distinction for international transportation, see United States department of transportation regulations in 49 C.F.R. 173 (as in effect on the effective date of this rule). A type B package approved before September 6, 1983, was designated only as type B. Limitations on its use are specified in 10 C.F.R. 71.19 (as in effect on the effective date of this rule).

(113) "Packaging" means the assembly of components necessary to ensure compliance with the packaging requirements of rule 49 C.F.R. 173 Subpart I (as in effect on the effective date of this rule). It may consist of one or more receptacles, absorbent materials, spacing structures, thermal insulation, radiation shielding, and devices for cooling or absorbing mechanical shocks. The vehicle, tie-down system and auxiliary equipment may be designated as part of the packaging.

(114) "Particle accelerator" means any machine capable of accelerating electrons, protons, deuterons, or other charged particles in a vacuum and of discharging the resultant particulate or other radiation into a medium at energies usually in excess of one megaelectron volt. For purposes of this definition, "accelerator" is an equivalent term.

(115) "Person" means any individual, corporation, association, business enterprise, or other legal entity either public or private and any legal successor, representative, agent, or agency of that individual, corporation, association, business enterprise, or other legal entity. Person also includes the United States, states, political subdivisions of states, and any department, agency, or instrumentality of the United States or a state, except the U.S. department of energy or the U.S. nuclear regulatory commission where the state regulation of radioactive material by either of those agencies is prohibited by federal law.

(116) "Personnel dosimeter", means a device that measures radiation dose that is processed and evaluated by an accredited "National Voluntary Laboratory Accreditation Program" (NVLAP) processor. Examples of personnel dosimeters include film badges, thermo-luminescent dosimeters (TLD), and optically stimulated luminescence (OSL) dosimeters.

(117) "Pharmacist" means a person who is licensed by the state of Ohio to practice pharmacy pursuant to Chapter 4731. of the Revised Code.

(118) "Physician" means a person who is licensed pursuant to Chapter 4731. of the Revised Code to practice medicine or surgery or osteopathic medicine or surgery.

(119) "Planned special exposure" means an infrequent exposure to radiation, separate from and in addition to the annual dose limits.

(120) "Podiatrist" means an individual licensed by the state of Ohio to practice podiatry pursuant to Chapter 4731. of the Revised Code.

(121) "Positive pressure respirator" means a respirator in which the pressure inside the respiratory inlet covering exceeds the ambient air pressure outside the respirator.

(122) "Positron Emission Tomography (PET) radionuclide production facility" means a facility operating a cyclotron or accelerator for the purpose of producing PET radionuclides.

(123) "Powered air-purifying respirator" or "PAPR" means an air-purifying respirator that uses a blower to force the ambient air through air purifying elements to the inlet covering.

(124) "Pressure demand respirator" means a positive pressure atmosphere supplying respirator that admits breathing air to the facepiece when the positive pressure is reduced inside the facepiece by inhalation.

(125) "Public dose" means the dose received by a member of the public from exposure to radiation and/or radioactive material released by the licensee, or to any other source of radiation under the control of a licensee or registrant. Public dose does not include occupational dose or doses received from background radiation, from any medical administration the individual has received, from exposures to individuals administered radioactive materials and released in accordance with rule 3701:1-58-30 of the Administrative Code or equivalent United States nuclear regulatory commission or agreement state regulations, or from voluntary participation in medical research programs.

(126) "Pyrophoric material" means any liquid that ignites spontaneously in dry or moist air at or below 54.4 degrees celsius (one hundred thirty degrees fahrenheit). A pyrophoric solid is any solid material, other than one classed as an explosive, which under normal conditions is liable to cause fires through friction, retained heat from manufacturing or processing, or which can be ignited readily and when ignited burns so vigorously and persistently as to create a serious transportation, handling, or disposal hazard. Included are spontaneously combustible and water-reactive materials.

(127) "Qualitative fit test" or "QLFT" means a pass/fail fit test to assess the adequacy of respirator fit that relies on the individual's response to the test agent.

(128) "Quality factor" or "Q" means the modifying factor, as listed in paragraphs (A) and (B) of rule 3701:1-38-11 of the Administrative Code, that is used to derive dose equivalent from absorbed dose.

(129) "Quantitative fit test" or "QNFT" means an assessment of the adequacy of respirator fit by numerically measuring the amount of leakage into the respirator.

(130) "Quarter" or "quarterly" means a period of time equal to one-fourth of the year observed by the licensee or registrant, approximately thirteen consecutive weeks, providing that the beginning of the first quarter in a year coincides with the starting date of the year and that no day is omitted or duplicated in consecutive quarters.

(131) "Rad" means the special unit of radiation absorbed dose. One rad is equal to an absorbed dose of one hundred ergs per gram, or 0.01 joule per kilogram, or 0.01 gray.

(132) "Radiation" or "ionizing radiation" means alpha particles, beta particles, gamma rays, x-rays, neutrons, high speed electrons, high speed protons, and other particles capable of producing ions. Radiation does not include nonionizing radiation, such as radio or microwaves, or visible, infrared or ultraviolet light.

(133) "Radiation area" means an area, accessible to individuals, in which radiation levels could result in an individual receiving a dose equivalent in excess of 0.05 millisievert (0.005 rem) in one hour at thirty centimeters from the source of radiation or from any surface that the radiation penetrates.

(134) "Radiation-generating equipment" or "RGE" means any manufactured product or device, or component of such a product or device, or any machine or system that during operation can generate or emit radiation, except those that emit radiation only from radioactive material. "Radiation-generating equipment" does not include either of the following:

(a) Diathermy machines;

(b) Microwave ovens, including food service microwave ovens used for commercial and industrial uses, television receivers, electric lamps, and other household appliances and products that generate very low levels of radiation.

(135) "Radiation Safety Officer" or "RSO" means an individual designated by the licensee who has the knowledge and responsibility for the overall radiation safety program at the facility, to include the implementation of the daily radiation safety operations and compliance with the rules.

(136) "Radioactive material" means any solid, liquid or gaseous material that emits ionizing radiation spontaneously. "Radioactive material" includes accelerator-produced and naturally occurring radioactive materials and byproduct, source, and special nuclear material.

(137) "Radioactive waste" means waste containing regulated radioactive material.

(138) "Radioactivity" means the transformation of unstable atoms by the emission of radiation.

(139) "Radiography" means the same as industrial radiography.

(140) "Reference man" means a hypothetical aggregation of human physical and physiological characteristics arrived at by international consensus. These characteristics may be used by researchers and public health workers to standardize results of experiments and to relate biological insult to a common base.

(141) "Registrant" means a person required by Chapter 3748. of the Revised Code to register radiation-generating equipment with the director.

(142) "Rem" means the special unit of any of the quantities expressed as dose equivalent. The dose equivalent in rem is equal to the absorbed dose in rads multiplied by the quality factor (one rem = 0.01 Sv).

(143) "Research and development" means

(a) Theoretical analysis, exploration, or experimentation; or

(b) The extension of investigative findings and theories of a scientific or technical nature into practical application for experimental and demonstration purposes, including the experimental production and testing of models, devices, equipment, materials and processes. "Research and development" does not include the internal or external administration of sources of radiation to human beings.

(144) "Residual radioactivity" means radioactivity in structures, materials, soils, groundwater, and other media at a site resulting from activities under the licensee's control. This includes radioactivity from all licensed and unlicensed sources used by the licensee, but excludes background radiation. It also includes radioactive materials remaining at the site as a result of routine or accidental releases of radioactive material at the site and previous burials at the site, even if those burials were made in accordance with the provisions of 10 C.F.R. 20 (as in effect on the effective date of this rule).

(145) "Respiratory protective equipment or device" means an apparatus, such as a respirator, used to reduce the individual's intake of airborne radioactive materials.

(146) "Restricted area" means an area access to which is limited by the licensee or registrant for the purpose of protecting individuals against undue risks from exposure to sources of radiation. Restricted area does not include areas used as residential quarters, but separate rooms in a residential building may be set apart as a restricted area.

(147) "Roentgen" means the amount of gamma or x-rays required to produce ions resulting in a charge of 0.000258 coulombs per kilogram of air under standard conditions.

(148) "Sanitary sewerage" means a system of public sewers for carrying off wastewater and refuse, but excluding sewage treatment facilities, septic tanks, and leach fields owned or operated by the licensee.

(149) "Sealed source" means radioactive material that is encased in a manner designed to prevent leakage or escape of the radioactive material.

(150) "Sealed source and device registry" means the national registry that contains all the registration certificates, generated by both the United States nuclear regulatory commission and the agreement states, that summarize the radiation safety information for the sealed sources and devices and describe the licensing and use conditions approved for the product.

(151) "Seismic area" means any area where the probability of a horizontal acceleration in rock of more than 0.3 times the acceleration of gravity in two hundred fifty years is greater than ten per cent, as designated by the United States geological survey.

(152) "Self-contained breathing apparatus" or "SCBA" means an atmosphere-supplying respirator for which the breathing air source is designed to be carried by the user.

(153) "Shallow dose equivalent" or "H_S" means the external exposure of the skin of the whole body or the skin of an extremity, is taken as the dose equivalent at a tissue depth of 0.007 centimeter, or seven milligrams per square centimeter.

(154) "Sievert" or "Sv" means the SI unit of any of the quantities expressed as dose equivalent. The dose equivalent in sieverts is equal to the absorbed dose in grays multiplied by the quality factor. One sievert equals one hundred rem.

(155) "Site area emergency" means events may occur, are in progress, or have occurred that could lead to a significant release of radioactive material and that could require a response by off-site response organizations to protect persons off-site.

(156) "Site boundary" means that line beyond which the land or property is not owned, leased, or otherwise controlled by the licensee or registrant.

(157) "Site closure and stabilization" means those actions that are taken upon completion of operations that prepare a disposal site for custodial care and that assure that the disposal site will remain stable and will not need ongoing active maintenance.

(158) "Source material" means uranium, thorium, or any combination thereof in any physical or chemical form, or any ores that contain by weight at least one-twentieth of one per cent (0.05 per cent) of uranium, thorium, or any combination thereof. Source material does not include special nuclear material.

(159) "Sources of radiation" means radioactive material or radiation generating equipment.

(160) "Special form radioactive material" means radioactive material that satisfies the following conditions:

(a) It is either a single solid piece or is contained in a sealed capsule that can be opened only by destroying the capsule;

(b) The piece or capsule has at least one dimension not less than five millimeters (0.2 inch); and

(c) It satisfies the test requirements specified by the United States nuclear regulatory commission in 10 C.F.R. 71.75 (as in effect on the effective date of this rule). A special form encapsulation designed in accordance with the United States nuclear regulatory commission requirements identified in 10 C.F.R. 71.4, in effect on June 30, 1983, and constructed prior to July 1, 1985; a special form encapsulation designed in accordance with the requirements of 10 C.F.R. 71.4 in effect on March 31, 1996, and constructed before April 1, 1998; and special form material that was successfully tested before September 10, 2015 in accordance with the requirements of 10 C.F.R. 71.75(d) of this section in effect before September 10, 2015 may continue to be used. Any other special form encapsulation must meet the specifications of this definition.

(161) "Special nuclear material" means either of the following:

(a) Plutonium, uranium-233, uranium enriched in the isotope 233, or in the isotope 235, and any other material that the United States nuclear regulatory commission determines to be special nuclear material, but does not include source material pursuant to section 51 of the Atomic Energy Act of 1954, 68 Stat 919, 42 USCA 2071, as amended (2005).

(b) Any material artificially enriched by any of the foregoing but does not include source material.

(162) "Special nuclear material in quantities not sufficient to form a critical mass" means uranium enriched in the isotope uranium-235 in quantities not exceeding three hundred fifty grams of contained uranium-235; uranium-233 in quantities not exceeding two hundred grams; plutonium in quantities not exceeding two hundred grams; or any combination of them in accordance with the following formula: for each kind of special nuclear material, determine the ratio between the quantity of that special nuclear material and the quantity specified in this paragraph for the same kind of special nuclear material. The sum of such ratios for all of the kinds of special nuclear material in combination shall not exceed unity.

(163) "Stochastic effect" means health effects that occur randomly and for which the probability of the effect occurring, rather than its severity, is assumed to be a linear function of dose without threshold. Hereditary effects and cancer incidence are examples of stochastic effects.

(164) "Supplied-air respirator" or "SAR" or "airline respirator" means an atmosphere-supplying respirator for which the source of breathing air is not designed to be carried by the user.

(165) "Surface contaminated object" or "SCO" means a solid object that is not itself classed as radioactive material, but which has radioactive material distributed on any of its surfaces. SCO must be in one of two groups with surface activity not exceeding the following limits:

(a) SCO-I: a solid object on which:

(i) The non-fixed contamination on the accessible surface averaged over three hundred square centimeters, or the area of the surface if less than three hundred square centimeters, does not exceed four becquerels per square centimeter (10^-4 microcurie per square centimeter) for beta and gamma and low toxicity alpha emitters, or 0.4 becquerels per square centimeter 10^-5 microcurie per square centimeter) for all other alpha emitters;

(ii) The fixed contamination on the accessible surface averaged over three hundred square centimeters, or the area of the surface if less than three hundred square centimeters, does not exceed forty thousand becquerels per square centimeter (one microcurie per square centimeter) for beta and gamma and low toxicity alpha emitters, or four thousand becquerels per square centimeter (0.1 microcurie per square centimeter) for all other alpha emitters; and

(iii) The non-fixed contamination plus the fixed contamination on the inaccessible surface averaged over three hundred square centimeters, or the area of the surface if less than three hundred square centimeters, does not exceed forty thousand becquerels per square centimeter (one microcurie per square centimeter) for beta and gamma and low toxicity alpha emitters, or four thousand becquerels per square centimeter (0.1 microcurie per square centimeter) for all other alpha emitters.

(b) SCO-II: a solid object on which the limits for SCO-I are exceeded and on which:

(i) The non-fixed contamination on the accessible surface averaged over three hundred square centimeters, or the area of the surface if less than three hundred square centimeter, does not exceed four hundred becquerels per square centimeter (10^-2 microcurie per square centimeter) for beta and gamma and low toxicity alpha emitters, or forty becquerels per square centimeter (10^-3 microcurie per square centimeter) for all other alpha emitters;

(ii) The fixed contamination on the accessible surface averaged over three hundred square centimeters, or the area of the surface if less than three hundred square centimeters, does not exceed eight hundred thousand becquerels per square centimeter (twenty microcuries per square centimeter) for beta and gamma and low toxicity alpha emitters, or eighty thousand becquerels per square centimeter (two microcuries per square centimeter) for all other alpha emitters; and

(iii) The non-fixed contamination plus the fixed contamination on the inaccessible surface averaged over three hundred square centimeters, or the area of the surface if less than three hundred square centimeters, does not exceed eight hundred thousand becquerels per square centimeter (twenty microcuries per square centimeter) for beta and gamma and low toxicity alpha emitters, or eighty thousand becquerels per square centimeter (two microcuries per square centimeter) for all other alpha emitters.

(166) "Survey" means an evaluation of the radiological conditions and potential hazards incident to the production, use, transfer, release, disposal or presence of radioactive material or other sources of radiation. When appropriate, such an evaluation includes a physical survey of the location of radioactive material, or the sources of radiation and measurements or calculations of levels of radiation, or concentrations or quantities of radioactive material present.

(167) "Tight-fitting facepiece" means a respiratory inlet covering that forms a complete seal with the face.

(168) "Total effective dose equivalent" or "TEDE" means the sum of the effective dose equivalent (for external exposures) and the committed effective dose equivalent (for internal exposures).

(169) "Transport index" means the dimensionless number, rounded up to the next tenth, placed on the label of a package, to designate the degree of control to be exercised by the carrier during transportation. The transport index is the number determined by multiplying the maximum radiation level in millisievert per hour at one meter (3.3 feet) from the external surface of the package by one hundred, which is equivalent to the maximum radiation level in millirem per hour at one meter (3.3 feet).

(170) "Type A quantity" means a quantity of radioactive material, the aggregate radioactivity of which does not exceed A₁ for special form radioactive material, or A₂ for normal form radioactive material, where A₁ and A₂ are given in rule 3701:1-50-25 of the Administrative Code.

(171) "Type B quantity" means a quantity of radioactive material greater than a type A quantity.

(172) "Type B package" is defined under "Package."

(173) "United States department of energy" means the department of energy established by the Department of Energy Organization Act, PL 95-91, 91 Stat. 565 (1977), 42 U.S.C. 7101 et seq., as amended (2006), to the extent that the department of energy or its duly authorized representatives, exercises functions formerly vested in the United States atomic energy commission, its chairman, members, officers and components and transferred to the United States energy research and development administration and to the administrator thereof pursuant to Sections 104(b) to (d) of the Energy Reorganization Act of 1974, PL 93-438, 88 Stat. 1233 at 1237 (1974), 42 U.S.C. 5814 and retransferred to the secretary of energy pursuant to Section 301(a) of the Department of Energy Organization Act, PL 95-91, 91 Stat. 565 at 577-578 (1977), 42 U.S.C. 7151.

(174) "Unrestricted area" or "uncontrolled area" means any area, access to which is neither restricted nor controlled by the licensee or registrant.

(175) "User seal check" or "fit check" means an action conducted by the respirator user to determine if the respirator is properly seated to the face. Examples include negative pressure check, positive pressure check, irritant smoke check, or isoamyl acetate check.

(176) "Very high radiation area" means an area, accessible to individuals, in which radiation levels from radiation sources external to the body could result in an individual receiving an absorbed dose in excess of five gray (five hundred rad) in one hour at one meter from a source of radiation or from any surface that the radiation penetrates. At very high doses received at high dose rates, units of absorbed dose, gray and rad, are appropriate, rather than units of dose equivalent, sievert and rem.

(177) "Veterinarian" means an individual licensed by the state of Ohio to practice veterinary medicine pursuant to Chapter 4741. of the Revised Code.

(178) "Waste" means those low-level radioactive wastes containing source, special nuclear, or byproduct material that are acceptable for disposal in a land disposal facility. For the purposes of this definition, low-level radioactive waste means radioactive waste not classified as high-level radioactive waste, transuranic waste, spent nuclear fuel, or byproduct material as defined in paragraph (A)(26)(b) of this rule, or byproduct material as defined in section 11 E. (3) and (4) of the Atomic Energy Act of 1954, 68 Stat. 919, 42 USC 2014, as amended (2005).

(179) "Week" means seven consecutive days starting on Sunday.

(180) "Weighting factor

• W_T" for an organ or tissue, (T), is the proportion of the risk of stochastic effects resulting from irradiation of that organ or tissue to the total risk of stochastic effects when the whole body is irradiated uniformly. For calculating the effective dose equivalent, the values of W_T are:

| Organ doseweighting factors | | | --- | --- | | Organ ortissue | W_T | | Gonads | 0.25 | | Breast | 0.15 | | Red bone marrow | 0.12 | | Lung | 0.12 | | Thyroid | 0.03 | | Bonesurfaces | 0.03 | | Remainder | 0.30^a | | Whole body | 1.00^b |

^\a 0.30 results from 0.06 for each of five "remainder" organs, excluding the skin and the lens of the eye, that receive the highest doses.

^\b for the purpose of weighting the external whole body dose (for adding it to the internal dose) a single weighting factor, W_T = 1.0, has been specified. The use of other weighting factors for external exposure will be approved on a case-by-case basis until such time as specific guidance is issued.

(181) "Whole body" means for purposes of external exposure, head; trunk, including male gonads; arms above the elbow; legs above the knee.

(182) "Worker" means an individual engaged in activities licensed or registered by the department and controlled by a licensee or registrant, but does not include the licensee or registrant.

(183) "Working level" or "WL" means any combination of short-lived radon decay products (for radon-222: polonium-218, lead-214, bismuth-214, and polonium-214; and for radon-220: polonium-216, lead-212, bismuth-212, and polonium-212) in one liter of air that will result in the ultimate emission of 1.3 x 10⁵ million electron volts alpha particle energy.

(184) "Working level month" or "WLM" means a cumulative exposure to one working level for one hundred seventy hours. (Two thousand working hours per year/twelve months per year equals approximately one hundred seventy hours per month.)

(185) "Year" means the period of time beginning in January used to determine compliance with the provisions of this rule. The licensee or registrant may change the starting date of the year used to determine compliance by the licensee or registrant provided that the change is made at the beginning of the year and that no day is omitted or duplicated in consecutive years.

(B) The terms set out in paragraph (A) of this rule may be redefined in other chapters as promulgated pursuant to Chapter 3748. of the Revised Code as used in that chapter only.

Last updated May 13, 2026 at 11:20 AM

History

• Effective: January 20, 2022
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-37-07

(A) General:

(1) Each licensee that possesses an aggregated quantity of radioactive material at or above the category two threshold shall establish, implement, and maintain its access authorization program in accordance with requirements of rules 3701:1-37-07 to 3701:1-37-13 of the Administrative Code.

(2) An applicant for a new license and each licensee that would become newly subject to the requirements of rules 3701:1-37-07 to 3701:1-37-13 of the Administrative Code upon application for modification of its license shall implement the requirements of rules 3701:1-37-07 to 3701:1-37-13 of the Administrative Code, as appropriate, before taking possession of an aggregated category one or category two quantity of radioactive material.

(3) Any licensee that has not previously implemented the security orders or been subject to the provisions of rules 3701:1-37-07 to 3701:1-37-13 of the Administrative Code shall implement these rules before aggregating radioactive material to a quantity that equals or exceeds the category two threshold.

(B) General performance objective: The licensee's access authorization program must ensure that the individuals specified in paragraph (C)(1) of this rule are trustworthy and reliable.

(C) Applicability:

(1) Licensees shall subject the following individuals to an access authorization program:

(a) Any individual whose assigned duties require unescorted access to category one or category two quantities of radioactive material or to any device that contains the radioactive material; and

(b) Reviewing officials.

(2) Licensees need not subject the categories of individuals listed in paragraphs (A)(1) to (A)(13) of rule 3701:1-37-11 of the Administrative Code to the investigation elements of the access authorization program.

(3) Licensees shall approve unescorted access to category one or category two quantities of radioactive material only for those individuals with job duties that require unescorted access to category one or category two quantities of radioactive material.

(4) Licensees may include individuals needing access to safeguards information in the access authorization program under rules 3701:1-37-07 to 3701:1-37-13 of the Administrative Code.

Last updated November 19, 2025 at 7:33 AM

History

• Effective: November 3, 2019
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-37-13

(A) Each licensee shall be responsible for the continuing effectiveness of the access authorization program. Each licensee shall ensure that access authorization programs are reviewed to confirm compliance with the requirements of rules 3701:1-37-07 to 3701:1-37-13 of the Administrative Code and that comprehensive actions are taken to correct any noncompliance that is identified. The review program shall evaluate all program performance objectives and requirements. Each licensee shall periodically (at least annually) review the access program content and implementation.

(B) The results of the reviews, along with any recommendations, must be documented. Each review report must identify conditions that are adverse to the proper performance of the access authorization program, the cause of the condition(s), and, when appropriate, recommend corrective actions, and corrective actions taken. The licensee shall review the findings and take any additional corrective actions necessary to preclude repetition of the condition, including reassessment of the deficient areas where indicated.

(C) Review records must be maintained for three years.

Last updated November 19, 2025 at 7:34 AM

History

• Effective: November 3, 2019
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-37-15

(A) Security plan:

(1) Each licensee identified in paragraph (A) of rule 3701:1-37-14 of the Administrative Code shall develop a written security plan specific to its facilities and operations. The purpose of the security plan is to establish the licensee's overall security strategy to ensure the integrated and effective functioning of the security program required by rules 3701:1-37-14 to 3701:1-37-22 of the Administrative Code. The security plan must, at a minimum:

(a) Describe the measures and strategies used to implement the requirements of rules 3701:1-37-14 to 3701:1-37-22 of the Administrative Code; and

(b) Identify the security resources, equipment, and technology used to satisfy the requirements of rules 3701:1-37-14 to 3701:1-37-22 of the Administrative Code.

(2) The security plan must be reviewed and approved by the individual with overall responsibility for the security program.

(3) A licensee shall revise its security plan as necessary to ensure the effective implementation of Ohio department of health requirements. The licensee shall ensure that:

(a) The revision has been reviewed and approved by the individual with overall responsibility for the security program; and

(b) The affected individuals are instructed on the revised plan before the changes are implemented.

(4) The licensee shall retain a copy of the current security plan as a record for three years after the security plan is no longer required. If any portion of the plan is superseded, the licensee shall retain the superseded material for three years after the record is superseded.

(B) Implementing procedures:

(1) The licensee shall develop and maintain written procedures that document how the requirements of rules 3701:1-37-14 to 3701:1-37-22 of the Administrative Code and the security plan will be met.

(2) The implementing procedures and revisions to these procedures must be approved in writing by the individual with overall responsibility for the security program.

(3) The licensee shall retain a copy of the current procedure as a record for three years after the procedure is no longer needed. Superseded portions of the procedure must be retained for three years after the record is superseded.

(C) Training:

(1) Each licensee shall conduct training to ensure that those individuals implementing the security program possess and maintain the knowledge, skills, and abilities to carry out their assigned duties and responsibilities effectively. The training must include instruction in:

(a) The licensee's security program and procedures to secure category one or category two quantities of radioactive material, and in the purposes and functions of the security measures employed;

(b) The responsibility to report promptly to the licensee any condition that causes or may cause a violation of department requirements;

(c) The responsibility of the licensee to report promptly to the local law enforcement agency (LLEA) and licensee any actual or attempted theft, sabotage, or diversion of category one or category two quantities of radioactive material; and

(d) The appropriate response to security alarms.

(2) In determining those individuals who shall be trained on the security program, the licensee shall consider each individual's assigned activities during authorized use and response to potential situations involving actual or attempted theft, diversion, or sabotage of category one or category two quantities of radioactive material. The extent of the training must be commensurate with the individual's potential involvement in the security of category one or category two quantities of radioactive material.

(3) Refresher training must be provided at a frequency not to exceed twelve months and when significant changes have been made to the security program. This training must include:

(a) Review of the training requirements of paragraph (C) of this rule and any changes made to the security program since the last training;

(b) Reports on any relevant security issues, problems, and lessons learned;

(c) Relevant results of Ohio department of health inspections; and

(d) Relevant results of the licensee's program review and testing and maintenance.

(4) The licensee shall maintain records of the initial and refresher training for three years from the date of the training. The training records must include dates of the training, topics covered, a list of licensee personnel in attendance, and related information.

(D) Protection of information:

(1) Licensees authorized to possess category one or category two quantities of radioactive material shall limit access to and unauthorized disclosure of their security plan, implementing procedures, and the list of individuals that have been approved for unescorted access.

(2) Efforts to limit access shall include the development, implementation, and maintenance of written policies and procedures for controlling access to, and for proper handling and protection against unauthorized disclosure of, the security plan, implementing procedures, and the list of individuals that have been approved for unescorted access.

(3) Before granting an individual access to the security plan, implementing procedures, or the list of individuals that have been approved for unescorted access, licensees shall:

(a) Evaluate an individual's need to know the security plan, implementing procedures, or the list of individuals that have been approved for unescorted access; and

(b) If the individual has not been authorized for unescorted access to category one or category two quantities of radioactive material, safeguards information, or safeguards information- modified handling, the licensee must complete a background investigation to determine the individual's trustworthiness and reliability. A trustworthiness and reliability determination shall be conducted by the reviewing official and shall include the background investigation elements contained in paragraphs (A)(2) to (A)(7) of rule 3701:1-37-09 of the Administrative Code.

(4) Licensees need not subject the following individuals to the background investigation elements for protection of information:

(a) The categories of individuals listed in rule 3701:1-37-11 of the Administrative Code; or

(b) Security service provider employees, provided written verification that the employee has been determined to be trustworthy and reliable, by the required background investigation in rule 3701:1-37-09 of the Administrative Code, has been provided by the security service provider.

(5) The licensee shall document the basis for concluding that an individual is trustworthy and reliable and should be granted access to the security plan, implementing procedures, or the list of individuals that have been approved for unescorted access.

(6) Licensees shall maintain a list of persons currently approved for access to the security plan, implementing procedures, or the list of individuals that have been approved for unescorted access. When a licensee determines that a person no longer needs access to the security plan, implementing procedures, or the list of individuals that have been approved for unescorted access, or no longer meets the access authorization requirements for access to the information, the licensee shall remove the person from the approved list as soon as possible, but no later than seven working days, and take prompt measures to ensure that the individual is unable to obtain the security plan, implementing procedures, or the list of individuals that have been approved for unescorted access.

(7) When not in use, the licensee shall store its security plan, implementing procedures, and the list of individuals that have been approved for unescorted access in a manner to prevent unauthorized access. Information stored in nonremovable electronic form must be password protected.

(8) The licensee shall retain as a record for three years after the document is no longer needed:

(a) A copy of the information protection procedures; and

(b) The list of individuals approved for access to the security plan, implementing procedures, or the list of individuals that have been approved for unescorted access.

Last updated November 19, 2025 at 7:34 AM

History

• Effective: May 15, 2023
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-37-02 Purpose.

This chapter has been established to provide the requirements for the physical protection program for any licensee that possesses an aggregated category one or category two quantity of radioactive material listed in appendix A to rule 3701:1-37-01 of the Administrative Code. These requirements provide reasonable assurance of the security of category one or category two quantities of radioactive material by protecting these materials from theft or diversion. Specific requirements for access to material, use of material, transfer of material, and transport of material are included. No provision of this chapter authorizes possession of licensed material.

Last updated November 19, 2025 at 7:33 AM

History

• Effective: October 1, 2014
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-37-03 Scope.

(A) Rules 3701:1-37-07 to 3701:1-37-22 of the Administrative Code apply to any person who, under the rules of this chapter, possesses or uses at any site, an aggregated category one or category two quantity of radioactive material.

(B) Rules 3701:1-37-23 to 3701:1-37-28 of the Administrative Code apply to any person who, under the rules of this chapter:

(1) Transports or delivers to a carrier for transport in a single shipment, a category one or category two quantity of radioactive material; or

(2) Imports or exports a category one or category two quantity of radioactive material; the provisions only apply to the domestic portion of the transport.

Last updated November 19, 2025 at 7:33 AM

History

• Effective: October 1, 2014
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-37-22

(A) The licensee shall immediately notify the LLEA after determining that an unauthorized entry resulted in an actual or attempted theft, sabotage, or diversion of a category one or category two quantity of radioactive material. As soon as possible after initiating a response, but not at the expense of causing delay or interfering with the LLEA response to the event, the licensee shall notify the director at (614) 644-2727 in accordance with rule 3701:1-37-05 of the Administrative Code. In no case shall the notification to the director be later than four hours after the discovery of any attempted or actual theft, sabotage, or diversion.

(B) The licensee shall assess any suspicious activity related to possible theft, sabotage, or diversion of category one or category two quantities of radioactive material and notify the LLEA as appropriate. As soon as possible but not later than four hours after notifying the LLEA, the licensee shall notify the director at (614) 644-2727 in accordance with rule 3701:1-37-05 of the Administrative Code.

(C) The initial telephonic notification to the director required by paragraph (A) of this rule must be followed within a period of thirty days by a written report submitted to the director by an appropriate method listed in rule 3701:1-37-04 of the Administrative Code. The report must include sufficient information for director analysis and evaluation, including identification of any necessary corrective actions to prevent future instances.

Last updated November 19, 2025 at 7:36 AM

History

• Effective: November 3, 2019
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-37-23

A licensee transferring a category one or category two quantity of radioactive material to a licensee of the U.S. nuclear regulatory commission or an agreement state shall meet the license verification provisions listed below instead of those listed in rule 3701:1-40-19 of the Administrative Code:

(A) Any licensee transferring category one quantities of radioactive material to a licensee of the U.S. nuclear regulatory commission or an agreement state, prior to conducting such transfer, shall verify with the U.S. nuclear regulatory commission's license verification system or the license issuing authority that the transferee's license authorizes the receipt of the type, form, and quantity of radioactive material to be transferred and that the licensee is authorized to receive radioactive material at the location requested for delivery. If the verification is conducted by contacting the license issuing authority, the transferor shall document the verification. For transfers within the same organization, the licensee does not need to verify the transfer.

(B) Any licensee transferring category two quantities of radioactive material to a licensee of the U.S. nuclear regulatory commission or an agreement state, prior to conducting such transfer, shall verify with the U.S. nuclear regulatory commission's license verification system or the license issuing authority that the transferee's license authorizes the receipt of the type, form, and quantity of radioactive material to be transferred. If the verification is conducted by contacting the license issuing authority, the transferor shall document the verification. For transfers within the same organization, the licensee does not need to verify the transfer.

(C) In an emergency where the licensee cannot reach the license issuing authority and the license verification system is nonfunctional, the licensee may accept a written certification by the transferee that it is authorized by license to receive the type, form, and quantity of radioactive material to be transferred. The certification must include the license number, current revision number, issuing agency, expiration date, and for a category one shipment the authorized address. The licensee shall keep a copy of the certification. The certification must be confirmed by use of the U.S. nuclear regulatory commission's license verification system or by contacting the license issuing authority by the end of the next business day.

(D) The transferor shall keep a copy of the verification documentation as a record for three years.

Last updated November 19, 2025 at 7:36 AM

History

• Effective: October 1, 2014
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-37-28

(A) The shipping licensee shall notify the appropriate LLEA and the director in accordance with rule 3701:1-37-05 of the Administrative Code within one hour of its determination that a shipment of category one quantities of radioactive material is lost or missing. The appropriate LLEA would be the law enforcement agency in the area of the shipment's last confirmed location. During the investigation required by paragraph (C) of rule 3701:1-37-27 of the Administrative Code, the shipping licensee will provide agreed upon updates to the director on the status of the investigation.

(B) The shipping licensee shall notify the director in accordance with rule 3701:1-37-05 of the Administrative Code within four hours of its determination that a shipment of category two quantities of radioactive material is lost or missing. If, after twenty-four hours of its determination that the shipment is lost or missing, the radioactive material has not been located and secured, the licensee shall immediately notify the director.

(C) The shipping licensee shall notify the designated LLEA along the shipment route as soon as possible upon discovery of any actual or attempted theft or diversion of a shipment or suspicious activities related to the theft or diversion of a shipment of a category one quantity of radioactive material. As soon as possible after notifying the LLEA, the licensee shall notify the director in accordance with rule 3701:1-37-05 of the Administrative Code upon discovery of any actual or attempted theft or diversion of a shipment, or any suspicious activity related to the shipment of category one radioactive material.

(D) The shipping licensee shall notify the director in accordance with rule 3701:1-37-05 of the Administrative Code as soon as possible upon discovery of any actual or attempted theft or diversion of a shipment, or any suspicious activity related to the shipment, of a category two quantity of radioactive material.

(E) The shipping licensee shall notify the director in accordance with rule 3701:1-37-05 of the Administrative Code and the LLEA as soon as possible upon recovery of any lost or missing category one quantities of radioactive material.

(F) The shipping licensee shall notify the director in accordance with rule 3701:1-37-05 of the Administrative Code as soon as possible upon recovery of any lost or missing category two quantities of radioactive materials.

(G) The initial telephonic notification required by paragraphs (A) to (D) of this rule must be followed within a period of thirty days by a written report submitted to the director by an appropriate method listed in rule 3701:1-37-04 of the Administrative Code. A written report is not required for notifications on suspicious activities required by paragraphs (C) and (D) of this rule. The report must set forth the following information:

(1) A description of the licensed material involved, including kind, quantity, and chemical and physical form;

(2) A description of the circumstances under which the loss or theft occurred;

(3) A statement of disposition, or probable disposition, of the licensed material involved;

(4) Actions that have been taken, or will be taken, to recover the material; and

(5) Procedures or measures that have been, or will be, adopted to ensure against a recurrence of the loss or theft of licensed material.

(H) Subsequent to filing the written report, the licensee shall also report any additional substantive information on the loss or theft within thirty days after the licensee learns of such information.

Last updated November 19, 2025 at 7:37 AM

History

• Effective: November 3, 2019
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-37-04 Communications.

(A) Except where otherwise specified or covered under the licensing program, all written communications and reports concerning the rules in this chapter may be sent to the following address:

"Ohio Department of Health

Bureau of Environmental Health and Radiation Protection

246 North High Street

Columbus, Ohio 43215"

(B) If permitted to submit via electronic mail, reports may be sent to the Ohio department of health at: "BRadiation@odh.ohio.gov"

Last updated November 19, 2025 at 7:33 AM

History

• Effective: November 3, 2019
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-37-05 Immediate notifications by telephone.

Notifications required by this chapter to be made in accordance with this rule shall be made by telephone to the Ohio department of health at (614) 644-2727.

Last updated November 19, 2025 at 7:33 AM

History

• Effective: November 3, 2019
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-37-06 Specific exemptions.

(A) The director may, upon application of any interested person or upon his or her own initiative, grant such exemptions from the requirements of the regulations in this chapter as he or she determines are authorized by law and will not endanger life or property or the common defense and security, and are otherwise in the public interest.

(B) A licensee that possesses radioactive waste that contains category one or category two quantities of radioactive material is exempt from the requirements of rules 3701:1-37-07 to 3701:1-37-28 of the Administrative Code. Except that any radioactive waste that contains discrete sources, ion-exchange resins, or activated material that weighs less than two thousand kilograms (four thousand four hundred nine pounds) is not exempt from the requirements of this chapter. The licensee shall implement the following requirements to secure the radioactive waste:

(1) Use continuous physical barriers that allow access to the radioactive waste only through established access control points;

(2) Use a locked door or gate with monitored alarm at the access control point;

(3) Assess and respond to each actual or attempted unauthorized access to determine whether an actual or attempted theft, sabotage, or diversion occurred; and

(4) Immediately notify the local law enforcement agency (LLEA) and request an armed response from the LLEA upon determination that there was an actual or attempted theft, sabotage, or diversion of the radioactive waste that contains category one or category two quantities of radioactive material.

Last updated November 19, 2025 at 7:33 AM

History

• Effective: October 1, 2014
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-37-11

(A) Fingerprinting, and the identification and criminal history records checks required by section 149 of the "Atomic Energy Act of 1954" (Pub. L. 83-703, 68 Stat. 919, 42 U.S.C. 2169), as amended, and this chapter, and other elements of the background investigation are not required for the following individuals prior to granting unescorted access to category one or category two quantities of radioactive materials:

(1) An employee of the U.S. nuclear regulatory commission or of the executive branch of the U.S. government who has undergone fingerprinting for a prior U.S. government criminal history records check;

(2) A member of congress;

(3) An employee of a member of congress or congressional committee who has undergone fingerprinting for a prior U.S. government criminal history records check;

(4) The governor of a state or his or her designated state employee representative;

(5) Federal, state, or local law enforcement personnel;

(6) State radiation control program directors and state homeland security advisors or their designated state employee representatives;

(7) Agreement state employees conducting security inspections on behalf of the U.S. nuclear regulatory commission under an agreement executed under section 274.i. of the "Atomic Energy Act" (Pub. L. 83-703, 68 Stat. 919, 42 U.S.C. 2021i.);

(8) Representatives of the international atomic energy agency (IAEA) engaged in activities associated with the U.S./IAEA safeguards agreement who have been certified by the U.S. nuclear regulatory commission;

(9) Emergency response personnel who are responding to an emergency;

(10) Commercial vehicle drivers for road shipments of category one and two quantities of radioactive material;

(11) Package handlers at transportation facilities such as freight terminals and railroad yards;

(12) Any individual who has an active federal security clearance, provided that he or she makes available the appropriate documentation. Written confirmation from the agency/employer that granted the federal security clearance or reviewed the criminal history records check must be provided to the licensee. The licensee shall retain this documentation for a period of three years from the date the individual no longer requires unescorted access to category one or category two quantities of radioactive material; and

(13) Any individual employed by a service provider licensee for which the service provider licensee has conducted the background investigation for the individual and approved the individual for unescorted access to category one or category two quantities of radioactive material. Written verification from the service provider must be provided to the licensee. The licensee shall retain the documentation for a period of three years from the date the individual no longer requires unescorted access to category one or category two quantities of radioactive material.

(B) Fingerprinting, and the identification and criminal history records checks required by section 149 of the "Atomic Energy Act of 1954" (Pub. L. 83-703, 68 Stat. 919, 42 U.S.C. 2169), as amended, are not required for an individual who has had a favorably adjudicated U.S. government criminal history records check within the last five years, under a comparable U.S. government program involving fingerprinting and an FBI identification and criminal history records check provided that he or she makes available the appropriate documentation. Written confirmation from the agency/employer that reviewed the criminal history records check must be provided to the licensee. The licensee shall retain this documentation for a period of three years from the date the individual no longer requires unescorted access to category one or category two quantities of radioactive material. These programs include, but are not limited to:

(1) National agency check;

(2) Transportation worker identification credentials (TWIC) under 49 CFR 1572 (in effect on the effective date of this rule);

(3) Bureau of alcohol, tobacco, firearms, and explosives background check and clearances under 27 CFR 555 (in effect on the effective date of this rule);

(4) Health and human services security risk assessments for possession and use of select agents and toxins under 42 CFR 73 (in effect on the effective date of this rule);

(5) Hazardous material security threat assessment for hazardous material endorsement to commercial driver's license under 49 CFR 1572 (in effect on the effective date of this rule); and

(6) Customs and border protection's free and secure trade (FAST) program.

Last updated November 19, 2025 at 7:34 AM

History

• Effective: November 3, 2019
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-37-08 Access authorization program requirements.

(A) Granting unescorted access authorization:

(1) Licensees shall implement the requirements of this rule for granting initial or reinstated unescorted access authorization.

(2) Individuals who have been determined to be trustworthy and reliable shall also complete the security training required by paragraph (C) of rule 3701:1-37-15 of the Administrative Code before being allowed unescorted access to category one or category two quantities of radioactive material.

(B) Reviewing officials:

(1) Reviewing officials are the only individuals who may make trustworthiness and reliability determinations that allow individuals to have unescorted access to category one or category two quantities of radioactive materials possessed by the licensee.

(2) Each licensee shall name one or more individuals to be reviewing officials. After completing the background investigation on the reviewing official, the licensee shall provide under oath or affirmation, a certification that the reviewing official is deemed trustworthy and reliable by the licensee. Provide oath or affirmation certifications to the director at the address specified in rule 3701:1-37-04 of the Administrative Code. The fingerprints of the named reviewing official must be taken by a law enforcement agency, federal or state agencies that provide fingerprinting services to the public, or commercial fingerprinting services authorized by a state to take fingerprints. The licensee shall recertify that the reviewing official is deemed trustworthy and reliable every ten years in accordance with paragraph (C) of rule 3701:1-37-09 of the Administrative Code.

(3) Reviewing officials must be permitted to have unescorted access to category one or category two quantities of radioactive materials or access to safeguards information or safeguards information-modified handling, if the licensee possesses safeguards information or safeguards information-modified handling.

(4) Reviewing officials cannot approve other individuals to act as reviewing officials.

(5) A reviewing official does not need to undergo a new background investigation before being named by the licensee as the reviewing official if:

(a) The individual has undergone a background investigation that included fingerprinting and a federal bureau of investigation (FBI) criminal history records check and has been determined to be trustworthy and reliable by the licensee; or

(b) The individual is subject to a category listed in paragraph (A) of rule 3701:1-37-11 of the Administrative Code.

(C) Informed consent:

(1) Licensees may not initiate a background investigation without the informed and signed consent of the subject individual. This consent must include authorization to share personal information with other individuals or organizations as necessary to complete the background investigation. Before a final adverse determination, the licensee shall provide the individual with an opportunity to correct any inaccurate or incomplete information that is developed during the background investigation. Licensees do not need to obtain signed consent from those individuals that meet the requirements of paragraph (B) of rule 3701:1-37-09 of the Administrative Code. A signed consent must be obtained prior to any reinvestigation.

(2) The subject individual may withdraw his or her consent at any time. Licensees shall inform the individual that:

(a) If an individual withdraws his or her consent, the licensee may not initiate any elements of the background investigation that were not in progress at the time the individual withdrew his or her consent; and

(b) The withdrawal of consent for the background investigation is sufficient cause for denial or termination of unescorted access authorization.

(D) Personal history disclosure: Any individual who is applying for unescorted access authorization shall disclose the personal history information that is required by the licensee's access authorization program for the reviewing official to make a determination of the individual's trustworthiness and reliability. Refusal to provide, or the falsification of, any personal history information required by rules 3701:1-37-07 to 3701:1-37-13 of the Administrative Code is sufficient cause for denial or termination of unescorted access.

(E) Determination basis:

(1) The reviewing official shall determine whether to permit, deny, unfavorably terminate, maintain, or administratively withdraw an individual's unescorted access authorization based on an evaluation of all of the information collected to meet the requirements of rules 3701:1-37-07 to 3701:1-37-13 of the Administrative Code.

(2) The reviewing official may not permit any individual to have unescorted access until the reviewing official has evaluated all of the information collected to meet the requirements of rules 3701:1-37-07 to 3701:1-37-13 of the Administrative Code and determined that the individual is trustworthy and reliable. The reviewing official may deny unescorted access to any individual based on information obtained at any time during the background investigation.

(3) The licensee shall document the basis for concluding whether or not there is reasonable assurance that an individual is trustworthy and reliable.

(4) The reviewing official may terminate or administratively withdraw an individual's unescorted access authorization based on information obtained after the background investigation has been completed and the individual has been granted unescorted access authorization.

(5) Licensees shall maintain a list of persons currently approved for unescorted access authorization. When a licensee determines that a person no longer requires unescorted access or meets the access authorization requirement, the licensee shall remove the person from the approved list as soon as possible, but no later than seven working days, and take prompt measures to ensure that the individual is unable to have unescorted access to the material.

(F) Procedures: licensees shall develop, implement, and maintain written procedures for implementing the access authorization program. The procedures must include provisions for the notification of individuals who are denied unescorted access. The procedures must include provisions for the review, at the request of the affected individual, of a denial or termination of unescorted access authorization. The procedures must contain a provision to ensure that the individual is informed of the grounds for the denial or termination of unescorted access authorization and allow the individual an opportunity to provide additional relevant information.

(G) Right to correct and complete information:

(1) Prior to any final adverse determination, licensees shall provide each individual subject to rules 3701:1-37-07 to 3701:1-37-13 of the Administrative Code with the right to complete, correct, and explain information obtained as a result of the licensee's background investigation. Confirmation of receipt by the individual of this notification must be maintained by the licensee for a period of one year from the date of the notification.

(2) If, after reviewing his or her criminal history record, an individual believes that it is incorrect or incomplete in any respect and wishes to change, correct, update, or explain anything in the record, the individual may initiate challenge procedures. These procedures include direct application by the individual challenging the record to the law enforcement agency that contributed the questioned information or a direct challenge as to the accuracy or completeness of any entry on the criminal history record to the "Federal Bureau of Investigation, Criminal Justice Information Services (CJIS) Division, ATTN: SCU, Mod. D-2, 1000 Custer Hollow Road, Clarksburg, WV 26306" as published in 28 CFR 16.30 through 16.34 (in effect on the effective date of this rule). In the latter case, the FBI will forward the challenge to the agency that submitted the data, and will request that the agency verify or correct the challenged entry. Upon receipt of an official communication directly from the agency that contributed the original information, the FBI identification division makes any changes necessary in accordance with the information supplied by that agency. Licensees must provide at least ten days for an individual to initiate action to challenge the results of an FBI criminal history records check after the record being made available for his or her review. The licensee may make a final adverse determination based upon the criminal history records only after receipt of the FBI's confirmation or correction of the record.

(H) Records:

(1) The licensee shall retain documentation regarding the trustworthiness and reliability of individual employees for three years from the date the individual no longer requires unescorted access to category one or category two quantities of radioactive material.

(2) The licensee shall retain a copy of the current access authorization program procedures as a record for three years after the procedure is no longer needed. If any portion of the procedure is superseded, the licensee shall retain the superseded material for three years after the record is superseded.

(3) The licensee shall retain the list of persons approved for unescorted access authorization for three years after the list is superseded or replaced.

Last updated November 19, 2025 at 7:34 AM

History

• Effective: May 15, 2023
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-37-09

(A) Initial investigation: before allowing an individual unescorted access to category one or category two quantities of radioactive material or to the devices that contain the material, licensees shall complete a background investigation of the individual seeking unescorted access authorization. The scope of the investigation must encompass at least the seven years preceding the date of the background investigation or since the individual's eighteenth birthday, whichever is shorter. The background investigation must include at a minimum:

(1) Fingerprinting and an FBI identification and criminal history records check in accordance with rule 3701:1-37-10 of the Administrative Code;

(2) Verification of true identity: licensees shall verify the true identity of the individual who is applying for unescorted access authorization to ensure that the applicant is who he or she claims to be. A licensee shall review official identification documents (e.g., driver's license; passport; government identification; certificate of birth issued by the state, province, or country of birth) and compare the documents to personal information data provided by the individual to identify any discrepancy in the information. Licensees shall document the type, expiration, and identification number of the identification document, or maintain a photocopy of identifying documents on file in accordance with rule 3701:1-37-12 of the Administrative Code. Licensees shall certify in writing that the identification was properly reviewed, and shall maintain the certification and all related documents for review upon inspection;

(3) Employment history verification: licensees shall complete an employment history verification, including military history. Licensees shall verify the individual's employment with each previous employer for the most recent seven years before the date of application;

(4) Verification of education: licensees shall verify that the individual participated in the education process during the claimed period;

(5) Character and reputation determination: licensees shall complete reference checks to determine the character and reputation of the individual who has applied for unescorted access authorization. Unless other references are not available, reference checks may not be conducted with any person who is known to be a close member of the individual's family, including but not limited to the individual's spouse, parents, siblings, or children, or any individual who resides in the individual's permanent household. Reference checks under rules 3701:1-37-07 to 3701:1-37-13 of the Administrative Code must be limited to whether the individual has been and continues to be trustworthy and reliable;

(6) The licensee shall also, to the extent possible, obtain independent information to corroborate that information provided by the individual (e.g., seek references not supplied by the individual); and

(7) If a previous employer, educational institution, or any other entity with which the individual claims to have been engaged fails to provide information or indicates an inability or unwillingness to provide information within a time frame deemed appropriate by the licensee but at least after ten business days of the request or if the licensee is unable to reach the entity, the licensee shall document the refusal, unwillingness, or inability in the record of investigation; and attempt to obtain the information from an alternate source.

(B) Grandfathering:

(1) Individuals who have been determined to be trustworthy and reliable for unescorted access to category one or category two quantities of radioactive material under the fingerprint orders may continue to have unescorted access to category one and category two quantities of radioactive material without further investigation. These individuals shall be subject to the reinvestigation requirement.

(2) Individuals who have been determined to be trustworthy and reliable under the provisions of 10 CFR 73 (in effect on the effective date of this rule), or the security orders for access to safeguards information, safeguards information-modified handling, or risk-significant material may have unescorted access to category one and category two quantities of radioactive material without further investigation. The licensee shall document that the individual was determined to be trustworthy and reliable under the provisions of 10 CFR 73 or a security order. Security order, in this context, refers to any order that was issued by the U.S. nuclear regulatory commission that required fingerprints and a FBI criminal history records check for access to safeguards information, safeguards information-modified handling, or risk significant material such as special nuclear material or large quantities of uranium hexafluoride. These individuals shall be subject to the reinvestigation requirement.

(C) Reinvestigations: licensees shall conduct a reinvestigation every ten years for any individual with unescorted access to category one or category two quantities of radioactive material. The reinvestigation shall consist of fingerprinting and a FBI identification and criminal history records check in accordance with rule 3701:1-37-10 of the Administrative Code. The reinvestigations must be completed within ten years of the date on which these elements were last completed.

Last updated November 19, 2025 at 7:34 AM

History

• Effective: November 3, 2019
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-37-10

(A) General performance objectives and requirements:

(1) Except for those individuals listed in rule 3701:1-37-11 of the Administrative Code and those individuals grandfathered under paragraph (B) of rule 3701:1-37-09 of the Administrative Code, each licensee subject to the provisions of rules 3701:1-37-07 to 3701:1-37-13 of the Administrative Code shall fingerprint each individual who is to be permitted unescorted access to category one or category two quantities of radioactive material. Licensees shall transmit all collected fingerprints to the U. S. nuclear regulatory commission for transmission to the FBI. The licensee shall use the information received from the FBI as part of the required background investigation to determine whether to grant or deny further unescorted access to category one or category two quantities of radioactive materials for that individual.

(2) The licensee shall notify each affected individual that his or her fingerprints will be used to secure a review of his or her criminal history record, and shall inform him or her of the procedures for revising the record or adding explanations to the record.

(3) Fingerprinting is not required if a licensee is reinstating an individual's unescorted access authorization to category one or category two quantities of radioactive materials if:

(a) The individual returns to the same facility that granted unescorted access authorization within three hundred sixty-five days of the termination of his or her unescorted access authorization; and

(b) The previous access was terminated under favorable conditions.

(4) Fingerprints do not need to be taken if an individual who is an employee of a licensee, contractor, manufacturer, or supplier has been granted unescorted access to category one or category two quantities of radioactive material, access to safeguards information, or safeguards information-modified handling by another licensee, based upon a background investigation conducted under rules 3701:1-37-07 to 3701:1-37-13 of the Administrative Code, the fingerprint orders, or 10 CFR 73 (in effect on the effective date of this rule). An existing criminal history records check file may be transferred to the licensee asked to grant unescorted access in accordance with the provisions of paragraph (C) of rule 3701:1-37-12 of the Administrative Code.

(5) Licensees shall use the information obtained as part of a criminal history records check solely for the purpose of determining an individual's suitability for unescorted access authorization to category one or category two quantities of radioactive materials, access to safeguards information, or safeguards information-modified handling.

(B) Prohibitions:

(1) Licensees may not base a final determination to deny an individual unescorted access authorization to category one or category two quantities of radioactive material solely on the basis of information received from the FBI involving:

(a) An arrest more than one year old for which there is no information of the disposition of the case; or

(b) An arrest that resulted in dismissal of the charge or an acquittal.

(2) Licensees may not use information received from a criminal history records check obtained under rules 3701:1-37-07 to 3701:1-37-13 of the Administrative Code in a manner that would infringe upon the rights of any individual under the first amendment to the Constitution of the United States, nor shall licensees use the information in any way that would discriminate among individuals on the basis of race, religion, national origin, gender, or age.

(C) Procedures for processing of fingerprint checks:

(1) For the purpose of complying with rules 3701:1-37-07 to 3701:1-37-13 of the Administrative Code, licensees shall submit to the "U.S. Nuclear Regulatory Commission, Director, Division of Physical and Cyber Security Policy, 11545 Rockville Pike, ATTN: Criminal History Program/Mail Stop T-07D04M, Rockville, Maryland 20852," one completed, legible standard fingerprint card (form FD-258, ORIMDNRCOOOZ), electronic fingerprint scan or, where practicable, other fingerprint record for each individual requiring unescorted access to category one or category two quantities of radioactive material. Copies of these forms may be obtained by emailing "MAILSVS.Resource@nrc.gov." Guidance on submitting electronic fingerprints can be found at https://www.nrc.gov/security/chp.html.

(2) Fees for the processing of fingerprint checks are due upon application. Licensees shall submit payment with the application for the processing of fingerprints through corporate check, certified check, cashier's check, money order, or electronic payment, made payable to "U.S. NRC." For guidance on making electronic payments, contact the "Division of Physical and Cyber Security Policy by emailing Crimhist.Resource@nrc.gov." Combined payment for multiple applications is acceptable. The U.S. nuclear regulatory commission publishes the amount of the fingerprint check application fee on the NRC public web site. To find the current fee amount, go to the "Licensee Criminal History Records Checks & Firearms Background Check" information page at https://www.nrc.gov/security/chp.html and see the link for "How do I determine how much to pay for the request?"

(3) The U. S. nuclear regulatory commission will forward to the submitting licensee all data received from the FBI as a result of the licensee's application(s) for criminal history records checks.

Last updated November 19, 2025 at 7:34 AM

History

• Effective: May 15, 2023
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-37-12

(A) Each licensee who obtains background information on an individual under rules 3701:1-37-07 to 3701:1-37-13 of the Administrative Code shall establish and maintain a system of files and written procedures for protection of the record and the personal information from unauthorized disclosure.

(B) The licensee may not disclose the record or personal information collected and maintained to persons other than the subject individual, his or her representative, or to those who have a need to have access to the information in performing assigned duties in the process of granting or denying unescorted access to category one or category two quantities of radioactive material, or to safeguards information or safeguards information-modified handling (as specified in 10 CFR 73, Code of Federal Regulations, January 1, 2019). No individual authorized to have access to the information may disseminate the information to any other individual who does not have a need to know.

(C) The personal information obtained on an individual from a background investigation may be provided to another licensee:

(1) Upon the individual's written request to the licensee holding the data to disseminate the information contained in his or her file; and

(2) The recipient licensee verifies information such as name, date of birth, social security number, gender, and other applicable physical characteristics.

(D) The licensee shall make background investigation records obtained under rules 3701:1-37-07 to 3701:1-37-13 of the Administrative Code available for examination by an authorized representative of the director to determine compliance with the regulations and laws.

(E) The licensee shall retain all fingerprint and criminal history records (including data indicating no record) received from the FBI, or a copy of these records if the individual's file has been transferred, on an individual for three years from the date the individual no longer requires unescorted access to category one or category two quantities of radioactive material.

Last updated November 19, 2025 at 7:34 AM

History

• Effective: November 3, 2019
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-37-14 Security program.

(A) Applicability:

(1) Each licensee that possesses an aggregated category one or category two quantity of radioactive material shall establish, implement, and maintain a security program in accordance with the requirements of rules 3701:1-37-14 to 3701:1-37-22 of the Administrative Code.

(2) An applicant for a new license and each licensee that would become newly subject to the requirements of rules 3701:1-37-14 to 3701:1-37-22 of the Administrative Code upon application for modification of its license shall implement the requirements of rules 3701:1-37-14 to 3701:1-37-22 of the Administrative Code, as appropriate, before taking possession of an aggregated category one or category two quantity of radioactive material.

(3) Any licensee that has not previously implemented the security orders or been subject to the provisions of rules 3701:1-37-14 to 3701:1-37-22 of the Administrative Code shall provide written notification to the director at the location specified in rule 3701:1-40-04 of the Administrative Code at least ninety days before aggregating radioactive material to a quantity that equals or exceeds the category two threshold.

(B) General performance objective: each licensee shall establish, implement, and maintain a security program that is designed to monitor and, without delay, detect, assess, and respond to an actual or attempted unauthorized access to category one or category two quantities of radioactive material.

(C) Program features: each licensee's security program must include the program features, as appropriate, described in rules 3701:1-37-15 to 3701:1-37-21 of the Administrative Code.

Last updated November 19, 2025 at 7:34 AM

History

• Effective: November 3, 2019
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-40-04

(A) Except as otherwise provided, any communication or report required by this chapter shall be filed in accordance with Chapter 3748. of the Revised Code and rules promulgated thereunder. Documents pertaining to license application or any license matter, unless otherwise directed in writing, shall be submitted to the following address or by electronic submission in a manner approved by the director:

"Ohio Department of Health

Bureau of Environmental Health and Radiation Protection

246 North High Street

Columbus, Ohio 43215."

(B) If pemitted to submit via electronic mail, communications may be sent to the Ohio department of health at:

"BRadiation@odh.ohio.gov"

Last updated April 19, 2022 at 8:33 AM

History

• Effective: April 17, 2022
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-37-21

(A) Each licensee shall be responsible for the continuing effectiveness of the security program. Each licensee shall ensure that the security program is reviewed to confirm compliance with the requirements of rules 3701:1-37-14 to 3701:1-37-22 of the Administrative Code and that comprehensive actions are taken to correct any noncompliance that is identified. The review must include the radioactive material security program content and implementation. Each licensee shall periodically (at least annually) review the security program content and implementation.

(B) The results of the review, along with any recommendations, must be documented. Each review report must identify conditions that are adverse to the proper performance of the security program, the cause of the condition(s), and, when appropriate, recommend corrective actions, and corrective actions taken. The licensee shall review the findings and take any additional corrective actions necessary to preclude repetition of the condition, including reassessment of the deficient areas where indicated.

(C) The licensee shall maintain the review documentation for three years.

Last updated November 19, 2025 at 7:36 AM

History

• Effective: November 3, 2019
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-37-16 LLEA coordination.

(A) A licensee subject to rules 3701:1-37-14 to 3701:1-37-22 of the Administrative Code shall coordinate, to the extent practicable, with an LLEA for responding to threats to the licensee's facility, including any necessary armed response. The information provided to the LLEA must include:

(1) A description of the facilities and the category one and category two quantities of radioactive materials along with a description of the licensee's security measures that have been implemented to comply with rules 3701:1-37-14 to 3701:1-37-22 of the Administrative Code; and

(2) A notification that the licensee will request a timely armed response by the LLEA to any actual or attempted theft, sabotage, or diversion of category one or category two quantities of material.

(3) A notification that provides a description of the facilities and the category one and category two quantities of radioactive materials along with a description of the licensee's security measures is not public record pursuant to section 149.433 of the Revised Code (exemption of security records).

(B) The licensee shall notify the director within three business days if:

(1) The LLEA has not responded to the request for coordination within sixty days of the coordination request; or

(2) The LLEA notifies the licensee that the LLEA does not plan to participate in coordination activities.

(C) The licensee shall document its efforts to coordinate with the LLEA. The documentation must be kept for three years.

(D) The licensee shall coordinate with the LLEA at least every twelve months, or when changes to the facility design or operation adversely affect the potential vulnerability of the licensee's material to theft, sabotage, or diversion.

Last updated November 19, 2025 at 7:35 AM

History

• Effective: November 3, 2019
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-37-17 Security zones.

(A) Licensees shall ensure that all aggregated category one and category two quantities of radioactive material are used or stored within licensee-established security zones. Security zones may be permanent or temporary.

(B) Temporary security zones must be established as necessary to meet the licensee's transitory or intermittent business activities, such as periods of maintenance, source delivery, and source replacement.

(C) Security zones must, at a minimum, allow unescorted access only to approved individuals through:

(1) Isolation of category one and category two quantities of radioactive materials by the use of continuous physical barriers that allow access to the security zone only through established access control points. A physical barrier is a natural or man-made structure or formation sufficient for the isolation of the category one or category two quantities of radioactive material within a security zone; or

(2) Direct control of the security zone by approved individuals at all times; or

(3) A combination of continuous physical barriers and direct control.

(D) For category one quantities of radioactive material during periods of maintenance, source receipt, preparation for shipment, installation, or source removal or exchange, the licensee shall, at a minimum, provide sufficient individuals approved for unescorted access to maintain continuous surveillance of sources in temporary security zones and in any security zone in which physical barriers or intrusion detection systems have been disabled to allow such activities.

(E) Individuals not approved for unescorted access to category one or category two quantities of radioactive material must be escorted by an approved individual when in a security zone.

Last updated November 19, 2025 at 7:35 AM

History

• Effective: October 1, 2014
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-37-18 Monitoring, detection, and assessment.

(A) Monitoring and detection:

(1) Licensees shall establish and maintain the capability to continuously monitor and detect without delay all unauthorized entries into its security zones. Licensees shall provide the means to maintain continuous monitoring and detection capability in the event of a loss of the primary power source, or provide for an alarm and response in the event of a loss of this capability to continuously monitor and detect unauthorized entries.

(2) Monitoring and detection must be performed by:

(a) A monitored intrusion detection system that is linked to an onsite or offsite central monitoring facility;

(b) Electronic devices for intrusion detection alarms that will alert nearby facility personnel;

(c) A monitored video surveillance system;

(d) Direct visual surveillance by approved individuals located within the security zone; or

(e) Direct visual surveillance by a licensee designated individual located outside the security zone.

(3) A licensee subject to rules 3701:1-37-14 to 3701:1-37-22 of the Administrative Code shall also have a means to detect unauthorized removal of the radioactive material from the security zone. This detection capability must provide:

(a) For category one quantities of radioactive material, immediate detection of any attempted unauthorized removal of the radioactive material from the security zone. Such immediate detection capability must be provided by:

(i) Electronic sensors linked to an alarm;

(ii) Continuous monitored video surveillance; or

(iii) Direct visual surveillance.

(b) For category two quantities of radioactive material, weekly verification through physical checks, tamper indicating devices, use, or other means to ensure that the radioactive material is present.

(B) Assessment: licensees shall immediately assess each actual or attempted unauthorized entry into the security zone to determine whether the unauthorized access was an actual or attempted theft, sabotage, or diversion.

(C) Personnel communications and data transmission: for personnel and automated or electronic systems supporting the licensee's monitoring, detection, and assessment systems, licensees shall:

(1) Maintain continuous capability for personnel communication and electronic data transmission and processing among site security systems; and

(2) Provide an alternative communication capability for personnel, and an alternative data transmission and processing capability, in the event of a loss of the primary means of communication or data transmission and processing. Alternative communications and data transmission systems may not be subject to the same failure modes as the primary systems.

(D) Response: licensees shall immediately respond to any actual or attempted unauthorized access to the security zones, or actual or attempted theft, sabotage, or diversion of category one or category two quantities of radioactive material at licensee facilities or temporary job sites. For any unauthorized access involving an actual or attempted theft, sabotage, or diversion of category one or category two quantities of radioactive material, the licensee's response shall include requesting, without delay, an armed response from the LLEA.

Last updated November 19, 2025 at 7:36 AM

History

• Effective: November 3, 2019
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-37-19 Maintenance and testing.

(A) Each licensee subject to rules 3701:1-37-14 to 3701:1-37-22 of the Administrative Code shall implement a maintenance and testing program to ensure that intrusion alarms, associated communication systems, and other physical components of the systems used to secure or detect unauthorized access to radioactive material are maintained in operable condition and are capable of performing their intended function when needed. The equipment relied on to meet the security requirements of this chapter must be inspected and tested for operability and performance at the manufacturer's suggested frequency. If there is no suggested manufacturer's suggested frequency, the testing must be performed at least annually, not to exceed twelve months.

(B) The licensee shall maintain records on the maintenance and testing activities for three years.

Last updated November 19, 2025 at 7:36 AM

History

• Effective: November 3, 2019
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-37-20 Requirements for mobile devices.

Each licensee that possesses mobile devices containing category one or category two quantities of radioactive material must:

(A) Have two independent physical controls that form tangible barriers to secure the material from unauthorized removal when the device is not under direct control and constant surveillance by the licensee; and

(B) For devices in or on a vehicle or trailer, unless the health and safety requirements for a site prohibit the disabling of the vehicle, the licensee shall utilize a method to disable the vehicle or trailer when not under direct control and constant surveillance by the licensee. Licensees shall not rely on the removal of an ignition key to meet this requirement.

Last updated November 19, 2025 at 7:36 AM

History

• Effective: October 1, 2014
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-40-19

(A) No licensee shall transfer radioactive material except as authorized by this rule.

(B) Except as otherwise provided in the license and subject to the provisions of paragraph (C) of this rule, any licensee may transfer radioactive material:

(1) To the United States department of energy;

(2) To the agency in any agreement state which regulates radioactive material pursuant to an agreement under section 274 of the "Atomic Energy Act", as amended;

(3) To any person exempt from the licensing requirements of the act and regulations in this chapter, to the extent permitted under such exemption;

(4) To any person in an agreement state, subject to the jurisdiction of that state, who has been exempted from the licensing requirements and regulations of that state, to the extent permitted under such exemption;

(5) To any person authorized to receive such radioactive material under terms of a specific license or a general license or their equivalents issued by the United States atomic energy commission, the United States nuclear regulatory commission, or an agreement state; or

(6) As otherwise authorized by the director in writing.

(C) Before transferring radioactive material to an entity specified in paragraph (B) of this rule, the licensee transferring the material shall verify that the transferee's license authorizes the receipt of the type, form, and quantity of radioactive material to be transferred. The licensee may verify the transferee's authorization to accept the material by possessing one of the following:

(1) A current copy of the transferee's specific license or registration certificate specifying the type, form, and quantity of radioactive material to be transferred;

(2) A written certification by the receiving licensee certifying that the licensee is authorized by license or registration certificate to receive the type, form, and quantity of radioactive material to be transferred, and further specifying the license or registration certificate number, issuing agency, and expiration date;

(3) In the case of an emergency shipment, the transferring licensee may accept oral certification by the receiving licensee that the licensee is authorized by license or registration certificate to receive the type, form, and quantity of radioactive material to be transferred, and further, specifying the license or registration certificate number, issuing agency and expiration date. The transferring licensee shall obtain written confirmation detailing the oral certification within ten days of the emergency transfer; or

(4) The transferor may obtain other sources of information compiled by a reporting service from official records of the department, United States nuclear regulatory commission, or the licensing agency of an agreement state as to the identity of the receiving licensee, whether the licensee is authorized by license or registration certificate to receive the type, form, and quantity of radioactive material to be transferred, and the expiration date of the receiving licensee's license or registration.

Last updated November 2, 2022 at 2:12 PM

History

• Effective: October 4, 2010
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-37-24 Applicability of physical protection of category one and category two quantities of radioactive material during transit.

(A) For shipments of category one quantities of radioactive material, each shipping licensee shall comply with the requirements for physical protection contained in rules 3701:1-37-25 to 3701:1-37-28 of the Administrative Code.

(B) For shipments of category two quantities of radioactive material, each shipping licensee shall comply with the requirements for physical protection contained in rules 3701:1-37-25, 3701:1-37-27 and 3701:1-37-28 of the Administrative Code. For those shipments of category two quantities of radioactive material that meet the criteria of rule 3701:1-50-23 of the Administrative Code, the shipping licensee shall also comply with the advance notification provisions of rule 3701:1-50-23 of the Administrative Code.

(C) The shipping licensee shall be responsible for meeting the requirements of rules 3701:1-37-23 to 3701:1-37-28 of the Administrative Code unless the receiving licensee has agreed in writing to arrange for the in-transit physical protection required under rules 3701:1-37-23 to 3701:1-37-28 of the Administrative Code.

(D) Each licensee that imports or exports category one quantities of radioactive material shall comply with the requirements for physical protection during transit contained in rules 3701:1-37-25 to 3701:1-37-28 of the Administrative Code for the domestic portion of the shipment.

(E) Each licensee that imports or exports category two quantities of radioactive material shall comply with the requirements for physical protection during transit contained in rules 3701:1-37-27 and 3701:1-37-28 of the Administrative Code for the domestic portion of the shipment.

Last updated November 19, 2025 at 7:36 AM

History

• Effective: November 3, 2019
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-37-25

(A) Each licensee that plans to transport, or deliver to a carrier for transport, licensed material that is a category one quantity of radioactive material outside the confines of the licensee's facility or other place of use or storage shall:

(1) Preplan and coordinate shipment arrival and departure times with the receiving licensee;

(2) Preplan and coordinate shipment information with the governor or the governor's designee of any state through which the shipment will pass to:

(a) Discuss the state's intention to provide law enforcement escorts; and

(b) Identity safe havens; and

(3) Document the preplanning and coordination activities.

(B) Each licensee that plans to transport, or deliver to a carrier for transport, licensed material that is a category two quantity of radioactive material outside the confines of the licensee's facility or other place of use or storage shall coordinate the shipment no-later-than arrival time and the expected shipment arrival with the receiving licensee. The licensee shall document the coordination activities.

(C) Each licensee who receives a shipment of a category two quantity of radioactive material shall confirm receipt of the shipment with the originator. If the shipment has not arrived by the no-later-than arrival time, the receiving licensee shall notify the originator.

(D) Each licensee, who transports or plans to transport a shipment of a category two quantity of radioactive material, and determines that the shipment will arrive after the no-later-than arrival time provided pursuant to paragraph (B) of this rule, shall promptly notify the receiving licensee of the new no-later-than arrival time.

(E) The licensee shall retain a copy of the documentation for preplanning and coordination and any revision thereof, as a record for three years.

Last updated November 19, 2025 at 7:36 AM

History

• Effective: October 1, 2014
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-50-23

(A)

(1) As specified in paragraphs (B), (C) and (D) of this rule, each licensee shall provide advance notification to the governor of a state, or the governor's designee, of the shipment of licensed material, through, or across the boundary of the state, before the transport, or delivery to a carrier, for transport, of licensed material outside the confines of the licensee's plant or other place of use or storage in compliance with section 4163.07 of the Revised Code.

(2) As specified in paragraphs (B), (C), and (D) of this rule, each licensee shall provide advance notification to the tribal official of participating indian tribes referenced in paragraph (C)(3)(c) of this rule, or the official's designee, of the shipment of licensed material, within or across the boundary of the indian tribe's reservation, before the transport, or delivery to a carrier, for transport, of licensed material outside the confines of the licensee's plant or other place of use or storage in compliance with section 4163.07 of the Revised Code.

(B) Advance notification is also required under this rule for shipments of licensed material, other than irradiated reactor fuel, meeting the following three conditions:

(1) The licensed material is required by this part to be in type B packaging for transportation;

(2) The licensed material is being transported to or across a state boundary in route to a disposal facility or to a collection point for transport to a disposal facility; and

(3) The quantity of licensed material in a single package exceeds the least of the following:

(a) Three thousand times the A₁ value of the radionuclides as specified in rule 3701:1-50-25 of the Administrative Code for special form radioactive material;

(b) Three thousand times the A₂ value of the radionuclides as specified in rule 3701:1-50-25 of the Administrative Code for normal form radioactive material; or

(c) One thousand terabecquerels (twenty-seven thousand curies).

(C) Each licensee shall submit an advance notification as follows:

(1) The notification must be made in writing to the office of each appropriate governor or governor's designee, the office of each appropriate tribal official or tribal official's designee, and to the director, office of nuclear security and incident response, United States nuclear regulatory commission.

(2) A notification delivered by mail must be postmarked at least seven days before the beginning of the seven-day period during which departure of the shipment is estimated to occur.

(3) A notification delivered by any other means than mail must reach the office of the governor or of the governor's designee or the tribal official or tribal official's designee at least four days before the beginning of the seven-day period during which departure of the shipment is estimated to occur.

(a) Contact information for each state, including telephone and mailing addresses of governors and governors' designees, and participating tribes, including telephone and mailing addresses of tribal officials and tribal official's designees, is available on the United States nuclear regulatory commission's web site at: https://scp.nrc.gov/special/designee.pdf.

(b) A list of the names and mailing addresses of the governors' designees and tribal officials' designees of participating tribes is available on request from the "Director, Division of Material Safety, Security, State, and Tribal Programs, Office of Nuclear Material Safety and Safeguards, United States Nuclear Regulatory Commission, Washington, DC 20555-0001."

(4) The licensee shall retain a copy of the notification as a record for three years.

(D) Each advance notification of shipment of nuclear waste must contain the following information:

(1) The name, address, and telephone number of the shipper, carrier, and receiver of the nuclear waste shipment;

(2) A description of the nuclear waste contained in the shipment, as specified in the regulation of DOT in 49 C.F.R. 172.202 and 49 C.F.R. 172.203(D) (as in effect on the effective date of this rule);

(3) The point of origin of the shipment and the seven-day period during which departure of the shipment is estimated to occur;

(4) The seven-day period during which arrival of the shipment at state boundaries, or tribal reservation boundaries is estimated to occur;

(5) The destination of the shipment, and the seven-day period during which arrival at the destination of the shipment is estimated to occur; and

(6) A point of contact, with a telephone number, for current shipment information.

(E) Revision notice.

(1) A licensee who finds that schedule information previously furnished to a governor or governor's designee or a tribal official or tribal official's designee, in accordance with this section, will not be met, shall telephone a responsible individual in the office of the governor of the state or of the governor's designee or the tribal official or the tribal official's designee and inform that individual of the extent of the delay beyond the schedule originally reported. The licensee shall maintain a record of the name of the individual contacted for three years.

(F) Cancellation notice.

(1) Each licensee who cancels a nuclear waste shipment for which advance notification has been sent shall send a cancellation notice to the offices listed in paragraph (A) of this rule previously notified, and to the director, office of nuclear security and incident response, United States nuclear regulatory commission.

(2) The licensee shall state in the notice that it is a cancellation and identify the advance notification that is being canceled. The licensee shall retain a copy of the notice as a record for three years.

Last updated May 15, 2023 at 4:02 AM

History

• Effective: May 15, 2023
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-37-27

(A) Shipments by road:

(1) Each licensee who transports, or delivers to a carrier for transport, in a single shipment, a category one quantity of radioactive material shall:

(a) Ensure that movement control centers are established that maintain position information from a remote location. These control centers must monitor shipments twenty-four hours a day, seven days a week, and have the ability to communicate immediately, in an emergency, with the appropriate law enforcement agencies.

(b) Ensure that redundant communications are established that allow the transport to contact the escort vehicle (when used) and movement control center at all times. Redundant communications may not be subject to the same interference factors as the primary communication.

(c) Ensure that shipments are continuously and actively monitored by a telemetric position monitoring system or an alternative tracking system reporting to a movement control center. A movement control center must provide positive confirmation of the location, status, and control over the shipment. The movement control center must be prepared to promptly implement preplanned procedures in response to deviations from the authorized route or a notification of actual, attempted, or suspicious activities related to the theft, loss, or diversion of a shipment. These procedures will include, but not be limited to, the identification of and contact information for the appropriate LLEA along the shipment route.

(d) Provide an individual to accompany the driver for those highway shipments with a driving time period greater than the maximum number or allowable hours of service in a twenty-four hour duty day as established by the United States department of transportation federal motor carrier safety administration. The accompanying individual may be another driver.

(e) Develop written normal and contingency procedures to address:

(i) Notifications to the communication center and law enforcement agencies;

(ii) Communication protocols: Communication protocols must include a strategy for the use of authentication codes and duress codes and provisions for refueling or other stops, detours, and locations where communication is expected to be temporarily lost;

(iii) Loss of communications; and

(iv) Responses to an actual or attempted theft or diversion of a shipment.

(f) Each licensee who makes arrangements for the shipments for category one quantities of radioactive material shall ensure that drivers, accompanying personnel, and movement control center personnel have access to the normal and contingency procedures.

(2) Each licensee that transports category two quantities of radioactive material shall maintain constant control and/or surveillance during transit and have the capability for immediate communication to summon appropriate response or assistance.

(3) Each licensee who delivers to a carrier for transport, in a single shipment, a category two quantity of radioactive material shall:

(a) Use carriers that have established package tracking systems. An established package tracking system is a documented, proven, and reliable system routinely used to transport objects of value. In order for a package tracking system to maintain constant control and/or surveillance, the package tracking system must allow the shipper or transporter to identify when and where the package was last and when it should arrive at the next point of control.

(b) Use carriers that maintain constant control and/or surveillance during transit and have the capability for immediate communication to summon appropriate response or assistance; and

(c) Use carriers that have established tracking systems that require an authorized signature prior to releasing the package for delivery or return.

(B) Shipments by rail:

(1) Each licensee who transports, or delivers to a carrier for transport, in a single shipment, a category one quantity of radioactive material shall:

(a) Ensure that rail shipments are monitored by a telemetric position monitoring system or an alternative tracking system reporting to the licensee, third-party, or railroad communications center. The communications center shall provide positive confirmation of the location of the shipment and its status. The communications center shall implement preplanned procedures in response to deviations from the authorized route or to a notification of actual, attempted, or suspicious activities related to the theft or diversion of a shipment. These procedures will include, but not be limited to, the identification of and contact information for the appropriate LLEA along the shipment route.

(b) Ensure that periodic reports to the communications center are made at preset intervals.

(2) Each licensee who transports, or delivers to a carrier for transport, in a single shipment, a category two quantity of radioactive material shall:

(a) Use carriers that have established package tracking systems. An established package tracking system is a documented, proven, and reliable system routinely used to transport objects of value. In order for a package tracking system to maintain constant control and/or surveillance, the package tracking system must allow the shipper or transporter to identify when and where the package was last and when it should arrive at the next point of control.

(b) Use carriers that maintain constant control and/or surveillance during transit and have the capability for immediate communication to summon appropriate response or assistance; and

(c) Use carriers that have established tracking systems that require an authorized signature prior to releasing the package for delivery of return.

(C) Investigations: Each licensee who makes arrangements for shipment of category one quantities of radioactive material shall immediately conduct an investigation upon the discovery that a category one shipment is lost or missing. Each licensee who makes arrangements for the shipment of category two quantities of radioactive material shall immediately conduct an investigation, in coordination with the receiving licensee, of any shipment that has not arrived by the designated no-later-than arrival time.

Last updated November 19, 2025 at 7:37 AM

History

• Effective: November 3, 2019
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-37-26 Advance notification of shipment of category one quantities of radioactive material.

As specified in paragraphs (A) and (B) of this rule, each licensee shall provide advance notification to the director and the governor of a state, or the governor's designee, of the shipment of licensed material in a category one quantity, through or across the boundary of the state, before the transport, or delivery to a carrier for transport of the radioactive material outside the confines of the licensee's facility or other place of use or storage.

(A) Procedures for submitting advance notification:

(1) The notification must be made to the office of each appropriate governor or governor's designee. The contact information, including telephone and mailing addresses, of governors and governors' designees, is available on the NRC website at https://scp.nrc.gov/special/designee.pdf. A list of the contact information is also available upon request from the "Director, Division of Material Safety, Security, State, and Tribal Programs, Office of Nuclear Material Safety and Safeguards, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001." The notification to the director may be made by an appropriate method listed in rule 3701:1-37-04 of the Administrative Code.

(2) A notification delivered by mail must be postmarked at least seven days before transport of the shipment commences at the shipping facility.

(3) A notification delivered by any means other than mail must reach the director at least four days before the transport of the shipment commences and must reach the office of the governor or the governor's designee at least four days before transport of a shipment within or through the state.

(B) Information to be furnished in advance notification of shipment: Each advance notification of shipment of category one quantities of radioactive material must contain the following information, if available at the time of notification:

(1) The name, address, and telephone number of the shipper, carrier, and receiver of the category one radioactive material;

(2) The license numbers of the shipper and receiver;

(3) A description of the radioactive material contained in the shipment, including the radionuclides and quantity;

(4) The point of origin of the shipment and the estimated time and date that shipment will commence;

(5) The estimated time and date that the shipment is expected to enter each state along the route;

(6) The estimated time and date of arrival of the shipment at the destination; and

(7) A point of contact, with a telephone number, for current shipment information.

(C) Revision notice:

(1) The licensee shall provide any information not previously available at the time of the initial notification, as soon as the information becomes available but not later than commencement of the shipment, to the governor of the state or the governor's designee and to the director.

(2) A licensee shall promptly notify the governor of the state or the governor's designee of any such changes to the information provided in accordance with paragraphs (B) and (C)(1) of this rule. The licensee shall also immediately notify the director of any such changes.

(D) Cancellation notice: each licensee who cancels a shipment for which the advance notification has been sent shall send a cancellation notice to the governor of each state or to the governor's designee previously notified and to the director. The licensee shall send the cancellation notice before the shipment would have commenced or as soon thereafter as possible. The licensee shall state in the notice that it is a cancellation and identify the advance notification that is being canceled.

(E) Records: the licensee shall retain a copy of the advance notification and any revision and cancellation notices as a record for three years.

(F) Protection of information: state officials, state employees, and other individuals, whether or not licensees of the U.S. nuclear regulatory commission or an agreement state, who receive schedule information of the kind specified in paragraph (B) of this rule shall protect that information against unauthorized disclosure as specified in paragraph (D) of rule 3701:1-37-15 of the Administrative Code.

Last updated November 19, 2025 at 7:37 AM

History

• Effective: May 15, 2023
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-37-29 Form of records.

Each record required by this chapter must be legible throughout the retention period specified by each rule in which the requirement appears. The record may be the original or a reproduced copy or a microform, provided that the copy or microform is authenticated by authorized personnel and that the microform is capable of producing a clear copy throughout the required retention period. The record may also be stored in electronic media with the capability for producing legible, accurate, and complete records during the required retention period. Records such as letters, drawings, and specifications, must include all pertinent information such as stamps, initials, and signatures. The licensee shall maintain adequate safeguards against tampering with and loss of records.

Last updated November 19, 2025 at 7:37 AM

History

• Effective: November 3, 2019
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-37-30 Record retention.

Licensees shall maintain the records that are required by the rules in this chapter for the period specified by the appropriate rule. If a retention period is not otherwise specified, these records must be retained until the director terminates the facility's license. All records related to this chapter may be destroyed upon director's termination of the facility's license.

Last updated November 19, 2025 at 7:38 AM

History

• Effective: October 1, 2014
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-37-31 Inspections.

(A) Each licensee shall afford the director at all reasonable times the opportunity to inspect category one or category two quantities of radioactive material and the premises and facilities wherein the nuclear material is used, produced, or stored.

(B) Each licensee shall make available to the director for inspection, upon reasonable notice, records kept by the licensee pertaining to its receipt, possession, use, acquisition, import, export, or transfer of category one or category two quantities of radioactive material.

Last updated November 19, 2025 at 7:38 AM

History

• Effective: October 1, 2014
• Promulgated Under: 119.03

Chapter 3701:1-38 License or Registration for Radiation Handlers

Ohio Adm.Code 3701:1-38-01 Definitions.

(A) As used in this chapter and all other rules promulgated pursuant to Chapter 3748. of the Revised Code:

(1) "A₁" means the maximum activity of special form radioactive material permitted in a type A package. These values are listed in rule 3701:1-50-25 of the Administrative Code, or may be derived in accordance with the procedure prescribed in rule 3701:1-50-25 of the Administrative Code.

(2) "A₂" means the maximum activity of radioactive material, other than special form, low specific activity and surface contaminated object material, permitted in a type A package. These values are listed in rule 3701:1-50-25 of the Administrative Code, or may be derived in accordance with the procedure prescribed in rule 3701:1-50-25 of the Administrative Code.

(3) "Absorbed dose" means the energy imparted by ionizing radiation per unit mass of irradiated material. The units of absorbed dose are the gray, or Gy, and the rad.

(4) "Accelerator or charged particle accelerator" means any of a class of radiation generating equipment designed to electronically accelerate atomic or sub-atomic particles for subsequent bombardment of targets.

(5) "Accelerator-produced radioactive material" means any material made radioactive by a particle accelerator.

(6) "Activity" means the rate of disintegration or transformation or decay of radioactive material. The units of activity are the becquerel, or Bq, and the curie, or Ci.

(7) "Address of use" means the building or buildings that are identified on the license or registration and where the source of radiation may be received, used, prepared, or stored, except for temporary job sites.

(8) "Administrative controls" means mechanisms used to protect health and minimize damage to life and property through the use of written policies, procedures, instructions, training, observation of work practices, and related compliance audits.

(9) "Administrative monetary penalty" means a monetary penalty assessed by the director under section 3748.05 of the Revised Code and in compliance with rules adopted thereunder, to emphasize the need for lasting remedial action and to deter future violations.

(10) "Adult" means an individual eighteen or more years of age.

(11) "Agreement state" means any state with which the United States nuclear regulatory commission or the atomic energy commission has entered into an effective agreement under subsection 274B of the Atomic Energy Act of 1954, 68 Stat. 919, 42 U.S.C. 2021, as amended (1978). Non-agreement state means any other state.

(12) "Airborne radioactive material" means radioactive material dispersed in the air in the form of dusts, fumes, particulates, mists, vapors, or gases.

(13) "Airborne radioactivity area" means a room, enclosure, or area in which airborne radioactive materials, composed wholly or partly of licensed material, exist in concentrations:

(a) In excess of the derived air concentrations (DACs) specified in appendix C to rule 3701:1-38-12 of the Administrative Code, or

(b) To such a degree that an individual present in the area without respiratory protective equipment could exceed, during the hours an individual is present in a week, an intake of 0.6 per cent of the annual limit on intake or twelve DAC-hours.

(14) "Air-purifying respirator" means a respirator with an air-purifying filter, cartridge, or canister that removes specific air contaminants by passing ambient air through the air-purifying element.

(15) "ALARA" or "as low as is reasonably achievable" means every reasonable effort to maintain exposures to radiation as far below the dose limits as is practical consistent with the purpose for which the licensed or registered activity is undertaken, taking into account the state of technology, the economics of improvements in relation to benefits to the public health and safety, and other societal and socioeconomic considerations, and in relation to utilization of nuclear energy and licensed materials and registered activities in the public interest.

(16) "Alert" means events may occur, are in progress, or have occurred that could lead to a release of radioactive material but that the release is not expected to require a response by off-site response organizations to protect persons off-site.

(17) "Annual limit on intake" or "ALI" means the derived limit for the amount of radioactive material taken into the body of an adult worker by inhalation or ingestion in a year. ALI is the smaller value of intake of a given radionuclide in a year by the reference man that would result in a committed effective dose equivalent of 0.05 sievert (five rem) or a committed dose equivalent of 0.5 sievert (fifty rem) to any individual organ or tissue. ALI values for intake by ingestion and by inhalation of selected radionuclides are given in appendix C to rule 3701:1-38-12 of the Administrative Code.

(18) "Annually" means either

(a) At intervals not to exceed one year; or

(b) Once per year, at about the same time each year, plus or minus one month.

(19) "Area of use" means a portion of an address of use that has been set aside for the purpose of receiving, preparing, using, or storing sources of radiation.

(20) "Assigned protection factor" or "APF" means the expected workplace level of respiratory protection that would be provided by a properly functioning respirator or a class of respirators to properly fitted and trained users. Operationally, the inhaled concentration can be estimated by dividing the ambient airborne concentration by the APF.

(21) "Atmosphere-supplying respirator" means a respirator that supplies the respirator user with breathing air from a source independent of the ambient atmosphere, and includes supplied air respirators, or SARs, and self-contained breathing apparatus, or SCBA, units.

(22) "Atomic energy commission" or "AEC" means the federal agency created by the Atomic Energy Act of 1954, 68 Stat. 919, 42 U.S.C. 2011, as amended (1964), and was the predecessor agency to the current United States nuclear regulatory commission.

(23) "Background radiation" means radiation from cosmic sources; naturally occurring radioactive materials, including radon, except as a decay product of source or special nuclear material, and global fallout as it exists in the environment from the testing of nuclear explosive devices or from past nuclear accidents such as Chernobyl that contribute to background radiation and are not under the control of the licensee. "Background radiation" does not include radiation from radioactive materials regulated by the department.

(24) "Becquerel" or "Bq" means the SI unit of activity. One becquerel is equal to one disintegration per second.

(25) "Bioassay" or "radiobioassay" means the determination of kinds, quantities or concentrations, and, in some cases, the locations of radioactive material in the human body, whether by direct measurement, in vivo counting, or by analysis and evaluation of materials excreted or removed from the human body.

(26) "Byproduct material" means

(a) Any radioactive material, except special nuclear material, yielded in or made radioactive by exposure to the radiation incident to the process of producing or utilizing special nuclear materials; or

(b) The tailings or wastes produced by the extraction or concentration of uranium or thorium from any ore processed primarily for its source material content, including discrete surface wastes resulting from solution extraction processes. Underground ore bodies depleted by such solution extraction do not constitute byproduct material within the definition.

(27) "Chelating agent" means a chemical compound or mixture that enhances the removal of radioactive material from the body, water or similar applications. Typical chelating agents include amine polycarboxylic acids such as EDTA or DTPA; hydroxy-carboxylic acids; and polycarboxylic acids such as citric acid, carbolic acid, and gluconic acid.

(28) "Chiropractor" means an individual licensed by the state of Ohio to practice chiropractic medicine pursuant to Chapter 4734. of the Revised Code.

(29) "Class" or "lung class" or "inhalation class" means a classification scheme for inhaled material according to its rate of clearance from the pulmonary region of the lung. Materials are classified as D, W, or Y, which applies to a range of clearance half-times: for class D, days, of less than ten days, for class W, weeks, from ten to one hundred days, and for class Y, years, of greater than one hundred days.

(30) "Collective dose" means the sum of the individual doses received in a given period of time by a specified population from exposure to a specified source of radiation.

(31) "Commencement of construction" means taking any action defined as "construction" or any other activity at the site of a facility subject to the rules promulgated pursuant to Chapter 3748. of the Revised Code that has a reasonable nexus to radiological health and safety.

(32) "Committed dose equivalent" or "H_T,50" means the dose equivalent to organs or tissues of reference, T, that will be received from an intake of radioactive material by an individual during the fifty year period following the intake.

(33) "Committed effective dose equivalent" or "H_E,50" means the sum of the products of the weighting factors applicable to each of the body organs or tissues, W_T, that are irradiated and the committed dose equivalent to each of these organs or tissues (H_{E, 50} = W_TH_T,50).

(34) "Consortium" means an association of medical use licensees and a PET radionuclide production facility in the same geographical area that jointly own or share in the operation and maintenance cost of the PET radionuclide production facility that produces PET radionuclides for use in producing radioactive drugs within the consortium for noncommercial distributions among its associated members for medical use. The PET radionuclide production facility within the consortium must be located at an educational institution or a medical facility.

(35) "Constraint" or "dose constraint" means a value above which specified licensee actions are required.

(36) "Construction" means the installation of foundations, or in-place assembly, erection, fabrication, or testing for any structure, system, or component of a facility or activity subject to the rules promulgated pursuant to Chapter 3748. of the Revised Code that are related to radiological safety or security. The term "construction" does not include:

(a) Changes for temporary use of the land for public recreational purposes;

(b) Site exploration, including necessary borings to determine foundation conditions or other preconstruction monitoring to establish background information related to the suitability of the site, the environmental impacts of construction or operation, or the protection of environmental values;

(c) Preparation of the site for construction of the facility, including clearing of the site, grading, installation of drainage, erosion and other environmental mitigation measures, and construction of temporary roads and borrow areas;

(d) Erection of fences and other access control measures that are not related to the safe use of, or security of, radiological materials subject to the rules promulgated pursuant to Chapter 3748. of the Revised Code;

(e) Excavation;

(f) Erection of support buildings (e.g. construction equipment storage sheds, warehouse and shop facilities, utilities, concrete mixing plants, docking and unloading facilities, and office buildings) for use in connection with the construction of the facility;

(g) Building of service facilities (e.g. paved roads, parking lots, railroad spurs, exterior utility and lighting systems, potable water systems, sanitary sewerage treatment facilities, and transmission lines);

(h) Procurement or fabrication of components or portions of the proposed facility occurring at other than the final, in-place location at the facility; or

(i) Taking any other action that has no reasonable nexus to radiological health and safety.

(37) "Controlled area" means an area, outside of a restricted area but inside the site boundary, access to which can be limited by the licensee or registrant for any reason.

(38) "Critical group" means the group of individuals reasonably expected to receive the greatest exposure to residual radioactivity for any applicable set of circumstances.

(39) "Curie" or "Ci" means a unit of activity. One curie equals 3.7 x 10¹⁰ disintegrations per second equals 3.7 x 10¹⁰ becquerels equals 2.22 x 10¹² disintegrations per minute.

(40) "Cyclotron" means a particle accelerator in which the charged particles travel in an outward spiral or circular path. A cyclotron accelerates charged particles at energies usually in excess of ten megaelectron volts and is commonly used for production of short half-life radionuclides for medical use.

(41) "Declared pregnant woman" means a woman who has voluntarily informed the licensee or registrant, in writing, of her pregnancy and the estimated date of conception. The declaration remains in effect until the declared pregnant woman withdraws the declaration in writing or is no longer pregnant.

(42) "Decommission" means to safely remove any licensed operation from service and reduce residual radioactivity to a level that permits release of the licensee's property for unrestricted use and termination of the license.

(43) "Dedicated check source" means a radioactive source that is used to assure the consistent performance of a radiation detection or measurement device over several months or years.

(44) "Deep dose equivalent" or "H_d" applies to external whole body exposure, and means the dose equivalent at a tissue depth of one centimeter, one thousand milligram per square centimeter.

(45) "Demand respirator" means an atmosphere-supplying respirator that admits breathing air to the facepiece only when a negative pressure is created inside the facepiece by inhalation.

(46) "Dentist" means an individual licensed by the state of Ohio to practice dentistry under Chapter 4715. of the Revised Code.

(47) "Department" means the Ohio department of health.

(48) "Depleted uranium" means uranium containing less uranium-235 than the naturally occurring distribution of uranium isotopes.

(49) "Derived air concentration" or "DAC" means the concentration of a given radionuclide in air which, if breathed by the reference man for a working year of two thousand hours under conditions of light work, results in an intake of one ALI. The condition of light work is inhaling 1.2 cubic meters of air per hour for two thousand hours in a year. DAC values are given in appendix C to rule 3701:1-38-12 of the Administrative Code.

(50) "Derived air concentration-hour or DAC-hour" means the product of the concentration of radioactive material in air, which is expressed as a fraction or multiple of the derived air concentration for each radionuclide, and the time of exposure to that radionuclide, in hours. A licensee or registrant may take two thousand DAC-hours to represent one ALI, equivalent to a committed effective dose equivalent of 0.05 Sv (five rem).

(51) "Direct reading dosimeter" means a device that measures radiation dose that does not require another device to read the measured radiation dose. Examples of direct reading dosimeters include pocket dosimeters and electronic dosimeters.

(52) "Director" means the director of health or a designee or authorized representative of the director.

(53) "Discipline" means a branch of knowledge or of teaching.

(54) "Discrete source" means a radionuclide that has been processed so that its concentration within a material has been purposely increased for use for commercial, medical, or research activities.

(55) "Disposable respirator" means a respirator for which maintenance is not intended and that is designed to be discarded after excessive breathing resistance, sorbent exhaustion, physical damage, or end-of service-life renders it unsuitable for use. Examples of this type of respirator are a disposable half-mask respirator or a disposable escape-only self-contained breathing apparatus.

(56) "Dose" or "radiation dose" is a generic term that means absorbed dose, dose equivalent, effective dose equivalent, committed effective dose equivalent, or total effective dose equivalent as defined in other paragraphs of this rule.

(57) "Dose equivalent" or "H_T" means the product of the absorbed dose in tissue, quality factor, and all other necessary modifying factors at the location of interest. The units of dose equivalent are the sievert and rem.

(58) "Dose limits" or "limits" means the permissible upper bounds of radiation doses established in accordance with these regulations but excludes background radiation and medical exposure.

(59) "Dosimetry processor" means a person that processes and evaluates individual monitoring devices in order to determine the radiation dose delivered to the monitoring devices.

(60) "Effective dose equivalent" or "H_E" means the sum of the products of the dose equivalent to each organ or tissue, H_T, and the weighting factor, W_T, applicable to each of the body organs or tissues that are irradiated: (H_E = ∑W_TH_T).

(61) "Embryo" or "fetus" means the developing human organism from conception until time of birth.

(62) "Engineering controls" means mechanisms used to protect health and minimize damage to life and property through engineering specifications, design, and construction of the product or facility including all of the security and safety features. This includes, but is not limited to, auxiliary security and safety features such as additional external shielding, barriers, and operational interlocks with associated processes.

(63) "Entrance" or "access point" means any opening through which an individual or extremity of an individual could gain access to radiation areas or to licensed radioactive materials or registered radiation generating equipment. This includes entry or exit portals of sufficient size to permit human entry, irrespective of their intended use.

(64) "Explosive material" means any chemical compound, mixture or device which produces a substantial instantaneous release of gas and heat spontaneously or by contact with sparks or flame.

(65) "Exposure" means being exposed to sources of ionizing radiation.

(66) "External dose" means that portion of the dose equivalent received from radiation sources outside the body.

(67) "Extremity" means hand, elbow, arm below the elbow, foot, knee, or leg below the knee.

(68) "Eye dose equivalent" means the same as lens dose equivalent.

(69) "Facility" means all buildings, equipment, structures and other stationary items that, in addition to the meaning defined in division (H) of section 3748.01 of the Revised Code, are:

(a) Located on a single site or on contiguous or adjacent sites and are operated by the same person and have common corporate or business interests; or

(b) Portions of a building or structure which are operated by the same person and have common corporate or business interests.

(70) "Filtering facepiece" or "dust mask" means a negative pressure particulate respirator with a filter as an integral part of the facepiece or with the entire facepiece composed of the filtering medium, not equipped with elastomeric sealing surfaces and adjustable straps.

(71) "Fissile material" means the radionuclides uranium-233, uranium-235, plutonium-239, and plutonium-241, or any combination of these radionuclides. Fissile material means the fissile nuclides themselves, not material containing fissile nuclides. Unirradiated natural uranium and depleted uranium and natural uranium or depleted uranium that has been irradiated in thermal reactors only, are not included in this definition. Certain exclusions from fissile material controls are provided in rule 3701:1-50-13 of the Administrative Code.

(72) "Fit factor" means quantitative estimate of the fit of a particular respirator to a specific individual, and typically estimates the ratio of the concentration of a substance in ambient air to its concentration inside the respirator when worn.

(73) "Fit test" means the use of a protocol to qualitatively or quantitatively evaluate the fit of a respirator on an individual.

(74) "Generally applicable environmental radiation standards" means standards issued by the United States environmental protection agency under the authority of the Atomic Energy Act of 1954, 68 Stat. 919, 42 U.S.C. 2011, as amended (2005), that impose limits on radiation exposures or levels, or concentrations or quantities of radioactive material, in the general environment outside the boundaries of locations under the control of persons possessing or using radioactive material.

(75) "Gray" or "Gy" means the SI unit of absorbed dose. One gray is equal to an absorbed dose of one joule per kilogram (one hundred rads).

(76) "Handle" means receive, possess, use, store, transfer, install, service, or dispose of sources of radiation unless possession is solely for the purpose of transportation.

(77) "Handler" means a facility that handles sources of radiation unless possession is solely for the purpose of transportation.

(78) "Hazardous waste" means those wastes designated as hazardous by rule 3745-51-03 of the Administrative Code.

(79) "Helmet" means a rigid respiratory inlet covering that also provides head protection against impact and penetration.

(80) "High radiation area" means an area, accessible to individuals, in which radiation levels from radiation sources external to the body could result in an individual receiving a dose equivalent in excess of one millisievert (0.1 rem) in one hour at thirty centimeters from the radiation source or thirty centimeters from any surface that the radiation penetrates.

(81) "Hood" means a respiratory inlet covering that completely covers the head and neck and may also cover portions of the shoulders and torso.

(82) "Individual" means any human being.

(83) "Individual monitoring" means

(a) The assessment of dose equivalent by the use of devices designed to be worn by an individual;

(b) The assessment of committed effective dose equivalent by bioassay or by determination of the time-weighted air concentrations to which an individual has been exposed, i.e. DAC-hours; or

(c) The assessment of dose equivalent by the use of survey data.

(84) "Individual monitoring devices" means devices designed to be worn by a single individual for the assessment of dose equivalent such as film badges; thermoluminescent dosimeters; optically stimulated luminescent dosimeters; pocket ionization chambers; and personal air sampling devices.

(85) "Industrial radiography" means the examination of the structure of materials by nondestructive methods, utilizing sealed sources of radioactive material or radiation-generating equipment.

(86) "Internal dose" means that portion of the dose equivalent received from radioactive material taken into the body.

(87) "Irradiator" means a facility that uses radioactive sealed sources for the irradiation of objects or materials and in which radiation dose rates exceeding five grays (five hundred rads) per hour exist at one meter from the sealed radioactive source in air or water, as applicable for the irradiator type, but does not include irradiators in which both the sealed source and the area subject to irradiation are contained within a device and are not accessible to personnel.

(88) "Lens dose equivalent" or "eye dose equivalent" means the external exposure of the lens of the eye and is taken as the dose equivalent at a tissue depth of 0.3 centimeters; i.e. three hundred milligrams per square centimeter.

(89) "License" means a license issued by the nuclear regulatory commission, the director, or another agreement state in accordance with rules adopted by those organizations.

(90) "Licensee" means a person to whom a license is issued.

(91) "Licensed activity" means an activity authorized by a radioactive material license which is essential to achieving the purpose for which the license was issued or amended.

(92) "Licensed material" means radioactive material received, possessed, used, transferred or disposed of under a general or specific license.

(93) "Loose-fitting facepiece" means a respiratory inlet covering that is designed to form a partial seal with the face.

(94) "Lost or missing licensed source of radiation" means a licensed source of radiation whose location is unknown. It includes material that has been shipped but has not reached its destination and whose location cannot be readily traced in the transportation system.

(95) "Low-level radioactive waste" or "LLRW," also "low-level waste," or "LLW" means radioactive waste which is not high-level radioactive waste, spent nuclear fuel, NARM, or byproduct material as defined in section 11 E. (2) of the Atomic Energy Act of 1954 68 Stat. 919, 42 U.S.C. 2011, as amended (2005), but is radioactive material that the United States nuclear regulatory commission classifies as low-level radioactive waste.

(96) "Low specific activity material" or "LSA" means radioactive material with limited specific activity which is nonfissile or is excepted under rule 3701:1-50-13 of the Administrative Code, and which satisfies the descriptions and limits set forth below. Shielding materials surrounding the LSA material may not be considered in determining the estimated average specific activity of the package contents. LSA must be in one of three groups:

(a) LSA - I.

(i) Uranium and thorium ores, concentrates of uranium and thorium ores, and other ores containing naturally occurring radioactive radionuclides that are intended to be processed for the use of these radionuclides;

(ii) Natural uranium, depleted uranium, natural thorium or their compounds or mixtures, provided they are unirradiated and in solid or liquid form;

(iii) Radioactive material other than fissile material, for which the A₂ value is unlimited; or

(iv) Other radioactive material in which the activity is distributed throughout and the estimated average specific activity does not exceed thirty times the value for exempt material activity concentration determined in accordance with rule 3701:1-50-25 of the Administrative Code.

(b) LSA-II.

(i) Water with tritium concentration up to 0.8 terabecquerels per liter (twenty curies per liter); or

(ii) Other material in which the activity is distributed throughout and the estimated average specific activity does not exceed ( 10^-4 A₂) per gram for solids and gases, and (10^-5 A₂) per gram for liquids.

(c) LSA-III. Solids (e.g., consolidated wastes, activated materials), excluding powders, that satisfy the requirements of 10 C.F.R. 71.77 (as in effect on the effective date of this rule), in which:

(i) The radioactive material is distributed throughout a solid or a collection of solid objects, or is essentially uniformly distributed in a solid compact binding agent (such as concrete, bitumen, ceramic, etc.);

(ii) The radioactive material is relatively insoluble, or it is intrinsically contained in a relatively insoluble material, so that even under loss of packaging, the loss of radioactive material per package by leaching, when placed in water for seven days, would not exceed (0.1 x A₂); and

(iii) The estimated average specific activity of the solid, excluding any shielding material, does not exceed (0.002 x A₂) per gram.

(97) "Management" means the chief executive officer or other individual having the authority to manage, direct, or administer the licensee's activities, or those persons' delegate or delegates.

(98) "Medical institution" means an organization in which more than one medical discipline is practiced.

(99) "Medical use" means the intentional internal or external administration of radioactive material or the radiation therefrom to patients or human research subjects under the supervision of an authorized user.

(100) "Member of the public" means any individual except when that individual is receiving an occupational dose.

(101) "Minor" means an individual less than eighteen years of age.

(102) "Monitoring" or "radiation monitoring" or "radiation protection monitoring" means the measurement of radiation levels, concentrations, surface area concentrations or quantities of radioactive material and the use of the results of these measurements to evaluate potential exposures and doses.

(103) "NARM" or "naturally occurring or accelerator-produced radioactive material" means naturally occurring or accelerator-produced radioactive material, including naturally occurring material that is technologically enhanced, and those nuclides that are generated in a charged particle accelerator, but does not include source material, byproduct material, or special nuclear material.

(104) "NARM licensing state" means any state with regulations equivalent to the suggested state regulations for control of radiation relating to, and an effective program for, the regulatory control of NARM and which has been granted final designation by the conference of radiation control program directors, inc.

(105) "Nationally tracked source" means a sealed source containing a quantity equal to or greater than "Category 1" or "Category 2" levels of any radioactive material listed in the appendix to rule 3701:1-38-25 of the Administrative Code. In this context a sealed source is defined as radioactive material that is sealed in a capsule or closely bonded, in a solid form and which is not exempt from regulatory control. It does not mean material encapsulated solely for disposal, or nuclear material contained in any fuel assembly, subassembly, fuel rod, or fuel pellet. "Category 1" nationally tracked sources are those containing radioactive material at a quantity equal to or greater than the "Category 1" threshold. "Category 2" nationally tracked sources are those containing radioactive material at a quantity equal to or greater than the "Category 2" threshold but less than the "Category 1" threshold.

(106) "Negative pressure respirator" or "tight fitting respirator" means a respirator in which the air pressure inside the facepiece is negative during inhalation with respect to the ambient air pressure outside the respirator.

(107) "Nonstochastic effect" or "deterministic effect" means health effects, the severity of which varies with the dose and for which a threshold is believed to exist. Radiation-induced cataract formation is an example of a nonstochastic effect.

(108) "NORM" or "naturally occurring radioactive material" means any nuclide that is radioactive in its natural physical state, but does not include source material, byproduct material, or special nuclear material.

(109) "Normal form radioactive material" means radioactive material that has not been demonstrated to qualify as special form radioactive material.

(110) "Nuclear regulatory commission" means the federal agency established by Title II of the Energy Reorganization Act of 1974, 88 Stat. 1233, 42 U.S.C.A. 5801, as amended (2005), comprising the members of the commission and all offices, employees, and representatives authorized to act in any case or matter related to licensing and related regulatory function previously assigned to the AEC.

(111) "Occupational dose" means the dose received by an individual in the course of employment in which the individual's assigned duties involve exposure to radiation or radioactive material from licensed and unlicensed sources of radiation, whether in the possession of the licensee or other person. Occupational dose does not include doses received from background radiation, from any medical administration the individual has received, from exposures to individuals administered radioactive materials and released in accordance with rule 3701:1-58-30 of the Administrative Code or equivalent United States nuclear regulatory commission or agreement state regulations, from voluntary participation in medical research programs, or as a member of the public.

(112) "Package" means the packaging together with its radioactive contents as presented for transport.

(a) Fissile material package or type AF package, type BF package, type B(U)F package, or type B(M)F package means a fissile material packaging together with its fissile material contents.

(b) Type A package means a type A packaging together with its radioactive contents. A type A package is defined and must comply with the United States department of transportation regulations in 49 C.F.R. 173 (as in effect on the effective date of this rule).

(c) Type B package means a type B packaging together with its radioactive contents. On approval, a type B package design is designated by the United States nuclear regulatory commission as B(U) unless the package has a maximum normal operating pressure of more than seven hundred kilopascals (one hundred pounds per square inch) gauge or a pressure relief device that would allow the release of radioactive material to the environment under the tests specified in 10 C.F.R. 71.73 (hypothetical accident conditions) (as in effect on the effective date of this rule), in which case it will receive a designation B(M). B(U) refers to the need for unilateral approval of international shipments; B(M) refers to the need for multilateral approval of international shipments. There is no distinction made in how packages with these designations may be used in domestic transportation. To determine their distinction for international transportation, see United States department of transportation regulations in 49 C.F.R. 173 (as in effect on the effective date of this rule). A type B package approved before September 6, 1983, was designated only as type B. Limitations on its use are specified in 10 C.F.R. 71.19 (as in effect on the effective date of this rule).

(113) "Packaging" means the assembly of components necessary to ensure compliance with the packaging requirements of rule 49 C.F.R. 173 Subpart I (as in effect on the effective date of this rule). It may consist of one or more receptacles, absorbent materials, spacing structures, thermal insulation, radiation shielding, and devices for cooling or absorbing mechanical shocks. The vehicle, tie-down system and auxiliary equipment may be designated as part of the packaging.

(114) "Particle accelerator" means any machine capable of accelerating electrons, protons, deuterons, or other charged particles in a vacuum and of discharging the resultant particulate or other radiation into a medium at energies usually in excess of one megaelectron volt. For purposes of this definition, "accelerator" is an equivalent term.

(115) "Person" means any individual, corporation, association, business enterprise, or other legal entity either public or private and any legal successor, representative, agent, or agency of that individual, corporation, association, business enterprise, or other legal entity. Person also includes the United States, states, political subdivisions of states, and any department, agency, or instrumentality of the United States or a state, except the U.S. department of energy or the U.S. nuclear regulatory commission where the state regulation of radioactive material by either of those agencies is prohibited by federal law.

(116) "Personnel dosimeter", means a device that measures radiation dose that is processed and evaluated by an accredited "National Voluntary Laboratory Accreditation Program" (NVLAP) processor. Examples of personnel dosimeters include film badges, thermo-luminescent dosimeters (TLD), and optically stimulated luminescence (OSL) dosimeters.

(117) "Pharmacist" means a person who is licensed by the state of Ohio to practice pharmacy pursuant to Chapter 4731. of the Revised Code.

(118) "Physician" means a person who is licensed pursuant to Chapter 4731. of the Revised Code to practice medicine or surgery or osteopathic medicine or surgery.

(119) "Planned special exposure" means an infrequent exposure to radiation, separate from and in addition to the annual dose limits.

(120) "Podiatrist" means an individual licensed by the state of Ohio to practice podiatry pursuant to Chapter 4731. of the Revised Code.

(121) "Positive pressure respirator" means a respirator in which the pressure inside the respiratory inlet covering exceeds the ambient air pressure outside the respirator.

(122) "Positron Emission Tomography (PET) radionuclide production facility" means a facility operating a cyclotron or accelerator for the purpose of producing PET radionuclides.

(123) "Powered air-purifying respirator" or "PAPR" means an air-purifying respirator that uses a blower to force the ambient air through air purifying elements to the inlet covering.

(124) "Pressure demand respirator" means a positive pressure atmosphere supplying respirator that admits breathing air to the facepiece when the positive pressure is reduced inside the facepiece by inhalation.

(125) "Public dose" means the dose received by a member of the public from exposure to radiation and/or radioactive material released by the licensee, or to any other source of radiation under the control of a licensee or registrant. Public dose does not include occupational dose or doses received from background radiation, from any medical administration the individual has received, from exposures to individuals administered radioactive materials and released in accordance with rule 3701:1-58-30 of the Administrative Code or equivalent United States nuclear regulatory commission or agreement state regulations, or from voluntary participation in medical research programs.

(126) "Pyrophoric material" means any liquid that ignites spontaneously in dry or moist air at or below 54.4 degrees celsius (one hundred thirty degrees fahrenheit). A pyrophoric solid is any solid material, other than one classed as an explosive, which under normal conditions is liable to cause fires through friction, retained heat from manufacturing or processing, or which can be ignited readily and when ignited burns so vigorously and persistently as to create a serious transportation, handling, or disposal hazard. Included are spontaneously combustible and water-reactive materials.

(127) "Qualitative fit test" or "QLFT" means a pass/fail fit test to assess the adequacy of respirator fit that relies on the individual's response to the test agent.

(128) "Quality factor" or "Q" means the modifying factor, as listed in paragraphs (A) and (B) of rule 3701:1-38-11 of the Administrative Code, that is used to derive dose equivalent from absorbed dose.

(129) "Quantitative fit test" or "QNFT" means an assessment of the adequacy of respirator fit by numerically measuring the amount of leakage into the respirator.

(130) "Quarter" or "quarterly" means a period of time equal to one-fourth of the year observed by the licensee or registrant, approximately thirteen consecutive weeks, providing that the beginning of the first quarter in a year coincides with the starting date of the year and that no day is omitted or duplicated in consecutive quarters.

(131) "Rad" means the special unit of radiation absorbed dose. One rad is equal to an absorbed dose of one hundred ergs per gram, or 0.01 joule per kilogram, or 0.01 gray.

(132) "Radiation" or "ionizing radiation" means alpha particles, beta particles, gamma rays, x-rays, neutrons, high speed electrons, high speed protons, and other particles capable of producing ions. Radiation does not include nonionizing radiation, such as radio or microwaves, or visible, infrared or ultraviolet light.

(133) "Radiation area" means an area, accessible to individuals, in which radiation levels could result in an individual receiving a dose equivalent in excess of 0.05 millisievert (0.005 rem) in one hour at thirty centimeters from the source of radiation or from any surface that the radiation penetrates.

(134) "Radiation-generating equipment" or "RGE" means any manufactured product or device, or component of such a product or device, or any machine or system that during operation can generate or emit radiation, except those that emit radiation only from radioactive material. "Radiation-generating equipment" does not include either of the following:

(a) Diathermy machines;

(b) Microwave ovens, including food service microwave ovens used for commercial and industrial uses, television receivers, electric lamps, and other household appliances and products that generate very low levels of radiation.

(135) "Radiation Safety Officer" or "RSO" means an individual designated by the licensee who has the knowledge and responsibility for the overall radiation safety program at the facility, to include the implementation of the daily radiation safety operations and compliance with the rules.

(136) "Radioactive material" means any solid, liquid or gaseous material that emits ionizing radiation spontaneously. "Radioactive material" includes accelerator-produced and naturally occurring radioactive materials and byproduct, source, and special nuclear material.

(137) "Radioactive waste" means waste containing regulated radioactive material.

(138) "Radioactivity" means the transformation of unstable atoms by the emission of radiation.

(139) "Radiography" means the same as industrial radiography.

(140) "Reference man" means a hypothetical aggregation of human physical and physiological characteristics arrived at by international consensus. These characteristics may be used by researchers and public health workers to standardize results of experiments and to relate biological insult to a common base.

(141) "Registrant" means a person required by Chapter 3748. of the Revised Code to register radiation-generating equipment with the director.

(142) "Rem" means the special unit of any of the quantities expressed as dose equivalent. The dose equivalent in rem is equal to the absorbed dose in rads multiplied by the quality factor (one rem = 0.01 Sv).

(143) "Research and development" means

(a) Theoretical analysis, exploration, or experimentation; or

(b) The extension of investigative findings and theories of a scientific or technical nature into practical application for experimental and demonstration purposes, including the experimental production and testing of models, devices, equipment, materials and processes. "Research and development" does not include the internal or external administration of sources of radiation to human beings.

(144) "Residual radioactivity" means radioactivity in structures, materials, soils, groundwater, and other media at a site resulting from activities under the licensee's control. This includes radioactivity from all licensed and unlicensed sources used by the licensee, but excludes background radiation. It also includes radioactive materials remaining at the site as a result of routine or accidental releases of radioactive material at the site and previous burials at the site, even if those burials were made in accordance with the provisions of 10 C.F.R. 20 (as in effect on the effective date of this rule).

(145) "Respiratory protective equipment or device" means an apparatus, such as a respirator, used to reduce the individual's intake of airborne radioactive materials.

(146) "Restricted area" means an area access to which is limited by the licensee or registrant for the purpose of protecting individuals against undue risks from exposure to sources of radiation. Restricted area does not include areas used as residential quarters, but separate rooms in a residential building may be set apart as a restricted area.

(147) "Roentgen" means the amount of gamma or x-rays required to produce ions resulting in a charge of 0.000258 coulombs per kilogram of air under standard conditions.

(148) "Sanitary sewerage" means a system of public sewers for carrying off wastewater and refuse, but excluding sewage treatment facilities, septic tanks, and leach fields owned or operated by the licensee.

(149) "Sealed source" means radioactive material that is encased in a manner designed to prevent leakage or escape of the radioactive material.

(150) "Sealed source and device registry" means the national registry that contains all the registration certificates, generated by both the United States nuclear regulatory commission and the agreement states, that summarize the radiation safety information for the sealed sources and devices and describe the licensing and use conditions approved for the product.

(151) "Seismic area" means any area where the probability of a horizontal acceleration in rock of more than 0.3 times the acceleration of gravity in two hundred fifty years is greater than ten per cent, as designated by the United States geological survey.

(152) "Self-contained breathing apparatus" or "SCBA" means an atmosphere-supplying respirator for which the breathing air source is designed to be carried by the user.

(153) "Shallow dose equivalent" or "H_S" means the external exposure of the skin of the whole body or the skin of an extremity, is taken as the dose equivalent at a tissue depth of 0.007 centimeter, or seven milligrams per square centimeter.

(154) "Sievert" or "Sv" means the SI unit of any of the quantities expressed as dose equivalent. The dose equivalent in sieverts is equal to the absorbed dose in grays multiplied by the quality factor. One sievert equals one hundred rem.

(155) "Site area emergency" means events may occur, are in progress, or have occurred that could lead to a significant release of radioactive material and that could require a response by off-site response organizations to protect persons off-site.

(156) "Site boundary" means that line beyond which the land or property is not owned, leased, or otherwise controlled by the licensee or registrant.

(157) "Site closure and stabilization" means those actions that are taken upon completion of operations that prepare a disposal site for custodial care and that assure that the disposal site will remain stable and will not need ongoing active maintenance.

(158) "Source material" means uranium, thorium, or any combination thereof in any physical or chemical form, or any ores that contain by weight at least one-twentieth of one per cent (0.05 per cent) of uranium, thorium, or any combination thereof. Source material does not include special nuclear material.

(159) "Sources of radiation" means radioactive material or radiation generating equipment.

(160) "Special form radioactive material" means radioactive material that satisfies the following conditions:

(a) It is either a single solid piece or is contained in a sealed capsule that can be opened only by destroying the capsule;

(b) The piece or capsule has at least one dimension not less than five millimeters (0.2 inch); and

(c) It satisfies the test requirements specified by the United States nuclear regulatory commission in 10 C.F.R. 71.75 (as in effect on the effective date of this rule). A special form encapsulation designed in accordance with the United States nuclear regulatory commission requirements identified in 10 C.F.R. 71.4, in effect on June 30, 1983, and constructed prior to July 1, 1985; a special form encapsulation designed in accordance with the requirements of 10 C.F.R. 71.4 in effect on March 31, 1996, and constructed before April 1, 1998; and special form material that was successfully tested before September 10, 2015 in accordance with the requirements of 10 C.F.R. 71.75(d) of this section in effect before September 10, 2015 may continue to be used. Any other special form encapsulation must meet the specifications of this definition.

(161) "Special nuclear material" means either of the following:

(a) Plutonium, uranium-233, uranium enriched in the isotope 233, or in the isotope 235, and any other material that the United States nuclear regulatory commission determines to be special nuclear material, but does not include source material pursuant to section 51 of the Atomic Energy Act of 1954, 68 Stat 919, 42 USCA 2071, as amended (2005).

(b) Any material artificially enriched by any of the foregoing but does not include source material.

(162) "Special nuclear material in quantities not sufficient to form a critical mass" means uranium enriched in the isotope uranium-235 in quantities not exceeding three hundred fifty grams of contained uranium-235; uranium-233 in quantities not exceeding two hundred grams; plutonium in quantities not exceeding two hundred grams; or any combination of them in accordance with the following formula: for each kind of special nuclear material, determine the ratio between the quantity of that special nuclear material and the quantity specified in this paragraph for the same kind of special nuclear material. The sum of such ratios for all of the kinds of special nuclear material in combination shall not exceed unity.

(163) "Stochastic effect" means health effects that occur randomly and for which the probability of the effect occurring, rather than its severity, is assumed to be a linear function of dose without threshold. Hereditary effects and cancer incidence are examples of stochastic effects.

(164) "Supplied-air respirator" or "SAR" or "airline respirator" means an atmosphere-supplying respirator for which the source of breathing air is not designed to be carried by the user.

(165) "Surface contaminated object" or "SCO" means a solid object that is not itself classed as radioactive material, but which has radioactive material distributed on any of its surfaces. SCO must be in one of two groups with surface activity not exceeding the following limits:

(a) SCO-I: a solid object on which:

(i) The non-fixed contamination on the accessible surface averaged over three hundred square centimeters, or the area of the surface if less than three hundred square centimeters, does not exceed four becquerels per square centimeter (10^-4 microcurie per square centimeter) for beta and gamma and low toxicity alpha emitters, or 0.4 becquerels per square centimeter 10^-5 microcurie per square centimeter) for all other alpha emitters;

(ii) The fixed contamination on the accessible surface averaged over three hundred square centimeters, or the area of the surface if less than three hundred square centimeters, does not exceed forty thousand becquerels per square centimeter (one microcurie per square centimeter) for beta and gamma and low toxicity alpha emitters, or four thousand becquerels per square centimeter (0.1 microcurie per square centimeter) for all other alpha emitters; and

(iii) The non-fixed contamination plus the fixed contamination on the inaccessible surface averaged over three hundred square centimeters, or the area of the surface if less than three hundred square centimeters, does not exceed forty thousand becquerels per square centimeter (one microcurie per square centimeter) for beta and gamma and low toxicity alpha emitters, or four thousand becquerels per square centimeter (0.1 microcurie per square centimeter) for all other alpha emitters.

(b) SCO-II: a solid object on which the limits for SCO-I are exceeded and on which:

(i) The non-fixed contamination on the accessible surface averaged over three hundred square centimeters, or the area of the surface if less than three hundred square centimeter, does not exceed four hundred becquerels per square centimeter (10^-2 microcurie per square centimeter) for beta and gamma and low toxicity alpha emitters, or forty becquerels per square centimeter (10^-3 microcurie per square centimeter) for all other alpha emitters;

(ii) The fixed contamination on the accessible surface averaged over three hundred square centimeters, or the area of the surface if less than three hundred square centimeters, does not exceed eight hundred thousand becquerels per square centimeter (twenty microcuries per square centimeter) for beta and gamma and low toxicity alpha emitters, or eighty thousand becquerels per square centimeter (two microcuries per square centimeter) for all other alpha emitters; and

(iii) The non-fixed contamination plus the fixed contamination on the inaccessible surface averaged over three hundred square centimeters, or the area of the surface if less than three hundred square centimeters, does not exceed eight hundred thousand becquerels per square centimeter (twenty microcuries per square centimeter) for beta and gamma and low toxicity alpha emitters, or eighty thousand becquerels per square centimeter (two microcuries per square centimeter) for all other alpha emitters.

(166) "Survey" means an evaluation of the radiological conditions and potential hazards incident to the production, use, transfer, release, disposal or presence of radioactive material or other sources of radiation. When appropriate, such an evaluation includes a physical survey of the location of radioactive material, or the sources of radiation and measurements or calculations of levels of radiation, or concentrations or quantities of radioactive material present.

(167) "Tight-fitting facepiece" means a respiratory inlet covering that forms a complete seal with the face.

(168) "Total effective dose equivalent" or "TEDE" means the sum of the effective dose equivalent (for external exposures) and the committed effective dose equivalent (for internal exposures).

(169) "Transport index" means the dimensionless number, rounded up to the next tenth, placed on the label of a package, to designate the degree of control to be exercised by the carrier during transportation. The transport index is the number determined by multiplying the maximum radiation level in millisievert per hour at one meter (3.3 feet) from the external surface of the package by one hundred, which is equivalent to the maximum radiation level in millirem per hour at one meter (3.3 feet).

(170) "Type A quantity" means a quantity of radioactive material, the aggregate radioactivity of which does not exceed A₁ for special form radioactive material, or A₂ for normal form radioactive material, where A₁ and A₂ are given in rule 3701:1-50-25 of the Administrative Code.

(171) "Type B quantity" means a quantity of radioactive material greater than a type A quantity.

(172) "Type B package" is defined under "Package."

(173) "United States department of energy" means the department of energy established by the Department of Energy Organization Act, PL 95-91, 91 Stat. 565 (1977), 42 U.S.C. 7101 et seq., as amended (2006), to the extent that the department of energy or its duly authorized representatives, exercises functions formerly vested in the United States atomic energy commission, its chairman, members, officers and components and transferred to the United States energy research and development administration and to the administrator thereof pursuant to Sections 104(b) to (d) of the Energy Reorganization Act of 1974, PL 93-438, 88 Stat. 1233 at 1237 (1974), 42 U.S.C. 5814 and retransferred to the secretary of energy pursuant to Section 301(a) of the Department of Energy Organization Act, PL 95-91, 91 Stat. 565 at 577-578 (1977), 42 U.S.C. 7151.

(174) "Unrestricted area" or "uncontrolled area" means any area, access to which is neither restricted nor controlled by the licensee or registrant.

(175) "User seal check" or "fit check" means an action conducted by the respirator user to determine if the respirator is properly seated to the face. Examples include negative pressure check, positive pressure check, irritant smoke check, or isoamyl acetate check.

(176) "Very high radiation area" means an area, accessible to individuals, in which radiation levels from radiation sources external to the body could result in an individual receiving an absorbed dose in excess of five gray (five hundred rad) in one hour at one meter from a source of radiation or from any surface that the radiation penetrates. At very high doses received at high dose rates, units of absorbed dose, gray and rad, are appropriate, rather than units of dose equivalent, sievert and rem.

(177) "Veterinarian" means an individual licensed by the state of Ohio to practice veterinary medicine pursuant to Chapter 4741. of the Revised Code.

(178) "Waste" means those low-level radioactive wastes containing source, special nuclear, or byproduct material that are acceptable for disposal in a land disposal facility. For the purposes of this definition, low-level radioactive waste means radioactive waste not classified as high-level radioactive waste, transuranic waste, spent nuclear fuel, or byproduct material as defined in paragraph (A)(26)(b) of this rule, or byproduct material as defined in section 11 E. (3) and (4) of the Atomic Energy Act of 1954, 68 Stat. 919, 42 USC 2014, as amended (2005).

(179) "Week" means seven consecutive days starting on Sunday.

(180) "Weighting factor

• W_T" for an organ or tissue, (T), is the proportion of the risk of stochastic effects resulting from irradiation of that organ or tissue to the total risk of stochastic effects when the whole body is irradiated uniformly. For calculating the effective dose equivalent, the values of W_T are:

| Organ doseweighting factors | | | --- | --- | | Organ ortissue | W_T | | Gonads | 0.25 | | Breast | 0.15 | | Red bone marrow | 0.12 | | Lung | 0.12 | | Thyroid | 0.03 | | Bonesurfaces | 0.03 | | Remainder | 0.30^a | | Whole body | 1.00^b |

^\a 0.30 results from 0.06 for each of five "remainder" organs, excluding the skin and the lens of the eye, that receive the highest doses.

^\b for the purpose of weighting the external whole body dose (for adding it to the internal dose) a single weighting factor, W_T = 1.0, has been specified. The use of other weighting factors for external exposure will be approved on a case-by-case basis until such time as specific guidance is issued.

(181) "Whole body" means for purposes of external exposure, head; trunk, including male gonads; arms above the elbow; legs above the knee.

(182) "Worker" means an individual engaged in activities licensed or registered by the department and controlled by a licensee or registrant, but does not include the licensee or registrant.

(183) "Working level" or "WL" means any combination of short-lived radon decay products (for radon-222: polonium-218, lead-214, bismuth-214, and polonium-214; and for radon-220: polonium-216, lead-212, bismuth-212, and polonium-212) in one liter of air that will result in the ultimate emission of 1.3 x 10⁵ million electron volts alpha particle energy.

(184) "Working level month" or "WLM" means a cumulative exposure to one working level for one hundred seventy hours. (Two thousand working hours per year/twelve months per year equals approximately one hundred seventy hours per month.)

(185) "Year" means the period of time beginning in January used to determine compliance with the provisions of this rule. The licensee or registrant may change the starting date of the year used to determine compliance by the licensee or registrant provided that the change is made at the beginning of the year and that no day is omitted or duplicated in consecutive years.

(B) The terms set out in paragraph (A) of this rule may be redefined in other chapters as promulgated pursuant to Chapter 3748. of the Revised Code as used in that chapter only.

Last updated May 13, 2026 at 11:20 AM

History

• Effective: January 20, 2022
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-50-25

This rule was filed with the Legislative Service Commission in PDF format and is presented here as filed.

View Rule Text

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Last updated May 18, 2023 at 11:21 AM

History

• Effective: May 15, 2023
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-38-12

(A) Except in the case of a planned special exposure pursuant to paragraph (F) of this rule, a licensee or registrant shall limit the occupational dose received by an individual adult, as follows:

(1) An annual limit, which is the more limiting of:

(a) The total effective dose equivalent being equal to 0.05 sievert (five rem); or

(b) The sum of the deep dose equivalent and the committed dose equivalent to any individual organ or tissue other than the lens of the eye being equal to 0.5 sievert (fifty rem).

(2) The annual limits to the lens of the eye, to the skin of the whole body, and to the skin of the extremities, which are:

(a) A lens dose equivalent of 0.15 sievert (fifteen rem), and

(b) A shallow-dose equivalent of 0.5 sievert (fifty rem) to the skin of the whole body or to the skin of any extremity.

(3) Doses received in excess of the annual limits, including doses received during accidents, emergencies, and planned special exposures, shall be subtracted from the limits for planned special exposures that the individual may receive during the current calendar year and during the individual's lifetime in accordance with paragraph (F)(5) of this rule.

(4) When the external exposure is determined by measurement with an external personal monitoring device, the deep-dose equivalent must be used in place of the effective dose equivalent, unless the effective dose equivalent is determined by a dosimetry method approved by the director. The assigned deep-dose equivalent must be for the part of the body receiving the highest exposure.

(a) The assigned shallow-dose equivalent must be the dose averaged over the contiguous ten square centimeters of skin receiving the highest exposure. The deep-dose equivalent, lens-dose equivalent, and shallow-dose equivalent may be assessed from surveys or other radiation measurements for the purpose of demonstrating compliance with the occupational dose limits, if the individual monitoring device was not in the region of highest potential exposure, or the results of individual monitoring are unavailable; or

(b) When a protective apron is worn while working with radiation-generating equipment and monitoring is conducted as specified in paragraph (C)(1) of rule 3701:1-38-14 of the Administrative Code, the effective dose equivalent for external radiation shall be determined as follows:

(i) When only one individual monitoring device is used and it is located at the neck outside the protective apron, the reported deep dose equivalent value multiplied by 0.3 shall be the effective dose equivalent for external radiation; or

(ii) When two individual monitoring devices are worn, one under the protective apron at the waist and the other outside the protective apron at the neck, the effective dose equivalent for external radiation shall be assigned the value of the sum of the deep dose equivalent reported for the individual monitoring device located at the waist under the protective apron multiplied by 1.5 and the deep dose equivalent reported for the individual monitoring device located at the neck outside the protective apron multiplied by 0.04; or

(iii) Through the use of computational methods endorsed by the "American National Standards Institute", recommended by the "National Council on Radiation Protection and Measurements", or approved by the director.

(5) Derived air concentration (DAC) and annual limit on intake (ALI) values are specified in appendix C to this rule and may be used by the licensee to determine the individual's dose and to demonstrate compliance with the occupational dose limits. Appendices A and B are explanatory supplements to appendix C to this rule. Notwithstanding the annual dose limits, the licensee shall limit the soluble uranium intake by an individual to ten milligrams in a week in consideration of chemical toxicity.

(6) In accordance with paragraph (E) of this rule, the licensee or registrant shall reduce the dose that an individual may be allowed to receive in the current year by the amount of occupational dose received while employed by any other person.

(B) Compliance with requirements for summation of external and internal doses shall be in accordance with the following:

(1) If the licensee is required to monitor under both paragraphs (B)(1) and (B)(2) of rule 3701:1-38-14 of the Administrative Code, the licensee shall demonstrate compliance with the dose limits by summing external and internal doses. If the licensee is required to monitor only under paragraph (B)(1) or only under paragraph (B)(2) of rule 3701:1-38-14 of the Administrative Code, then summation is not required to demonstrate compliance with the dose limits. The licensee may demonstrate compliance with the requirements for summation of external and internal doses by meeting one of the conditions specified in paragraph (B)(2) of this rule and the conditions in paragraphs (B)(3) and (B)(4) of this rule. The dose equivalents for the lens of the eye, the skin, and the extremities are not included in the summation, but are subject to separate limits.

(2) If the only intake of radionuclides is by inhalation, the total effective dose equivalent limit is not exceeded if the sum of the deep dose equivalent divided by the total effective dose equivalent limit, plus one of the following does not exceed unity:

(a) The sum of the fractions of the inhalation ALI for each radionuclide; or

(b) The total number of derived air concentration-hours, or DAC-hours, for all radionuclides divided by two thousand; or

(c) The sum of the calculated committed effective dose equivalents to all significantly irradiated organs or tissues (T) calculated from bioassay data using appropriate biological models and expressed as a fraction of the annual limit. For purposes of this requirement, an organ or tissue is deemed to be significantly irradiated if, for that organ or tissue, the product of the weighting factors, W_T, and the committed dose equivalent, H_T,50, per unit intake is greater than ten per cent of the maximum weighted value of H_T,50, that is, W_TH_T,50, per unit intake for any organ or tissue.

(3) If the occupationally exposed individual also receives an intake of radionuclides by oral ingestion greater than ten percent of the applicable oral ALI, the licensee shall account for this intake and include it in demonstrating compliance with the limits set forth in paragraph (A) of this rule.

(4) The licensee shall evaluate and, to the extent practical, account for intakes through wounds or skin absorption. The intake through intact skin has been included in the calculation of DAC for hydrogen-3 and does not need to be further evaluated or accounted for pursuant to this paragraph.

(C) Determination of external dose from airborne radioactive material shall be in accordance with the following:

(1) When determining the dose from airborne radioactive material, the licensee shall include the contribution to the deep dose equivalent, lens dose equivalent, and shallow dose equivalent from external exposure to the radioactive cloud as specified in appendix C to this rule, footnotes ^A and ^B.

(2) The licensee should not use airborne radioactivity measurements or DAC values as the primary means to assess the deep dose equivalent when the airborne radioactive material includes radionuclides other than noble gases, or if the cloud of airborne radioactive material is not relatively uniform. The determination of the deep dose equivalent to an individual should be based upon measurements using instruments or individual monitoring devices.

(D) Determination of internal exposure shall be in accordance with the following:

(1) For purposes of assessing dose used to determine compliance with occupational dose equivalent limits, the licensee shall, when required under paragraph (B) of rule 3701:1-38-14 of the Administrative Code, take suitable and timely measurements of:

(a) Concentrations of radioactive materials in air in work areas; or

(b) Quantities of radionuclides in the body; or

(c) Quantities of radionuclides excreted from the body; or

(d) Combinations of these measurements.

(2) Unless respiratory protective equipment is used, as provided in paragraph (C) of rule 3701:1-38-16 of the Administrative Code or the assessment of intake is based on bioassays, the licensee shall assume that an individual inhales radioactive material at the airborne concentration in which the individual is present.

(3) When specific information on the physical and biochemical properties of the radionuclides taken into the body or the behavior of the material in an individual is known, the licensee may:

(a) Use that information to calculate the committed effective dose equivalent, and, if used, the licensee shall document that information in the individual's record; and

(b) Upon prior approval of the department, adjust the DAC or ALI values to reflect the actual physical and chemical characteristics of airborne radioactive material, for example, aerosol size distribution or density; and

(c) Separately assess the contribution of fractional intakes of Class D, W, or Y compounds of a given radionuclide to the committed effective dose equivalent as specified in appendix A to this rule.

(4) If the licensee chooses to assess intakes of Class Y material using the measurements given in paragraph (D)(1)(b) or (D)(1)(c) of this rule in order to make additional measurements basic to the assessments, the licensee may delay the recording and reporting of the assessments for periods up to seven months, unless otherwise required by paragraph (B)(2) or (C) of rule 3701:1-38-21 of the Administrative Code.

(5) If the identity and concentration of each radionuclide in a mixture are known, the fraction of the DAC applicable to the mixture for use in calculating DAC-hours shall be either:

(a) The sum of the ratios of the concentration to the appropriate DAC value, that is, D, W, or Y, from appendix C to this rule for each radionuclide in the mixture; or

(b) The ratio of the total concentration for all radionuclides in the mixture to the most restrictive DAC value for any radionuclide in the mixture.

(6) If the identity of each radionuclide in a mixture is known, but the concentration of one or more of the radionuclides in the mixture is not known, the DAC for the mixture shall by the most restrictive DAC of any radionuclide in the mixture.

(7) When a mixture of radionuclides in air exists, a licensee may disregard certain radionuclides in the mixture if all of the following occur:

(a) The licensee uses the total activity of the mixture in demonstrating compliance with the dose limits in paragraph (A) of this rule and in complying with the monitoring requirements in paragraph (B) of rule 3701:1-38-14 of the Administrative Code;

(b) The concentration of any radionuclide disregarded is less than ten percent of its DAC; and

(c) The sum of these percentages for all of the radionuclides disregarded in the mixture does not exceed thirty percent.

(8) When determining the committed effective dose equivalent, the licensee may consider the following:

(a) In order to calculate the committed effective dose equivalent, the licensee may assume that the inhalation of one ALI, or an exposure of two thousand DAC-hours, results in a committed effective dose equivalent of 0.05 sievert (five rem), for radionuclides that have their ALIs or DACs based on the committed effective dose equivalent; or

(b) For an ALI and the associated DAC determined by the nonstochastic organ dose limit of 0.5 sievert (fifty rem), the intake of radionuclides that would result in a committed effective dose equivalent of 0.05 sievert (five rem), that is, the stochastic ALI, is listed in parentheses in table I of appendix C to this rule. The licensee may, as a simplifying assumption, use the stochastic ALI to determine committed effective dose equivalent. However, if the licensee uses the stochastic ALI, the licensee shall also demonstrate that the limit in paragraph (A)(1)(b) of this rule is met.

(E) Determination of prior occupational dose shall be made in accordance with the following:

(1) For each individual who is likely to receive an annual occupational dose requiring monitoring pursuant to paragraph (B) of rule 3701:1-38-14 of the Administrative Code, the licensee or registrant shall determine the occupational radiation dose received during the current year.

(2) Prior to permitting an individual to participate in a planned special exposure, the licensee shall determine:

(a) The internal and external doses from all previous planned special exposures; and

(b) All doses in excess of the limits, including doses received during accidents and emergencies, received during the lifetime of the individual.

(3) In complying with the requirements of paragraph (E)(1) or (E)(2) of this rule, a licensee or registrant may:

(a) Accept, as a record of the occupational dose that the individual received during the current year, a written signed statements from the individual, or from the individual's most recent employer for work involving radiation exposure, that discloses the nature and the amount of any occupational dose that the individual may have received during the current year;

(b) Accept, as the record of lifetime cumulative radiation dose, a current department form entitled "lifetime occupational exposure history" or equivalent, signed by the individual and countersigned by an appropriate official of the most recent employer for work involving radiation exposure, or the individual's current employer, if the individual is not employed by the licensee or registrant; and

(c) Obtain reports of the individual's dose equivalent from the most recent employer for work involving radiation exposure, or the individual's current employer, if the individual is not employed by the licensee or registrant, by telephone, telegram, facsimile, e-mail or letter. The licensee or registrant shall request a written verification of the dose data if the authenticity of the transmitted report cannot be established.

(4) The licensee or registrant shall record the exposure history, as required by paragraph (A) of this rule, on a form provided by the department or other clear and legible record, of all the information required on that form. The form or record shall show each period in which the individual received occupational exposure to radiation or radioactive material and shall be signed by the individual who received the exposure. For each period for which the licensee or registrant obtains reports, the licensee or registrant shall use the dose shown in the report in preparing the exposure history form. For any period in which the licensee or registrant does not obtain a report, the licensee or registrant shall place a notation on the exposure history form indicating the periods of time for which data are not available.

(5) If the licensee or registrant is unable to obtain a complete record of an individual's current and previously accumulated occupational dose, the licensee or registrant shall assume:

(a) In establishing administrative controls pursuant to paragraph (A)(6) of this rule for the current year, that the allowable dose limit for the individual is reduced by 12.5 millisievert (1.25 rem), for each quarter for which records were unavailable and the individual was engaged in activities that could have resulted in occupational radiation exposure; and

(b) That the individual is not available for planned special exposures.

(6) The licensee or registrant shall retain the records on the exposure history form until the department terminates each pertinent license or registration requiring this record. The licensee or registrant shall retain records used in preparing the exposure history form for three years after the record is made.

(F) A planned special exposure may be authorized by a licensee in accordance with this paragraph. A licensee may authorize an adult worker to receive doses in addition to and accounted for separately from the doses received under the limits specified in paragraph (A) of this rule provided that each of the following is satisfied:

(1) The licensee authorizes a planned special exposure only in an exceptional situation when alternatives that might avoid the higher exposure are unavailable or impractical;

(2) The licensee and employer, if the employer is not the licensee, specifically authorizes the planned special exposure, in writing, before the exposure occurs;

(3) Before a planned special exposure, the licensee ensures that each individual involved is:

(a) Informed of the purpose of the planned operation; and

(b) Informed of the estimated doses and associated potential risks and specific radiation levels or other conditions that might be involved in performing the task; and

(c) Instructed in the measures to be taken to keep the dose ALARA considering other risks that may be present;

(4) Prior to permitting an individual to participate in a planned special exposure, the licensee ascertains prior doses as required by paragraph (E)(2) of this rule during the lifetime of the individual for each individual involved;

(5) The licensee shall not authorize a planned special exposure that would cause an individual to receive a dose from all planned special exposures and all doses in excess of the limits to exceed:

(a) The numerical values of any of the dose limits in paragraph (A) of this rule in any calendar year; and

(b) Five times the annual dose limits specified in paragraph (A) of this rule during the individual's lifetime;

(6) The licensee maintains records of the conduct of a planned special exposure in accordance with paragraph (E) of rule 3701:1-38-20 of the Administrative Code and submits a written report in accordance with paragraph (D) of rule 3701:1-38-21 of the Administrative Code;

(7) The licensee records the best estimate of the dose resulting from the planned special exposure in the individual's record and informs the individual, in writing, of the dose within thirty days from the date of the planned special exposure. The dose from planned special exposures shall not be considered in controlling future occupational dose of the individual pursuant to paragraph (A)(1) of this rule, but shall be included in evaluations required by paragraphs (F)(4) and (F)(5) of this rule.

(G) Occupational dose limits for minors shall be ten per cent of the annual occupational dose limits specified for adult workers in paragraph (A) of this rule.

(H) Dose equivalent to an embryo or fetus shall be in accordance with the following:

(1) The licensee or registrant shall ensure that the dose equivalent to an embryo or fetus during the entire pregnancy, due to occupational exposure of a declared pregnant woman, does not exceed five millisievert (0.5 rem). Records shall be maintained in accordance with paragraph (I) of rule 3701:1-38-20 of the Administrative Code.

(2) The licensee or registrant shall make efforts to avoid substantial variation above a uniform monthly exposure rate to a declared pregnant woman so as to satisfy the limit in paragraph (H)(1) of this rule.

(3) The dose equivalent to the embryo or fetus is the sum of:

(a) The deep-dose equivalent to the declared pregnant woman; and

(b) The dose equivalent to the embryo or fetus resulting from radionuclides in the embryo or fetus and from radionuclides in the declared pregnant woman.

(4) If the declared pregnant woman's exposure includes exposure from radiation generating equipment and a protective apron is worn, the dose equivalent to an embryo or fetus shall be taken as the sum of:

(a) The dose equivalent to the embryo or fetus from radionuclides in the embryo or fetus and radionuclides in the declared pregnant woman; and

(b) The dose equivalent that is most representative of the dose to the embryo or fetus from external radiation, that is, in the mother's lower torso region.

(i) If multiple measurements have not been made, assignment of the highest deep dose equivalent for the declared pregnant woman shall be the dose to the embryo or fetus, in accordance with paragraph (A)(4) of this rule; or

(ii) If multiple measurements have been made, assignment of the deep dose equivalent for the declared pregnant woman from the individual monitoring device which is most representative of the dose to the embryo or fetus shall be the dose to the embryo or fetus. Assignment of the highest deep dose equivalent for the declared pregnant woman to the embryo or fetus is not required unless that dose is also the most representative deep dose equivalent for the region of the embryo or fetus.

(5) If by the time the woman declares pregnancy to the licensee or registrant, the dose equivalent to the embryo or fetus has exceeded five millisievert, or 0.5 rem, the licensee or registrant shall be deemed to be in compliance with paragraph (A) of this rule, provided that the additional dose equivalent to the embryo or fetus does not exceed 0.5 millisievert (0.05 rem), during the remainder of the pregnancy.

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Last updated November 2, 2022 at 2:10 PM

History

• Effective: October 4, 2010
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-50-13

Fissile material meeting the requirements of at least one of the paragraphs (A) to (F) of this rule are exempt from classification as fissile material and from the fissile material package standards of 10 C.F.R. 71.55 and 10 C.F.R. 71.59 (as in effect on the effective date of this rule), but are subject to all other requirements of this chapter, except as noted.

(A) Individual package containing two grams or less fissile material.

(B) Individual or bulk packaging containing fifteen grams or less of fissile material provided the package has at least two hundred grams of solid nonfissile material for every gram of fissile material. Lead, beryllium, graphite, and hydrogenous material enriched in deuterium may be present in the package but must not be included in determining the required mass for solid nonfissile material.

(C)

(1) Low concentrations of solid fissile material commingled with solid nonfissile material, provided that:

(a) There is at least two thousand grams of solid nonfissile material for every gram of fissile material, and

(b) There is no more than one hundred eighty grams of fissile material distributed within three hundred sixty kilograms of contiguous nonfissile material.

(2) Lead, beryllium, graphite, and hydrogenous material enriched in deuterium may be present in the package but must not be included in determining the required mass of solid nonfissile material.

(D) Uranium enriched in uranium-235 to a maximum of one per cent by weight, and with total plutonium and uranium-233 content of up to one per cent of the mass of uranium-235, provided that the mass of any beryllium, graphite, and hydrogenous material enriched in deuterium constitutes less than five per cent of the uranium mass, and that the fissile material is distributed homogeneously and does not form a lattice arrangement within the package.

(E) Liquid solutions of uranyl nitrate enriched in uranium-235 to a maximum of two per cent by mass, with a total plutonium and uranium-233 content not exceeding 0.002 per cent of the mass of uranium, and with a minimum nitrogen to uranium atomic ratio (N/U) of two. The material must be contained in at least DOT type A package.

(F) Packages containing, individually, a total plutonium mass of not more than one thousand grams, of which not more than twenty per cent by mass may consist of plutonium-239, plutonium-241, or any combination of these radionuclides.

History

• Effective: February 15, 2021
• Promulgated Under: 119.03

Ohio Adm.Code 3745-51-03

(A) A "waste," as defined in rule 3745-51-02 of the Administrative Code, is a "hazardous waste" if:

(1) The waste is not excluded from regulation as a hazardous waste under paragraph (B) of rule 3745-51-04 of the Administrative Code; and

(2) The waste meets any of the following criteria:

(a) The waste exhibits any of the characteristics of hazardous waste identified in rules 3745-51-20 to 3745-51-24 of the Administrative Code. However, any mixture of a waste from the extraction, beneficiation, and processing of ores and minerals excluded under paragraph (B)(7) of rule 3745-51-04 of the Administrative Code and any other waste exhibiting a characteristic of hazardous waste under rules 3745-51-20 to 3745-51-24 of the Administrative Code is a hazardous waste only if such mixture exhibits a characteristic that would not have been exhibited by the excluded waste alone if such mixture had not occurred, or if such mixture continues to exhibit any of the characteristics exhibited by the non-excluded wastes prior to mixture. Further, for the purposes of applying the toxicity characteristic leaching procedure to such mixtures, the mixture is also a hazardous waste if such mixture exceeds the maximum concentration for any contaminant listed in the table in rule 3745-51-24 of the Administrative Code that would not have been exceeded by the excluded waste alone if the mixture had not occurred or if such mixture continues to exceed the maximum concentration for any contaminant exceeded by the nonexempt waste prior to mixture.

(b) The waste is listed in rules 3745-51-30 to 3745-51-35 of the Administrative Code and has not been excluded from the lists in rules 3745-51-30 to 3745-51-35 of the Administrative Code under 40 CFR 260.20 and 40 CFR 260.22.

(c) [Reserved.]

(d) The waste is a mixture of waste and one or more hazardous wastes listed in rules 3745-51-30 to 3745-51-35 of the Administrative Code and has not been excluded from paragraph (A)(2) of this rule under 40 CFR 260.20 and 40 CFR 260.22, paragraph (G) of this rule, or paragraph (H) of this rule. However, the following mixtures of wastes and hazardous wastes listed in rules 3745-51-30 to 3745-51-35 of the Administrative Code are not hazardous wastes [except by application of paragraph (A)(2)(a) or (A)(2)(b) of this rule] if the generator can demonstrate that the mixture consists of wastewater, the discharge of which is subject to regulation under either Section 402 or Section 307(b) of the Clean Water Act (CWA) (including wastewater at facilities which have eliminated the discharge of wastewater) and:

(i) One or more of the following spent solvents listed in rule 3745-51-31 of the Administrative Code - benzene, carbon tetrachloride, tetrachloroethylene, trichloroethylene or the scrubber waters derived-from the combustion of these spent solvents- provided that the maximum total weekly usage of these solvents (other than the amounts that can be demonstrated not to be discharged to wastewater) divided by the average weekly flow of wastewater into the headworks of the facility's wastewater treatment or pretreatment system does not exceed one part per million; or the total measured concentration of these solvents entering the headworks of the facility's wastewater treatment system (at facilities subject to regulation under the Clean Air Act (CAA) at 40 CFR Part 60, 40 CFR Part 61, or 40 CFR Part 63, or at facilities subject to an enforceable limit in a federal operating permit that minimizes fugitive emissions), does not exceed one part per million on an average weekly basis. Any facility that uses benzene as a solvent and claims this exemption shall use an aerated biological wastewater treatment system and shall use only lined surface impoundments or tanks prior to secondary clarification in the wastewater treatment system. Facilities that choose to measure concentration levels shall file a copy of the facility's sampling and analysis plan with the regional administrator, or the director, as the context requires. A facility shall file a copy of a revised sampling and analysis plan only if the initial plan is rendered inaccurate by changes in the facility's operations. The sampling and analysis plan shall include the monitoring point location (headworks), the sampling frequency and methodology, and a list of constituents to be monitored. A facility is eligible for the direct monitoring option once the facility receives confirmation that the sampling and analysis plan has been received by the director. The director may reject the sampling and analysis plan if the director finds that the sampling and analysis plan fails to include the information required in this paragraph, or if the plan parameters would not enable the facility to accurately calculate the weekly average concentration of these chemicals. If the director rejects the sampling and analysis plan, or if the director finds that the facility is not following the sampling and analysis plan, the director shall notify the facility to cease the use of the direct monitoring option until such time as the bases for rejection are corrected; or

(ii) One or more of the following spent solvents listed in rule 3745-51-31 of the Administrative Code - methylene chloride, 1,1,1-trichloroethane, chlorobenzene, o-dichlorobenzene, cresols, cresylic acid, nitrobenzene, toluene, methyl ethyl ketone, carbon disulfide, isobutanol, pyridine, spent chlorofluorocarbon solvents, 2-ethoxyethanol, or the scrubber waters derived-from the combustion of these spent solvents - provided that the maximum total weekly usage of these solvents (other than the amounts that can be demonstrated not to be discharged to wastewater) divided by the average weekly flow of wastewater into the headworks of the facility's wastewater treatment or pretreatment system does not exceed twenty-five parts per million, or the total measured concentration of these solvents entering the headworks of the facility's wastewater treatment system (at facilities subject to regulation under the CAA at 40 CFR Part 60, 40 CFR Part 61, or 40 CFR Part 63, or at facilities subject to an enforceable limit in a federal operating permit that minimizes fugitive emissions), does not exceed twenty-five parts per million on an average weekly basis. Facilities that choose to measure concentration levels shall file a copy of the facility's sampling and analysis plan with the regional administrator, or the director, as the context requires. A facility shall file a copy of a revised sampling and analysis plan only if the initial plan is rendered inaccurate by changes in the facility's operations. The sampling and analysis plan shall include the monitoring point location (headworks), the sampling frequency and methodology, and a list of constituents to be monitored. A facility is eligible for the direct monitoring option once the facility receives confirmation that the sampling and analysis plan has been received by the director. The director may reject the sampling and analysis plan if the director finds that the sampling and analysis plan fails to include the information required in this paragraph, or if the plan parameters would not enable the facility to accurately calculate the weekly average concentration of these chemicals. If the director rejects the sampling and analysis plan, or if the director finds that the facility is not following the sampling and analysis plan, the director shall notify the facility to cease the use of the direct monitoring option until such time as the bases for rejection are corrected; or

(iii) One of the following wastes listed in rule 3745-51-32 of the Administrative Code, provided that the wastes are discharged to the refinery oil recovery sewer before primary oil or water or solids separation - heat exchanger bundle cleaning sludge from the petroleum refining industry (EPA hazardous waste number K050), crude oil storage tank sediment from petroleum refining operations (EPA hazardous waste number K169), clarified slurry oil tank sediment or in-line filter solids or separation solids from petroleum refining operations (EPA hazardous waste number K170), spent hydrotreating catalyst (EPA hazardous waste number K171), and spent hydrorefining catalyst (EPA hazardous waste number K172); or

(iv) A discarded hazardous waste, commercial chemical product, or chemical intermediate listed in rules 3745-51-31 to 3745-51-33 of the Administrative Code, arising from de minimis losses of these materials. For purposes of this paragraph, "de minimis losses" are inadvertent releases to a wastewater treatment system, including those from normal material handling operations (e.g., spills from the unloading or transfer of materials from bins or other containers, leaks from pipes, valves, or other devices used to transfer materials); minor leaks of process equipment, storage tanks, or containers; leaks from well-maintained pump packings and seals; sample purgings; relief device discharges; discharges from safety showers and rinsing and cleaning of personal safety equipment; and rinsate from empty containers or from containers that are rendered empty by that rinsing. Any manufacturing facility that claims an exemption for de minimis quantities of wastes listed in rules 3745-51-31 to 3745-51-32 of the Administrative Code, or any non-manufacturing facility that claims an exemption for de minimis quantities of wastes listed in rules 3745-51-30 to 3745-51-35 of the Administrative Code, either shall have eliminated the discharge of wastewaters or shall have included in the facility's CWA permit application or submittal to the facility's pretreatment control authority the constituents for which each waste was listed (in the appendix to rule 3745-51-30 of the Administrative Code); and the constituents in the table "Treatment Standards for Hazardous Wastes" in rule 3745-270-40 of the Administrative Code for which each waste has a treatment standard (i.e., land disposal restriction constituents). A facility is eligible to claim the exemption once the permit writer or control authority has been notified of possible de minimis releases via the CWA permit application or the pretreatment control authority submittal. A copy of the CWA permit application or the submittal to the pretreatment control authority shall be placed in the facility's on-site files; or

(v) Wastewater resulting from laboratory operations containing toxic (T) wastes listed in rules 3745-51-30 to 3745-51-35 of the Administrative Code, provided that the annualized average flow of laboratory wastewater does not exceed one per cent of total wastewater flow into the headworks of the facility's wastewater treatment or pretreatment system, or provided the wastes' combined annualized average concentration does not exceed one part per million in the headworks of the facility's wastewater treatment or pretreatment facility. Toxic (T) wastes used in laboratories that are demonstrated not to be discharged to wastewater are not to be included in this calculation; or

(vi) One or more of the following wastes listed in rule 3745-51-32 of the Administrative Code - wastewaters from the production of carbamates and carbamoyl oximes (EPA hazardous waste number K157) - provided that the maximum weekly usage of formaldehyde, methyl chloride, methylene chloride, and triethylamine (including all amounts that cannot be demonstrated to be reacted in the process, destroyed through treatment, or is recovered, i.e., what is discharged or volatilized) divided by the average weekly flow of process wastewater prior to any dilutions into the headworks of the facility's wastewater treatment system does not exceed a total of five parts per million by weight; or the total measured concentration of these chemicals entering the headworks of the facility's wastewater treatment system (at facilities subject to regulation under the CAA at 40 CFR Part 60, 40 CFR Part 61, or 40 CFR Part 63, or at facilities subject to an enforceable limit in a federal operating permit that minimizes fugitive emissions), does not exceed five parts per million on an average weekly basis. Facilities that choose to measure concentration levels shall file a copy of the facility's sampling and analysis plan with the regional administrator, or the director, as the context requires. A facility shall file a copy of a revised sampling and analysis plan only if the initial plan is rendered inaccurate by changes in the facility's operations. The sampling and analysis plan shall include the monitoring point location (headworks), the sampling frequency and methodology, and a list of constituents to be monitored. A facility is eligible for the direct monitoring option once the facility receives confirmation that the sampling and analysis plan has been received by the director. The director may reject the sampling and analysis plan if the director finds that the sampling and analysis plan fails to include the information required in this paragraph, or if the plan parameters would not enable the facility to accurately calculate the weekly average concentration of these chemicals. If the director rejects the sampling and analysis plan, or if the director finds that the facility is not following the sampling and analysis plan, the director shall notify the facility to cease the use of the direct monitoring option until such time as the bases for rejection are corrected; or

(vii) Wastewaters derived-from the treatment of one or more of the following wastes listed in rule 3745-51-32 of the Administrative Code- organic waste (including heavy ends, still bottoms, light ends, spent solvents, filtrates, and decantates) from the production of carbamates and carbamoyl oximes (EPA hazardous waste number K156) - provided that the maximum concentration of formaldehyde, methyl chloride, methylene chloride, and triethylamine prior to any dilutions into the headworks of the facility's wastewater treatment system does not exceed a total of five milligrams per liter or the total measured concentration of these chemicals entering the headworks of the facility's wastewater treatment system (at facilities subject to regulation under the CAA at 40 CFR Part 60, 40 CFR Part 61, or 40 CFR Part 63, or at facilities subject to an enforceable limit in a federal operating permit that minimizes fugitive emissions), does not exceed five milligrams per liter on an average weekly basis. Facilities that choose to measure concentration levels shall file a copy of the facility's sampling and analysis plan with the regional administrator, or the director, as the context requires. A facility shall file a copy of a revised sampling and analysis plan only if the initial plan is rendered inaccurate by changes in the facility's operations. The sampling and analysis plan shall include the monitoring point location (headworks), the sampling frequency and methodology, and a list of constituents to be monitored. A facility is eligible for the direct monitoring option once the facility receives confirmation that the sampling and analysis plan has been received by the director. The director may reject the sampling and analysis plan if the director finds that the sampling and analysis plan fails to include the information required in this paragraph, or if the plan parameters would not enable the facility to accurately calculate the weekly average concentration of these chemicals. If the director rejects the sampling and analysis plan, or if the director finds that the facility is not following the sampling and analysis plan, the director shall notify the facility to cease the use of the direct monitoring option until such time as the bases for rejection are corrected.

(e) Rebuttable presumption for used oil. Used oil containing more than one thousand parts per million total halogens is presumed to be a hazardous waste because the used oil has been mixed with halogenated hazardous waste listed in rules 3745-51-30 to 3745-51-35 of the Administrative Code. Persons may rebut this presumption by demonstrating that the used oil does not contain hazardous waste (for example, to show that the used oil does not contain significant concentrations of halogenated hazardous constituents listed in the appendix to rule 3745-51-11 of the Administrative Code).

(i) The rebuttable presumption does not apply to metalworking oils or fluids containing chlorinated paraffins, if they are processed, through a tolling agreement, to reclaim metalworking oils or fluids. The presumption does apply to metalworking oils or fluids if such oils or fluids are recycled in any other manner, or disposed.

(ii) The rebuttable presumption does not apply to used oils contaminated with chlorofluorocarbons (CFCs) removed from refrigeration units where the CFCs are destined for reclamation. The rebuttable presumption does apply to used oils contaminated with CFCs that have been mixed with used oil from sources other than refrigeration units.

(B) A waste which is not excluded from regulation under paragraph (A)(1) of this rule becomes a hazardous waste when any of the following events occur:

(1) In the case of a waste listed in rules 3745-51-30 to 3745-51-35 of the Administrative Code, when the waste first meets the listing description in rules 3745-51-30 to 3745-51-35 of the Administrative Code.

(2) In the case of a mixture of waste and one or more listed hazardous wastes, when a hazardous waste listed in rules 3745-51-30 to 3745-51-35 of the Administrative Code is first added to the waste.

(3) In the case of any other waste (including a waste mixture), when the waste exhibits any of the characteristics identified in rules 3745-51-20 to 3745-51-24 of the Administrative Code.

(C) Unless and until a hazardous waste meets the criteria of paragraph (D) of this rule:

(1) A hazardous waste will remain a hazardous waste.

(2)

(a) Except as otherwise provided in paragraph (C)(2)(b), (G), or (H) of this rule, any waste generated from the treatment, storage, or disposal of a hazardous waste, including any sludge, spill residue, ash emission control dust, or leachate (but not including precipitation run-off) is a hazardous waste. (However, materials that are reclaimed from wastes and that are used beneficially are not wastes and hence are not hazardous wastes under this provision unless the reclaimed material is burned for energy recovery or used in a manner constituting disposal.)

(b) The following wastes are not hazardous even though the wastes are generated from the treatment, storage, or disposal of a hazardous waste, unless the wastes exhibit one or more of the characteristics of hazardous waste:

(i) Waste pickle liquor sludge generated by lime stabilization of spent pickle liquor from the iron and steel industry (SIC codes 331X and 332X).

(ii) Waste from burning any of the materials exempted from regulation by paragraphs (A)(3)(c) and (A)(3)(d) of rule 3745-51-06 of the Administrative Code.

(iii)

(a) Nonwastewater residues, such as slag, resulting from high temperature metals recovery (HTMR) processing of K061, K062, or F006 waste, in units defined as rotary kilns, flame reactors, electric furnaces, plasma arc furnaces, slag reactors, rotary hearth furnance or electric furnace combinations, or industrial furnaces [as defined in subparagraphs (f), (g), and (m) of "industrial furnace" in rule 3745-50-10 of the Administrative Code], that are disposed in licensed solid waste landfills, provided that these residues meet the generic exclusion levels identified in the table in this paragraph for all constituents, and exhibit no characteristics of hazardous waste. Testing requirements shall be incorporated in a facility's waste analysis plan or a generator's self-implementing waste analysis plan. At a minimum, composite samples of residues shall be collected and analyzed quarterly or when the process or operation generating the waste changes. Persons claiming this exclusion in an enforcement action will have the burden of proving by clear and convincing evidence that the material meets all the exclusion requirements.

| Table | | | --- | --- | | Constituent | Maximum for any single composite sample - TCLP(mg/L) | | Generic exclusion levels for K061 and K062 nonwastewater HTMRresidues | | | Antimony | 0.1 | | Arsenic | 0.5 | | Barium | 7.6 | | Beryllium | 0.01 | | Cadmium | 0.05 | | Chromium (total) | 0.33 | | Lead | 0.15 | | Mercury | 0.009 | | Nickel | 1.0 | | Selenium | 0.16 | | Silver | 0.3 | | Thallium | 0.02 | | Zinc | 70.0 | | Generic exclusion levels for F006 nonwastewater HTMRresidues | | | Antimony | 0.1 | | Arsenic | 0.5 | | Barium | 7.6 | | Beryllium | 0.01 | | Cadmium | 0.05 | | Chromium (total) | 0.33 | | Cyanide (total) (mg/kg) | 1.8 | | Lead | 0.15 | | Mercury | 0.009 | | Nickel | 1.0 | | Selenium | 0.16 | | Silver | 0.3 | | Thallium | 0.02 | | Zinc | 70.0 |

(b) A one-time notification and certification shall be placed in the facility's files and sent to the director for K061, K062, or F006 HTMR residues that meet the generic exclusion levels for all constituents and do not exhibit any characteristics that are sent to licensed solid waste landfills. The notification and certification that is placed in the generator's or treater's files shall be updated if the process or operation generating the waste changes or if the licensed solid waste landfill receiving the waste changes. However, the generator or treater need only notify the director on an annual basis if such changes occur. Such notification and certification should be sent to the director by the end of the calendar year, but no later than December thirty-first. The notification shall include the following information:

(i) The name and address of the licensed solid waste landfill receiving the waste shipments;

(ii) The EPA hazardous waste numbers and treatability groups at the initial point of generation; and

(iii) The treatment standards in Chapter 3745-270 of the Administrative Code applicable to the waste at the initial point of generation.

(iv) The certification shall be signed by an authorized representative and shall state as follows:

"I certify under penalty of law that the generic exclusion levels for all constituents have been met without impermissible dilution and that no characteristic of hazardous waste is exhibited. I am aware that there are significant penalties for submitting a false certification, including the possibility of fine and imprisonment."

(iv) Biological treatment sludge from the treatment of one of the following wastes listed in rule 3745-51-32 of the Administrative Code - organic waste (including heavy ends, still bottoms, light ends, spent solvents, filtrates, and decantates) from the production of carbamates and carbamoyl oximes (EPA hazardous waste number K156), and wastewaters from the production of carbamates and carbamoyl oximes (EPA hazardous waste number K157).

(v) Catalyst inert support media separated from one of the following wastes listed in rule 3745-51-32 of the Administrative Code - spent hydrotreating catalyst (EPA hazardous waste number K171), and spent hydrorefining catalyst (EPA hazardous waste number K172).

(D) Any waste described in paragraph (C) of this rule is not a hazardous waste if the waste meets the following criteria:

(1) In the case of any waste, the waste does not exhibit any of the characteristics of hazardous waste identified in rules 3745-51-20 to 3745-51-24 of the Administrative Code. However, wastes that exhibit a characteristic at the point of generation may still be subject to Chapter 3745-270 of the Administrative Code, even if the wastes no longer exhibit a characteristic at the point of land disposal.)

(2) In the case of a waste which is listed in rules 3745-51-30 to 3745-51-35 of the Administrative Code, or contains a hazardous waste listed in rules 3745-51-30 to 3745-51-35 of the Administrative Code, or is derived from a hazardous waste listed in rules 3745-51-30 to 3745-51-35 of the Administrative Code, the hazardous waste also has been excluded from paragraph (C) of this rule under 40 CFR 260.20 and 40 CFR 260.22.

(E) [Reserved.]

(F) Notwithstanding paragraphs (A) to (D) of this rule and provided the "debris" as defined in rule 3745-270-02 of the Administrative Code does not exhibit a characteristic identified in rules 3745-51-20 to 3745-51-24 of the Administrative Code, the following materials are not subject to regulation under Chapter 3745-50, 3745-51, 3745-52, 3745-53, 3745-54 to 3745-57 and 3745-205, 3745-65 to 3745-69 and 3745-256, 3745-266, or 3745-270 of the Administrative Code:

(1) "Hazardous debris" as defined in rule 3745-270-02 of the Administrative Code that has been treated using one of the required extraction or destruction technologies identified in the table in rule 3745-270-45 of the Administrative Code. Persons claiming this exclusion in an enforcement action will have the burden of proving by clear and convincing evidence that the material meets all the exclusion requirements; or

(2) "Debris" as defined in rule 3745-270-02 of the Administrative Code that the director, considering the extent of contamination, has determined is no longer contaminated with hazardous waste.

(G)

(1) A hazardous waste that is listed in rules 3745-51-30 to 3745-51-35 of the Administrative Code solely because the waste exhibits one or more characteristics of ignitability as identified in rule 3745-51-21 of the Administrative Code, characteristic of corrosivity as identified in rule 3745-51-22 of the Administrative Code, or characteristic of reactivity as identified in rule 3745-51-23 of the Administrative Code is not a hazardous waste, if the waste no longer exhibits any characteristic of hazardous waste identified in rules 3745-51-20 to 3745-51-24 of the Administrative Code.

(2) The exclusion described in paragraph (G)(1) of this rule also pertains to:

(a) Any mixture of a waste and a hazardous waste listed in rules 3745-51-30 to 3745-51-35 of the Administrative Code solely because the mixture exhibits the characteristic of ignitability, characteristic of corrosivity, or characteristic of reactivity as regulated under paragraph (A)(2)(d) of this rule; and

(b) Any waste generated from treating, storing, or disposing of a hazardous waste listed in rules 3745-51-30 to 3745-51-35 of the Administrative Code solely because the waste exhibits the characteristic of ignitability, characteristic of corrosivity, or characteristic of reactivity as regulated under paragraph (C)(2)(a) of this rule.

(3) Wastes excluded under this rule are subject to Chapter 3745-270 of the Administrative Code (as applicable), even if such wastes no longer exhibit a characteristic at the point of land disposal.

(4) Any mixture of a waste excluded from regulation under paragraph (B)(7) of rule 3745-51-04 of the Administrative Code and a hazardous waste listed in rules 3745-51-30 to 3745-51-35 of the Administrative Code solely because the mixture exhibits one or more of the characteristic of ignitability, characteristic of corrosivity, or characteristic of reactivity as regulated under paragraph (A)(2)(d) of this rule is not a hazardous waste, if the mixture no longer exhibits any characteristic of hazardous waste identified in rules 3745-51-20 to 3745-51-24 of the Administrative Code for which the hazardous waste listed in rules 3745-51-30 to 3745-51-35 of the Administrative Code was listed.

(H)

(1) Hazardous waste containing radioactive waste is no longer a hazardous waste when the waste meets the eligibility criteria and conditions of rules 3745-266-210 to 3745-266-335 of the Administrative Code ("eligible radioactive mixed waste").

(2) The exemption described in paragraph (H)(1) of this rule also pertains to:

(a) Any mixture of a waste and an eligible radioactive mixed waste; and

(b) Any waste generated from treating, storing, or disposing of an eligible radioactive mixed waste.

(3) Waste exempted under this rule shall meet the eligibility criteria and specified conditions in paragraph (B) of rule 3745-266-220, paragraph (C) of rule 3745-266-220 (for storage and treatment), rule 3745-266-310, and paragraph (A) of rule 3745-266-315 of the Administrative Code (for transportation and disposal). Waste that fails to satisfy these eligibility criteria and conditions is regulated as hazardous waste.

[Comment: For dates of non-regulatory government publications, publications of recognized organizations and associations, federal rules, and federal statutory provisions referenced in this rule, see rule 3745-50-11 of the Administrative Code titled "Incorporated by reference."]

Last updated March 7, 2025 at 8:12 AM

History

• Effective: March 7, 2025
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-38-25

Each licensee who manufactures, transfers, receives, disassembles, or disposes of a nationally tracked source shall complete and submit a national source tracking transaction report as specified in paragraphs (A) to (E) of this rule for each type of transaction.

(A) Each licensee who manufactures a nationally tracked source shall complete and submit a national source tracking transaction report. The report must include the following information:

(1) The name, address, and license number of the reporting licensee;

(2) The name of the individual preparing the report;

(3) The manufacturer, model, and serial number of the source;

(4) The radioactive material in the source;

(5) The initial source strength in becquerels (curies) at the time of manufacture; and

(6) The manufacture date of the source.

(B) Each licensee that transfers a nationally tracked source to another person shall complete and submit a national source tracking transaction report. The report must include the following information:

(1) The name, address, and license number of the reporting licensee;

(2) The name of the individual preparing the report;

(3) The name and license number of the recipient facility and the shipping address;

(4) The manufacturer, model, and serial number of the source or, if not available, other information to uniquely identify the source;

(5) The radioactive material in the source;

(6) The initial or current source strength in becquerels (curies);

(7) The date for which the source strength is reported;

(8) The shipping date;

(9) The estimated arrival date; and

(10) For nationally tracked sources transferred as waste under a uniform low-level radioactive waste manifest, the waste manifest number and the container identification of the container with the nationally tracked source.

(C) Each licensee that receives a nationally tracked source shall complete and submit a national source tracking transaction report. The report must include the following information:

(1) The name, address, and license number of the reporting licensee;

(2) The name of the individual preparing the report;

(3) The name, address, and license number of the person that provided the source;

(4) The manufacturer, model, and serial number of the source or, if not available, other information to uniquely identify the source;

(5) The radioactive material in the source;

(6) The initial or current source strength in becquerels (curies);

(7) The date for which the source strength is reported;

(8) The date of receipt; and

(9) For material received under a uniform low-level radioactive waste manifest, the waste manifest number and the container identification with the nationally tracked source.

(D) Each licensee that disassembles a nationally tracked source shall complete and submit a national source tracking transaction report. The report must include the following information:

(1) The name, address, and license number of the reporting licensee;

(2) The name of the individual preparing the report;

(3) The manufacturer, model, and serial number of the source or, if not available, other information to uniquely identify the source;

(4) The radioactive material in the source;

(5) The initial or current source strength in becquerels (curies);

(6) The date for which the source strength is reported; and

(7) The disassemble date of the source.

(E) Each licensee who disposes of a nationally tracked source shall complete and submit a national source tracking transaction report. The report must include the following information:

(1) The name, address, and license number of the reporting licensee;

(2) The name of the individual preparing the report;

(3) The waste manifest number;

(4) The container identification with the nationally tracked source;

(5) The date of disposal; and

(6) The method of disposal.

(F) The reports discussed in paragraphs (A) to (E) of this rule must be submitted by the close of the next business day after the transaction. A single report may be submitted for multiple sources and transactions. The reports must be submitted to the national source tracking system by using:

(1) The on-line national source tracking system;

(2) Electronically using a computer readable format;

(3) By facsimile;

(4) By mail to the address on the national source tracking transaction report form (NRC form 748); or

(5) By telephone with followup by facsimile or mail.

(G) Each licensee shall correct any error in previously filed reports or file a new report for any missed transaction within five business days of the discovery of the error or missed transaction. Such errors may be detected by a variety of methods such as administrative reviews or by physical inventories required by regulation. In addition, each licensee shall reconcile the inventory of nationally tracked sources possessed by the licensee against that licensee's data in the national source tracking system. The reconciliation must be conducted during the month of January in each year. The reconciliation process must include resolving any discrepancies between the national source tracking system and the actual inventory by filing the reports identified by paragraphs (A) to (E) of this rule. By January thirty-first, of each year, each licensee must submit to the national source tracking system confirmation that the data in the national source tracking system is correct.

View Appendix

Last updated November 2, 2022 at 2:11 PM

History

• Effective: November 14, 2013
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-58-30

(A) A licensee may authorize the release from its control of any individual who has been administered unsealed radioactive material or implants containing radioactive material if the total effective dose equivalent to any other individual from exposure to the released individual is not likely to exceed five millisieverts (0.5 rem).

(B) A licensee shall provide the released individual, or the individual's parent or guardian, with instructions, including written instructions, on actions recommended to maintain doses to other individuals as low as is reasonably achievable if the total effective dose equivalent to any other individual is likely to exceed one millisievert (0.1 rem). If the total effective dose equivalent to a nursing infant or child could exceed one millisievert (0.1 rem) assuming there were no interruption of breast-feeding, the instructions must also include:

(1) Guidance on the interruption or discontinuation of breast-feeding; and

(2) Information on the potential consequences, if any, of failure to follow the guidance.

(C) A licensee shall maintain a record of the basis for authorizing the release of an individual in accordance with paragraph (A) of rule 3701:1-58-82 of the Administrative Code.

(D) The licensee shall maintain a record of instructions provided to a breast-feeding female in accordance with rule 3701:1-58-82 of the Administrative Code.

(E) Any patient administered gamma emitting radiopharmaceuticals or permanent brachytherapy sources and is required to be furnished written instructions in accordance with paragraph (B) of this rule shall be provided a patient release card to include:

(1) The patient's name;

(2) The radionuclide administered and its activity;

(3) The facility name which administered the radionuclide;

(4) The date of the administration of the radionuclide; and

(5) The expiration date of the card.

The card is not applicable to those patients who are institutionalized in facilities such as hospitals, nursing homes, correctional institutions, etc. or to those patients whose radiation levels do not exceed one microsievert per hour (0.1 mrem/hr) at one meter.

Last updated October 6, 2022 at 8:25 AM

History

• Effective: October 6, 2022
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-38-11

(A) Quality factors for converting absorbed dose to dose equivalent are as follows:

| Type of radiation | Quality factor (Q) | Absorbed dose equal to a unit dose equivalent^A/ | | --- | --- | --- | | X-, gamma, or beta radiation and high-speed electrons ..... | 1 | 1 | | Alpha particles, multiple-charged particles, fission fragments and heavy particles of unknown charge ..... | 20 | 0.05 | | Neutrons of unknown energy .... | 10 | 0.1 | | High-energy protons ..... | 10 | 0.1 |

^A/ Absorbed dose in gray equal to one sievert or the absorbed dose in rad equal to one rem.

(B) If it is more convenient to measure the neutron fluence rate than to determine the neutron dose equivalent rate in sievert per hour or rem per hour, as provided in paragraph (A) of this rule, 0.01 sievert (one rem) of neutron radiation of unknown energies may, for purposes of these regulations, be assumed to result from a total fluence of twenty-five million neutrons per square centimeter incident upon the body. If sufficient information exists to estimate the approximate energy distribution of the neutrons, the licensee may use the fluence rate per unit dose equivalent or the appropriate Q value as provided in this paragraph to convert a measured tissue dose in gray or rad to dose equivalent in sievert or rem as follows:

| | Neutron energy (MeV) | Quality factor^A/ (Q) | Fluence per unit dose equivalent^B/ (neutrons cm^-2 rem^-1) | Fluence per unit dose equivalent^B/ (neutrons cm^-2 Sv^-1) | | --- | --- | --- | --- | --- | | (Thermal)........ | 2.5x10^-8 | 2 | 980x10⁶ | 980x10⁸ | | | 1x10^-7 | 2 | 980x10⁶ | 980x10⁸ | | | 1x10^-6 | 2 | 810x10⁶ | 810x10⁸ | | | 1x10^-5 | 2 | 810x10⁶ | 810x10⁸ | | | 1x10^-4 | 2 | 840x10⁶ | 840x10⁸ | | | 1x10^-3 | 2 | 980x10⁶ | 980x10⁸ | | | 1x10^-2 | 2.5 | 1010x10⁶ | 1010x10⁸ | | | 1x10^-1 | 7.5 | 170x10⁶ | 170x10⁸ | | | 5x10^-1 | 11 | 39x10⁶ | 39x10⁸ | | | 1 | 11 | 27x10⁶ | 27x10⁸ | | | 2.5 | 9 | 29x10⁶ | 29x10⁸ | | | 5 | 8 | 23x10⁶ | 23x10⁸ | | | 7 | 7 | 24x10⁶ | 24x10⁸ | | | 10 | 6.5 | 24x10⁶ | 24x10⁸ | | | 14 | 7.5 | 17x10⁶ | 17x10⁸ | | | 20 | 8 | 16x10⁶ | 16x10⁸ | | | 40 | 7 | 14x10⁶ | 14x10⁸ | | | 60 | 5.5 | 16x10⁶ | 16x10⁸ | | | 1x10² | 4 | 20x10⁶ | 20x10⁸ | | | 2x10² | 3.5 | 19x10⁶ | 19x10⁸ | | | 3x10² | 3.5 | 16x10⁶ | 16x10⁸ | | | 4x10² | 3.5 | 14x10⁶ | 14x10⁸ |

^A/Value of quality factor (Q) at the point where the dose equivalent is maximum in a 30-centimeter diameter cylinder tissue-equivalent phantom.

^B/Monoenergetic neutrons incident normally on a 30-centimeter diameter cylinder tissue-equivalent phantom.

(C) For the purpose of Chapter 3701:1-38 of the Administrative Code, activity is expressed in the SI unit of becquerel, Bq, or in the special unit of curie, Ci, or their multiples, or disintegrations or transformations per unit of time.

(D) Radiation protection programs.

(1) Each licensee or registrant shall develop, document, and implement a radiation protection program commensurate with the scope and extent of licensed or registered activities to ensure compliance with the provisions of this chapter. Record keeping requirements are provided in paragraph (B) of rule 3701:1-38-20 of the Administrative Code.

(2) The licensee or registrant shall use, to the extent practicable, procedures and engineering controls based upon sound radiation protection principles to achieve occupational doses and public doses that are as low as is reasonably achievable.

(3) The licensee or registrant shall, at intervals not to exceed twelve months, review the radiation protection program content and implementation.

(4) To implement the ALARA requirements of paragraph (D)(2) of this rule, and notwithstanding the requirements in rule 3701:1-38-13 of the Administrative Code, a constraint on air emissions of radioactive material to the environment, excluding radon-222 and its daughters, shall be established by licensees, such that the individual member of the public likely to receive the highest dose will not be expected to receive a total effective dose equivalent in excess of 0.1 millisievert (ten millirem) per year from these emissions. If a licensee subject to this requirement exceeds this dose constraint, the licensee shall report the amount exceeding the dose constraint as provided in paragraph (C) of rule 3701:1-38-21 of the Administrative Code and promptly take appropriate corrective action to ensure against recurrence.

Last updated November 2, 2022 at 2:10 PM

History

• Effective: September 1, 2011
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-38-02 Fees for inspection, application, amendment, and renewal of radioactive material sources of radiation.

(A) As used in this rule, "facility" has the meaning defined in division (H) of section 3748.01 of the Revised Code and the following:

(1) All buildings, equipment, structures, and other stationary items that are located on a single site or on contiguous or adjacent sites and that are operated by the same person and have common corporate or business interests; and

(2) Portions of a building or structure which are operated by the same person and have common corporate or business interests.

(B) Notwithstanding the definition of "facility," the director may consider sites that are not contiguous or adjacent as one facility provided that:

(1) The sites are operated by the same person;

(2) The sites are in the same license category or categories;

(3) The applicant for a license provides for one radiation safety officer, and if applicable, one radiation safety committee, as responsible for all sites; and

(4) The director is reasonably satisfied from the information provided in the application that the applicant will adequately control radioactive material at all sites listed in the application.

(a) Unless the director has information of violations of Chapter 3748. of the Revised Code or the rules adopted thereunder at one or more sites, the director shall presume the applicant will adequately control radioactive material at all sites if the sites are located not more than twenty miles driving distance apart as documented by the licensee, and if all sites are within a twenty mile radius from the main site as designated on the license.

(b) The director shall continue to renew a license issued under this paragraph that contains all the sites listed thereon provided the licensee demonstrates continued compliance with this paragraph, Chapter 3748. of the Revised Code, and the rules adopted thereunder.

(C) Every facility that handles radioactive material in any license category as specified in appendix A to this rule for which licensure is required shall apply for a license, license amendment, or license renewal in accordance with this rule. Application for a license, license amendment, or license renewal shall be made on any format prescribed and provided by the director. Licenses shall be issued in accordance with the requirements of Chapter 3748. of the Revised Code, and the rules adopted thereunder. Except as otherwise provided in this rule, a license shall expire five years from the date of issuance.

(1) As used in this paragraph, site means an address of use listed on the license. Temporary job sites are exempted.

(a) Any individual applying for a new license with one or more additional sites or a current licensee amending a license to add one or more additional sites that are located more than twenty miles from the main site shall pay an additional site fee for each such site as follows:

(i) The additional site fee(s) shall be seventy-five percent of the applicable annual fee, as those fees are set forth in paragraphs (D), (F), and (J) of this rule.

(ii) Additional site fees will be invoiced annually with the annual fee.

(b) Broad scope licensees are exempt from paragraph (C)(1)(a) of this rule.

(2) As used in this paragraph, "service" means activities performed by a person, other than a worker as defined in rule 3701:1-38-01 of the Administrative Code, pursuant to an agreement with the facility to perform activities that deal with sources of radiation for the facility.

(a) These activities include, but are not limited to the following:

(i) Conduct leak tests;

(ii) Calibrate survey instruments;

(iii) Provide quality control tests;

(iv) Conduct surveys, characterization, and/or remediation activities;

(v) Manage the disposal of radioactive waste for other persons; or

(vi) Install sources or devices or change sources within a device.

(b) License categories affected are:

(i) 3219 - decontamination services;

(ii) 3220 - leak test service;

(iii) 3221 - instrument calibration service only - source less than 3.7 terabecquerels (one hundred curies);

(iv) 3222 - instrument calibration service only - source equal to or greater than 3.7 terabecquerels (one hundred curies);

(v) 3223 - leak test and instrument calibration - source less than 3.7 terabecquerels (one hundred curies);

(vi) 3224 - leak test and instrument calibration - source equal to or greater than 3.7 terabecquerels (one hundred curies);

(vii) 3225 - other services - including teletherapy, irradiator, and gauge service;

(viii) 3232 - waste disposal service prepackaged only;

(ix) 3233 - waste disposal service - incineration; and

(x) 3234 - waste disposal service processing and/or repackaging.

(D) A radioactive materials license issued by the department may, at the discretion of the director, have more than one license category on any one specific license. A licensee may have more than one radioactive materials license. Except as otherwise provided in paragraph (J) of this rule, the annual fee for a radioactive material license shall be in an amount in accordance with appendix A to this rule.

(1) Upon receipt of an application for a new radioactive material license, the department will issue an invoice for the appropriate fee specified in appendix A to this rule or paragraph (J) of this rule. Annual fees will be invoiced based on the month of the license expiration date and the invoice will state that the fee is due thirty days after the date of the invoice. License fees are not refundable.

(2) An applicant for a new or a renewal or amendment of a radioactive material license must submit a complete application before the director will finalize the review of the application. A complete application is one in which the applicant has provided all the information requested by the director, including any additional information requested after receipt of the application package.

(3) Upon receipt of an application for a license amendment, the department will issue an invoice for the appropriate fee for the proposed amendment as specified in appendix A to this rule. If the amendment is to change the license from operational phase to storage of sealed sources only incident to disposal of the sources, after the amendment the annual fee for the license shall be reduced to fifty per cent of the fee for the operational phase of the license, provided that the sources continue to be in safe storage and leak tested as provided by license condition for the specific sources in storage. The inspection frequency will remain the same as that for the operational phase of the license until after source disposal.

(4) The applicant for a new, or renewal or amendment of a radioactive materials license shall provide to the director all additional information requested within sixty days from the date of the information request. If the director does not receive the requested information within the stated time period, the director may consider the application abandoned. Any further consideration of a new license, or a renewal or amendment of a license shall be pursuant to another application.

(5) The director shall grant a new license, license amendment, or license renewal to any applicant who has submitted a complete application and is in compliance with Chapter 3748. of the Revised Code and the rules adopted thereunder.

(6) When an amendment to a license results in a change to a license category with a higher fee, the licensee will be charged the higher of the two amendment fees for that category. The annual fee for the licensee will escalate to the new category fee on the date of the next annual invoice.

(7) The director shall charge a fee for minor license amendments that do not require review by members of the technical staff at a rate of one hundred dollars per amendment provided that no licensee shall be required to pay more than one thousand dollars for minor amendments in any calendar year. Minor amendments include, but are not limited to, adding a new gauge of the same type already licensed unless that additional gauge increases the license or inspection fee, a corporate name change if the corporate ownership does not change, adding a user name that does not require review of education and experience, and corporate address change if the location of the use of the radioactive material does not change. Amendments to change the radiation safety officer or the chair or members of the radiation safety committee that require review of education or experience are not minor amendments.

(8) License terminations shall be handled as follows:

(a) Except as provided in paragraph (D)(8)(c) of this rule, a termination fee of five hundred dollars or fifty per cent of the annual fee, whichever is less, will be invoiced upon written request from the licensee for termination of the license. This fee is not refundable.

(b) Except as provided in paragraph (D)(8)(c) of this rule, if the termination cost, as determined by paragraph (M) of this rule, exceeds the termination fee in paragraph (D)(8)(a) of this rule, the remainder of the termination expense will be assessed at full cost.

(c) If the license termination would be covered under paragraph (D)(9) of this rule, that paragraph will be used for the termination process.

(d) The license termination process will not be completed until the licensee is in compliance with all rules, including payment of fees.

(9) Licenses, and other approvals related to the licensed activity requiring decommissioning, decontamination, reclamation, site restoration, or long-term care due to the continued presence of radioactive materials shall be charged an annual fee based on the approved decommissioning funding plan as specified in appendix B to this rule.

(a) A decommissioning plan must be approved by the department. Prior to approval of the decommissioning plan the licensee must submit an amendment requesting decommissioning. Until the amendment is approved the licensee's annualized license fee will be reduced by fifty per cent. After approval of the amendment containing the decommissioning plan, the licensee will be invoiced at the annual fee specified in appendix B to this rule.

(b) The annual fee specified in appendix B to this rule is based on the cost of decommissioning. The fee is payable within thirty days of mailing of an invoice by the department.

(c) Routine decommissioning oversight by the department will be charged against the annual amount received and additional invoices will not be issued unless the cost of activities exceeds the annual amount in any given year.

(d) The facility shall receive a monthly statement of items and amounts charged against the annual fee.

(e) If the cost of additional activities arise that require use of additional staff, including any consulting service that exceeds the amount of the annual fee paid by the licensee, these additional costs will be included in any invoice as separate items invoiced for the full cost of the oversight by additional staff or consultants. Oversight activities will be performed at a frequency which adequately monitors health, safety, and the environment.

(f) When the approved decommissioning plan is less than one hundred thousand dollars, the licensee will remain in the current license category and continue to pay the required annual fee specified in appendix A to this rule during decommissioning. Inspections of these licensees will be done as non-routine inspections. Non-routine inspection fees will not be applied until the number of decommissioning inspections performed exceed the inspections that would have been performed if the licensee had not chosen the decommissioning option.

(g) When the licensee has completed the decommissioning, and the director has determined that the licensee cannot terminate the license as provided by the Administrative Code, Chapter 3748. of the Revised Code or the rules adopted thereunder, but the licensee has successfully completed the decommissioning of the operation as required by the approved decommissioning plan, the director will amend the license to a decommissioning/possession only license. The annual fee for a decommissioning/possession only license is provided in appendix B to this rule.

(E) Licenses shall be renewed in accordance with the standard renewal procedure established in Chapter 4745. of the Revised Code, except that a licensee, other than a broad scope licensee, shall apply for renewal of the license ninety days prior to the expiration date of the current license and broad scope licensees shall apply for renewal of their license one hundred eighty days prior to expiration.

(F) The annual fee is listed in appendix A to this rule "column 5" for a new license or "column 6" for a renewal license. To recover the costs of oversight activities where radioactive material is found in the public domain and there is no evident individual that is determined to be responsible, a surcharge of 5.25 per cent has been included in the annual fee listed in "column 5" and "column 6" of appendix A to this rule.

(G) The department shall charge an inspection fee for all non-routine inspections. A non-routine inspection is defined as any inspection that the department conducts in addition to the scheduled routine inspections and one follow-up inspection if necessary. Non-routine inspections include, without limitation:

(1) An inspection performed as a result of an incident;

(2) Any pre-license inspections for a new license applicant when the director determines that an inspection is necessary to assess the adequacy of the information provided in the application;

(3) Inspections prior to license amendment, category change, or termination;

(4) An inspection performed at a facility that results in the issuance of an adjudication order by the director; or

(5) Other enforcement or regulatory inspections, not specified above, that the director determines is necessary to assess compliance with Chapter 3748. of the Revised Code.

(H) The fee for a non-routine inspection shall be based on the actual cost for conducting the inspection which shall include:

(1) An hourly charge of seventy dollars per staff person assigned to the inspection, except staff participating as training will not be included in the charges;

(2) An administrative fee of three hundred thirty dollars;

(3) All necessary laboratory analysis costs for samples collected by department personnel; and

(4) Any staff travel costs which shall be calculated in accordance with rule 126-01-02 of the Administrative Code.

(I) All fees invoiced as provided within this rule, including full cost, routine, and non-routine inspection fees, shall be paid within thirty days of the invoice date specified on the invoice. In accordance with sections 3748.07 and 3748.13 of the Revised Code, any fee that remains unpaid on the ninety-first day after the original invoice date shall be assessed an additional amount equal to ten per cent of the original fee.

(1) The department shall mail invoices by ordinary U.S. mail to the most recent address provided by the licensee.

(2) The department shall maintain a list of the invoices issued and date mailed.

(J) Notwithstanding paragraph (D) of this rule, the department shall charge the following types of licensees reduced license fees in the following specified amounts:

(1) A private entity that provides services, does not engage in manufacturing, and that has three hundred fifty thousand to two million dollars in gross annual receipts, shall pay a total license fee of seventy-five per cent of the amount specified for that use of radioactive materials in appendix A to this rule.

(2) A private entity that provides services, does not engage in manufacturing, and that has less than three hundred fifty thousand dollars in gross annual receipts shall pay a total license fee of fifty per cent of the amount specified for that use of radioactive material in appendix A to this rule.

(3) A private entity that engages in manufacturing and that has thirty-five to two hundred employees, irrespective of gross annual receipts, shall pay a total license fee of seventy-five per cent of the amount specified for that use of radioactive material in appendix A to this rule.

(4) A private entity that engages in manufacturing and that has less than thirty-five employees, irrespective of gross annual receipts, shall pay a total license fee of fifty per cent of the amount specified for that use of radioactive material in appendix A to this rule.

(5) A nonprofit entity that has gross annual receipts of three hundred fifty thousand dollars to two million dollars shall pay a total license fee of seventy-five per cent of the amount specified for that use of radioactive material in appendix A to this rule.

(6) A nonprofit entity that has gross annual receipts of less than three hundred fifty thousand dollars shall pay a total license fee of fifty per cent of the amount specified for that use of radioactive material in appendix A to this rule.

(7) A government jurisdiction or district with a population of twenty thousand to fifty thousand shall pay a total license fee of seventy-five per cent of the amount specified for that use of radioactive material as specified in appendix A to this rule.

(8) A government jurisdiction or district with a population of less than twenty thousand shall pay a total license fee of fifty per cent of the amount specified for that use of radioactive materials as specified in appendix A to this rule.

(9) A health district as defined in section 3709.01 of the Revised Code shall pay a total license fee of twenty-five per cent of the amount specified in appendix A to this rule.

(10) An accredited private or public college or university possessing or using radioactive material in a sealed or unsealed source solely as a part of a college or university course supported by tuition and leading to an accredited degree, but excluding clinical training, shall pay a total license fee as set forth for category "1129" as that amount is specified in appendix A to this rule.

The reduced annual fees specified in this paragraph do not apply to any other fees that a licensee may be required to pay under Chapter 3748. of the Revised Code or rules adopted thereunder. Licensees shall provide certification of their compliance with the provisions of paragraphs (J)(1) to (J)(6) of this rule upon initial application and renewal.

(K) The director may modify the inspection frequency of licensed facilities based upon the performance of the facility.

(L) In accordance with section 3748.22 of the Revised Code, the department shall charge fees sufficient to cover all costs of regulatory, administrative, and enforcement activities conducted pursuant to Chapter 3748. of the Revised Code. The director shall recommend to the radiation advisory council and the public health council changes in the radioactive materials fees if the director finds that fees do not meet the requirements of section 3748.22 of the Revised Code.

(M) Fees for those categories listed as "full cost" such as decommissioning activities, for either partial, building or selected area of a licensed site, or full decommissioning leading to license amendment, category change, or termination and for review of sources and/or devices shall be specified as "full cost" and shall be calculated as the sum of the seventy dollar hourly charge per staff member for the number of hours spent on document review and preparation, licensing, inspection, meetings, teleconferences, in travel, administrative time, the cost of any special contractors as determined necessary by the director, any environmental monitoring for radioactive materials and laboratory analysis, any other associated activities. The administrative fee from paragraph (H)(2) of this rule shall be used for administrative time. Travel expenses shall also be invoiced and shall be calculated at the rate determined by rule 126-1-02 of the Administrative Code. These fees will be invoiced monthly.

(N)

(1) Reciprocity to engage in activities in the state of Ohio which involve radioactive materials may be authorized provided:

(a) The person requesting reciprocity possesses a valid radioactive materials license issued by another agreement state or the United States nuclear regulatory commission which authorizes the same activities proposed to be conducted in Ohio;

(b) The request for reciprocity is made by submission of a completed reciprocity application provided by the director, a copy of the person's radioactive materials license, and payment of the reciprocity fee specified in appendix A to this rule;

(c) The duration of activities to be performed in Ohio under reciprocity does not exceed one hundred eighty days in any one calendar year.

(2) A person who has been granted reciprocity in Ohio shall notify the director at least three business days in advance of each time the person proposes to begin a new use of radioactive materials in the state of Ohio, with the notification made on a form provided by the director.

(3) Activities conducted in Ohio under reciprocity are subject to inspection by the department at any time and the department shall invoice a reciprocity inspection fee of one thousand dollars for each inspection of a person's authorized reciprocity activities.

(4) Reciprocity is authorized for one calendar year, beginning on January first or later date when reciprocity is initially applied for, and ending on December thirty-first.

(5) A person who is authorized reciprocity shall apply for an Ohio radioactive materials license at least thirty days prior to exceeding one hundred eighty days of activities in Ohio.

(O) Requests for safety evaluation of devices, products, or sealed sources used for radioactive materials either for commercial distribution or manufactured in accordance with the unique specifications of, and for use by, a single applicant shall be submitted to the director on a form provided by the director for that review prior to manufacture or commercial distribution.

(1) The application shall specify a license amendment for one of the areas listed below:

(a) Safety evaluation of sealed sources or devices or products containing NARM, byproduct material, source material, or special nuclear material (less than critical mass) for commercial distribution.

(b) Safety evaluation of sealed sources or devices or products containing NARM, byproduct material, source material, or special nuclear material (less than critical mass) manufactured in accordance with the unique specifications of, and for use by, a single applicant.

(2) The amendment fee for a source or device review shall be "full cost" as outlined in paragraph ((M) of this rule.

(3) The amendment fee in appendix A to this rule for categories under manufacturing and distribution shall be for amendments other than source or device reviews.

(4) Licensees for categories 3211, 3212, 3213, 3214, and 22162 shall pay an annual surcharge of six hundred fifty dollars to cover administrative costs of overall maintenance activities associated with source or device data submitted to the United States nuclear regulatory commission. This surcharge is included in the annual fee for the above listed categories in "column 5" and "column 6" of appendix A to this rule.

(P) When considered necessary by the director, the director may conduct a review of shielding plans or the adequacy of shielding. The director may also conduct such a review upon the request of the licensee or the applicant for a license. The applicant or licensee shall pay a fee for review of shielding plans or adequacy of shielding as specified in paragraph (M) of this rule.

(Q) Individuals with implanted pacemakers that have a radioactive source will not be charged an annual fee as an individual because of the necessity of possessing the device. Unless the director determines other provisions are required, the medical institution that implanted the device shall hold the license for the individual.

(R) If, because of the complexity of a review, such as that for a sealed source or device, decommissioning, license, or incident, it is necessary to obtain the services of a consultant to assist in a final determination, the licensee or applicant will be invoiced for the consulting services.

(S) Licensees with general licenses requiring an annual report to the director shall submit the report with a fee of four hundred twenty dollars within thirty days of mailing an invoice by the department and are subject to late penalties in paragraph (I) of this rule. If a facility has a specific license which is in a category that would include the generally licensed material, the facility may add the generally licensed material to the specific license and will not be charged the additional fee for that generally licensed material. Annual reports are required for devices under a general license containing radionuclides at or above activities listed in paragraph (C)(13) of rule 3701:1-46-05 of the Administrative Code.

View AppendixView Appendix

Last updated November 2, 2022 at 2:09 PM

History

• Effective: April 15, 2013
• Promulgated Under: 119.03

Ohio Adm.Code 126-1-02

(A) Definitions

(1) "State agency" means every organized body, office, or agency established by the laws of the state for the exercise of any function of state government which uses money that has been appropriated to it directly, but does not include the general assembly, supreme court, court of appeals, court of claims, any agency of these, or any state university or college as defined in division (A)(1) of section 3345.12 of the Revised Code.

(2) "State agent" means any officer, member, or employee of a state agency whose compensation is paid, in whole or in part, from state funds but does not include any volunteer serving without compensation:

(3) "Travel at state expense" means travel expenses which are paid from moneys appropriated directly to a state agency by the general assembly, but does not include travel by a state agent where expenses are paid pursuant to rule 102-3-08 of the Administrative Code.

(4) "Conference" means a prearranged gathering with a formal agenda, for consultation or exchange of information or discussion that benefits the state, such as seminars, trainings, meetings, and other professional events.

(5) "Paid travel status" means the designation given to a state agent who is traveling on behalf of the state and is in an active pay status.

(6) "Ride-sharing service" means a transportation service where passengers use an online platform to request transportation from drivers using their personal vehicle for a fee.

(7) "Short-term rental" means a property that is temporarily leased for lodging in exchange for compensation through an online platform.

(8) "Commercial transportation" means taxi cabs, ride-sharing services, automobile rentals, airfare, ferries, subways, bus, trains, and other similar commercial transportation providers.

(B) Authority for travel and reimbursement

Authority for travel

All state agents traveling at state expense or on paid travel status must be approved prior to travel by the head of a state agency or their designee. Travel may be approved only for official state business. State agents must, incur only expenses for the official business of the state. The head of a state agency or their designee shall determine the appropriate mode of transportation.

(C) Travel expenses

At the agency's discretion, a state agency may make direct payment to a supplier who provides travel services for the state agent, in lieu of reimbursing the state agent for travel expenses. A direct payment shall comply with the applicable rates and requirements specified in this rule. Alternatively, subject to this rule, the state agency may choose to reimburse the state agent for travel expenses incurred. Travel expenses which a state agent may request reimbursement or direct payment by an agency under this rule include only the following, subject to the approval of the director of the office of budget and management or their designee:

(1) Automobile expenses

(a) Incurred service expenses necessary to the efficient and safe operation of a state-owned or leased vehicle when a state agent or other party has been properly approved by a state agency and endorsed onto insurance coverage through the department of administrative services.

(b) Pursuant to this paragraph, mileage expenses incurred on state business when traveling by privately owned automobile, not including ride-sharing services, when the automobile owner has been so approved and is insured under a policy of liability insurance complying with the requirements of section 4509.51 of the Revised Code. Such reimbursement shall not exceed the rates described in this rule and shall only be made to one state agent.

(i) Mileage reimbursement for state business is authorized at a rate up to the internal revenue service's business standard mileage rate, within the discretion of the director of the office of budget and management. The reimbursement rate shall not be lower than forty-five cents per mile unless the internal revenue service's rate falls below that threshold, in which case the director may reduce the rate. The director of the office of budget and management shall review the rate at least annually. State agents shall not reimbursed for mileage between their residence and assigned work location. If traveling to a location other than their assigned work location, reimbursement is limited to the distance from the residence to the alternate location, minus their normal commute distance.

(ii) This paragraph does not apply to a collective bargaining agreement that supersedes the amount contemplated in this rule.

(c) Automobile rental only if automobile rental has been approved and is more economical than any other mode of transportation or if the state agent's destination is not easily accessible by any other mode of transportation. The state agent must purchase liability insurance and loss damage waiver for accidents arising out of the operation or use of the automobile and include that cost in determining whether the automobile rental is the most economical mode of transportation.

(2) Commercial transportation expenses

(a) Travel expenses by commercial transportation at the most efficient available rate. When any segment of travel by commercial transportation exceeds eight hours, the head of the state agency may approve business class travel for the state agent.

(b) Travel within the state of Ohio by common air carrier at the most efficient available rate is approved for elected officials, directors, assistant directors, deputy directors, board and commission members, and heads of state agencies. State employees not listed in this paragraph are approved to travel within the state of Ohio by common air carrier at the lowest available rate only if flying is more economical than other modes of travel.

(c) Commercial transportation travel insurance when approved by the head of the state agency.

(d) Tips/gratuities for a ride-share service or taxi that does not exceed fifteen per cent of the total cost of the ride.

(3) Meal and incidental expenses/per diem

(a) Inside the continental U.S.

(i) Meals and incidental per diem for state agents is authorized only when overnight lodging is required, subject to this rule. Per diem rates are based on the U.S. general services administration (GSA) rates, adjusted by lodging location. Per diem is intended to offset, not fully cover these expenses, and amounts shall be adjusted for departure and return based on travel time.

(a) Standard per diem applies to a full twenty-four hour travel day within the continental U.S. When on paid travel status for less than twenty-four hours, per diem is pro-rated by twenty-five per cent for each six-hour period of travel up to one hundred per cent for eighteen hours or more of travel. For example, zero to six hours equals twenty-five per cent per diem.

(b) If a state agent is approved to travel out of state by air and returns the same day, meals and incidental per diem are authorized, pro-rated as outlined in this paragraph.

(ii) If the state agent is in paid travel status in the continental U.S. for more than one week, including a weekend, miscellaneous living expenses will be reimbursed when such expense is reasonable as determined by the head of the state agency or their designee.

(iii) State agencies may choose to reimburse the state agent for meal and incidental expenses provided the reimbursement complies with this rule.

(b) Outside the continental U.S.

(i) A state agent traveling outside the continental U.S, or otherwise on paid travel status outside the continental U.S., including international conferences, shall be entitled to reimbursement of meals when such cost is reasonable as determined by the head of the state agency or their designee.

(ii) If the state agent is outside the continental U.S. on paid travel status for more than one week, including a weekend, miscellaneous living expenses will be reimbursed when such expense is reasonable as determined by the head of the state agency or their designee.

(c) Conferences

If a conference provides a meal, the state agent shall not be reimbursed or receive per diem for that meal and any reimbursement for a registration fee shall be adjusted accordingly. However if a meal is not provided, a state agent shall receive per diem or reimbursement at the rate prescribed by the GSA. The state agent has the responsibility of specifying the number and type of meals. If the state agent has dietary restrictions and the event does not honor the state agent's request for an alternative meal, the state agent is not required to deduct the applicable meal allowance from per diem.

(4) Lodging

(a) Inside the continental U.S.

In accordance with the per diem rates established by the GSA, reimbursement of expenses incurred while on official travel status within the continental U.S. is authorized per state agent per calendar day for lodging in commercial establishments or short-term rentals at actual cost up to the maximum allowable lodging rate for that location, plus applicable taxes on the entire room. Alternatively, an agency may choose to pay in advance for lodging expenses provided the payment does not exceed the rates set forth in this rule.

(b) Outside the continental U.S.

Reimbursement for lodging in commercial establishments or short-term rentals is authorized per state agent per calendar day at actual cost when such cost is reasonable as determined by the head of a state agency or their designee.

(c) Conferences

Lodging at the event site or lodging at a hotel identified in a conference registration materials as one of the event hotels may be reimbursed or paid for at actual cost, provided such cost is reasonable as determined by the head of a state agency or their designee.

(d) Limits

Overnight lodging will only be reimbursed or paid with state funds when the state agent is traveling at a location greater than forty-five miles from both the state agent's residence and their assigned work location as determined by their state agency. However, when traveling for conference purpose, the limit is thirty miles.

(5) Miscellaneous expenses

(a) Conference registration fees.

(b) Miscellaneous transportation expenses such as parking charges, road tolls, and other reasonably incurred transportation expenses directly related to authorized travel. Such expenses are to be listed separately on a state agent's travel expense reimbursement request if the state agent is seeking reimbursement for those expenses.

(c) Miscellaneous business expenses such as telephone, facsimile, internet, and other similar charges paid by the state agent for official state business, provided that there are no free alternatives to such services.

(d) Miscellaneous living expenses such as laundry, dry cleaning, and postage when a state agent is on travel status for more than five consecutive days.

(D) Non-payable or reimbursable expenses

"Non-Reimbursable travel expenses" include but are not be limited to:

(1) Alcoholic beverages purchased by the state agent.

(2) Entertainment expenses purchased by the state agent.

(3) Personal expenses incurred during travel that are primarily for the benefit of the state agent and not directly related to the official purpose of the travel.

(4) Political expenses paid by the state agent.

(5) Travel insurance expenses paid by the state agent; for purposes of this paragraph, the use of the term "travel insurance expense" does not mean liability coverage and loss damage waiver expenses incurred in renting an automobile pursuant to paragraph (C)(1) of this rule or approved commercial travel insurance approved pursuant to paragraph (C)(2) of this rule.

(6) The cost of traffic fines and parking tickets.

(7) Unused reservations for commercial transportation, automobile rentals, or lodging unless the state agency is satisfied that the failure to cancel or use the reservation was unavoidable. State agency approval is required as supporting documentation and may be subject to the approval of the director of budget and management or their designee.

(8) Any amount equal to a promotion or credit used to pay for a travel expense.

(9) Any transportation expense for travel undertaken for the purpose of obtaining meals that are discretionary in nature.

(E) Reimbursement requirements

A state agent seeking reimbursement for travel expenses shall submit all supporting documents under this rule and a travel expense reimbursement request in a format specified by the office of budget and management to the head of their state agency or designee within ninety days of the last date of travel, unless the terms of an applicable collectively bargained agreement differs. All amounts shall be recorded in U.S. dollars. Approval by the head of a state agency or their designee, submitted in a format specified by the office of budget and management with all supporting documents, shall certify that the reimbursement of the state agent's travel expenses is proper. The request may be denied by the state agency or office of budget and management for a state agent's failure to submit a request in a timely, accurate, or truthful manner. Reimbursement for approved travel expenses shall be made by the state agency via deposit in U.S. dollars into the system offered by the office of budget and management for payment and/or reimbursement of travel expenses or in a matter determined by the head of a state agency or their designee with approval from the office of budget and management, but at no time shall a state agent claim or be reimbursed more than is allowable under this rule. Supporting documents shall include the following as applicable:

(1) Receipts

A state agent shall obtain and provide all required receipts for travel charges which they are seeking reimbursement under this rule to their state agency in a manner and format specified by the office of budget and management. Required receipts for reimbursement shall include:

(a) Any receipt for a miscellaneous living or business expense.

(b) Any receipt for commercial transportation expenses.

(c) Any service expense incurred in connection with the operation of a state vehicle.

(d) Itemized receipts for all lodging expenses.

(e) Itemized receipts when a gratuity is automatically included.

(f) Any other receipt for expenses exceeding thirty dollars.

(2) Supporting documentation

Upon request of a head of a state agency or their designee or the office of budget and management, the state agent shall provide the following documents that validate expense claims. Such documents shall include but are not limited to the following:

(a) Conference materials and meeting agendas.

(b) Currency exchange rates when requesting payment or reimbursement for foreign goods or services. Such rates shall be evidenced by a foreign exchange currency receipt, bank or credit card statement, or the exchange rate issued by an authoritative source as determined by the office of budget and management.

(c) Documentation if a conference or professional event does not honor a state agent's request for an alternative meal.

(d) Any additional reasonable form of verification of an expense if necessary for verification or if supporting documentation is not available.

(3) A travel expense report.

(F) Agency contractors

State agencies desiring to reimburse travel, lodging, and meal expenses should negotiate such reimbursement with the contractor or supplier when negotiating the cost of the contract, but shall not negotiate rates higher than those authorized by this rule.

(G) Exceptions may be requested by submitting a written request to the director of budget and management by the head of a state agency or their designee. State agents should make every effort to request an exception prior to travel taking place. The director of the office of budget and management may grant exceptions to this rule only for travel by law enforcement officials, insurance examiners, state agents on continuous travel status for two or more consecutive days, state agents requiring special travel arrangements due to a disability, and state agents whose workday is other than eight a.m. to five p.m. or if state agents whose in-state travel and lodging arrangements are economically advantageous to the state. Other exceptions may be granted upon a written request submitted to the director of budget and management by the head of a state agency or their designee prior to the expense being incurred or, at the director's discretion, after the expense has been incurred. No exception shall remain in effect for more than one fiscal year.

(H) Amendment to this rule

An amendment to this rule applies to travel on or after the effective date of the amendment.

Last updated December 5, 2025 at 8:34 AM

History

• Effective: November 13, 2025
• Promulgated Under: 111.15

Ohio Adm.Code 3701:1-46-05

(A) A general license is hereby issued to commercial and industrial firms; research, educational, and medical institutions; individuals in the conduct of their business; and state or local government agencies to acquire, receive, possess, use or transfer, in accordance with the provisions of paragraphs (B) to (D) of this rule, radioactive material contained in devices designed and manufactured for the purpose of detecting, measuring, gauging or controlling thickness, density, level, interface location, radiation, leakage, or qualitative or quantitative chemical composition, or for producing light or an ionized atmosphere.

(B)

(1) The general license in paragraph (A) of this rule applies only to radioactive material contained in devices which have been manufactured or initially transferred and labeled in accordance with the specifications contained in:

(a) A specific license issued under rule 3701:1-46-30 of the Administrative Code;

(b) An equivalent specific license issued by an agreement state; or

(c) An equivalent specific license issued by the United States nuclear regulatory commission.

(2) The devices must have been received from one of the specific licensees described in paragraph (B)(1) of this rule or through a transfer made under paragraph (C)(9) of this rule.

(C) Any person who acquires, receives, possesses, uses or transfers radioactive material in a device pursuant to the general license in paragraph (A) of this rule:

(1) Shall assure that all labels affixed to the device at the time of receipt and bearing a statement that removal of the label is prohibited are maintained thereon and shall comply with all instructions and precautions provided by such labels;

(2) Shall assure that the device is tested for leakage of radioactive material and proper operation of the on-off mechanism and indicator, if any, at no longer than six-month intervals or at such other intervals as are specified in the label; however:

(a) Devices containing only krypton need not be tested for leakage of radioactive material, and

(b) Devices containing only tritium or not more than 3.7 megabecquerels (one hundred microcuries) of other beta and/or gamma emitting material or three hundred seventy kilobecquerels (ten microcuries) of alpha emitting material and devices held in storage in the original shipping container prior to initial installation need not be tested for any purpose;

(3) Shall assure that the tests required by paragraph (C)(2) of this rule and other testing, installation, servicing, and removal from installation involving the radioactive materials, its shielding or containment, are performed:

(a) In accordance with the instructions provided by the labels; or

(b) By a person holding a specific license pursuant to this chapter and Chapter 3701:1-40 of the Administrative Code or from an agreement state or the United States nuclear regulatory commission to perform such activities;

(4) Shall maintain records showing compliance with the requirements of paragraphs (C)(2) and (C)(3) of this rule. The records must show the results of tests. The records also must show the dates of performance of, and the names of persons performing, testing, installing, servicing, and removing from the installation radioactive material and its shielding or containment. The licensee shall retain these records as follows:

(a) Each record of a test for leakage or radioactive material required by paragraph (C)(2) of this rule must be retained for three years after the next required leak test is performed or until the sealed source is transferred or disposed of.

(b) Each record of a test of the on-off mechanism and indicator required by paragraph (C)(2) of this rule must be retained for three years after the next required test of the on-off mechanism and indicator is performed or until the sealed source is transferred or disposed of.

(c) Each record that is required by paragraph (C)(3) of this rule must be retained for three years from the date of the recorded event or until the device is transferred or disposed of.

(5) Shall immediately suspend operation of the device if there is a failure of, or damage to, or any indication of a possible failure of or damage to, the shielding of the radioactive material or the on-off mechanism or indicator, or upon the detection of one hundred eighty-five becquerels (0.005 microcurie) or more removable radioactive material. The device may not be operated until it has been repaired by the manufacturer or other person holding a specific license to repair such devices that was issued under Chapters 3701:1-40 and 3701:1-46 of the Administrative Code or by an agreement state or the United States nuclear regulatory commission. The device and any radioactive material from the device may only be disposed of by transfer to a person authorized by a specific license to receive the radioactive material in the device or as otherwise approved by the director. A report containing a brief description of the event and the remedial action taken; and, in the case of detection of one hundred eighty-five becquerels (0.005 microcurie) or more removable radioactive material or failure of or damage to a source likely to result in contamination of the premises or the environs, a plan for ensuring that the premises and environs are acceptable for unrestricted use, must be furnished to the director within thirty days.

(6) Shall not abandon the device containing radioactive material;

(7) Shall not export the device containing radioactive material except in accordance with applicable United States nuclear regulatory commission regulations;

(8)

(a) Shall transfer or dispose of the device containing radioactive material only by export as provided by paragraph (C)(7) of this rule, by transfer to another general licensee as authorized in paragraph (C)(9) of this rule, or to a person authorized to receive the device by a specific license issued under this chapter and Chapter 3701:1-40 of the Administrative Code, utilizing a licensed broker or other authorized waste collector, or equivalent regulations of an agreement state, United States nuclear regulatory commission, or as approved under paragraph (C)(8)(c) of this rule.

(b) Shall within thirty days after the transfer of a device to a specific licensee or export, furnish a report to the director by an appropriate method listed in rule 3701:1-40-04 of the Administrative Code, The report must contain:

(i) The identification of the device by manufacturer's (or initial transferor's) name, model number, and serial number;

(ii) The name, address, and license number of the person receiving the device; and

(iii) The date of the transfer.

(c) Shall obtain written director approval before transferring the device to any other specific licensee not specifically identified in paragraph (C)(8)(a) of this rule; however, a holder of a specific license may transfer a device for possession and use under its own specific license without prior approval, if the holder:

(i) Verifies that the specific license authorizes the possession and use, or applies for and obtains an amendment to the license authorizing the possession and use;

(ii) Removes, alters, covers, or clearly and unambiguously augments the existing label (otherwise required by paragraph (C)(1) of this rule) so that the device is labeled in compliance with rule 3701:1-38-18 of the Administrative Code; however the manufacturer, model number, and serial number must be retained;

(iii) Obtains the manufacturer's or initial transferor's information concerning maintenance that would be applicable under the specific license (such as leak testing procedures); and

(iv) Reports the transfer under paragraph (C)(8)(b) of this rule.

(9) Shall transfer the device to another general licensee only if:

(a) The device remains in use at a particular location. In this case, the transferor shall give the transferee a copy of this rule and any safety documents identified in the label of the device. Within thirty days of the transfer, the transferor shall report to the director:

(i) The manufacturer's (or initial transferor's) name;

(ii) The model number and the serial number of the device transferred;

(iii) The transferee's name and mailing address for the location of use; and

(iv) The name, title, and phone number of the responsible individual identified by the transferee in accordance with paragraph (C)(12) of this rule to have knowledge of and authority to take actions to ensure compliance with the appropriate rules and requirements; or

(b) The device is held in storage by an intermediate person in the original shipping container at its intended location of use prior to initial use by a general licensee.

(10) Shall comply with the provisions of paragraphs (A) and (B) of rule 3701:1-38-21 of the Administrative Code for reporting radiation incidents, theft or loss of licensed material, but shall be exempt from the other requirements of Chapter 3701:1-38 of the Administrative Code.

(11) Shall respond to written requests from the director to provide information relating to the general license within thirty calendar days of the date of the request, or other time specified in the request. If the general licensee cannot provide the requested information within the allotted time, it shall, within that same time period, request a longer period to supply the information by providing the director, by an appropriate method listed in rule 3701:1-40-04 of the Administrative Code, a written justification for the request.

(12) Shall appoint an individual responsible for having knowledge of the appropriate rules and requirements and the authority for taking required actions to comply with appropriate rules and requirements. The general licensee, through this individual, shall ensure the day-to-day compliance with appropriate rules and requirements. This appointment does not relieve the general licensee of responsibility in this regard.

(13)

(a) Shall report, in accordance with paragraphs (C)(13)(b) and (C)(13)(c) of this rule, devices containing at least three hundred seventy megabecquerels (ten millicuries) of cesium-137, 3.7 megabecquerels (0.1 millicurie) of strontium-90, thirty-seven megabecquerels (one millicurie) of cobalt-60, 3.7 megabecquerels (0.1 millicurie) of radium, or thirty-seven megabecquerels (one millicurie) of americium-241 or any other transuranic, i.e., element with atomic number greater than uranium (92), based on the activity indicated on the label. Each address for a location of use, as described under paragraph (C)(13)(c)(iv) of this rule, represents a separate general license and requires a separate registration and fee.

(b) If in possession of a device meeting the criteria of paragraph (C)(13)(a) of this rule, shall report these devices annually to the director and shall pay the fee required by paragraph (S) of rule 3701:1-38-02 of the Administrative Code. Reporting must be done by verifying, correcting, and/or adding to the information provided in a request received from the director. The information must be submitted to the director within thirty days of the date of the request for information or as otherwise indicated in the request. In addition, a general licensee holding devices meeting the criteria of paragraph (C)(13)(a) of this rule is subject to the bankruptcy notification requirement in Chapter 3701:1-40 of the Administrative Code.

(c) In reporting the devices, the general licensee shall furnish the following information and any other information specifically requested by the director:

(i) Name and mailing address of the general licensee;

(ii) Information about each device: the manufacturer (or initial transferor), model number, serial number, the radionuclide and activity (as indicated on the label);

(iii) Name, title, and telephone number of the responsible person designated as a representative of the general licensee under paragraph (C)(12) of this rule;

(iv) Address or location at which the device(s) are used and/or stored;

(v) Certification by the responsible representative of the general licensee that the information concerning the device(s) has been verified through a physical inventory and checking of label information; and

(vi) Certification by the responsible representative of the general licensee that they are aware of the requirements of the general license.

(14) Shall report changes to the mailing address for the location of use (including change in name of general licensee) to the director within thirty days of the effective date of the change.

(15) May not hold devices that are not in use for longer than two years. If devices with shutters are not being used, the shutter must be locked in the closed position. The testing required by paragraph (C)(2) of this rule need not be performed during the period of storage only. However, when devices are put back into service or transferred to another person, and have not been tested within the required test interval, they must be tested for leakage before use or transfer and the shutter tested before use. Devices kept in standby for future use are excluded from the two year time limit if the general licensee performs quarterly physical inventories of these devices while they are in standby.

(D) The director may order the inspection of any facility licensed under this rule if the director determines that an appropriate reason for the inspection exists. These inspections shall be considered as full cost inspections as defined in rule 3701:1-38-02 of the Administrative Code. The reasons the director may conduct for cause inspections include, but are not limited to;

(1) Failure to respond to official correspondence;

(2) Release of radioactive material to the environment;

(3) Investigations of alleged violations of department rules; or

(4) Failure to comply with the license application process.

(E) The general license in paragraph (A) of this rule does not authorize the manufacture or import of devices containing radioactive material.

Last updated July 10, 2025 at 12:13 PM

History

• Effective: December 1, 2012
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-38-03 Application and renewal of registrations for handlers of radiation-generating equipment.

(A) As used in this rule, "facility" means the state, any political subdivision, person, public or private institution, or group, or any unit of one of those entities, but does not include the federal government agencies, and includes the following:

(1) All buildings, equipment, structures and other stationary items that are located on a single site or on contiguous or adjacent sites and that are operated by the same person and have common corporate or business purposes; and

(2) Portions of a building or structure which are operated by the same person and have common corporate or business purposes.

(B) Notwithstanding the definition of "facility," the director may consider sites that are not contiguous or adjacent as one facility provided that:

(1) The sites are operated by the same person;

(2) The sites are of the same facility type as categorized in paragraph (B) of rule 3701:1-38-04 of the Administrative Code;

(3) The applicant for a registration provides for one individual responsible for radiation protection and implementing quality assurance procedures and policies necessary for effective compliance with Chapter 3748. of the Revised Code and rules adopted thereunder, and if applicable, one quality assurance committee, as responsible for all sites; and

(4) The director is reasonably satisfied from the information provided in the application that the applicant will adequately control the radiation-generating equipment at all sites listed in the application. Unless the director has information of violations of Chapter 3748. of the Revised Code or the rules adopted thereunder at one or more sites, he or she shall presume the applicant will adequately control the radiation-generating equipment at all sites if the sites are located not more than five miles apart.

The director shall continue to renew a registration issued under this paragraph that contains all the sites listed thereon provided the registrant demonstrates continued compliance with this paragraph, Chapter 3748. of the Revised Code, and the rules adopted thereunder.

(C) Except as provided in paragraph (D) of this rule, every facility that proposes to handle radiation-generating equipment shall apply for a registration at least thirty days prior to handling the equipment. Registration is required for dental, medical, therapeutic, and non-medical radiation-generating equipment. Application for a registration or renewal thereof shall be made on a form prescribed and provided by the director and shall be accompanied by a non-refundable registration fee in accordance with section 3748.07 of the Revised Code. The application shall include the name and qualifications of the individual designated as responsible and readily available for radiation protection and implementing quality assurance policy and procedures necessary for assuring compliance with Chapter 3748. of the Revised Code and rules adopted thereunder. Registrations shall expire two years from the date of issuance.

Registration certificates are not transferable. If a facility is sold or otherwise transferred to another person after a certificate of registration has been issued, the new handler is required to apply and receive a new registration certificate for the radiation-generating equipment.

(D) Facilities do not need to register the following types of radiation-generating equipment:

(1) Electronic equipment that produces ionizing radiation incidental to its operation for other purposes, if the exposure rate averaged over an area of ten square centimeters does not exceed one-half milliroentgen per hour at a distance of five centimeters from any accessible surface of such equipment; or

(2) Radiation-generating equipment that is already registered under Chapter 3748. of the Revised Code by its possessor.

(E) An applicant for a registration shall submit to the director a complete application for registration on a form provided by the director together with the required registration fee. The application shall contain all the information required on the form and accompanying instructions. The applicant for a registration shall provide to the director within thirty days of receipt of the request, all additional requested information. If the director does not receive the requested information within the thirty days, the director may consider the application abandoned. Any further consideration for a new registration shall be pursuant to another application accompanied by another nonrefundable registration fee.

(F) The director shall grant a new registration or renewal to any applicant who has submitted a complete application, paid the registration fee, and is in compliance with applicable rules adopted under Chapter 3748. of the Revised Code.

(G) Registrations shall be renewed in accordance with the standard renewal procedure established in Chapter 4745. of the Revised Code. The registrant shall apply for renewal at least thirty days prior to the expiration of the registration.

(H) Any handler that assembles, installs, or disposes of radiation-generating equipment within this state shall notify the director, in writing, at least quarterly of such actions.

Each report shall contain the name and address of the facility that received equipment; the manufacturer, model, and serial number of the x-ray tube or x-ray generator transferred, disposed of, or installed; and the date of transfer, disposal, or installation of the radiation-generating equipment.

The state copy of the United States department of health and human services, food and drug administration "Report of Assembly of a Diagnostic X-ray System" form, used for reporting diagnostic x-ray systems which contain certified components, may be used to meet the notification requirements for this rule.

(I) No handler shall transfer, service, or install radiation-generating equipment or the components used in connection with such equipment unless such components and equipment, when properly placed in operation and used, meet the requirements of this chapter and all applicable requirements of Chapter 3701:1-66, 3701:1-67, or 3701:1-68 of the Administrative Code.

(J) The registrant shall notify the director, in writing, fifteen days prior to making any change which would render the information contained in the application for registration or registration certificate no longer accurate.

(K) Notwithstanding any other requirements of this rule, out-of-state owners of radiation-generating equipment who:

(1) Operate the radiation-generating equipment within Ohio are required to:

(a) Possess a valid Ohio registration;

(b) Provide written notification three days prior to the dates when the radiation-generating equipment will be used in Ohio; and

(c) Assure that the operation of the radiation-generating equipment complies with all applicable rules in Chapters 3701:1-38, 3701:1-66, 3701:1-67, 3701:1-68, and 3701-72 of the Administrative Code.

(2) Solely transport the radiation-generating equipment to an Ohio facility to be operated by the Ohio facility are not required to register. The Ohio facility using the radiation-generating equipment shall:

(a) Possess a valid Ohio registration;

(b) Provide written notification three days prior to the dates when the radiation-generating equipment will be used in Ohio; and

(c) Verify that the operation of the radiation-generating equipment complies with all applicable rules in Chapters 3701:1-38, 3701:1-66, 3701:1-67, 3701:1-68, and 3701-72 of the Administrative Code.

(L) Any facility found as an unregistered handler shall be notified by the director that registration is required pursuant to the requirements of paragraph (C) of this rule. Any such facility that does not apply for registration within ten business days of receiving a notice to register shall be inspected by the department. The unregistered handler shall pay the fee required by section 3748.13 of the Revised Code.

A facility that handles radiation-generating equipment and engages in activities involving the use of radiation-generating equipment that does not obtain an Ohio registration as required by this rule is subject to the fee for the inspection of an unregistered handler specified in section 3748.13 of the Revised Code.

Last updated January 20, 2022 at 8:46 AM

History

• Effective: January 20, 2022
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-38-04

(A) Each handler will afford the director, at all reasonable times, opportunity to inspect radiation-generating equipment and equipment shielding, surroundings, records and other equipment and devices used in connection with handling radiation-generating equipment. Each handler also will perform, as requested by the director, such tests as the director determines may be necessary for the handler to demonstrate compliance with the obligations of Chapter 3748. of the Revised Code and rules adopted thereunder and to evaluate the extent of radiation hazards that may be present.

(B) The director will routinely inspect radiation-generating equipment unless that equipment is registered as in storage and rendered inoperable. Routine inspections will be conducted according to the schedule by facility category listed in appendix A to this rule.

(C) Notwithstanding the inspection frequencies specified in paragraph (B) of this rule, radiation-generating equipment capable of operating at or above two hundred fifty kilovoltage peak may be inspected every twelve months irrespective of facility category.

(D) The director may modify the inspection frequency of a registered facility based upon the performance of the facility.

(E) In addition to any inspections obligated under this rule, inspections of new or newly installed radiation-generating equipment may be performed within twelve months of installation of the equipment.

(F) Non-routine or special inspections of facilities may be conducted by the director upon receiving complaints or other evidence of violation of the obligations of Chapter 3748. of the Revised Code or rules adopted thereunder, or orders of the director issued pursuant thereto.

(G) Any handler of radiation-generating equipment that is a medical practitioner or a corporation, partnership, or other business entity consisting of medical practitioners, other than a hospital as defined in section 3727.01 of the Revised Code, will pay to the department of health an inspection fee according to the schedule and categories listed in appendix B to this rule. For purposes of this section "medical practitioner" means a person authorized to practice dentistry pursuant to Chapter 4715. of the Revised Code; medicine and surgery, osteopathic medicine and surgery, or podiatry pursuant to Chapter 4731. of the Revised Code; or chiropracty pursuant to Chapter 4734. of the Revised Code.

(H) Except as otherwise provided in paragraph (G) of this rule, all handlers of radiation-generating equipment will pay an inspection fee according to the schedule listed in appendix C to this rule.

(I) In accordance with division (B) of section 3748.13 of the Revised Code, the fee for the inspection of a facility that does not possess or that has not applied for registration and for which registration is obligated, will pay the amount obligated in division (B) of section 3748.13 of the Revised Code plus any obligated amount specified under paragraph (G) or (H) of this rule.

(J) In accordance with section 3748.13 of the Revised Code, the fee for any inspection to determine whether notice of violations cited in a previous inspection have been corrected is fifty per cent of the fee specified in paragraphs (G) and (H) of this rule. Inspections to determine compliance with a notice of violation issued pursuant to paragraph (A) of rule 3701:1-38-06 of the Administrative Code may include, but is not limited to, compliance reviews done off-site.

View AppendixView AppendixView Appendix

Last updated May 3, 2024 at 7:39 AM

History

• Effective: May 3, 2024
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-38-06

(A) The director may suspend or revoke a license or a certificate of registration, or issue adjudication orders for failure by the licensee or registrant to comply with Chapter 3748. of the Revised Code or a rule adopted thereunder. Except as otherwise provided in paragraphs (B), and (D) to (F) of this rule, prior to suspending or revoking a license or certificate of registration, the director shall first give written notice of violation to the licensee or registrant, by certified mail, return-receipt requested, specifying the section of Chapter 3748. of the Revised Code or the rule violated and specifically describing the violation. The notice of violation shall include information concerning the applicable penalties established under sections 3748.19 and 3748.99 of the Revised Code. The director shall provide the licensee or registrant with an informal meeting provided that the licensee or registrant requests the meeting and provided that the meeting is held within thirty days of the date that the licensee or registrant receives the notice of violation or at a later date as determined by the director. If, after thirty days from the date the licensee or registrant received the notice of violation, the facility remains in violation the director may issue an adjudication order. The adjudication order shall specify the section of Chapter 3748. of the Revised Code or the rule violated, specifically describe the violation, specify the action ordered to abate the violation, and order the action to be taken within a specified reasonable time. In the order, the director also may propose to suspend or revoke the license or certificate of registration should the licensee or registrant fail to take the action specified in the order within the specified time.

(B) If the director determines that an emergency exists requiring immediate action to protect the public health or safety, he or she may issue an emergency adjudication order, reciting the existence of an emergency and specifying the necessary action that shall be taken to meet the emergency. The order shall be effective immediately, without notice or hearing, but shall not remain effective for more than ninety days after its issuance. Any facility to which the order is directed shall comply immediately.

(C) In the case of a failure by a licensee or registrant to comply with Chapter 3748. of the Revised Code or the rules adopted thereunder, the director may issue an adjudication order, emergency adjudication order, or may propose the suspension or revocation of the facility's license or registration. The licensee or registrant shall be notified as soon as practicable that the licensee or registrant may appeal any adjudication order, emergency adjudication order, or proposed license or registration suspension or revocation in accordance with Chapter 119. of the Revised Code, provided that the licensee or registrant requests a hearing within thirty days of the time of mailing the order or proposed suspension or revocation. In the case of an emergency adjudication order, the hearing shall be held within thirty days of the request. The director may continue, modify, suspend or revoke an adjudication order at any time, or withdraw a proposed suspension or revocation prior to a final order. In accordance with Chapter 3748. of the Revised Code and this rule, the director may concurrently assert against a licensee or registrant more than one administrative remedy. In the event the licensee or registrant appeals more than one administrative action, the director may consolidate into one hearing any or all issues to be heard.

(D) Registration, license, and inspection fees shall be paid no later than thirty days after the invoice for the fee is mailed. In accordance with sections 3748.07 and 3748.13 of the Revised Code, any fee that remains unpaid on the ninety-first day after the original invoice date shall be assessed an additional amount equal to ten per cent of the original fee. All invoices issued by the department shall include thereon information regarding the assessment for late payment or nonpayment that is specified in division (B) of section 3748.13 of the Revised Code.

(1) The department shall mail invoices by ordinary United States mail to the most recent address provided by the registrant or licensee on his or her application or current registration.

(2) The department shall maintain a list of the invoices issued and date mailed.

(E) The director may impound or order the impounding of sources of radiation that are not stored, used, or disposed of in accordance with Chapter 3748. of the Revised Code or the rules adopted under it if the source of radiation has been abandoned or if the owner cannot be identified or located. If the director determines that an emergency exists requiring immediate impoundment to protect the public health or safety, the director may issue an emergency adjudication order in accordance with paragraph (B) of this rule. The director may make any disposition of the source of radiation consistent with Chapter 3748. of the Revised Code and the rules adopted thereunder.

(F) If the director determines that a licensee has failed to comply with Chapter 3748. of the Revised Code or the rules adopted thereunder, the director may at any time assess and collect an administrative monetary penalty in accordance with rules adopted pursuant to section 3748.05 of the Revised Code. The director may assess the administrative penalty independent of any and all other remedies that may be asserted by the department but may not assess any administrative monetary penalty until specified by rule in accordance with section 3748.05 of the Revised Code. The licensee may appeal the assessment of an administrative monetary penalty in accordance with Chapter 119. of the Revised Code, provided that the licensee requests a hearing within thirty days of the time of mailing the administrative penalty assessment.

Last updated November 2, 2022 at 2:09 PM

History

• Effective: April 15, 2013
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-38-05 Administrative penalties.

(A) As used in this rule:

(1) "Repetitive violation" means a same or similar violation that reasonably could have been prevented by a facility's corrective action for the previous violation normally occurring either within the past two years of the inspection at issue or the period within the last two inspections, whichever is longer.

(2) "Event" means a situation involving licensable material and characterized by:

(a) An active adverse impact on equipment or personnel readily obvious by human observation or instrumentation; or

(b) A radiological impact on personnel, the general public, or the environment in excess of regulatory limits, such as an overexposure, a release of radioactive material above the limits set forth in rule 3701:1-38-21 of the Administrative Code or a loss of radioactive material in quantities reportable pursuant to rule 3701:1-38-21 of the Administrative Code.

(B) The director may assess an administrative monetary penalty for failure of any facility required to be licensed under Chapter 3748. of the Revised Code to comply with that chapter or rules adopted thereunder. Any administrative monetary penalty imposed shall be assessed in accordance with this rule. Unless otherwise provided in this rule, the director may issue an order imposing an administrative penalty in addition to and concurrent or subsequent to issuing a written notice of violation as provided in rule 3701:1-38-06 of the Administrative Code. The director may assess an administrative monetary penalty independent of any and all other remedies that may be asserted by the department. Any orders issued or payments or other requirements imposed shall not affect any civil, criminal or administrative enforcement proceedings brought under this chapter or any other provision of state or local law.

(C) Administrative monetary penalties specified in this rule are based upon the level of severity of the violation which includes factors such as the importance or significance of the violation, the length or duration of the violation, whether the violation is repetitive in nature or is similar to previous violations, and the time period between the current violation and any previous violation. The director may issue an administrative monetary penalty as follows:

| Severity Level of Violation | Penalty | | --- | --- | | I | $5,000 | | II | $4,000 | | III | $2,500 | | IV | up to $500 |

(D) In addition to the issuance of a notice of violation, in the case of a severity level IV violation the director shall do either of the following:

(1) If within thirty days of the issuance of the notice of violation, or such greater time as the director may determine, the facility remedies the violation and documents to the satisfaction of the director that the facility is in compliance, the director shall withdraw the assessment of an administrative monetary penalty; or

(2) If there remain any items of non-compliance thirty days or such greater time as the director may determine after the issuance of the notice of violation, the director shall maintain the administrative monetary penalty for the items of non-compliance. The director shall reduce the administrative monetary penalty in an amount up to fifty per cent of the penalty assessed for the violation or violations found at severity level IV provided that the facility has corrected at least fifty per cent of the violations.

A group of severity level IV violations may be evaluated in the aggregate and assigned a single severity level III, if the violations have the same or similar underlying cause or program deficiencies, or the violations contributed to or were unavoidable consequences of the underlying problem or program deficiencies.

(E) In addition to the issuance of a notice of violation, in the case of a severity level III violation the director shall assess an administrative monetary penalty in accordance with the following:

(1) If within thirty days of the issuance of the notice of violation or such greater time as the director may determine the facility remedies the violation and documents to the satisfaction of the director that the facility is in compliance, the director may determine to withdraw the assessment of the administrative monetary penalty; or

(2) If there remain any items of non-compliance thirty days after the issuance of the notice of violation or such greater time as the director may determine, the director shall reduce the administrative monetary penalty in an amount up to fifty per cent of the penalty assessed for the violation or violations found at severity level III provided that the facility has corrected at least fifty per cent of the violations.

(F) In the case of a severity level I or II violation, the director shall issue an administrative monetary penalty. The director may reduce the penalty up to fifty per cent of the assessed amount if it is a non-repetitive violation and the facility achieves and documents compliance to the satisfaction of the director within thirty days of receiving the notice of violation.

(G) Notwithstanding paragraphs (C) to (F) of this rule, in the case of a repetitive violation, the director shall not reduce the administrative monetary penalty specified in paragraph (C) of this rule. In the case of a third or subsequent occurrence of the repetitive violation, the director may increase the administrative monetary penalty specified in paragraph (C) of this rule by an additional twenty-five per cent and continue to increase the penalty by an additional twenty-five per cent for each subsequent occurrence.

(H) When a violation occurs and the facility identifies the violation before it results in an event or is cited by the department, the director may reduce the penalty specified in paragraph (C) of this rule as follows:

(1) In the case of a facility that identified the violation as a result of observation, the director may reduce the administrative monetary penalty assessed in accordance with paragraph (C) of this rule in an amount of up to twenty-five per cent.

(2) In the case of a facility that discovered the violation as a result of a self-monitoring effort, such as an audit, test, surveillance, design review, or trouble shooting, the director may reduce the administrative monetary penalty assessed in accordance with paragraph (C) of this rule in an amount up to fifty per cent.

(3) In the case of a facility that self-corrects a severity III or IV violation in a manner and time period approved by director, the director shall not issue an administrative monetary penalty.

(I) Notwithstanding any other provision in this rule, after determination of the severity level of a violation found by the department, the director may increase the amount of the administrative monetary penalty as follows:

(1) In the case of overall past poor facility performance the administrative monetary penalty assessed in accordance with paragraph (C) of this rule may be increased up to one hundred per cent.

(2) In the case of a violation that is flagrant or reckless and that results in a substantial increase in risk to personnel, the general public or the environment, including cases in which the duration of the violation has contributed to the substantial increase in risk, the administrative monetary penalty assessed in accordance with paragraph (C) of this rule may be increased up to one hundred per cent.

(3) In the case of a willful violation within the administrative control of the licensee, the administrative monetary penalty assessed in accordance with paragraph (C) of this rule may be increased up to one hundred per cent.

(J) The facility may appeal the assessment of an administrative monetary penalty in accordance with Chapter 119. of the Revised Code, provided that the facility requests a hearing within thirty days of the time of mailing the notice of the administrative penalty assessment. The director may consolidate a hearing on an administrative monetary penalty assessed under this rule with any other complaint or finding of the director where the director determines that there are one or more issues of fact or law in common. No more than one hearing will be conducted with respect to each violation alleged.

Last updated January 20, 2022 at 8:46 AM

History

• Effective: January 20, 2022
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-38-21

(A) The licensee or registrant shall report stolen, lost, or missing licensed or registered sources of radiation to the director in accordance with the following:

(1) Telephone reports shall be made as follows:

(a) To the bureau of environmental health and radiation protection point of contact (POC) in accordance with the form "Notice to Employees" issued by the director.

(b) In the case of a licensee, he or she shall make contact:

(i) Immediately after the licensee determines that licensed radioactive material is stolen, lost, or missing in an aggregate quantity equal to or greater than one thousand times the quantity specified in the appendix to rule 3701:1-38-18 of the Administrative Code under such circumstances that it appears to the licensee that an exposure could result to individuals in unrestricted areas;

(ii) Within thirty days after its occurrence becomes known to the licensee, lost, stolen, or missing licensed radioactive material in an aggregate quantity greater than ten times the quantity specified in the appendix to rule 3701:1-38-18 of the Administrative Code that is still missing.

(c) In the case of a registrant, he or she shall make contact immediately after it becomes known that radiation-generating equipment has been stolen, lost, or is missing.

(2) Written reports shall be made as follows:

(a) Each licensee or registrant required to make a report pursuant to paragraph (A)(1) of this rule shall, within thirty days after making the telephone report, make a written report to the director setting forth the following information, where applicable:

(i) A description of the licensed or registered source of radiation involved, including, for radioactive material, the kind, quantity, and chemical and physical form, and in the case of radiation-generating equipment, the manufacturer, model and serial number, type and maximum energy of the radiation emitted;

(ii) A description of the circumstances under which the loss or theft occurred;

(iii) A statement of disposition, or probable disposition, of the licensed or registered source of radiation involved;

(iv) Exposures of individuals to radiation, circumstances under which the exposures occurred, and the possible total effective dose equivalent to persons in unrestricted areas;

(v) Actions that have been taken, or will be taken, to recover the source of radiation; and

(vi) Procedures or measures that have been, or will be, adopted to ensure against a recurrence of the loss or theft of licensed or registered sources of radiation.

(b) Subsequent to filing the written report, the licensee or registrant shall also report additional substantive information on the loss or theft within thirty days after the licensee or registrant learns of such information.

(c) The licensee or registrant shall prepare any report filed with the director pursuant to this rule so that names of individuals who may have received exposure to radiation are stated in a separate and detachable portion of the report.

(B) Notification of incidents shall be made as follows:

(1) Excluding prescribed medical doses to patients, each licensee or registrant shall immediately report each event involving a source of radiation possessed by the licensee or registrant that may have caused or threatens to cause any of the following conditions:

(a) An individual receiving:

(i) A total effective dose equivalent of 0.25 sievert (twenty-five rem) or more;

(ii) A lens dose equivalent of 0.75 sievert (seventy-five rem) or more; or

(iii) A shallow dose equivalent to the skin or extremities or a total organ dose equivalent of 2.5 sievert (two hundred fifty rem) or more; or

(b) The release of radioactive material, inside or outside of a restricted area that, had an individual been present for twenty-four hours, the individual could have received an intake five times the occupational ALI. This provision does not apply to locations where personnel are not normally stationed during routine operations, such as hot-cells or process enclosures.

(2) Each licensee or registrant shall report to the director, within twenty-four hours of discovery, each event involving loss of control of a licensed or registered source of radiation possessed by the licensee or registrant that may have caused, or threatens to cause, any of the following:

(a) An individual to receive, in a period of twenty-four hours:

(i) A total effective dose equivalent exceeding 0.05 sievert (five rem);

(ii) An lens dose equivalent exceeding 0.15 sievert (fifteen rem); or

(iii) A shallow dose equivalent to the skin or extremities or a total organ dose equivalent exceeding 0.5 sievert (fifty rem); or

(b) The release of radioactive material, inside or outside of a restricted area that, had an individual been present for twenty-four hours, the individual could have received an intake in excess of one occupational ALI. This provision does not apply to locations where personnel are not normally stationed during routine operations, such as hot-cells or process enclosures.

(3) Licensees or registrants shall make the reports required by paragraphs (B)(1) and (B)(2) of this rule to the POC by telephone to the department and shall confirm the initial contact by telegram, mailgram, electronic mail, or facsimile to the director.

(4) The licensee or registrant shall prepare each report filed with the director pursuant to this rule so that names of individuals who have received exposure to sources of radiation are stated in a separate and detachable portion of the report.

(5) The provisions of paragraph (B) of this rule do not apply to doses that result from planned special exposures, provided such doses are within the limits for planned special exposures and are reported in accordance with this paragraph.

(C) Reports of exposures, radiation levels, and concentrations of radioactive material exceeding the limits shall be made by the licensee or registrant as follows:

(1) Reportable events that are specified in this paragraph shall, in addition to the notification requirements in paragraph (B) of this rule, be reported to the director in writing within thirty days after learning of any of the following occurrences:

(a) Incidents for which notification is required by paragraph (B) of this rule and with doses in excess of any of the following:

(i) The occupational dose limits for adults in paragraphs (A)(1) and (A)(2) of rule 3701:1-38-12 of the Administrative Code;

(ii) The occupational dose limits for a minor in paragraph (G) of rule 3701:1-38-12 of the Administrative Code;

(iii) The limits for an embryo or fetus of a declared pregnant woman in paragraph (H) of rule 3701:1-38-12 of the Administrative Code;

(iv) The limits for an individual member of the public in paragraph (A) of rule 3701:1-38-13 of the Administrative Code;

(v) Any applicable limit in the license or registration; or

(vi) The ALARA constraints for air emissions established under paragraph (D)(4) of rule 3701:1-38-11 of the Administrative Code; or

(b) Levels of radiation or concentrations of radioactive material in:

(i) A restricted area in excess of applicable limits in the license or registration; or

(ii) An unrestricted area in excess of ten times the applicable limit set forth in this chapter or in the license or registration, whether or not involving exposure of any individual in excess of the limits in paragraph (A) of rule 3701:1-38-13 of the Administrative Code; or

(c) For licensees subject to the provisions of the United States environmental protection agency generally applicable environmental radiation standards in 40 C.F.R. 190 (as in effect on the effective date of this rule), levels of radiation or releases of radioactive material in excess of those standards, or of license conditions related to those standards.

(2) Each report required by this rule shall describe the extent of exposure of individuals to radiation and radioactive material, including, as appropriate:

(a) Estimates of each individual's dose, the level of radiation and concentration of radioactive material involved, and the cause of the elevated exposure, dose rate, or concentration; and

(b) Corrective steps taken or planned to ensure against a recurrence, including the schedule for achieving conformance with applicable limits, ALARA constraints, generally applicable environmental standards, and associated license or registration conditions.

(3) Each report filed pursuant to this rule shall include, for each occupationally overexposed individual, the name, social security account number, and date of birth of the individual. In the case of the limit for an embryo or fetus in paragraph (H) of rule 3701:1-38-12 of the Administrative Code, the identifiers should be those of the declared pregnant woman. The report shall be prepared so that information on each individual is stated in a separate and detachable portion of the report.

(4) All licensees or registrants who make reports pursuant to this rule shall submit the report in writing to the director.

(D) Reports of planned special exposures shall be submitted by the licensee in a written report to the director within thirty days following any planned special exposure conducted in accordance with paragraph (F) of rule 3701:1-38-12 of the Administrative Code, informing the director that a planned special exposure was conducted and indicating the date the planned special exposure occurred and the information required by paragraph (G) of rule 3701:1-38-20 of the Administrative Code.

(E) When a licensee or registrant is required pursuant to paragraph (C) or (D) of this rule to report to the director any exposure of an identified occupationally exposed individual, or an identified member of the public, to radiation or radioactive material, the licensee or registrant shall also provide the individual a report on his or her exposure data included in the report to the director. This report shall be transmitted no later than the transmittal to the director, and shall comply with the provisions of paragraph (C)(1) of rule 3701:1-38-10 of the Administrative Code.

(F) A report of a leaking or contaminated sealed source shall be filed by the licensee with the director within five days of the test results, if the test reveals the presence of one hundred eighty-five becquerels (0.005 microcurie) or more of removable contamination. The report shall include the equipment involved, the test results and the corrective action taken.

Last updated January 20, 2022 at 8:48 AM

History

• Effective: January 20, 2022
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-38-07 General provisions; purpose, scope, and communications.

(A) Chapter 3701:1-38 of the Administrative Code establishes standards for protection against ionizing radiation resulting from activities conducted under licenses and registrations issued by the director. It is the purpose of Chapter 3701:1-38 of the Administrative Code to control the receipt, possession, use, transfer, and disposal of radiation sources by any licensee or registrant in such a manner that the total dose to an individual, including doses resulting from licensed and unlicensed radioactive material and from radiation sources other than background radiation, does not exceed the standards for protection against radiation prescribed in this chapter. The rules in Chapter 3701:1-38 of the Administrative Code apply to facilities that receive, possess, use, transfer, or dispose of radioactive material, and to handlers of radiation-generating equipment. Nothing in this chapter shall be construed as limiting actions of the director that may be necessary to protect health, safety or the environment. The limits in Chapter 3701:1-38 of the Administrative Code do not apply to doses due to background radiation, any medical administration the individual has received, from exposures to individuals administered radioactive materials and released in accordance with rule 3701:1-58-30 of the Administrative Code, or equivalent United States nuclear regulatory commission or agreement state regulations, or voluntary participation in medical research programs.

(B) Communications and reports, unless otherwise specified in Chapter 3701:1-38 of the Administrative Code, shall be addressed to "Ohio Department of Health, Bureau of Environmental Health and Radiation Protection, 246 North High Street, Columbus, Ohio 43215."

Last updated January 20, 2022 at 8:47 AM

History

• Effective: January 20, 2022
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-38-08 Waivers, variances, additional requirementsand vacating premises.

(A) The director, upon application of the licensee or registrant, or upon his or her own initiative, may grant a waiver or variance from the requirements of this chapter as he or she determines is authorized by law, provided that the licensee or registrant shows to the satisfaction of the director that there is good cause for the waiver or variance and that the waiver or variance will not result in any undue hazard on public health and safety or detrimental effect on the environment. The terms, conditions and expiration of the waiver shall be set forth in writing by the director. Failure to comply with the terms of the waiver or variance may result in immediate withdrawal of the waiver or variance. The director may issue an order, a license amendment or impose requirements on a license or registration in addition to those established in this chapter, as the director deems appropriate or necessary to protect the public health, safety or the environment.

(B) A licensee or registrant shall notify the department in writing of intent to vacate at least thirty days prior to vacating or relinquishing possession or control of a premises which may be contaminated with radioactive material as a result of his or her activities.

Last updated November 2, 2022 at 2:09 PM

History

• Effective: August 30, 2015
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-38-09 Inspection and investigation.

(A) Each licensee or registrant shall afford to the department at all reasonable times, the opportunity to inspect materials, machines, activities, facilities, premises, and records and any other matters relative to the handling of radioactive material or radiation-generating equipment.

(1) During an inspection, department inspectors may consult privately with workers as specified in paragraph (B) of this rule. The licensee or registrant may accompany department inspectors at any other time during the inspection.

(2) If, at the time of inspection, an individual has been authorized by the workers to represent them during department inspections, the licensee or registrant shall notify the inspector of such authorization and shall give the worker's representative an opportunity to accompany the inspector during the inspection of physical working conditions. Each worker's representative shall be routinely engaged in licensed or registered activity under control of the licensee or registrant and shall have received instructions as to the provisions specified in paragraph (B) of rule 3701:1-38-10 of the Administrative Code. Different representatives of licensees or registrants and workers may accompany the inspectors during different phases of an inspection if there is no resulting interference with the conduct of the inspection. However, only one worker's representative at a time may accompany an inspector.

(3) With the approval of the licensee or registrant and the worker's representative, an individual who is not routinely engaged in work under control of the licensee or registrant, for example, a consultant to the licensee or registrant or to the worker's representative, shall be afforded the opportunity to accompany the department inspector during the inspection of physical working conditions.

(4) Notwithstanding any other provision in paragraph (A) of this rule, a department inspector may refuse to permit accompaniment by any individual who deliberately interferes with a fair and orderly inspection. With regard to areas containing information classified by an agency of the United States government in the interest of national security, an individual who accompanies an inspector may have access to such information only if properly authorized. With regard to any area containing proprietary information or trade secrets, the worker's representative for that area shall be an individual previously authorized by the licensee or registrant to enter that area.

(B) Private consultation between a department inspector and a worker during inspections shall be subject to the following:

(1) A department inspector may consult privately with workers concerning matters of occupational radiation protection and other matters related to applicable provisions of a license condition, order, or rules adopted pursuant to Chapter 3748. of the Revised Code.

(2) During the course of an inspection, any worker privately may bring to the attention of a department inspector, either orally or in writing, any past or present condition which the worker has reason to believe may have contributed to or caused any violation of rules adopted pursuant to Chapter 3748. of the Revised Code, license condition, order, or any unnecessary exposure of an individual to sources of radiation under the licensee's or registrant's control. Any such notice in writing shall comply with the requirements specified in paragraph (C) of this rule. The provisions of this paragraph shall not be interpreted as authorization to disregard instructions pursuant to paragraph (B) of rule 3701:1-38-10 of the Administrative Code.

(C) Requests by workers for a department inspection shall be in accordance with the following:

(1) Any worker or representative of workers believing that a violation of Chapter 3748. of the Revised Code or rules adopted thereunder, license condition or order, or any unnecessary exposure of an individual to sources of radioactive material or radiation-generating equipment under the licensee's or registrant's control has occurred in the handling of radioactive material or radiation-generating equipment relative to working conditions may request an inspection by giving notice of the alleged violation to the director. Any such notice shall be in writing, shall set forth the specific grounds for the notice, and shall be signed by the worker or representative of the workers. A copy shall be provided to the licensee or registrant by the department no later than at the time of inspection except that, upon the request of the worker giving such notice, such worker's name and the name of individuals referred to therein shall not appear in such copy or on any record published, released, or made available by the department, except for good cause shown.

(2) If, upon receipt of such notice, the director determines that the written complaint meets the requirements specified in paragraph (C)(1) of this rule and that the director determines that there are reasonable grounds to believe that the alleged violation exists or has occurred or that further investigation is necessary, the department shall inspect the facility as soon as practicable to determine if such alleged violation exists or has occurred. Any such inspection is not limited to matters referred to in the written complaint.

(3) The department shall notify the complainant in writing of the results of the investigation. The complainant may resubmit the written complaint without prejudice.

(D) If the department determines under paragraph (C) of this rule that an inspection is not warranted by a written complaint, such determination shall be in accordance with the following:

(1) If the department determines that an inspection is not warranted because there are no reasonable grounds to believe that a violation exists or has occurred, the department shall notify the complainant in writing of such determination. The complainant may obtain review of such determination by submitting a written statement of position with the department. The department will provide the licensee or registrant with a copy of such statement, excluding, at the request of the complainant, the name of the complainant. The licensee or registrant may submit an opposing written statement of position with the department. The department will provide any opposing statement to the complainant.

(2) Upon the request of the complainant, the director may hold an informal conference in which the complainant and the licensee or registrant may orally present their views. An informal conference may also be held at the request of the licensee or registrant, but disclosure of the identity of the complainant will be made only following receipt of written authorization from the complainant. The director shall consider all written and oral views presented and shall notify the parties in writing of his or her decision on whether an inspection is warranted and the reason therefore.

(E) No licensee or registrant, or contractor or subcontractor of a licensee or registrant shall instruct any employee to withhold information from a department inspector or retaliate or discriminate against any employee or former employee for exercising rights or engaging in activities protected under rules adopted pursuant to Chapter 3748. of the Revised Code.

Last updated November 2, 2022 at 2:09 PM

History

• Effective: August 30, 2015
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-38-10

(A) Posting of notices to workers.

(1) Each licensee or registrant shall post current copies of the following documents:

(a) All applicable rules promulgated pursuant to Chapters 3748. and 4773. of the Revised Code;

(b) The license or certificate of registration, including, any conditions or documents incorporated by reference into a license and amendments thereto;

(c) The safe operating procedures applicable to activities under the license or registration; and

(d) Any notice of violation involving radiological working conditions, proposed imposition of civil or administrative monetary penalty, or order issued pursuant to rule 3701:1-38-06 of the Administrative Code and any response from the licensee or registrant. Such document shall be posted within five working days after receipt of the document. The licensee's or registrant's response, if any, shall be posted within five working days after dispatch of the document to the director. Such documents shall remain posted for a minimum of five working days or until action correcting the violation has been completed, whichever is later.

(e) The Ohio department of health, bureau of environmental health and radiation protection issued form titled "Notice to Employees."

(2) If posting of a document specified in paragraphs (A)(1)(a) to (A)(1)(c) of this rule is not practical, the licensee or registrant may post a notice which describes the document and states where it may be readily examined.

(3) Documents, notices, or forms posted pursuant to paragraph (A) of this rule shall appear in a sufficient number of places to permit individuals engaged in licensed or registered activity under the license or registration to observe them on the way to or from any particular work location to which the document applies, shall be conspicuous, and shall be replaced if defaced or altered.

(B) Instruction to workers.

(1) The licensee or registrant shall, with respect to all individuals likely to receive an annual TEDE occupational dose in excess of one millisievert (one hundred millirem):

(a) Keep such individuals informed of the storage, transfer, or use of sources of radiation in the licensee's or registrant's workplace;

(b) Instruct such individuals in the health effects associated with exposure to radiation or radioactive material to the individual and potential offspring, in precautions or procedures to minimize exposure, and in the purposes and functions of protective devices employed;

(c) Instruct such individuals in, and instruct such individuals to observe, to the extent within the individual's control, the applicable provisions of rules promulgated under Chapter 3748. of the Revised Code and any license conditions for the protection of personnel from exposures to radiation or radioactive material;

(d) Instruct each such individual of his or her responsibility to report promptly to the licensee or registrant any condition which may constitute, lead to, or cause a violation of Chapter 3748. of the Revised Code, the rules promulgated thereunder, any license condition, or order, and any unnecessary exposure to radiation or radioactive material;

(e) Instruct such individuals in the appropriate response to warnings made in the event of any unusual occurrence or malfunction that may involve exposure to radiation or radioactive material; and

(f) Advise such individuals of any radiation exposure reports furnished pursuant to paragraph (C) of this rule.

(2) In determining those individuals subject to the requirements of paragraph (B)(1) of this rule, licensees and registrants shall take into consideration assigned activities during normal and abnormal situations involving exposure to radiation and radioactive materials which can reasonably be expected to occur during the life of the facility. The extent of these instructions shall be commensurate with potential radiological health protection problems present in the workplace.

(C) Notifications and reports to individuals.

(1) Radiation exposure data for an individual and the results of any measurements, analyses, and calculations of radioactive material deposited or retained in the body of an individual shall be reported to the individual as specified in this rule. The information reported shall include data and results obtained pursuant to Chapter 3748. of the Revised Code or rules adopted thereunder, an order, or license condition as shown in records maintained by the licensee or registrant pursuant to paragraph (H) of rule 3701:1-38-20 of the Administrative Code. Each notification and report shall:

(a) Be in writing;

(b) Include appropriate identifying data such as the name of the licensee or registrant, the name of the individual, and the individual's identification number, preferably social security number;

(c) Include the individual's exposure information; and

(d) Contain the statement: "This report is furnished to you under the provisions of rule 3701:1-38-10 of the Administrative Code. You should preserve this report for further reference."

(2) Each licensee or registrant shall make dose information available to workers as shown in records maintained by the licensee under the provisions of paragraph (H) of rule 3701:1-38-20 of the Administrative Code. The licensee or registrant shall provide an annual report to each individual monitored under rule 3701:1-38-14 of the Administrative Code, of the dose received in that monitoring year if:

(a) The individual's occupational dose exceeds one millisievert (one hundred millirem) TEDE or one millisievert (one hundred millirem) to any individual organ or tissue; or

(b) The individual requests his or her annual dose report.

(3) Each licensee or registrant shall furnish reports to workers.

(a) At the request of a worker formerly engaged in activities controlled by the licensee or registrant, each licensee or registrant shall furnish to the worker a report of the worker's exposure to sources of radiation:

(i) As shown in records maintained by the licensee or registrant pursuant to rule 3701:1-38-20 of the Administrative Code for each year the worker was required to be monitored under the provisions of rule 3701:1-38-14 of the Administrative Code; and

(ii) For each year the worker was required to be monitored under the monitoring requirements in effect prior to August 31, 1999.

(b) This report must be furnished within thirty days from the time the request is made or within thirty days after the exposure of the individual has been determined by the licensee or registrant, whichever is later. This report must cover the period of time that the worker's activities involved exposure to sources of radiation licensed or registered by the director and must include the dates and locations of licensed or registered activities in which the worker participated during this period.

(4) When a licensee or registrant is required pursuant to paragraphs (A) to (C) of rule 3701:1-38-21 of the Administrative Code to report to the director any exposure of an individual to sources of radiation, the licensee or the registrant shall also provide the individual a written report on the exposure data included in the report to the director. This report must be transmitted no later than the transmittal to the director.

(5) At the request of a worker who is terminating employment with the licensee or registrant that involved exposure to sources of radiation during the current calendar quarter or the current year, each licensee or registrant shall provide at termination to each worker, or to the worker's designee, a written report regarding the radiation dose received by that worker from operations of the licensee or registrant during the current calendar year or fraction thereof. If the most recent individual monitoring results are not available at that time, a written estimate of the dose must be provided together with a clear indication that this is an estimate.

Last updated November 2, 2022 at 2:09 PM

History

• Effective: May 17, 2018
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-38-20

(A) Each licensee or registrant shall use the SI units becquerel, gray, sievert and coulomb per kilogram, or the special units curie, rad, rem and roentgen, including multiples and subdivisions, and shall clearly indicate the units of all quantities on records required by this chapter. The licensee or registrant shall make a clear distinction among the quantities entered on the records such as, total effective dose equivalent, total organ dose equivalent, shallow dose equivalent, lens dose equivalent, deep dose equivalent, or committed effective dose equivalent.

(B) Each licensee or registrant shall maintain records of the radiation protection program, including the provisions of the program and audits and other reviews of program content and implementation. The licensee or registrant shall retain the records of the provisions of the program until the department terminates each license or registration pertinent to the record. The licensee or registrant shall retain all the other records required by this paragraph for three years after the record is made.

(C) Records of surveys showing the results of surveys and calibrations required by paragraph (A) of rule 3701:1-38-14 and paragraph (F) of rule 3701:1-38-18 of the Administrative Code shall be maintained and retained by the licensee or registrant for three years after the record is made.

(D) The licensee or registrant shall retain each of the following records until the department terminates each license or registration pertinent to the record:

(1) Records of the results of surveys to determine the dose from external sources of radiation used, in the absence of or in combination with individual monitoring data, in the assessment of individual dose equivalents;

(2) Records of the results of measurements and calculations used to determine individual intakes of radioactive material and used in the assessment of internal dose;

(3) Records showing the results of air sampling, surveys, and bioassays required pursuant to paragraphs (C)(2)(a) and (C)(2)(b) of rule 3701:1-38-16 of the Administrative Code; and

(4) Records of the results of measurements and calculations used to evaluate the release of radioactive effluents to the environment.

(E) Records of tests for leakage or contamination of sealed sources shall be kept in units of becquerel or microcurie, or multiples thereof, and maintained for inspection by the department for at least three years after the records are made.

(F) Records of prior occupational dose and exposure history as required in paragraph (E) of rule 3701:1-38-12 of the Administrative Code shall be recorded by the licensee or registrant on a form provided by the department entitled "lifetime occupational exposure history" in accordance with the instructions for completing this form, or in clear and legible records containing all the information required by the same form. The licensee or registrant shall maintain these records until the department terminates each license or registration pertinent to this record. The licensee or registrant shall retain records used in preparing the form for three years after the record is made.

(G) Records of planned special exposures as required in paragraph (F) of rule 3701:1-38-12 of the Administrative Code shall be maintained by the licensee:

(1) The licensee shall maintain records that describe the following:

(a) The exceptional circumstances requiring the use of a planned special exposure;

(b) The name of the management official who authorized the planned special exposure and a copy of the signed authorization;

(c) What actions were necessary;

(d) Why the actions were necessary;

(e) What precautions were taken to assure that doses were maintained ALARA;

(f) What individual and collective doses were expected to result; and

(g) The doses actually received in the planned special exposure.

(2) The licensee shall retain the records until the department terminates each license pertinent to these records.

(H) Records of individual dose monitoring results shall be maintained by each licensee or registrant for each individual for whom monitoring is required pursuant to paragraph (B) of rule 3701:1-38-14 of the Administrative Code, and records of doses received during planned special exposures, accidents, and emergency conditions. Assessments of dose equivalent and records made using units in effect before the effective date of these rules need not be changed.

(1) These records shall include, when applicable:

(a) The deep dose equivalent to the whole body, lens dose equivalent, shallow dose equivalent to the skin, and shallow dose equivalent to the extremities;

(b) The estimated intake or radionuclides as provided in paragraph (B) of rule 3701:1-38-12 of the Administrative Code;

(c) The committed effective dose equivalent assigned to the intake of radionuclides; and

(d) The specific information used to calculate the committed effective dose equivalent pursuant to paragraph (D)(8) of rule 3701:1-38-12 of the Administrative Code; and

(e) The total effective dose equivalent when required by paragraph (B) of rule 3701:1-38-12 of the Administrative Code; and

(f) The total of the deep dose equivalent and the committed dose to the organ receiving the highest total dose.

(2) The licensee or registrant shall make entries of the records specified in paragraph (H) of this rule at least annually.

(I) Each licensee or registrant shall maintain the records specified in paragraph (H) of this rule on department form entitled "occupational exposure record for a monitoring period" in accordance with the instructions for completing this form, or in clear and legible records containing all the information required by the same form. The licensee or registrant shall maintain the records of dose to an embryo or fetus with the records of dose to the declared pregnant woman. The declaration of pregnancy shall also be kept on file, but may be maintained separately from the dose records. The licensee or registrant shall retain each required form or record until the department terminates each license or registration pertinent to the record.

(J) Each licensee or registrant shall maintain records sufficient to demonstrate compliance with the dose limits for individual members of the public specified in paragraph (A) of rule 3701:1-38-13 of the Administrative Code. Each licensee or registrant shall retain the records required by paragraph (H) of this rule until the department terminates each license or registration pertinent to the record.

(K) Records of the disposal of licensed material shall be maintained by each licensee in accordance with paragraphs (C), (D), (F), and (G) of rule 3701:1-38-19, and Chapter 3701:1-54 of the Administrative Code. The licensee shall retain the records required by this paragraph until the department terminates each pertinent license that requires the record.

(L) Records of tests performed on entry control devices located in a very high radiation area shall be maintained by each licensee in accordance with Chapter 3701:1-52 of the Administrative Code or registrant in accordance with Chapters 3701:1-66, 3701:1-67, and 3701:1-68 of the Administrative Code. These records must include the date, time, and results of each such test of function. The licensee or registrant shall retain the records required by this paragraph for at least three years after the record is made.

(M) Each record required by this chapter shall be legible throughout the specified retention period. The record shall be the original or a reproduced copy or a microform, provided that the copy or microform is authenticated by authorized personnel and that the microform is capable of producing a clear copy throughout the required retention period. The record may also be stored in electronic media with the capability for producing legible, accurate, and complete records during the required retention period. Records, such as letters, drawings, and specifications, shall include all pertinent information, such as stamps, initials, and signatures. The licensee or registrant shall maintain adequate safeguards against tampering with and loss of records.

Last updated January 20, 2022 at 8:48 AM

History

• Effective: January 20, 2022
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-38-14

(A) Each licensee or registrant shall:

(1) Make, or cause to be made, surveys of areas, including the subsurface, that are:

(a) Necessary to comply with this chapter: and

(b) Reasonable under the circumstances to evaluate:

(i) Radiation levels;

(ii) Concentrations or quantities of residual radioactivity; and

(iii) The potential radiological hazards of the radiation levels and residual radioactivity detected.

(2) Notwithstanding paragraph (C) of rule 3701:1-38-20 of the Administrative Code, records from surveys describing the location and amount of subsurface residual radioactivity identified at the site must be kept with records important for decommissioning, and such records must be retained in accordance with paragraph (I) of rule 3701:1-40-17, paragraph (F) of rule 3701:1-44-18, and paragraph (D) of rule 3701:1-56-19 of the Administrative Code, as applicable.

(3) Ensure that instruments and equipment used for quantitative radiation measurements, such as dose rate and effluent monitoring, are calibrated annually for the radiation measured, except as otherwise specified in Chapter 3748. of the Revised Code, rules adopted thereunder, or a license condition.

(4) Ensure that all personnel dosimeters, except for direct and indirect reading dosimeters used to measure the dose to any extremity, that require processing to determine the radiation dose and that are used to comply with paragraph (A) of rule 3701:1-38-12 of the Administrative Code, with other applicable provisions of these regulations, or with conditions specified in a license or registration shall be processed and evaluated by a dosimetry processor that:

(a) Holds a current personnel dosimetry accreditation from the national voluntary laboratory accreditation program of the national institute of standards and technology; and

(b) Is approved in this accreditation process for the type of radiation or radiations included in the national voluntary laboratory accreditation program that most closely approximates the type of radiation or radiations for which the individual wearing the dosimeter is monitored; and

(5) Have procedures in place to minimize the likelihood of a deceptive exposure of an individual monitoring device, and in the event of a suspected deceptive exposure, an investigation should be conducted by the radiation safety officer for licensees or individual responsible for radiation protection for registrants which will lead to corrective action as necessary.

(B) Conditions requiring individual monitoring of external and internal occupational dose are as follows:

(1) Each licensee or registrant shall monitor exposures from sources of radiation at levels sufficient to demonstrate compliance with the occupational dose limits of rule 3701:1-38-12 of the Administrative Code. Each licensee or registrant shall monitor occupational exposure to radiation from sources of radiation under the control of the licensee or registrant and shall supply and require the use of individual monitoring devices by:

(a) Adults likely to receive, in one year from sources of radiation external to the body, a dose in excess of ten per cent of the limits in paragraph (A) of rule 3701:1-38-12 of the Administrative Code;

(b) Minors likely to receive, in one year, from radiation sources external to the body, a deep dose equivalent in excess of one millisievert (0.1 rem), a lens dose equivalent in excess of 1.5 millisievert (0.15 rem), or a shallow dose equivalent to the skin or to the extremities in excess of five millisievert (0.5 rem);

(c) Declared pregnant women likely to receive during the entire pregnancy, from radiation sources external to the body, a deep dose equivalent in excess of one millisievert (0.1 rem); and

(d) Individuals entering a high or very high radiation area.

(2) To determine compliance with paragraph (D) of rule 3701:1-38-12 of the Administrative Code, each licensee shall monitor the occupational intake of radioactive material by and assess the committed effective dose equivalent to:

(a) Adults likely to receive, in one year, an intake in excess of ten per cent of the applicable ALI in appendix C to rule 3701:1-38-12 of the Administrative Code;

(b) Minors likely to receive, in one year, a committed effective dose equivalent in excess of one millisievert (0.1 rem); and

(c) Declared pregnant women likely to receive, during the entire pregnancy, a committed effective dose equivalent in excess of one millisievert (0.1 rem).

(C) Each licensee or registrant shall ensure that any individual who is required to monitor occupational doses in accordance with paragraph (B)(1) of this rule wears an individual monitoring device as follows:

(1) An individual monitoring device, used for monitoring the dose to the whole body, shall be worn at the unshielded location of the whole body likely to receive the highest exposure. When a protective apron is worn, the location of the individual monitoring device is typically at the neck.

(2) An individual monitoring device, used for monitoring the dose to an embryo or fetus of a declared pregnant woman pursuant to paragraph (H) of rule 3701:1-38-12 of the Administrative Code, shall be located at the waist under any protective apron being worn by the woman.

(3) An individual monitoring device, used for monitoring the lens dose equivalent, to demonstrate compliance with paragraph (A) of rule 3701:1-38-12 of the Administrative Code, shall be located at the neck outside any protective apron being worn by the monitored individual, or at an unshielded location close to the eye.

(4) An individual monitoring device, used for monitoring the dose to the extremities, to demonstrate compliance with paragraph (A)(2) of rule 3701:1-38-12 of the Administrative Code, shall be worn on the extremity likely to receive the highest exposure. Each individual monitoring device shall be oriented to measure the highest dose to the extremity being monitored.

(5) When only one individual monitoring device is used to determine the effective dose equivalent for external radiation pursuant to paragraph (A)(4)(b) of rule 3701:1-38-12 of the Administrative Code, it shall be located at the neck outside the protective apron. When a second individual monitoring device is used for the same purpose, it shall be located under the protective apron at the waist. The second individual monitoring device is required for a declared pregnant woman.

Last updated November 2, 2022 at 2:10 PM

History

• Effective: August 30, 2015
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-38-13

(A) Each licensee or registrant shall conduct operations so that:

(1) The total effective dose equivalent to individual members of the public from the licensed or registered operation does not exceed one millisievert (0.1 rem) in a year, exclusive of the dose contribution from the following:

(a) Background radiation;

(b) Radiation attributable to any medical administration the individual has received;

(c) Exposure to an individual that was administered radioactive materials and has been released in accordance with rule 3701:1-58-30 of the Administrative Code or equivalent United States nuclear regulatory agency or agreement state regulations;

(d) Voluntary participation in medical research programs;

(e) The licensee's disposal of radioactive material into sanitary sewerage in accordance with paragraph (D) of rule 3701:1-38-19 of the Administrative Code; and

(2) The dose in any unrestricted area from external sources, exclusive of the dose contribution from patients administered radioactive material and released in accordance with rule 3701:1-58-30 of the Administrative Code or equivalent United States nuclear regulatory agency or agreement state regulations, does not exceed 0.02 millisievert (0.002 rem) in any one hour.

(B) If the licensee or registrant permits members of the public to have access to controlled or restricted areas, the limits for members of the public continue to apply to those individuals.

(C) A licensee, registrant, or an applicant for a license or registration may apply for prior department authorization to operate up to an annual dose limit for an individual member of the public of five millisievert (0.5 rem). This application shall include the following information:

(1) Demonstration of the need for and the expected duration of operation in excess of the limit set forth in paragraph (A) of this rule;

(2) The licensee's or registrant's program to assess and control dose within the five millisievert (0.5 rem) annual limit; and

(3) The procedures that the registrant or licensee will follow to maintain the dose ALARA.

(4) Notwithstanding paragraph (A)(1) of this rule, a licensee may permit visitors to an individual who cannot be released, under rule 3701:1-58-30 of the Administrative Code, to receive a radiation dose greater than one millisievert (0.1 rem) if:

(a) The radiation dose received does not exceed five millisievert (0.5 rem); and

(b) The authorized user, as defined in Chapter 3701:1-58 of the Administrative Code, has determined before the visit that it is appropriate.

(D) In addition to the requirements of paragraphs (A) and (B) of this rule:

(1) A licensee subject to the provisions of the United States environmental protection agency's generally applicable environmental radiation standards in 40 C.F.R. 190 (as in effect on the effective date of this rule), shall also comply with those standards.

(2) The department may impose additional restrictions on radiation levels in unrestricted areas and on the total quantity of radionuclides that a licensee may release in effluents in order to restrict the collective dose.

(E) The licensee or registrant shall demonstrate compliance with dose limits for individual members of the public.

(1) The licensee or registrant shall make or cause to be made surveys of radiation levels in unrestricted and controlled areas and radioactive materials in effluents released to unrestricted and controlled areas to demonstrate compliance with the dose limits for individual members of the public in paragraph (A) of this rule.

(2) A licensee or registrant shall show compliance with the annual dose limit in paragraph (A) of this rule by:

(a) Demonstrating by measurement or calculation that the total effective dose equivalent to the individual likely to receive the highest dose from the licensed or registered operation does not exceed the annual dose limit; or

(b) Demonstrating that:

(i) The annual average concentrations of radioactive material released in gaseous and liquid effluents at the boundary of the unrestricted area do not exceed the values specified in appendix C to rule 3701:1-38-12 of the Administrative Code; and

(ii) If an individual were continuously present in an unrestricted area, the dose from external sources would not exceed 0.02 millisievert (0.002 rem) in an hour and 0.5 millisievert (0.05 rem) in a year.

(3) Upon approval from the department, the licensee may adjust the effluent concentration values in appendix C to rule 3701:1-38-12 of the Administrative Code for members of the public, to take into account the actual physical and chemical characteristics of the effluents, such as aerosol size distribution, solubility, density, radioactive decay equilibrium, or chemical form.

Last updated January 20, 2022 at 8:47 AM

History

• Effective: January 20, 2022
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-38-16

(A) To the extent practical, the licensee shall use process or other engineering controls, such as containment, decontamination or ventilation, to control the concentrations of radioactive material in air. When it is not practical to apply process or other engineering controls to control the concentrations of radioactive material in air to values below those that define an airborne radioactivity area, the licensee shall increase monitoring and limit intakes, consistent with maintaining the total effective dose equivalent ALARA, by one or more of the following means:

(1) Control of access;

(2) Limitation of exposure times;

(3) Use of respiratory protection equipment; or

(4) Other controls as determined by the director.

(B) The licensee may consider safety factors other than radiological factors when determining whether to use respirators. The licensee should also consider the impact of respirator use on workers' industrial health and safety.

(C) If the licensee uses respiratory protection equipment to limit the intake of radioactive material, the licensee shall:

(1) Use only respiratory protection equipment that is tested and certified by the national institute for occupational safety and health (NIOSH) and the mine safety and health administration (MSHA), except that the licensee may use equipment that has not been tested or certified by NIOSH and MSHA, or for which there is no schedule for testing or certification, provided that:

(a) The licensee has submitted and the director has approved an application for authorized use of that equipment; and

(b) The licensee has demonstrated by testing, or demonstrated on the basis of test information, that the material and performance characteristics of the equipment are capable of providing the appropriate proposed degree of protection under anticipated conditions of use;

(2) Implement and maintain a respiratory protection program that includes:

(a) Air sampling sufficient to identify the potential hazard, permit proper equipment selection, and estimate doses;

(b) Surveys and bioassays, as appropriate, to evaluate actual intakes;

(c) Testing whether each respirator is operable immediately prior to each use;

(d) Written procedures regarding the following:

(i) Monitoring, including air sampling and bioassays;

(ii) Supervision and training of respirator users;

(iii) Fit testing;

(iv) Respirator selection;

(v) Breathing air quality;

(vi) Inventory and control;

(vii) Storage, issuance, maintenance, repair, testing, and quality assurance of respiratory protection equipment;

(viii) Recordkeeping; and

(ix) Limitations on periods of respirator use and relief from respirator use.

(e) Determination by a physician that the individual user is medically fit to use the respiratory protection equipment:

(i) Before the initial fitting of a face sealing respirator;

(ii) Before the first field use of non-face sealing respirators; and

(iii) Either every twelve months thereafter, or periodically at a frequency determined by a physician.

(f) Fit testing, with fit factor greater than or equal to ten times the assigned protection factor (APF) for negative pressure devices, and a fit factor greater than or equal to five hundred for any positive pressure, continuous flow, and pressure-demand devices, before the first field use of tight-fitting, face-sealing respirators and periodically thereafter at a frequency not to exceed one year. Fit testing must be performed with the facepiece operating in the negative pressure mode.

(3) Issue a written policy statement or procedure on respirator usage covering:

(a) The use of process or other engineering controls, in lieu of respirators;

(b) The routine, nonroutine, and emergency use of respirators;

(c) The length of periods individuals may use a respirator; and

(d) Conditions for relief from respirator use.

(4) Advise each respirator user that the user may leave the area at any time for relief from respirator use in the event of equipment malfunction, physical or psychological distress, procedural or communication failure, significant deterioration of operating conditions, or any other conditions that might require such relief.

(5) The licensee shall also consider limitations appropriate to the type and mode of use. The licensee shall use respiratory protection equipment within the equipment manufacturer's expressed limitations for type and mode of use and shall provide for adequate vision, communication, low temperature work environments, concurrent use of other safety or radiological protection equipment, and other special capabilities, such as adequate skin protection, when needed. The licensee shall use equipment in such a way as not to interfere with the proper operation of the respirator.

(6) Standby rescue persons are required whenever one-piece atmosphere-supplying suits, or any combination of supplied air respiratory protection device and personnel protective equipment are used from which an unaided individual would have difficulty extricating himself or herself. The standby persons must be equipped with respiratory protection devices or other apparatus appropriate for the potential hazards. The standby rescue persons shall observe or otherwise maintain continuous communication with the workers (visual, voice, signal line, telephone, radio, or other suitable means), and be immediately able to assist them in case of a failure of the air supply or for any other reason that requires relief from distress. A sufficient number of rescue persons must be immediately available to assist all users of this type of equipment and to provide effective emergency rescue if needed.

(7) Atmosphere-supplying respirators must be supplied with respirable air of grade D quality or better as defined by the compressed gas association in publication G-7.1, "commodity specifications for air," 1997 and included in 29 C.F.R. 1910.134(i)(1)(ii)(A) to (E) (as in effect on the effective date of this rule).

(8) The licensee shall ensure that no objects, materials, or substances, such as facial hair, or any conditions that interfere with the seal between the face and facepiece or valve function, and that are under the control of the respiratory wearer, are present between the skin of the wearer's face and the sealing surface of a tight-fitting respirator facepiece.

(D) When estimating exposure of individuals to airborne radioactive materials, the licensee may make allowance for respiratory protection equipment used to limit intakes pursuant to paragraph (A) of this rule, provided that the following requirements, in addition to those in paragraph (C)(1) of this rule, are satisfied:

(1) The licensee selects respiratory protection equipment that provides a protection factor, as specified in the appendix to this rule, greater than the multiple by which peak concentrations of airborne radioactive materials in the working area are expected to exceed the values specified in appendix C to rule 3701:1-38-12 of the Administrative Code. The concentration of radioactive material in the air that is inhaled when respirators are worn may be initially estimated by dividing the ambient concentration in air, without respiratory protection, during each period of uninterrupted use, by the protection factor. If the exposure is later found to be greater than initially estimated, the corrected value shall be used. If the exposure is later found to be less than initially estimated, the corrected value may be used; and

(2) The licensee shall obtain authorization from the department before assigning respiratory protection factors in excess of those specified in the appendix to this rule. The department may authorize a licensee to use higher protection factors on receipt of an application that:

(a) Describes the situation for which a need exists for higher protection factors; and

(b) Demonstrates that the respiratory protection equipment provides these higher protection factors under the proposed conditions of use.

(E) The department may impose restrictions in addition to the provisions of this rule in order to:

(1) Ensure that the respiratory protection program of the licensee is adequate to limit doses to individuals from intakes of airborne radioactive materials consistent with maintaining total effective dose equivalent ALARA; and

(2) Limit the extent to which a licensee may use respiratory protection equipment instead of process or other engineering controls.

(F) The licensee shall notify the department in writing at least thirty days before the date that respiratory protection equipment is first used pursuant to either paragraph (C) or (D) of this rule, except for emergency use.

View Appendix

Last updated January 20, 2022 at 8:47 AM

History

• Effective: January 20, 2022
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-38-19

(A) A licensee shall dispose of licensed radioactive material in accordance with this rule. Licensed material shall be disposed of in one of the following manners:

(1) By transfer to an authorized recipient as provided in this chapter, Chapter 3701:1-40 of the Administrative Code, or to the United States department of energy;

(2) By decay in storage provided that the radionuclide has a half-life of one hundred twenty days or less, or as otherwise permitted by the license;

(3) By release in effluents within the limits set forth in rule 3701:1-38-13 of the Administrative Code; or

(4) As authorized pursuant to paragraphs (B) to (F) of this rule.

(B) A person shall be specifically licensed to receive waste containing licensed material from another person for:

(1) Treatment prior to disposal;

(2) Treatment or disposal by incineration;

(3) Decay in storage;

(4) Disposal at a land disposal facility licensed pursuant to rules 3701:1-54-06 to 3701:1-54-12 of the Administrative Code or equivalent United States nuclear regulatory commission or agreement state regulations; or

(5) Storage until transfer to a storage or disposal facility authorized to receive the waste.

(C) A licensee or applicant for a license may apply to the director for approval of proposed disposal procedures that are not otherwise authorized in these rules for the disposal of licensed material generated in the licensee's operations. Each application shall include:

(1) A description of the waste containing licensed material to be disposed of, including the physical and chemical properties that have an impact on risk evaluation, and the proposed manner and conditions of waste disposal;

(2) An analysis and evaluation of pertinent information on the nature of the environment;

(3) The nature and location of other potentially affected facilities; and

(4) An analysis and procedures to ensure that doses are maintained ALARA and within the dose limits in rules 3701:1-38-12 and 3701:1-38-13 of the Administrative Code.

(D) A licensee may discharge licensed material into sanitary sewerage as follows:

(1) The material is readily soluble in water or is a biological material that is readily dispersible in water;

(2) The quantity of licensed or other radioactive material that the licensee releases into the sewer in one month divided by the average monthly volume of water released into the sewer by the licensee does not exceed the concentration listed in table III of appendix C to rule 3701:1-38-12 of the Administrative Code; and

(3) If more than one radionuclide is to be released, the following conditions must also be satisfied:

(a) The licensee shall determine the fraction of the limit in table III of appendix C to rule 3701:1-38-12 of the Administrative Code represented by discharges into sanitary sewerage by dividing the actual monthly average concentration of each radionuclide released by the licensee into the sewer by the concentration of that radionuclide listed in table III of appendix C to rule 3701:1-38-12 of the Administrative Code; and

(b) The sum of the fractions for each radionuclide required by paragraph (D)(3)(a) of this rule does not exceed unity.

(4) The total quantity of licensed and other radioactive material that the licensee releases into the sanitary sewerage in a year does not exceed one hundred eighty-five gigabecquerels (five curies) of hydrogen-3, thirty-seven gigabecquerels (one curie) of carbon-14, and thirty-seven gigabecquerels (one curie) of all other radioactive materials combined.

(5) Excreta from an individual undergoing medical diagnosis or therapy with radioactive material is not subject to the limitations contained in paragraph (D) of this rule.

(E) A licensee may dispose of licensed material by decay in storage. A licensee may hold radioactive material with a physical half-life of one hundred twenty days or less for decay-in-storage before disposal as non-radioactive material provided the licensee does the following:

(1) Monitors the material at the container surface prior to disposal and determines that the radioactivity cannot be distinguished from the background radiation level with an appropriate radiation detection survey meter set on its most sensitive scale and with no interposing shielding;

(2) Removes or obliterates all radiation caution labels and symbols, unless otherwise specified in the license; and

(3) Retains a record of the disposal for three years.

(F) A licensee may treat or dispose of licensed material by incineration only in the form and concentration specified in paragraph (G) of this rule or as specifically approved by the director pursuant to paragraph (C) of this rule.

(G) A licensee may dispose of the following licensed material as if it were not radioactive. The licensee shall maintain records in accordance with paragraph (K) of rule 3701:1-38-20 of the Administrative Code.

(1) 1.85 kilobecquerels (0.05 microcurie) or less, of hydrogen-3 or carbon-14 per gram of medium used for liquid scintillation counting; or

(2) 1.85 kilobecquerels (0.05 microcurie) or less, of hydrogen-3 or carbon-14 per gram of animal tissue, averaged over the weight of the entire animal. A licensee shall not dispose of tissue pursuant to this paragraph in a manner that would permit its use either as food for humans or as animal feed.

(H) A licensee shall transfer and dispose of licensed material in accordance with the following:

(1) For transfer of radioactive waste intended for disposal at a licensed radioactive waste disposal facility, establish a manifest tracking system, and supplement existing requirements concerning transfers and recordkeeping for those wastes. Each shipment of radioactive waste designated for disposal at a licensed radioactive waste disposal facility shall be accompanied by a shipment manifest as specified in the appendix to this rule.

(2) Each shipment manifest shall include a certification by the waste generator in accordance with the appendix to this rule.

(3) Each person involved in the transfer of waste for disposal or in the disposal of waste, including the waste generator, waste collector, waste processor, and disposal facility operator, shall comply with the requirements specified in the appendix to this rule.

(I) Nothing in this rule relieves a licensee from complying with other applicable federal, state and local regulations governing any other toxic or hazardous properties of materials that may be disposed of under this rule.

View Appendix

Last updated January 20, 2022 at 8:48 AM

History

• Effective: January 20, 2022
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-40-17

(A) Prior to the director issuing a radioactive materials license:

(1) Each applicant for a specific license or license renewal authorizing the possession and use of unsealed radioactive material of half-life greater than one hundred twenty days and in quantities exceeding ten thousand times the applicable quantities set forth in appendix A to this rule shall submit a decommissioning funding plan as described in paragraph (D) of this rule. The decommissioning funding plan must also be submitted when a combination of radionuclides is involved if R divided by ten thousand is greater than one, where R is defined here as the sum of the ratios of the quantity of each radionuclide to the applicable value in appendix A to this rule.

(2) Each applicant for a specific license or license renewal authorizing the possession and use of sealed sources or plated foils of half-life greater than one hundred twenty days and in quantities exceeding one trillion times the applicable quantities of appendix A to this rule, shall submit a decommissioning funding plan as described in paragraph (D) of this rule. The decommissioning funding plan must also be submitted when a combination of radionuclides is involved if R divided by one trillion is greater than one, where R is defined here as the sum of the ratios of the quantity of each radionuclide to the applicable value in appendix A to this rule.

(B) Prior to the director issuing a radioactive materials license, each applicant for a specific license or license renewal authorizing possession and use of radioactive material of half-life greater than one hundred twenty days and in quantities specified in paragraph (C) of this rule shall either:

(1) Submit a decommissioning funding plan as described in paragraph (D) of this rule; or

(2) Submit a certification that financial assurance for decommissioning has been provided in the amount prescribed by paragraph (C) of this rule using one of the methods described in paragraph (E) of this rule. The applicant shall submit to the director, as part of the certification, a signed original of the financial instrument obtained to satisfy the requirements of paragraph (E) of this rule.

(C) Prior to the director issuing a radioactive materials license, an applicant providing certification of financial assurance for decommissioning as specified in paragraph (B)(2) of this rule shall provide the certification in a monetary amount based upon the quantity of licensed material specified as follows:

(1) Greater than one thousand but less than or equal to ten thousand times the applicable quantities of appendix A to this rule in unsealed form. For a combination of radionuclides, if R, as defined in paragraph (A) of this rule, divided by one thousand is greater than one but R divided by ten thousand is less than or equal to one, the sum of three hundred thousand dollars.

(2) Greater than ten billion but less than one trillion times the applicable quantities of appendix A to this rule in sealed sources or plated foils. For a combination of radionuclides, if R, as defined in paragraph (A) of this rule, divided by ten billion is greater than one but R divided by one trillion is less than or equal to one, the sum of one hundred fifty thousand dollars.

(D) .

(1) Each decommissioning funding plan must be submitted for review and approval and must contain:

(a) A detailed cost estimate for decommissioning, in an amount reflecting:

(i) The cost of an independent contractor to perform all decommissioning activities;

(ii) The cost of meeting the criteria specified in paragraph (B) of rule 3701:1-38-22 of the Administrative Code for unrestricted use, provided that, if the applicant or licensee can demonstrate its ability to meet the provisions of paragraph (D) of rule 3701:1-38-22 of the Administrative Code, the cost estimate may be based on meeting this criteria;

(iii) The volume of onsite subsurface material containing residual radioactivity that will require remediation to meet the criteria for license termination; and

(iv) An adequate contingency factor.

(b) Identification of and justification for using the key assumptions contained in the decommissioning cost estimate;

(c) A description of the method of assuring funds for decommissioning from paragraph (E) of this rule, including means for adjusting cost estimates and associated funding levels periodically over the life of the facility;

(d) A certification by the licensee that financial assurance for decommissioning has been provided in the amount of the cost estimate for decommissioning; and

(e) A signed original of the financial instrument obtained to satisfy the requirements of paragraph (E) of this rule (unless a previously submitted and accepted financial instrument continues to cover the cost estimate for decommissioning).

(2) At the time of license renewal and at intervals not to exceed three years, the decommissioning funding plan must be resubmitted with adjustments as necessary to account for the changes in costs and the extent of contamination. If the amount of financial assurance will be adjusted downward, this cannot be done until the updated decommissioning funding plan is approved. The decommissioning funding plan must update the information submitted with the original or prior approved plan, and must specifically consider the effect of the following events on decommissioning costs:

(a) Spills of radioactive material producing additional residual radioactivity in onsite subsurface material;

(b) Waste inventory increasing above the amount previously estimated;

(c) Waste disposal costs increasing above the amount previously estimated;

(d) Facility modifications;

(e) Changes in authorized possession limits;

(f) Actual remediation costs that exceed the previous cost estimate;

(g) Onsite disposal; and

(h) Use of a settling pond.

(E) Financial assurance for decommissioning, either by a decommissioning funding plan or certification of financial assurance, shall be provided by the licensee and approved by the director prior to the issuance of the license and shall be provided by one or more of the following methods:

(1) Prepayment by depositing into an account segregated from licensee assets and outside the licensee's administrative control, cash or liquid assets such that the amount of funds will be sufficient to pay decommissioning costs. Prepayment may be in the form of a trust, escrow account, government fund, certificate of deposit, or deposit of government securities.

(2) Surety, insurance, or other method in accordance with paragraph (F) of this rule, that guarantees that decommissioning costs will be paid. A surety method may be in the form of a surety bond, letter of credit, or line of credit. A guarantee by the applicant or licensee may not be used in combination with any other financial methods used to satisfy the requirements of this paragraph or in any situation where the applicant or licensee has a parent company holding majority control of the voting stock of the company.

(3) A parent company guarantee of funds for decommissioning costs based on a financial test may be used provided that the parent company meets the requirements specified in appendix B of this rule. A parent company guarantee may not be used in combination with other financial methods to satisfy the requirements of this rule.

(4) For commercial corporations that issue bonds, a guarantee of funds by the applicant or licensee for decommissioning costs based on a financial test may be used provided that the guarantee meets the requirements of appendix C to this rule.

(5) For commercial companies that do not issue bonds, a guarantee of funds for decommissioning costs may be used provided that the guarantee meets the requirements of appendix D to this rule.

(6) For nonprofit colleges, universities, hospitals, or research and development entities, a guarantee of funds for decommissioning costs may be used provided that the guarantee meets the requirements of appendix E to this rule. The director may require proof of nonprofit status.

(7) An external sinking fund in which deposits are made at least annually, coupled with a surety method or insurance, the value of which may decrease by the amount being accumulated in the sinking fund. An external sinking fund is a fund established and maintained by setting aside funds periodically in an account segregated from licensee assets and outside the licensee's administrative control in which the total amount of funds would be sufficient to pay decommissioning costs at the time termination of operation is expected. An external sinking fund may be in the form of a trust, escrow account, government fund, certificate of deposit, or deposit of government securities. The surety or insurance provisions must be as stated in paragraph (F) of this rule.

(8) In the case of state or local government licensee, a statement of intent containing a cost estimate for decommissioning or an amount specified in paragraphs (C)(1) to (C)(2) of this rule, and indicating that funds for decommissioning will be obtained when necessary. As used in this rule, "state or local government licensee" does not include government owned or assisted colleges, universities or hospitals.

(F) Any surety method or insurance used to provide financial assurance for decommissioning shall be in the form of instruments that contain language as provided in appendix F to this rule, and shall contain the following conditions:

(1) The surety method or insurance must be open-ended or, if written for a specified term, such as five years, must be renewed automatically unless ninety days or more prior to the renewal date, the issuer notifies the director, the beneficiary, and the licensee of its intention not to renew. The surety method or insurance must also provide that the full face amount be paid to the beneficiary automatically prior to the expiration without proof of forfeiture if the licensee fails to provide a replacement acceptable to the director within thirty days after receipt of notification of cancellation.

(2) The surety method or insurance must be payable to a trust established for decommissioning costs. The trustee and trust must be acceptable to the director. An acceptable trustee includes an appropriate state or federal government agency or an entity which has the authority to act as a trustee and whose trust operations are regulated and examined by a federal or state agency.

(3) The surety method or insurance must remain in effect until the director has terminated the license.

(4) The surety company issuing the bond must, at a minimum, be among those listed as acceptable in the "Circular 570" of the United States department of the treasury (as in effect on the effective date of this rule).

(G) A licensee must notify the director by certified mail within ten business days of the commencement of a voluntary or involuntary bankruptcy proceeding under Title 11 of the United States Code (as amended April 20, 2005). A licensee who fulfills the financial assurance requirements by obtaining a trust fund, surety bond, or other acceptable financial assurance will be deemed to be without the required financial assurance or liability coverage in the event of bankruptcy of the trustee or issuing institution, or a suspension or revocation of the authority of the trustee institution issuing the instrument. The licensee shall establish other financial assurance within sixty days after such an event.

(H) Financial assurance for decommissioning, either by a decommissioning funding plan or certification of financial assurance, that is provided by a contract of insurance shall not include any arrangement that constitutes self-insurance. As used in this rule:

(1) "Insurance" means a contract issued or underwritten by an insurance company, insurance service, or insurance organization which is licensed to engage in the business of insurance in Ohio, that binds the insurer to indemnify another against a specified loss in return for premiums paid.

(2) "Self insurance" means a contract of insurance issued either by the licensee or by an insurer affiliated with or an affiliate of the licensee.

(3) "Affiliate of" or "affiliated with" means that the licensee, either directly or indirectly, through one or more intermediaries or subsidiaries, controls, is controlled by, or is under common control with the insurer.

(4) "Control", including "controlled by", and "under common control with" means the possession, direct or indirect, of the power to direct or cause the direction of the management and policies of a person, whether through the ownership of voting securities, by contract, proxy, membership on the board, or otherwise.

(I) Each person licensed under this chapter, and rule 3701:1-38-02 of the Administrative Code as well as chapters containing rules regarding manufacturing and distribution (Chapter 3701:1-46 of the Administrative Code), industrial radiography (Chapter 3701:1-48 of the Administrative Code), well logging Chapter 3701:1-49 of the Administrative Code), irradiators (Chapter 3701:1-52 of the Administrative Code), and medical use (Chapter 3701:1-58 of the Administrative Code) promulgated pursuant to Chapter 3748. of the Revised Code shall keep records of information important to the decommissioning of a facility in an identified location until the site is released for unrestricted use. Before licensed activities are transferred or assigned in accordance with paragraph (B) of rule 3701:1-40-20 of the Administrative Code, a licensee shall transfer all records described in this paragraph to the new licensee, which will be responsible for maintaining these records until the license is terminated. If records important to the decommissioning of a facility are kept for other purposes, reference to these records and their locations may be used. As used in this rule, "information important to the decommissioning of a facility" includes the following:

(1) Records of spills or other unusual occurrences involving the spread of contamination in and around the facility, equipment, or site. These records may be limited to instances when contamination remains after any cleanup procedures or when there is reasonable likelihood that contaminants may have spread to inaccessible areas as in the case of possible seepage into porous materials such as concrete. These records must include any known information on identification of involved radionuclides, quantities, forms, and concentrations.

(2) As-built drawings and modifications of structures and equipment in restricted areas where radioactive materials are used or stored, and of locations of possible inaccessible contamination such as buried pipes which may be subject to contamination. If required drawings are referenced, each relevant document need not be indexed individually. If drawings are not available, the licensee shall substitute appropriate records of available information concerning these areas and locations.

(3) Except in the case of an area that contains only a sealed source, provided the source has not leaked or no contamination remains after any leak, or in the case of a byproduct or accelerator produced material having only a half-life of less than sixty-five days, a list contained in a single document and updated every two years, of the following:

(a) All areas designated and formerly designated restricted areas as defined in rule 3701:1-38-01 of the Administrative Code.

(b) All areas outside of restricted areas that require documentation under paragraph (I)(1) of this rule.

(c) All areas outside of restricted areas where current and previous wastes have been buried as documented under rule 3701:1-38-20 of the Administrative Code; and

(d) All areas outside of restricted areas that contain material such that, if the license expired, the licensee would be required to either decontaminate the area to meet the criteria for decommissioning in rule 3701:1-38-22 of the Administrative Code, or apply for approval for disposal under rule 3701:1-38-19 of the Administrative Code.

(4) Records of the cost estimate performed for the decommissioning funding plan or of the amount certified for decommissioning, and records of the funding method used for assuring funds if either a funding plan or certification is used.

View AppendixView AppendixView AppendixView AppendixView AppendixView Appendix

Last updated April 19, 2022 at 8:35 AM

History

• Effective: April 17, 2022
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-44-18

Except for licenses authorizing the receipt, possession, and use of source material for uranium or thorium milling, or byproduct material at sites formerly associated with such milling, for which financial assurance requirements are set forth in the appendix to rule 3701:1-44-14 of the Administrative Code, criteria for providing financial assurance for decommissioning are as follows:

(A) Each applicant for a specific license authorizing the possession and use of more than 3.7 gigabecquerels (one hundred millicuries) of source material in a readily dispersible form shall submit a decommissioning funding plan as described in paragraph (D) of this rule.

(B) Each applicant for a specific license authorizing possession and use of quantities of source material greater than 0.37 gigabecquerels (ten millicuries) but less than or equal to 3.7 gigabecquerels (one hundred millicuries) in a readily dispersible form shall either:

(1) Submit a decommissioning funding plan as described in paragraph (D) of this rule; or

(2) Submit a certification that financial assurance for decommissioning has been provided in the amount of two hundred twenty-five thousand dollars using one of the methods described in paragraph (E) of this rule. For an applicant, this certification may state that the appropriate assurance will be obtained after the application has been approved and the license issued but before the receipt of licensed material. If the applicant defers execution of the financial instrument until after the license has been issued, a signed original of the financial instrument obtained to satisfy the requirements of paragraph (E) of this rule must be submitted to the director prior to receipt of licensed material. If the applicant does not defer execution of the financial instrument, the applicant shall submit to the director, as part of the certification, a signed original of the financial instrument obtained to satisfy the requirements of paragraph (E) of this rule.

(C)

(1) Each holder of a specific license issued on or after July 27, 1990, which is covered by paragraph (A) or (B) of this rule, shall provide financial assurance for decommissioning in accordance with the criteria set forth in this rule.

(2) Each holder of a specific license issued before July 27, 1990, and of a type described in paragraph (A) of this rule shall submit a decommissioning funding plan as described in paragraph (D) of this rule or a certification of financial assurance for decommissioning in an amount at least equal to one million one hundred twenty-five thousand dollars in accordance with the criteria set forth in this rule. If the licensee submits the certification of financial assurance rather than a decommissioning funding plan, the licensee shall include a decommissioning funding plan in any application for license renewal.

(3) Each holder of a specific license issued before July 27, 1990, and of a type described in paragraph (B) of this rule shall submit a decommissioning funding plan, as described in paragraph (D) of this rule, or a certification of financial assurance for decommissioning in accordance with the criteria set forth in this rule.

(4) Any licensee who has submitted an application for renewal of license in accordance with rule 3701:1-38-02 of the Administrative Code shall provide financial assurance for decommissioning in accordance with paragraphs (A) and (B) of this rule.

(D)

(1) Each decommissioning funding plan must be submitted for review and approval and must contain:

(a) A detailed cost estimate for decommissioning, in an amount reflecting:

(i) The cost of an independent contractor to perform all decommissioning activities;

(ii) The cost of meeting the criteria specified in paragraph (B) of rule 3701:1-38-22 of the Administrative Code for unrestricted use, provided that, if the applicant or licensee can demonstrate its ability to meet the provisions of paragraph (D) of rule 3701:1-38-22 of the Administrative Code, the cost estimate may be based on meeting this criteria;

(iii) The volume of onsite subsurface material containing residual radioactivity that will require remediation; and

(iv) An adequate contingency factor.

(b) Identification of and justification for using the key assumptions contained in the decommissioning cost estimate;

(c) A description of the method of assuring funds for decommissioning from paragraph (E) of this rule, including means for adjusting cost estimates and associated funding levels periodically over the life of the facility;

(d) A certification by the licensee that financial assurance for decommissioning has been provided in the amount of the cost estimate for decommissioning; and

(e) A signed original of the financial instrument obtained to satisfy the requirements of paragraph (E) of this rule (unless a previously submitted and accepted financial instrument continues to cover the cost estimate for decommissioning).

(2) At the time of license renewal and at intervals not to exceed three years, the decommissioning funding plan must be resubmitted with adjustments as necessary to account for the changes in costs and the extent of contamination. If the amount of financial assurance will be adjusted downward, this cannot be done until the updated decommissioning funding plan is approved. The decommissioning funding plan must update the information submitted with the original or prior approved plan, and must specifically consider the effect of the following events on decommissioning costs:

(a) Spills of radioactive material producing additional residual radioactivity in onsite subsurface material;

(b) Waste inventory increasing above the amount previously estimated;

(c) Waste disposal costs increasing above the amount previously estimated;

(d) Facility modifications;

(e) Changes in authorized possession limits;

(f) Actual remediation costs that exceed the previous cost estimate;

(g) Onsite disposal; and

(h) Use of a settling pond.

(E) Financial assurance for decommissioning must be provided by one or more of the following methods:

(1) Prepayment is the deposit prior to the start of operation into an account segregated from licensee assets and outside the licensee's administrative control of cash or liquid assets such that the amount of funds would be sufficient to pay decommissioning costs. Prepayment may be in the form of a trust, escrow account, government fund, certificate of deposit, or deposit of government securities.

(2) A surety method, insurance, or other guarantee method. These methods guarantee that decommissioning costs will be paid. A surety method may be in the form of a surety bond, letter of credit, or line of credit. A parent company guarantee of funds for decommissioning costs based on a financial test may be used if the guarantee and test are as contained in appendix B to rule 3701:1-40-17 of the Administrative Code. A parent company guarantee may not be used in combination with other financial methods to satisfy the requirements of this rule. For commercial corporations that issue bonds, a guarantee of funds by the applicant or licensee for decommissioning costs based on a financial test may be used if the guarantee and test are as contained in appendix C to rule 3701:1-40-17 of the Administrative Code. For commercial companies that do not issue bonds, a guarantee of funds by the applicant or licensee for decommissioning costs may be used if the guarantee and test are as contained in appendix D to rule 3701:1-40-17 of the Administrative Code. For nonprofit entities, such as colleges, universities, and nonprofit hospitals, a guarantee of funds by the applicant or licensee may be used if the guarantee and test are as contained in appendix E to rule 3701:1-40-17 of the Administrative Code. A guarantee by the applicant or licensee may not be used in combination with any other financial methods used to satisfy the requirements of this rule or in any situation where the applicant or licensee has a parent company holding majority control of the voting stock of the company. Any surety method or insurance used to provide financial assurance for decommissioning must contain the following conditions:

(a) The surety method or insurance must be open-ended or, if written for a specified term, such as five years, must be renewed automatically unless ninety days or more prior to the renewal date, the issuer notifies the director, the beneficiary, and the licensee of its intention not to renew. The surety method or insurance must also provide that the full face amount be paid to the beneficiary automatically prior to the expiration without proof of forfeiture if the licensee fails to provide a replacement acceptable to the director within thirty days after receipt of notification of cancellation.

(b) The surety method or insurance must be payable to a trust established for decommissioning costs. The trustee and trust must be acceptable to the director. An acceptable trustee includes an appropriate state or federal government agency or an entity which has the authority to act as a trustee and whose trust operations are regulated and examined by a federal or state agency.

(c) The surety method or insurance must remain in effect until the director has terminated the license.

(3) An external sinking fund in which deposits are made at least annually, coupled with a surety method or insurance, the value of which may decrease by the amount being accumulated in the sinking fund. An external sinking fund is a fund established and maintained by setting aside funds periodically in an account segregated from licensee assets and outside the licensee's administrative control in which the total amount of funds would be sufficient to pay decommissioning costs at the time termination of operation is expected. An external sinking fund may be in the form of a trust, escrow account, government fund, certificate of deposit, or deposit of government securities. The surety or insurance provision must be as stated in paragraph (E)(2) of this rule.

(4) In the case of federal, state, or local government licensees, a statement of intent containing a cost estimate for decommissioning or an amount based on paragraph (B) of this rule, and indicating that funds for decommissioning will be obtained when necessary.

(5) When a government entity is assuming custody and ownership of a site, an arrangement that is deemed acceptable by such government entity.

(F) Each person licensed under Chapter 3701:1-44 of the Administrative Code shall keep records of information important to the decommissioning of a facility in an identified location until the site is released for unrestricted use. Before licensed activities are transferred or assigned in accordance with paragraph (B) of rule 3701:1-44-19 of the Administrative Code licensees shall transfer all records described in this paragraph to the new licensee. In this case, the new licensee will be responsible for maintaining these records until the license is terminated. If records important to the decommissioning of a facility are kept for other purposes, reference to these records and their locations may be used. Information the director considers important to decommissioning consists of:

(1) Records of spills or other unusual occurrences involving the spread of contamination in and around the facility, equipment, or site. These records may be limited to instances when contamination remains after any cleanup procedures or when there is reasonable likelihood that contaminants may have spread to inaccessible areas as in the case of possible seepage into porous materials such as concrete. These records must include any known information on identification of involved nuclides, quantities, forms, and concentrations.

(2) As-built drawings and modifications of structures and equipment in restricted areas where radioactive materials are used and/or stored, and of locations of possible inaccessible contamination such as buried pipes which may be subject to contamination. If required drawings are referenced, each relevant document need not be indexed individually. If drawings are not available, the licensee shall substitute appropriate records of available information concerning these areas and locations.

(3) Except for areas containing depleted uranium used only for shielding or as penetrators in unused munitions, a list contained in a single document and updated every two years, of the following:

(a) All areas designated and formerly designated as restricted areas as defined in rule 3701:1-38-01 of the Administrative Code;

(b) All areas outside of restricted areas that require documentation under paragraph (F)(1) of this rule;

(c) All areas outside of restricted areas where current and previous wastes have been buried as documented under paragraph (K) of rule 3701:1-38-20 of the Administrative Code; and

(d) All areas outside of restricted areas that contain material such that, if the license expired, the licensee would be required to either decontaminate the area to meet the criteria for decommissioning in rule 3701:1-38-22 of the Administrative Code, or apply for approval for disposal under paragraph (C) of rule 3701:1-38-19 of the Administrative Code.

(4) Records of the cost estimate performed for the decommissioning funding plan or of the amount certified for decommissioning, and records of the funding method used for assuring funds if either a funding plan or certification is used.

Last updated July 10, 2025 at 12:13 PM

History

• Effective: November 22, 2013
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-56-19

(A) Each applicant for a specific license authorizing possession and use of unsealed special nuclear material in quantities specified in paragraph (B) of this rule shall either:

(1) Submit a decommissioning funding plan as described in paragraph (C) of this rule; or

(2) Submit a certification that financial assurance for decommissioning has been provided in the amount prescribed by paragraph (B) of this rule using one of the methods described in rule 3701:1-40-17 of the Administrative Code. For an applicant, this certification may state that the appropriate assurance will be obtained after the application has been approved and the license issued but before the receipt of licensed material. If the applicant defers execution of the financial instrument until after the license has been issued, a signed original of the financial instrument obtained to satisfy the requirements of rule 3701:1-40-17 of the Administrative Code must be submitted to the director prior to receipt of licensed material. If the applicant does not defer execution of the financial instrument, the applicant shall submit to the director, as part of the certification, a signed original of the financial instrument obtained to satisfy the requirements of rule 3701:1-40-17 of the Administrative Code.

(B) Prior to the director issuing a radioactive materials license, an applicant providing certification of financial assurance for decommissioning as specified in paragraph (A)(1) of this rule shall provide the certification in a monetary amount based upon the quantity of licensed material specified as follows:

(1) Greater than ten thousand but less than or equal to one hundred thousand times the applicable quantities in appendix A to rule 3701:1-40-17 of the Administrative Code. For a combination of radionuclides if R, where R is defined as the sum of the ratios of the quantity of each radionuclide to the applicable value in appendix A to rule 3701:1-40-17 of the Administrative Code, divided by ten thousand is greater than one but R divided by one hundred thousand is less than or equal to one, the sum of one million one hundred twenty-five thousand dollars.

(2) Greater than one thousand but less than or equal to ten thousand times the applicable quantities of appendix A to rule 3701:1-40-17 of the Administrative Code. For a combination of radionuclides, if R, where R is defined as the sum of the ratios of the quantity of each radionuclide to the applicable value in appendix A to rule 3701:1-40-17 of the Administrative Code, divided by one thousand is greater than one but R divided by ten thousand is less than or equal to one, the sum of two hundred twenty-five thousand dollars.

(C)

Each decommissioning funding plan must be submitted for review and approval and must contain:

(1) A detailed cost estimate for decommissioning, in an amount reflecting:

(a) The cost of an independent contractor to perform all decommissioning activities;

(b) The cost of meeting the criteria specified in paragraph (B) of rule 3701:1-38-22 of the Administrative Code for unrestricted use, provided that, if the applicant or licensee can demonstrate its ability to meet the provisions of paragraph (D) of rule 3701:1-38-22 of the Administrative Code, the cost estimate may be based on meeting this criteria;

(c) The volume of onsite subsurface material containing residual radioactivity that will require remediation; and

(d) An adequate contingency factor.

(2) Identification of and justification for using the key assumptions contained in the decommissioning cost estimate;

(3) A description of the method of assuring funds for decommissioning in accordance with rule 3701:1-40-17 of the Administrative Code, including means for adjusting cost estimates and associated funding levels periodically over the life of the facility;

(4) A certification by the licensee that financial assurance for decommissioning has been provided in the amount of the cost estimate for decommissioning; and

(5) A signed original of the financial instrument obtained to satisfy the requirements of rule 3701:1-40-17 of the Administrative Code (unless a previously submitted and accepted financial instrument continues to cover the cost estimate for decommissioning).

(D) At the time of license renewal and at intervals not to exceed three years, the decommissioning funding plan must be resubmitted with adjustments as necessary to account for the changes in costs and the extent of contamination. If the amount of financial assurance will be adjusted downward, this cannot be done until the updated decommissioning funding plan is approved. The decommissioning funding plan must update the information submitted with the original or prior approved plan, and must specifically consider the effect of the following events on decommissioning costs:

(1) Spills of radioactive material producing additional residual radioactivity in onsite subsurface material;

(2) Waste inventory increasing above the amount previously estimated;

(3) Waste disposal costs increasing above the amount previously estimated;

(4) Facility modifications;

(5) Changes in authorized possession limits;

(6) Actual remediation costs that exceed the previous estimate;

(7) Onsite disposal; and

(8) Use of a settling pond.

(E) Each person licensed under Chapter 3701:1-56 of the Administrative Code shall keep records of information important to the decommissioning of a facility in an identified location until the site is released for unrestricted use. If records important to the decommissioning of a facility are kept for other purposes, reference to these records and their locations may be used. Information the director considers important to decommissioning consists of:

(1) Records of spills or other unusual occurrences involving the spread of contamination in and around the facility, equipment, or site. These records may be limited to instances when contamination remains after any cleanup procedures or when there is reasonable likelihood that contaminants may have spread to inaccessible areas as in the case of possible seepage into porous materials such as concrete. These records must include any known information on identification of involved nuclides, quantities, forms, and concentrations.

(2) As-built drawings and modifications of structures and equipment in restricted areas where radioactive materials are used and/or stored, and of locations of possible inaccessible contamination such as buried pipes which may be subject to contamination. If required drawings are referenced, each relevant document need not be indexed individually. If drawings are not available, the licensee shall substitute appropriate records of available information concerning these areas and locations.

(3) Except for areas containing only sealed sources (provided the sources have not leaked or no contamination remains after cleanup of any leak), a list contained in a single document and updated every two years, of the following:

(a) All areas designated and formerly designated as restricted areas as defined in rule 3701:1-38-01 of the Administrative Code;

(b) All areas outside of restricted areas that require documentation under paragraph (D)(1) of this rule;

(c) All areas outside of restricted areas where current and previous wastes have been buried as documented under paragraph (K) of rule 3701:1-38-20 of the Administrative Code; and

(d) All areas outside of restricted areas that contain material such that, if the license expired, the licensee would be required to either decontaminate the area to meet the criteria for decommissioning in rule 3701:1-38-22 of the Administrative Code, or apply for approval for disposal under paragraph (C) of rule 3701:1-38-19 of the Administrative Code.

(4) Records of the cost estimate performed for the decommissioning funding plan or of the amount certified for decommissioning, and records of the funding method used for assuring funds if either a funding plan or certification is used.

Last updated July 10, 2025 at 10:48 AM

History

• Effective: November 22, 2013
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-38-15 Control of exposure from external sources in high and very high radiation areas.

(A) Control of access to high radiation areas shall be maintained by the licensee or registrant.

(1) Control of access shall be maintained by ensuring that each entrance or access point to a high radiation area has one or more of the following features:

(a) A control device that, upon entry into the area, causes the level of radiation to be reduced below that level at which an individual might receive a deep dose equivalent of one millisievert (0.1 rem) in one hour at thirty centimeters from the source of radiation or from any surface that the radiation penetrates; or

(b) A control device that energizes a conspicuous visible or audible alarm signal so that the individual entering the high radiation area and the supervisor of the activity are made aware of the entry; or

(c) Entryways that are locked, except during periods when access to the areas is required, with administrative and/or engineering control over each individual entry.

(2) In place of the controls required by paragraph (A)(1) of this rule, in the case of a high radiation area, the licensee or registrant may substitute continuous direct or electronic surveillance that is capable of preventing unauthorized entry.

(3) The licensee or registrant may apply to the department for approval of alternative methods for controlling access to high radiation areas.

(4) The licensee or registrant shall establish the controls required by paragraphs (A)(1) and (A)(3) of this rule in a way that does not prevent individuals from leaving a high radiation area.

(5) The licensee is not required to control each entrance or access point to a room or other area that is a high radiation area solely because of the presence of radioactive materials prepared for transport and packaged and labeled in accordance with the regulations of the United States department of transportation provided that:

(a) The packages do not remain in the area longer than three days; and

(b) The dose rate at one meter from the external surface of any package does not exceed 0.1 millisievert (0.01 rem) per hour.

(6) The licensee is not required to control entrance or access to rooms or other areas in hospitals solely because of the presence of patients containing radioactive material, provided that there are personnel in attendance who are taking the necessary precautions to prevent the exposure of individuals to radiation or radioactive material in excess of the established limits in paragraph (A) of rule 3701:1-38-13 of the Administrative Code and to operate within the ALARA provisions of the licensee's radiation protection program.

(7) The registrant is not required to control entrance or access to rooms or other areas containing sources of radiation capable of producing a high radiation area as described in paragraphs (A)(1) to (A)(4) of this rule if the registrant has met all the specific requirements for access and control specified in other applicable rules, such as, the requirements for industrial radiography, x-rays in the healing arts, and particle accelerators as provided in Chapters 3701:1-66, 3701:1-67, and 3701:1-68 of the Administrative Code.

(B) In the case of access to a very high radiation area, the licensee or registrant shall control access as follows:

(1) In addition to the requirements in paragraph (A) of this rule, and except as provided in paragraph (B)(2) of this rule, the licensee or registrant shall institute measures to ensure that an individual is not able to gain unauthorized or inadvertent access to a very high radiation area. This requirement does not apply to rooms or areas in which diagnostic x-ray systems are the only source of radiation.

(2) The registrant is not required to control entrance or access to rooms or other areas containing sources of radiation capable of producing a very high radiation area as provided in paragraph (B)(1) of this rule if the registrant has met all the specific requirements for access and control specified in other applicable rules, such as, requirements for industrial radiography, x-rays in the healing arts, and particle accelerators as provided in Chapters 3701:1-66, 3701:1-67, and 3701:1-68 of the Administrative Code.

Last updated January 20, 2022 at 8:47 AM

History

• Effective: January 20, 2022
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-38-17 Storage and control of a licensed or registered source of radiation.

(A) The licensee shall secure licensed radioactive material from unauthorized removal or access.

(B) The licensee shall maintain constant surveillance and shall use devices or administrative procedures to prevent unauthorized use of licensed radioactive material that is in an unrestricted area and that is not in storage.

(C) The registrant shall use devices or administrative procedures to prevent unauthorized use of radiation-generating equipment.

Last updated November 2, 2022 at 2:10 PM

History

• Effective: September 1, 2011
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-38-18 Posting, labeling, and receipt of packages.

(A) Except as provided in paragraph (B) of this rule, caution signs and posting requirements for licensees and registrants are as follows:

(1) The standard radiation symbol, unless otherwise authorized by the department or as provided in paragraph (A)(2) of this rule, shall use the colors magenta, purple, or black on yellow background. The symbol prescribed is the three-bladed design as follows:

(2) Notwithstanding paragraph (A)(1) of this rule, licensees and registrants are authorized to label sources, source holders, or device components containing sources of radiation that are subjected to high temperatures, with conspicuously cast, etched or stamped radiation caution symbols and without a color requirement.

(3) In addition to the contents of signs and labels prescribed in this chapter, the licensee or registrant may provide, on or near the required signs and labels, additional information, as appropriate, to make individuals aware of potential radiation exposures and to minimize the exposures.

(4) Posting of radiation areas shall be accomplished as follows:

(a) The licensee or registrant shall post each radiation area with a conspicuous sign or signs bearing the radiation symbol and the words "Caution, Radiation Area".

(b) The licensee or registrant shall post each high radiation area with a conspicuous sign or signs bearing the radiation symbol and the words "Caution, High Radiation Area" or "Danger, High Radiation Area".

(c) The licensee or registrant shall post each very high radiation area with conspicuous sign or signs bearing the radiation symbol and words "Grave Danger, Very High Radiation Area".

(d) The licensee shall post each airborne radioactivity area with a conspicuous sign or signs bearing the radiation symbol and the words "Caution, Airborne Radioactivity Area" or "Danger, Airborne Radioactivity Area".

(e) The licensee shall post each area or room in which there is an amount of licensed material used or stored which exceeds ten times the quantity of such material specified in the appendix A ofto this rule with a conspicuous sign or signs bearing the radiation symbol and the words "Caution, Radioactive Material(s)" or "Danger, Radioactive Material(s)".

(f) The licensee shall post access openings to manufacturing or process equipment (such as tanks and vessels) on or in which radiation sources are mounted, if a person could gain access to the radiation beam and receive an annual dose to any part of their body which is greater than the applicable, permissible limits for individuals in rules 3701:1-38-12 and 3701:1-38-13 of the Administrative Code. The posting must include a conspicuous sign or signs bearing the radiation symbol and warning of the hazard.

(B) The following are exceptions to posting requirements set forth in paragraph (A) of this rule:

(1) A licensee or registrant is not required to post caution signs in an area or room that contains a source of radiation provided that the source is located in the area or room for a period of less than eight hours, and the source of radiation is continuously attended to during these periods by an individual who takes the precautions necessary to prevent the exposure of individuals to sources of radiation in excess of the limits established in rule 3701:1-38-13 of the Administrative Code, and the area or room is subject to licensee or registrant control.

(2) Rooms or other areas in hospitals that are occupied by patients are not required to be posted with caution signs pursuant to paragraph (A) of this rule provided that the patient could be released from licensee control in accordance with rule 3701:1-58-30 of the Administrative Code.

(3) A room or area is not required to be posted with a caution sign because of the presence of a sealed source provided the radiation level at thirty centimeters from the surface of the sealed source container or housing does not exceed 0.05 millisievert (0.005 rem) per hour.

(4) A room or area is not required to be posted with a caution sign because of the presence of radiation-generating equipment used solely for diagnosis in the healing arts.

(5) Rooms in hospitals or clinics that are used for teletherapy are exempt from the requirement to post caution signs if access to the room is controlled pursuant to rule 3701:1-58-59 of the Administrative Code and personnel in attendance take necessary precautions to prevent the inadvertent exposure of workers, other patients, and members of the public to radiation in excess of the limits established in this chapter.

(C) Except as provided in paragraph (E) of this rule, containers shall be labeled as follows:

(1) The licensee shall ensure that each container of licensed material bears a durable, clearly visible label bearing the radiation symbol and the words "Caution, Radioactive Material" or "Danger, Radioactive Material". The label shall also provide information, such as the radionuclides present, an estimate of the quantity of radioactivity, the date for which the activity is estimated, radiation levels, kinds of materials, and mass enrichment, to permit individuals handling or using the containers, or working in the vicinity of the containers, to take precautions to avoid or minimize exposures.

(2) Prior to removal or disposal of empty uncontaminated containers to unrestricted areas, each licensee shall, remove or deface the radioactive material label or otherwise clearly indicate that the container no longer contains radioactive materials.

(D) Each registrant shall ensure that each radiation-generating equipment is labeled in a conspicuous manner which cautions individuals that radiation is produced when it is energized.

(E) A licensee is not required to label the following:

(1) Containers holding licensed material in quantities less than the quantities listed in the appendix A to this rule;

(2) Containers holding licensed material in concentrations less than those specified in table III of appendix C to rule 3701:1-38-12 of the Administrative Code;

(3) Containers attended by an individual who takes the precautions necessary to prevent the exposure of individuals in excess of the limits established by rule 3701:1-38-13 of the Administrative Code;

(4) Containers when they are in transport and packaged and labeled in accordance with the regulations of the United States department of transportation;

(5) Containers that are accessible only to individuals authorized to handle or use them, or to work in the vicinity of the containers, if the contents are identified to these individuals by a readily available written record. Examples of containers of this type are containers in locations such as water-filled canals, storage vaults, or hot cells. The record shall be retained as long as the containers are in use for the purpose indicated on the record; or

(6) Manufacturing or processing equipment such as contaminated piping and tanks, and vessels on or in which radiation sources are installed.

(F) Each licensee shall:

(1) Monitor the external surfaces of a labeled package for radioactive contamination unless the package contains only radioactive material in the form of gas or in special form as defined in rule 3701:1-38-01 of the Administrative Code;

(2) Monitor the external surfaces of a labeled package for radiation levels unless the package contains quantities of radioactive material that are less than or equal to the type A quantity; and

(3) Monitor all packages known to contain radioactive material for radioactive contamination and radiation levels if there is evidence of degradation of package integrity, such as a package that is crushed, wet, or damaged.

(4) Perform the monitoring required by this paragraph as soon as practicable after receipt of the package, but not later than three hours after the package is received at the licensee's facility, if it is received during the licensee's normal working hours. If a package is received after working hours, the package shall be monitored no later than three hours from the beginning of the next working day.

(G) Each licensee who expects to receive a package containing quantities of radioactive material in excess of a type A quantity as defined in rule 3701:1-38-01 of the Administrative Code and as provided in rule 3701:1-50-25 of the Administrative Code, shall make arrangements to receive the package when the carrier offers it for delivery or expeditiously upon receiving notification that the package is available for pick-up.

(H) The licensee shall immediately notify the final delivery carrier and the department by telephone and either telegram, mailgram, or facsimile, when:

(1) Removable radioactive surface contamination exceeds the limits as provided in 49 C.F.R. 173.443 (as published in the October 1, 2009 Code of Federal Regulationsin effect on the effective date of this rule); or

(2) External radiation levels exceed the limits as provided in 49 C.F.R. 172.403 (as published in the October 1, 2009 Code of Federal Regulationsin effect on the effective date of this rule).

(I) Each licensee shall:

(1) Establish, maintain, and retain written procedures for safely opening packages in which radioactive material is received; and

(2) Ensure that the procedures are followed and that due consideration is given to special instructions for the type of package being opened.

(J) A licensee that transfers a special form source to and from a work site in a vehicle owned or operated by the licensee is exempt from the contamination monitoring requirements of this rule, but is not exempt from the monitoring requirement in this rule for measuring radiation levels that ensures that the source is still properly lodged in its shield.

View Appendix

Last updated June 6, 2022 at 9:29 AM

History

• Effective: June 4, 2022
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-58-59

(A) A licensee shall control access to the treatment room by a door at each entrance.

(B) A licensee shall equip each entrance to the treatment room with an electrical interlock system that will:

(1) Prevent the operator from initiating the treatment cycle unless each treatment room entrance door is closed;

(2) Cause the source(s) to be shielded when an entrance door is opened; and

(3) Prevent the source(s) from being exposed following an interlock interruption until all treatment room entrance doors are closed and the source(s) on-off control is reset at the console.

(C) A licensee shall require any individual entering the treatment room to assure, through the use of appropriate radiation monitors, that radiation levels have returned to ambient levels.

(D) Except for low-dose remote afterloader units, a licensee shall construct or equip each treatment room with viewing and intercom systems to permit continuous observation of the patient or the human research subject from the treatment console during irradiation.

(E) For licensed activities where sources are placed within the patient's or human research subject's body, a licensee shall only conduct treatments which allow for expeditious removal of a decoupled or jammed source.

(F) In addition to the requirements specified in paragraphs (A) to (E) of this rule, a licensee shall:

(1) For medium dose-rate and pulsed dose-rate remote afterloader units, require:

(a) An authorized medical physicist and either an authorized user or a physician, under the supervision of an authorized user, who has been trained in the operation and emergency response for the unit to be physically present during the initiation of all patient treatments involving the unit; and

(b) An authorized medical physicist and either an authorized user or an individual, under the supervision of an authorized user, who has been trained to remove the source applicator(s) in the event of an emergency involving the unit, to be immediately available during continuation of all patient treatments involving the unit.

(2) For high dose-rate remote afterloader units, require:

(a) An authorized user and an authorized medical physicist to be physically present during the initiation of all patient treatments involving the unit; and

(b) An authorized medical physicist and either an authorized user or a physician, under the supervision of an authorized user, who has been trained in the operation and emergency response for the unit, to be physically present during continuation of all patient treatments involving the unit.

(3) For gamma stereotactic radiosurgery units, require an authorized user and an authorized medical physicist to be physically present throughout all patient treatments involving the unit.

(4) Notify the radiation safety officer, or his/her designee, and an authorized user as soon as possible if the patient or human research subject has a medical emergency or dies.

(G) A licensee shall have applicable emergency response equipment available near each treatment room to respond to a source:

(1) Remaining in the unshielded position; or

(2) Lodged within the patient following completion of the treatment.

Last updated November 18, 2022 at 8:37 AM

History

• Effective: August 15, 2005
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-54-06

(A) The purpose of rules 3701:1-54-06 to 3701:1-54-12 of the Administrative Code is to establish procedures, criteria, and terms and conditions upon which the department issues licenses for the land disposal of radioactive waste received from another licensee and radioactive waste disposed of in accordance with paragraph (C) of rule 3701:1-38-19 of the Administrative Code.

(B) The requirements of rules 3701:1-54-06 to 3701:1-54-12 of the Administrative Code are in addition to those in Chapter 3701:1-40 of the Administrative Code, and other rules adopted pursuant to Chapter 3748. of the Revised Code.

(C) The requirements of rules 3701:1-54-06 to 3701:1-54-12 of the Administrative Code apply to a radioactive waste land disposal facility used by more than one licensee to dispose of radioactive waste or to a licensee that disposes of any radioactive waste at a location other than its currently licensed facility.

(1) Rules 3701:1-54-06 to 3701:1-54-12 of the Administrative Code establish performance objectives and technical requirements for the land disposal of radioactive waste received from another licensee.

(2) The objectives are to protect the public health and safety, to minimize exposures to ionizing radiation, and not to adversely affect the environment from the land disposal of radioactive wastes received from another licensee.

(3) The land disposal requirements in rules 3701:1-54-06 to 3701:1-54-12 of the Administrative Code are in addition to, and not a substitution for, other applicable rules.

(4) Rules 3701:1-54-06 to 3701:1-54-12 of the Administrative Code do not apply to byproduct material as defined in section 11e(2) of the Atomic Energy Act and codified in 42 U.S.C. 2014e(2).

(5) As used in rules 3701:1-54-06 to 3701:1-54-12 of the Administrative Code, "waste" means the same as "radioactive waste" as defined in rule 3701:1-38-01 of the Administrative Code.

(D) The requirements of rules 3701:1-54-06 to 3701:1-54-12 of the Administrative Code apply to radioactive waste disposal facilities utilizing an above grade engineered structure.

Last updated August 1, 2023 at 2:47 PM

History

• Effective: February 6, 2006
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-54-12

The licensee shall maintain records, reports, and transfers as recorded in this rule.

(A) Each licensee shall maintain any records and make any reports in connection with the licensed activities as may be required by the conditions of the license or by the rules, regulations, and orders of the department.

(B) Records which are required by the regulations in this chapter or by license conditions must be maintained for a period specified by the appropriate regulations in this chapter or by license condition. If a retention period is not otherwise specified, these records must be maintained and transferred to the officials specified in paragraph (E) of this rule as a condition of license termination unless the department otherwise authorizes their disposition.

(C) Records which must be maintained pursuant to this chapter may be the original or a reproduced copy or a microform if this reproduced copy or microform is capable of producing copy that is clear and legible at the end of the required retention period. The record may also be stored in electronic media with the capability for producing legible, accurate, and complete records during the required retention period. Records such as letters, drawings, or specifications, must include all pertinent information such as stamps, initials, and signatures. The licensee shall maintain adequate safeguards against tampering with and loss of records.

(D) If there is a conflict between the department's regulations in this chapter, license condition, or other written department approval or authorization pertaining to the retention period for the same type of record, the longest retention period specified takes precedence.

(E) Notwithstanding paragraphs (A) to (D) of this rule, the licensee shall record the location and the quantity of radioactive wastes contained in the disposal site and transfer these records upon license termination to the department and other agencies as designated by the department.

(F) Following receipt and acceptance of a shipment of radioactive waste, the licensee shall record the following information and retain these records until the department transfers or terminates the license that authorizes the activities described in this paragraph.

(1) The date that the shipment is received at the disposal facility;

(2) The date of disposal of the waste;

(3) A traceable shipment manifest number;

(4) A description of any engineered barrier or structural overpack provided for disposal of the waste;

(5) The location of disposal at the disposal site;

(6) The containment integrity of the waste disposal containers as received;

(7) Any discrepancies between materials listed on the manifest and those received;

(8) The volume of any pallets, bracing, or other shipping or onsite generated materials that are contaminated, and are disposed of as contaminated or suspect materials;

(9) Any evidence of leaking or damaged disposal containers or radiation or contamination levels in excess of limits specified in rule 3701:1-50-17 of the Administrative Code and United States department of transportation regulations of 49 C.F.R. 173.443 (as in effect on the effective date of this rule);

(10) A description of any repackaging operations of any of the disposal containers included in the shipment; and

(11) Any other information required by the department as a license condition.

(G) Each licensee shall comply with the safeguards reporting requirements of 10 C.F.R. 30.55, 40.64, 70.53 and 70.54 (as in effect on the effective date of this rule), if the quantities or activities of materials received or transferred exceed the limits of these sections. Inventory reports required by these sections are not required for materials after disposal.

(H) Each licensee authorized to dispose of radioactive waste received from other persons shall file a copy of its financial report or a certified financial statement annually with the department in order to update the information base for determining financial qualifications.

(I) Each licensee authorized to dispose of waste materials received from other persons, pursuant to this chapter, shall submit annual reports to the department. Reports must be submitted by the end of the first calendar quarter of each year for the preceding year. The reports shall include:

(1) Specification of the quantity of each of the principal radionuclides released to unrestricted areas in liquid and in airborne effluents during the preceding year;

(2) The results of the environmental monitoring program;

(3) A summary of licensee disposal unit survey and maintenance activities;

(4) A summary, by waste class, of activities and quantities of radionuclides disposed of;

(5) Any instances in which observed site characteristics were significantly different from those described in the application for a license; and

(6) Any other information the department may require. If the quantities of radioactive materials released during the reporting period, monitoring results, or maintenance performed are significantly different from those expected in the materials previously reviewed as part of the licensing action, the report must cover this specifically.

(J) Each licensee shall report in accordance with the requirements of 10 C.F.R. 70.52 (as in effect on the effective date of this rule), to the department and the United States nuclear regulatory commission.

(K) Any transfer of radioactive material by the licensee is subject to the requirements in rules 3701:1-40-19, 3701:1-44-21, and 3701:1-56-08 of the Administrative Code.

(L) In addition to the other requirements of this rule, the licensee shall store, or have stored, manifest and other information pertaining to receipt and disposal of radioactive waste in an electronic recordkeeping system.

(1) The manifest information that must be electronically stored is:

(a) That information required in appendix G to rule 3701:1-38-19 of the Administrative Code with the exception of shipper and carrier telephone numbers and shipper and consignee certifications; and

(b) That information required in paragraph (F) of this rule.

(2) As specified in facility license conditions, the licensee shall report the stored information, or subsets of this information, on a computer-readable medium.

Last updated November 15, 2022 at 8:58 AM

History

• Effective: November 14, 2022
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-38-22 Decommissioning.

(A) This rule applies to the decommissioning of facilities licensed under Chapter 3748. of the Revised Code. For low-level waste disposal facilities, this rule applies only to ancillary surface facilities that support radioactive waste disposal activities. This rule does not apply to uranium and thorium recovery facilities already subject to source material licensing requirements in Chapter 3701:1-44 of the Administrative Code or to uranium solution extraction facilities.

(B) Decommissioning with license termination shall be limited to sites considered acceptable for unrestricted release where the residual radioactivity that is distinguishable from background radiation results in a total effective dose equivalent (TEDE) to an average member of the critical group that does not exceed 0.25 millisievert (twenty-five millirem) per year, including that from groundwater sources of drinking water, and the residual radioactivity has been reduced to levels that are as low as reasonably achievable (ALARA). Determination of the levels which are ALARA must take into account consideration of detriments, such as deaths from transportation accidents, expected to potentially result from decontamination and waste disposal.

(C) After a facility has been decommissioned and the license terminated in accordance with the criteria in this rule, the director will require additional cleanup only if, based on new information, it is determined that the criteria of this rule were not met and residual radioactivity remaining at the site could result in a significant threat to public health and safety. When calculating TEDE to the average member of the critical group the licensee shall determine the peak annual TEDE dose expected within the first one thousand years after decommissioning.

(D) A licensee may decommission a facility and maintain a decommissioning possession only license using alternate criteria greater than the dose criterion specified in paragraph (B) of this rule, provided that the licensee:

(1) Provides assurance that public health and safety would continue to be protected, and that it is unlikely that the dose from all man-made sources combined, other than medical, would be more than the one millisievert (one hundred millirem) per year limit set forth in this chapter, by submitting an analysis of possible sources of exposure;

(2) Has employed, to the extent practicable, restrictions on site use in minimizing exposures at the site;

(3) Reduces doses to ALARA levels, taking into consideration any detriments, such as traffic accidents expected to potentially result from decontamination and waste disposal; and

(4) Has submitted a decommissioning plan or license termination plan (LTP) to the director indicating the licensee's intent to decommission in accordance with rule 3701:1-40-18 of the Administrative Code, and specifying that the licensee proposes to decommission by restricting use of the site. The licensee shall document in the decommissioning plan or LTP how the advice of individuals and institutions in the community who may be affected by the decommissioning has been sought and incorporated, as appropriate, following analysis of that advice. In seeking such advice, the licensee shall provide for:

(a) Participation by representatives of a broad cross section of community interests who may be affected by the decommissioning;

(b) An opportunity for a comprehensive, collective discussion on the issues by the participants represented; and

(c) A publicly available summary of the results of all such discussions, including a description of the individual viewpoints of the participants on the issues and the extent of agreement and disagreement among the participants on the issues.

(5) Has provided sufficient financial assurance in the form of a trust fund to enable an independent third party, including a governmental custodian of a site, to assume and carry out responsibilities for any necessary control and maintenance of the site.

(E) When a decommissioning with restrictions is proposed by a licensee, a decommissioning possession only license is required to assure that the provisions of the decommissioning plan as approved by the director remain effective. The license will contain a condition that the director will not require further cleanup unless he or she determines that the criteria of this rule or terms of the license were not met or that residual radioactivity at the site could result in a significant threat to public health and safety.

(F) Any facility that has been decommissioned and has had the United States nuclear regulatory commission license terminated in accordance with a plan approved by the commission on or before August 31, 1999, will not be required to obtain a license or conduct further cleanup unless the director determines that residual radioactivity at the site could result in a significant threat to the public health and safety.

(G) Applicants for licenses, other than renewals, shall describe in the application how facility design and procedures for operation will minimize, to the extent practical, contamination of the facility and the environment, facilitate eventual decommissioning, and minimize, to the extent practical, the generation of radioactive waste.

(H) Licensees shall, to the extent practical, conduct operations to minimize the introduction of residual radioactivity into the site, including the subsurface, in accordance with the existing radiation protection requirements in rule 3701:1-38-11 of the Administrative Code and radiological criteria for license termination in accordance with this rule.

Last updated November 2, 2022 at 2:10 PM

History

• Effective: August 30, 2015
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-40-18

(A) Each specific license expires at the end of the day on the expiration date stated in the license unless the licensee has filed an application for renewal in accordance with paragraph (E) of rule 3701:1-38-02 of the Administrative Code. If an application for renewal has been filed at least ninety days, or in the case of a broad scope license, at least one hundred eighty days prior to the expiration date stated in the existing license, the existing license expires at the later of the end of the day on which the director makes a final determination to deny the renewal application or, if the determination states an expiration date, the expiration date stated in the determination.

(B) Each specific license for the possession of radioactive material that requires a decommissioning plan shall continue in effect and shall be renewed during the decommissioning period, until the director notifies the licensee in writing after decommissioning that the license is terminated. During this time, the licensee shall:

(1) Limit actions involving radioactive material to those related to decommissioning; and

(2) Continue to control entry to any restricted area until that area is suitable for release in accordance with department requirements as may be imposed by rule 3701:1-38-22 of the Administrative Code.

(C) A licensee shall provide written notice to the director within sixty days of the occurrence of any of the following, in accordance with rule 3701:1-40-04 of the Administrative Code:

(1) The license has expired;

(2) The licensee has decided to permanently cease licensed activities at the entire site or in any separate building, room or outdoor area that contains residual radioactivity such that the building, room or outdoor area is unsuitable for release in accordance with the definition of "decommissioning" in Chapter 3748. of the Revised Code and the regulations for decommissioning in rule 3701:1-38-22 of the Administrative Code.

(3) No licensed activities have been conducted for a period of twenty-four months; or

(4) No licensed activities have been conducted for a period of twenty-four months in any separate building, room or outdoor area that contains residual radioactivity such that the building, room or outdoor area is unsuitable for release in accordance with rule 3701:1-38-22 of the Administrative Code.

(D) In the event of an occurrence as set forth in paragraph (C) of this rule, the licensee shall either:

(1) Begin decommissioning the site, and any separate building, room or outdoor area that contains residual radioactivity so that the site, building, room and outdoor area are suitable for release in accordance with rule 3701:1-38-22 of the Administrative Code; or

(2) If required by paragraph (G)(1) of this rule, submit within twelve months of notification, a decommissioning plan and begin decommissioning upon the director's approval of that plan.

(E) In addition to written notification of an occurrence, the licensee shall maintain all decommissioning financial assurances established by the licensee pursuant to rule 3701:1-40-17 of the Administrative Code in conjunction with a license issuance or renewal or as required by this rule.

(F) The director may grant a request to extend the twelve-month time period to submit a decommissioning plan established in paragraph (D)(2) of this rule provided that the director determines that the alternative schedule is necessary to the effective conduct of decommissioning operations and that the extension is not detrimental to the public health and safety or the environment and is otherwise in the public interest. The extension request must be submitted no later than thirty days after the occurrence for which notification is required. Decommissioning set forth in paragraph (D)(2) of this rule may not commence until the director has made a determination on the extension request.

(G) The licensee shall submit a decommissioning plan to the director prior to commencing any decommissioning in the following cases:

(1) If required by license condition; or

(2) If the procedures and activities necessary to carry out decommissioning of the site or separate building, room or outdoor area have not been previously approved by the director and these procedures could increase potential health and safety risk to workers or to the public, such as in any of the following cases:

(a) Decommissioning procedures would involve techniques not applied routinely during cleanup or maintenance operations;

(b) Workers would be entering areas not normally occupied where surface contamination and radiation levels are significantly higher than routinely encountered during operation;

(c) Decommissioning procedures could result in significantly greater airborne concentrations of radioactive materials than are present during operation; or

(d) Decommissioning procedures could result in significantly greater releases of radioactive material to the environment than those associated with operation.

(H) A proposed decommissioning plan for a site or separate building, room or outdoor area shall include the following:

(1) A description of the conditions of the site or separate building, room or outdoor area sufficient to evaluate the acceptability of the plan;

(2) A description of planned decommissioning activities;

(3) A description of methods used to ensure protection of workers and the environment against radiation hazards during decommissioning;

(4) A description of the planned final radiation survey;

(5) An updated detailed cost estimate for decommissioning, comparison of that estimate with present funds set aside for decommissioning, and a plan for assuring the availability of adequate funds for completion of decommissioning; and

(6) In the case of a decommissioning plan that results in the licensee completing decommissioning later than twenty-four months after plan approval, the plan shall include a justification for the delay based on the criteria in paragraph (J) of this rule.

The proposed decommissioning plan will be approved by the director if the information therein demonstrates compliance with rule 3701:1-38-22 of the Administrative Code, that the decommissioning will be completed as soon as practicable, and that the health and safety of workers and the public will be adequately protected.

(I) Except as provided in paragraph (J) of this rule, a licensee shall:

(1) Complete decommissioning of the site or separate building or outdoor area as soon as practicable but no later than twenty-four months following the initiation of decommissioning; and

(2) When decommissioning involves the entire site, request license termination as soon as practicable but no later than twenty-four months following the initiation of decommissioning, unless the decommissioning is still actively in progress.

(J) The director may approve a request for an alternative schedule for completion of decommissioning and license termination. In considering whether an alternative schedule is warranted, the director shall consider the following:

(1) Whether it is technically feasible to complete decommissioning within twenty-four months;

(2) Whether sufficient waste disposal capacity is available to allow completion of decommissioning within twenty-four months;

(3) Whether a significant volume reduction in wastes requiring disposal will be achieved by allowing short-lived radionuclides to decay;

(4) Whether a significant reduction in radiation exposure to workers can be achieved by allowing short-lived radionuclides to decay; and

(5) Any other factor that the director finds is unique to the site, such as the regulatory requirements of other government agencies, lawsuits, ground-water treatment activities, monitored natural ground-water restoration, actions that could result in more environmental harm than deferred cleanup, and other factors beyond the control of the licensee.

(K) After decommissioning the site, the licensee shall:

(1) Certify the disposition of all licensed material, including accumulated wastes, by submitting a completed disposition of radioactive materials form provided by the director; and

(2) Conduct a radiation survey of the premises where the licensed activities were carried out and submit a report of the results of this survey, unless the licensee demonstrates in some other manner that the premises are suitable for release in accordance with the criteria for decommissioning set forth in rule 3701:1-38-22 of the Administrative Code. The licensee shall survey and report as follows:

(a) Levels of gamma radiation in units of millisieverts (microroentgen) per hour at one meter from surfaces and radioactivity, including alpha and beta, in units of megabecquerels (disintegrations per minute or microcuries) per one hundred square centimeters, removable and fixed, for surfaces, megabecquerels (microcuries) per milliliter for water, and becquerels (picocuries) per gram for solids such as soils or concrete; and

(b) Identification of any survey instrument used and a certification that each instrument was properly calibrated and tested prior to being used to measure radioactivity at the site.

(L) Specific licenses, including expired licenses, will be terminated by written notice to the licensee when the director determines that:

(1) Radioactive material has been properly disposed;

(2) Reasonable effort has been made to eliminate residual radioactive contamination, if present;

(3) A radiation survey has been performed which demonstrates that the premises are suitable for release in accordance with the criteria for decommissioning, or other information is submitted by the licensee that is sufficient to demonstrate that the premises are suitable for release in accordance with the criteria for decommissioning in this chapter and rule 3701:1-38-22 of the Administrative Code; and

(4) All applicable fees have been paid.

Last updated April 19, 2022 at 8:35 AM

History

• Effective: April 17, 2022
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-38-23 Reporting of defects and noncompliance.

(A) As used in this rule:

(1) "Basic component" means:

(a) A structure, system, or component, or part thereof that affects their safety function, that is directly procured by the licensee or registrant of facility or activity subject to the rules promulgated pursuant to Chapter 3748. of the Revised Code and in which a defect or failure to comply with any rule promulgated pursuant to Chapter 3748. of the Revised Code, order issued by the director, or license issued by the department could create a substantial safety hazard; and

(b) Safety-related design, analysis, inspection, testing, fabrication, replacement of parts, or consulting services that are associated with the component hardware whether these services are performed by the component supplier or others.

(2) "Commercial grade item" means an item that is:

(a) Not subject to design or specification requirements that are unique to those facilities or activities;

(b) Used in applications other than those facilities or activities; and

(c) To be ordered from the manufacturer or supplier on the basis of specifications set forth in the manufacturer's published product description, such as a catalog.

(3) "Constructing" or "construction" means the analysis, design, manufacture, fabrication, placement, erection, installation, modification, inspection, or testing of a facility or activity which is subject to this rule and consulting services related to the facility or activity that are safety related.

(4) "Dedication" means an item has been received and designated for use as a basic component.

(5) "Defect" means:

(a) A deviation in a basic component delivered to a purchaser for use in a facility or an activity subject to this rule, if, on the basis of an evaluation, the deviation could create a substantial safety hazard; or

(b) The installation, use, or operation of a basic component containing a defect as defined in this paragraph.

(6) "Deviation" means a departure form the manufacturer's specification's or technical specifications as part of a license or registration issued by the department for a given safety device or safety system associated with that device.

(7) "Discovery" means the completion of the documentation first identifying the existence of a deviation or failure to comply potentially associated with a substantial safety hazard within the evaluation procedures discussed in paragraph (G) of this rule.

(8) "Evaluation" means the process of determining whether a particular deviation could create a substantial hazard or determining whether a failure to comply is associated with a substantial safety hazard.

(9) "Failure to comply" means a failure to meet the requirements of any of the following that could create a substantial safety hazard:

(a) A rule promulgated pursuant to Chapter 3748. of the Revised Code;

(b) An order issued by the director; or

(c) License issued by the department.

(10) "Operating" or "operation" means the operation of a facility or the conduct of a licensed or registered activity which is subject to this rule and consulting services related to operations that are safety related.

(11) "Responsible officer" means:

(a) The president, vice-president or other individual in the organization of a corporation, partnership, or other entity who is vested with executive authority over activities subject to this rule, or

(b) An individual who is appointed or elected according to law, who is authorized to manage and direct the affairs of a corporation, partnership or other entity. In the case of an individual proprietorship, responsible officer means the individual.

(12) "Substantial safety hazard" means a loss of safety function to the extent that there is a major reduction in the degree of protection provided to either public health and safety or the environment, for any facility or activity licensed or registered pursuant to Chapter 3748. of the Revised Code.

(13) "Supplying" or "supplies" means contractually responsible for a basic component used or to be used in a facility or activity which is subject to this rule.

(B) This rule establishes procedures and requirements for implementation of section 3748.04 of the Revised Code, which applies to reporting of defects in equipment used for licensed or registered activities. Any responsible corporate officer of a firm constructing, owning, operating or supplying the components of any facility or activity which is licensed, registered, or otherwise regulated pursuant to Chapter 3748. of the Revised Code, obtaining information reasonably indicating either of the following, shall notify the director within twenty-four hours:

(1) That the facility, activity or basic component supplied to such facility or activity fails to comply with any applicable rule, regulation, order, registration, or license of the department relating to substantial safety hazards; or

(2) That the facility, activity, or basic component supplied to such facility or activity contains defects, which could create a substantial safety hazard.

(C) This rule applies, except as specifically provided otherwise in Chapter 3748. of the Revised Code, to each individual, partnership, corporation, or other entity licensed or registered pursuant to Chapter 3748. of the Revised Code to possess, use, or transfer within the state of Ohio source material, radioactive material, special nuclear material, or to construct, manufacture, possess, own, operate or transfer within the state of Ohio any radiation-generating equipment and to each responsible officer of such a licensee or registrant. This rule applies also to each individual, corporation, partnership or other entity doing business within the state of Ohio, that supplies basic components for a facility or activity licensed, under Chapter 3748. of the Revised Code.

(D) Nothing in this rule should be deemed to preclude either an individual, a manufacturer, or a supplier of a commercial grade item not subject to this rule from reporting to the director, a known or suspected defect or failure to comply and, as authorized by law, the identity of anyone so reporting will be withheld from disclosure. The department will accept collect telephone calls from individuals who wish to speak to department representatives concerning radiation safety-related problems.

(E) Each individual, partnership, corporation, dedicating entity, or other entity subject to this rule shall post current copies of this rule and procedures adopted pursuant to this rule. These documents must be posted in a conspicuous position on any premises within the state of Ohio where the activities subject to this rule are conducted. If posting of this rule or the procedures adopted pursuant to this rule is not practicable, the licensee, registrant, or firm subject to this rule may post a notice which describes the rules and procedures, including the name of the individual to whom reports may be made, and where the rules and procedures may be examined.

(F) The director may, upon application of any interested person or upon the director's own initiative, grant such exemptions from the requirements of this rule as the director determines to be authorized by law and will not endanger public health and safety or the environment, and are otherwise in the public interest. Suppliers of commercial grade items are exempt from the provisions of this rule to the extent that they supply commercial grade items.

(G) Each individual, corporation, partnership, dedicating entity, or other entity subject to this rule shall adopt appropriate procedures to:

(1) Initiate evaluations of deviations and failures to comply that are associated with substantial safety hazards as soon as practicable, but no later than ten days from the date of discovery of the deviation or failure to comply. The director shall be notified of any such deviation or failure to comply in accordance with paragraph (B) of this rule.

(2) Evaluate a reportable defect or failure to comply that could create a substantial safety hazard, were it to remain uncorrected, within thirty days of its discovery, except as provided by paragraph (G)(3) of this rule.

(3) Ensure that if an evaluation of an identified deviation or failure to comply potentially associated with a substantial safety hazard cannot be completed within thirty days from discovery of the deviation or failure to comply, an interim report is prepared and submitted to the director through a responsible corporate officer. The interim report should describe the deviation or failure to comply that is being evaluated and should also state when the evaluation will be completed. This interim report must be submitted in writing within thirty days of discovery of the deviation or failure to comply; and

(4) Ensure that a responsible corporate officer subject to this rule is informed as soon as practicable, and, in all cases, within five working days after completion of the evaluation described in this paragraph if the construction or operation of a facility or activity, or a basic component supplied for such facility or activity either fails to comply with any applicable rule, regulation, order, or license or registration of the department relating to a substantial safety hazard, or contains a defect.

(H) If the deviation or failure to comply is discovered by a supplier of basic components, or services associated with basic components, and the supplier determines that it does not have the capability to perform the evaluation to determine if a defect exists, then the supplier must inform the purchasers or affected licensees or registrants within five working days of this determination so that the purchasers or affected licensees or registrants may evaluate the deviation or failure to comply, pursuant to paragraph (G) of this rule. Nothing in this rule shall be deemed to require manufacturers or suppliers to adopt or maintain procedures for defect identification and evaluation, where the item or service is not dedicated for purposes of licensed or registered activities or equipment. Instead, such is the responsibility of the registrant or licensee, in accordance with paragraph (B) of this rule.

(I) A responsible corporate officer subject to this rule must notify the director within thirty days when he or she obtains information reasonably indicating a failure to comply or a defect affecting:

(1) The construction or operation of a facility or any activity within the state of Ohio that is subject to the licensing or registration requirements under Chapter 3748. of the Revised Code and that is within the facility's responsibility; or

(2) A basic component that is within the facility's responsibility and is supplied for a facility or an activity within the state of Ohio that is subject to the licensing requirements of Chapter 3748. of the Revised Code.

(J) The notification required by paragraphs (B) and (I) of this rule shall include the following information, to the extent known:

(1) Name and address of the individual or individuals informing the director.

(2) Identification of the facility, the activity, or the basic component supplied for such facility or such activity within the state of Ohio which fails to comply or contains a defect.

(3) Identification of the firm constructing the facility or supplying the basic component which fails to comply or contains a defect.

(4) Nature of the defect or failure to comply and the safety hazard which is created or could be created by such defect or failure to comply.

(5) The date on which the information of such defect or failure to comply was obtained.

(6) In the case of a basic component which contains a defect or fails to comply, the number and location of all such components in use at, supplied for, or being supplied for one or more facilities or activities subject to this rule.

(7) The corrective action which has been, is being, or will be taken; the name of the individual or organization responsible for the action; and the length of time that has been or will be taken to complete the action.

(8) Any advice related to the defect or failure to comply about the facility, activity, or basic component that has been, is being, or will be given to purchasers or licensees.

(K) The responsible corporate officer may authorize an individual to provide the notification required by paragraph (J) of this rule, provided that, this shall not relieve the responsible corporate officer of his or her responsibility under this paragraph. Individuals subject to this rule may be required by the director to supply additional information related to a defect or failure to comply. Department action to obtain additional information may be based on reports of defects from other reporting entities.

(L) Each individual, corporation, partnership, or other entity subject to this rule shall prepare and maintain records necessary to accomplish the requirements of this rule, including retaining evaluations of all deviations and failures to comply for a minimum of five years after the date of the evaluation. Each individual, corporation, partnership, dedicating entity, or other entity subject to this rule shall permit the department the opportunity to inspect records pertaining to basic components that relate to the identification and evaluation of deviations, and the reporting of defects and failures to comply, including any advice given to purchasers or licensees on the placement, erection, installation, operation, maintenance, modification, or inspection of a basic component.

(M) Suppliers of basic components must retain any notifications sent to purchasers and affected licenses for a minimum of five years after the date of the notification. Suppliers of basic components must retain a record of the purchasers of basic components for ten years after delivery of the basic component or service associated with a basic component.

Last updated November 2, 2022 at 2:11 PM

History

• Effective: September 1, 2011
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-38-24 Testing for leakage or contamination of sealed sources.

(A) The licensee in possession of any sealed source not subject to the testing requirements of rule 3701:1-46-05, 3701:1-48-09, 3701:1-49-07, 3701:1-52-22, or 3701:1-58-27 of the Administrative Code, shall assure that:

(1) Each sealed source, except as specified in paragraph (B) of this rule, is tested for leakage or contamination and the test results are received before the sealed source is put into use unless the licensee has a certificate from the transferor indicating that the sealed source was tested within six months before transfer to the licensee;

(2) Each sealed source that is not designed to emit alpha particles is tested for leakage or contamination at intervals not to exceed six months or at alternative intervals as specified in the sealed source and device registry sheet;

(3) Each sealed source that is designed to emit alpha particles is tested for leakage or contamination at intervals not to exceed three months or at alternative intervals as specified in the sealed source and device registry sheet;

(4) For each sealed source that is required to be tested for leakage or contamination, at any other time there is reason to suspect that the sealed source might have been damaged or might be leaking, the licensee shall assure that the sealed source is tested for leakage or contamination before further use;

(5) Tests for leakage for all sealed sources shall be capable of detecting the presence of one hundred eighty-five becquerels (0.005 microcurie) of radioactive material on a test sample. Test samples shall be taken from the sealed source or from the surfaces of the container in which the sealed source is stored or mounted on which one might expect contamination to accumulate. For a sealed source contained in a device, test samples are obtained when the source is in the off position;

(B) A licensee need not perform tests for leakage or contamination on the following sealed sources:

(1) Sealed sources containing only radioactive material with a half-life of less than thirty days;

(2) Sealed sources containing only radioactive material as a gas;

(3) Sealed sources containing 3.7 megabecquerels (one hundred microcuries) or less of beta or photon emitting material or three hundred seventy kilobecquerels (ten microcuries) or less of alpha-emitting material;

(4) Sealed sources containing only hydrogen-3;

(5) Seeds of iridium-192 encased in nylon ribbon; and

(6) Sealed sources which are stored, not being used and identified as in storage. The licensee shall, however, test each such sealed source for leakage or contamination and receive the test results before any use or transfer unless it has been tested for leakage or contamination within six months before the date of use or transfer.

(C) Tests for leakage or contamination from sealed sources shall be performed by persons specifically authorized by the director, an agreement state, or the United States nuclear regulatory commission to perform such services.

(D) Test results shall be kept in units of becquerel or microcurie and maintained for inspection by the director. Records of test results for sealed sources shall be made pursuant to paragraph (E) of rule 3701:1-38-20 of the Administrative Code.

(E) A sealed source shall be considered to be leaking if the presence of one hundred eighty-five becquerels (0.005 microcurie) or more of removable contamination on any test sample is identified.

(F) The licensee shall immediately withdraw a leaking sealed source from use and shall take action to prevent the spread of contamination. The leaking sealed source shall be repaired or disposed of in accordance with this chapter.

(G) Reports of test results for leaking or contaminated sealed sources shall be made pursuant to paragraph (F) of rule 3701:1-38-21 of the Administrative Code.

Last updated November 2, 2022 at 2:11 PM

History

• Effective: January 29, 2007
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-48-09

(A) The replacement of any sealed source fastened to or contained in a radiographic exposure device and leak testing of any sealed source must be performed by persons authorized by the director, the United States nuclear regulatory commission, or an agreement state to do so.

(B) The opening, repair, or modification of any sealed source must be performed by persons specifically authorized by the director, the United States nuclear regulatory commission, or an agreement state to do so.

(C)

(1) Each licensee who uses a sealed source shall have the source tested for leakage at intervals not to exceed six months. The leak testing of the source must be performed using a method approved by the director, the United States nuclear regulatory commission or by an agreement state. The wipe sample should be taken from the nearest accessible point to the sealed source where contamination might accumulate. The wipe sample must be analyzed for radioactive contamination. The analysis must be capable of detecting the presence of one hundred eighty-five becquerels (0.005 microcurie) of radioactive material on the test sample and must be performed by a person specifically authorized by the director, the United States nuclear regulatory commission, or an agreement state to perform the analysis.

(2) The licensee shall maintain records of the leak tests in accordance with paragraph (D) of rule 3701:1-48-23 of the Administrative Code.

(3) Unless a sealed source is accompanied by a certificate from the transferor that shows that it has been leak tested within six months before the transfer, it may not be used by the licensee until tested for leakage. Sealed sources that are in storage and not in use do not require leak testing, but must be tested before use or transfer to another person if the interval of storage exceeds six months.

(D) Any test conducted pursuant to paragraph (C) of this rule which reveals the presence of one hundred eighty-five becquerels (0.005 microcurie) or more of removable radioactive material must be considered evidence that the sealed source is leaking. The licensee shall immediately withdraw the equipment involved from use and shall have it decontaminated and repaired or disposed of in accordance with department rules. A report must be filed with the director, within five days of any test with results that exceed the threshold in this paragraph, describing the equipment involved, the test results, and the corrective action taken.

(E) Each exposure device using depleted uranium shielding and an S-tube configuration must be tested for depleted uranium contamination at intervals not to exceed twelve months. The analysis must be capable of detecting the presence of one hundred eighty-five becquerels (0.005 microcurie) of radioactive material on the test sample and must be performed by a person specifically authorized by the director, the United States nuclear regulatory commission or an agreement state to perform the analysis. Should such testing reveal the presence of one hundred eighty-five becquerels (0.005 microcurie) or more of removable depleted uranium contamination, the exposure device must be removed from use until an evaluation of the wear of the S-tube has been made. Should the evaluation reveal that the S-tube is worn through, the device may not be used again. Depleted uranium shielded devices do not have to be tested for depleted uranium contamination while in storage and not in use. Before using or transferring such a device, however, the device must be tested for depleted uranium contamination, if the interval of storage has exceeded twelve months. A record of the depleted uranium leak-test must be made in accordance with paragraph (D) of rule 3701:1-48-23 of the Administrative Code.

Last updated July 10, 2025 at 12:13 PM

History

• Effective: January 1, 2012
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-49-07

(A) Each licensee who uses a sealed source shall have the source tested for leakage. The licensee shall keep a record of leak test results in units of microcuries and retain the record for inspection by the director for three years after the leak test is performed.

(B) The wipe of a sealed source must be performed using a leak test kit or method approved by the director, the United States nuclear regulatory commission or an agreement state. The wipe sample must be taken from the nearest accessible point to the sealed source where contamination might accumulate. The wipe sample must be analyzed for radioactive contamination. The analysis must be capable of detecting the presence of one hundred eighty-five becquerels (0.005 microcurie) of radioactive material on the test sample and must be performed by a person approved by the director, the United States nuclear regulatory commission or an agreement state to perform the analysis.

(C) Sealed sources must be tested at the following frequencies:

(1) Each sealed source (except an energy compensation source (ECS)) must be tested at intervals not to exceed six months. In the absence of a certificate from a transferor that a test has been made within the six months before the transfer, the sealed source may not be used until tested.

(2) Each ECS that is not exempt from testing in accordance with paragraph (E) of this rule must be tested at intervals not to exceed three years. In the absence of a certificate from a transferor that a test has been made within the three years before the transfer, the ECS may not be used until tested.

(D) If a sealed source is found to be leaking the licensee shall:

(1) If the test conducted pursuant to paragraphs (A) and (B) of this rule reveals the presence of one hundred eighty-five becquerels (0.005 microcurie) or more of removable radioactive material, the licensee shall remove the sealed source from service immediately and have it decontaminated, repaired, or disposed of by a United States nuclear regulatory commission or agreement state licensee that is authorized to perform these functions. The licensee shall check the equipment associated with the leaking source for radioactive contamination and, if contaminated, have it decontaminated or disposed of by a United States nuclear regulatory commission or agreement state licensee that is authorized to perform these functions.

(2) The licensee shall submit a report to the director within five days of receiving the test results. The report must describe the equipment involved in the leak, the test results, any contamination which resulted from the leaking source, and the corrective actions taken up to the time the report is made.

(E) The following sealed sources are exempt from the periodic leak test requirements set out in paragraphs (A) to (D) of this rule:

(1) Hydrogen-3 (tritium) sources;

(2) Sources containing licensed material with a half-life of thirty days or less;

(3) Sealed sources containing licensed material in gaseous form;

(4) Sources of beta- or gamma-emitting radioactive material with an activity of 3.7 megabecquerels (one hundred microcuries) or less; and

(5) Sources of alpha- or neutron-emitting radioactive material with an activity of three hundred seventy kilobecquerels (ten microcuries) or less.

Last updated November 2, 2022 at 2:40 PM

History

• Effective: September 1, 2012
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-52-22

(A) Each dry-source-storage sealed source must be tested for leakage at intervals not to exceed six months using a leak test kit or method approved by the United States nuclear regulatory commission, the director, or an agreement state. In the absence of a certificate from a transferor that a test has been made within the six months before the transfer, the sealed source may not be used until tested. The test must be capable of detecting the presence of one hundred eighty-five becquerels (0.005 microcurie) of radioactive material and must be performed by a person approved by the United States nuclear regulatory commission, the director, or an agreement state to perform the test.

(B) For pool irradiators, sources may not be put into the pool unless the licensee tests the sources for leaks or has a certificate from a transferor that a leak test has been done within the six months before the transfer. Water from the pool must be checked for contamination each day the irradiator operates. The check may be done either by using a radiation monitor on a pool water circulating system or by analysis of a sample of pool water. If a check for contamination is done by analysis of a sample of pool water, the results of the analysis must be available within twenty-four hours. If the licensee uses a radiation monitor on a pool water circulating system, the detection of above normal radiation levels must activate an alarm. The alarm set-point must be set as low as practical, but high enough to avoid false alarms. The licensee may reset the alarm set-point to a higher level if necessary to operate the pool water purification system to clean up contamination in the pool if specifically provided for in written emergency procedures.

(C) If a leaking source is detected, the licensee shall arrange to remove the leaking source from service and have it decontaminated, repaired, or disposed of by an organization licensed by the United States nuclear regulatory commission, the director, or an agreement state to perform these functions. The licensee shall promptly check its personnel, equipment, facilities, and irradiated product for radioactive contamination. No product may be shipped until the product has been checked and found free of contamination. If a product has been shipped that may have been inadvertently contaminated, the licensee shall arrange to locate and survey that product for contamination. If any personnel are found to be contaminated, decontamination must be performed promptly. If contaminated equipment, facilities, or products are found, the licensee shall arrange to have them decontaminated or disposed of by an organization licensed by the United States nuclear regulatory commission, the director, or an agreement state to perform these functions. If a pool is contaminated, the licensee shall arrange to clean the pool until the contamination levels do not exceed the appropriate concentration in accordance with table II of appendix C to rule 3701:1-38-12 of the Administrative Code, "Annual Limits on Intake (ALI) and Derived Air Concentrations (DAC) of Radionuclides for Occupational Exposure; Effluent Concentrations; Concentrations for Release to Sanitary Sewerage."

Last updated August 1, 2023 at 2:41 PM

History

• Effective: January 15, 2017
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-58-27

(A) A licensee in possession of any sealed source or brachytherapy source shall follow the radiation safety and handling instructions supplied by the manufacturer.

(B) A licensee in possession of a sealed source shall:

(1) Test the source for leakage before its first use unless the licensee has a certificate from the supplier indicating that the source was tested within six months before transfer to the licensee; and

(2) Test the source for leakage at intervals not to exceed six months or at other intervals approved by the director, United States nuclear regulatory commission, or an agreement state.

(C) To satisfy the leak test requirements of this rule, the licensee shall measure the sample so that the leak test can detect the presence of one hundred eighty-five becquerels (0.005 microcurie) of radioactive material in the sample.

(D) A licensee shall retain leak test records in accordance with paragraph (A) of rule 3701:1-58-80 of the Administrative Code.

(E) If the leak test reveals the presence of one hundred eighty-five becquerels (0.005 microcurie) or more of removable contamination, the licensee shall:

(1) Immediately withdraw the sealed source from use and store, dispose, or cause it to be repaired in accordance with the requirements in Chapter 3701:1-38 of the Administrative Code, and

(2) File a report within five days of the leak test in accordance with rule 3701:1-58-103 of the Administrative Code.

(F) A licensee need not perform a leak test on the following sources:

(1) Sources containing only radioactive material with a half-life of less than thirty days;

(2) Sources containing only radioactive material as a gas;

(3) Sources containing 3.7 megabecquerels (one hundred microcuries) or less of beta or gamma-emitting material or 0.37 megabecquerel (ten microcuries) or less of alpha-emitting material;

(4) Seeds of iridium-192 encased in nylon ribbon; and

(5) Sources stored and not being used. However, the licensee shall test each such source for leakage before any use or transfer unless it has been leak tested within six months before the date of use or transfer.

(G) A licensee in possession of sealed sources or brachytherapy sources, except for gamma stereotactic radiosurgery sources, shall conduct a semi-annual physical inventory of all such sources in its possession. The licensee shall retain each inventory record in accordance with paragraph (B) of rule 3701:1-58-80 of the Administrative Code.

Last updated November 18, 2022 at 8:32 AM

History

• Effective: October 4, 2010
• Promulgated Under: 119.03

Chapter 3701:1-40 Byproduct and Accelerator Produced Materials

Ohio Adm.Code 3701:1-40-01 Definitions.

Terms defined in rule 3701:1-38-01 of the Administrative Code shall have the same meaning when used in Chapter 3701:1-40 of the Administrative Code except terms redefined within a given rule for use within that rule only, and additionally, as used in Chapter 3701:1-40 of the Administrative Code:

(A) "Bureau assessment report" means a document prepared by the department that briefly provides evidence and analysis of whether there is an adverse radiological impact on human health or the human environment or whether there is no significant impact.

(B) "Categorical exclusion" means a category of actions which do not individually or cumulatively have a significant effect on human health or the human environment.

(C) "Environmental report" means a document submitted to the department by an applicant for a license, renewal, or amendment thereof, that aids the department in completing the bureau assessment report.

Last updated November 2, 2022 at 2:11 PM

History

• Effective: October 4, 2010
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-38-01

(A) As used in this chapter and all other rules promulgated pursuant to Chapter 3748. of the Revised Code:

(1) "A₁" means the maximum activity of special form radioactive material permitted in a type A package. These values are listed in rule 3701:1-50-25 of the Administrative Code, or may be derived in accordance with the procedure prescribed in rule 3701:1-50-25 of the Administrative Code.

(2) "A₂" means the maximum activity of radioactive material, other than special form, low specific activity and surface contaminated object material, permitted in a type A package. These values are listed in rule 3701:1-50-25 of the Administrative Code, or may be derived in accordance with the procedure prescribed in rule 3701:1-50-25 of the Administrative Code.

(3) "Absorbed dose" means the energy imparted by ionizing radiation per unit mass of irradiated material. The units of absorbed dose are the gray, or Gy, and the rad.

(4) "Accelerator or charged particle accelerator" means any of a class of radiation generating equipment designed to electronically accelerate atomic or sub-atomic particles for subsequent bombardment of targets.

(5) "Accelerator-produced radioactive material" means any material made radioactive by a particle accelerator.

(6) "Activity" means the rate of disintegration or transformation or decay of radioactive material. The units of activity are the becquerel, or Bq, and the curie, or Ci.

(7) "Address of use" means the building or buildings that are identified on the license or registration and where the source of radiation may be received, used, prepared, or stored, except for temporary job sites.

(8) "Administrative controls" means mechanisms used to protect health and minimize damage to life and property through the use of written policies, procedures, instructions, training, observation of work practices, and related compliance audits.

(9) "Administrative monetary penalty" means a monetary penalty assessed by the director under section 3748.05 of the Revised Code and in compliance with rules adopted thereunder, to emphasize the need for lasting remedial action and to deter future violations.

(10) "Adult" means an individual eighteen or more years of age.

(11) "Agreement state" means any state with which the United States nuclear regulatory commission or the atomic energy commission has entered into an effective agreement under subsection 274B of the Atomic Energy Act of 1954, 68 Stat. 919, 42 U.S.C. 2021, as amended (1978). Non-agreement state means any other state.

(12) "Airborne radioactive material" means radioactive material dispersed in the air in the form of dusts, fumes, particulates, mists, vapors, or gases.

(13) "Airborne radioactivity area" means a room, enclosure, or area in which airborne radioactive materials, composed wholly or partly of licensed material, exist in concentrations:

(a) In excess of the derived air concentrations (DACs) specified in appendix C to rule 3701:1-38-12 of the Administrative Code, or

(b) To such a degree that an individual present in the area without respiratory protective equipment could exceed, during the hours an individual is present in a week, an intake of 0.6 per cent of the annual limit on intake or twelve DAC-hours.

(14) "Air-purifying respirator" means a respirator with an air-purifying filter, cartridge, or canister that removes specific air contaminants by passing ambient air through the air-purifying element.

(15) "ALARA" or "as low as is reasonably achievable" means every reasonable effort to maintain exposures to radiation as far below the dose limits as is practical consistent with the purpose for which the licensed or registered activity is undertaken, taking into account the state of technology, the economics of improvements in relation to benefits to the public health and safety, and other societal and socioeconomic considerations, and in relation to utilization of nuclear energy and licensed materials and registered activities in the public interest.

(16) "Alert" means events may occur, are in progress, or have occurred that could lead to a release of radioactive material but that the release is not expected to require a response by off-site response organizations to protect persons off-site.

(17) "Annual limit on intake" or "ALI" means the derived limit for the amount of radioactive material taken into the body of an adult worker by inhalation or ingestion in a year. ALI is the smaller value of intake of a given radionuclide in a year by the reference man that would result in a committed effective dose equivalent of 0.05 sievert (five rem) or a committed dose equivalent of 0.5 sievert (fifty rem) to any individual organ or tissue. ALI values for intake by ingestion and by inhalation of selected radionuclides are given in appendix C to rule 3701:1-38-12 of the Administrative Code.

(18) "Annually" means either

(a) At intervals not to exceed one year; or

(b) Once per year, at about the same time each year, plus or minus one month.

(19) "Area of use" means a portion of an address of use that has been set aside for the purpose of receiving, preparing, using, or storing sources of radiation.

(20) "Assigned protection factor" or "APF" means the expected workplace level of respiratory protection that would be provided by a properly functioning respirator or a class of respirators to properly fitted and trained users. Operationally, the inhaled concentration can be estimated by dividing the ambient airborne concentration by the APF.

(21) "Atmosphere-supplying respirator" means a respirator that supplies the respirator user with breathing air from a source independent of the ambient atmosphere, and includes supplied air respirators, or SARs, and self-contained breathing apparatus, or SCBA, units.

(22) "Atomic energy commission" or "AEC" means the federal agency created by the Atomic Energy Act of 1954, 68 Stat. 919, 42 U.S.C. 2011, as amended (1964), and was the predecessor agency to the current United States nuclear regulatory commission.

(23) "Background radiation" means radiation from cosmic sources; naturally occurring radioactive materials, including radon, except as a decay product of source or special nuclear material, and global fallout as it exists in the environment from the testing of nuclear explosive devices or from past nuclear accidents such as Chernobyl that contribute to background radiation and are not under the control of the licensee. "Background radiation" does not include radiation from radioactive materials regulated by the department.

(24) "Becquerel" or "Bq" means the SI unit of activity. One becquerel is equal to one disintegration per second.

(25) "Bioassay" or "radiobioassay" means the determination of kinds, quantities or concentrations, and, in some cases, the locations of radioactive material in the human body, whether by direct measurement, in vivo counting, or by analysis and evaluation of materials excreted or removed from the human body.

(26) "Byproduct material" means

(a) Any radioactive material, except special nuclear material, yielded in or made radioactive by exposure to the radiation incident to the process of producing or utilizing special nuclear materials; or

(b) The tailings or wastes produced by the extraction or concentration of uranium or thorium from any ore processed primarily for its source material content, including discrete surface wastes resulting from solution extraction processes. Underground ore bodies depleted by such solution extraction do not constitute byproduct material within the definition.

(27) "Chelating agent" means a chemical compound or mixture that enhances the removal of radioactive material from the body, water or similar applications. Typical chelating agents include amine polycarboxylic acids such as EDTA or DTPA; hydroxy-carboxylic acids; and polycarboxylic acids such as citric acid, carbolic acid, and gluconic acid.

(28) "Chiropractor" means an individual licensed by the state of Ohio to practice chiropractic medicine pursuant to Chapter 4734. of the Revised Code.

(29) "Class" or "lung class" or "inhalation class" means a classification scheme for inhaled material according to its rate of clearance from the pulmonary region of the lung. Materials are classified as D, W, or Y, which applies to a range of clearance half-times: for class D, days, of less than ten days, for class W, weeks, from ten to one hundred days, and for class Y, years, of greater than one hundred days.

(30) "Collective dose" means the sum of the individual doses received in a given period of time by a specified population from exposure to a specified source of radiation.

(31) "Commencement of construction" means taking any action defined as "construction" or any other activity at the site of a facility subject to the rules promulgated pursuant to Chapter 3748. of the Revised Code that has a reasonable nexus to radiological health and safety.

(32) "Committed dose equivalent" or "H_T,50" means the dose equivalent to organs or tissues of reference, T, that will be received from an intake of radioactive material by an individual during the fifty year period following the intake.

(33) "Committed effective dose equivalent" or "H_E,50" means the sum of the products of the weighting factors applicable to each of the body organs or tissues, W_T, that are irradiated and the committed dose equivalent to each of these organs or tissues (H_{E, 50} = W_TH_T,50).

(34) "Consortium" means an association of medical use licensees and a PET radionuclide production facility in the same geographical area that jointly own or share in the operation and maintenance cost of the PET radionuclide production facility that produces PET radionuclides for use in producing radioactive drugs within the consortium for noncommercial distributions among its associated members for medical use. The PET radionuclide production facility within the consortium must be located at an educational institution or a medical facility.

(35) "Constraint" or "dose constraint" means a value above which specified licensee actions are required.

(36) "Construction" means the installation of foundations, or in-place assembly, erection, fabrication, or testing for any structure, system, or component of a facility or activity subject to the rules promulgated pursuant to Chapter 3748. of the Revised Code that are related to radiological safety or security. The term "construction" does not include:

(a) Changes for temporary use of the land for public recreational purposes;

(b) Site exploration, including necessary borings to determine foundation conditions or other preconstruction monitoring to establish background information related to the suitability of the site, the environmental impacts of construction or operation, or the protection of environmental values;

(c) Preparation of the site for construction of the facility, including clearing of the site, grading, installation of drainage, erosion and other environmental mitigation measures, and construction of temporary roads and borrow areas;

(d) Erection of fences and other access control measures that are not related to the safe use of, or security of, radiological materials subject to the rules promulgated pursuant to Chapter 3748. of the Revised Code;

(e) Excavation;

(f) Erection of support buildings (e.g. construction equipment storage sheds, warehouse and shop facilities, utilities, concrete mixing plants, docking and unloading facilities, and office buildings) for use in connection with the construction of the facility;

(g) Building of service facilities (e.g. paved roads, parking lots, railroad spurs, exterior utility and lighting systems, potable water systems, sanitary sewerage treatment facilities, and transmission lines);

(h) Procurement or fabrication of components or portions of the proposed facility occurring at other than the final, in-place location at the facility; or

(i) Taking any other action that has no reasonable nexus to radiological health and safety.

(37) "Controlled area" means an area, outside of a restricted area but inside the site boundary, access to which can be limited by the licensee or registrant for any reason.

(38) "Critical group" means the group of individuals reasonably expected to receive the greatest exposure to residual radioactivity for any applicable set of circumstances.

(39) "Curie" or "Ci" means a unit of activity. One curie equals 3.7 x 10¹⁰ disintegrations per second equals 3.7 x 10¹⁰ becquerels equals 2.22 x 10¹² disintegrations per minute.

(40) "Cyclotron" means a particle accelerator in which the charged particles travel in an outward spiral or circular path. A cyclotron accelerates charged particles at energies usually in excess of ten megaelectron volts and is commonly used for production of short half-life radionuclides for medical use.

(41) "Declared pregnant woman" means a woman who has voluntarily informed the licensee or registrant, in writing, of her pregnancy and the estimated date of conception. The declaration remains in effect until the declared pregnant woman withdraws the declaration in writing or is no longer pregnant.

(42) "Decommission" means to safely remove any licensed operation from service and reduce residual radioactivity to a level that permits release of the licensee's property for unrestricted use and termination of the license.

(43) "Dedicated check source" means a radioactive source that is used to assure the consistent performance of a radiation detection or measurement device over several months or years.

(44) "Deep dose equivalent" or "H_d" applies to external whole body exposure, and means the dose equivalent at a tissue depth of one centimeter, one thousand milligram per square centimeter.

(45) "Demand respirator" means an atmosphere-supplying respirator that admits breathing air to the facepiece only when a negative pressure is created inside the facepiece by inhalation.

(46) "Dentist" means an individual licensed by the state of Ohio to practice dentistry under Chapter 4715. of the Revised Code.

(47) "Department" means the Ohio department of health.

(48) "Depleted uranium" means uranium containing less uranium-235 than the naturally occurring distribution of uranium isotopes.

(49) "Derived air concentration" or "DAC" means the concentration of a given radionuclide in air which, if breathed by the reference man for a working year of two thousand hours under conditions of light work, results in an intake of one ALI. The condition of light work is inhaling 1.2 cubic meters of air per hour for two thousand hours in a year. DAC values are given in appendix C to rule 3701:1-38-12 of the Administrative Code.

(50) "Derived air concentration-hour or DAC-hour" means the product of the concentration of radioactive material in air, which is expressed as a fraction or multiple of the derived air concentration for each radionuclide, and the time of exposure to that radionuclide, in hours. A licensee or registrant may take two thousand DAC-hours to represent one ALI, equivalent to a committed effective dose equivalent of 0.05 Sv (five rem).

(51) "Direct reading dosimeter" means a device that measures radiation dose that does not require another device to read the measured radiation dose. Examples of direct reading dosimeters include pocket dosimeters and electronic dosimeters.

(52) "Director" means the director of health or a designee or authorized representative of the director.

(53) "Discipline" means a branch of knowledge or of teaching.

(54) "Discrete source" means a radionuclide that has been processed so that its concentration within a material has been purposely increased for use for commercial, medical, or research activities.

(55) "Disposable respirator" means a respirator for which maintenance is not intended and that is designed to be discarded after excessive breathing resistance, sorbent exhaustion, physical damage, or end-of service-life renders it unsuitable for use. Examples of this type of respirator are a disposable half-mask respirator or a disposable escape-only self-contained breathing apparatus.

(56) "Dose" or "radiation dose" is a generic term that means absorbed dose, dose equivalent, effective dose equivalent, committed effective dose equivalent, or total effective dose equivalent as defined in other paragraphs of this rule.

(57) "Dose equivalent" or "H_T" means the product of the absorbed dose in tissue, quality factor, and all other necessary modifying factors at the location of interest. The units of dose equivalent are the sievert and rem.

(58) "Dose limits" or "limits" means the permissible upper bounds of radiation doses established in accordance with these regulations but excludes background radiation and medical exposure.

(59) "Dosimetry processor" means a person that processes and evaluates individual monitoring devices in order to determine the radiation dose delivered to the monitoring devices.

(60) "Effective dose equivalent" or "H_E" means the sum of the products of the dose equivalent to each organ or tissue, H_T, and the weighting factor, W_T, applicable to each of the body organs or tissues that are irradiated: (H_E = ∑W_TH_T).

(61) "Embryo" or "fetus" means the developing human organism from conception until time of birth.

(62) "Engineering controls" means mechanisms used to protect health and minimize damage to life and property through engineering specifications, design, and construction of the product or facility including all of the security and safety features. This includes, but is not limited to, auxiliary security and safety features such as additional external shielding, barriers, and operational interlocks with associated processes.

(63) "Entrance" or "access point" means any opening through which an individual or extremity of an individual could gain access to radiation areas or to licensed radioactive materials or registered radiation generating equipment. This includes entry or exit portals of sufficient size to permit human entry, irrespective of their intended use.

(64) "Explosive material" means any chemical compound, mixture or device which produces a substantial instantaneous release of gas and heat spontaneously or by contact with sparks or flame.

(65) "Exposure" means being exposed to sources of ionizing radiation.

(66) "External dose" means that portion of the dose equivalent received from radiation sources outside the body.

(67) "Extremity" means hand, elbow, arm below the elbow, foot, knee, or leg below the knee.

(68) "Eye dose equivalent" means the same as lens dose equivalent.

(69) "Facility" means all buildings, equipment, structures and other stationary items that, in addition to the meaning defined in division (H) of section 3748.01 of the Revised Code, are:

(a) Located on a single site or on contiguous or adjacent sites and are operated by the same person and have common corporate or business interests; or

(b) Portions of a building or structure which are operated by the same person and have common corporate or business interests.

(70) "Filtering facepiece" or "dust mask" means a negative pressure particulate respirator with a filter as an integral part of the facepiece or with the entire facepiece composed of the filtering medium, not equipped with elastomeric sealing surfaces and adjustable straps.

(71) "Fissile material" means the radionuclides uranium-233, uranium-235, plutonium-239, and plutonium-241, or any combination of these radionuclides. Fissile material means the fissile nuclides themselves, not material containing fissile nuclides. Unirradiated natural uranium and depleted uranium and natural uranium or depleted uranium that has been irradiated in thermal reactors only, are not included in this definition. Certain exclusions from fissile material controls are provided in rule 3701:1-50-13 of the Administrative Code.

(72) "Fit factor" means quantitative estimate of the fit of a particular respirator to a specific individual, and typically estimates the ratio of the concentration of a substance in ambient air to its concentration inside the respirator when worn.

(73) "Fit test" means the use of a protocol to qualitatively or quantitatively evaluate the fit of a respirator on an individual.

(74) "Generally applicable environmental radiation standards" means standards issued by the United States environmental protection agency under the authority of the Atomic Energy Act of 1954, 68 Stat. 919, 42 U.S.C. 2011, as amended (2005), that impose limits on radiation exposures or levels, or concentrations or quantities of radioactive material, in the general environment outside the boundaries of locations under the control of persons possessing or using radioactive material.

(75) "Gray" or "Gy" means the SI unit of absorbed dose. One gray is equal to an absorbed dose of one joule per kilogram (one hundred rads).

(76) "Handle" means receive, possess, use, store, transfer, install, service, or dispose of sources of radiation unless possession is solely for the purpose of transportation.

(77) "Handler" means a facility that handles sources of radiation unless possession is solely for the purpose of transportation.

(78) "Hazardous waste" means those wastes designated as hazardous by rule 3745-51-03 of the Administrative Code.

(79) "Helmet" means a rigid respiratory inlet covering that also provides head protection against impact and penetration.

(80) "High radiation area" means an area, accessible to individuals, in which radiation levels from radiation sources external to the body could result in an individual receiving a dose equivalent in excess of one millisievert (0.1 rem) in one hour at thirty centimeters from the radiation source or thirty centimeters from any surface that the radiation penetrates.

(81) "Hood" means a respiratory inlet covering that completely covers the head and neck and may also cover portions of the shoulders and torso.

(82) "Individual" means any human being.

(83) "Individual monitoring" means

(a) The assessment of dose equivalent by the use of devices designed to be worn by an individual;

(b) The assessment of committed effective dose equivalent by bioassay or by determination of the time-weighted air concentrations to which an individual has been exposed, i.e. DAC-hours; or

(c) The assessment of dose equivalent by the use of survey data.

(84) "Individual monitoring devices" means devices designed to be worn by a single individual for the assessment of dose equivalent such as film badges; thermoluminescent dosimeters; optically stimulated luminescent dosimeters; pocket ionization chambers; and personal air sampling devices.

(85) "Industrial radiography" means the examination of the structure of materials by nondestructive methods, utilizing sealed sources of radioactive material or radiation-generating equipment.

(86) "Internal dose" means that portion of the dose equivalent received from radioactive material taken into the body.

(87) "Irradiator" means a facility that uses radioactive sealed sources for the irradiation of objects or materials and in which radiation dose rates exceeding five grays (five hundred rads) per hour exist at one meter from the sealed radioactive source in air or water, as applicable for the irradiator type, but does not include irradiators in which both the sealed source and the area subject to irradiation are contained within a device and are not accessible to personnel.

(88) "Lens dose equivalent" or "eye dose equivalent" means the external exposure of the lens of the eye and is taken as the dose equivalent at a tissue depth of 0.3 centimeters; i.e. three hundred milligrams per square centimeter.

(89) "License" means a license issued by the nuclear regulatory commission, the director, or another agreement state in accordance with rules adopted by those organizations.

(90) "Licensee" means a person to whom a license is issued.

(91) "Licensed activity" means an activity authorized by a radioactive material license which is essential to achieving the purpose for which the license was issued or amended.

(92) "Licensed material" means radioactive material received, possessed, used, transferred or disposed of under a general or specific license.

(93) "Loose-fitting facepiece" means a respiratory inlet covering that is designed to form a partial seal with the face.

(94) "Lost or missing licensed source of radiation" means a licensed source of radiation whose location is unknown. It includes material that has been shipped but has not reached its destination and whose location cannot be readily traced in the transportation system.

(95) "Low-level radioactive waste" or "LLRW," also "low-level waste," or "LLW" means radioactive waste which is not high-level radioactive waste, spent nuclear fuel, NARM, or byproduct material as defined in section 11 E. (2) of the Atomic Energy Act of 1954 68 Stat. 919, 42 U.S.C. 2011, as amended (2005), but is radioactive material that the United States nuclear regulatory commission classifies as low-level radioactive waste.

(96) "Low specific activity material" or "LSA" means radioactive material with limited specific activity which is nonfissile or is excepted under rule 3701:1-50-13 of the Administrative Code, and which satisfies the descriptions and limits set forth below. Shielding materials surrounding the LSA material may not be considered in determining the estimated average specific activity of the package contents. LSA must be in one of three groups:

(a) LSA - I.

(i) Uranium and thorium ores, concentrates of uranium and thorium ores, and other ores containing naturally occurring radioactive radionuclides that are intended to be processed for the use of these radionuclides;

(ii) Natural uranium, depleted uranium, natural thorium or their compounds or mixtures, provided they are unirradiated and in solid or liquid form;

(iii) Radioactive material other than fissile material, for which the A₂ value is unlimited; or

(iv) Other radioactive material in which the activity is distributed throughout and the estimated average specific activity does not exceed thirty times the value for exempt material activity concentration determined in accordance with rule 3701:1-50-25 of the Administrative Code.

(b) LSA-II.

(i) Water with tritium concentration up to 0.8 terabecquerels per liter (twenty curies per liter); or

(ii) Other material in which the activity is distributed throughout and the estimated average specific activity does not exceed ( 10^-4 A₂) per gram for solids and gases, and (10^-5 A₂) per gram for liquids.

(c) LSA-III. Solids (e.g., consolidated wastes, activated materials), excluding powders, that satisfy the requirements of 10 C.F.R. 71.77 (as in effect on the effective date of this rule), in which:

(i) The radioactive material is distributed throughout a solid or a collection of solid objects, or is essentially uniformly distributed in a solid compact binding agent (such as concrete, bitumen, ceramic, etc.);

(ii) The radioactive material is relatively insoluble, or it is intrinsically contained in a relatively insoluble material, so that even under loss of packaging, the loss of radioactive material per package by leaching, when placed in water for seven days, would not exceed (0.1 x A₂); and

(iii) The estimated average specific activity of the solid, excluding any shielding material, does not exceed (0.002 x A₂) per gram.

(97) "Management" means the chief executive officer or other individual having the authority to manage, direct, or administer the licensee's activities, or those persons' delegate or delegates.

(98) "Medical institution" means an organization in which more than one medical discipline is practiced.

(99) "Medical use" means the intentional internal or external administration of radioactive material or the radiation therefrom to patients or human research subjects under the supervision of an authorized user.

(100) "Member of the public" means any individual except when that individual is receiving an occupational dose.

(101) "Minor" means an individual less than eighteen years of age.

(102) "Monitoring" or "radiation monitoring" or "radiation protection monitoring" means the measurement of radiation levels, concentrations, surface area concentrations or quantities of radioactive material and the use of the results of these measurements to evaluate potential exposures and doses.

(103) "NARM" or "naturally occurring or accelerator-produced radioactive material" means naturally occurring or accelerator-produced radioactive material, including naturally occurring material that is technologically enhanced, and those nuclides that are generated in a charged particle accelerator, but does not include source material, byproduct material, or special nuclear material.

(104) "NARM licensing state" means any state with regulations equivalent to the suggested state regulations for control of radiation relating to, and an effective program for, the regulatory control of NARM and which has been granted final designation by the conference of radiation control program directors, inc.

(105) "Nationally tracked source" means a sealed source containing a quantity equal to or greater than "Category 1" or "Category 2" levels of any radioactive material listed in the appendix to rule 3701:1-38-25 of the Administrative Code. In this context a sealed source is defined as radioactive material that is sealed in a capsule or closely bonded, in a solid form and which is not exempt from regulatory control. It does not mean material encapsulated solely for disposal, or nuclear material contained in any fuel assembly, subassembly, fuel rod, or fuel pellet. "Category 1" nationally tracked sources are those containing radioactive material at a quantity equal to or greater than the "Category 1" threshold. "Category 2" nationally tracked sources are those containing radioactive material at a quantity equal to or greater than the "Category 2" threshold but less than the "Category 1" threshold.

(106) "Negative pressure respirator" or "tight fitting respirator" means a respirator in which the air pressure inside the facepiece is negative during inhalation with respect to the ambient air pressure outside the respirator.

(107) "Nonstochastic effect" or "deterministic effect" means health effects, the severity of which varies with the dose and for which a threshold is believed to exist. Radiation-induced cataract formation is an example of a nonstochastic effect.

(108) "NORM" or "naturally occurring radioactive material" means any nuclide that is radioactive in its natural physical state, but does not include source material, byproduct material, or special nuclear material.

(109) "Normal form radioactive material" means radioactive material that has not been demonstrated to qualify as special form radioactive material.

(110) "Nuclear regulatory commission" means the federal agency established by Title II of the Energy Reorganization Act of 1974, 88 Stat. 1233, 42 U.S.C.A. 5801, as amended (2005), comprising the members of the commission and all offices, employees, and representatives authorized to act in any case or matter related to licensing and related regulatory function previously assigned to the AEC.

(111) "Occupational dose" means the dose received by an individual in the course of employment in which the individual's assigned duties involve exposure to radiation or radioactive material from licensed and unlicensed sources of radiation, whether in the possession of the licensee or other person. Occupational dose does not include doses received from background radiation, from any medical administration the individual has received, from exposures to individuals administered radioactive materials and released in accordance with rule 3701:1-58-30 of the Administrative Code or equivalent United States nuclear regulatory commission or agreement state regulations, from voluntary participation in medical research programs, or as a member of the public.

(112) "Package" means the packaging together with its radioactive contents as presented for transport.

(a) Fissile material package or type AF package, type BF package, type B(U)F package, or type B(M)F package means a fissile material packaging together with its fissile material contents.

(b) Type A package means a type A packaging together with its radioactive contents. A type A package is defined and must comply with the United States department of transportation regulations in 49 C.F.R. 173 (as in effect on the effective date of this rule).

(c) Type B package means a type B packaging together with its radioactive contents. On approval, a type B package design is designated by the United States nuclear regulatory commission as B(U) unless the package has a maximum normal operating pressure of more than seven hundred kilopascals (one hundred pounds per square inch) gauge or a pressure relief device that would allow the release of radioactive material to the environment under the tests specified in 10 C.F.R. 71.73 (hypothetical accident conditions) (as in effect on the effective date of this rule), in which case it will receive a designation B(M). B(U) refers to the need for unilateral approval of international shipments; B(M) refers to the need for multilateral approval of international shipments. There is no distinction made in how packages with these designations may be used in domestic transportation. To determine their distinction for international transportation, see United States department of transportation regulations in 49 C.F.R. 173 (as in effect on the effective date of this rule). A type B package approved before September 6, 1983, was designated only as type B. Limitations on its use are specified in 10 C.F.R. 71.19 (as in effect on the effective date of this rule).

(113) "Packaging" means the assembly of components necessary to ensure compliance with the packaging requirements of rule 49 C.F.R. 173 Subpart I (as in effect on the effective date of this rule). It may consist of one or more receptacles, absorbent materials, spacing structures, thermal insulation, radiation shielding, and devices for cooling or absorbing mechanical shocks. The vehicle, tie-down system and auxiliary equipment may be designated as part of the packaging.

(114) "Particle accelerator" means any machine capable of accelerating electrons, protons, deuterons, or other charged particles in a vacuum and of discharging the resultant particulate or other radiation into a medium at energies usually in excess of one megaelectron volt. For purposes of this definition, "accelerator" is an equivalent term.

(115) "Person" means any individual, corporation, association, business enterprise, or other legal entity either public or private and any legal successor, representative, agent, or agency of that individual, corporation, association, business enterprise, or other legal entity. Person also includes the United States, states, political subdivisions of states, and any department, agency, or instrumentality of the United States or a state, except the U.S. department of energy or the U.S. nuclear regulatory commission where the state regulation of radioactive material by either of those agencies is prohibited by federal law.

(116) "Personnel dosimeter", means a device that measures radiation dose that is processed and evaluated by an accredited "National Voluntary Laboratory Accreditation Program" (NVLAP) processor. Examples of personnel dosimeters include film badges, thermo-luminescent dosimeters (TLD), and optically stimulated luminescence (OSL) dosimeters.

(117) "Pharmacist" means a person who is licensed by the state of Ohio to practice pharmacy pursuant to Chapter 4731. of the Revised Code.

(118) "Physician" means a person who is licensed pursuant to Chapter 4731. of the Revised Code to practice medicine or surgery or osteopathic medicine or surgery.

(119) "Planned special exposure" means an infrequent exposure to radiation, separate from and in addition to the annual dose limits.

(120) "Podiatrist" means an individual licensed by the state of Ohio to practice podiatry pursuant to Chapter 4731. of the Revised Code.

(121) "Positive pressure respirator" means a respirator in which the pressure inside the respiratory inlet covering exceeds the ambient air pressure outside the respirator.

(122) "Positron Emission Tomography (PET) radionuclide production facility" means a facility operating a cyclotron or accelerator for the purpose of producing PET radionuclides.

(123) "Powered air-purifying respirator" or "PAPR" means an air-purifying respirator that uses a blower to force the ambient air through air purifying elements to the inlet covering.

(124) "Pressure demand respirator" means a positive pressure atmosphere supplying respirator that admits breathing air to the facepiece when the positive pressure is reduced inside the facepiece by inhalation.

(125) "Public dose" means the dose received by a member of the public from exposure to radiation and/or radioactive material released by the licensee, or to any other source of radiation under the control of a licensee or registrant. Public dose does not include occupational dose or doses received from background radiation, from any medical administration the individual has received, from exposures to individuals administered radioactive materials and released in accordance with rule 3701:1-58-30 of the Administrative Code or equivalent United States nuclear regulatory commission or agreement state regulations, or from voluntary participation in medical research programs.

(126) "Pyrophoric material" means any liquid that ignites spontaneously in dry or moist air at or below 54.4 degrees celsius (one hundred thirty degrees fahrenheit). A pyrophoric solid is any solid material, other than one classed as an explosive, which under normal conditions is liable to cause fires through friction, retained heat from manufacturing or processing, or which can be ignited readily and when ignited burns so vigorously and persistently as to create a serious transportation, handling, or disposal hazard. Included are spontaneously combustible and water-reactive materials.

(127) "Qualitative fit test" or "QLFT" means a pass/fail fit test to assess the adequacy of respirator fit that relies on the individual's response to the test agent.

(128) "Quality factor" or "Q" means the modifying factor, as listed in paragraphs (A) and (B) of rule 3701:1-38-11 of the Administrative Code, that is used to derive dose equivalent from absorbed dose.

(129) "Quantitative fit test" or "QNFT" means an assessment of the adequacy of respirator fit by numerically measuring the amount of leakage into the respirator.

(130) "Quarter" or "quarterly" means a period of time equal to one-fourth of the year observed by the licensee or registrant, approximately thirteen consecutive weeks, providing that the beginning of the first quarter in a year coincides with the starting date of the year and that no day is omitted or duplicated in consecutive quarters.

(131) "Rad" means the special unit of radiation absorbed dose. One rad is equal to an absorbed dose of one hundred ergs per gram, or 0.01 joule per kilogram, or 0.01 gray.

(132) "Radiation" or "ionizing radiation" means alpha particles, beta particles, gamma rays, x-rays, neutrons, high speed electrons, high speed protons, and other particles capable of producing ions. Radiation does not include nonionizing radiation, such as radio or microwaves, or visible, infrared or ultraviolet light.

(133) "Radiation area" means an area, accessible to individuals, in which radiation levels could result in an individual receiving a dose equivalent in excess of 0.05 millisievert (0.005 rem) in one hour at thirty centimeters from the source of radiation or from any surface that the radiation penetrates.

(134) "Radiation-generating equipment" or "RGE" means any manufactured product or device, or component of such a product or device, or any machine or system that during operation can generate or emit radiation, except those that emit radiation only from radioactive material. "Radiation-generating equipment" does not include either of the following:

(a) Diathermy machines;

(b) Microwave ovens, including food service microwave ovens used for commercial and industrial uses, television receivers, electric lamps, and other household appliances and products that generate very low levels of radiation.

(135) "Radiation Safety Officer" or "RSO" means an individual designated by the licensee who has the knowledge and responsibility for the overall radiation safety program at the facility, to include the implementation of the daily radiation safety operations and compliance with the rules.

(136) "Radioactive material" means any solid, liquid or gaseous material that emits ionizing radiation spontaneously. "Radioactive material" includes accelerator-produced and naturally occurring radioactive materials and byproduct, source, and special nuclear material.

(137) "Radioactive waste" means waste containing regulated radioactive material.

(138) "Radioactivity" means the transformation of unstable atoms by the emission of radiation.

(139) "Radiography" means the same as industrial radiography.

(140) "Reference man" means a hypothetical aggregation of human physical and physiological characteristics arrived at by international consensus. These characteristics may be used by researchers and public health workers to standardize results of experiments and to relate biological insult to a common base.

(141) "Registrant" means a person required by Chapter 3748. of the Revised Code to register radiation-generating equipment with the director.

(142) "Rem" means the special unit of any of the quantities expressed as dose equivalent. The dose equivalent in rem is equal to the absorbed dose in rads multiplied by the quality factor (one rem = 0.01 Sv).

(143) "Research and development" means

(a) Theoretical analysis, exploration, or experimentation; or

(b) The extension of investigative findings and theories of a scientific or technical nature into practical application for experimental and demonstration purposes, including the experimental production and testing of models, devices, equipment, materials and processes. "Research and development" does not include the internal or external administration of sources of radiation to human beings.

(144) "Residual radioactivity" means radioactivity in structures, materials, soils, groundwater, and other media at a site resulting from activities under the licensee's control. This includes radioactivity from all licensed and unlicensed sources used by the licensee, but excludes background radiation. It also includes radioactive materials remaining at the site as a result of routine or accidental releases of radioactive material at the site and previous burials at the site, even if those burials were made in accordance with the provisions of 10 C.F.R. 20 (as in effect on the effective date of this rule).

(145) "Respiratory protective equipment or device" means an apparatus, such as a respirator, used to reduce the individual's intake of airborne radioactive materials.

(146) "Restricted area" means an area access to which is limited by the licensee or registrant for the purpose of protecting individuals against undue risks from exposure to sources of radiation. Restricted area does not include areas used as residential quarters, but separate rooms in a residential building may be set apart as a restricted area.

(147) "Roentgen" means the amount of gamma or x-rays required to produce ions resulting in a charge of 0.000258 coulombs per kilogram of air under standard conditions.

(148) "Sanitary sewerage" means a system of public sewers for carrying off wastewater and refuse, but excluding sewage treatment facilities, septic tanks, and leach fields owned or operated by the licensee.

(149) "Sealed source" means radioactive material that is encased in a manner designed to prevent leakage or escape of the radioactive material.

(150) "Sealed source and device registry" means the national registry that contains all the registration certificates, generated by both the United States nuclear regulatory commission and the agreement states, that summarize the radiation safety information for the sealed sources and devices and describe the licensing and use conditions approved for the product.

(151) "Seismic area" means any area where the probability of a horizontal acceleration in rock of more than 0.3 times the acceleration of gravity in two hundred fifty years is greater than ten per cent, as designated by the United States geological survey.

(152) "Self-contained breathing apparatus" or "SCBA" means an atmosphere-supplying respirator for which the breathing air source is designed to be carried by the user.

(153) "Shallow dose equivalent" or "H_S" means the external exposure of the skin of the whole body or the skin of an extremity, is taken as the dose equivalent at a tissue depth of 0.007 centimeter, or seven milligrams per square centimeter.

(154) "Sievert" or "Sv" means the SI unit of any of the quantities expressed as dose equivalent. The dose equivalent in sieverts is equal to the absorbed dose in grays multiplied by the quality factor. One sievert equals one hundred rem.

(155) "Site area emergency" means events may occur, are in progress, or have occurred that could lead to a significant release of radioactive material and that could require a response by off-site response organizations to protect persons off-site.

(156) "Site boundary" means that line beyond which the land or property is not owned, leased, or otherwise controlled by the licensee or registrant.

(157) "Site closure and stabilization" means those actions that are taken upon completion of operations that prepare a disposal site for custodial care and that assure that the disposal site will remain stable and will not need ongoing active maintenance.

(158) "Source material" means uranium, thorium, or any combination thereof in any physical or chemical form, or any ores that contain by weight at least one-twentieth of one per cent (0.05 per cent) of uranium, thorium, or any combination thereof. Source material does not include special nuclear material.

(159) "Sources of radiation" means radioactive material or radiation generating equipment.

(160) "Special form radioactive material" means radioactive material that satisfies the following conditions:

(a) It is either a single solid piece or is contained in a sealed capsule that can be opened only by destroying the capsule;

(b) The piece or capsule has at least one dimension not less than five millimeters (0.2 inch); and

(c) It satisfies the test requirements specified by the United States nuclear regulatory commission in 10 C.F.R. 71.75 (as in effect on the effective date of this rule). A special form encapsulation designed in accordance with the United States nuclear regulatory commission requirements identified in 10 C.F.R. 71.4, in effect on June 30, 1983, and constructed prior to July 1, 1985; a special form encapsulation designed in accordance with the requirements of 10 C.F.R. 71.4 in effect on March 31, 1996, and constructed before April 1, 1998; and special form material that was successfully tested before September 10, 2015 in accordance with the requirements of 10 C.F.R. 71.75(d) of this section in effect before September 10, 2015 may continue to be used. Any other special form encapsulation must meet the specifications of this definition.

(161) "Special nuclear material" means either of the following:

(a) Plutonium, uranium-233, uranium enriched in the isotope 233, or in the isotope 235, and any other material that the United States nuclear regulatory commission determines to be special nuclear material, but does not include source material pursuant to section 51 of the Atomic Energy Act of 1954, 68 Stat 919, 42 USCA 2071, as amended (2005).

(b) Any material artificially enriched by any of the foregoing but does not include source material.

(162) "Special nuclear material in quantities not sufficient to form a critical mass" means uranium enriched in the isotope uranium-235 in quantities not exceeding three hundred fifty grams of contained uranium-235; uranium-233 in quantities not exceeding two hundred grams; plutonium in quantities not exceeding two hundred grams; or any combination of them in accordance with the following formula: for each kind of special nuclear material, determine the ratio between the quantity of that special nuclear material and the quantity specified in this paragraph for the same kind of special nuclear material. The sum of such ratios for all of the kinds of special nuclear material in combination shall not exceed unity.

(163) "Stochastic effect" means health effects that occur randomly and for which the probability of the effect occurring, rather than its severity, is assumed to be a linear function of dose without threshold. Hereditary effects and cancer incidence are examples of stochastic effects.

(164) "Supplied-air respirator" or "SAR" or "airline respirator" means an atmosphere-supplying respirator for which the source of breathing air is not designed to be carried by the user.

(165) "Surface contaminated object" or "SCO" means a solid object that is not itself classed as radioactive material, but which has radioactive material distributed on any of its surfaces. SCO must be in one of two groups with surface activity not exceeding the following limits:

(a) SCO-I: a solid object on which:

(i) The non-fixed contamination on the accessible surface averaged over three hundred square centimeters, or the area of the surface if less than three hundred square centimeters, does not exceed four becquerels per square centimeter (10^-4 microcurie per square centimeter) for beta and gamma and low toxicity alpha emitters, or 0.4 becquerels per square centimeter 10^-5 microcurie per square centimeter) for all other alpha emitters;

(ii) The fixed contamination on the accessible surface averaged over three hundred square centimeters, or the area of the surface if less than three hundred square centimeters, does not exceed forty thousand becquerels per square centimeter (one microcurie per square centimeter) for beta and gamma and low toxicity alpha emitters, or four thousand becquerels per square centimeter (0.1 microcurie per square centimeter) for all other alpha emitters; and

(iii) The non-fixed contamination plus the fixed contamination on the inaccessible surface averaged over three hundred square centimeters, or the area of the surface if less than three hundred square centimeters, does not exceed forty thousand becquerels per square centimeter (one microcurie per square centimeter) for beta and gamma and low toxicity alpha emitters, or four thousand becquerels per square centimeter (0.1 microcurie per square centimeter) for all other alpha emitters.

(b) SCO-II: a solid object on which the limits for SCO-I are exceeded and on which:

(i) The non-fixed contamination on the accessible surface averaged over three hundred square centimeters, or the area of the surface if less than three hundred square centimeter, does not exceed four hundred becquerels per square centimeter (10^-2 microcurie per square centimeter) for beta and gamma and low toxicity alpha emitters, or forty becquerels per square centimeter (10^-3 microcurie per square centimeter) for all other alpha emitters;

(ii) The fixed contamination on the accessible surface averaged over three hundred square centimeters, or the area of the surface if less than three hundred square centimeters, does not exceed eight hundred thousand becquerels per square centimeter (twenty microcuries per square centimeter) for beta and gamma and low toxicity alpha emitters, or eighty thousand becquerels per square centimeter (two microcuries per square centimeter) for all other alpha emitters; and

(iii) The non-fixed contamination plus the fixed contamination on the inaccessible surface averaged over three hundred square centimeters, or the area of the surface if less than three hundred square centimeters, does not exceed eight hundred thousand becquerels per square centimeter (twenty microcuries per square centimeter) for beta and gamma and low toxicity alpha emitters, or eighty thousand becquerels per square centimeter (two microcuries per square centimeter) for all other alpha emitters.

(166) "Survey" means an evaluation of the radiological conditions and potential hazards incident to the production, use, transfer, release, disposal or presence of radioactive material or other sources of radiation. When appropriate, such an evaluation includes a physical survey of the location of radioactive material, or the sources of radiation and measurements or calculations of levels of radiation, or concentrations or quantities of radioactive material present.

(167) "Tight-fitting facepiece" means a respiratory inlet covering that forms a complete seal with the face.

(168) "Total effective dose equivalent" or "TEDE" means the sum of the effective dose equivalent (for external exposures) and the committed effective dose equivalent (for internal exposures).

(169) "Transport index" means the dimensionless number, rounded up to the next tenth, placed on the label of a package, to designate the degree of control to be exercised by the carrier during transportation. The transport index is the number determined by multiplying the maximum radiation level in millisievert per hour at one meter (3.3 feet) from the external surface of the package by one hundred, which is equivalent to the maximum radiation level in millirem per hour at one meter (3.3 feet).

(170) "Type A quantity" means a quantity of radioactive material, the aggregate radioactivity of which does not exceed A₁ for special form radioactive material, or A₂ for normal form radioactive material, where A₁ and A₂ are given in rule 3701:1-50-25 of the Administrative Code.

(171) "Type B quantity" means a quantity of radioactive material greater than a type A quantity.

(172) "Type B package" is defined under "Package."

(173) "United States department of energy" means the department of energy established by the Department of Energy Organization Act, PL 95-91, 91 Stat. 565 (1977), 42 U.S.C. 7101 et seq., as amended (2006), to the extent that the department of energy or its duly authorized representatives, exercises functions formerly vested in the United States atomic energy commission, its chairman, members, officers and components and transferred to the United States energy research and development administration and to the administrator thereof pursuant to Sections 104(b) to (d) of the Energy Reorganization Act of 1974, PL 93-438, 88 Stat. 1233 at 1237 (1974), 42 U.S.C. 5814 and retransferred to the secretary of energy pursuant to Section 301(a) of the Department of Energy Organization Act, PL 95-91, 91 Stat. 565 at 577-578 (1977), 42 U.S.C. 7151.

(174) "Unrestricted area" or "uncontrolled area" means any area, access to which is neither restricted nor controlled by the licensee or registrant.

(175) "User seal check" or "fit check" means an action conducted by the respirator user to determine if the respirator is properly seated to the face. Examples include negative pressure check, positive pressure check, irritant smoke check, or isoamyl acetate check.

(176) "Very high radiation area" means an area, accessible to individuals, in which radiation levels from radiation sources external to the body could result in an individual receiving an absorbed dose in excess of five gray (five hundred rad) in one hour at one meter from a source of radiation or from any surface that the radiation penetrates. At very high doses received at high dose rates, units of absorbed dose, gray and rad, are appropriate, rather than units of dose equivalent, sievert and rem.

(177) "Veterinarian" means an individual licensed by the state of Ohio to practice veterinary medicine pursuant to Chapter 4741. of the Revised Code.

(178) "Waste" means those low-level radioactive wastes containing source, special nuclear, or byproduct material that are acceptable for disposal in a land disposal facility. For the purposes of this definition, low-level radioactive waste means radioactive waste not classified as high-level radioactive waste, transuranic waste, spent nuclear fuel, or byproduct material as defined in paragraph (A)(26)(b) of this rule, or byproduct material as defined in section 11 E. (3) and (4) of the Atomic Energy Act of 1954, 68 Stat. 919, 42 USC 2014, as amended (2005).

(179) "Week" means seven consecutive days starting on Sunday.

(180) "Weighting factor

• W_T" for an organ or tissue, (T), is the proportion of the risk of stochastic effects resulting from irradiation of that organ or tissue to the total risk of stochastic effects when the whole body is irradiated uniformly. For calculating the effective dose equivalent, the values of W_T are:

| Organ doseweighting factors | | | --- | --- | | Organ ortissue | W_T | | Gonads | 0.25 | | Breast | 0.15 | | Red bone marrow | 0.12 | | Lung | 0.12 | | Thyroid | 0.03 | | Bonesurfaces | 0.03 | | Remainder | 0.30^a | | Whole body | 1.00^b |

^\a 0.30 results from 0.06 for each of five "remainder" organs, excluding the skin and the lens of the eye, that receive the highest doses.

^\b for the purpose of weighting the external whole body dose (for adding it to the internal dose) a single weighting factor, W_T = 1.0, has been specified. The use of other weighting factors for external exposure will be approved on a case-by-case basis until such time as specific guidance is issued.

(181) "Whole body" means for purposes of external exposure, head; trunk, including male gonads; arms above the elbow; legs above the knee.

(182) "Worker" means an individual engaged in activities licensed or registered by the department and controlled by a licensee or registrant, but does not include the licensee or registrant.

(183) "Working level" or "WL" means any combination of short-lived radon decay products (for radon-222: polonium-218, lead-214, bismuth-214, and polonium-214; and for radon-220: polonium-216, lead-212, bismuth-212, and polonium-212) in one liter of air that will result in the ultimate emission of 1.3 x 10⁵ million electron volts alpha particle energy.

(184) "Working level month" or "WLM" means a cumulative exposure to one working level for one hundred seventy hours. (Two thousand working hours per year/twelve months per year equals approximately one hundred seventy hours per month.)

(185) "Year" means the period of time beginning in January used to determine compliance with the provisions of this rule. The licensee or registrant may change the starting date of the year used to determine compliance by the licensee or registrant provided that the change is made at the beginning of the year and that no day is omitted or duplicated in consecutive years.

(B) The terms set out in paragraph (A) of this rule may be redefined in other chapters as promulgated pursuant to Chapter 3748. of the Revised Code as used in that chapter only.

Last updated May 13, 2026 at 11:20 AM

History

• Effective: January 20, 2022
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-40-02 Scope.

(A) This chapter prescribes specific radiation protection requirements applicable to all persons in Ohio handling radioactive material for which licensure is required. The requirements of this chapter are in addition to, and not in substitution for, other requirements of the Administrative Code. In any conflict between the requirements in this chapter and a specific requirement in another chapter of the Administrative Code adopted pursuant to Chapter 3748. of the Revised Code, the more specific requirement governs.

(B) The director may issue licenses for radioactive material as outlined in this chapter. Handlers of source material and special nuclear material less than critical mass shall comply with the requirements of Chapters 3701:1-44 and 3701:1-56 of the Administrative Code, respectively. The director shall issue a specific license to a named person upon application filed in accordance with paragraph (C) of rule 3701:1-38-02 of the Administrative Code. A general license may be effective without application to the director based on criteria in rules covering manufacture and distribution of radioactive material and rule 3701:1-38-02 of the Administrative Code.

Last updated November 2, 2022 at 2:11 PM

History

• Effective: October 4, 2010
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-38-02

(A) As used in this rule, "facility" has the meaning defined in division (H) of section 3748.01 of the Revised Code and the following:

(1) All buildings, equipment, structures, and other stationary items that are located on a single site or on contiguous or adjacent sites and that are operated by the same person and have common corporate or business interests; and

(2) Portions of a building or structure which are operated by the same person and have common corporate or business interests.

(B) Notwithstanding the definition of "facility," the director may consider sites that are not contiguous or adjacent as one facility provided that:

(1) The sites are operated by the same person;

(2) The sites are in the same license category or categories;

(3) The applicant for a license provides for one radiation safety officer, and if applicable, one radiation safety committee, as responsible for all sites; and

(4) The director is reasonably satisfied from the information provided in the application that the applicant will adequately control radioactive material at all sites listed in the application.

(a) Unless the director has information of violations of Chapter 3748. of the Revised Code or the rules adopted thereunder at one or more sites, the director shall presume the applicant will adequately control radioactive material at all sites if the sites are located not more than twenty miles driving distance apart as documented by the licensee, and if all sites are within a twenty mile radius from the main site as designated on the license.

(b) The director shall continue to renew a license issued under this paragraph that contains all the sites listed thereon provided the licensee demonstrates continued compliance with this paragraph, Chapter 3748. of the Revised Code, and the rules adopted thereunder.

(C) Every facility that handles radioactive material in any license category as specified in appendix A to this rule for which licensure is required shall apply for a license, license amendment, or license renewal in accordance with this rule. Application for a license, license amendment, or license renewal shall be made on any format prescribed and provided by the director. Licenses shall be issued in accordance with the requirements of Chapter 3748. of the Revised Code, and the rules adopted thereunder. Except as otherwise provided in this rule, a license shall expire five years from the date of issuance.

(1) As used in this paragraph, site means an address of use listed on the license. Temporary job sites are exempted.

(a) Any individual applying for a new license with one or more additional sites or a current licensee amending a license to add one or more additional sites that are located more than twenty miles from the main site shall pay an additional site fee for each such site as follows:

(i) The additional site fee(s) shall be seventy-five percent of the applicable annual fee, as those fees are set forth in paragraphs (D), (F), and (J) of this rule.

(ii) Additional site fees will be invoiced annually with the annual fee.

(b) Broad scope licensees are exempt from paragraph (C)(1)(a) of this rule.

(2) As used in this paragraph, "service" means activities performed by a person, other than a worker as defined in rule 3701:1-38-01 of the Administrative Code, pursuant to an agreement with the facility to perform activities that deal with sources of radiation for the facility.

(a) These activities include, but are not limited to the following:

(i) Conduct leak tests;

(ii) Calibrate survey instruments;

(iii) Provide quality control tests;

(iv) Conduct surveys, characterization, and/or remediation activities;

(v) Manage the disposal of radioactive waste for other persons; or

(vi) Install sources or devices or change sources within a device.

(b) License categories affected are:

(i) 3219 - decontamination services;

(ii) 3220 - leak test service;

(iii) 3221 - instrument calibration service only - source less than 3.7 terabecquerels (one hundred curies);

(iv) 3222 - instrument calibration service only - source equal to or greater than 3.7 terabecquerels (one hundred curies);

(v) 3223 - leak test and instrument calibration - source less than 3.7 terabecquerels (one hundred curies);

(vi) 3224 - leak test and instrument calibration - source equal to or greater than 3.7 terabecquerels (one hundred curies);

(vii) 3225 - other services - including teletherapy, irradiator, and gauge service;

(viii) 3232 - waste disposal service prepackaged only;

(ix) 3233 - waste disposal service - incineration; and

(x) 3234 - waste disposal service processing and/or repackaging.

(D) A radioactive materials license issued by the department may, at the discretion of the director, have more than one license category on any one specific license. A licensee may have more than one radioactive materials license. Except as otherwise provided in paragraph (J) of this rule, the annual fee for a radioactive material license shall be in an amount in accordance with appendix A to this rule.

(1) Upon receipt of an application for a new radioactive material license, the department will issue an invoice for the appropriate fee specified in appendix A to this rule or paragraph (J) of this rule. Annual fees will be invoiced based on the month of the license expiration date and the invoice will state that the fee is due thirty days after the date of the invoice. License fees are not refundable.

(2) An applicant for a new or a renewal or amendment of a radioactive material license must submit a complete application before the director will finalize the review of the application. A complete application is one in which the applicant has provided all the information requested by the director, including any additional information requested after receipt of the application package.

(3) Upon receipt of an application for a license amendment, the department will issue an invoice for the appropriate fee for the proposed amendment as specified in appendix A to this rule. If the amendment is to change the license from operational phase to storage of sealed sources only incident to disposal of the sources, after the amendment the annual fee for the license shall be reduced to fifty per cent of the fee for the operational phase of the license, provided that the sources continue to be in safe storage and leak tested as provided by license condition for the specific sources in storage. The inspection frequency will remain the same as that for the operational phase of the license until after source disposal.

(4) The applicant for a new, or renewal or amendment of a radioactive materials license shall provide to the director all additional information requested within sixty days from the date of the information request. If the director does not receive the requested information within the stated time period, the director may consider the application abandoned. Any further consideration of a new license, or a renewal or amendment of a license shall be pursuant to another application.

(5) The director shall grant a new license, license amendment, or license renewal to any applicant who has submitted a complete application and is in compliance with Chapter 3748. of the Revised Code and the rules adopted thereunder.

(6) When an amendment to a license results in a change to a license category with a higher fee, the licensee will be charged the higher of the two amendment fees for that category. The annual fee for the licensee will escalate to the new category fee on the date of the next annual invoice.

(7) The director shall charge a fee for minor license amendments that do not require review by members of the technical staff at a rate of one hundred dollars per amendment provided that no licensee shall be required to pay more than one thousand dollars for minor amendments in any calendar year. Minor amendments include, but are not limited to, adding a new gauge of the same type already licensed unless that additional gauge increases the license or inspection fee, a corporate name change if the corporate ownership does not change, adding a user name that does not require review of education and experience, and corporate address change if the location of the use of the radioactive material does not change. Amendments to change the radiation safety officer or the chair or members of the radiation safety committee that require review of education or experience are not minor amendments.

(8) License terminations shall be handled as follows:

(a) Except as provided in paragraph (D)(8)(c) of this rule, a termination fee of five hundred dollars or fifty per cent of the annual fee, whichever is less, will be invoiced upon written request from the licensee for termination of the license. This fee is not refundable.

(b) Except as provided in paragraph (D)(8)(c) of this rule, if the termination cost, as determined by paragraph (M) of this rule, exceeds the termination fee in paragraph (D)(8)(a) of this rule, the remainder of the termination expense will be assessed at full cost.

(c) If the license termination would be covered under paragraph (D)(9) of this rule, that paragraph will be used for the termination process.

(d) The license termination process will not be completed until the licensee is in compliance with all rules, including payment of fees.

(9) Licenses, and other approvals related to the licensed activity requiring decommissioning, decontamination, reclamation, site restoration, or long-term care due to the continued presence of radioactive materials shall be charged an annual fee based on the approved decommissioning funding plan as specified in appendix B to this rule.

(a) A decommissioning plan must be approved by the department. Prior to approval of the decommissioning plan the licensee must submit an amendment requesting decommissioning. Until the amendment is approved the licensee's annualized license fee will be reduced by fifty per cent. After approval of the amendment containing the decommissioning plan, the licensee will be invoiced at the annual fee specified in appendix B to this rule.

(b) The annual fee specified in appendix B to this rule is based on the cost of decommissioning. The fee is payable within thirty days of mailing of an invoice by the department.

(c) Routine decommissioning oversight by the department will be charged against the annual amount received and additional invoices will not be issued unless the cost of activities exceeds the annual amount in any given year.

(d) The facility shall receive a monthly statement of items and amounts charged against the annual fee.

(e) If the cost of additional activities arise that require use of additional staff, including any consulting service that exceeds the amount of the annual fee paid by the licensee, these additional costs will be included in any invoice as separate items invoiced for the full cost of the oversight by additional staff or consultants. Oversight activities will be performed at a frequency which adequately monitors health, safety, and the environment.

(f) When the approved decommissioning plan is less than one hundred thousand dollars, the licensee will remain in the current license category and continue to pay the required annual fee specified in appendix A to this rule during decommissioning. Inspections of these licensees will be done as non-routine inspections. Non-routine inspection fees will not be applied until the number of decommissioning inspections performed exceed the inspections that would have been performed if the licensee had not chosen the decommissioning option.

(g) When the licensee has completed the decommissioning, and the director has determined that the licensee cannot terminate the license as provided by the Administrative Code, Chapter 3748. of the Revised Code or the rules adopted thereunder, but the licensee has successfully completed the decommissioning of the operation as required by the approved decommissioning plan, the director will amend the license to a decommissioning/possession only license. The annual fee for a decommissioning/possession only license is provided in appendix B to this rule.

(E) Licenses shall be renewed in accordance with the standard renewal procedure established in Chapter 4745. of the Revised Code, except that a licensee, other than a broad scope licensee, shall apply for renewal of the license ninety days prior to the expiration date of the current license and broad scope licensees shall apply for renewal of their license one hundred eighty days prior to expiration.

(F) The annual fee is listed in appendix A to this rule "column 5" for a new license or "column 6" for a renewal license. To recover the costs of oversight activities where radioactive material is found in the public domain and there is no evident individual that is determined to be responsible, a surcharge of 5.25 per cent has been included in the annual fee listed in "column 5" and "column 6" of appendix A to this rule.

(G) The department shall charge an inspection fee for all non-routine inspections. A non-routine inspection is defined as any inspection that the department conducts in addition to the scheduled routine inspections and one follow-up inspection if necessary. Non-routine inspections include, without limitation:

(1) An inspection performed as a result of an incident;

(2) Any pre-license inspections for a new license applicant when the director determines that an inspection is necessary to assess the adequacy of the information provided in the application;

(3) Inspections prior to license amendment, category change, or termination;

(4) An inspection performed at a facility that results in the issuance of an adjudication order by the director; or

(5) Other enforcement or regulatory inspections, not specified above, that the director determines is necessary to assess compliance with Chapter 3748. of the Revised Code.

(H) The fee for a non-routine inspection shall be based on the actual cost for conducting the inspection which shall include:

(1) An hourly charge of seventy dollars per staff person assigned to the inspection, except staff participating as training will not be included in the charges;

(2) An administrative fee of three hundred thirty dollars;

(3) All necessary laboratory analysis costs for samples collected by department personnel; and

(4) Any staff travel costs which shall be calculated in accordance with rule 126-01-02 of the Administrative Code.

(I) All fees invoiced as provided within this rule, including full cost, routine, and non-routine inspection fees, shall be paid within thirty days of the invoice date specified on the invoice. In accordance with sections 3748.07 and 3748.13 of the Revised Code, any fee that remains unpaid on the ninety-first day after the original invoice date shall be assessed an additional amount equal to ten per cent of the original fee.

(1) The department shall mail invoices by ordinary U.S. mail to the most recent address provided by the licensee.

(2) The department shall maintain a list of the invoices issued and date mailed.

(J) Notwithstanding paragraph (D) of this rule, the department shall charge the following types of licensees reduced license fees in the following specified amounts:

(1) A private entity that provides services, does not engage in manufacturing, and that has three hundred fifty thousand to two million dollars in gross annual receipts, shall pay a total license fee of seventy-five per cent of the amount specified for that use of radioactive materials in appendix A to this rule.

(2) A private entity that provides services, does not engage in manufacturing, and that has less than three hundred fifty thousand dollars in gross annual receipts shall pay a total license fee of fifty per cent of the amount specified for that use of radioactive material in appendix A to this rule.

(3) A private entity that engages in manufacturing and that has thirty-five to two hundred employees, irrespective of gross annual receipts, shall pay a total license fee of seventy-five per cent of the amount specified for that use of radioactive material in appendix A to this rule.

(4) A private entity that engages in manufacturing and that has less than thirty-five employees, irrespective of gross annual receipts, shall pay a total license fee of fifty per cent of the amount specified for that use of radioactive material in appendix A to this rule.

(5) A nonprofit entity that has gross annual receipts of three hundred fifty thousand dollars to two million dollars shall pay a total license fee of seventy-five per cent of the amount specified for that use of radioactive material in appendix A to this rule.

(6) A nonprofit entity that has gross annual receipts of less than three hundred fifty thousand dollars shall pay a total license fee of fifty per cent of the amount specified for that use of radioactive material in appendix A to this rule.

(7) A government jurisdiction or district with a population of twenty thousand to fifty thousand shall pay a total license fee of seventy-five per cent of the amount specified for that use of radioactive material as specified in appendix A to this rule.

(8) A government jurisdiction or district with a population of less than twenty thousand shall pay a total license fee of fifty per cent of the amount specified for that use of radioactive materials as specified in appendix A to this rule.

(9) A health district as defined in section 3709.01 of the Revised Code shall pay a total license fee of twenty-five per cent of the amount specified in appendix A to this rule.

(10) An accredited private or public college or university possessing or using radioactive material in a sealed or unsealed source solely as a part of a college or university course supported by tuition and leading to an accredited degree, but excluding clinical training, shall pay a total license fee as set forth for category "1129" as that amount is specified in appendix A to this rule.

The reduced annual fees specified in this paragraph do not apply to any other fees that a licensee may be required to pay under Chapter 3748. of the Revised Code or rules adopted thereunder. Licensees shall provide certification of their compliance with the provisions of paragraphs (J)(1) to (J)(6) of this rule upon initial application and renewal.

(K) The director may modify the inspection frequency of licensed facilities based upon the performance of the facility.

(L) In accordance with section 3748.22 of the Revised Code, the department shall charge fees sufficient to cover all costs of regulatory, administrative, and enforcement activities conducted pursuant to Chapter 3748. of the Revised Code. The director shall recommend to the radiation advisory council and the public health council changes in the radioactive materials fees if the director finds that fees do not meet the requirements of section 3748.22 of the Revised Code.

(M) Fees for those categories listed as "full cost" such as decommissioning activities, for either partial, building or selected area of a licensed site, or full decommissioning leading to license amendment, category change, or termination and for review of sources and/or devices shall be specified as "full cost" and shall be calculated as the sum of the seventy dollar hourly charge per staff member for the number of hours spent on document review and preparation, licensing, inspection, meetings, teleconferences, in travel, administrative time, the cost of any special contractors as determined necessary by the director, any environmental monitoring for radioactive materials and laboratory analysis, any other associated activities. The administrative fee from paragraph (H)(2) of this rule shall be used for administrative time. Travel expenses shall also be invoiced and shall be calculated at the rate determined by rule 126-1-02 of the Administrative Code. These fees will be invoiced monthly.

(N)

(1) Reciprocity to engage in activities in the state of Ohio which involve radioactive materials may be authorized provided:

(a) The person requesting reciprocity possesses a valid radioactive materials license issued by another agreement state or the United States nuclear regulatory commission which authorizes the same activities proposed to be conducted in Ohio;

(b) The request for reciprocity is made by submission of a completed reciprocity application provided by the director, a copy of the person's radioactive materials license, and payment of the reciprocity fee specified in appendix A to this rule;

(c) The duration of activities to be performed in Ohio under reciprocity does not exceed one hundred eighty days in any one calendar year.

(2) A person who has been granted reciprocity in Ohio shall notify the director at least three business days in advance of each time the person proposes to begin a new use of radioactive materials in the state of Ohio, with the notification made on a form provided by the director.

(3) Activities conducted in Ohio under reciprocity are subject to inspection by the department at any time and the department shall invoice a reciprocity inspection fee of one thousand dollars for each inspection of a person's authorized reciprocity activities.

(4) Reciprocity is authorized for one calendar year, beginning on January first or later date when reciprocity is initially applied for, and ending on December thirty-first.

(5) A person who is authorized reciprocity shall apply for an Ohio radioactive materials license at least thirty days prior to exceeding one hundred eighty days of activities in Ohio.

(O) Requests for safety evaluation of devices, products, or sealed sources used for radioactive materials either for commercial distribution or manufactured in accordance with the unique specifications of, and for use by, a single applicant shall be submitted to the director on a form provided by the director for that review prior to manufacture or commercial distribution.

(1) The application shall specify a license amendment for one of the areas listed below:

(a) Safety evaluation of sealed sources or devices or products containing NARM, byproduct material, source material, or special nuclear material (less than critical mass) for commercial distribution.

(b) Safety evaluation of sealed sources or devices or products containing NARM, byproduct material, source material, or special nuclear material (less than critical mass) manufactured in accordance with the unique specifications of, and for use by, a single applicant.

(2) The amendment fee for a source or device review shall be "full cost" as outlined in paragraph ((M) of this rule.

(3) The amendment fee in appendix A to this rule for categories under manufacturing and distribution shall be for amendments other than source or device reviews.

(4) Licensees for categories 3211, 3212, 3213, 3214, and 22162 shall pay an annual surcharge of six hundred fifty dollars to cover administrative costs of overall maintenance activities associated with source or device data submitted to the United States nuclear regulatory commission. This surcharge is included in the annual fee for the above listed categories in "column 5" and "column 6" of appendix A to this rule.

(P) When considered necessary by the director, the director may conduct a review of shielding plans or the adequacy of shielding. The director may also conduct such a review upon the request of the licensee or the applicant for a license. The applicant or licensee shall pay a fee for review of shielding plans or adequacy of shielding as specified in paragraph (M) of this rule.

(Q) Individuals with implanted pacemakers that have a radioactive source will not be charged an annual fee as an individual because of the necessity of possessing the device. Unless the director determines other provisions are required, the medical institution that implanted the device shall hold the license for the individual.

(R) If, because of the complexity of a review, such as that for a sealed source or device, decommissioning, license, or incident, it is necessary to obtain the services of a consultant to assist in a final determination, the licensee or applicant will be invoiced for the consulting services.

(S) Licensees with general licenses requiring an annual report to the director shall submit the report with a fee of four hundred twenty dollars within thirty days of mailing an invoice by the department and are subject to late penalties in paragraph (I) of this rule. If a facility has a specific license which is in a category that would include the generally licensed material, the facility may add the generally licensed material to the specific license and will not be charged the additional fee for that generally licensed material. Annual reports are required for devices under a general license containing radionuclides at or above activities listed in paragraph (C)(13) of rule 3701:1-46-05 of the Administrative Code.

View AppendixView Appendix

Last updated November 2, 2022 at 2:09 PM

History

• Effective: April 15, 2013
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-40-03 Activities requiring license.

Unless otherwise exempt as provided in rule 3701:1-43-07 of the Administrative Code, or unless possession is solely for the purpose of transportation, no person shall handle or possess (including manufacture, produce, acquire, or own) or dispose of (including closure, decommissioning, reclamation, or long-term surveillance or care) radioactive material except as authorized in a specific or general license issued in accordance with this chapter, or other chapters of the Administrative Code adopted pursuant to Chapter 3748. of the Revised Code and rule 3701:1-38-02 of the Administrative Code.

Last updated November 2, 2022 at 2:11 PM

History

• Effective: May 23, 2013
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-43-07

(A) Persons who receive, possess, use, process, transfer, distribute, or dispose of TENORM are exempt from the requirements of this chapter with respect to any combination of radium-226 and radium-228 if the materials contain, or are contaminated at, concentrations less than one hundred eighty-five becquerel per kilogram (five picocuries per gram) excluding natural background. The progeny of the exempt TENORM radium-226 and radium-228 are also exempt. Manufacture of consumer or retail products at concentrations greater than one hundred eighty-five becquerel per kilogram (five picocuries per gram) is regulated pursuant to paragraph (C) of rule 3701:1-43-10 and rule 3701:1-43-11 of the Administrative Code.

(B) Persons who receive products or materials containing TENORM distributed in accordance with a specific license issued by the director pursuant to paragraph (A) of rule 3701:1-43-03 of the Administrative Code, or by an equivalent license issued by another state, are exempt from this chapter with regard to those products or materials.

(C) Persons who receive, possess, use, process, transfer and distribute, including preparation of custom blends for distribution, phosphate or potash ore-based fertilizers containing TENORM are exempt from this chapter.

(D) Persons who receive, possess, use, process, transfer, dispose into a permitted landfill, or distribute, including preparation of custom blends for distribution, zirconia, zircon, and products of zirconia and zircon containing TENORM are exempt from this chapter provided that the radioactive constituent is consistent with the radioactivity levels stated in the safety data sheet accompanying the zirconium-bearing materials. A facility that manufactures zirconium metal from ore or chemically processes zirconia or zircon resulting in increased environmental mobility of TENORM is not exempt from this chapter.

(E) Persons who possess TENORM waste regulated by the Comprehensive Environmental Response, Compensation and Liability Act (CERCLA 42 USC 9601 to 9628 as amended, as published in the United States Code, 2006 edition) or by the Resource Conservation and Recovery Act (RCRA 42 USC 6901 et seq. as amended, as published in the United States Code, 2006 edition) are exempt from this chapter for the TENORM waste regulated by either of these federal acts.

(F) Other persons who possess or use TENORM will be exempt when the director makes a determination, upon his or her own initiative or upon request for such determination, that the reasonably maximally exposed individual will not receive a public dose with a total effective dose equivalent (TEDE) of more than one millisievert (0.1 rem) in one year from all licensed or registered sources of radiation including TENORM.

(G) Persons who receive, possess, use, transfer, distribute, or dispose of materials in the recycling process contaminated with scale or residue not otherwise exempted or other equipment containing TENORM with a radiation exposure level that does not exceed 0.5 microsieverts (fifty microrem) per hour, including background at any accessible point are hereby exempt from the requirements of this chapter.

(H) Persons engaged in the manufacture, wholesale or retail commercial distribution, use, or disposal of the following products or materials, or the recycling of equipment used to produce, contain, or transport the following materials are exempt from the requirements of this chapter:

(1) Potassium or potassium compounds that have not been isotopically enriched in the radionuclide potassium-40;

(2) Fossil fuel or byproducts from fossil fuel combustion, including bottom ash, fly ash, and flue-gas emission control byproducts; or

(3) Material used for building construction, industrial processing, sandblasting, metal castings, or other material in which the radionuclide content has not been concentrated to a level higher than is found in its natural state.

(I) Persons who receive, possess, use, process, transfer, or dispose of TENORM or TENORM waste from oil and gas wells and production operations within the state are exempt from the requirements of this chapter in that they are subject to the regulatory oversight of the Ohio department of natural resources in accordance with section 1509.02 of the Revised Code. This exemption does not apply to service providers performing radiological decontamination of scale containing TENORM in pipe and other equipment.

(J) Persons who receive, possess, use, process, transfer, or dispose of waste water facility sludges that contain TENORM, are exempt from the requirements of this chapter in that they are subject to regulatory oversight by the Ohio environmental protection agency in accordance with section 6111.03 of the Revised Code.

(K) Persons who possess, store, use, transport, or commercially distribute compressed gases and compressed gas products containing TENORM are exempt from the requirements of this chapter. The exemptions contained in this paragraph do not apply to a facility that processes compressed gas or compressed gas products containing TENORM.

Last updated May 15, 2023 at 1:06 AM

History

• Effective: May 15, 2023
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-40-04 Communications.

(A) Except as otherwise provided, any communication or report required by this chapter shall be filed in accordance with Chapter 3748. of the Revised Code and rules promulgated thereunder. Documents pertaining to license application or any license matter, unless otherwise directed in writing, shall be submitted to the following address or by electronic submission in a manner approved by the director:

"Ohio Department of Health

Bureau of Environmental Health and Radiation Protection

246 North High Street

Columbus, Ohio 43215."

(B) If pemitted to submit via electronic mail, communications may be sent to the Ohio department of health at:

"BRadiation@odh.ohio.gov"

Last updated April 19, 2022 at 8:33 AM

History

• Effective: April 17, 2022
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-40-05 Completeness and accuracy of information.

All information provided to the director by an applicant for a license, or by a licensee, and all information required to be maintained by the applicant or the licensee in accordance with license conditions or by Chapter 3748. of the Revised Code or rules adopted thereunder, shall be complete and accurate in all material respects.

Last updated November 2, 2022 at 2:12 PM

History

• Effective: August 15, 2005
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-40-06 Department of energy contractors.

(A) Except to the extent that United States department of energy facilities or activities of the types subject to licensing pursuant to section 202 of the "Energy Reorganization Act of 1974" (Pub.L. 93-438, 88 Stat. 1233, 42 U.S.C. 5842) are involved, any prime contractor of the United States department of energy is exempt from the license requirements set forth in sections 81 and 82 of the "Atomic Energy Act of 1954" (Pub.L. 83-703, 68 Stat. 919, 42 U.S.C. 2111 and 2112) and from the regulations in this chapter to the extent that such contractor, under his prime contract with the United States department of energy, manufactures, produces, transfers, receives, acquires, owns, possesses, or uses byproduct material for:

(1) The performance of work for the United States department of energy at a United States government-owned or controlled site, including the transportation of byproduct material to or from such site and the performance of contract services during temporary interruptions of such transportation;

(2) Research in, or development, manufacture, storage, testing or transportation of, atomic weapons or components thereof; or

(3) The use or operation of nuclear reactors or other nuclear devices in a United States government-owned vehicle or vessel.

(B) In addition to the exemptions specified in paragraph (A) of this rule, and subject to the requirement for licensing of the United States department of energy facilities and activities pursuant to section 202 of the "Energy Reorganization Act of 1974" (Pub.L. 93-438, 88 Stat. 1233, 42 U.S.C. 5842), any prime contractor or subcontractor of the United States department of energy or the United States nuclear regulatory commission is exempt from the requirements for a license set forth in sections 81 and 82 of the "Atomic Energy Act of 1954" (Pub.L. 83-703, 68 Stat. 919, 42 U.S.C. 2111 and 2112) and from the regulations in this chapter to the extent that such prime contractor or subcontractor manufactures, produces, transfers, receives, acquires, owns, possesses, or uses byproduct material under his prime contract or subcontract when the United States nuclear regulatory commission determines that the exemption of the prime contractor or subcontractor is authorized by law; and that, under the terms of the contract or subcontract, there is adequate assurance that the work thereunder can be accomplished without undue risk to the public health and safety.

Last updated April 19, 2022 at 8:33 AM

History

• Effective: April 17, 2022
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-40-07 Carriers.

Common and contract carriers, freight forwarders, warehousemen, and the U.S. postal service are exempt from the regulations in this chapter and Chapters 3701:1-37, 3701:1-46, 3701:1-48, 3701:1-49, 3701:1-52, and 3701:1-58 of the Administrative Code, to the extent that they are not required to be licensed as set forth in Chapter 3748. of the Revised Code and rule 3701:1-38-02 of the Administrative Code, and to the extent that they only transport or store radioactive material in the regular course of carriage for another or storage incident thereto.

Last updated November 2, 2022 at 2:12 PM

History

• Effective: May 15, 2014
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-40-08 Exempt concentrations.

(A) Except as may be required in paragraphs (C) and (D) of this rule, any person is exempt from the requirements for a license set forth in this chapter and Chapters 3701:1-46, 3701:1-48, 3701:1-49, 3701:1-52, and 3701:1-58 of the Administrative Code to the extent that such person receives, possesses, uses, transfers, owns, or acquires products or materials containing radioactive material in concentrations that do not exceed those listed in the appendix to this rule.

(B) This rule shall not be deemed to authorize the import of radioactive material or products containing radioactive material.

(C) A manufacturer, processor, or producer of a product or material is exempt from the rules in this chapter and Chapters 3701:1-46, 3701:1-48, 3701:1-49, 3701:1-52, and 3701:1-58 of the Administrative Code to the extent that the person transfers radioactive material contained in a product or material in concentrations not in excess of those specified in the appendix to this rule and introduced into the product or material by a licensee holding a specific license issued by an agreement state, the United States nuclear regulatory commission, or the director, expressly authorizing such introduction. This exemption does not apply to the transfer of radioactive material contained in any food, beverage, cosmetic, drug, or other commodity or product designed for ingestion or inhalation by, or application to, a human being.

(D) No person may introduce radioactive material into a product or material knowing or having reason to believe that it will be transferred to persons exempt under this rule, except in accordance with a license issued by the United States nuclear regulatory commission.

View Appendix

Last updated November 2, 2022 at 2:12 PM

History

• Effective: May 11, 2009
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-40-09 Certain items containing radioactive material.

(A) Except for persons who apply radioactive material to, or persons who incorporate radioactive material into, the following products, or persons who initially transfer for sale or distribution the following products containing radioactive material, any person is exempt from the requirements for a license set forth in this chapter and Chapters 3701:1-38, 3701:1-46, 3701:1-48, 3701:1-49, 3701:1-52, and 3701:1-58 of the Administrative Code to the extent that such person receives, possesses, uses, transfers, owns, or acquires the following products:

(1) Timepieces or hands or dials containing not more than the following specified quantities of radioactive material and not exceeding the following specified levels of radiation:

(a) Nine hundred twenty-five megabecquerels (twenty-five millicuries) of tritium per timepiece,

(b) One hundred eighty-five megabecquerels (five millicuries) of tritium per hand,

(c) Five hundred fifty-five megabecquerels (fifteen millicuries) of tritium per dial (bezels when used shall be considered as part of the dial),

(d) 3.7 megabecquerels (one hundred microcuries) of promethium-147 per watch or 7.4 megabecquerels (two hundred microcuries) of promethium-147 per any other timepiece,

(e) Seven hundred forty kilobecquerels (twenty microcuries) of promethium-147 per watch hand or 1.48 megabecquerels (forty microcuries) of promethium-147 per other timepiece hand,

(f) 2.22 megabecquerels (sixty microcuries) of promethium-147 per watch dial or 4.44 megabecquerels (one hundred twenty microcuries) of promethium-147 per other timepiece dial (bezels when used shall be considered as part of the dial), and

(g) The levels of radiation from hands and dials containing promethium-147 will not exceed, when measured through fifty milligrams per square centimeter of absorber:

(i) For wrist watches, one microgray (0.1 millirad) per hour at ten centimeters from any surface,

(ii) For pocket watches, one microgray (0.1 millirad) per hour at one centimeter from any surface, and

(iii) For any other timepiece, two microgray (0.2 millirad) per hour at ten centimeters from any surface.

(h) Thirty-seven kilobecquerels (one microcurie) of radium-226 per timepiece in intact timepieces manufactured prior to November 30, 2007.

(2)

(a) Static elimination devices which contain, as a sealed source or sources, radioactive material consisting of a total of not more than 18.5 megabecquerels (five hundred microcuries) of polonium-210 per device.

(b) Ion generating tubes designed for ionization of air that contain, as a sealed source or sources, byproduct material consisting of a total of not more than 18.5 megabecquerels (five hundred microcuries) of polonium-210 per device or of a total of not more than 1.85 gigabecquerels (fifty millicuries) of hydrogen-3 (tritium) per device.

(c) Such devices authorized before October 23, 2012 for use under the general license then provided in rule 3701:1-46-04 of the Administrative Code and equivalent regulations of "Agreement States" and manufactured, tested, and labeled by the manufacturer in accordance with the specifications contained in a specific license issued by the director.

(3) Balances of precision containing not more than thirty-seven megabecquerels (one millicurie) of tritium per balance or not more than 18.5 megabecquerels (0.5 millicurie) of tritium per balance part manufactured before December 17, 2007.

(4) Marine compasses containing not more than 27.75 gigabecquerels (seven hundred fifty millicuries) of tritium gas and other marine navigational instruments containing not more than 9.25 gigabecquerels (two hundred fifty millicuries) of tritium gas manufactured before December 17, 2007.

(5) Ionization chamber smoke detectors containing not more than thirty-seven kilobecquerels (one microcurie) of americium-241 per detector in the form of a foil and designed to protect life and property from fires.

(6) Electron tubes: provided, that each tube does not contain more than one of the following specified quantities of byproduct material:

(a) 5.55 gigabecquerels (one hundred fifty millicuries) of tritium per microwave receiver protector tube or three hundred seventy megabecquerels (ten millicuries) of tritium per any other electron tube;

(b) Thirty-seven kilobecquerels (one microcurie) of cobalt-60;

(c) One hundred eighty-five kilobecquerels (five microcuries) of nickel-63;

(d) 1.11 megabecquerels (thirty microcuries) of krypton-85;

(e) One hundred eighty-five kilobecquerels (five microcuries) of cesium-137; or

(f) 1.11 megabecquerels (thirty microcuries) of promethium-147;

And provided further, that the levels of radiation from each electron tube containing radioactive material do not exceed ten microgray (one millirad) per hour at one centimeter from any surface when measured through seven milligrams per square centimeter of absorber. For purposes of this paragraph, electron tubes include spark gap tubes, power tubes, gas tubes including glow lamps, receiving tubes, microwave tubes, indicator tubes, pickup tubes, radiation detection tubes, and any other completely sealed tube that is designed to conduct or control electrical currents.

(7) Ionizing radiation measuring instruments containing, for purposes of internal calibration or standardization, one or more sources of radioactive material, provided that:

(a) Each source contains no more than one exempt quantity as set forth in the appendix to rule 3701:1-40-11 of the Administrative Code; and

(b) Each instrument contains no more than ten exempt quantities. For the purposes of this paragraph, an instrument's source may contain either one type or different types of radionuclides, and an individual exempt quantity may be composed of fractional parts of one or more of the exempt quantities in the appendix to rule 3701:1-40-11 of the Administrative Code, provided that the sum of such fractions shall not exceed unity.

(c) For purposes of this paragraph, 1.85 kilobecquerels (0.05 microcurie) of americium-241 is considered an exempt quantity under the appendix to rule 3701:1-40-11 of the Administrative Code.

(B) Any person who desires to apply radioactive material to, or to incorporate radioactive material into, the products exempted in paragraph (A) of this rule, or who desires to initially transfer for sale or distribution such products containing radioactive material, shall apply for a specific license issued by the United States nuclear regulatory commission.

Last updated July 10, 2025 at 12:13 PM

History

• Effective: June 25, 2015
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-40-11

(A) Except as provided in paragraphs (C) to (E) of this rule, any person is exempt from requirements set forth in this chapter and from the rules in Chapters 3701:1-46, 3701:1-48, 3701:1-49, and 3701:1-52 of the Administrative Code, to the extent that such person receives, possesses, uses, transfers, owns, or acquires radioactive material in individual quantities each of which does not exceed the applicable quantity set forth in the appendix to this rule.

(B) Any person who possesses radioactive material received or acquired before September 25, 1971, under the general license then provided in 10 C.F.R. 31.4 or similar general license of a state, is exempt from the requirements for a license set forth in this chapter and from the rules in Chapters 3701:1-46, 3701:1-48, 3701:1-49, and 3701:1-52 of the Administrative Code, to the extent that this person possesses, uses, transfers, or owns radioactive material.

(C) This rule does not authorize for purposes of commercial distribution the production, packaging, repackaging, or transfer of radioactive material or the incorporation of radioactive material into products intended for commercial distribution.

(D) No person may, for purposes of commercial distribution, transfer radioactive material in the individual quantities set forth in the appendix to this rule, knowing or having reason to believe that such quantities of radioactive material will be transferred to persons exempt under this chapter or equivalent regulations of an agreement state or the United States nuclear regulatory commission, except in accordance with a license, issued by the United States nuclear regulatory commission, which states that the radioactive material may be transferred by the licensee to persons exempt under this rule or the equivalent regulations of an agreement state or the United States nuclear regulatory commission.

(E) No person may, for purposes of producing an increased radiation level, combine quantities of radioactive material covered by this exemption so that the aggregate quantity exceeds the limits set forth in the appendix to this rule, except for radioactive material combined within a device placed in use before May 3, 1999, or as otherwise permitted by the rules in this chapter.

View Appendix

Last updated April 19, 2022 at 8:34 AM

History

• Effective: April 17, 2022
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-40-10 Certain industrial devices.

(A) Except for persons who manufacture, process, produce, or initially transfer for sale or distribution industrial devices containing radioactive material designed and manufactured for the purpose of detecting, measuring, gauging or controlling thickness, density, level, interface location, radiation, leakage, or qualitative or quantitative chemical composition, or for producing an ionized atmosphere, any person is exempt from the requirements for a license set forth in Chapters 3701:1-38, 3701:1-46, 3701:1-48, 3701:1-49, 3701:1-52, and 3701:1-58 of the Administrative Code to the extent that such a person receives, possesses, uses, transfers, owns, or acquires radioactive material, in these certain detecting, measuring, gauging, or controlling devices and certain devices for producing an ionized atmosphere, and manufactured, processed, produced, or initially transferred in accordance with a specific license issued under 10 C.F.R. 32.30, (as in effect on the effective date of this rule) which license authorizes the initial transfer of the device for use under this section. This exemption does not cover sources not incorporated into a device, such as calibration and reference sources.

(B) Any person who desires to manufacture, process, produce, initially transfer for sale or distribution industrial devices containing radioactive material for use under paragraph (A) of this rule, shall apply for a specific license issued by the United States nuclear regulatory commission and for a certificate of registration in accordance with rule 3701:1-46-49 of the Administrative Code.

Last updated April 19, 2022 at 8:34 AM

History

• Effective: April 17, 2022
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-46-49

(A) Any manufacturer or initial distributor of a sealed source or device containing a sealed source may submit a request to the director for evaluation of radiation safety information about its product and for its registration.

(B) The request for review must be made in duplicate and sent to the director at the following address:

"Ohio Department of Health

Bureau of Environmental Health and Radiation Protection

246 North High Street

Columbus, Ohio 43215"

(C) The request for review of a sealed source or a device must include sufficient information about the design, manufacture, prototype testing, quality control program, labeling, proposed uses and leak testing and, for a device, the request must also include sufficient information about installation, service and maintenance, operating and safety instructions, and its potential hazards, to provide reasonable assurance that the radiation safety properties of the source or device are adequate to protect health and minimize danger to life and property.

(D) The director normally evaluates a sealed source or a device using radiation safety criteria in accepted industry standards. If these standards and criteria do not readily apply to a particular case, the director formulates reasonable standards and criteria with the help of the manufacturer or distributor. The director shall use criteria and standards sufficient to ensure that the radiation safety properties of the device or sealed source are adequate to protect health and minimize danger to life and property.

(E) After completion of the evaluation, the director issues a certificate of registration to the person making the request. The certificate of registration acknowledges the availability of the submitted information for inclusion in an application for a specific license proposing use of the product, or concerning use under an exemption from licensing or general license as applicable for the category of certificate.

(F) The person submitting the request for evaluation and registration of safety information about the product shall manufacture and distribute the product in accordance with:

(1) The statements and representations, including quality control program, contained in the request; and

(2) The provisions of the registration certificate.

(G) Authority to manufacture or initially distribute a sealed source or device to specific licensees may be provided in the license without the issuance of a certificate of registration in the following cases:

(1) Calibration and reference sources containing no more than:

(a) Thirty seven megabecquerels (one millicurie), for beta and/or gamma emitting radionuclides; or

(b) 0.37 megabecquerels (10 microcuries), for alpha emitting radionuclides; or

(2) The intended recipients are qualified by training and experience and have sufficient facilities and equipment to safely use and handle the requested quantity of radioactive material in any form in the case of unregistered sources or, for registered sealed sources contained in unregistered devices, are qualified by training and experience and have sufficient facilities and equipment to safely use and handle the requested quantity of radioactive material in unshielded form, as specified in their licenses; and

(a) The intended recipients are licensed under chapter 3701:1-40 of the Administrative Code or comparable provisions of another agreement state or the United States nuclear regulatory commission; or

(b) The recipients are authorized for research and development; or

(c) The sources and devices are to be built to the unique specifications of the particular recipient and contain no more than seven hundred forty gigabecquerels (twenty curies) of tritium or 7.4 gigabecquerels (two hundred millicuries) of any other radionuclide.

(H) After the certificate is issued, the director may conduct an additional review as he/she determines is necessary to ensure compliance with current regulatory standards. In conducting the review, the director will complete his/her evaluation in accordance with criteria specified in this rule. The director may request such additional information as he/she considers necessary to conduct his/her review and the certificate holder shall provide the information as requested.

(I) A certificate holder who no longer manufactures or initially transfers any of the sealed source(s) or device(s) covered by a particular certificate issued by the director shall request inactivation of the registration certificate. Such a request must be made to the director by an appropriate method listed in rule 3701:1-40-04 of the Administrative Code and must normally be made no later than two years after the initial distribution of all of the source(s) or device(s) covered by the certificate has ceased. However, if the certificate holder determines that an initial transfer was in fact the last initial transfer more than two years after that transfer, the certificate holder shall request inactivation of the certificate within ninety days of this determination and briefly describe the circumstances of the delay.

(J) If a distribution license is to be terminated in accordance with rule 3701:1-40-18 of the Administrative Code, the licensee shall request inactivation of its registration certificates associated with that distribution license before the director will terminate the license. Such a request for inactivation of certificate(s) must indicate that the license is being terminated and include the associated specific license number.

(K) A specific license to manufacture or initially transfer a source or device covered only by an inactivated certificate no longer authorizes the licensee to initially transfer such sources or devices for use. Servicing of devices must be in accordance with any conditions in the certificate, including in the case of an inactive certificate.

Last updated November 2, 2022 at 2:36 PM

History

• Effective: November 8, 2015
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-40-12 Self-luminous products containing tritium, krypton-85, or promethium-147.

(A) Except for persons who manufacture, process, produce, or initially transfer for sale or distribution self-luminous products containing tritium, krypton-85, or promethium-147, and except as provided in paragraph (C) of this rule, a person is exempt from the license requirements set forth in Chapters 3701:1-38, 3701:1-46, 3701:1-48, 3701:1-49, 3701:1-52, and 3701:1-58 of the Administrative Code to the extent that such person receives, possesses, uses, transfers, owns, or acquires tritium, krypton-85, or promethium-147 in self-luminous products manufactured, processed, produced, or initially transferred in accordance with a specific license issued pursuant to 10 C.F.R. 32.22, (as in effect on the effective date of this rule) which license authorizes the initial transfer of the product for use.

(B) Any person who desires to manufacture, process, or produce, or initially transfer for sale or distribution self-luminous products containing tritium, krypton-85, or promethium-147 for use pursuant to paragraph (A) of this rule, shall apply for a specific license issued by the United States nuclear regulatory commission and for a certificate of registration in accordance with rule 3701:1-46-49 of the Administrative Code.

(C) The exemption in paragraph (A) of this rule does not apply to tritium, krypton-85, or promethium-147 used in products primarily for frivolous purposes or in toys or adornments.

Last updated April 19, 2022 at 8:34 AM

History

• Effective: April 17, 2022
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-40-13 Gas and aerosol detectors containing radioactive material.

(A) Except for persons who manufacture, process, produce, or initially transfer for sale or distribution gas and aerosol detectors containing radioactive material, a person is exempt from license requirements set forth in this chapter or Chapters 3701:1-38, 3701:1-46, 3701:1-48, 3701:1-49, 3701:1-52, and 3701:1-58 of the Administrative Code to the extent that such person receives, possesses, uses, transfers, owns, or acquires radioactive material, in gas and aerosol detectors designed to protect health, safety, or property, and manufactured, processed, produced, or initially transferred in accordance with a specific license for manufacture and distribution issued pursuant to 10 C.F.R. 32.26 (as in effect on the effective date of this rule). This exemption also covers gas and aerosol detectors manufactured or distributed before November 30, 2007, in accordance with a specific license issued by a state under comparable provisions to 10 C.F.R. 32.26 authorizing distribution to persons exempt from regulatory requirements.

(B) A person who desires to manufacture, process, or produce gas and aerosol detectors containing radioactive material, or to initially transfer such products for use pursuant to paragraph (A) of this rule, shall apply for a specific license for manufacture and distribution issued by the United States nuclear regulatory commission and for a certificate of registration in accordance with rule 3701:1-46-49 of the Administrative Code.

Last updated April 19, 2022 at 8:34 AM

History

• Effective: April 17, 2022
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-40-14 Application for specific licenses.

(A) An applicant for a license to receive and possess radioactive material shall apply in accordance with rule 3701:1-38-02 of the Administrative Code and this chapter on a form prescribed by the director. The original application shall be filed with the director. Information contained in previous applications, statements or reports filed with the director may be incorporated by reference, provided that the reference is clear, specific, and has been on file with the department for not more than two licensing periods, and provided that the item being referenced in the document is being referenced without change.

(B) The director may at any time after the filing of the original application require additional information from the applicant in order to determine whether a license should be issued or whether a current license should be modified or revoked.

(C) Each application shall be signed by the applicant or a person duly authorized to act for the applicant.

(D) An application for a license to receive and possess radioactive material for the conduct of any activity which the director has determined pursuant to rule 3701:1-40-36 of the Administrative Code could potentially affect the quality of the environment shall be filed at least nine months prior to commencement of construction of the plant or facility in which the activity will be conducted and shall be accompanied by any environmental report required pursuant to rule 3701:1-40-36 of the Administrative Code. The applicant is prohibited from the commencement of construction activities in areas covered by the environmental reporting requirements identified in rules 3701:1-40-30 to 3701:1-40-38 of the Administrative Code before the conclusion of these reviews. The terms "construction" and "commencement of construction" shall have the same meaning as identified in rule 3701:1-38-01 of the Administrative Code.

(E)

(1) Except as provided in paragraphs (E)(2), (E)(3), and (E)(4) of this rule, an application for a specific license to use radioactive material in the form of a sealed source or in a device that contains the sealed sources must either:

(a) Identify the source or device by manufacturer and model number as registered in the sealed source and device registry of the United States nuclear regulatory commission in accordance with sealed source and device registry requirements contained in rule 3701:1-46-49 of the Administrative Code, or with equivalent requirements from an agreement state or the United States nuclear regulatory commission; or

(b) Contain the information specified in sealed source and device registry requirements contained in paragraph (C) of rule 3701:1-46-49 of the Administrative Code so that the director is able to perform the review.

(2) For sources or devices manufactured before October 23, 2012 that are not registered with the director in accordance with rule 3701:1-46-49 of the Administrative Code or equivalent requirements from an agreement state or the United States nuclear regulatory commission, and for which the applicant is unable to provide all categories of information specified in rule 3701:1-46-49 of the Administrative Code, the applicant must provide:

(a) All available information identified in rule 3701:1-46-49 of the Administrative Code concerning the source, and, if applicable, the device; and

(b) Sufficient additional information to demonstrate that there is reasonable assurance that the radiation safety properties of the source or device are adequate to protect health and minimize danger to life and property. Such information must include a description of the source or device, a description of radiation safety features, the intended use and associated operating experience, and the results of a recent leak test.

(3) For sealed sources and devices allowed to be distributed without registration of safety information in accordance with rule 3701:1-46-49 of the Administrative Code, the applicant may supply only the manufacturer, model number, and radionuclide and quantity.

(4) If it is not feasible to identify each sealed source and device individually, the applicant may propose constraints on the number and type of sealed sources and devices to be used and the conditions under which they will be used, in lieu of identifying each sealed sources and device.

(F) In the case of an application for a license specified in rule 3701:1-40-16 of the Administrative Code, or an application for a specific license specified in Chapter 3701:1-46, 3701:1-48, or 3701:1-58 of the Administrative Code, the applicant shall provide a proposed decommissioning funding plan or a certification of financial assurance for decommissioning.

(G) Requirement for an emergency response plan:

(1) Each application to possess radioactive materials in excess of the quantities specified in the appendix to this rule, whether in unsealed form, on foils or plated sources, or sealed in glass, shall contain either:

(a) An evaluation showing that the maximum dose to a person offsite due to a release of radioactive materials would not exceed 0.01 sievert (one rem) TEDE or 0.05 sievert (five rem) to the thyroid; or

(b) An emergency plan for responding to a release of radioactive material.

(2) One or more of the following factors may be used to support an evaluation of the need to submit an emergency plan under this paragraph:

(a) The radioactive material is physically separated so that only a portion of the material could be involved in an accident;

(b) All or part of the radioactive material is not subject to release during an accident because of the way it is stored or packaged;

(c) The release fraction in the respirable size range would be lower than the release fraction specified in the appendix to this rule due to the chemical or physical form of the material;

(d) The solubility of the radioactive material would reduce the dose received;

(e) Facility design or engineered safety features in the facility would cause the release fraction to be lower than the limit specified in the appendix to this rule;

(f) Operating restrictions or procedures would prevent a release fraction as large as that shown in the appendix to this rule; or

(g) Other factors appropriate for the specific facility as determined by the director.

(3) An emergency plan for responding to a release of radioactive material submitted under paragraph (G)(1)(b) of this rule shall include the following information:

(a) A brief description of the licensee's facility and the area near the site.

(b) An identification of each type of possible radioactive material accident which may require protective action.

(c) A classification system for classifying an accident as either an alert or a site area emergency.

(d) Identification of the means of detecting each type of accident in a timely manner.

(e) A brief description of the means and equipment for mitigating the consequences of each type of accident, including those provided to protect workers onsite, and a description of the program for maintaining the equipment.

(f) A brief description of the methods and equipment to assess releases of byproduct and accelerator produced materials.

(g) A brief description of the responsibilities of the licensee's personnel should an accident occur, including identification of personnel responsible for promptly notifying offsite response organizations and the department, and identification of personnel responsible for developing, maintaining, and updating the plan.

(h) A commitment to, and a brief description of, the means to promptly notify offsite response organizations and request offsite assistance, including medical assistance for the treatment of contaminated injured onsite workers when appropriate. A control point shall be established. The notification and coordination shall be planned so that in the event that some personnel, parts of the facility, or some equipment is not available, that unavailability will not prevent such notification and coordination. The licensee shall also commit to notifying the department immediately after notification of the appropriate offsite response organizations and not later than one hour after the licensee declares an emergency. These reporting requirements do not supersede or release licensees from complying with the requirements of the "Emergency Planning and Community Right-to-Know Act of 1986, "Title III of Pub. L. 99-499, 100 Stat. 1728, 42 U.S.C. 11001 et seg. or other state or federal reporting requirements.

(i) A brief description of the types of information on facility status, radioactive releases, and recommended protective actions, if necessary, to be given to offsite response organizations and to the department.

(j) A brief description of the frequency, performance objectives and plans for the training that the licensee will provide workers on how to respond to an emergency including any special instructions and orientation tours the licensee would offer to fire, police, medical and other emergency personnel. The training shall familiarize personnel with site-specific emergency procedures. The training also shall thoroughly prepare site personnel for their responsibilities in the event of an accident, including training on the emergency scenarios postulated as most probable for the specific site, and the use of team training for such scenarios.

(k) A brief description of the means of restoring the facility to a safe condition after an accident.

(l) Provisions for conducting quarterly communication checks with offsite response organizations and biennial onsite exercises to test response to simulated emergencies. Quarterly communication checks with offsite response organizations must include the check and update of all necessary telephone numbers. The licensee shall invite offsite response organizations to participate in the biennial exercises. Participation of offsite response organizations in biennial exercises, although recommended, is not required. Exercises must use accident scenarios postulated as most probable for the specific site and the scenarios shall not be known to most exercise participants. The licensee shall critique each exercise using individuals not having direct implementation responsibility for the plan. Critiques of exercises must evaluate the appropriateness of the plan, emergency procedures, facilities, equipment, training of personnel, and overall effectiveness of the response. Deficiencies found by the critiques must be corrected.

(m) A certification that the applicant has met all responsibilities under the "Emergency Planning and Community Right-to-Know Act of 1986, "Title III of Pub. L. 99-499, 100 Stat. 1728, 42 U.S.C. 11001 et seq, if applicable to the applicant's activities at the proposed place of use of the byproduct or accelerator produced material.

(n) The licensee must have and maintain liability coverage for incidents which would activate the plan to cover bodily injury and property damage to third parties caused by incidents which would activate the plan in the amount of at least one million dollars per occurrence with an annual aggregate of at least two million dollars, exclusive of legal defense costs.

(4) The licensee shall allow the offsite response organizations expected to respond in case of an accident sixty days to comment on the licensee's emergency plan before submitting it to the department. The licensee shall provide any comments received within the sixty days to the department with the emergency plan.

(H) Information provided by a licensee or applicant for a license or license renewal that constitutes a "trade secret" as defined in section 1333.61 of the Revised Code is not subject to public disclosure in accordance with sections 1333.61 to 1333.69 of the Revised Code.

(I) An application from a medical facility, or educational institution to produce positron emission tomography (PET) radioactive drugs for noncommercial transfer to licensees in its consortium authorized for medical use in accordance with rules in Chapter 3701:1-58 of the Administrative Code shall include:

(1) A request for authorization for the production of PET radionuclides or evidence of an existing license issued in accordance with rule 3701:1-38-02 of the Administrative Code for a PET radionuclide production facility within its consortium from which it receives PET radionuclides.

(2) Evidence that the applicant is qualified to produce radioactive drugs for medical use by meeting one of the criteria in paragraph (A)(2) of rule 3701:1-46-43 of the Administrative Code.

(3) Identification of individual(s) authorized to prepare the PET radioactive drugs if the applicant is a pharmacy, and documentation that each individual meets the requirements of an authorized nuclear pharmacist as specified in paragraph (B)(2) of rule 3701:1-46-43 of the Administrative Code.

(4) Information identified in paragraph (A)(3) of rule 3701:1-46-43 of the Administrative Code, on the PET drugs to be non-commercially transferred to members of its consortium.

View Appendix

Last updated July 10, 2025 at 12:13 PM

History

• Effective: April 17, 2022
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-40-36

(A) If a final bureau assessment report is required, the report shall become part of the director's decision. The decision shall be clearly identified and shall include the following:

(1) A statement of the decision.

(2) Identification of all alternatives considered by the department, a statement that these alternatives were included in the range of alternatives discussed in the bureau assessment report, and a statement specifying any alternative that is considered to be environmentally preferable.

(3) A discussion of preferences among alternatives based on relevant factors including statutory requirements in Chapter 3748. of the Revised Code.

(4) A statement indicating whether the department has taken all practicable measures to avoid or minimize environmental harm from the alternative selected, and if not, to explain why those measures were not adopted. The statement also shall summarize any license conditions and monitoring programs adopted in connection with mitigation measures.

(B) The decision may be integrated into any other record prepared by the department in connection with the action.

(C) The decision may incorporate by reference material contained in a final bureau assessment report. The applicant may appeal a final decision as provided in rule 3701:1-38-06 of the Administrative Code.

Last updated November 2, 2022 at 2:14 PM

History

• Effective: July 22, 2001
• Promulgated Under: Ch 119.

Ohio Adm.Code 3701:1-40-30

(A) The department shall require an environmental report to be submitted with the license application and a bureau assessment report following the department review of the environmental report in the case of any of the following:

(1) The applicant proposes a major action that could potentially affect the environment as it relates to human health;

(2) Any other action which the director determines is a major action which could potentially affect the environment as it relates to human health;

(3) The applicant applies for a license to possess and use source material for uranium milling or production of uranium hexafluoride pursuant to Chapter 3701:1-44 of the Administrative Code;

(4) The applicant applies for a license or renewal authorizing receipt and disposal of radioactive waste from other persons pursuant to Chapter 3701:1-54 of the Administrative Code.

(5) The applicant applies for a license amendment pursuant to Chapter 3701:1-54 of the Administrative Code authorizing either of the following:

(a) Closure of a land disposal site; or

(b) Transfer of the license to the disposal site owner for the purpose of institutional control; or

(6) Notwithstanding paragraph (C) of this rule, and in accordance with paragraph (B) of this rule, the department may, in special circumstances, require the preparation of an environmental report and bureau assessment report on an action that is listed as a categorical exclusion.

(B) Except in special circumstances as determined by the director at his or her discretion, an environmental report and bureau assessment report is not required in the case of an action included in the list of categorical exclusions set forth in paragraph (C) of this rule. Notwithstanding paragraph (C) of this rule, the director, at his or her discretion, may require an environmental report and bureau assessment report if he or she determines that special circumstances exist because the proposed action involves an unreasonable or unnecessary individual or cumulative risk to the human environment.

(C) The following categories of actions are considered categorical exclusions:

(1) Issuance of an amendment to a license for a radioactive material waste disposal site or an amendment to a radioactive materials license if required by Chapter 3701:1-54 of the Administrative Code which are administrative, organizational, or procedural in nature, or which result in a change in process operations or equipment, provided that:

(a) There is no significant change in the type or significant increase in the amount of any effluent that may be released offsite;

(b) There is no significant increase in individual or cumulative occupational radiation exposure;

(c) There is no significant construction impact; and

(d) There is no significant increase in the potential for or consequences from radiological accidents.

(2) Issuance, amendment or renewal of radioactive materials licenses issued pursuant to this chapter and Chapters 3701:1-44, 3701:1-46, 3701:1-48, 3701:1-49, 3701:1-52, 3701:1-56 and 3701:1-58 of the Administrative Code affecting general licenses, manufacture and distribution, industrial radiography, well logging, irradiators, medical use, source material, special nuclear material of less than critical mass authorizing the following:

(a) Distribution of radioactive materials and devices or products containing radioactive material to general licensees and to persons exempt from licensing;

(b) Distribution of radiopharmaceuticals, generators, reagent kits, or sealed sources to persons licensed in accordance with Chapter 3701:1-58 of the Administrative Code;

(c) Nuclear pharmacies;

(d) Medical and veterinary facilities;

(e) Use of radioactive materials for research and development and for educational purposes;

(f) Industrial radiography;

(g) Irradiators;

(h) Use of sealed sources or gauging devices, analytical instruments or other devices containing sealed sources;

(i) Use of uranium as shielding material in containers or devices;

(j) Possession of radioactive material incident to performing services such as installation, maintenance, leak tests and calibration;

(k) Use of sealed sources or radioactive tracers in well-logging procedures;

(l) Acceptance of packaged radioactive wastes from others for transfer to a licensed disposal facility, provided that the interim storage period for any package does not exceed one hundred eighty days and the total possession limit for all packages held in interim storage at the same time does not exceed 1.85 terabecquerels (fifty curies);

(m) Manufacturing or processing of source, radioactive, or special nuclear materials for distribution to other licensees, except processing of source material for extraction of rare earth and other metals and processing of radioactive material for extraction of metals;

(n) Nuclear laundries;

(o) Possession, manufacturing, processing, shipment, testing, or other use of depleted uranium military munitions; or

(p) Any use of source, radioactive, or special nuclear material not listed in paragraphs (C)(2)(a) to (C)(2)(o) of this rule which involves quantities and forms of source, radioactive, or special nuclear material of quantities less than a critical mass, similar to those listed in paragraphs (C)(2)(a) to (C)(2)(o) of this rule.

Last updated April 19, 2022 at 8:36 AM

History

• Effective: April 17, 2022
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-40-38

(A) The scope of this process applies to the initial licensing, decommissioning, and any major amendment for the following types of facilities: waste disposal, assured isolation storage, waste processing, and facilities required to have an emergency response plan pursuant to paragraph (G) of rule 3701:1-40-14 of the Administrative Code. A major amendment consists of proposed changes to a facility or operations within a facility that would impact radiological operations to the extent that an enhancement of radiation dose to the general public may potentially exist.

(B) Notice of complete license application will be given to the public. A public notice of the pending action will be issued in the local newspaper of general circulation in the county where the applicant is located. The contiguous local governments in proximity to the facility in question will be likewise notified. A copy of the public notice will be placed in the depository library closest to the proposed facility. A notice that the department has received a complete license application for any facility referenced in paragraph (A) of this rule will be provided to everyone on the mailing list of interested parties and the listserv of the bureau of environmental health and radiation protection at the conclusion of the completeness review of an application for such a facility. The notice will also be posted on the department's web page for a period of forty-five days. The public may submit comments on the application to the department for consideration during the forty-five day comment period.

(C) A public participation program will be part of this process. The applicant for a facility listed in paragraph (A) of this rule shall be required to include, in any application for a license or major amendment to a license, the information provided to the public and the mechanism for such provision. This information shall be adequate to portray the types of radiological operations on site, the potential dose to the general population in proximity to the site, precautions to be taken to maintain such exposure ALARA, and how any member of the public can obtain additional information.

(D) The director may establish a public meeting process for the types of actions identified in paragraph (A) of this rule, if the director believes that such is needed in order to adequately address issues associated with the application.

(1) The scope of the meeting shall be limited to whether the application complies with applicable provisions of Chapter 3748. of the Revised Code and all applicable rules adopted thereunder.

(a) The department may hold one or more public meetings on the application at the discretion of the director.

(b) The department shall provide public notice of the meeting to one newspaper having general circulation in the county of the facility and to the individuals specified in paragraph (B) of this rule, including the availability of guidance.

(c) The department shall develop and provide guidance on the process for participation. Individuals may contact the department to obtain a copy of the guidance in advance of the meeting.

(2) The department is responsible for maintaining all records, exhibits, and correspondence submitted or issued in any public meeting. The department will maintain these documents on file for the duration of the license.

(3) The director shall designate a facilitator for any public meeting that is held.

(4) In any public meeting the applicant shall be a participant. Any other person may present information, orally or in writing, at the public meeting.

(5) After publication of a notice of public meeting, participants are afforded the opportunity to submit written presentations. If a participant provides a written presentation, the presentation shall describe in detail any deficiency resulting in a regulatory noncompliance in the license application, why such is deficient, and the relief sought.

(6) The facilitator shall allow oral presentations. Oral presentations shall focus on the content requirements specified in paragraph (D)(5) of this rule. Time limits may also be imposed by the facilitator.

(7) The processing of information received by the department shall be as follows:

(a) All information received concerning the application shall be considered by the department in deliberations for approval or denial of the license application under consideration.

(b) No later than forty-five days after the meeting, the department shall issue a written summary of the information presented pursuant to this rule. The report will be available on the department's web page.

(c) Written comments may be submitted to the department within two weeks following issuance of a summary report by the department on the public meeting.

(8) The applicant for a facility license shall pay all costs associated with the conduct of any public meeting(s) conducted pursuant to this rule. The costs associated with the meeting shall be invoiced at full cost in accordance with paragraph (M) of rule 3701:1-38-02 of the Administrative Code.

Last updated April 19, 2022 at 8:37 AM

History

• Effective: April 17, 2022
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-40-16

(A)

(1) A license, or any right under a license, shall not be transferred, assigned or in any manner disposed of, either voluntarily or involuntarily, directly or indirectly, through transfer of control of any license to any person, unless the director finds that the transfer is in accordance with this rule and Chapters 3701:1-46, 3701:1-48, 3701:1-49, 3701:1-52, and 3701:1-58 of the Administrative Code. A license or any right contained therein may not be transferred or conveyed without the written authorization of the director. If the director approves the transfer and receives payment of the appropriate licensing fee, a new license will be issued to the transferee.

(2) An application for transfer of license must include:

(a) The identity, technical and financial qualifications of the proposed transferee; and

(b) Financial assurance for decommissioning information required by rule 3701:1-40-17 of the Administrative Code.

(B) Each licensee shall confine possession and use of radioactive material to the locations and purposes authorized in the license. Preparation for shipment and transport of radioactive material shall be in accordance with Chapter 3701:1-50 of the Administrative Code.

(C) The director may incorporate at the time of issuance, or thereafter by appropriate rule, regulation, or order, such additional requirements or conditions with respect to the licensee's receipt, possession, use and transfer of radioactive material as the director deems appropriate or necessary in order to protect the environment, protect health, or minimize danger to life or property. The director may require such reports and the keeping of such records, and provide for such inspections of activities under the license as may be necessary to effectuate the purposes of Chapter 3748. of the Revised Code or rules adopted thereunder.

(D) A licensee that is required to submit an emergency plan pursuant to rule 3701:1-40-14 of the Administrative Code shall follow the emergency plan approved by the director. The licensee may amend the approved plan without approval of the director provided that the amendment does not decrease the effectiveness of the plan. Within six months after amending the emergency plan, the licensee shall furnish the amended plan to both the director and to affected offsite response organizations. Any proposed amendment to the emergency plan that decreases, or potentially decreases, the effectiveness of the approved emergency plan may not be implemented without prior approval by the director.

(E) Each licensee preparing technetium-99m radiopharmaceuticals from molybdenum-99/technetium-99m generators or rubidium-82 from strontium-82/rubidium-82 generators shall test the generator eluates for molybdenum-99 breakthrough or strontium-82 and strontium-85 contamination, respectively, in accordance with rule 3701:1-58-35 of the Administrative Code. The licensee shall record the results of each test and retain each record for three years after the record is made. The licensee shall report the results of any test that exceeds the permissible concentration listed in paragraph (A) of rule 3701:1-58-35 of the Administrative Code at the time of generator elution, in accordance with rule 3701:1-58-105 of the Administrative Code.

(F) Each licensee must notify the director by certified mail within ten business days of the commencement of a voluntary or involuntary bankruptcy petition that has been filed by or against:

(1) The licensee;

(2) An entity, defined in this rule as person, estate, trust, governmental unit, and United States trustee, controlling the licensee or listing the license or licensee as property of the estate; or

(3) An affiliate of the licensee defined in this rule as an entity that directly or indirectly owns, controls, or holds with power to vote, twenty per cent or more of the outstanding voting securities of the debtor, other than an entity that holds such securities:

(a) In a fiduciary or agency capacity without sole discretionary power to vote such securities; or

(b) Solely to secure a debt, if such entity has not in fact exercised such power to vote.

The notification shall specify the bankruptcy court in which the petition for bankruptcy was filed and the date of the filing petition.

(G) The director may, upon application including adequate documentation by a person or by his own initiative, grant such exemptions from the requirements of this chapter or other chapters of the Administrative Code involving radioactive materials promulgated under Chapter 3748. of the Revised Code that are authorized by law and will not result in undue hazard to life or property and are otherwise in the public interest.

(H) Each portable gauge licensee shall use a minimum of two independent physical controls that form tangible barriers to secure portable gauges from unauthorized removal, whenever portable gauges are not under the control and constant surveillance of the licensee.

(I)

(1) Authorization under paragraph (I) of rule 3701:1-40-14 of the Administrative Code to produce positron emission tomography (PET) radioactive drugs for noncommercial transfer to medical use licensees in its consortium does not relieve the licensee from complying with applicable United States federal drug administration, other federal, and state requirements governing radioactive drugs.

(2) Each licensee authorized under paragraph (I) of rule 3701:1-40-14 of the Administrative Code to produce PET radioactive drugs for noncommercial transfer to medical use licensees in its consortium shall:

(a) Satisfy the labeling requirements in paragraph (A)(4) of rule 3701:1-46-43 of the Administrative Code for each PET radioactive drug transport radiation shield and each syringe, vial, or other container used to hold a PET radioactive drug intended for noncommercial distribution to members of its consortium.

(b) Possess and use instrumentation to measure the radioactivity of the PET radioactive drugs intended for noncommercial distribution to members of its consortium and meet the procedural, radioactivity measurement, instrument test, instrument check, and instrument adjustment requirements in paragraph (C) of rule 3701:1-46-43 of the Administrative Code.

(3) A licensee that is a pharmacy authorized under paragraph (I) of rule 3701:1-40-14 of the Administrative Code to produce PET radioactive drugs for noncommercial transfer to medical use licensees in its consortium shall require that any individual that prepares PET radioactive drugs shall be:

(a) An authorized nuclear pharmacist that meets the requirements in paragraph (B)(2) of rule 3701:1-46-43 of the Administrative Code, or

(b) An individual under the supervision of an authorized nuclear pharmacist as specified in rule 3701:1-58-14 of the Administrative Code.

(4) A pharmacy, authorized under paragraph (I) of rule 3701:1-40-14 of the Administrative Code to produce PET radioactive drugs for noncommercial transfer to medical use licensees in its consortium that allows an individual to work as an authorized nuclear pharmacist, shall meet the requirements of paragraph (B)(5) of rule 3701:1-46-43 of the Administrative Code.

Last updated August 17, 2021 at 11:43 PM

History

• Effective: August 15, 2021
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-46-43

(A) An application for a specific license to manufacture, prepare, or transfer for commercial distribution radioactive drugs containing radioactive material for use by persons authorized pursuant to Chapter 3701:1-58 of the Administrative Code or equivalent regulations of an agreement state will be approved if:

(1) The applicant satisfies the general requirements specified in rule 3701:1-40-15 of the Administrative Code;

(2) The applicant submits evidence that the applicant is at least one of the following:

(a) Registered with the United States food and drug administration as the owner or operator of a drug establishment that engages in the manufacture, preparation, propagation, compounding, or processing of a drug under 21 C.F.R. 207.20(a) (as in effect on the effective date of this rule);

(b) Registered or licensed with a state agency as a drug manufacturer;

(c) Licensed as a pharmacy by a state board of pharmacy;

(d) Operating as a nuclear pharmacy within a federal medical institution; or

(e) A positron emission tomography (PET) drug production facility registered with a state agency.

(3) The applicant submits information on the radionuclide; the chemical and physical form; the maximum activity per vial, syringe, generator, or other container of the radioactive drug; and the shielding provided by the packaging to show it is appropriate for the safe handling and storage of the radioactive drugs by medical use licensees; and

(4) The applicant commits to the following labeling requirements:

(a) A label is affixed to each transport radiation shield, whether it is constructed of lead, glass, plastic, or other material, of a radioactive drug to be transferred for commercial distribution. The label must include the radiation symbol and the words "CAUTION, RADIOACTIVE MATERIAL" or "DANGER, RADIOACTIVE MATERIAL"; the name of the radioactive drug or its abbreviation; and the quantity of radioactivity at a specified date and time. For radioactive drugs with a half-life greater than one hundred days, the time may be omitted.

(b) A label is affixed to each syringe, vial, or other container used to hold a radioactive drug to be transferred for commercial distribution. The label must include the radiation symbol and the words "CAUTION, RADIOACTIVE MATERIAL" or "DANGER, RADIOACTIVE MATERIAL" and an identifier that ensures that the syringe, vial, or other container can be correlated with the information on the transport radiation shield label.

(B) A licensee described by paragraph (A)(2)(c) or (A)(2)(d) of this rule:

(1) May prepare radioactive drugs for medical use, as defined in rule 3701:1-38-01 of the Administrative Code, provided that the radioactive drug is prepared by either an authorized nuclear pharmacist, as specified in paragraphs (B)(2) and (B)(3) of this rule, or an individual under the supervision of an authorized nuclear pharmacist as specified in rule 3701:1-58-14 of the Administrative Code.

(2) May allow a pharmacist to work as an authorized nuclear pharmacist if:

(a) This individual qualifies as an authorized nuclear pharmacist as defined in rule 3701:1-58-01 of the Administrative Code,

(b) This individual meets the requirements specified in paragraph (B) of rule 3701:1-58-20 of the Administrative Code and rule 3701:1-58-22 of the Administrative Code and the licensee has received an approved license amendment identifying this individual as an authorized nuclear pharmacist, or

(c) This individual is designated as an authorized nuclear pharmacist in accordance with paragraph (B)(4) of this rule.

(3) The actions authorized in paragraphs (B)(1) and (B)(2) of this rule are permitted in spite of more restrictive language in license conditions.

(4) May designate a pharmacist as an authorized nuclear pharmacist if:

(a) The individual was a nuclear pharmacist preparing only radioactive drugs containing accelerator-produced radioactive material, and

(b) The individual practiced at a pharmacy at a government agency or federally recognized indian tribe before November 30, 2007 or at all other pharmacies before August 8, 2009, or an earlier date as noticed by the United States nuclear regulatory commission.

(5) Shall provide to the director a copy of:

(a) A copy of each individual's certification by a specialty board whose certification process has been recognized by the United States nuclear regulatory commission or an agreement state as specified in paragraph (A) of rule 3701:1-58-20 of the Administrative Code; or

(b) The United States nuclear regulatory commission or agreement state license; or

(c) The permit issued by a United States nuclear regulatory commission master materials licensee; or

(d) The permit issued by a licensee or United States nuclear regulatory commission master materials permittee of broad scope; or

(e) The authorization from a commercial nuclear pharmacy authorized to list its own authorized nuclear pharmacist; or

(f) Documentation that only accelerator-produced radioactive materials were used in the practice of nuclear pharmacy at a government agency or federally recognized indian tribe before November 30, 2007, or at all other locations of use before August 8, 2009, or an earlier date as noticed by the United States nuclear regulatory commission; and

(g) State pharmacy licensure or registration, no later than thirty days after the date that the licensee allows, under paragraphs (B)(2)(a) and (B)(2)(c) of this rule, the individual to work as an authorized nuclear pharmacist.

(C) A licensee shall possess and use instrumentation to measure the radioactivity of radioactive drugs. The licensee shall have procedures for use of the instrumentation. The licensee shall measure, by direct measurement or by combination of measurements and calculations, the amount of radioactivity in dosages of alpha-, beta-, or photon-emitting radioactive drugs prior to transfer for commercial distribution. In addition, the licensee shall:

(1) Perform tests before initial use, periodically, and following repair, on each instrument for accuracy, linearity, and geometry dependence, as appropriate for the use of the instrument; and make adjustments when necessary; and

(2) Check each instrument for constancy and proper operation at the beginning of each day of use.

(D) A licensee shall satisfy the labeling requirements in paragraph (A)(4) of this rule.

(E) Nothing in this rule relieves the licensee from complying with applicable United States food and drug administration, other federal, and state requirements governing radioactive drugs.

Last updated August 1, 2023 at 2:36 PM

History

• Effective: August 15, 2021
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-40-15 General requirements for issuance of specific licenses.

(A) An application for a specific license will be approved if:

(1) The application is for a purpose authorized by Chapter 3748. of the Revised Code and the rules adopted thereunder;

(2) The applicant's proposed equipment and facilities are adequate to protect health and minimize danger to life or property or the environment;

(3) The applicant is qualified by training and experience to use the radioactive material for the purpose requested in such manner as to protect health and minimize danger to life or property or the environment;

(4) The applicant satisfies any special requirements contained in rule 3701:1-38-02 of the Administrative Code, and Chapters 3701:1-46, 3701:1-48, 3701:1-49, 3701:1-52, and 3701:1-58 of the Administrative Code; and

(5) In the case of an application for a license to receive and possess radioactive material for the conduct of any activity which the director determines could potentially affect the quality of the environment, the department, before commencement of construction of the plant or facility in which the activity will be conducted, on the basis of information filed and evaluations made pursuant to rule 3701:1-40-30 of the Administrative Code, has concluded, after weighing the environmental, economic, technical, and other benefits against environmental costs and considering available alternatives, shall conclude that the action called for is the issuance of the proposed license, with any appropriate conditions to protect environmental values. Commencement of construction prior to such conclusion shall be grounds for denial of a license to receive and possess radioactive material in such plant or facility. As used in this paragraph the term "commencement of construction" is as defined in rule 3701:1-38-01 of the Administrative Code.

(B) Upon a determination that an application meets the requirements of Chapter 3748. of the Revised Code and the rules adopted thereunder, the director will issue a specific license authorizing the possession and use of radioactive material.

Last updated November 2, 2022 at 2:12 PM

History

• Effective: July 25, 2013
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-40-17

(A) Prior to the director issuing a radioactive materials license:

(1) Each applicant for a specific license or license renewal authorizing the possession and use of unsealed radioactive material of half-life greater than one hundred twenty days and in quantities exceeding ten thousand times the applicable quantities set forth in appendix A to this rule shall submit a decommissioning funding plan as described in paragraph (D) of this rule. The decommissioning funding plan must also be submitted when a combination of radionuclides is involved if R divided by ten thousand is greater than one, where R is defined here as the sum of the ratios of the quantity of each radionuclide to the applicable value in appendix A to this rule.

(2) Each applicant for a specific license or license renewal authorizing the possession and use of sealed sources or plated foils of half-life greater than one hundred twenty days and in quantities exceeding one trillion times the applicable quantities of appendix A to this rule, shall submit a decommissioning funding plan as described in paragraph (D) of this rule. The decommissioning funding plan must also be submitted when a combination of radionuclides is involved if R divided by one trillion is greater than one, where R is defined here as the sum of the ratios of the quantity of each radionuclide to the applicable value in appendix A to this rule.

(B) Prior to the director issuing a radioactive materials license, each applicant for a specific license or license renewal authorizing possession and use of radioactive material of half-life greater than one hundred twenty days and in quantities specified in paragraph (C) of this rule shall either:

(1) Submit a decommissioning funding plan as described in paragraph (D) of this rule; or

(2) Submit a certification that financial assurance for decommissioning has been provided in the amount prescribed by paragraph (C) of this rule using one of the methods described in paragraph (E) of this rule. The applicant shall submit to the director, as part of the certification, a signed original of the financial instrument obtained to satisfy the requirements of paragraph (E) of this rule.

(C) Prior to the director issuing a radioactive materials license, an applicant providing certification of financial assurance for decommissioning as specified in paragraph (B)(2) of this rule shall provide the certification in a monetary amount based upon the quantity of licensed material specified as follows:

(1) Greater than one thousand but less than or equal to ten thousand times the applicable quantities of appendix A to this rule in unsealed form. For a combination of radionuclides, if R, as defined in paragraph (A) of this rule, divided by one thousand is greater than one but R divided by ten thousand is less than or equal to one, the sum of three hundred thousand dollars.

(2) Greater than ten billion but less than one trillion times the applicable quantities of appendix A to this rule in sealed sources or plated foils. For a combination of radionuclides, if R, as defined in paragraph (A) of this rule, divided by ten billion is greater than one but R divided by one trillion is less than or equal to one, the sum of one hundred fifty thousand dollars.

(D) .

(1) Each decommissioning funding plan must be submitted for review and approval and must contain:

(a) A detailed cost estimate for decommissioning, in an amount reflecting:

(i) The cost of an independent contractor to perform all decommissioning activities;

(ii) The cost of meeting the criteria specified in paragraph (B) of rule 3701:1-38-22 of the Administrative Code for unrestricted use, provided that, if the applicant or licensee can demonstrate its ability to meet the provisions of paragraph (D) of rule 3701:1-38-22 of the Administrative Code, the cost estimate may be based on meeting this criteria;

(iii) The volume of onsite subsurface material containing residual radioactivity that will require remediation to meet the criteria for license termination; and

(iv) An adequate contingency factor.

(b) Identification of and justification for using the key assumptions contained in the decommissioning cost estimate;

(c) A description of the method of assuring funds for decommissioning from paragraph (E) of this rule, including means for adjusting cost estimates and associated funding levels periodically over the life of the facility;

(d) A certification by the licensee that financial assurance for decommissioning has been provided in the amount of the cost estimate for decommissioning; and

(e) A signed original of the financial instrument obtained to satisfy the requirements of paragraph (E) of this rule (unless a previously submitted and accepted financial instrument continues to cover the cost estimate for decommissioning).

(2) At the time of license renewal and at intervals not to exceed three years, the decommissioning funding plan must be resubmitted with adjustments as necessary to account for the changes in costs and the extent of contamination. If the amount of financial assurance will be adjusted downward, this cannot be done until the updated decommissioning funding plan is approved. The decommissioning funding plan must update the information submitted with the original or prior approved plan, and must specifically consider the effect of the following events on decommissioning costs:

(a) Spills of radioactive material producing additional residual radioactivity in onsite subsurface material;

(b) Waste inventory increasing above the amount previously estimated;

(c) Waste disposal costs increasing above the amount previously estimated;

(d) Facility modifications;

(e) Changes in authorized possession limits;

(f) Actual remediation costs that exceed the previous cost estimate;

(g) Onsite disposal; and

(h) Use of a settling pond.

(E) Financial assurance for decommissioning, either by a decommissioning funding plan or certification of financial assurance, shall be provided by the licensee and approved by the director prior to the issuance of the license and shall be provided by one or more of the following methods:

(1) Prepayment by depositing into an account segregated from licensee assets and outside the licensee's administrative control, cash or liquid assets such that the amount of funds will be sufficient to pay decommissioning costs. Prepayment may be in the form of a trust, escrow account, government fund, certificate of deposit, or deposit of government securities.

(2) Surety, insurance, or other method in accordance with paragraph (F) of this rule, that guarantees that decommissioning costs will be paid. A surety method may be in the form of a surety bond, letter of credit, or line of credit. A guarantee by the applicant or licensee may not be used in combination with any other financial methods used to satisfy the requirements of this paragraph or in any situation where the applicant or licensee has a parent company holding majority control of the voting stock of the company.

(3) A parent company guarantee of funds for decommissioning costs based on a financial test may be used provided that the parent company meets the requirements specified in appendix B of this rule. A parent company guarantee may not be used in combination with other financial methods to satisfy the requirements of this rule.

(4) For commercial corporations that issue bonds, a guarantee of funds by the applicant or licensee for decommissioning costs based on a financial test may be used provided that the guarantee meets the requirements of appendix C to this rule.

(5) For commercial companies that do not issue bonds, a guarantee of funds for decommissioning costs may be used provided that the guarantee meets the requirements of appendix D to this rule.

(6) For nonprofit colleges, universities, hospitals, or research and development entities, a guarantee of funds for decommissioning costs may be used provided that the guarantee meets the requirements of appendix E to this rule. The director may require proof of nonprofit status.

(7) An external sinking fund in which deposits are made at least annually, coupled with a surety method or insurance, the value of which may decrease by the amount being accumulated in the sinking fund. An external sinking fund is a fund established and maintained by setting aside funds periodically in an account segregated from licensee assets and outside the licensee's administrative control in which the total amount of funds would be sufficient to pay decommissioning costs at the time termination of operation is expected. An external sinking fund may be in the form of a trust, escrow account, government fund, certificate of deposit, or deposit of government securities. The surety or insurance provisions must be as stated in paragraph (F) of this rule.

(8) In the case of state or local government licensee, a statement of intent containing a cost estimate for decommissioning or an amount specified in paragraphs (C)(1) to (C)(2) of this rule, and indicating that funds for decommissioning will be obtained when necessary. As used in this rule, "state or local government licensee" does not include government owned or assisted colleges, universities or hospitals.

(F) Any surety method or insurance used to provide financial assurance for decommissioning shall be in the form of instruments that contain language as provided in appendix F to this rule, and shall contain the following conditions:

(1) The surety method or insurance must be open-ended or, if written for a specified term, such as five years, must be renewed automatically unless ninety days or more prior to the renewal date, the issuer notifies the director, the beneficiary, and the licensee of its intention not to renew. The surety method or insurance must also provide that the full face amount be paid to the beneficiary automatically prior to the expiration without proof of forfeiture if the licensee fails to provide a replacement acceptable to the director within thirty days after receipt of notification of cancellation.

(2) The surety method or insurance must be payable to a trust established for decommissioning costs. The trustee and trust must be acceptable to the director. An acceptable trustee includes an appropriate state or federal government agency or an entity which has the authority to act as a trustee and whose trust operations are regulated and examined by a federal or state agency.

(3) The surety method or insurance must remain in effect until the director has terminated the license.

(4) The surety company issuing the bond must, at a minimum, be among those listed as acceptable in the "Circular 570" of the United States department of the treasury (as in effect on the effective date of this rule).

(G) A licensee must notify the director by certified mail within ten business days of the commencement of a voluntary or involuntary bankruptcy proceeding under Title 11 of the United States Code (as amended April 20, 2005). A licensee who fulfills the financial assurance requirements by obtaining a trust fund, surety bond, or other acceptable financial assurance will be deemed to be without the required financial assurance or liability coverage in the event of bankruptcy of the trustee or issuing institution, or a suspension or revocation of the authority of the trustee institution issuing the instrument. The licensee shall establish other financial assurance within sixty days after such an event.

(H) Financial assurance for decommissioning, either by a decommissioning funding plan or certification of financial assurance, that is provided by a contract of insurance shall not include any arrangement that constitutes self-insurance. As used in this rule:

(1) "Insurance" means a contract issued or underwritten by an insurance company, insurance service, or insurance organization which is licensed to engage in the business of insurance in Ohio, that binds the insurer to indemnify another against a specified loss in return for premiums paid.

(2) "Self insurance" means a contract of insurance issued either by the licensee or by an insurer affiliated with or an affiliate of the licensee.

(3) "Affiliate of" or "affiliated with" means that the licensee, either directly or indirectly, through one or more intermediaries or subsidiaries, controls, is controlled by, or is under common control with the insurer.

(4) "Control", including "controlled by", and "under common control with" means the possession, direct or indirect, of the power to direct or cause the direction of the management and policies of a person, whether through the ownership of voting securities, by contract, proxy, membership on the board, or otherwise.

(I) Each person licensed under this chapter, and rule 3701:1-38-02 of the Administrative Code as well as chapters containing rules regarding manufacturing and distribution (Chapter 3701:1-46 of the Administrative Code), industrial radiography (Chapter 3701:1-48 of the Administrative Code), well logging Chapter 3701:1-49 of the Administrative Code), irradiators (Chapter 3701:1-52 of the Administrative Code), and medical use (Chapter 3701:1-58 of the Administrative Code) promulgated pursuant to Chapter 3748. of the Revised Code shall keep records of information important to the decommissioning of a facility in an identified location until the site is released for unrestricted use. Before licensed activities are transferred or assigned in accordance with paragraph (B) of rule 3701:1-40-20 of the Administrative Code, a licensee shall transfer all records described in this paragraph to the new licensee, which will be responsible for maintaining these records until the license is terminated. If records important to the decommissioning of a facility are kept for other purposes, reference to these records and their locations may be used. As used in this rule, "information important to the decommissioning of a facility" includes the following:

(1) Records of spills or other unusual occurrences involving the spread of contamination in and around the facility, equipment, or site. These records may be limited to instances when contamination remains after any cleanup procedures or when there is reasonable likelihood that contaminants may have spread to inaccessible areas as in the case of possible seepage into porous materials such as concrete. These records must include any known information on identification of involved radionuclides, quantities, forms, and concentrations.

(2) As-built drawings and modifications of structures and equipment in restricted areas where radioactive materials are used or stored, and of locations of possible inaccessible contamination such as buried pipes which may be subject to contamination. If required drawings are referenced, each relevant document need not be indexed individually. If drawings are not available, the licensee shall substitute appropriate records of available information concerning these areas and locations.

(3) Except in the case of an area that contains only a sealed source, provided the source has not leaked or no contamination remains after any leak, or in the case of a byproduct or accelerator produced material having only a half-life of less than sixty-five days, a list contained in a single document and updated every two years, of the following:

(a) All areas designated and formerly designated restricted areas as defined in rule 3701:1-38-01 of the Administrative Code.

(b) All areas outside of restricted areas that require documentation under paragraph (I)(1) of this rule.

(c) All areas outside of restricted areas where current and previous wastes have been buried as documented under rule 3701:1-38-20 of the Administrative Code; and

(d) All areas outside of restricted areas that contain material such that, if the license expired, the licensee would be required to either decontaminate the area to meet the criteria for decommissioning in rule 3701:1-38-22 of the Administrative Code, or apply for approval for disposal under rule 3701:1-38-19 of the Administrative Code.

(4) Records of the cost estimate performed for the decommissioning funding plan or of the amount certified for decommissioning, and records of the funding method used for assuring funds if either a funding plan or certification is used.

View AppendixView AppendixView AppendixView AppendixView AppendixView Appendix

Last updated April 19, 2022 at 8:35 AM

History

• Effective: April 17, 2022
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-58-35

(A) A licensee may not administer to humans a radiopharmaceutical that contains:

(1) More than 0.15 kilobecquerel of molybdenum-99 per megabecquerel of technetium-99m (0.15 microcurie of molybdenum-99 per millicurie of technetium-99m); or

(2) More than 0.02 kilobecquerel of strontium-82 per megabecquerel of rubidium-82 chloride injection (0.02 microcurie of strontium-82 per millicurie of rubidium-82 chloride); or more than 0.2 kilobecquerel of strontium-85 per megabecquerel of rubidium-82 chloride injection (0.2 microcurie of strontium-85 per millicurie of rubidium-82).

(B) A licensee that uses molybdenum-99/technetium-99m generators for preparing a technetium-99m radiopharmaceutical shall measure the molybdenum-99 concentration of the first eluate from a generator to demonstrate compliance with paragraph (A) of this rule.

(C) A licensee that uses a strontium-82/rubidium-82 generator for preparing a rubidium-82 radiopharmaceutical shall, before the first patient use of the day, measure the concentration of radionuclides strontium-82 and strontium-85 to demonstrate compliance with paragraph (A) of this rule.

(D) If a licensee is required to measure the molybdenum-99 concentration or strontium-82 and strontium-85 concentrations, the licensee shall retain a record of each measurement in accordance with rule 3701:1-58-85 of the Administrative Code.

(E) The licensee shall report any measurement that exceeds the limits in paragraph (A) of this rule at the time of generator elution, in accordance with rule 3701:1-58-105 of the Administrative Code.

Last updated November 18, 2022 at 8:33 AM

History

• Effective: August 15, 2021
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-58-105

(A) The licensee shall notify by telephone the department at 614-644-2727 and the distributor of the generator within seven calendar days after discovery that an eluate exceeded the permissible concentration listed in paragraph (A) of rule 3701:1-58-35 of the Administrative Code at the time of generator elution. The telephone report to the department must include the manufacturer, model number, and serial number (or lot number) of the generator; the results of the measurement; the date of the measurement; whether dosages were administered to patients or human research subjects, when the distributor was notified, and the action taken.

(B) By an appropriate method listed in rule 3701:1-40-04 of the Administrative Code, the licensee shall submit a written report to the department within thirty calendar days after discovery of an eluate exceeding the permissible concentration at the time of generator elution. The written report must include the action taken by the licensee; the patient dose assessment; the methodology used to make this dose assessment if the eluate was administered to patients or human research subjects; and the probable cause and an assessment of failure in the licensee's equipment, procedures or training that contributed to the excessive readings if an error occurred in the licensee's breakthrough determination; and the information in the telephone report as required by paragraph (A) of this rule.

Last updated November 18, 2022 at 8:43 AM

History

• Effective: August 15, 2021
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-58-14

(A) A licensee that permits the receipt, possession, use, or transfer of radioactive material by an individual under the supervision of an authorized user, as allowed by paragraph (B)(1) of rule 3701:1-58-06 of the Administrative Code, shall:

(1) In addition to the requirements in rule 3701:1-38-10 of the Administrative Code, instruct the supervised individual in the licensee's written radiation protection procedures, written directive procedures, regulations of this chapter, and license conditions with respect to the use of radioactive material; and

(2) Require the supervised individual to follow the instructions of the supervising authorized user for medical uses of radioactive material, written radiation protection procedures established by the licensee, written directive procedures, regulations of this chapter, and license conditions with respect to the medical use of radioactive material.

(B) A licensee that permits the preparation of radioactive material for medical use by an individual under the supervision of an authorized nuclear pharmacist or physician who is an authorized user, as allowed by paragraph (B)(2) of rule 3701:1-58-06 of the Administrative Code shall:

(1) In addition to the requirements in rule 3701:1-38-10 of the Administrative Code, instruct the supervised individual in the preparation of radioactive material for medical use, as appropriate to that individual's involvement with radioactive material; and

(2) Require the supervised individual to follow the instructions of the supervising authorized user or authorized nuclear pharmacist regarding the preparation of radioactive material for medical use, written radiation protection procedures established by the licensee, the rules of this chapter, and license conditions.

(C) A licensee that permits supervised activities under paragraphs (A) and (B) of this rule is responsible for the acts and omissions of the supervised individual.

Last updated November 18, 2022 at 8:30 AM

History

• Effective: August 15, 2005
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-38-22

(A) This rule applies to the decommissioning of facilities licensed under Chapter 3748. of the Revised Code. For low-level waste disposal facilities, this rule applies only to ancillary surface facilities that support radioactive waste disposal activities. This rule does not apply to uranium and thorium recovery facilities already subject to source material licensing requirements in Chapter 3701:1-44 of the Administrative Code or to uranium solution extraction facilities.

(B) Decommissioning with license termination shall be limited to sites considered acceptable for unrestricted release where the residual radioactivity that is distinguishable from background radiation results in a total effective dose equivalent (TEDE) to an average member of the critical group that does not exceed 0.25 millisievert (twenty-five millirem) per year, including that from groundwater sources of drinking water, and the residual radioactivity has been reduced to levels that are as low as reasonably achievable (ALARA). Determination of the levels which are ALARA must take into account consideration of detriments, such as deaths from transportation accidents, expected to potentially result from decontamination and waste disposal.

(C) After a facility has been decommissioned and the license terminated in accordance with the criteria in this rule, the director will require additional cleanup only if, based on new information, it is determined that the criteria of this rule were not met and residual radioactivity remaining at the site could result in a significant threat to public health and safety. When calculating TEDE to the average member of the critical group the licensee shall determine the peak annual TEDE dose expected within the first one thousand years after decommissioning.

(D) A licensee may decommission a facility and maintain a decommissioning possession only license using alternate criteria greater than the dose criterion specified in paragraph (B) of this rule, provided that the licensee:

(1) Provides assurance that public health and safety would continue to be protected, and that it is unlikely that the dose from all man-made sources combined, other than medical, would be more than the one millisievert (one hundred millirem) per year limit set forth in this chapter, by submitting an analysis of possible sources of exposure;

(2) Has employed, to the extent practicable, restrictions on site use in minimizing exposures at the site;

(3) Reduces doses to ALARA levels, taking into consideration any detriments, such as traffic accidents expected to potentially result from decontamination and waste disposal; and

(4) Has submitted a decommissioning plan or license termination plan (LTP) to the director indicating the licensee's intent to decommission in accordance with rule 3701:1-40-18 of the Administrative Code, and specifying that the licensee proposes to decommission by restricting use of the site. The licensee shall document in the decommissioning plan or LTP how the advice of individuals and institutions in the community who may be affected by the decommissioning has been sought and incorporated, as appropriate, following analysis of that advice. In seeking such advice, the licensee shall provide for:

(a) Participation by representatives of a broad cross section of community interests who may be affected by the decommissioning;

(b) An opportunity for a comprehensive, collective discussion on the issues by the participants represented; and

(c) A publicly available summary of the results of all such discussions, including a description of the individual viewpoints of the participants on the issues and the extent of agreement and disagreement among the participants on the issues.

(5) Has provided sufficient financial assurance in the form of a trust fund to enable an independent third party, including a governmental custodian of a site, to assume and carry out responsibilities for any necessary control and maintenance of the site.

(E) When a decommissioning with restrictions is proposed by a licensee, a decommissioning possession only license is required to assure that the provisions of the decommissioning plan as approved by the director remain effective. The license will contain a condition that the director will not require further cleanup unless he or she determines that the criteria of this rule or terms of the license were not met or that residual radioactivity at the site could result in a significant threat to public health and safety.

(F) Any facility that has been decommissioned and has had the United States nuclear regulatory commission license terminated in accordance with a plan approved by the commission on or before August 31, 1999, will not be required to obtain a license or conduct further cleanup unless the director determines that residual radioactivity at the site could result in a significant threat to the public health and safety.

(G) Applicants for licenses, other than renewals, shall describe in the application how facility design and procedures for operation will minimize, to the extent practical, contamination of the facility and the environment, facilitate eventual decommissioning, and minimize, to the extent practical, the generation of radioactive waste.

(H) Licensees shall, to the extent practical, conduct operations to minimize the introduction of residual radioactivity into the site, including the subsurface, in accordance with the existing radiation protection requirements in rule 3701:1-38-11 of the Administrative Code and radiological criteria for license termination in accordance with this rule.

Last updated November 2, 2022 at 2:10 PM

History

• Effective: August 30, 2015
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-40-20

(A) Except as provided in paragraph (D) of this rule, each licensee shall notify the department as soon as possible, but not later than four hours after the discovery of an event that prevents immediate protective action necessary to avoid exposure to radiation or radioactive material that could exceed regulatory limits, or a release of licensed material that could exceed regulatory limits. An event that requires such an immediate report may include a fire, explosion, or toxic gas release.

(B) Each licensee shall notify the department within twenty-four hours after the discovery of any of the following events involving licensed material:

(1) An unplanned contamination event that involves:

(a) Access to the contaminated area, by workers or the public, to be restricted for more than twenty-four hours by imposing additional radiological controls or by prohibiting entry into the area;

(b) A quantity of material greater than five times the lowest annual limit on intake specified in the appendices to rule 3701:1-38-12 of the Administrative Code; and

(c) Access to the area restricted for a reason other than to allow radionuclides with a half-life of less than twenty-four hours to decay prior to decontamination.

(2) An event in which equipment is disabled or fails to function as designed when:

(a) The equipment is required by regulation or license condition to prevent a release exceeding regulatory limits, to prevent exposure to radiation or radioactive material exceeding regulatory limits, or to mitigate the consequences of an accident;

(b) The equipment is required to be available and operable when it is disabled or fails to function; and

(c) No redundant equipment is available and operable to perform the required safety function.

(3) An event that requires unplanned medical treatment of an individual with spreadable radioactive contamination on the individual's clothing or body.

(4) An unplanned fire or explosion damaging any licensed material or any device, container, or equipment containing licensed material when:

(a) The quantity of material involved is greater than five times the lowest annual limit on intake specified in the appendices to rule 3701:1-38-12 of the Administrative Code; and

(b) The damage affects the integrity of the licensed material or its container.

(C) The licensee shall prepare and submit a report in response to the requirements of this rule as follows:

(1) Licensees shall make reports required by paragraphs (A) and (B) of this rule by telephone, to the department at the telephone number listed in the notice to employees required by paragraph (A)(1)(e) of rule 3701:1-38-10 of the Administrative Code. To the extent that the information is available at the time of notification, the information provided in these reports must include:

(a) The caller's name and call back telephone number;

(b) A description of the event, including date and time;

(c) The exact location of the event;

(d) The radionuclides, quantities, and chemical and physical form of the licensed material involved; and

(e) Any personnel radiation exposure data available.

(2) Each licensee who makes a report required by paragraph (A) or (B) of this rule shall submit a written follow-up report within thirty days of the initial report. Written reports prepared pursuant to other regulations may be submitted to fulfill this requirement if the report contains all of the necessary information and the appropriate distribution is made. These written reports shall be sent to the department in the manner specified in rule 3701:1-40-04 of the Administrative Code. The report must include the following:

(a) A description of the event, including the probable cause and the manufacturer and model number, if applicable, of any equipment that failed or malfunctioned;

(b) The exact location of the event;

(c) The radionuclides, quantities, and chemical and physical form of the licensed material involved;

(d) Date and time of the event;

(e) Corrective actions taken or planned and the results of any evaluations or assessments; and

(f) The extent of exposure of individuals to radiation or to radioactive materials without identification of individuals by name.

(D) This rule applies to all licensees possessing material licensed under rule 3701:1-38-02 of the Administrative Code. This rule does not apply to material under a license subject to the notification requirements in 10 C.F.R. 50.72 (as in effect on the effective date of this rule).

(E) An applicant for a license or a licensee shall notify the department within two working days of information identified by the applicant or licensee as having for the regulated activity, an active adverse impact on equipment or personnel readily obvious by human observation or instrumentation, or a radiological impact on personnel or the environment in excess of regulatory limits. An applicant or licensee violates this paragraph only if the applicant or licensee fails to notify the director of information that the applicant or licensee has or should have identified.

Last updated April 19, 2022 at 8:35 AM

History

• Effective: April 17, 2022
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-38-20

(A) Each licensee or registrant shall use the SI units becquerel, gray, sievert and coulomb per kilogram, or the special units curie, rad, rem and roentgen, including multiples and subdivisions, and shall clearly indicate the units of all quantities on records required by this chapter. The licensee or registrant shall make a clear distinction among the quantities entered on the records such as, total effective dose equivalent, total organ dose equivalent, shallow dose equivalent, lens dose equivalent, deep dose equivalent, or committed effective dose equivalent.

(B) Each licensee or registrant shall maintain records of the radiation protection program, including the provisions of the program and audits and other reviews of program content and implementation. The licensee or registrant shall retain the records of the provisions of the program until the department terminates each license or registration pertinent to the record. The licensee or registrant shall retain all the other records required by this paragraph for three years after the record is made.

(C) Records of surveys showing the results of surveys and calibrations required by paragraph (A) of rule 3701:1-38-14 and paragraph (F) of rule 3701:1-38-18 of the Administrative Code shall be maintained and retained by the licensee or registrant for three years after the record is made.

(D) The licensee or registrant shall retain each of the following records until the department terminates each license or registration pertinent to the record:

(1) Records of the results of surveys to determine the dose from external sources of radiation used, in the absence of or in combination with individual monitoring data, in the assessment of individual dose equivalents;

(2) Records of the results of measurements and calculations used to determine individual intakes of radioactive material and used in the assessment of internal dose;

(3) Records showing the results of air sampling, surveys, and bioassays required pursuant to paragraphs (C)(2)(a) and (C)(2)(b) of rule 3701:1-38-16 of the Administrative Code; and

(4) Records of the results of measurements and calculations used to evaluate the release of radioactive effluents to the environment.

(E) Records of tests for leakage or contamination of sealed sources shall be kept in units of becquerel or microcurie, or multiples thereof, and maintained for inspection by the department for at least three years after the records are made.

(F) Records of prior occupational dose and exposure history as required in paragraph (E) of rule 3701:1-38-12 of the Administrative Code shall be recorded by the licensee or registrant on a form provided by the department entitled "lifetime occupational exposure history" in accordance with the instructions for completing this form, or in clear and legible records containing all the information required by the same form. The licensee or registrant shall maintain these records until the department terminates each license or registration pertinent to this record. The licensee or registrant shall retain records used in preparing the form for three years after the record is made.

(G) Records of planned special exposures as required in paragraph (F) of rule 3701:1-38-12 of the Administrative Code shall be maintained by the licensee:

(1) The licensee shall maintain records that describe the following:

(a) The exceptional circumstances requiring the use of a planned special exposure;

(b) The name of the management official who authorized the planned special exposure and a copy of the signed authorization;

(c) What actions were necessary;

(d) Why the actions were necessary;

(e) What precautions were taken to assure that doses were maintained ALARA;

(f) What individual and collective doses were expected to result; and

(g) The doses actually received in the planned special exposure.

(2) The licensee shall retain the records until the department terminates each license pertinent to these records.

(H) Records of individual dose monitoring results shall be maintained by each licensee or registrant for each individual for whom monitoring is required pursuant to paragraph (B) of rule 3701:1-38-14 of the Administrative Code, and records of doses received during planned special exposures, accidents, and emergency conditions. Assessments of dose equivalent and records made using units in effect before the effective date of these rules need not be changed.

(1) These records shall include, when applicable:

(a) The deep dose equivalent to the whole body, lens dose equivalent, shallow dose equivalent to the skin, and shallow dose equivalent to the extremities;

(b) The estimated intake or radionuclides as provided in paragraph (B) of rule 3701:1-38-12 of the Administrative Code;

(c) The committed effective dose equivalent assigned to the intake of radionuclides; and

(d) The specific information used to calculate the committed effective dose equivalent pursuant to paragraph (D)(8) of rule 3701:1-38-12 of the Administrative Code; and

(e) The total effective dose equivalent when required by paragraph (B) of rule 3701:1-38-12 of the Administrative Code; and

(f) The total of the deep dose equivalent and the committed dose to the organ receiving the highest total dose.

(2) The licensee or registrant shall make entries of the records specified in paragraph (H) of this rule at least annually.

(I) Each licensee or registrant shall maintain the records specified in paragraph (H) of this rule on department form entitled "occupational exposure record for a monitoring period" in accordance with the instructions for completing this form, or in clear and legible records containing all the information required by the same form. The licensee or registrant shall maintain the records of dose to an embryo or fetus with the records of dose to the declared pregnant woman. The declaration of pregnancy shall also be kept on file, but may be maintained separately from the dose records. The licensee or registrant shall retain each required form or record until the department terminates each license or registration pertinent to the record.

(J) Each licensee or registrant shall maintain records sufficient to demonstrate compliance with the dose limits for individual members of the public specified in paragraph (A) of rule 3701:1-38-13 of the Administrative Code. Each licensee or registrant shall retain the records required by paragraph (H) of this rule until the department terminates each license or registration pertinent to the record.

(K) Records of the disposal of licensed material shall be maintained by each licensee in accordance with paragraphs (C), (D), (F), and (G) of rule 3701:1-38-19, and Chapter 3701:1-54 of the Administrative Code. The licensee shall retain the records required by this paragraph until the department terminates each pertinent license that requires the record.

(L) Records of tests performed on entry control devices located in a very high radiation area shall be maintained by each licensee in accordance with Chapter 3701:1-52 of the Administrative Code or registrant in accordance with Chapters 3701:1-66, 3701:1-67, and 3701:1-68 of the Administrative Code. These records must include the date, time, and results of each such test of function. The licensee or registrant shall retain the records required by this paragraph for at least three years after the record is made.

(M) Each record required by this chapter shall be legible throughout the specified retention period. The record shall be the original or a reproduced copy or a microform, provided that the copy or microform is authenticated by authorized personnel and that the microform is capable of producing a clear copy throughout the required retention period. The record may also be stored in electronic media with the capability for producing legible, accurate, and complete records during the required retention period. Records, such as letters, drawings, and specifications, shall include all pertinent information, such as stamps, initials, and signatures. The licensee or registrant shall maintain adequate safeguards against tampering with and loss of records.

Last updated January 20, 2022 at 8:48 AM

History

• Effective: January 20, 2022
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-38-19

(A) A licensee shall dispose of licensed radioactive material in accordance with this rule. Licensed material shall be disposed of in one of the following manners:

(1) By transfer to an authorized recipient as provided in this chapter, Chapter 3701:1-40 of the Administrative Code, or to the United States department of energy;

(2) By decay in storage provided that the radionuclide has a half-life of one hundred twenty days or less, or as otherwise permitted by the license;

(3) By release in effluents within the limits set forth in rule 3701:1-38-13 of the Administrative Code; or

(4) As authorized pursuant to paragraphs (B) to (F) of this rule.

(B) A person shall be specifically licensed to receive waste containing licensed material from another person for:

(1) Treatment prior to disposal;

(2) Treatment or disposal by incineration;

(3) Decay in storage;

(4) Disposal at a land disposal facility licensed pursuant to rules 3701:1-54-06 to 3701:1-54-12 of the Administrative Code or equivalent United States nuclear regulatory commission or agreement state regulations; or

(5) Storage until transfer to a storage or disposal facility authorized to receive the waste.

(C) A licensee or applicant for a license may apply to the director for approval of proposed disposal procedures that are not otherwise authorized in these rules for the disposal of licensed material generated in the licensee's operations. Each application shall include:

(1) A description of the waste containing licensed material to be disposed of, including the physical and chemical properties that have an impact on risk evaluation, and the proposed manner and conditions of waste disposal;

(2) An analysis and evaluation of pertinent information on the nature of the environment;

(3) The nature and location of other potentially affected facilities; and

(4) An analysis and procedures to ensure that doses are maintained ALARA and within the dose limits in rules 3701:1-38-12 and 3701:1-38-13 of the Administrative Code.

(D) A licensee may discharge licensed material into sanitary sewerage as follows:

(1) The material is readily soluble in water or is a biological material that is readily dispersible in water;

(2) The quantity of licensed or other radioactive material that the licensee releases into the sewer in one month divided by the average monthly volume of water released into the sewer by the licensee does not exceed the concentration listed in table III of appendix C to rule 3701:1-38-12 of the Administrative Code; and

(3) If more than one radionuclide is to be released, the following conditions must also be satisfied:

(a) The licensee shall determine the fraction of the limit in table III of appendix C to rule 3701:1-38-12 of the Administrative Code represented by discharges into sanitary sewerage by dividing the actual monthly average concentration of each radionuclide released by the licensee into the sewer by the concentration of that radionuclide listed in table III of appendix C to rule 3701:1-38-12 of the Administrative Code; and

(b) The sum of the fractions for each radionuclide required by paragraph (D)(3)(a) of this rule does not exceed unity.

(4) The total quantity of licensed and other radioactive material that the licensee releases into the sanitary sewerage in a year does not exceed one hundred eighty-five gigabecquerels (five curies) of hydrogen-3, thirty-seven gigabecquerels (one curie) of carbon-14, and thirty-seven gigabecquerels (one curie) of all other radioactive materials combined.

(5) Excreta from an individual undergoing medical diagnosis or therapy with radioactive material is not subject to the limitations contained in paragraph (D) of this rule.

(E) A licensee may dispose of licensed material by decay in storage. A licensee may hold radioactive material with a physical half-life of one hundred twenty days or less for decay-in-storage before disposal as non-radioactive material provided the licensee does the following:

(1) Monitors the material at the container surface prior to disposal and determines that the radioactivity cannot be distinguished from the background radiation level with an appropriate radiation detection survey meter set on its most sensitive scale and with no interposing shielding;

(2) Removes or obliterates all radiation caution labels and symbols, unless otherwise specified in the license; and

(3) Retains a record of the disposal for three years.

(F) A licensee may treat or dispose of licensed material by incineration only in the form and concentration specified in paragraph (G) of this rule or as specifically approved by the director pursuant to paragraph (C) of this rule.

(G) A licensee may dispose of the following licensed material as if it were not radioactive. The licensee shall maintain records in accordance with paragraph (K) of rule 3701:1-38-20 of the Administrative Code.

(1) 1.85 kilobecquerels (0.05 microcurie) or less, of hydrogen-3 or carbon-14 per gram of medium used for liquid scintillation counting; or

(2) 1.85 kilobecquerels (0.05 microcurie) or less, of hydrogen-3 or carbon-14 per gram of animal tissue, averaged over the weight of the entire animal. A licensee shall not dispose of tissue pursuant to this paragraph in a manner that would permit its use either as food for humans or as animal feed.

(H) A licensee shall transfer and dispose of licensed material in accordance with the following:

(1) For transfer of radioactive waste intended for disposal at a licensed radioactive waste disposal facility, establish a manifest tracking system, and supplement existing requirements concerning transfers and recordkeeping for those wastes. Each shipment of radioactive waste designated for disposal at a licensed radioactive waste disposal facility shall be accompanied by a shipment manifest as specified in the appendix to this rule.

(2) Each shipment manifest shall include a certification by the waste generator in accordance with the appendix to this rule.

(3) Each person involved in the transfer of waste for disposal or in the disposal of waste, including the waste generator, waste collector, waste processor, and disposal facility operator, shall comply with the requirements specified in the appendix to this rule.

(I) Nothing in this rule relieves a licensee from complying with other applicable federal, state and local regulations governing any other toxic or hazardous properties of materials that may be disposed of under this rule.

View Appendix

Last updated January 20, 2022 at 8:48 AM

History

• Effective: January 20, 2022
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-40-18 Expiration or termination of license; decommissioning of sites and separate buildings or outdoor areas.

(A) Each specific license expires at the end of the day on the expiration date stated in the license unless the licensee has filed an application for renewal in accordance with paragraph (E) of rule 3701:1-38-02 of the Administrative Code. If an application for renewal has been filed at least ninety days, or in the case of a broad scope license, at least one hundred eighty days prior to the expiration date stated in the existing license, the existing license expires at the later of the end of the day on which the director makes a final determination to deny the renewal application or, if the determination states an expiration date, the expiration date stated in the determination.

(B) Each specific license for the possession of radioactive material that requires a decommissioning plan shall continue in effect and shall be renewed during the decommissioning period, until the director notifies the licensee in writing after decommissioning that the license is terminated. During this time, the licensee shall:

(1) Limit actions involving radioactive material to those related to decommissioning; and

(2) Continue to control entry to any restricted area until that area is suitable for release in accordance with department requirements as may be imposed by rule 3701:1-38-22 of the Administrative Code.

(C) A licensee shall provide written notice to the director within sixty days of the occurrence of any of the following, in accordance with rule 3701:1-40-04 of the Administrative Code:

(1) The license has expired;

(2) The licensee has decided to permanently cease licensed activities at the entire site or in any separate building, room or outdoor area that contains residual radioactivity such that the building, room or outdoor area is unsuitable for release in accordance with the definition of "decommissioning" in Chapter 3748. of the Revised Code and the regulations for decommissioning in rule 3701:1-38-22 of the Administrative Code.

(3) No licensed activities have been conducted for a period of twenty-four months; or

(4) No licensed activities have been conducted for a period of twenty-four months in any separate building, room or outdoor area that contains residual radioactivity such that the building, room or outdoor area is unsuitable for release in accordance with rule 3701:1-38-22 of the Administrative Code.

(D) In the event of an occurrence as set forth in paragraph (C) of this rule, the licensee shall either:

(1) Begin decommissioning the site, and any separate building, room or outdoor area that contains residual radioactivity so that the site, building, room and outdoor area are suitable for release in accordance with rule 3701:1-38-22 of the Administrative Code; or

(2) If required by paragraph (G)(1) of this rule, submit within twelve months of notification, a decommissioning plan and begin decommissioning upon the director's approval of that plan.

(E) In addition to written notification of an occurrence, the licensee shall maintain all decommissioning financial assurances established by the licensee pursuant to rule 3701:1-40-17 of the Administrative Code in conjunction with a license issuance or renewal or as required by this rule.

(F) The director may grant a request to extend the twelve-month time period to submit a decommissioning plan established in paragraph (D)(2) of this rule provided that the director determines that the alternative schedule is necessary to the effective conduct of decommissioning operations and that the extension is not detrimental to the public health and safety or the environment and is otherwise in the public interest. The extension request must be submitted no later than thirty days after the occurrence for which notification is required. Decommissioning set forth in paragraph (D)(2) of this rule may not commence until the director has made a determination on the extension request.

(G) The licensee shall submit a decommissioning plan to the director prior to commencing any decommissioning in the following cases:

(1) If required by license condition; or

(2) If the procedures and activities necessary to carry out decommissioning of the site or separate building, room or outdoor area have not been previously approved by the director and these procedures could increase potential health and safety risk to workers or to the public, such as in any of the following cases:

(a) Decommissioning procedures would involve techniques not applied routinely during cleanup or maintenance operations;

(b) Workers would be entering areas not normally occupied where surface contamination and radiation levels are significantly higher than routinely encountered during operation;

(c) Decommissioning procedures could result in significantly greater airborne concentrations of radioactive materials than are present during operation; or

(d) Decommissioning procedures could result in significantly greater releases of radioactive material to the environment than those associated with operation.

(H) A proposed decommissioning plan for a site or separate building, room or outdoor area shall include the following:

(1) A description of the conditions of the site or separate building, room or outdoor area sufficient to evaluate the acceptability of the plan;

(2) A description of planned decommissioning activities;

(3) A description of methods used to ensure protection of workers and the environment against radiation hazards during decommissioning;

(4) A description of the planned final radiation survey;

(5) An updated detailed cost estimate for decommissioning, comparison of that estimate with present funds set aside for decommissioning, and a plan for assuring the availability of adequate funds for completion of decommissioning; and

(6) In the case of a decommissioning plan that results in the licensee completing decommissioning later than twenty-four months after plan approval, the plan shall include a justification for the delay based on the criteria in paragraph (J) of this rule.

The proposed decommissioning plan will be approved by the director if the information therein demonstrates compliance with rule 3701:1-38-22 of the Administrative Code, that the decommissioning will be completed as soon as practicable, and that the health and safety of workers and the public will be adequately protected.

(I) Except as provided in paragraph (J) of this rule, a licensee shall:

(1) Complete decommissioning of the site or separate building or outdoor area as soon as practicable but no later than twenty-four months following the initiation of decommissioning; and

(2) When decommissioning involves the entire site, request license termination as soon as practicable but no later than twenty-four months following the initiation of decommissioning, unless the decommissioning is still actively in progress.

(J) The director may approve a request for an alternative schedule for completion of decommissioning and license termination. In considering whether an alternative schedule is warranted, the director shall consider the following:

(1) Whether it is technically feasible to complete decommissioning within twenty-four months;

(2) Whether sufficient waste disposal capacity is available to allow completion of decommissioning within twenty-four months;

(3) Whether a significant volume reduction in wastes requiring disposal will be achieved by allowing short-lived radionuclides to decay;

(4) Whether a significant reduction in radiation exposure to workers can be achieved by allowing short-lived radionuclides to decay; and

(5) Any other factor that the director finds is unique to the site, such as the regulatory requirements of other government agencies, lawsuits, ground-water treatment activities, monitored natural ground-water restoration, actions that could result in more environmental harm than deferred cleanup, and other factors beyond the control of the licensee.

(K) After decommissioning the site, the licensee shall:

(1) Certify the disposition of all licensed material, including accumulated wastes, by submitting a completed disposition of radioactive materials form provided by the director; and

(2) Conduct a radiation survey of the premises where the licensed activities were carried out and submit a report of the results of this survey, unless the licensee demonstrates in some other manner that the premises are suitable for release in accordance with the criteria for decommissioning set forth in rule 3701:1-38-22 of the Administrative Code. The licensee shall survey and report as follows:

(a) Levels of gamma radiation in units of millisieverts (microroentgen) per hour at one meter from surfaces and radioactivity, including alpha and beta, in units of megabecquerels (disintegrations per minute or microcuries) per one hundred square centimeters, removable and fixed, for surfaces, megabecquerels (microcuries) per milliliter for water, and becquerels (picocuries) per gram for solids such as soils or concrete; and

(b) Identification of any survey instrument used and a certification that each instrument was properly calibrated and tested prior to being used to measure radioactivity at the site.

(L) Specific licenses, including expired licenses, will be terminated by written notice to the licensee when the director determines that:

(1) Radioactive material has been properly disposed;

(2) Reasonable effort has been made to eliminate residual radioactive contamination, if present;

(3) A radiation survey has been performed which demonstrates that the premises are suitable for release in accordance with the criteria for decommissioning, or other information is submitted by the licensee that is sufficient to demonstrate that the premises are suitable for release in accordance with the criteria for decommissioning in this chapter and rule 3701:1-38-22 of the Administrative Code; and

(4) All applicable fees have been paid.

Last updated April 19, 2022 at 8:35 AM

History

• Effective: April 17, 2022
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-40-19 Transfer of radioactive material.

(A) No licensee shall transfer radioactive material except as authorized by this rule.

(B) Except as otherwise provided in the license and subject to the provisions of paragraph (C) of this rule, any licensee may transfer radioactive material:

(1) To the United States department of energy;

(2) To the agency in any agreement state which regulates radioactive material pursuant to an agreement under section 274 of the "Atomic Energy Act", as amended;

(3) To any person exempt from the licensing requirements of the act and regulations in this chapter, to the extent permitted under such exemption;

(4) To any person in an agreement state, subject to the jurisdiction of that state, who has been exempted from the licensing requirements and regulations of that state, to the extent permitted under such exemption;

(5) To any person authorized to receive such radioactive material under terms of a specific license or a general license or their equivalents issued by the United States atomic energy commission, the United States nuclear regulatory commission, or an agreement state; or

(6) As otherwise authorized by the director in writing.

(C) Before transferring radioactive material to an entity specified in paragraph (B) of this rule, the licensee transferring the material shall verify that the transferee's license authorizes the receipt of the type, form, and quantity of radioactive material to be transferred. The licensee may verify the transferee's authorization to accept the material by possessing one of the following:

(1) A current copy of the transferee's specific license or registration certificate specifying the type, form, and quantity of radioactive material to be transferred;

(2) A written certification by the receiving licensee certifying that the licensee is authorized by license or registration certificate to receive the type, form, and quantity of radioactive material to be transferred, and further specifying the license or registration certificate number, issuing agency, and expiration date;

(3) In the case of an emergency shipment, the transferring licensee may accept oral certification by the receiving licensee that the licensee is authorized by license or registration certificate to receive the type, form, and quantity of radioactive material to be transferred, and further, specifying the license or registration certificate number, issuing agency and expiration date. The transferring licensee shall obtain written confirmation detailing the oral certification within ten days of the emergency transfer; or

(4) The transferor may obtain other sources of information compiled by a reporting service from official records of the department, United States nuclear regulatory commission, or the licensing agency of an agreement state as to the identity of the receiving licensee, whether the licensee is authorized by license or registration certificate to receive the type, form, and quantity of radioactive material to be transferred, and the expiration date of the receiving licensee's license or registration.

Last updated November 2, 2022 at 2:12 PM

History

• Effective: October 4, 2010
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-38-12

(A) Except in the case of a planned special exposure pursuant to paragraph (F) of this rule, a licensee or registrant shall limit the occupational dose received by an individual adult, as follows:

(1) An annual limit, which is the more limiting of:

(a) The total effective dose equivalent being equal to 0.05 sievert (five rem); or

(b) The sum of the deep dose equivalent and the committed dose equivalent to any individual organ or tissue other than the lens of the eye being equal to 0.5 sievert (fifty rem).

(2) The annual limits to the lens of the eye, to the skin of the whole body, and to the skin of the extremities, which are:

(a) A lens dose equivalent of 0.15 sievert (fifteen rem), and

(b) A shallow-dose equivalent of 0.5 sievert (fifty rem) to the skin of the whole body or to the skin of any extremity.

(3) Doses received in excess of the annual limits, including doses received during accidents, emergencies, and planned special exposures, shall be subtracted from the limits for planned special exposures that the individual may receive during the current calendar year and during the individual's lifetime in accordance with paragraph (F)(5) of this rule.

(4) When the external exposure is determined by measurement with an external personal monitoring device, the deep-dose equivalent must be used in place of the effective dose equivalent, unless the effective dose equivalent is determined by a dosimetry method approved by the director. The assigned deep-dose equivalent must be for the part of the body receiving the highest exposure.

(a) The assigned shallow-dose equivalent must be the dose averaged over the contiguous ten square centimeters of skin receiving the highest exposure. The deep-dose equivalent, lens-dose equivalent, and shallow-dose equivalent may be assessed from surveys or other radiation measurements for the purpose of demonstrating compliance with the occupational dose limits, if the individual monitoring device was not in the region of highest potential exposure, or the results of individual monitoring are unavailable; or

(b) When a protective apron is worn while working with radiation-generating equipment and monitoring is conducted as specified in paragraph (C)(1) of rule 3701:1-38-14 of the Administrative Code, the effective dose equivalent for external radiation shall be determined as follows:

(i) When only one individual monitoring device is used and it is located at the neck outside the protective apron, the reported deep dose equivalent value multiplied by 0.3 shall be the effective dose equivalent for external radiation; or

(ii) When two individual monitoring devices are worn, one under the protective apron at the waist and the other outside the protective apron at the neck, the effective dose equivalent for external radiation shall be assigned the value of the sum of the deep dose equivalent reported for the individual monitoring device located at the waist under the protective apron multiplied by 1.5 and the deep dose equivalent reported for the individual monitoring device located at the neck outside the protective apron multiplied by 0.04; or

(iii) Through the use of computational methods endorsed by the "American National Standards Institute", recommended by the "National Council on Radiation Protection and Measurements", or approved by the director.

(5) Derived air concentration (DAC) and annual limit on intake (ALI) values are specified in appendix C to this rule and may be used by the licensee to determine the individual's dose and to demonstrate compliance with the occupational dose limits. Appendices A and B are explanatory supplements to appendix C to this rule. Notwithstanding the annual dose limits, the licensee shall limit the soluble uranium intake by an individual to ten milligrams in a week in consideration of chemical toxicity.

(6) In accordance with paragraph (E) of this rule, the licensee or registrant shall reduce the dose that an individual may be allowed to receive in the current year by the amount of occupational dose received while employed by any other person.

(B) Compliance with requirements for summation of external and internal doses shall be in accordance with the following:

(1) If the licensee is required to monitor under both paragraphs (B)(1) and (B)(2) of rule 3701:1-38-14 of the Administrative Code, the licensee shall demonstrate compliance with the dose limits by summing external and internal doses. If the licensee is required to monitor only under paragraph (B)(1) or only under paragraph (B)(2) of rule 3701:1-38-14 of the Administrative Code, then summation is not required to demonstrate compliance with the dose limits. The licensee may demonstrate compliance with the requirements for summation of external and internal doses by meeting one of the conditions specified in paragraph (B)(2) of this rule and the conditions in paragraphs (B)(3) and (B)(4) of this rule. The dose equivalents for the lens of the eye, the skin, and the extremities are not included in the summation, but are subject to separate limits.

(2) If the only intake of radionuclides is by inhalation, the total effective dose equivalent limit is not exceeded if the sum of the deep dose equivalent divided by the total effective dose equivalent limit, plus one of the following does not exceed unity:

(a) The sum of the fractions of the inhalation ALI for each radionuclide; or

(b) The total number of derived air concentration-hours, or DAC-hours, for all radionuclides divided by two thousand; or

(c) The sum of the calculated committed effective dose equivalents to all significantly irradiated organs or tissues (T) calculated from bioassay data using appropriate biological models and expressed as a fraction of the annual limit. For purposes of this requirement, an organ or tissue is deemed to be significantly irradiated if, for that organ or tissue, the product of the weighting factors, W_T, and the committed dose equivalent, H_T,50, per unit intake is greater than ten per cent of the maximum weighted value of H_T,50, that is, W_TH_T,50, per unit intake for any organ or tissue.

(3) If the occupationally exposed individual also receives an intake of radionuclides by oral ingestion greater than ten percent of the applicable oral ALI, the licensee shall account for this intake and include it in demonstrating compliance with the limits set forth in paragraph (A) of this rule.

(4) The licensee shall evaluate and, to the extent practical, account for intakes through wounds or skin absorption. The intake through intact skin has been included in the calculation of DAC for hydrogen-3 and does not need to be further evaluated or accounted for pursuant to this paragraph.

(C) Determination of external dose from airborne radioactive material shall be in accordance with the following:

(1) When determining the dose from airborne radioactive material, the licensee shall include the contribution to the deep dose equivalent, lens dose equivalent, and shallow dose equivalent from external exposure to the radioactive cloud as specified in appendix C to this rule, footnotes ^A and ^B.

(2) The licensee should not use airborne radioactivity measurements or DAC values as the primary means to assess the deep dose equivalent when the airborne radioactive material includes radionuclides other than noble gases, or if the cloud of airborne radioactive material is not relatively uniform. The determination of the deep dose equivalent to an individual should be based upon measurements using instruments or individual monitoring devices.

(D) Determination of internal exposure shall be in accordance with the following:

(1) For purposes of assessing dose used to determine compliance with occupational dose equivalent limits, the licensee shall, when required under paragraph (B) of rule 3701:1-38-14 of the Administrative Code, take suitable and timely measurements of:

(a) Concentrations of radioactive materials in air in work areas; or

(b) Quantities of radionuclides in the body; or

(c) Quantities of radionuclides excreted from the body; or

(d) Combinations of these measurements.

(2) Unless respiratory protective equipment is used, as provided in paragraph (C) of rule 3701:1-38-16 of the Administrative Code or the assessment of intake is based on bioassays, the licensee shall assume that an individual inhales radioactive material at the airborne concentration in which the individual is present.

(3) When specific information on the physical and biochemical properties of the radionuclides taken into the body or the behavior of the material in an individual is known, the licensee may:

(a) Use that information to calculate the committed effective dose equivalent, and, if used, the licensee shall document that information in the individual's record; and

(b) Upon prior approval of the department, adjust the DAC or ALI values to reflect the actual physical and chemical characteristics of airborne radioactive material, for example, aerosol size distribution or density; and

(c) Separately assess the contribution of fractional intakes of Class D, W, or Y compounds of a given radionuclide to the committed effective dose equivalent as specified in appendix A to this rule.

(4) If the licensee chooses to assess intakes of Class Y material using the measurements given in paragraph (D)(1)(b) or (D)(1)(c) of this rule in order to make additional measurements basic to the assessments, the licensee may delay the recording and reporting of the assessments for periods up to seven months, unless otherwise required by paragraph (B)(2) or (C) of rule 3701:1-38-21 of the Administrative Code.

(5) If the identity and concentration of each radionuclide in a mixture are known, the fraction of the DAC applicable to the mixture for use in calculating DAC-hours shall be either:

(a) The sum of the ratios of the concentration to the appropriate DAC value, that is, D, W, or Y, from appendix C to this rule for each radionuclide in the mixture; or

(b) The ratio of the total concentration for all radionuclides in the mixture to the most restrictive DAC value for any radionuclide in the mixture.

(6) If the identity of each radionuclide in a mixture is known, but the concentration of one or more of the radionuclides in the mixture is not known, the DAC for the mixture shall by the most restrictive DAC of any radionuclide in the mixture.

(7) When a mixture of radionuclides in air exists, a licensee may disregard certain radionuclides in the mixture if all of the following occur:

(a) The licensee uses the total activity of the mixture in demonstrating compliance with the dose limits in paragraph (A) of this rule and in complying with the monitoring requirements in paragraph (B) of rule 3701:1-38-14 of the Administrative Code;

(b) The concentration of any radionuclide disregarded is less than ten percent of its DAC; and

(c) The sum of these percentages for all of the radionuclides disregarded in the mixture does not exceed thirty percent.

(8) When determining the committed effective dose equivalent, the licensee may consider the following:

(a) In order to calculate the committed effective dose equivalent, the licensee may assume that the inhalation of one ALI, or an exposure of two thousand DAC-hours, results in a committed effective dose equivalent of 0.05 sievert (five rem), for radionuclides that have their ALIs or DACs based on the committed effective dose equivalent; or

(b) For an ALI and the associated DAC determined by the nonstochastic organ dose limit of 0.5 sievert (fifty rem), the intake of radionuclides that would result in a committed effective dose equivalent of 0.05 sievert (five rem), that is, the stochastic ALI, is listed in parentheses in table I of appendix C to this rule. The licensee may, as a simplifying assumption, use the stochastic ALI to determine committed effective dose equivalent. However, if the licensee uses the stochastic ALI, the licensee shall also demonstrate that the limit in paragraph (A)(1)(b) of this rule is met.

(E) Determination of prior occupational dose shall be made in accordance with the following:

(1) For each individual who is likely to receive an annual occupational dose requiring monitoring pursuant to paragraph (B) of rule 3701:1-38-14 of the Administrative Code, the licensee or registrant shall determine the occupational radiation dose received during the current year.

(2) Prior to permitting an individual to participate in a planned special exposure, the licensee shall determine:

(a) The internal and external doses from all previous planned special exposures; and

(b) All doses in excess of the limits, including doses received during accidents and emergencies, received during the lifetime of the individual.

(3) In complying with the requirements of paragraph (E)(1) or (E)(2) of this rule, a licensee or registrant may:

(a) Accept, as a record of the occupational dose that the individual received during the current year, a written signed statements from the individual, or from the individual's most recent employer for work involving radiation exposure, that discloses the nature and the amount of any occupational dose that the individual may have received during the current year;

(b) Accept, as the record of lifetime cumulative radiation dose, a current department form entitled "lifetime occupational exposure history" or equivalent, signed by the individual and countersigned by an appropriate official of the most recent employer for work involving radiation exposure, or the individual's current employer, if the individual is not employed by the licensee or registrant; and

(c) Obtain reports of the individual's dose equivalent from the most recent employer for work involving radiation exposure, or the individual's current employer, if the individual is not employed by the licensee or registrant, by telephone, telegram, facsimile, e-mail or letter. The licensee or registrant shall request a written verification of the dose data if the authenticity of the transmitted report cannot be established.

(4) The licensee or registrant shall record the exposure history, as required by paragraph (A) of this rule, on a form provided by the department or other clear and legible record, of all the information required on that form. The form or record shall show each period in which the individual received occupational exposure to radiation or radioactive material and shall be signed by the individual who received the exposure. For each period for which the licensee or registrant obtains reports, the licensee or registrant shall use the dose shown in the report in preparing the exposure history form. For any period in which the licensee or registrant does not obtain a report, the licensee or registrant shall place a notation on the exposure history form indicating the periods of time for which data are not available.

(5) If the licensee or registrant is unable to obtain a complete record of an individual's current and previously accumulated occupational dose, the licensee or registrant shall assume:

(a) In establishing administrative controls pursuant to paragraph (A)(6) of this rule for the current year, that the allowable dose limit for the individual is reduced by 12.5 millisievert (1.25 rem), for each quarter for which records were unavailable and the individual was engaged in activities that could have resulted in occupational radiation exposure; and

(b) That the individual is not available for planned special exposures.

(6) The licensee or registrant shall retain the records on the exposure history form until the department terminates each pertinent license or registration requiring this record. The licensee or registrant shall retain records used in preparing the exposure history form for three years after the record is made.

(F) A planned special exposure may be authorized by a licensee in accordance with this paragraph. A licensee may authorize an adult worker to receive doses in addition to and accounted for separately from the doses received under the limits specified in paragraph (A) of this rule provided that each of the following is satisfied:

(1) The licensee authorizes a planned special exposure only in an exceptional situation when alternatives that might avoid the higher exposure are unavailable or impractical;

(2) The licensee and employer, if the employer is not the licensee, specifically authorizes the planned special exposure, in writing, before the exposure occurs;

(3) Before a planned special exposure, the licensee ensures that each individual involved is:

(a) Informed of the purpose of the planned operation; and

(b) Informed of the estimated doses and associated potential risks and specific radiation levels or other conditions that might be involved in performing the task; and

(c) Instructed in the measures to be taken to keep the dose ALARA considering other risks that may be present;

(4) Prior to permitting an individual to participate in a planned special exposure, the licensee ascertains prior doses as required by paragraph (E)(2) of this rule during the lifetime of the individual for each individual involved;

(5) The licensee shall not authorize a planned special exposure that would cause an individual to receive a dose from all planned special exposures and all doses in excess of the limits to exceed:

(a) The numerical values of any of the dose limits in paragraph (A) of this rule in any calendar year; and

(b) Five times the annual dose limits specified in paragraph (A) of this rule during the individual's lifetime;

(6) The licensee maintains records of the conduct of a planned special exposure in accordance with paragraph (E) of rule 3701:1-38-20 of the Administrative Code and submits a written report in accordance with paragraph (D) of rule 3701:1-38-21 of the Administrative Code;

(7) The licensee records the best estimate of the dose resulting from the planned special exposure in the individual's record and informs the individual, in writing, of the dose within thirty days from the date of the planned special exposure. The dose from planned special exposures shall not be considered in controlling future occupational dose of the individual pursuant to paragraph (A)(1) of this rule, but shall be included in evaluations required by paragraphs (F)(4) and (F)(5) of this rule.

(G) Occupational dose limits for minors shall be ten per cent of the annual occupational dose limits specified for adult workers in paragraph (A) of this rule.

(H) Dose equivalent to an embryo or fetus shall be in accordance with the following:

(1) The licensee or registrant shall ensure that the dose equivalent to an embryo or fetus during the entire pregnancy, due to occupational exposure of a declared pregnant woman, does not exceed five millisievert (0.5 rem). Records shall be maintained in accordance with paragraph (I) of rule 3701:1-38-20 of the Administrative Code.

(2) The licensee or registrant shall make efforts to avoid substantial variation above a uniform monthly exposure rate to a declared pregnant woman so as to satisfy the limit in paragraph (H)(1) of this rule.

(3) The dose equivalent to the embryo or fetus is the sum of:

(a) The deep-dose equivalent to the declared pregnant woman; and

(b) The dose equivalent to the embryo or fetus resulting from radionuclides in the embryo or fetus and from radionuclides in the declared pregnant woman.

(4) If the declared pregnant woman's exposure includes exposure from radiation generating equipment and a protective apron is worn, the dose equivalent to an embryo or fetus shall be taken as the sum of:

(a) The dose equivalent to the embryo or fetus from radionuclides in the embryo or fetus and radionuclides in the declared pregnant woman; and

(b) The dose equivalent that is most representative of the dose to the embryo or fetus from external radiation, that is, in the mother's lower torso region.

(i) If multiple measurements have not been made, assignment of the highest deep dose equivalent for the declared pregnant woman shall be the dose to the embryo or fetus, in accordance with paragraph (A)(4) of this rule; or

(ii) If multiple measurements have been made, assignment of the deep dose equivalent for the declared pregnant woman from the individual monitoring device which is most representative of the dose to the embryo or fetus shall be the dose to the embryo or fetus. Assignment of the highest deep dose equivalent for the declared pregnant woman to the embryo or fetus is not required unless that dose is also the most representative deep dose equivalent for the region of the embryo or fetus.

(5) If by the time the woman declares pregnancy to the licensee or registrant, the dose equivalent to the embryo or fetus has exceeded five millisievert, or 0.5 rem, the licensee or registrant shall be deemed to be in compliance with paragraph (A) of this rule, provided that the additional dose equivalent to the embryo or fetus does not exceed 0.5 millisievert (0.05 rem), during the remainder of the pregnancy.

View AppendixView AppendixView Appendix

Last updated November 2, 2022 at 2:10 PM

History

• Effective: October 4, 2010
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-38-10

(A) Posting of notices to workers.

(1) Each licensee or registrant shall post current copies of the following documents:

(a) All applicable rules promulgated pursuant to Chapters 3748. and 4773. of the Revised Code;

(b) The license or certificate of registration, including, any conditions or documents incorporated by reference into a license and amendments thereto;

(c) The safe operating procedures applicable to activities under the license or registration; and

(d) Any notice of violation involving radiological working conditions, proposed imposition of civil or administrative monetary penalty, or order issued pursuant to rule 3701:1-38-06 of the Administrative Code and any response from the licensee or registrant. Such document shall be posted within five working days after receipt of the document. The licensee's or registrant's response, if any, shall be posted within five working days after dispatch of the document to the director. Such documents shall remain posted for a minimum of five working days or until action correcting the violation has been completed, whichever is later.

(e) The Ohio department of health, bureau of environmental health and radiation protection issued form titled "Notice to Employees."

(2) If posting of a document specified in paragraphs (A)(1)(a) to (A)(1)(c) of this rule is not practical, the licensee or registrant may post a notice which describes the document and states where it may be readily examined.

(3) Documents, notices, or forms posted pursuant to paragraph (A) of this rule shall appear in a sufficient number of places to permit individuals engaged in licensed or registered activity under the license or registration to observe them on the way to or from any particular work location to which the document applies, shall be conspicuous, and shall be replaced if defaced or altered.

(B) Instruction to workers.

(1) The licensee or registrant shall, with respect to all individuals likely to receive an annual TEDE occupational dose in excess of one millisievert (one hundred millirem):

(a) Keep such individuals informed of the storage, transfer, or use of sources of radiation in the licensee's or registrant's workplace;

(b) Instruct such individuals in the health effects associated with exposure to radiation or radioactive material to the individual and potential offspring, in precautions or procedures to minimize exposure, and in the purposes and functions of protective devices employed;

(c) Instruct such individuals in, and instruct such individuals to observe, to the extent within the individual's control, the applicable provisions of rules promulgated under Chapter 3748. of the Revised Code and any license conditions for the protection of personnel from exposures to radiation or radioactive material;

(d) Instruct each such individual of his or her responsibility to report promptly to the licensee or registrant any condition which may constitute, lead to, or cause a violation of Chapter 3748. of the Revised Code, the rules promulgated thereunder, any license condition, or order, and any unnecessary exposure to radiation or radioactive material;

(e) Instruct such individuals in the appropriate response to warnings made in the event of any unusual occurrence or malfunction that may involve exposure to radiation or radioactive material; and

(f) Advise such individuals of any radiation exposure reports furnished pursuant to paragraph (C) of this rule.

(2) In determining those individuals subject to the requirements of paragraph (B)(1) of this rule, licensees and registrants shall take into consideration assigned activities during normal and abnormal situations involving exposure to radiation and radioactive materials which can reasonably be expected to occur during the life of the facility. The extent of these instructions shall be commensurate with potential radiological health protection problems present in the workplace.

(C) Notifications and reports to individuals.

(1) Radiation exposure data for an individual and the results of any measurements, analyses, and calculations of radioactive material deposited or retained in the body of an individual shall be reported to the individual as specified in this rule. The information reported shall include data and results obtained pursuant to Chapter 3748. of the Revised Code or rules adopted thereunder, an order, or license condition as shown in records maintained by the licensee or registrant pursuant to paragraph (H) of rule 3701:1-38-20 of the Administrative Code. Each notification and report shall:

(a) Be in writing;

(b) Include appropriate identifying data such as the name of the licensee or registrant, the name of the individual, and the individual's identification number, preferably social security number;

(c) Include the individual's exposure information; and

(d) Contain the statement: "This report is furnished to you under the provisions of rule 3701:1-38-10 of the Administrative Code. You should preserve this report for further reference."

(2) Each licensee or registrant shall make dose information available to workers as shown in records maintained by the licensee under the provisions of paragraph (H) of rule 3701:1-38-20 of the Administrative Code. The licensee or registrant shall provide an annual report to each individual monitored under rule 3701:1-38-14 of the Administrative Code, of the dose received in that monitoring year if:

(a) The individual's occupational dose exceeds one millisievert (one hundred millirem) TEDE or one millisievert (one hundred millirem) to any individual organ or tissue; or

(b) The individual requests his or her annual dose report.

(3) Each licensee or registrant shall furnish reports to workers.

(a) At the request of a worker formerly engaged in activities controlled by the licensee or registrant, each licensee or registrant shall furnish to the worker a report of the worker's exposure to sources of radiation:

(i) As shown in records maintained by the licensee or registrant pursuant to rule 3701:1-38-20 of the Administrative Code for each year the worker was required to be monitored under the provisions of rule 3701:1-38-14 of the Administrative Code; and

(ii) For each year the worker was required to be monitored under the monitoring requirements in effect prior to August 31, 1999.

(b) This report must be furnished within thirty days from the time the request is made or within thirty days after the exposure of the individual has been determined by the licensee or registrant, whichever is later. This report must cover the period of time that the worker's activities involved exposure to sources of radiation licensed or registered by the director and must include the dates and locations of licensed or registered activities in which the worker participated during this period.

(4) When a licensee or registrant is required pursuant to paragraphs (A) to (C) of rule 3701:1-38-21 of the Administrative Code to report to the director any exposure of an individual to sources of radiation, the licensee or the registrant shall also provide the individual a written report on the exposure data included in the report to the director. This report must be transmitted no later than the transmittal to the director.

(5) At the request of a worker who is terminating employment with the licensee or registrant that involved exposure to sources of radiation during the current calendar quarter or the current year, each licensee or registrant shall provide at termination to each worker, or to the worker's designee, a written report regarding the radiation dose received by that worker from operations of the licensee or registrant during the current calendar year or fraction thereof. If the most recent individual monitoring results are not available at that time, a written estimate of the dose must be provided together with a clear indication that this is an estimate.

Last updated November 2, 2022 at 2:09 PM

History

• Effective: May 17, 2018
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-40-21 Records.

(A) Each person who receives radioactive material under a license issued pursuant to the rules in this chapter, and other chapters of the Administrative Code adopted pursuant to Chapter 3748. of the Revised Code, and rule 3701:1-38-02 of the Administrative Code, shall keep records showing the receipt, transfer, and disposal of the radioactive material as follows:

(1) The licensee shall retain each record of receipt of radioactive material as long as the material is possessed and for three years following transfer or disposal of the material.

(2) The licensee who transferred the material shall retain each record of transfer for three years after each transfer unless otherwise specified by rule for that particular licensed activity.

(3) The licensee who disposed of the material shall retain each record of disposal of radioactive material until the director terminates each license that authorizes disposal of the material.

(B) Except as provided in paragraph (C) of this rule, the licensee shall retain each record that is required by this chapter, Chapters 3701:1-46, 3701:1-48, 3701:1-49, 3701:1-52, and 3701:1-58 of the Administrative Code, and rule 3701:1-38-02 of the Administrative Code, or by license condition for the period specified by the appropriate regulation or license condition. If a retention period is not otherwise specified by rule or license condition, the record must be retained until the director terminates each license that authorizes the activity that is subject to the record-keeping requirement. Such records may be either the original record or a reproduced copy or microform, provided that such copy or microform is duly authenticated by authorized personnel and the microform is capable of producing a clear and legible copy after storage for the period specified by the director. The record also may be stored in electronic media provided that the licensee is capable of producing legible, accurate, and complete records during the required retention period. Records such as letters, drawings, specifications, must include all pertinent information such as stamps, initials, and signatures. The licensee shall maintain adequate safeguards against record tampering and loss.

(C) In the case of a conflict between a record requirement specified in rule and that requirement specified as a license condition, the licensee shall comply with the license condition.

(D) Prior to license termination, each licensee authorized to possess radioactive material with a half-life greater than one hundred twenty days, in an unsealed form, shall forward to the department, records of disposal of radioactive material buried without specific state authority or buried without authorization from the United States nuclear regulatory commission prior to January 28, 1981, pursuant to 10 C.F.R. 20.304, as that section existed on January 1, 1981.

(E) If licensed activities are transferred or assigned in accordance with paragraph (B) of rule 3701:1-40-19 of the Administrative Code, each licensee authorized to possess radioactive material, with a half-life greater than one hundred twenty days, in an unsealed form, shall transfer the following records to the new licensee and the new licensee will be responsible for maintaining these records until the license is terminated:

(1) Records of disposal of licensed material made under rule 3701:1-38-19 of the Administrative Code, including any burial authorized under a United States nuclear regulatory commission license on or before January 28, 1981, or a previous "section 20.304" permitted burial of a small quantity of licensed material in soil by a United States nuclear regulatory commission licensee on or before January 28, 1981, without specific authorization, in accordance with 10 C.F.R. 20.304 as that section existed on January 1, 1981.

(2) Records required by rule 3701:1-38-20 of the Administrative Code.

(F) Prior to license termination, each licensee shall forward to the department all the records required by paragraph (I) of rule 3701:1-40-17 of the Administrative Code.

Last updated April 19, 2022 at 8:35 AM

History

• Effective: April 17, 2022
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-40-22 Specific licenses of broad scope.

(A) An application for specific license of broad scope shall be made in accordance with rules 3701:1-38-02 and 3701:1-40-14 of the Administrative Code.

(1) If a current licensee wants to obtain a broad scope license, the application will be considered by the director if the application addresses and meets requirements of this chapter and rule 3701:1-38-02 of the Administrative Code.

(2) Broad scope licensees are not exempt from the notification requirements in paragraph (C) of rule 3701:1-40-18 of the Administrative Code.

(B) A "type A specific license of broad scope", or "type A broad license" is a specific license authorizing receipt, acquisition, ownership, possession, use, and transfer of any chemical or physical form of the radioactive material specified in the license, but not exceeding quantities specified in the license, for authorized purposes, with quantities usually greater than one curie.

(C) A "type B specific license of broad scope" or "type B broad license" is a specific license authorizing receipt, acquisition, ownership, possession, use, and transfer of any chemical or physical form of radioactive material specified in column I of the appendix to this rule for authorized purposes. The possession limit for a type B broad license, if only one radionuclide is possessed thereunder, is the quantity specified for that radionuclide in column I of the appendix to this rule. If two or more radionuclides are possessed under a type B broad license, the possession limit for each is calculated as follows:

(1) For each radionuclide, determine the ratio of the quantity possessed to the applicable quantity specified for that radionuclide in column I of the appendix to this rule.

(2) Add the ratios for all radionuclides possessed under the license. The possession limit is reached when the sum of all ratios exceeds unity.

(D) A "type C specific license of broad scope" or "type C broad license" is a specific license authorizing receipt, acquisition, ownership, possession, use, and transfer of any chemical or physical form of radioactive material specified in column II of the appendix to this rule, for authorized purposes. The possession limit for a type C broad license, if only one radionuclide is possessed thereunder, is the quantity specified for that radionuclide in column II of the appendix to this rule. If two or more radionuclides are possessed under a type C broad license, the possession limit for each is calculated as follows:

(1) For each radionuclide, determine the ratio of the quantity possessed to the applicable quantity specified for that radionuclide in column II of the appendix to this rule.

(2) Add the ratios for all radionuclides possessed under the license. The possession limit is reached when the sum of all ratios exceeds unity.

View Appendix

Last updated April 19, 2022 at 8:35 AM

History

• Effective: April 17, 2022
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-40-23 Requirements for the issuance of a type A specific license of broad scope.

The director shall approve an application for a type A specific license of broad scope provided that the applicant:

(A) Satisfies the general requirements specified in rules 3701:1-38-02 and 3701:1-40-15 of the Administrative Code;

(B) Has engaged in a reasonable number of activities involving the use of radioactive material; and

(C) Has established administrative controls and provisions relating to organization and management, procedures, record keeping, material control, and accounting and management review that are necessary to assure safe operations, including:

(1) The establishment of a radiation safety committee composed of such persons as a radiation safety officer, a representative of management, and persons trained and experienced in the safe use of radioactive materials;

(2) The appointment of a radiation safety officer who is qualified by training and experience in radiation protection, and who is available for advice and assistance on radiological safety matters; and

(3) The establishment of appropriate administrative procedures to assure:

(a) Control of procurement and use of radioactive material;

(b) Completion of safety evaluations of proposed uses of radioactive material which take into consideration such matters as the adequacy of facilities and equipment, training and experience of the user, and the operating or handling procedures; and

(c) Review, approval, and recording by the radiation safety committee of safety evaluations of proposed uses prepared in accordance with paragraph (C)(3)(b) of this rule prior to use of the radioactive material.

Last updated November 2, 2022 at 2:13 PM

History

• Effective: October 4, 2010
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-40-24 Requirements for the issuance of a type B specific license of broad scope.

The director shall approve an application for a type B specific license of broad scope provided that the applicant:

(A) Satisfies the general requirements specified in rules 3701:1-38-02 and 3701:1-40-15 of the Administrative Code; and

(B) Has established administrative controls and provisions relating to organization and management, procedures, record keeping, material control and accounting, and management review that are necessary to assure safe operations, including:

(1) The appointment of a radiation safety officer who is qualified by training and experience in radiation protection, and who is available for advice and assistance on radiological safety matters; and

(2) The establishment of appropriate administrative procedures to assure:

(a) Control of procurement and use of radioactive material;

(b) Completion of safety evaluations of proposed uses of radioactive material which take into consideration such matters as the adequacy of facilities and equipment, training and experience of the user, and the operating or handling procedures; and

(c) Review, approval, and recording by the radiation safety officer of safety evaluations of proposed uses prepared in accordance with paragraph (B)(2)(b) of this rule prior to use of the radioactive material.

Last updated August 1, 2023 at 2:36 PM

History

• Effective: October 4, 2010
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-40-25 Requirements for the issuance of a type C specific license of broad scope.

The director shall approve an application for a type C specific license of broad scope provided that the applicant:

(A) Satisfies the general requirements specified in rules 3701:1-38-02 and 3701:1-40-15 of the Administrative Code;

(B) The applicant submits a statement that radioactive material will be used only by, or under the direct supervision of, individuals who have received:

(1) A college degree from an accredited institution at the bachelor level, or equivalent training and experience, in the physical or biological sciences or in engineering; and

(2) At least forty hours of training and experience in the safe handling of radioactive materials, and in the characteristics of ionizing radiation, units of radiation dose and quantities, radiation detection instrumentation, and biological hazards of exposure to radiation appropriate to the type and forms of radioactive material to be used; and

(C) The applicant has established administrative controls and provisions relating to procurement of radioactive material, procedures, record keeping, material control and accounting, and management review necessary to assure safe operations.

Last updated November 2, 2022 at 2:13 PM

History

• Effective: October 4, 2010
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-40-26 Conditions of specific licenses of broad scope.

(A) Unless specifically authorized pursuant to other rules of this chapter, persons licensed under rules 3701:1-40-22 to 3701:1-40-25 of the Administrative Code shall not:

(1) Conduct tracer studies in the environment involving direct release of radioactive material;

(2) Receive, acquire, own, possess, use, transfer, or import devices containing three thousand seven hundred terabecquerels (one hundred thousand curies) or more of radioactive material in sealed sources used for irradiation of materials;

(3) Conduct activities for which a specific license issued by the director under this chapter or Chapter 3701:1-46, 3701:1-48, or 3701:1-58 of the Administrative Code is required; or

(4) Add or cause the addition of radioactive material to any food, beverage, cosmetic, drug, or other product designed for ingestion or inhalation by, or application to, a human being.

(B) Each type A specific license of broad scope issued under this chapter and rule 3701:1-38-02 of the Administrative Code shall be subject to the condition that radioactive material possessed under the license may only be used by, or under the direct supervision of, individuals approved by the licensee's radiation safety committee.

(C) Each type B specific license of broad scope issued under this chapter and rule 3701:1-38-02 of the Administrative Code shall be subject to the condition that radioactive material possessed under the license may only be used by, or under the direct supervision of, individuals approved by the licensee's radiation safety officer.

(D) Each type C specific license of broad scope issued under this chapter and rule 3701:1-38-02 of the Administrative Code shall be subject to the condition that radioactive material possessed under the license may only be used by, or under the direct supervision of, individuals who satisfy the requirements of rule 3701:1-40-25 of the Administrative Code.

Last updated November 2, 2022 at 2:13 PM

History

• Effective: October 4, 2010
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-40-27 Exemptions and continued regulatory authority in agreement states and in offshore waters under section 274 of the Atomic Energy Act.

(A) Except as provided in paragraph (B) of this rule, a person who receives, possesses, uses or transfers byproduct material, source, or special nuclear material in Ohio, in quantities not sufficient to form a critical mass is required to obtain a license from Ohio in accordance with Chapter 3748. of the Revised Code, and rule 3701:1-38-02 of the Administrative Code.

(B) The following activities are exempt based on section 3748.21 of the Revised Code since these activities are under United States nuclear regulatory commission jurisdiction:

(1) Activities set forth in 10 C.F.R. 150.15, (as in effect on the effective date of this rule) and any person in offshore waters with respect to byproduct, source, and special nuclear material.

(2) All persons who knowingly provide to any licensee, contractor, or subcontractor, components, equipment, materials, or other goods or services that relate to a licensee's activities, and as such, may be individually subject to enforcement action by the United States nuclear regulatory commission for violation of 10 C.F.R. 30.10, 40.10, and 70.10, (as in effect on the effective date of this rule) if applicable, for radioactive material taken or used in a non-agreement state outside of the state of Ohio or within Ohio under exclusive federal jurisdiction.

(3) Any federal government agency as that term is defined in 10 C.F.R. 150.3 (as in effect on the effective date of this rule).

Last updated April 19, 2022 at 8:36 AM

History

• Effective: April 17, 2022
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-40-28 Recognition of agreement state licenses - reciprocity.

(A) Any person who holds a specific license from another agreement state or the United States nuclear regulatory commission and who maintains an office from which the licensee directs the licensed activity and retains radiation safety records, will be granted reciprocity in the state of Ohio to conduct the same licensed activity provided that:

(1) The reciprocity form is current;

(2) The person has not violated Chapter 3748. of the Revised Code or the rules adopted thereunder;

(3) The person applies for reciprocity as outlined in this rule;

(4) The person notifies the department at least three days in advance of each entry into the state after the reciprocity agreement has been granted unless all dates and locations are specified within the agreement document; and

(5) There is no permanent location in Ohio requiring a specific license for radioactive materials.

(B) The United States nuclear regulatory commission retains authority to issue a general license to conduct the same activity in non-agreement states, areas of exclusive federal jurisdiction within agreement states, and offshore waters. The provisions of this paragraph do not apply if the agreement state, or the United States nuclear regulatory commission limits the authorized activity to a specific installation or location not within Ohio.

(C) A person applying for reciprocity in the state of Ohio as specified in paragraph (A) of this rule shall do the following:

(1) At least three days prior to engaging in each activity for the first time in a calendar year, the person shall submit on a form provided by the director, an application for reciprocity to conduct the activity in the state of Ohio, and a copy of his or her United States nuclear regulatory commission or agreement state specific license. The person shall pay the invoiced fee as prescribed in rule 3701:1-38-02 of the Administrative Code.

(2) If the person, due to an emergency, is unable to file the submittal three days before engaging in activities under reciprocity, the department may waive the three-day time requirement provided that the licensee:

(a) Informs the department by telephone or facsimile of the information provided on the reciprocity application;

(b) Receives oral or written authorization for the activity from the department; and

(c) Within three days after the notification, files the reciprocity application form, and a copy of the United States nuclear regulatory commission or agreement state license.

(3) For changes in work locations, radioactive material, or work activities different from the information contained on the initial reciprocity application, the person shall file an amended reciprocity form and pay the invoiced fee as prescribed in rule 3701:1-38-02 of the Administrative Code.

(D) An Ohio reciprocity agreement shall expire on the last day of December of the same year that the reciprocity agreement was issued.

(E) A licensee that is engaging in activities authorized by an Ohio reciprocity agreement shall comply with all terms and conditions of the specific license for which Ohio reciprocity was issued, except for such terms or conditions as are contrary to the requirements of this rule.

(F) No person shall engage in the activities authorized by an Ohio reciprocity agreement for more than one hundred eighty days in any calendar year.

Last updated November 2, 2022 at 2:13 PM

History

• Effective: June 25, 2015
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-40-29 Funds for reclamation of radioactive material.

(A) The total amount of funds the department collects, pursuant to a license for radioactive material or for any activity that results in the production of such material, for reclamation or long term maintenance and monitoring of such material shall, after November 8, 1981, be transferred to the United States if title and custody of such material and its disposal site is transferred to the United States upon termination of such license. Such funds include, but are not limited to, sums collected for long term surveillance which includes continued site observation, monitoring and, where necessary, maintenance. Such funds do not, however, include monies held as surety where no default has occurred and the reclamation or other bonded activity has been performed.

(B) The payments the department receives for reclamation or long term surveillance must, after November 8, 1981, be sufficient to ensure compliance with those standards established by the United States nuclear regulatory commission pertaining to bonds, sureties, and financial arrangements to ensure adequate reclamation and long term management of such radioactive material and its disposal site.

Last updated April 19, 2022 at 8:36 AM

History

• Effective: April 17, 2022
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-40-31 Determination to prepare bureau assessment report; eligibility for categorical exclusion.

(A) Before taking a proposed action subject to the provisions of this rule, the department will determine whether the proposed action is of the type listed in paragraph (C) of rule 3701:1-40-30 of the Administrative Code as a categorical exclusion, or whether an environmental report is required and a bureau assessment report will be prepared. A bureau assessment report may be a finding of either no significant impact, or a report that assesses the adverse radiological impact of a proposed facility or action.

(B) Whenever the director determines that a bureau assessment report will be prepared by the department in connection with a proposed action, the department shall develop an action plan and proposed time line. The department shall also do the following:

(1) Publish notice of a public meeting on the proposed license and content of the applicant's environmental report as provided in rule 3701:1-40-37 of the Administrative Code.

(2) Provide that the public meeting includes discussion on the proposed environmental report, action plan and time line for the bureau assessment report and provide the outline and deadlines for public comment.

(3) Provide the locations where a copy of the environmental report may be viewed.

(C) In preparing the bureau assessment report, the department shall, to the extent necessary:

(1) Involve any state agency which has jurisdiction or relevant, substantial expertise with respect to any environmental impact involved or which is authorized to develop and enforce relevant environmental standards;

(2) Involve affected federal and local agencies, including those authorized to develop and enforce relevant environmental standards;

(3) Identify other environmental review and consultation requirements related to the proposed action so that other required analyses and studies may be prepared concurrently and integrated with the bureau assessment report;

(4) Indicate the relationship between the timing of the preparation of environmental analyses and the department's tentative planning and decision-making schedule;

(5) Identify any cooperating agencies, and as appropriate, allocate assignments for preparation and schedules for completion of the assessment report to the director and any cooperating agencies;

(6) Describe the means by which the bureau assessment report will be prepared, including any contractor assistance to be used;

(7) Prepare the report, which shall include at least the following:

(a) A discussion of the proposed action;

(b) The need for the proposed action;

(c) Alternatives;

(d) The environmental impact of the proposed action and the alternatives, as appropriate; and

(e) A list of agencies and persons consulted, and identification of sources used; and

(8) Provide a concise summary of the determinations and conclusions reached, including the significant issues identified.

(D) At any time prior to issuance of the bureau assessment report, the director may revise the determinations made under paragraphs (B) and (C) of this rule, as appropriate, if substantial changes are made in the proposed action, or if significant new circumstances or information arise which bear on the proposed action or its impacts.

Last updated November 2, 2022 at 2:13 PM

History

• Effective: August 15, 2005
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-40-37

(A) As used in this rule, the term "publish" shall mean a printed notice in a newspaper of general circulation in the county where a proposed action or a facility is or is to be located. The department shall invoice the applicant and the applicant shall pay for all costs of publishing notices required by this rule.

(B) In accordance with rule 3701:1-40-31 of the Administrative Code, the department shall publish a notice of intent stating that a bureau assessment report will be prepared. The notice will contain the information specified in paragraph (B) of rule 3701:1-40-31 of the Administrative Code. Copies of the notice will be sent to appropriate federal, state, and local agencies, and appropriate state, regional, and metropolitan clearinghouses.

(C) Upon completion of a draft bureau assessment report or any supplement to a draft bureau assessment report, the department shall publish a notice of availability of the draft report. The notice of availability will request comments on the proposed action and on the draft report or any supplement to the draft report and will specify where comments should be submitted and when the comment period expires. The notice further shall state that copies of the draft report or any supplement to the draft report are available for public inspection at the department along with any comments received from interested persons. Copies of the notice will be sent to appropriate state, regional, and metropolitan clearinghouses, the involved licensee or applicant, and to interested persons upon request.

(D) Upon completion of a final bureau assessment report or any supplement to a final bureau assessment report, the department shall publish a notice of availability of the final report. The notice will state that copies of the final report or any supplement to the final report are available for public inspection and that inspection may be made at the department. Copies of the notice will be sent to appropriate federal, state and local agencies and appropriate state regional, and metropolitan clearinghouses, the involved licensee or applicant, and to interested persons upon request.

(E) In accordance with rule 3701:1-40-32 of the Administrative Code, the department shall publish the finding of no significant impact. The finding of no significant impact will be identified as a draft or final finding, and shall contain the information specified in rule 3701:1-40-32 of the Administrative Code, as appropriate. A draft finding of no significant impact will include a request for comments which specifies where comments should be submitted and when the comment period expires. The finding will state that copies of the finding, the environmental report setting forth the basis for the finding and any related environmental documents are available for public inspection at the department.

(F) A copy of a draft or final finding of no significant impact will be sent to the applicant and to appropriate federal, state, and local agencies and appropriate state, regional, and metropolitan clearinghouses. A copy of the draft finding also shall be sent to each person making comment.

(G) Copies of environmental reports, draft and final bureau assessment reports, bureau assessment report and findings of no significant impact, together with any related comments and environmental documents, will be placed in the department of health, bureau of environmental health and radiation protection library at 246 North High Street, Columbus, Ohio.

Last updated April 19, 2022 at 8:37 AM

History

• Effective: April 17, 2022
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-40-32 Finding of no significant impact.

(A) In accordance with paragraph (A) of rule 3701:1-40-31 of the Administrative Code, the department may prepare a bureau assessment report that makes a finding that the proposed action presents no significant radiological impact to the environment as it affects human health. A finding of no significant impact shall:

(1) Identify the proposed action;

(2) State that the department has determined not to prepare a formal bureau assessment report for the proposed action;

(3) Briefly present the reasons why the proposed action will not have a significant adverse radiological impact on the quality of human health or the environment;

(4) Note any other related environmental documents; and

(5) State that the finding and any related environmental documents are available for public inspection and where the documents may be inspected.

(B) As provided in paragraph (C) of this rule, the department may make a determination to prepare and issue a draft finding of no significant impact for public review and comment before making a final determination whether to prepare a bureau assessment report or a final finding of no significant impact on the proposed action. The department may use consultants to prepare a draft or final finding of no significant impact. The cost of any such finding is a part of the licensing or renewal of a facility and shall be paid by the applicant upon receipt of an invoice from the department.

(C) Circumstances in which a draft finding of no significant impact may be prepared may include the following:

(1) A finding of no significant impact appears warranted for the proposed action but the proposed action is closely similar to one which normally requires the preparation of bureau assessment report, or

(2) The proposed action is without precedent.

(D) A draft finding of no significant impact will:

(1) Be marked "draft";

(2) Contain the information specified in paragraph (A) of this rule;

(3) Be accompanied by or include a request for comments on the proposed action and on the draft finding within thirty days, or such longer period as may be specified in the notice of the draft finding; and

(4) Be published in the appropriate newspapers within the state of Ohio as required by paragraph (I) of this rule and rule 3701:1-40-37 of the Administrative Code.

(E) A draft finding of no significant impact shall be distributed as provided for a bureau assessment report in rule 3701:1-40-34 of the Administrative Code.

(F) When a draft finding of no significant impact is issued for a proposed action, a final determination to prepare a bureau assessment report or a final finding of no significant impact for that action shall not be made until the last day of the public comment period has expired.

(G) Except as provided in paragraph (B) of this rule, the finding of no significant impact will be prepared by the department.

(H) The department will conduct a public meeting prior to issuing a final finding of no significant impact. The meeting shall be noticed in accordance with the requirements of rule 3701:1-40-37 of the Administrative Code and shall be held in the county where the proposed facility is located. Whenever the department makes a draft or final finding of no significant impact on a proposed action, the finding will be published as provided for a bureau assessment report in rule 3701:1-40-34 of the Administrative Code.

(I) The department shall not take the proposed action until after the final finding has been published in accordance with the requirements of rule 3701:1-40-37 of the Administrative Code.

Last updated November 2, 2022 at 2:13 PM

History

• Effective: October 4, 2010
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-40-34

(A) The department shall prepare either a draft or final bureau assessment report as soon as practicable after receipt of the applicant's environmental report and after a determination that a finding of no significant impact is not appropriate. The action plan and time line shall address whether a draft assessment report shall be prepared prior to preparation of the final bureau assessment report. To the fullest extent practicable, the bureau assessment report shall be prepared concurrently or integrated with environmental impact analyses and related surveys and studies if required by state or federal law.

(B) The bureau assessment report, and any draft report thereof, shall be concise, clear and analytic, and written in plain language with appropriate graphics. The report shall state how alternatives considered in it and decisions based on it will or will not achieve the requirements of any relevant and applicable environmental laws and policies. The report also shall identify any methodologies used and sources relied upon, and shall be supported by evidence that the necessary environmental analyses have been made.

(C) The director shall cooperate with other relevant state and local agencies and the United States nuclear regulatory commission to the fullest extent possible to reduce duplication between federal, state and local requirements.

(D) To the extent sufficient information is available, the bureau assessment report, and any draft report thereof, shall include consideration of major points of view concerning the environmental impacts of the proposed action and the alternatives, and contain an analysis of significant problems and objections raised by other federal, state, and local agencies and by any comments received from the public.

The bureau assessment report and any draft report thereof, shall include a preliminary analysis that considers and weighs the environmental effects of the proposed action; the environmental impacts of alternatives to the proposed action; and alternatives available for reducing or avoiding adverse environmental effects. The analysis for all bureau assessment reports shall, to the fullest extent practicable, quantify the various factors considered. To the extent that there are important qualitative considerations or factors that cannot be quantified, these considerations or factors shall be discussed in qualitative terms. Due consideration shall be given to compliance with environmental quality standards and requirements that have been imposed by federal or state agencies having responsibility for environmental protection. Satisfaction of department of health standards and criteria pertaining to radiological effects shall be necessary to meet the licensing requirements of Chapter 3748. of the Revised Code. The analysis shall consider the radiological effects of the proposed action and alternatives.

(E) The bureau assessment report, and any draft report thereof, shall list all state and federal permits, licenses, approvals, and other entitlements which must be obtained in implementing the proposed action and shall describe the status of compliance with those requirements. If it is uncertain whether a state or federal permit, license, approval, or other entitlement is necessary, the bureau assessment report shall so indicate.

(F) The bureau assessment report normally shall include a recommendation by the director respecting the proposed action. This recommendation shall be based on the information and analysis described in paragraphs (A) to (E) of this rule and shall be reached after considering the environmental effects of the proposed action and reasonable alternatives.

(G) The department shall prepare a supplement to a bureau assessment report for which a notice of availability has been published if there are substantial changes in the proposed action that are relevant to adverse radiological concerns that bear on the proposed action or its impacts.

(H) The department may prepare a supplement to a bureau assessment report when preparation of a supplement will provide additional information necessary to address concerns related to adverse radiological impact.

(I) The supplement to a bureau assessment report shall be prepared and noticed in the same manner as the bureau assessment report except that additional action plans and time lines need not be used.

(J) Each bureau assessment report, and each supplement to a bureau assessment report distributed in accordance with this rule, and each news release provided pursuant to this rule, shall be accompanied by or include a request for comments on the proposed action and on the bureau assessment report or any supplement to the bureau assessment report and shall state where comments should be submitted and the date on which the comment period closes. A minimum comment period of forty-five days shall be provided. The comment period shall be calculated from the publication date for the notice in the applicable area newspapers. If no comments are provided within the time specified, it will be presumed, unless the applicant requests an extension of time, that the applicant has no comment. To the extent practicable, the department will grant reasonable requests for extensions of time of up to fifteen days. The comment period for any agency is concurrent with the public comment period.

(K) A copy of the bureau assessment report shall be distributed to:

(1) The Ohio environmental protection agency;

(2) Any other state or federal agency which has special expertise or jurisdiction by law with respect to any environmental impact involved or which is authorized to develop and enforce relevant environmental standards;

(3) The applicant;

(4) Appropriate federal, state, and local agencies authorized to develop and enforce relevant environmental standards, land use, and zoning;

(5) Appropriate state, regional and metropolitan clearinghouses; and

(6) Upon request, any other person to the extent available.

(L) A supplement to a bureau assessment report shall be distributed in the same manner as the bureau assessment report to which it relates.

(M) News releases stating the availability for comment and place for obtaining or inspecting a bureau assessment report or supplement will be provided to at least one local newspaper of general circulation in the county where the action is proposed to occur.

(N) A notice of availability shall be published in appropriate area newspapers in accordance with rule 3701:1-40-37 of the Administrative Code.

(O) The director shall not render a decision on a proposed action, including the issuance of a license, or amendment to, or renewal of a license, for which a bureau assessment report is required, until the later of the following dates:

(1) Forty-five days after the department publishes in an appropriate area newspaper, a notice stating that the draft bureau assessment report is available at the department for review.

(2) Thirty days after the department publishes in an appropriate area newspaper, a notice stating that the final bureau assessment report has been completed and is available at the department for review.

If a notice of filing of a final bureau assessment report is published by the department within forty-five days after a notice of a draft bureau assessment report has been published by the department, the minimum thirty-day period and the minimum forty-five-day period may run concurrently to the extent they overlap.

(P) The cost of preparing a bureau assessment report shall be paid by the applicant for the action being requested. The amount shall include the cost of any contractors employed by the department, and staff time involved in the preparation and analysis of the environmental report and the subsequent bureau assessment report.

(Q) The format of the report shall be in accordance with department guidelines for the preparation of a bureau assessment report.

Last updated November 2, 2022 at 2:14 PM

History

• Effective: August 15, 2005
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-40-33 Environmental report.

(A) Each applicant for a license or license amendment or a renewal of a license that is listed in paragraphs (F)(1) to (F)(5) of this rule, shall submit to the department the application with a separate document entitled "applicant's environmental report" or "supplement to applicant's environmental report." The applicant's environmental report shall contain the information specified in this rule. If the application is for an amendment to or a renewal of a license for which the applicant has previously submitted an environmental report, the supplement to applicant's environmental report may be limited to incorporating by reference, updating or supplementing the information previously submitted to reflect any significant environmental change, including a change resulting from operational experience or a change in operations or proposed decommissioning activities. If the applicant is a contractor of the United States department of energy that is licensed by the state of Ohio for the possession and use of radioactive materials, the environmental report may be in the form of either an environmental impact statement or an environmental assessment, as appropriate. An applicant may submit a supplement to an environmental report at any time.

(B) The environmental report shall contain a description of the proposed action, a statement of its purposes, a description of the environment affected, and discuss all of the following:

(1) The radiological impact of the proposed action on the environment;

(2) Any adverse radiological environmental effects which cannot be avoided should the proposal be implemented; and

(3) A complete discussion of alternatives in order to aid the department in developing and exploring appropriate alternatives to recommended courses of action. To the extent practicable, the environmental impacts of the proposal and the alternatives should be presented in comparative form.

(C) The environmental report shall include an analysis that considers and balances the environmental effects of the proposed action, the environmental impacts of alternatives to the proposed action, and alternatives available for reducing or avoiding adverse environmental effects as they relate to human health. The analyses for environmental reports shall, to the fullest extent practicable, quantify the various factors considered. To the extent that there are important qualitative considerations or factors that cannot be quantified, those considerations or factors shall be discussed in qualitative terms. The environmental report should contain sufficient data to aid the department in development of an independent analysis.

(D) The environmental report shall list all state of Ohio permits, licenses, approvals and other entitlements which must be obtained in connection with the proposed action and all federal permits, licenses, approvals and other entitlements which must be obtained in connection with the proposed action and shall describe the status of compliance with these requirements. The environmental report shall also include a discussion of the status of compliance with applicable environmental quality standards and requirements including, but not limited to, applicable zoning and land-use regulations, and water pollution limitations or requirements which have been imposed by federal or state agencies having responsibility for environmental protection. The discussion of alternatives in the report shall include a discussion of whether the alternatives will comply with such applicable environmental quality standards and requirements.

(E) The information submitted pursuant to paragraphs (B) to (D) of this rule should not be confined to information supporting the proposed action but shall also include any adverse information.

(F) In accordance with paragraph (A) of this rule, each applicant shall prepare an environmental report for the following types of actions:

(1) Issuance or renewal of a license for:

(a) Possession and use of special nuclear material for processing, scrap recovery, or conversion of uranium hexafluoride pursuant to Chapter 3701:1-56 of the Administrative Code.

(b) Possession and use of source material for uranium milling or production of uranium hexafluoride pursuant to Chapter 3701:1-44 of the Administrative Code.

(c) Receipt, processing, or disposal of radioactive waste from other persons pursuant to Chapter 3701:1-54 of the Administrative Code.

(d) Processing of source material for extraction of rare earth and other metals.

(e) Use of radioactive tracers in field flood studies involving secondary and tertiary oil and gas recovery.

(f) Processing or recycling of radioactive material that would result in concentration of radioactivity in waste materials in amounts that exceed concentrations provided in Chapter 3701:1-40 of the Administrative Code for the processing or recycling of radioactive material.

(g) Processing or recycling of soils or materials containing concentrations of source or radioactive material that exceed concentrations provided in Chapter 3701:1-40 of the Administrative Code relative to disposal.

(2) Issuance of an amendment that would authorize or result in:

(a) A significant expansion of a site;

(b) A significant change in the types of effluents;

(c) A significant increase in the amounts of effluents;

(d) A significant increase in individual or cumulative occupational radiation exposure; or

(e) A significant increase in the potential for or consequences from radiological accidents.

(3) Termination of a license for the possession and use of source material for uranium milling.

(4) Issuance of a license amendment pursuant to Chapter 3701:1-54 of the Administrative Code authorizing:

(a) Closure of a land disposal site;

(b) Transfer of the license to the disposal site owner for the purpose of institutional control; or

(5) Any other licensing action for which the director determines an environmental report is necessary.

(G) Each applicant for issuance of a license for disposal of radioactive waste pursuant to Chapter 3701:1-54 of the Administrative Code shall submit to the department with the application a separate document, entitled "applicant's environmental report - license for disposal of radioactive waste." The environmental report and any supplement to the environmental report may incorporate by reference information contained in the application or in any previous application, statement or report filed with the director, provided that such references are clear and specific and that copies of the information so incorporated are available at the department and in any public document room established by the director near the proposed disposal site.

(H) The environmental report shall contain the information specified in this rule, shall address the applicant's environmental monitoring program required by Chapter 3701:1-54 of the Administrative Code, and shall be as complete as possible in the light of information that is available at the time the environmental report is submitted.

(I) The applicant shall supplement the environmental report in a timely manner as necessary to permit the department to review, prior to issuance, amendment or renewal of a license, new information regarding the environmental impact of previously proposed activities, information regarding the environmental impact of any changes in previously proposed activities, or any significant new information regarding the environmental impact of closure activities and long-term performance of the disposal site.

(J) Each applicant for a license, or an amendment to, or renewal of a license that pursuant to these rules requires an environmental report shall submit such report or any supplement to an environmental report. The applicant shall retain additional copies of the environmental report or any supplement to the environmental report in the number of copies specified for distribution to federal, state, and local officials in accordance with written instructions issued by the director.

Last updated April 19, 2022 at 8:36 AM

History

• Effective: April 17, 2022
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-40-35 Final publishing of bureau assessment report.

(A) The department shall consider comments received pursuant to rules 3701:1-40-34 and 3701:1-40-37 of this chapter and prepare a final bureau assessment report that contains the elements specified in rule 3701:1-40-34 of the Administrative Code.

(B) The final bureau assessment report shall contain all of the following:

(1) A summary of responses to any relevant comments received on the draft bureau assessment report or on any supplement to the draft bureau assessment report;

(2) A discussion of any relevant opposing view not adequately discussed in the draft bureau assessment report or in any supplement to the draft bureau assessment report, and a response to the issues raised;

(3) A statement on how the alternatives considered in it and decisions based on it will or will not achieve the requirements of any relevant and applicable environmental laws and policies; and

(4) A final analysis and a final recommendation on the action to be taken.

(C) If the proposed action has not been taken, the department will prepare a supplement to a final bureau assessment report for which a notice of availability has been published as provided in rule 3701:1-40-37 of the Administrative Code, if:

(1) There are substantial changes in the proposed action that are relevant to environmental concerns; or

(2) There are significant new circumstances or information relevant to environmental concerns and bearing on the proposed action or its impacts.

The supplement shall contain a request for comments as provided in rule 3701:1-40-34 of the Administrative Code, and a notice of availability shall be published in applicable local newspapers as provided in rule 3701:1-40-37 of the Administrative Code. If comments are not received, a notice of availability of a supplement to a final bureau assessment report shall be published as provided in rule 3701:1-40-37 of the Administrative Code.

(D) The supplement to a final bureau assessment report will be prepared in the same manner as the final bureau assessment report.

(E) A copy of the final bureau assessment report will be distributed to the following:

(1) The Ohio environmental protection agency;

(2) The applicant;

(3) Appropriate federal, state, regional and metropolitan clearinghouses; and

(4) Each person providing comment.

Additional copies will be made available by request to the department.

(F) If the final bureau assessment report is unusually long, or there are so many comments on a draft bureau assessment report or any supplement to a draft bureau assessment report that distribution of the entire final report to all persons providing comments is impracticable, a summary of the final statement and the substantive comments may be distributed.

(G) A supplement to a final bureau assessment report shall be distributed in the same manner as the final bureau assessment report to which it relates.

(H) News releases stating the availability and place for obtaining or inspecting a final bureau assessment report or supplement shall be provided to area newspapers where the proposed action is to occur and other appropriate media.

(I) A notice of availability will be published in accordance with rule 3701:1-40-37 of the Administrative Code.

(J) The final bureau assessment report, together with any comments and any supplement, will accompany the application and be considered in the director's decision-making process. The final bureau assessment report, together with any comments and any supplement, will be made a part of the record of any adjudicatory proceeding resulting from the director's decision.

Last updated April 19, 2022 at 8:37 AM

History

• Effective: April 17, 2022
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-38-06

(A) The director may suspend or revoke a license or a certificate of registration, or issue adjudication orders for failure by the licensee or registrant to comply with Chapter 3748. of the Revised Code or a rule adopted thereunder. Except as otherwise provided in paragraphs (B), and (D) to (F) of this rule, prior to suspending or revoking a license or certificate of registration, the director shall first give written notice of violation to the licensee or registrant, by certified mail, return-receipt requested, specifying the section of Chapter 3748. of the Revised Code or the rule violated and specifically describing the violation. The notice of violation shall include information concerning the applicable penalties established under sections 3748.19 and 3748.99 of the Revised Code. The director shall provide the licensee or registrant with an informal meeting provided that the licensee or registrant requests the meeting and provided that the meeting is held within thirty days of the date that the licensee or registrant receives the notice of violation or at a later date as determined by the director. If, after thirty days from the date the licensee or registrant received the notice of violation, the facility remains in violation the director may issue an adjudication order. The adjudication order shall specify the section of Chapter 3748. of the Revised Code or the rule violated, specifically describe the violation, specify the action ordered to abate the violation, and order the action to be taken within a specified reasonable time. In the order, the director also may propose to suspend or revoke the license or certificate of registration should the licensee or registrant fail to take the action specified in the order within the specified time.

(B) If the director determines that an emergency exists requiring immediate action to protect the public health or safety, he or she may issue an emergency adjudication order, reciting the existence of an emergency and specifying the necessary action that shall be taken to meet the emergency. The order shall be effective immediately, without notice or hearing, but shall not remain effective for more than ninety days after its issuance. Any facility to which the order is directed shall comply immediately.

(C) In the case of a failure by a licensee or registrant to comply with Chapter 3748. of the Revised Code or the rules adopted thereunder, the director may issue an adjudication order, emergency adjudication order, or may propose the suspension or revocation of the facility's license or registration. The licensee or registrant shall be notified as soon as practicable that the licensee or registrant may appeal any adjudication order, emergency adjudication order, or proposed license or registration suspension or revocation in accordance with Chapter 119. of the Revised Code, provided that the licensee or registrant requests a hearing within thirty days of the time of mailing the order or proposed suspension or revocation. In the case of an emergency adjudication order, the hearing shall be held within thirty days of the request. The director may continue, modify, suspend or revoke an adjudication order at any time, or withdraw a proposed suspension or revocation prior to a final order. In accordance with Chapter 3748. of the Revised Code and this rule, the director may concurrently assert against a licensee or registrant more than one administrative remedy. In the event the licensee or registrant appeals more than one administrative action, the director may consolidate into one hearing any or all issues to be heard.

(D) Registration, license, and inspection fees shall be paid no later than thirty days after the invoice for the fee is mailed. In accordance with sections 3748.07 and 3748.13 of the Revised Code, any fee that remains unpaid on the ninety-first day after the original invoice date shall be assessed an additional amount equal to ten per cent of the original fee. All invoices issued by the department shall include thereon information regarding the assessment for late payment or nonpayment that is specified in division (B) of section 3748.13 of the Revised Code.

(1) The department shall mail invoices by ordinary United States mail to the most recent address provided by the registrant or licensee on his or her application or current registration.

(2) The department shall maintain a list of the invoices issued and date mailed.

(E) The director may impound or order the impounding of sources of radiation that are not stored, used, or disposed of in accordance with Chapter 3748. of the Revised Code or the rules adopted under it if the source of radiation has been abandoned or if the owner cannot be identified or located. If the director determines that an emergency exists requiring immediate impoundment to protect the public health or safety, the director may issue an emergency adjudication order in accordance with paragraph (B) of this rule. The director may make any disposition of the source of radiation consistent with Chapter 3748. of the Revised Code and the rules adopted thereunder.

(F) If the director determines that a licensee has failed to comply with Chapter 3748. of the Revised Code or the rules adopted thereunder, the director may at any time assess and collect an administrative monetary penalty in accordance with rules adopted pursuant to section 3748.05 of the Revised Code. The director may assess the administrative penalty independent of any and all other remedies that may be asserted by the department but may not assess any administrative monetary penalty until specified by rule in accordance with section 3748.05 of the Revised Code. The licensee may appeal the assessment of an administrative monetary penalty in accordance with Chapter 119. of the Revised Code, provided that the licensee requests a hearing within thirty days of the time of mailing the administrative penalty assessment.

Last updated November 2, 2022 at 2:09 PM

History

• Effective: April 15, 2013
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-40-39 Radioactive drug: capsules containing carbon-14 urea for "in vivo" diagnostic use for humans.

(A) Except as provided in paragraphs (B) and (C) of this rule, any person is exempt from the requirements for a license set forth in this chapter and Chapter 3701:1-58 of the Administrative Code, provided that such person receives, possesses, uses, transfers, owns, or acquires capsules containing thirty-seven kilobecquerels (one microcurie) carbon-14 urea (allowing for nominal variation that may occur during the manufacturing process) each, for "in vivo" diagnostic use for humans.

(B) Any person who desires to use the capsules for research involving human subjects shall apply for and receive a specific license under Chapter 3701:1-58 of the Administrative Code.

(C) Any person who desires to manufacture, prepare, process, produce, package, repackage, or transfer for commercial distribution such capsules shall apply for and receive a specific license under Chapter 3701:1-46 of the Administrative Code.

(D) Nothing in this rule relieves persons from complying with applicable United States food and drug administration, other federal, and state requirements governing receipt, administration, and use of drugs.

Last updated November 2, 2022 at 2:14 PM

History

• Effective: October 4, 2010
• Promulgated Under: 119.03

Chapter 3701:1-43 Technologically Enhanced Naturally Occurring Radioactive Material

Ohio Adm.Code 3701:1-43-01 Definitions.

Terms defined in rule 3701:1-38-01 of the Administrative Code will have the same meaning when used in this chapter except terms redefined within a given rule for use within that rule only, and additionally, as used in Chapter 3701:1-43 of the Administrative Code:

(A) "Beneficial to the product" means that the radioactivity of the technologically enhanced naturally occurring radioactive material (TENORM) is necessary to the use of the product.

(B) "Commencement of construction" means any clearing of land, excavation, or other substantial action that would adversely affect the environment of a site. The term does not mean site exploration, necessary roads for site exploration, borings to determine foundation conditions, or other preconstruction monitoring or testing to establish background information related to the suitability of the site or the protection of the environment.

(C) "Conditional release" means release by a licensee for a specified use other than release for unrestricted use.

(D) "Consumer" means a member of the public exposed to TENORM from final end-use products available on a retail basis.

(E) "Consumer or retail product" means any product, article, or component part thereof, produced, distributed or sold for use by a consumer in or around a permanent or temporary household or residence, or for the personal use, consumption, or enjoyment of a consumer, or for use in or around a school or playground.

(F) "Product" means something produced, made, manufactured, refined, or beneficiated.

(G) "Reasonably maximally exposed individual" means a representative of a population who is exposed to TENORM at the maximum TENORM concentration measured in environmental media found at a site along with reasonable maximum case exposure assumptions. The exposure is determined by using maximum values for one or more of the most sensitive parameters affecting exposure, based on cautious but reasonable assumptions, while leaving the others at their mean value.

(H) "Technologically Enhanced Naturally Occurring Radioactive Material (TENORM)" means naturally occurring radioactive material whose radionuclide concentrations are increased by or as a result of past or present human practices. TENORM does not include drill cuttings, or natural background radiation. TENORM does not include "source material" and "byproduct material" as both are defined in rule 3701:1-38-01 of the Administrative Code.

(I) "Transfer" means the physical relocation of TENORM within a business' operation, or between general or specific licensees. This term does not include commercial distribution. This term does not include a change in legal title to TENORM that does not involve physical movement of those materials.

Last updated May 15, 2023 at 1:06 AM

History

• Effective: May 15, 2023
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-38-01

(A) As used in this chapter and all other rules promulgated pursuant to Chapter 3748. of the Revised Code:

(1) "A₁" means the maximum activity of special form radioactive material permitted in a type A package. These values are listed in rule 3701:1-50-25 of the Administrative Code, or may be derived in accordance with the procedure prescribed in rule 3701:1-50-25 of the Administrative Code.

(2) "A₂" means the maximum activity of radioactive material, other than special form, low specific activity and surface contaminated object material, permitted in a type A package. These values are listed in rule 3701:1-50-25 of the Administrative Code, or may be derived in accordance with the procedure prescribed in rule 3701:1-50-25 of the Administrative Code.

(3) "Absorbed dose" means the energy imparted by ionizing radiation per unit mass of irradiated material. The units of absorbed dose are the gray, or Gy, and the rad.

(4) "Accelerator or charged particle accelerator" means any of a class of radiation generating equipment designed to electronically accelerate atomic or sub-atomic particles for subsequent bombardment of targets.

(5) "Accelerator-produced radioactive material" means any material made radioactive by a particle accelerator.

(6) "Activity" means the rate of disintegration or transformation or decay of radioactive material. The units of activity are the becquerel, or Bq, and the curie, or Ci.

(7) "Address of use" means the building or buildings that are identified on the license or registration and where the source of radiation may be received, used, prepared, or stored, except for temporary job sites.

(8) "Administrative controls" means mechanisms used to protect health and minimize damage to life and property through the use of written policies, procedures, instructions, training, observation of work practices, and related compliance audits.

(9) "Administrative monetary penalty" means a monetary penalty assessed by the director under section 3748.05 of the Revised Code and in compliance with rules adopted thereunder, to emphasize the need for lasting remedial action and to deter future violations.

(10) "Adult" means an individual eighteen or more years of age.

(11) "Agreement state" means any state with which the United States nuclear regulatory commission or the atomic energy commission has entered into an effective agreement under subsection 274B of the Atomic Energy Act of 1954, 68 Stat. 919, 42 U.S.C. 2021, as amended (1978). Non-agreement state means any other state.

(12) "Airborne radioactive material" means radioactive material dispersed in the air in the form of dusts, fumes, particulates, mists, vapors, or gases.

(13) "Airborne radioactivity area" means a room, enclosure, or area in which airborne radioactive materials, composed wholly or partly of licensed material, exist in concentrations:

(a) In excess of the derived air concentrations (DACs) specified in appendix C to rule 3701:1-38-12 of the Administrative Code, or

(b) To such a degree that an individual present in the area without respiratory protective equipment could exceed, during the hours an individual is present in a week, an intake of 0.6 per cent of the annual limit on intake or twelve DAC-hours.

(14) "Air-purifying respirator" means a respirator with an air-purifying filter, cartridge, or canister that removes specific air contaminants by passing ambient air through the air-purifying element.

(15) "ALARA" or "as low as is reasonably achievable" means every reasonable effort to maintain exposures to radiation as far below the dose limits as is practical consistent with the purpose for which the licensed or registered activity is undertaken, taking into account the state of technology, the economics of improvements in relation to benefits to the public health and safety, and other societal and socioeconomic considerations, and in relation to utilization of nuclear energy and licensed materials and registered activities in the public interest.

(16) "Alert" means events may occur, are in progress, or have occurred that could lead to a release of radioactive material but that the release is not expected to require a response by off-site response organizations to protect persons off-site.

(17) "Annual limit on intake" or "ALI" means the derived limit for the amount of radioactive material taken into the body of an adult worker by inhalation or ingestion in a year. ALI is the smaller value of intake of a given radionuclide in a year by the reference man that would result in a committed effective dose equivalent of 0.05 sievert (five rem) or a committed dose equivalent of 0.5 sievert (fifty rem) to any individual organ or tissue. ALI values for intake by ingestion and by inhalation of selected radionuclides are given in appendix C to rule 3701:1-38-12 of the Administrative Code.

(18) "Annually" means either

(a) At intervals not to exceed one year; or

(b) Once per year, at about the same time each year, plus or minus one month.

(19) "Area of use" means a portion of an address of use that has been set aside for the purpose of receiving, preparing, using, or storing sources of radiation.

(20) "Assigned protection factor" or "APF" means the expected workplace level of respiratory protection that would be provided by a properly functioning respirator or a class of respirators to properly fitted and trained users. Operationally, the inhaled concentration can be estimated by dividing the ambient airborne concentration by the APF.

(21) "Atmosphere-supplying respirator" means a respirator that supplies the respirator user with breathing air from a source independent of the ambient atmosphere, and includes supplied air respirators, or SARs, and self-contained breathing apparatus, or SCBA, units.

(22) "Atomic energy commission" or "AEC" means the federal agency created by the Atomic Energy Act of 1954, 68 Stat. 919, 42 U.S.C. 2011, as amended (1964), and was the predecessor agency to the current United States nuclear regulatory commission.

(23) "Background radiation" means radiation from cosmic sources; naturally occurring radioactive materials, including radon, except as a decay product of source or special nuclear material, and global fallout as it exists in the environment from the testing of nuclear explosive devices or from past nuclear accidents such as Chernobyl that contribute to background radiation and are not under the control of the licensee. "Background radiation" does not include radiation from radioactive materials regulated by the department.

(24) "Becquerel" or "Bq" means the SI unit of activity. One becquerel is equal to one disintegration per second.

(25) "Bioassay" or "radiobioassay" means the determination of kinds, quantities or concentrations, and, in some cases, the locations of radioactive material in the human body, whether by direct measurement, in vivo counting, or by analysis and evaluation of materials excreted or removed from the human body.

(26) "Byproduct material" means

(a) Any radioactive material, except special nuclear material, yielded in or made radioactive by exposure to the radiation incident to the process of producing or utilizing special nuclear materials; or

(b) The tailings or wastes produced by the extraction or concentration of uranium or thorium from any ore processed primarily for its source material content, including discrete surface wastes resulting from solution extraction processes. Underground ore bodies depleted by such solution extraction do not constitute byproduct material within the definition.

(27) "Chelating agent" means a chemical compound or mixture that enhances the removal of radioactive material from the body, water or similar applications. Typical chelating agents include amine polycarboxylic acids such as EDTA or DTPA; hydroxy-carboxylic acids; and polycarboxylic acids such as citric acid, carbolic acid, and gluconic acid.

(28) "Chiropractor" means an individual licensed by the state of Ohio to practice chiropractic medicine pursuant to Chapter 4734. of the Revised Code.

(29) "Class" or "lung class" or "inhalation class" means a classification scheme for inhaled material according to its rate of clearance from the pulmonary region of the lung. Materials are classified as D, W, or Y, which applies to a range of clearance half-times: for class D, days, of less than ten days, for class W, weeks, from ten to one hundred days, and for class Y, years, of greater than one hundred days.

(30) "Collective dose" means the sum of the individual doses received in a given period of time by a specified population from exposure to a specified source of radiation.

(31) "Commencement of construction" means taking any action defined as "construction" or any other activity at the site of a facility subject to the rules promulgated pursuant to Chapter 3748. of the Revised Code that has a reasonable nexus to radiological health and safety.

(32) "Committed dose equivalent" or "H_T,50" means the dose equivalent to organs or tissues of reference, T, that will be received from an intake of radioactive material by an individual during the fifty year period following the intake.

(33) "Committed effective dose equivalent" or "H_E,50" means the sum of the products of the weighting factors applicable to each of the body organs or tissues, W_T, that are irradiated and the committed dose equivalent to each of these organs or tissues (H_{E, 50} = W_TH_T,50).

(34) "Consortium" means an association of medical use licensees and a PET radionuclide production facility in the same geographical area that jointly own or share in the operation and maintenance cost of the PET radionuclide production facility that produces PET radionuclides for use in producing radioactive drugs within the consortium for noncommercial distributions among its associated members for medical use. The PET radionuclide production facility within the consortium must be located at an educational institution or a medical facility.

(35) "Constraint" or "dose constraint" means a value above which specified licensee actions are required.

(36) "Construction" means the installation of foundations, or in-place assembly, erection, fabrication, or testing for any structure, system, or component of a facility or activity subject to the rules promulgated pursuant to Chapter 3748. of the Revised Code that are related to radiological safety or security. The term "construction" does not include:

(a) Changes for temporary use of the land for public recreational purposes;

(b) Site exploration, including necessary borings to determine foundation conditions or other preconstruction monitoring to establish background information related to the suitability of the site, the environmental impacts of construction or operation, or the protection of environmental values;

(c) Preparation of the site for construction of the facility, including clearing of the site, grading, installation of drainage, erosion and other environmental mitigation measures, and construction of temporary roads and borrow areas;

(d) Erection of fences and other access control measures that are not related to the safe use of, or security of, radiological materials subject to the rules promulgated pursuant to Chapter 3748. of the Revised Code;

(e) Excavation;

(f) Erection of support buildings (e.g. construction equipment storage sheds, warehouse and shop facilities, utilities, concrete mixing plants, docking and unloading facilities, and office buildings) for use in connection with the construction of the facility;

(g) Building of service facilities (e.g. paved roads, parking lots, railroad spurs, exterior utility and lighting systems, potable water systems, sanitary sewerage treatment facilities, and transmission lines);

(h) Procurement or fabrication of components or portions of the proposed facility occurring at other than the final, in-place location at the facility; or

(i) Taking any other action that has no reasonable nexus to radiological health and safety.

(37) "Controlled area" means an area, outside of a restricted area but inside the site boundary, access to which can be limited by the licensee or registrant for any reason.

(38) "Critical group" means the group of individuals reasonably expected to receive the greatest exposure to residual radioactivity for any applicable set of circumstances.

(39) "Curie" or "Ci" means a unit of activity. One curie equals 3.7 x 10¹⁰ disintegrations per second equals 3.7 x 10¹⁰ becquerels equals 2.22 x 10¹² disintegrations per minute.

(40) "Cyclotron" means a particle accelerator in which the charged particles travel in an outward spiral or circular path. A cyclotron accelerates charged particles at energies usually in excess of ten megaelectron volts and is commonly used for production of short half-life radionuclides for medical use.

(41) "Declared pregnant woman" means a woman who has voluntarily informed the licensee or registrant, in writing, of her pregnancy and the estimated date of conception. The declaration remains in effect until the declared pregnant woman withdraws the declaration in writing or is no longer pregnant.

(42) "Decommission" means to safely remove any licensed operation from service and reduce residual radioactivity to a level that permits release of the licensee's property for unrestricted use and termination of the license.

(43) "Dedicated check source" means a radioactive source that is used to assure the consistent performance of a radiation detection or measurement device over several months or years.

(44) "Deep dose equivalent" or "H_d" applies to external whole body exposure, and means the dose equivalent at a tissue depth of one centimeter, one thousand milligram per square centimeter.

(45) "Demand respirator" means an atmosphere-supplying respirator that admits breathing air to the facepiece only when a negative pressure is created inside the facepiece by inhalation.

(46) "Dentist" means an individual licensed by the state of Ohio to practice dentistry under Chapter 4715. of the Revised Code.

(47) "Department" means the Ohio department of health.

(48) "Depleted uranium" means uranium containing less uranium-235 than the naturally occurring distribution of uranium isotopes.

(49) "Derived air concentration" or "DAC" means the concentration of a given radionuclide in air which, if breathed by the reference man for a working year of two thousand hours under conditions of light work, results in an intake of one ALI. The condition of light work is inhaling 1.2 cubic meters of air per hour for two thousand hours in a year. DAC values are given in appendix C to rule 3701:1-38-12 of the Administrative Code.

(50) "Derived air concentration-hour or DAC-hour" means the product of the concentration of radioactive material in air, which is expressed as a fraction or multiple of the derived air concentration for each radionuclide, and the time of exposure to that radionuclide, in hours. A licensee or registrant may take two thousand DAC-hours to represent one ALI, equivalent to a committed effective dose equivalent of 0.05 Sv (five rem).

(51) "Direct reading dosimeter" means a device that measures radiation dose that does not require another device to read the measured radiation dose. Examples of direct reading dosimeters include pocket dosimeters and electronic dosimeters.

(52) "Director" means the director of health or a designee or authorized representative of the director.

(53) "Discipline" means a branch of knowledge or of teaching.

(54) "Discrete source" means a radionuclide that has been processed so that its concentration within a material has been purposely increased for use for commercial, medical, or research activities.

(55) "Disposable respirator" means a respirator for which maintenance is not intended and that is designed to be discarded after excessive breathing resistance, sorbent exhaustion, physical damage, or end-of service-life renders it unsuitable for use. Examples of this type of respirator are a disposable half-mask respirator or a disposable escape-only self-contained breathing apparatus.

(56) "Dose" or "radiation dose" is a generic term that means absorbed dose, dose equivalent, effective dose equivalent, committed effective dose equivalent, or total effective dose equivalent as defined in other paragraphs of this rule.

(57) "Dose equivalent" or "H_T" means the product of the absorbed dose in tissue, quality factor, and all other necessary modifying factors at the location of interest. The units of dose equivalent are the sievert and rem.

(58) "Dose limits" or "limits" means the permissible upper bounds of radiation doses established in accordance with these regulations but excludes background radiation and medical exposure.

(59) "Dosimetry processor" means a person that processes and evaluates individual monitoring devices in order to determine the radiation dose delivered to the monitoring devices.

(60) "Effective dose equivalent" or "H_E" means the sum of the products of the dose equivalent to each organ or tissue, H_T, and the weighting factor, W_T, applicable to each of the body organs or tissues that are irradiated: (H_E = ∑W_TH_T).

(61) "Embryo" or "fetus" means the developing human organism from conception until time of birth.

(62) "Engineering controls" means mechanisms used to protect health and minimize damage to life and property through engineering specifications, design, and construction of the product or facility including all of the security and safety features. This includes, but is not limited to, auxiliary security and safety features such as additional external shielding, barriers, and operational interlocks with associated processes.

(63) "Entrance" or "access point" means any opening through which an individual or extremity of an individual could gain access to radiation areas or to licensed radioactive materials or registered radiation generating equipment. This includes entry or exit portals of sufficient size to permit human entry, irrespective of their intended use.

(64) "Explosive material" means any chemical compound, mixture or device which produces a substantial instantaneous release of gas and heat spontaneously or by contact with sparks or flame.

(65) "Exposure" means being exposed to sources of ionizing radiation.

(66) "External dose" means that portion of the dose equivalent received from radiation sources outside the body.

(67) "Extremity" means hand, elbow, arm below the elbow, foot, knee, or leg below the knee.

(68) "Eye dose equivalent" means the same as lens dose equivalent.

(69) "Facility" means all buildings, equipment, structures and other stationary items that, in addition to the meaning defined in division (H) of section 3748.01 of the Revised Code, are:

(a) Located on a single site or on contiguous or adjacent sites and are operated by the same person and have common corporate or business interests; or

(b) Portions of a building or structure which are operated by the same person and have common corporate or business interests.

(70) "Filtering facepiece" or "dust mask" means a negative pressure particulate respirator with a filter as an integral part of the facepiece or with the entire facepiece composed of the filtering medium, not equipped with elastomeric sealing surfaces and adjustable straps.

(71) "Fissile material" means the radionuclides uranium-233, uranium-235, plutonium-239, and plutonium-241, or any combination of these radionuclides. Fissile material means the fissile nuclides themselves, not material containing fissile nuclides. Unirradiated natural uranium and depleted uranium and natural uranium or depleted uranium that has been irradiated in thermal reactors only, are not included in this definition. Certain exclusions from fissile material controls are provided in rule 3701:1-50-13 of the Administrative Code.

(72) "Fit factor" means quantitative estimate of the fit of a particular respirator to a specific individual, and typically estimates the ratio of the concentration of a substance in ambient air to its concentration inside the respirator when worn.

(73) "Fit test" means the use of a protocol to qualitatively or quantitatively evaluate the fit of a respirator on an individual.

(74) "Generally applicable environmental radiation standards" means standards issued by the United States environmental protection agency under the authority of the Atomic Energy Act of 1954, 68 Stat. 919, 42 U.S.C. 2011, as amended (2005), that impose limits on radiation exposures or levels, or concentrations or quantities of radioactive material, in the general environment outside the boundaries of locations under the control of persons possessing or using radioactive material.

(75) "Gray" or "Gy" means the SI unit of absorbed dose. One gray is equal to an absorbed dose of one joule per kilogram (one hundred rads).

(76) "Handle" means receive, possess, use, store, transfer, install, service, or dispose of sources of radiation unless possession is solely for the purpose of transportation.

(77) "Handler" means a facility that handles sources of radiation unless possession is solely for the purpose of transportation.

(78) "Hazardous waste" means those wastes designated as hazardous by rule 3745-51-03 of the Administrative Code.

(79) "Helmet" means a rigid respiratory inlet covering that also provides head protection against impact and penetration.

(80) "High radiation area" means an area, accessible to individuals, in which radiation levels from radiation sources external to the body could result in an individual receiving a dose equivalent in excess of one millisievert (0.1 rem) in one hour at thirty centimeters from the radiation source or thirty centimeters from any surface that the radiation penetrates.

(81) "Hood" means a respiratory inlet covering that completely covers the head and neck and may also cover portions of the shoulders and torso.

(82) "Individual" means any human being.

(83) "Individual monitoring" means

(a) The assessment of dose equivalent by the use of devices designed to be worn by an individual;

(b) The assessment of committed effective dose equivalent by bioassay or by determination of the time-weighted air concentrations to which an individual has been exposed, i.e. DAC-hours; or

(c) The assessment of dose equivalent by the use of survey data.

(84) "Individual monitoring devices" means devices designed to be worn by a single individual for the assessment of dose equivalent such as film badges; thermoluminescent dosimeters; optically stimulated luminescent dosimeters; pocket ionization chambers; and personal air sampling devices.

(85) "Industrial radiography" means the examination of the structure of materials by nondestructive methods, utilizing sealed sources of radioactive material or radiation-generating equipment.

(86) "Internal dose" means that portion of the dose equivalent received from radioactive material taken into the body.

(87) "Irradiator" means a facility that uses radioactive sealed sources for the irradiation of objects or materials and in which radiation dose rates exceeding five grays (five hundred rads) per hour exist at one meter from the sealed radioactive source in air or water, as applicable for the irradiator type, but does not include irradiators in which both the sealed source and the area subject to irradiation are contained within a device and are not accessible to personnel.

(88) "Lens dose equivalent" or "eye dose equivalent" means the external exposure of the lens of the eye and is taken as the dose equivalent at a tissue depth of 0.3 centimeters; i.e. three hundred milligrams per square centimeter.

(89) "License" means a license issued by the nuclear regulatory commission, the director, or another agreement state in accordance with rules adopted by those organizations.

(90) "Licensee" means a person to whom a license is issued.

(91) "Licensed activity" means an activity authorized by a radioactive material license which is essential to achieving the purpose for which the license was issued or amended.

(92) "Licensed material" means radioactive material received, possessed, used, transferred or disposed of under a general or specific license.

(93) "Loose-fitting facepiece" means a respiratory inlet covering that is designed to form a partial seal with the face.

(94) "Lost or missing licensed source of radiation" means a licensed source of radiation whose location is unknown. It includes material that has been shipped but has not reached its destination and whose location cannot be readily traced in the transportation system.

(95) "Low-level radioactive waste" or "LLRW," also "low-level waste," or "LLW" means radioactive waste which is not high-level radioactive waste, spent nuclear fuel, NARM, or byproduct material as defined in section 11 E. (2) of the Atomic Energy Act of 1954 68 Stat. 919, 42 U.S.C. 2011, as amended (2005), but is radioactive material that the United States nuclear regulatory commission classifies as low-level radioactive waste.

(96) "Low specific activity material" or "LSA" means radioactive material with limited specific activity which is nonfissile or is excepted under rule 3701:1-50-13 of the Administrative Code, and which satisfies the descriptions and limits set forth below. Shielding materials surrounding the LSA material may not be considered in determining the estimated average specific activity of the package contents. LSA must be in one of three groups:

(a) LSA - I.

(i) Uranium and thorium ores, concentrates of uranium and thorium ores, and other ores containing naturally occurring radioactive radionuclides that are intended to be processed for the use of these radionuclides;

(ii) Natural uranium, depleted uranium, natural thorium or their compounds or mixtures, provided they are unirradiated and in solid or liquid form;

(iii) Radioactive material other than fissile material, for which the A₂ value is unlimited; or

(iv) Other radioactive material in which the activity is distributed throughout and the estimated average specific activity does not exceed thirty times the value for exempt material activity concentration determined in accordance with rule 3701:1-50-25 of the Administrative Code.

(b) LSA-II.

(i) Water with tritium concentration up to 0.8 terabecquerels per liter (twenty curies per liter); or

(ii) Other material in which the activity is distributed throughout and the estimated average specific activity does not exceed ( 10^-4 A₂) per gram for solids and gases, and (10^-5 A₂) per gram for liquids.

(c) LSA-III. Solids (e.g., consolidated wastes, activated materials), excluding powders, that satisfy the requirements of 10 C.F.R. 71.77 (as in effect on the effective date of this rule), in which:

(i) The radioactive material is distributed throughout a solid or a collection of solid objects, or is essentially uniformly distributed in a solid compact binding agent (such as concrete, bitumen, ceramic, etc.);

(ii) The radioactive material is relatively insoluble, or it is intrinsically contained in a relatively insoluble material, so that even under loss of packaging, the loss of radioactive material per package by leaching, when placed in water for seven days, would not exceed (0.1 x A₂); and

(iii) The estimated average specific activity of the solid, excluding any shielding material, does not exceed (0.002 x A₂) per gram.

(97) "Management" means the chief executive officer or other individual having the authority to manage, direct, or administer the licensee's activities, or those persons' delegate or delegates.

(98) "Medical institution" means an organization in which more than one medical discipline is practiced.

(99) "Medical use" means the intentional internal or external administration of radioactive material or the radiation therefrom to patients or human research subjects under the supervision of an authorized user.

(100) "Member of the public" means any individual except when that individual is receiving an occupational dose.

(101) "Minor" means an individual less than eighteen years of age.

(102) "Monitoring" or "radiation monitoring" or "radiation protection monitoring" means the measurement of radiation levels, concentrations, surface area concentrations or quantities of radioactive material and the use of the results of these measurements to evaluate potential exposures and doses.

(103) "NARM" or "naturally occurring or accelerator-produced radioactive material" means naturally occurring or accelerator-produced radioactive material, including naturally occurring material that is technologically enhanced, and those nuclides that are generated in a charged particle accelerator, but does not include source material, byproduct material, or special nuclear material.

(104) "NARM licensing state" means any state with regulations equivalent to the suggested state regulations for control of radiation relating to, and an effective program for, the regulatory control of NARM and which has been granted final designation by the conference of radiation control program directors, inc.

(105) "Nationally tracked source" means a sealed source containing a quantity equal to or greater than "Category 1" or "Category 2" levels of any radioactive material listed in the appendix to rule 3701:1-38-25 of the Administrative Code. In this context a sealed source is defined as radioactive material that is sealed in a capsule or closely bonded, in a solid form and which is not exempt from regulatory control. It does not mean material encapsulated solely for disposal, or nuclear material contained in any fuel assembly, subassembly, fuel rod, or fuel pellet. "Category 1" nationally tracked sources are those containing radioactive material at a quantity equal to or greater than the "Category 1" threshold. "Category 2" nationally tracked sources are those containing radioactive material at a quantity equal to or greater than the "Category 2" threshold but less than the "Category 1" threshold.

(106) "Negative pressure respirator" or "tight fitting respirator" means a respirator in which the air pressure inside the facepiece is negative during inhalation with respect to the ambient air pressure outside the respirator.

(107) "Nonstochastic effect" or "deterministic effect" means health effects, the severity of which varies with the dose and for which a threshold is believed to exist. Radiation-induced cataract formation is an example of a nonstochastic effect.

(108) "NORM" or "naturally occurring radioactive material" means any nuclide that is radioactive in its natural physical state, but does not include source material, byproduct material, or special nuclear material.

(109) "Normal form radioactive material" means radioactive material that has not been demonstrated to qualify as special form radioactive material.

(110) "Nuclear regulatory commission" means the federal agency established by Title II of the Energy Reorganization Act of 1974, 88 Stat. 1233, 42 U.S.C.A. 5801, as amended (2005), comprising the members of the commission and all offices, employees, and representatives authorized to act in any case or matter related to licensing and related regulatory function previously assigned to the AEC.

(111) "Occupational dose" means the dose received by an individual in the course of employment in which the individual's assigned duties involve exposure to radiation or radioactive material from licensed and unlicensed sources of radiation, whether in the possession of the licensee or other person. Occupational dose does not include doses received from background radiation, from any medical administration the individual has received, from exposures to individuals administered radioactive materials and released in accordance with rule 3701:1-58-30 of the Administrative Code or equivalent United States nuclear regulatory commission or agreement state regulations, from voluntary participation in medical research programs, or as a member of the public.

(112) "Package" means the packaging together with its radioactive contents as presented for transport.

(a) Fissile material package or type AF package, type BF package, type B(U)F package, or type B(M)F package means a fissile material packaging together with its fissile material contents.

(b) Type A package means a type A packaging together with its radioactive contents. A type A package is defined and must comply with the United States department of transportation regulations in 49 C.F.R. 173 (as in effect on the effective date of this rule).

(c) Type B package means a type B packaging together with its radioactive contents. On approval, a type B package design is designated by the United States nuclear regulatory commission as B(U) unless the package has a maximum normal operating pressure of more than seven hundred kilopascals (one hundred pounds per square inch) gauge or a pressure relief device that would allow the release of radioactive material to the environment under the tests specified in 10 C.F.R. 71.73 (hypothetical accident conditions) (as in effect on the effective date of this rule), in which case it will receive a designation B(M). B(U) refers to the need for unilateral approval of international shipments; B(M) refers to the need for multilateral approval of international shipments. There is no distinction made in how packages with these designations may be used in domestic transportation. To determine their distinction for international transportation, see United States department of transportation regulations in 49 C.F.R. 173 (as in effect on the effective date of this rule). A type B package approved before September 6, 1983, was designated only as type B. Limitations on its use are specified in 10 C.F.R. 71.19 (as in effect on the effective date of this rule).

(113) "Packaging" means the assembly of components necessary to ensure compliance with the packaging requirements of rule 49 C.F.R. 173 Subpart I (as in effect on the effective date of this rule). It may consist of one or more receptacles, absorbent materials, spacing structures, thermal insulation, radiation shielding, and devices for cooling or absorbing mechanical shocks. The vehicle, tie-down system and auxiliary equipment may be designated as part of the packaging.

(114) "Particle accelerator" means any machine capable of accelerating electrons, protons, deuterons, or other charged particles in a vacuum and of discharging the resultant particulate or other radiation into a medium at energies usually in excess of one megaelectron volt. For purposes of this definition, "accelerator" is an equivalent term.

(115) "Person" means any individual, corporation, association, business enterprise, or other legal entity either public or private and any legal successor, representative, agent, or agency of that individual, corporation, association, business enterprise, or other legal entity. Person also includes the United States, states, political subdivisions of states, and any department, agency, or instrumentality of the United States or a state, except the U.S. department of energy or the U.S. nuclear regulatory commission where the state regulation of radioactive material by either of those agencies is prohibited by federal law.

(116) "Personnel dosimeter", means a device that measures radiation dose that is processed and evaluated by an accredited "National Voluntary Laboratory Accreditation Program" (NVLAP) processor. Examples of personnel dosimeters include film badges, thermo-luminescent dosimeters (TLD), and optically stimulated luminescence (OSL) dosimeters.

(117) "Pharmacist" means a person who is licensed by the state of Ohio to practice pharmacy pursuant to Chapter 4731. of the Revised Code.

(118) "Physician" means a person who is licensed pursuant to Chapter 4731. of the Revised Code to practice medicine or surgery or osteopathic medicine or surgery.

(119) "Planned special exposure" means an infrequent exposure to radiation, separate from and in addition to the annual dose limits.

(120) "Podiatrist" means an individual licensed by the state of Ohio to practice podiatry pursuant to Chapter 4731. of the Revised Code.

(121) "Positive pressure respirator" means a respirator in which the pressure inside the respiratory inlet covering exceeds the ambient air pressure outside the respirator.

(122) "Positron Emission Tomography (PET) radionuclide production facility" means a facility operating a cyclotron or accelerator for the purpose of producing PET radionuclides.

(123) "Powered air-purifying respirator" or "PAPR" means an air-purifying respirator that uses a blower to force the ambient air through air purifying elements to the inlet covering.

(124) "Pressure demand respirator" means a positive pressure atmosphere supplying respirator that admits breathing air to the facepiece when the positive pressure is reduced inside the facepiece by inhalation.

(125) "Public dose" means the dose received by a member of the public from exposure to radiation and/or radioactive material released by the licensee, or to any other source of radiation under the control of a licensee or registrant. Public dose does not include occupational dose or doses received from background radiation, from any medical administration the individual has received, from exposures to individuals administered radioactive materials and released in accordance with rule 3701:1-58-30 of the Administrative Code or equivalent United States nuclear regulatory commission or agreement state regulations, or from voluntary participation in medical research programs.

(126) "Pyrophoric material" means any liquid that ignites spontaneously in dry or moist air at or below 54.4 degrees celsius (one hundred thirty degrees fahrenheit). A pyrophoric solid is any solid material, other than one classed as an explosive, which under normal conditions is liable to cause fires through friction, retained heat from manufacturing or processing, or which can be ignited readily and when ignited burns so vigorously and persistently as to create a serious transportation, handling, or disposal hazard. Included are spontaneously combustible and water-reactive materials.

(127) "Qualitative fit test" or "QLFT" means a pass/fail fit test to assess the adequacy of respirator fit that relies on the individual's response to the test agent.

(128) "Quality factor" or "Q" means the modifying factor, as listed in paragraphs (A) and (B) of rule 3701:1-38-11 of the Administrative Code, that is used to derive dose equivalent from absorbed dose.

(129) "Quantitative fit test" or "QNFT" means an assessment of the adequacy of respirator fit by numerically measuring the amount of leakage into the respirator.

(130) "Quarter" or "quarterly" means a period of time equal to one-fourth of the year observed by the licensee or registrant, approximately thirteen consecutive weeks, providing that the beginning of the first quarter in a year coincides with the starting date of the year and that no day is omitted or duplicated in consecutive quarters.

(131) "Rad" means the special unit of radiation absorbed dose. One rad is equal to an absorbed dose of one hundred ergs per gram, or 0.01 joule per kilogram, or 0.01 gray.

(132) "Radiation" or "ionizing radiation" means alpha particles, beta particles, gamma rays, x-rays, neutrons, high speed electrons, high speed protons, and other particles capable of producing ions. Radiation does not include nonionizing radiation, such as radio or microwaves, or visible, infrared or ultraviolet light.

(133) "Radiation area" means an area, accessible to individuals, in which radiation levels could result in an individual receiving a dose equivalent in excess of 0.05 millisievert (0.005 rem) in one hour at thirty centimeters from the source of radiation or from any surface that the radiation penetrates.

(134) "Radiation-generating equipment" or "RGE" means any manufactured product or device, or component of such a product or device, or any machine or system that during operation can generate or emit radiation, except those that emit radiation only from radioactive material. "Radiation-generating equipment" does not include either of the following:

(a) Diathermy machines;

(b) Microwave ovens, including food service microwave ovens used for commercial and industrial uses, television receivers, electric lamps, and other household appliances and products that generate very low levels of radiation.

(135) "Radiation Safety Officer" or "RSO" means an individual designated by the licensee who has the knowledge and responsibility for the overall radiation safety program at the facility, to include the implementation of the daily radiation safety operations and compliance with the rules.

(136) "Radioactive material" means any solid, liquid or gaseous material that emits ionizing radiation spontaneously. "Radioactive material" includes accelerator-produced and naturally occurring radioactive materials and byproduct, source, and special nuclear material.

(137) "Radioactive waste" means waste containing regulated radioactive material.

(138) "Radioactivity" means the transformation of unstable atoms by the emission of radiation.

(139) "Radiography" means the same as industrial radiography.

(140) "Reference man" means a hypothetical aggregation of human physical and physiological characteristics arrived at by international consensus. These characteristics may be used by researchers and public health workers to standardize results of experiments and to relate biological insult to a common base.

(141) "Registrant" means a person required by Chapter 3748. of the Revised Code to register radiation-generating equipment with the director.

(142) "Rem" means the special unit of any of the quantities expressed as dose equivalent. The dose equivalent in rem is equal to the absorbed dose in rads multiplied by the quality factor (one rem = 0.01 Sv).

(143) "Research and development" means

(a) Theoretical analysis, exploration, or experimentation; or

(b) The extension of investigative findings and theories of a scientific or technical nature into practical application for experimental and demonstration purposes, including the experimental production and testing of models, devices, equipment, materials and processes. "Research and development" does not include the internal or external administration of sources of radiation to human beings.

(144) "Residual radioactivity" means radioactivity in structures, materials, soils, groundwater, and other media at a site resulting from activities under the licensee's control. This includes radioactivity from all licensed and unlicensed sources used by the licensee, but excludes background radiation. It also includes radioactive materials remaining at the site as a result of routine or accidental releases of radioactive material at the site and previous burials at the site, even if those burials were made in accordance with the provisions of 10 C.F.R. 20 (as in effect on the effective date of this rule).

(145) "Respiratory protective equipment or device" means an apparatus, such as a respirator, used to reduce the individual's intake of airborne radioactive materials.

(146) "Restricted area" means an area access to which is limited by the licensee or registrant for the purpose of protecting individuals against undue risks from exposure to sources of radiation. Restricted area does not include areas used as residential quarters, but separate rooms in a residential building may be set apart as a restricted area.

(147) "Roentgen" means the amount of gamma or x-rays required to produce ions resulting in a charge of 0.000258 coulombs per kilogram of air under standard conditions.

(148) "Sanitary sewerage" means a system of public sewers for carrying off wastewater and refuse, but excluding sewage treatment facilities, septic tanks, and leach fields owned or operated by the licensee.

(149) "Sealed source" means radioactive material that is encased in a manner designed to prevent leakage or escape of the radioactive material.

(150) "Sealed source and device registry" means the national registry that contains all the registration certificates, generated by both the United States nuclear regulatory commission and the agreement states, that summarize the radiation safety information for the sealed sources and devices and describe the licensing and use conditions approved for the product.

(151) "Seismic area" means any area where the probability of a horizontal acceleration in rock of more than 0.3 times the acceleration of gravity in two hundred fifty years is greater than ten per cent, as designated by the United States geological survey.

(152) "Self-contained breathing apparatus" or "SCBA" means an atmosphere-supplying respirator for which the breathing air source is designed to be carried by the user.

(153) "Shallow dose equivalent" or "H_S" means the external exposure of the skin of the whole body or the skin of an extremity, is taken as the dose equivalent at a tissue depth of 0.007 centimeter, or seven milligrams per square centimeter.

(154) "Sievert" or "Sv" means the SI unit of any of the quantities expressed as dose equivalent. The dose equivalent in sieverts is equal to the absorbed dose in grays multiplied by the quality factor. One sievert equals one hundred rem.

(155) "Site area emergency" means events may occur, are in progress, or have occurred that could lead to a significant release of radioactive material and that could require a response by off-site response organizations to protect persons off-site.

(156) "Site boundary" means that line beyond which the land or property is not owned, leased, or otherwise controlled by the licensee or registrant.

(157) "Site closure and stabilization" means those actions that are taken upon completion of operations that prepare a disposal site for custodial care and that assure that the disposal site will remain stable and will not need ongoing active maintenance.

(158) "Source material" means uranium, thorium, or any combination thereof in any physical or chemical form, or any ores that contain by weight at least one-twentieth of one per cent (0.05 per cent) of uranium, thorium, or any combination thereof. Source material does not include special nuclear material.

(159) "Sources of radiation" means radioactive material or radiation generating equipment.

(160) "Special form radioactive material" means radioactive material that satisfies the following conditions:

(a) It is either a single solid piece or is contained in a sealed capsule that can be opened only by destroying the capsule;

(b) The piece or capsule has at least one dimension not less than five millimeters (0.2 inch); and

(c) It satisfies the test requirements specified by the United States nuclear regulatory commission in 10 C.F.R. 71.75 (as in effect on the effective date of this rule). A special form encapsulation designed in accordance with the United States nuclear regulatory commission requirements identified in 10 C.F.R. 71.4, in effect on June 30, 1983, and constructed prior to July 1, 1985; a special form encapsulation designed in accordance with the requirements of 10 C.F.R. 71.4 in effect on March 31, 1996, and constructed before April 1, 1998; and special form material that was successfully tested before September 10, 2015 in accordance with the requirements of 10 C.F.R. 71.75(d) of this section in effect before September 10, 2015 may continue to be used. Any other special form encapsulation must meet the specifications of this definition.

(161) "Special nuclear material" means either of the following:

(a) Plutonium, uranium-233, uranium enriched in the isotope 233, or in the isotope 235, and any other material that the United States nuclear regulatory commission determines to be special nuclear material, but does not include source material pursuant to section 51 of the Atomic Energy Act of 1954, 68 Stat 919, 42 USCA 2071, as amended (2005).

(b) Any material artificially enriched by any of the foregoing but does not include source material.

(162) "Special nuclear material in quantities not sufficient to form a critical mass" means uranium enriched in the isotope uranium-235 in quantities not exceeding three hundred fifty grams of contained uranium-235; uranium-233 in quantities not exceeding two hundred grams; plutonium in quantities not exceeding two hundred grams; or any combination of them in accordance with the following formula: for each kind of special nuclear material, determine the ratio between the quantity of that special nuclear material and the quantity specified in this paragraph for the same kind of special nuclear material. The sum of such ratios for all of the kinds of special nuclear material in combination shall not exceed unity.

(163) "Stochastic effect" means health effects that occur randomly and for which the probability of the effect occurring, rather than its severity, is assumed to be a linear function of dose without threshold. Hereditary effects and cancer incidence are examples of stochastic effects.

(164) "Supplied-air respirator" or "SAR" or "airline respirator" means an atmosphere-supplying respirator for which the source of breathing air is not designed to be carried by the user.

(165) "Surface contaminated object" or "SCO" means a solid object that is not itself classed as radioactive material, but which has radioactive material distributed on any of its surfaces. SCO must be in one of two groups with surface activity not exceeding the following limits:

(a) SCO-I: a solid object on which:

(i) The non-fixed contamination on the accessible surface averaged over three hundred square centimeters, or the area of the surface if less than three hundred square centimeters, does not exceed four becquerels per square centimeter (10^-4 microcurie per square centimeter) for beta and gamma and low toxicity alpha emitters, or 0.4 becquerels per square centimeter 10^-5 microcurie per square centimeter) for all other alpha emitters;

(ii) The fixed contamination on the accessible surface averaged over three hundred square centimeters, or the area of the surface if less than three hundred square centimeters, does not exceed forty thousand becquerels per square centimeter (one microcurie per square centimeter) for beta and gamma and low toxicity alpha emitters, or four thousand becquerels per square centimeter (0.1 microcurie per square centimeter) for all other alpha emitters; and

(iii) The non-fixed contamination plus the fixed contamination on the inaccessible surface averaged over three hundred square centimeters, or the area of the surface if less than three hundred square centimeters, does not exceed forty thousand becquerels per square centimeter (one microcurie per square centimeter) for beta and gamma and low toxicity alpha emitters, or four thousand becquerels per square centimeter (0.1 microcurie per square centimeter) for all other alpha emitters.

(b) SCO-II: a solid object on which the limits for SCO-I are exceeded and on which:

(i) The non-fixed contamination on the accessible surface averaged over three hundred square centimeters, or the area of the surface if less than three hundred square centimeter, does not exceed four hundred becquerels per square centimeter (10^-2 microcurie per square centimeter) for beta and gamma and low toxicity alpha emitters, or forty becquerels per square centimeter (10^-3 microcurie per square centimeter) for all other alpha emitters;

(ii) The fixed contamination on the accessible surface averaged over three hundred square centimeters, or the area of the surface if less than three hundred square centimeters, does not exceed eight hundred thousand becquerels per square centimeter (twenty microcuries per square centimeter) for beta and gamma and low toxicity alpha emitters, or eighty thousand becquerels per square centimeter (two microcuries per square centimeter) for all other alpha emitters; and

(iii) The non-fixed contamination plus the fixed contamination on the inaccessible surface averaged over three hundred square centimeters, or the area of the surface if less than three hundred square centimeters, does not exceed eight hundred thousand becquerels per square centimeter (twenty microcuries per square centimeter) for beta and gamma and low toxicity alpha emitters, or eighty thousand becquerels per square centimeter (two microcuries per square centimeter) for all other alpha emitters.

(166) "Survey" means an evaluation of the radiological conditions and potential hazards incident to the production, use, transfer, release, disposal or presence of radioactive material or other sources of radiation. When appropriate, such an evaluation includes a physical survey of the location of radioactive material, or the sources of radiation and measurements or calculations of levels of radiation, or concentrations or quantities of radioactive material present.

(167) "Tight-fitting facepiece" means a respiratory inlet covering that forms a complete seal with the face.

(168) "Total effective dose equivalent" or "TEDE" means the sum of the effective dose equivalent (for external exposures) and the committed effective dose equivalent (for internal exposures).

(169) "Transport index" means the dimensionless number, rounded up to the next tenth, placed on the label of a package, to designate the degree of control to be exercised by the carrier during transportation. The transport index is the number determined by multiplying the maximum radiation level in millisievert per hour at one meter (3.3 feet) from the external surface of the package by one hundred, which is equivalent to the maximum radiation level in millirem per hour at one meter (3.3 feet).

(170) "Type A quantity" means a quantity of radioactive material, the aggregate radioactivity of which does not exceed A₁ for special form radioactive material, or A₂ for normal form radioactive material, where A₁ and A₂ are given in rule 3701:1-50-25 of the Administrative Code.

(171) "Type B quantity" means a quantity of radioactive material greater than a type A quantity.

(172) "Type B package" is defined under "Package."

(173) "United States department of energy" means the department of energy established by the Department of Energy Organization Act, PL 95-91, 91 Stat. 565 (1977), 42 U.S.C. 7101 et seq., as amended (2006), to the extent that the department of energy or its duly authorized representatives, exercises functions formerly vested in the United States atomic energy commission, its chairman, members, officers and components and transferred to the United States energy research and development administration and to the administrator thereof pursuant to Sections 104(b) to (d) of the Energy Reorganization Act of 1974, PL 93-438, 88 Stat. 1233 at 1237 (1974), 42 U.S.C. 5814 and retransferred to the secretary of energy pursuant to Section 301(a) of the Department of Energy Organization Act, PL 95-91, 91 Stat. 565 at 577-578 (1977), 42 U.S.C. 7151.

(174) "Unrestricted area" or "uncontrolled area" means any area, access to which is neither restricted nor controlled by the licensee or registrant.

(175) "User seal check" or "fit check" means an action conducted by the respirator user to determine if the respirator is properly seated to the face. Examples include negative pressure check, positive pressure check, irritant smoke check, or isoamyl acetate check.

(176) "Very high radiation area" means an area, accessible to individuals, in which radiation levels from radiation sources external to the body could result in an individual receiving an absorbed dose in excess of five gray (five hundred rad) in one hour at one meter from a source of radiation or from any surface that the radiation penetrates. At very high doses received at high dose rates, units of absorbed dose, gray and rad, are appropriate, rather than units of dose equivalent, sievert and rem.

(177) "Veterinarian" means an individual licensed by the state of Ohio to practice veterinary medicine pursuant to Chapter 4741. of the Revised Code.

(178) "Waste" means those low-level radioactive wastes containing source, special nuclear, or byproduct material that are acceptable for disposal in a land disposal facility. For the purposes of this definition, low-level radioactive waste means radioactive waste not classified as high-level radioactive waste, transuranic waste, spent nuclear fuel, or byproduct material as defined in paragraph (A)(26)(b) of this rule, or byproduct material as defined in section 11 E. (3) and (4) of the Atomic Energy Act of 1954, 68 Stat. 919, 42 USC 2014, as amended (2005).

(179) "Week" means seven consecutive days starting on Sunday.

(180) "Weighting factor

• W_T" for an organ or tissue, (T), is the proportion of the risk of stochastic effects resulting from irradiation of that organ or tissue to the total risk of stochastic effects when the whole body is irradiated uniformly. For calculating the effective dose equivalent, the values of W_T are:

| Organ doseweighting factors | | | --- | --- | | Organ ortissue | W_T | | Gonads | 0.25 | | Breast | 0.15 | | Red bone marrow | 0.12 | | Lung | 0.12 | | Thyroid | 0.03 | | Bonesurfaces | 0.03 | | Remainder | 0.30^a | | Whole body | 1.00^b |

^\a 0.30 results from 0.06 for each of five "remainder" organs, excluding the skin and the lens of the eye, that receive the highest doses.

^\b for the purpose of weighting the external whole body dose (for adding it to the internal dose) a single weighting factor, W_T = 1.0, has been specified. The use of other weighting factors for external exposure will be approved on a case-by-case basis until such time as specific guidance is issued.

(181) "Whole body" means for purposes of external exposure, head; trunk, including male gonads; arms above the elbow; legs above the knee.

(182) "Worker" means an individual engaged in activities licensed or registered by the department and controlled by a licensee or registrant, but does not include the licensee or registrant.

(183) "Working level" or "WL" means any combination of short-lived radon decay products (for radon-222: polonium-218, lead-214, bismuth-214, and polonium-214; and for radon-220: polonium-216, lead-212, bismuth-212, and polonium-212) in one liter of air that will result in the ultimate emission of 1.3 x 10⁵ million electron volts alpha particle energy.

(184) "Working level month" or "WLM" means a cumulative exposure to one working level for one hundred seventy hours. (Two thousand working hours per year/twelve months per year equals approximately one hundred seventy hours per month.)

(185) "Year" means the period of time beginning in January used to determine compliance with the provisions of this rule. The licensee or registrant may change the starting date of the year used to determine compliance by the licensee or registrant provided that the change is made at the beginning of the year and that no day is omitted or duplicated in consecutive years.

(B) The terms set out in paragraph (A) of this rule may be redefined in other chapters as promulgated pursuant to Chapter 3748. of the Revised Code as used in that chapter only.

Last updated May 13, 2026 at 11:20 AM

History

• Effective: January 20, 2022
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-43-02 Purpose and scope.

(A) This chapter establishes radiation protection standards for "Technologically Enhanced Naturally Occurring Radioactive Material" (TENORM). These standards include the possession, use, processing, manufacture, distribution, transfer, and disposal of TENORM and of products with TENORM. This chapter also provides for the licensing of TENORM, including license termination. The requirements of this chapter are in addition to, and not a substitution for, other requirements of Chapter 3748. of the Revised Code and the rules promulgated thereunder.

(B) Except as otherwise excluded in this rule, this chapter applies to any person who receives, possesses, uses, processes, transfers, distributes, or disposes of TENORM.

(C) The manufacture and distribution of products containing TENORM in which the TENORM's emitted radiation is considered beneficial to the products are licensed pursuant to the provisions of Chapter 3701:1-40 of the Administrative Code.

(D) This chapter also addresses the introduction of TENORM into products in which the radiation emitted from the TENORM is not considered to be beneficial to the products.

(E) This chapter does not apply to source material and byproduct material as both are defined in rule 3701:1-38-01 of the Administrative Code.

(F) Storage incident to transportation and transportation of TENORM will be in accordance with the requirements in Chapter 3701:1-38 and Chapter 3701:1-50 of the Administrative Code.

Last updated May 15, 2023 at 1:06 AM

History

• Effective: May 15, 2023
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-43-03 Activities requiring a specific license.

(A) A specific license is prescribed pursuant to paragraph (C) of rule 3701:1-43-10 and rule 3701:1-43-11 of the Administrative Code to manufacture and distribute any consumer or retail product containing TENORM unless the manufacture and distribution are:

(1) Authorized as specified by paragraph (A) of rule 3701:1-43-08 or paragraph (F) of rule 3701:1-43-08 of the Administrative Code;

(2) Licensed under the provisions of Chapter 3701:1-40 of the Administrative Code;

(3) Exempted under the provisions of rule 3701:1-43-07 of the Administrative Code; or

(4) Otherwise exempt in accordance with another chapter of the Administrative Code.

(B) A specific license is needed to decontaminate equipment or land not exempted under the provisions of rule 3701:1-43-07 of the Administrative Code or to decontaminate facilities contaminated with TENORM in excess of the levels in rule 3701:1-43-15 of the Administrative Code. As used in this rule, the term "decontaminate" will not include routine maintenance which results in the incidental removal of contamination.

(C) A specific license is needed to receive TENORM from other persons for storage, treatment, or disposal unless otherwise provided in this chapter or authorized in writing by the director.

Last updated May 15, 2023 at 1:06 AM

History

• Effective: May 15, 2023
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-43-10

(A) An application for a specific license will be approved if:

(1) The application is for a purpose authorized by Chapter 3748. of the Revised Code and the rules adopted thereunder;

(2) The applicant's proposed equipment and facilities are adequate to protect health and minimize danger to life or property or the environment;

(3) The applicant is qualified by training and experience to use the TENORM in question for the purpose requested in such manner as to protect health and minimize danger to life or property or the environment;

(4) The applicant satisfied all applicable special requirements in rule 3701:1-38-02, Chapter 3701:1-40, and Chapter 3701:1-43 of the Administrative Code;

(5) For an application that involves an activity that could potentially affect the quality of the environment, the director has:

(a) Reviewed the information filed and evaluations made pursuant to rule 3701:1-40-30 of the Administrative Code;

(b) Weighed the environmental, economic, technical, and other benefits against environmental costs and considered available alternatives; and

(c) Concluded that the proposed activity, along with any appropriate conditions to protect the environment, would be acceptable.

Commencement of construction prior to such conclusion will be grounds for denial of a license to receive and possess radioactive material in such plant or facility.

(6) The applicant has met the financial assurance requirements of rule 3701:1-43-13 of the Administrative Code;

(7) The applicant has adequately addressed the following items in the application:

(a) Procedures and equipment for monitoring and protecting workers;

(b) An evaluation of the radiation levels and concentrations of contamination expected during normal operations;

(c) Operating and emergency procedures, including procedures for waste reduction and quality assurance of items released for unrestricted use; and

(d) A method for managing the radioactive material removed from contaminated equipment, facilities, and land.

(8) For each location to be listed on the license as an authorized use location, the applicant will submit either:

(a) A statement that the applicant owns the facility where radioactive material is to be used or stored; or

(b) A statement verifying that the facility owner has been informed, in writing, of the use or storage of radioactive material at the facility, and that the use of such material is subject to the rules of the director.

(B) An application for a specific license to decontaminate equipment, land, or facilities contaminated with TENORM in excess of the levels set forth in rule 3701:1-43-15 of the Administrative Code, as applicable, and to dispose of the resulting waste will be approved if the applicant satisfies the general requirements specified in paragraph (A) of rule 3701:1-43-10 of the Administrative Code.

(C) An application for a specific license to transfer or manufacture or distribute consumer or retail products containing TENORM to persons exempted from these rules pursuant to paragraph (B) of rule 3701:1-43-07 of the Administrative Code will be approved if:

(1) The applicant satisfies the general requirements specified in paragraph (A) of rule 3701:1-43-10 of the Administrative Code;

(2) The TENORM is not contained in any food, beverage, cosmetic, drug, or other commodity designed for ingestion or inhalation by, or application to, a human being; and

(3) The applicant submits sufficient information relating to the design, manufacture, prototype testing, quality control procedures, labeling or marking, and conditions of handling, storage, use, and disposal of the TENORM product to demonstrate that the product will meet the safety criteria set forth in rule 3701:1-43-11 of the Administrative Code. The information will include:

(a) A description of the product and its intended use or uses;

(b) The type, quantity, and concentration of TENORM in each product;

(c) The chemical and physical form of the TENORM in the product and changes in chemical and physical form that may occur during the useful life of the product;

(d) An analysis of the solubility in water and body fluids of the radionuclides in the product;

(e) The details of manufacture and design of the product relating to containment and shielding of the TENORM and other safety features under normal and severe conditions of handling, storage, use, reuse, and disposal of the product;

(f) The degree of access of human beings to the TENORM product during normal handling, use, and disposal;

(g) The total quantity of TENORM expected to be distributed annually in the product;

(h) The expected useful life of the product;

(i) The proposed method of labeling or marking each unit of the product with identification of the manufacturer or initial transferor of the product and the radionuclides and quantity of TENORM in the product;

(j) The procedures for prototype testing of the product to demonstrate the effectiveness of the containment, shielding, and other safety features under both normal and severe conditions of handling, storage, use, reuse, and disposal;

(k) The results of the prototype testing of the product, including any change in the form of the TENORM contained in it, the extent to which the TENORM may be released to the environment, any change in radiation levels, and any other changes in safety features;

(l) The estimated external radiation doses and committed dose equivalent relevant to the safety criteria in rule 3701:1-43-11 of the Administrative Code and the basis for such estimates;

(m) A determination that the probabilities with respect to doses referred to in rule 3701:1-43-11 of the Administrative Code meet the safety criteria;

(n) The quality control procedures to be followed in the processing of production lots of the product, and the quality control standards the product will be obliged to meet; and

(o) Any additional information, including experimental studies and tests, prescribed by the director to facilitate a determination of the radiation safety of the product.

(D) Notwithstanding the provisions of paragraph (B) of rule 3701:1-43-11 of the Administrative Code, the director may deny an application for a specific license if the end uses of the product are frivolous or cannot be reasonably foreseen.

(E) Upon a determination that an application meets the requirements of Chapter 3748. of the Revised Code and the rules adopted thereunder, the director will issue a specific license authorizing the possession and use of TENORM.

Last updated May 15, 2023 at 1:06 AM

History

• Effective: May 15, 2023
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-43-11

An applicant for a license pursuant to paragraph (C) of rule 3701:1-43-10 of the Administrative Code, will demonstrate that the product is designed and will be manufactured so that:

(A) In normal use and disposal of a single exempt item, and in normal handling and storage of the quantities of exempt items likely to accumulate in one location during marketing, distribution, installation, and servicing of the product, it is unlikely that the dose in any one year, to a suitable sample of the group of individuals expected to be most highly exposed to radiation or radioactive material from the product will exceed the doses in column I of the table in the appendix to this rule.

(B) In use and disposal of a single exempt item and in handling and storage of the quantities of exempt items likely to accumulate in one location during marketing, distribution, installation, and servicing of the product, the probability is low (not more than one such failure per year for each ten thousand exempt units distributed) that the containment, shielding, or other safety features of the product would fail under such circumstances that a person would receive an external radiation dose or committed dose equivalent in excess of the dose to the appropriate part of the body as specified in column II of the table in the appendix to this rule and the probability is negligible (not more than one such failure per year for each one million exempt units distributed) that a person would receive an external radiation dose or committed dose equivalent in excess of the dose to the appropriate part of the body as specified in column III of the table in the appendix to this rule.

(C) It is unlikely that there will be a significant reduction in the effectiveness of the containment, shielding, or other safety features of the product from wear and abuse likely to occur in normal handling and use of the product during its useful life.

View Appendix

Last updated May 15, 2023 at 1:06 AM

History

• Effective: May 15, 2023
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-43-08

(A) Subject to the requirements of Chapter 3701:1-38, rule 3701:1-43-08, and rule 3701:1-43-18 of the Administrative Code, unless and until a specific license has been issued in accordance with rule 3701:1-43-03 of the Administrative Code, a general license is hereby issued to possess, use, transfer, distribute or dispose of TENORM without regard to quantity.

(B) This general license does not authorize the manufacture of consumer or retail products containing TENORM in concentrations greater than those specified in paragraph (A) of rule 3701:1-43-07 of the Administrative Code or the receipt and disposal of wastes from other persons.

(C) Employees or contractors under control and supervision of a general licensee may perform routine maintenance on equipment, facilities, and land owned or controlled by the general licensee. Maintenance that provides a pathway for exposure different from that found in periodic maintenance operations and that increases the potential for additional exposure is not considered routine maintenance. The decontamination of equipment, facilities, and land will be performed only by persons specifically licensed by the director, an agreement state, or another licensing state to conduct such work.

(D) Any person subject to the general license issued by paragraph (A) of this rule, will notify the director within sixty days of becoming subject to the general license. Such notification will include:

(1) Name and address of the licensee;

(2) Location and description of the facility, facilities, or portion of a facility where the TENORM is situated;

(3) Description of the TENORM including estimates of the amount and extent of TENORM.

(E) Transfer of material, equipment or real property.

(1) The transfer of TENORM not exempt from the requirements of this chapter, from one general licensee to another general licensee, is authorized if the equipment and facilities contaminated with TENORM are to be used by the recipient for a similar purpose, provided that no member of the public will receive a dose in excess of that allowed under rule 3701:1-38-13 of the Administrative Code.

(2) For transfers not made in accordance with paragraph (E)(1) of this rule, prior written approval by the director is needed. To obtain director approval, the transferor will submit information that demonstrates compliance with rule 3701:1-43-15 of the Administrative Code. Records of such compliance will be maintained as specified in rule 3701:1-43-17 of the Administrative Code.

(3) For transfers made under paragraph (E)(1) of this rule, the general licensee who makes the transfer will assess the amount and extent of TENORM contamination or material present, inform the general licensee receiving the TENORM of these assessments prior to such transfer, and maintain records prescribed by these regulations that include:

(a) The date, recipient name, and location;

(b) A description and quantity of the material; and

(c) A description of the procedures and mechanisms used to ensure that material will not be released in another manner, such as an unrestricted release.

(4) A general licensee intending to transfer material or real property for unrestricted use will document compliance with the requirements of rule 3701:1-43-15 of the Administrative Code. Records of such compliance will be maintained as specified in rule 3701:1-43-17 of the Administrative Code.

(F) The distribution of TENORM products not exempt from these regulations, from one general licensee to another general licensee, is authorized provided the product is accompanied by labels or manifests which identify the type and amount of TENORM. This may be accomplished by providing notification to the recipient through literature such as safety data sheets, manifests, or labeling accompanying the product.

(G) The director may, by written notice, prescribe any person authorized by a general license to apply for, and obtain, a specific license if the director determines that specific licensure is necessary to ensure that exposures do not exceed the criteria of rule 3701:1-38-12 and rule 3701:1-38-13 of the Administrative Code. The notice will state the reason or reasons for requiring a specific license.

Last updated May 15, 2023 at 1:06 AM

History

• Effective: May 15, 2023
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-43-07

(A) Persons who receive, possess, use, process, transfer, distribute, or dispose of TENORM are exempt from the requirements of this chapter with respect to any combination of radium-226 and radium-228 if the materials contain, or are contaminated at, concentrations less than one hundred eighty-five becquerel per kilogram (five picocuries per gram) excluding natural background. The progeny of the exempt TENORM radium-226 and radium-228 are also exempt. Manufacture of consumer or retail products at concentrations greater than one hundred eighty-five becquerel per kilogram (five picocuries per gram) is regulated pursuant to paragraph (C) of rule 3701:1-43-10 and rule 3701:1-43-11 of the Administrative Code.

(B) Persons who receive products or materials containing TENORM distributed in accordance with a specific license issued by the director pursuant to paragraph (A) of rule 3701:1-43-03 of the Administrative Code, or by an equivalent license issued by another state, are exempt from this chapter with regard to those products or materials.

(C) Persons who receive, possess, use, process, transfer and distribute, including preparation of custom blends for distribution, phosphate or potash ore-based fertilizers containing TENORM are exempt from this chapter.

(D) Persons who receive, possess, use, process, transfer, dispose into a permitted landfill, or distribute, including preparation of custom blends for distribution, zirconia, zircon, and products of zirconia and zircon containing TENORM are exempt from this chapter provided that the radioactive constituent is consistent with the radioactivity levels stated in the safety data sheet accompanying the zirconium-bearing materials. A facility that manufactures zirconium metal from ore or chemically processes zirconia or zircon resulting in increased environmental mobility of TENORM is not exempt from this chapter.

(E) Persons who possess TENORM waste regulated by the Comprehensive Environmental Response, Compensation and Liability Act (CERCLA 42 USC 9601 to 9628 as amended, as published in the United States Code, 2006 edition) or by the Resource Conservation and Recovery Act (RCRA 42 USC 6901 et seq. as amended, as published in the United States Code, 2006 edition) are exempt from this chapter for the TENORM waste regulated by either of these federal acts.

(F) Other persons who possess or use TENORM will be exempt when the director makes a determination, upon his or her own initiative or upon request for such determination, that the reasonably maximally exposed individual will not receive a public dose with a total effective dose equivalent (TEDE) of more than one millisievert (0.1 rem) in one year from all licensed or registered sources of radiation including TENORM.

(G) Persons who receive, possess, use, transfer, distribute, or dispose of materials in the recycling process contaminated with scale or residue not otherwise exempted or other equipment containing TENORM with a radiation exposure level that does not exceed 0.5 microsieverts (fifty microrem) per hour, including background at any accessible point are hereby exempt from the requirements of this chapter.

(H) Persons engaged in the manufacture, wholesale or retail commercial distribution, use, or disposal of the following products or materials, or the recycling of equipment used to produce, contain, or transport the following materials are exempt from the requirements of this chapter:

(1) Potassium or potassium compounds that have not been isotopically enriched in the radionuclide potassium-40;

(2) Fossil fuel or byproducts from fossil fuel combustion, including bottom ash, fly ash, and flue-gas emission control byproducts; or

(3) Material used for building construction, industrial processing, sandblasting, metal castings, or other material in which the radionuclide content has not been concentrated to a level higher than is found in its natural state.

(I) Persons who receive, possess, use, process, transfer, or dispose of TENORM or TENORM waste from oil and gas wells and production operations within the state are exempt from the requirements of this chapter in that they are subject to the regulatory oversight of the Ohio department of natural resources in accordance with section 1509.02 of the Revised Code. This exemption does not apply to service providers performing radiological decontamination of scale containing TENORM in pipe and other equipment.

(J) Persons who receive, possess, use, process, transfer, or dispose of waste water facility sludges that contain TENORM, are exempt from the requirements of this chapter in that they are subject to regulatory oversight by the Ohio environmental protection agency in accordance with section 6111.03 of the Revised Code.

(K) Persons who possess, store, use, transport, or commercially distribute compressed gases and compressed gas products containing TENORM are exempt from the requirements of this chapter. The exemptions contained in this paragraph do not apply to a facility that processes compressed gas or compressed gas products containing TENORM.

Last updated May 15, 2023 at 1:06 AM

History

• Effective: May 15, 2023
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-43-15

The following criteria apply for persons subject to a specific or general license under this chapter:

(A) Equipment can be released from the site for unrestricted use when that equipment is not contaminated with TENORM at levels greater than those in the appendix to this rule. Upon application, specific approval of alternative levels may be granted by the director.

(B) The director will release a site for unrestricted use upon request by the licensee who has demonstrated to the director that the following applicable criteria have been met:

(1) The average member of the critical group will not receive annually a public dose in excess of 0.25 millisievert (0.025 rem) TEDE from residual radioactive materials on site other than residual TENORM radium-226 and radium-228 and their progeny;

(2) The concentration of residual TENORM radium-226 and radium-228, on land averaged over one hundred square meters, is less than one hundred eighty-five becquerels per kilogram (five picocuries per gram) above the background concentration, averaged over any fifteen centimeter layer of soil. The fifteen centimeter layers are contiguous depth increments from the surface down. Each of the progeny radionuclides of the residual TENORM radium-226 and radium-228 may also be present in concentrations similar to the residual TENORM radium-226 and radium-228 concentration;

(3) Where residual TENORM radium-226 and radium-228 and their progeny and other residual TENORM radionuclide contamination are present, the sum of fractions will be used for combining the criteria of paragraph (B)(1) and paragraph (B)(2) of this rule. The sum of fractions is determined by dividing each average radium concentration by the radium limit of one hundred eighty-five becquerels per kilogram (five picocuries per gram) and dividing the estimated annual dose from other residual TENORM radionuclides by 0.25 millisievert (0.025 rem) and then adding the ratios together. The sum of the fractions will be less than, or equal to, one to meet this criterion; and

(4) All license termination requirements in rule 3701:1-38-22 of the Administrative Code have been satisfied.

(C) Persons with a specific license will comply also with requirements of paragraphs (A)(7) and (A)(8) of rule 3701:1-43-12 of the Administrative Code and rule 3701:1-43-14 of the Administrative Code that are applicable to remediation and termination of the license.

(D) Persons with a general license will also notify the director in writing prior to commencing activities to reclaim the site. Decontamination activities need a specific license.

(E) Actions taken to confine TENORM on site or to remediate sites will be based on expected longevity-related controls for one thousand years.

(F) Equipment contaminated with TENORM in excess of levels specified in the appendix to this rule may be transferred pursuant to paragraph (E) of rule 3701:1-43-08 of the Administrative Code.

(G) Other transfers of TENORM will be in accordance with rules 3701:1-43-03, 3701:1-43-08, and 3701:1-43-18 of the Administrative Code.

(H) When a general licensee has permanently ceased use of radioactive materials at a site or portion of a site or facility or when an area has not been used for a period of two years, the licensee will, within sixty days, provide the following information in writing to the director:

(1) The location of the site or area; and

(2) The plan for reclaiming or decontaminating the site or area.

Last updated May 26, 2023 at 1:06 PM

History

• Effective: May 15, 2023
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-43-04 Communications.

Except as otherwise provided, any communication or report required by Chapter 3701:1-38 or Chapter 3701:1-43 of the Administrative Code, shall be filed in accordance with Chapter 3748. of the Revised Code and rules promulgated thereunder. Documents pertaining to license application or any license matter, unless otherwise directed in writing, shall be submitted to the director at the following address or by electronic submission in a manner approved by the director:

"Ohio Department of Health

Bureau of Environmental Health and Radiation Protection

246 North High Street

Columbus, OH 43215"

Electronic mail communications may be sent to the Ohio department of health at:

"BRadiation@odh.ohio.gov"

Last updated May 15, 2023 at 1:06 AM

History

• Effective: May 15, 2023
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-43-05 Completeness and accuracy of information.

(A) Information provided to the director by an applicant for a license or by a licensee, or information prescribed by statute or by the director's rules, orders, or license conditions to be maintained by the applicant or the licensee, will be complete and accurate in all material respects.

(B) Each applicant or licensee will notify the director of information identified by the applicant or licensee as having for the regulated activity a significant implication for public health and safety or common defense and security. An applicant or licensee violates this paragraph only if the applicant or licensee fails to notify the director of information that the applicant or licensee has identified as having a significant implication for public health and safety or common defense and security. Notification will be provided to the director within two working days of identifying the information. This requirement is not applicable to information which is already obliged to be provided to the director by other reporting or updating requirements.

Last updated May 15, 2023 at 1:06 AM

History

• Effective: May 15, 2023
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-43-06 Carriers.

Common and contract carriers, freight forwarders, warehousemen, and the United States postal service are exempt from the regulations in this chapter to the extent that they are not prescribed to be licensed as set forth in Chapter 3748. of the Revised Code and rule 3701:1-38-02 of the Administrative Code, and to the extent that they only transport or store TENORM in the regular course of carriage for another or storage incident thereto.

Last updated May 15, 2023 at 1:06 AM

History

• Effective: May 15, 2023
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-38-02

(A) As used in this rule, "facility" has the meaning defined in division (H) of section 3748.01 of the Revised Code and the following:

(1) All buildings, equipment, structures, and other stationary items that are located on a single site or on contiguous or adjacent sites and that are operated by the same person and have common corporate or business interests; and

(2) Portions of a building or structure which are operated by the same person and have common corporate or business interests.

(B) Notwithstanding the definition of "facility," the director may consider sites that are not contiguous or adjacent as one facility provided that:

(1) The sites are operated by the same person;

(2) The sites are in the same license category or categories;

(3) The applicant for a license provides for one radiation safety officer, and if applicable, one radiation safety committee, as responsible for all sites; and

(4) The director is reasonably satisfied from the information provided in the application that the applicant will adequately control radioactive material at all sites listed in the application.

(a) Unless the director has information of violations of Chapter 3748. of the Revised Code or the rules adopted thereunder at one or more sites, the director shall presume the applicant will adequately control radioactive material at all sites if the sites are located not more than twenty miles driving distance apart as documented by the licensee, and if all sites are within a twenty mile radius from the main site as designated on the license.

(b) The director shall continue to renew a license issued under this paragraph that contains all the sites listed thereon provided the licensee demonstrates continued compliance with this paragraph, Chapter 3748. of the Revised Code, and the rules adopted thereunder.

(C) Every facility that handles radioactive material in any license category as specified in appendix A to this rule for which licensure is required shall apply for a license, license amendment, or license renewal in accordance with this rule. Application for a license, license amendment, or license renewal shall be made on any format prescribed and provided by the director. Licenses shall be issued in accordance with the requirements of Chapter 3748. of the Revised Code, and the rules adopted thereunder. Except as otherwise provided in this rule, a license shall expire five years from the date of issuance.

(1) As used in this paragraph, site means an address of use listed on the license. Temporary job sites are exempted.

(a) Any individual applying for a new license with one or more additional sites or a current licensee amending a license to add one or more additional sites that are located more than twenty miles from the main site shall pay an additional site fee for each such site as follows:

(i) The additional site fee(s) shall be seventy-five percent of the applicable annual fee, as those fees are set forth in paragraphs (D), (F), and (J) of this rule.

(ii) Additional site fees will be invoiced annually with the annual fee.

(b) Broad scope licensees are exempt from paragraph (C)(1)(a) of this rule.

(2) As used in this paragraph, "service" means activities performed by a person, other than a worker as defined in rule 3701:1-38-01 of the Administrative Code, pursuant to an agreement with the facility to perform activities that deal with sources of radiation for the facility.

(a) These activities include, but are not limited to the following:

(i) Conduct leak tests;

(ii) Calibrate survey instruments;

(iii) Provide quality control tests;

(iv) Conduct surveys, characterization, and/or remediation activities;

(v) Manage the disposal of radioactive waste for other persons; or

(vi) Install sources or devices or change sources within a device.

(b) License categories affected are:

(i) 3219 - decontamination services;

(ii) 3220 - leak test service;

(iii) 3221 - instrument calibration service only - source less than 3.7 terabecquerels (one hundred curies);

(iv) 3222 - instrument calibration service only - source equal to or greater than 3.7 terabecquerels (one hundred curies);

(v) 3223 - leak test and instrument calibration - source less than 3.7 terabecquerels (one hundred curies);

(vi) 3224 - leak test and instrument calibration - source equal to or greater than 3.7 terabecquerels (one hundred curies);

(vii) 3225 - other services - including teletherapy, irradiator, and gauge service;

(viii) 3232 - waste disposal service prepackaged only;

(ix) 3233 - waste disposal service - incineration; and

(x) 3234 - waste disposal service processing and/or repackaging.

(D) A radioactive materials license issued by the department may, at the discretion of the director, have more than one license category on any one specific license. A licensee may have more than one radioactive materials license. Except as otherwise provided in paragraph (J) of this rule, the annual fee for a radioactive material license shall be in an amount in accordance with appendix A to this rule.

(1) Upon receipt of an application for a new radioactive material license, the department will issue an invoice for the appropriate fee specified in appendix A to this rule or paragraph (J) of this rule. Annual fees will be invoiced based on the month of the license expiration date and the invoice will state that the fee is due thirty days after the date of the invoice. License fees are not refundable.

(2) An applicant for a new or a renewal or amendment of a radioactive material license must submit a complete application before the director will finalize the review of the application. A complete application is one in which the applicant has provided all the information requested by the director, including any additional information requested after receipt of the application package.

(3) Upon receipt of an application for a license amendment, the department will issue an invoice for the appropriate fee for the proposed amendment as specified in appendix A to this rule. If the amendment is to change the license from operational phase to storage of sealed sources only incident to disposal of the sources, after the amendment the annual fee for the license shall be reduced to fifty per cent of the fee for the operational phase of the license, provided that the sources continue to be in safe storage and leak tested as provided by license condition for the specific sources in storage. The inspection frequency will remain the same as that for the operational phase of the license until after source disposal.

(4) The applicant for a new, or renewal or amendment of a radioactive materials license shall provide to the director all additional information requested within sixty days from the date of the information request. If the director does not receive the requested information within the stated time period, the director may consider the application abandoned. Any further consideration of a new license, or a renewal or amendment of a license shall be pursuant to another application.

(5) The director shall grant a new license, license amendment, or license renewal to any applicant who has submitted a complete application and is in compliance with Chapter 3748. of the Revised Code and the rules adopted thereunder.

(6) When an amendment to a license results in a change to a license category with a higher fee, the licensee will be charged the higher of the two amendment fees for that category. The annual fee for the licensee will escalate to the new category fee on the date of the next annual invoice.

(7) The director shall charge a fee for minor license amendments that do not require review by members of the technical staff at a rate of one hundred dollars per amendment provided that no licensee shall be required to pay more than one thousand dollars for minor amendments in any calendar year. Minor amendments include, but are not limited to, adding a new gauge of the same type already licensed unless that additional gauge increases the license or inspection fee, a corporate name change if the corporate ownership does not change, adding a user name that does not require review of education and experience, and corporate address change if the location of the use of the radioactive material does not change. Amendments to change the radiation safety officer or the chair or members of the radiation safety committee that require review of education or experience are not minor amendments.

(8) License terminations shall be handled as follows:

(a) Except as provided in paragraph (D)(8)(c) of this rule, a termination fee of five hundred dollars or fifty per cent of the annual fee, whichever is less, will be invoiced upon written request from the licensee for termination of the license. This fee is not refundable.

(b) Except as provided in paragraph (D)(8)(c) of this rule, if the termination cost, as determined by paragraph (M) of this rule, exceeds the termination fee in paragraph (D)(8)(a) of this rule, the remainder of the termination expense will be assessed at full cost.

(c) If the license termination would be covered under paragraph (D)(9) of this rule, that paragraph will be used for the termination process.

(d) The license termination process will not be completed until the licensee is in compliance with all rules, including payment of fees.

(9) Licenses, and other approvals related to the licensed activity requiring decommissioning, decontamination, reclamation, site restoration, or long-term care due to the continued presence of radioactive materials shall be charged an annual fee based on the approved decommissioning funding plan as specified in appendix B to this rule.

(a) A decommissioning plan must be approved by the department. Prior to approval of the decommissioning plan the licensee must submit an amendment requesting decommissioning. Until the amendment is approved the licensee's annualized license fee will be reduced by fifty per cent. After approval of the amendment containing the decommissioning plan, the licensee will be invoiced at the annual fee specified in appendix B to this rule.

(b) The annual fee specified in appendix B to this rule is based on the cost of decommissioning. The fee is payable within thirty days of mailing of an invoice by the department.

(c) Routine decommissioning oversight by the department will be charged against the annual amount received and additional invoices will not be issued unless the cost of activities exceeds the annual amount in any given year.

(d) The facility shall receive a monthly statement of items and amounts charged against the annual fee.

(e) If the cost of additional activities arise that require use of additional staff, including any consulting service that exceeds the amount of the annual fee paid by the licensee, these additional costs will be included in any invoice as separate items invoiced for the full cost of the oversight by additional staff or consultants. Oversight activities will be performed at a frequency which adequately monitors health, safety, and the environment.

(f) When the approved decommissioning plan is less than one hundred thousand dollars, the licensee will remain in the current license category and continue to pay the required annual fee specified in appendix A to this rule during decommissioning. Inspections of these licensees will be done as non-routine inspections. Non-routine inspection fees will not be applied until the number of decommissioning inspections performed exceed the inspections that would have been performed if the licensee had not chosen the decommissioning option.

(g) When the licensee has completed the decommissioning, and the director has determined that the licensee cannot terminate the license as provided by the Administrative Code, Chapter 3748. of the Revised Code or the rules adopted thereunder, but the licensee has successfully completed the decommissioning of the operation as required by the approved decommissioning plan, the director will amend the license to a decommissioning/possession only license. The annual fee for a decommissioning/possession only license is provided in appendix B to this rule.

(E) Licenses shall be renewed in accordance with the standard renewal procedure established in Chapter 4745. of the Revised Code, except that a licensee, other than a broad scope licensee, shall apply for renewal of the license ninety days prior to the expiration date of the current license and broad scope licensees shall apply for renewal of their license one hundred eighty days prior to expiration.

(F) The annual fee is listed in appendix A to this rule "column 5" for a new license or "column 6" for a renewal license. To recover the costs of oversight activities where radioactive material is found in the public domain and there is no evident individual that is determined to be responsible, a surcharge of 5.25 per cent has been included in the annual fee listed in "column 5" and "column 6" of appendix A to this rule.

(G) The department shall charge an inspection fee for all non-routine inspections. A non-routine inspection is defined as any inspection that the department conducts in addition to the scheduled routine inspections and one follow-up inspection if necessary. Non-routine inspections include, without limitation:

(1) An inspection performed as a result of an incident;

(2) Any pre-license inspections for a new license applicant when the director determines that an inspection is necessary to assess the adequacy of the information provided in the application;

(3) Inspections prior to license amendment, category change, or termination;

(4) An inspection performed at a facility that results in the issuance of an adjudication order by the director; or

(5) Other enforcement or regulatory inspections, not specified above, that the director determines is necessary to assess compliance with Chapter 3748. of the Revised Code.

(H) The fee for a non-routine inspection shall be based on the actual cost for conducting the inspection which shall include:

(1) An hourly charge of seventy dollars per staff person assigned to the inspection, except staff participating as training will not be included in the charges;

(2) An administrative fee of three hundred thirty dollars;

(3) All necessary laboratory analysis costs for samples collected by department personnel; and

(4) Any staff travel costs which shall be calculated in accordance with rule 126-01-02 of the Administrative Code.

(I) All fees invoiced as provided within this rule, including full cost, routine, and non-routine inspection fees, shall be paid within thirty days of the invoice date specified on the invoice. In accordance with sections 3748.07 and 3748.13 of the Revised Code, any fee that remains unpaid on the ninety-first day after the original invoice date shall be assessed an additional amount equal to ten per cent of the original fee.

(1) The department shall mail invoices by ordinary U.S. mail to the most recent address provided by the licensee.

(2) The department shall maintain a list of the invoices issued and date mailed.

(J) Notwithstanding paragraph (D) of this rule, the department shall charge the following types of licensees reduced license fees in the following specified amounts:

(1) A private entity that provides services, does not engage in manufacturing, and that has three hundred fifty thousand to two million dollars in gross annual receipts, shall pay a total license fee of seventy-five per cent of the amount specified for that use of radioactive materials in appendix A to this rule.

(2) A private entity that provides services, does not engage in manufacturing, and that has less than three hundred fifty thousand dollars in gross annual receipts shall pay a total license fee of fifty per cent of the amount specified for that use of radioactive material in appendix A to this rule.

(3) A private entity that engages in manufacturing and that has thirty-five to two hundred employees, irrespective of gross annual receipts, shall pay a total license fee of seventy-five per cent of the amount specified for that use of radioactive material in appendix A to this rule.

(4) A private entity that engages in manufacturing and that has less than thirty-five employees, irrespective of gross annual receipts, shall pay a total license fee of fifty per cent of the amount specified for that use of radioactive material in appendix A to this rule.

(5) A nonprofit entity that has gross annual receipts of three hundred fifty thousand dollars to two million dollars shall pay a total license fee of seventy-five per cent of the amount specified for that use of radioactive material in appendix A to this rule.

(6) A nonprofit entity that has gross annual receipts of less than three hundred fifty thousand dollars shall pay a total license fee of fifty per cent of the amount specified for that use of radioactive material in appendix A to this rule.

(7) A government jurisdiction or district with a population of twenty thousand to fifty thousand shall pay a total license fee of seventy-five per cent of the amount specified for that use of radioactive material as specified in appendix A to this rule.

(8) A government jurisdiction or district with a population of less than twenty thousand shall pay a total license fee of fifty per cent of the amount specified for that use of radioactive materials as specified in appendix A to this rule.

(9) A health district as defined in section 3709.01 of the Revised Code shall pay a total license fee of twenty-five per cent of the amount specified in appendix A to this rule.

(10) An accredited private or public college or university possessing or using radioactive material in a sealed or unsealed source solely as a part of a college or university course supported by tuition and leading to an accredited degree, but excluding clinical training, shall pay a total license fee as set forth for category "1129" as that amount is specified in appendix A to this rule.

The reduced annual fees specified in this paragraph do not apply to any other fees that a licensee may be required to pay under Chapter 3748. of the Revised Code or rules adopted thereunder. Licensees shall provide certification of their compliance with the provisions of paragraphs (J)(1) to (J)(6) of this rule upon initial application and renewal.

(K) The director may modify the inspection frequency of licensed facilities based upon the performance of the facility.

(L) In accordance with section 3748.22 of the Revised Code, the department shall charge fees sufficient to cover all costs of regulatory, administrative, and enforcement activities conducted pursuant to Chapter 3748. of the Revised Code. The director shall recommend to the radiation advisory council and the public health council changes in the radioactive materials fees if the director finds that fees do not meet the requirements of section 3748.22 of the Revised Code.

(M) Fees for those categories listed as "full cost" such as decommissioning activities, for either partial, building or selected area of a licensed site, or full decommissioning leading to license amendment, category change, or termination and for review of sources and/or devices shall be specified as "full cost" and shall be calculated as the sum of the seventy dollar hourly charge per staff member for the number of hours spent on document review and preparation, licensing, inspection, meetings, teleconferences, in travel, administrative time, the cost of any special contractors as determined necessary by the director, any environmental monitoring for radioactive materials and laboratory analysis, any other associated activities. The administrative fee from paragraph (H)(2) of this rule shall be used for administrative time. Travel expenses shall also be invoiced and shall be calculated at the rate determined by rule 126-1-02 of the Administrative Code. These fees will be invoiced monthly.

(N)

(1) Reciprocity to engage in activities in the state of Ohio which involve radioactive materials may be authorized provided:

(a) The person requesting reciprocity possesses a valid radioactive materials license issued by another agreement state or the United States nuclear regulatory commission which authorizes the same activities proposed to be conducted in Ohio;

(b) The request for reciprocity is made by submission of a completed reciprocity application provided by the director, a copy of the person's radioactive materials license, and payment of the reciprocity fee specified in appendix A to this rule;

(c) The duration of activities to be performed in Ohio under reciprocity does not exceed one hundred eighty days in any one calendar year.

(2) A person who has been granted reciprocity in Ohio shall notify the director at least three business days in advance of each time the person proposes to begin a new use of radioactive materials in the state of Ohio, with the notification made on a form provided by the director.

(3) Activities conducted in Ohio under reciprocity are subject to inspection by the department at any time and the department shall invoice a reciprocity inspection fee of one thousand dollars for each inspection of a person's authorized reciprocity activities.

(4) Reciprocity is authorized for one calendar year, beginning on January first or later date when reciprocity is initially applied for, and ending on December thirty-first.

(5) A person who is authorized reciprocity shall apply for an Ohio radioactive materials license at least thirty days prior to exceeding one hundred eighty days of activities in Ohio.

(O) Requests for safety evaluation of devices, products, or sealed sources used for radioactive materials either for commercial distribution or manufactured in accordance with the unique specifications of, and for use by, a single applicant shall be submitted to the director on a form provided by the director for that review prior to manufacture or commercial distribution.

(1) The application shall specify a license amendment for one of the areas listed below:

(a) Safety evaluation of sealed sources or devices or products containing NARM, byproduct material, source material, or special nuclear material (less than critical mass) for commercial distribution.

(b) Safety evaluation of sealed sources or devices or products containing NARM, byproduct material, source material, or special nuclear material (less than critical mass) manufactured in accordance with the unique specifications of, and for use by, a single applicant.

(2) The amendment fee for a source or device review shall be "full cost" as outlined in paragraph ((M) of this rule.

(3) The amendment fee in appendix A to this rule for categories under manufacturing and distribution shall be for amendments other than source or device reviews.

(4) Licensees for categories 3211, 3212, 3213, 3214, and 22162 shall pay an annual surcharge of six hundred fifty dollars to cover administrative costs of overall maintenance activities associated with source or device data submitted to the United States nuclear regulatory commission. This surcharge is included in the annual fee for the above listed categories in "column 5" and "column 6" of appendix A to this rule.

(P) When considered necessary by the director, the director may conduct a review of shielding plans or the adequacy of shielding. The director may also conduct such a review upon the request of the licensee or the applicant for a license. The applicant or licensee shall pay a fee for review of shielding plans or adequacy of shielding as specified in paragraph (M) of this rule.

(Q) Individuals with implanted pacemakers that have a radioactive source will not be charged an annual fee as an individual because of the necessity of possessing the device. Unless the director determines other provisions are required, the medical institution that implanted the device shall hold the license for the individual.

(R) If, because of the complexity of a review, such as that for a sealed source or device, decommissioning, license, or incident, it is necessary to obtain the services of a consultant to assist in a final determination, the licensee or applicant will be invoiced for the consulting services.

(S) Licensees with general licenses requiring an annual report to the director shall submit the report with a fee of four hundred twenty dollars within thirty days of mailing an invoice by the department and are subject to late penalties in paragraph (I) of this rule. If a facility has a specific license which is in a category that would include the generally licensed material, the facility may add the generally licensed material to the specific license and will not be charged the additional fee for that generally licensed material. Annual reports are required for devices under a general license containing radionuclides at or above activities listed in paragraph (C)(13) of rule 3701:1-46-05 of the Administrative Code.

View AppendixView Appendix

Last updated November 2, 2022 at 2:09 PM

History

• Effective: April 15, 2013
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-43-18

(A) A licensee will dispose of licensed TENORM material in accordance with this rule. Licensed TENORM material will be disposed of in one of the following manners:

(1) By transfer of the wastes for storage, treatment, or disposal at a facility licensed by the director, the applicable agency of another state, or the United States nuclear regulatory commission, or authorized by the United States department of energy for storage, treatment, or disposal of TENORM;

(2) By transfer of the wastes for storage, treatment, or disposal to a facility licensed by the director, the applicable agency of another state, or the United States nuclear regulatory commission for storage, treatment or disposal of low-level radioactive waste unless the disposal facility license prohibits disposal of TENORM;

(3) By disposal in an injection well approved in accordance with Chapter 3745-34 of the Administrative Code, or by transfer for disposal at an out-of-state injection well approved by the applicable governmental authority;

(4) By transfer for disposal in another state as otherwise approved by the applicable governmental authority and with written approval of the director; or

(5) In accordance with alternate methods authorized by the permitting agency for the disposal site upon application or upon the director's initiative, consistent with rule 3701:1-38-19 of the Administrative Code and, where applicable, the Clean Water Act (33 U.S.C. 1251 et. seq as amended, as published in the United States Code, 2006 edition), Safe Drinking Water Act (42 U.S.C. 300f et. seq. as amended, as published in the United States Code, 2006 edition) and other requirements of the United States environmental protection agency for disposal of such wastes.

(B) Records of disposal, including manifests for TENORM, will be maintained consistent with the provisions of rule 3701:1-38-20 of the Administrative Code.

(C) Purposeful dilution of TENORM waste for the sole purpose of making the waste exempt from the disposal requirements will not be performed without prior director approval. The criteria in rule 3701:1-38-19 of the Administrative Code will be used by the director to determine whether or not to approve such a request. Dilution resulting from normal product processing is not considered purposeful dilution.

Last updated May 15, 2023 at 1:06 AM

History

• Effective: May 15, 2023
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-38-13

(A) Each licensee or registrant shall conduct operations so that:

(1) The total effective dose equivalent to individual members of the public from the licensed or registered operation does not exceed one millisievert (0.1 rem) in a year, exclusive of the dose contribution from the following:

(a) Background radiation;

(b) Radiation attributable to any medical administration the individual has received;

(c) Exposure to an individual that was administered radioactive materials and has been released in accordance with rule 3701:1-58-30 of the Administrative Code or equivalent United States nuclear regulatory agency or agreement state regulations;

(d) Voluntary participation in medical research programs;

(e) The licensee's disposal of radioactive material into sanitary sewerage in accordance with paragraph (D) of rule 3701:1-38-19 of the Administrative Code; and

(2) The dose in any unrestricted area from external sources, exclusive of the dose contribution from patients administered radioactive material and released in accordance with rule 3701:1-58-30 of the Administrative Code or equivalent United States nuclear regulatory agency or agreement state regulations, does not exceed 0.02 millisievert (0.002 rem) in any one hour.

(B) If the licensee or registrant permits members of the public to have access to controlled or restricted areas, the limits for members of the public continue to apply to those individuals.

(C) A licensee, registrant, or an applicant for a license or registration may apply for prior department authorization to operate up to an annual dose limit for an individual member of the public of five millisievert (0.5 rem). This application shall include the following information:

(1) Demonstration of the need for and the expected duration of operation in excess of the limit set forth in paragraph (A) of this rule;

(2) The licensee's or registrant's program to assess and control dose within the five millisievert (0.5 rem) annual limit; and

(3) The procedures that the registrant or licensee will follow to maintain the dose ALARA.

(4) Notwithstanding paragraph (A)(1) of this rule, a licensee may permit visitors to an individual who cannot be released, under rule 3701:1-58-30 of the Administrative Code, to receive a radiation dose greater than one millisievert (0.1 rem) if:

(a) The radiation dose received does not exceed five millisievert (0.5 rem); and

(b) The authorized user, as defined in Chapter 3701:1-58 of the Administrative Code, has determined before the visit that it is appropriate.

(D) In addition to the requirements of paragraphs (A) and (B) of this rule:

(1) A licensee subject to the provisions of the United States environmental protection agency's generally applicable environmental radiation standards in 40 C.F.R. 190 (as in effect on the effective date of this rule), shall also comply with those standards.

(2) The department may impose additional restrictions on radiation levels in unrestricted areas and on the total quantity of radionuclides that a licensee may release in effluents in order to restrict the collective dose.

(E) The licensee or registrant shall demonstrate compliance with dose limits for individual members of the public.

(1) The licensee or registrant shall make or cause to be made surveys of radiation levels in unrestricted and controlled areas and radioactive materials in effluents released to unrestricted and controlled areas to demonstrate compliance with the dose limits for individual members of the public in paragraph (A) of this rule.

(2) A licensee or registrant shall show compliance with the annual dose limit in paragraph (A) of this rule by:

(a) Demonstrating by measurement or calculation that the total effective dose equivalent to the individual likely to receive the highest dose from the licensed or registered operation does not exceed the annual dose limit; or

(b) Demonstrating that:

(i) The annual average concentrations of radioactive material released in gaseous and liquid effluents at the boundary of the unrestricted area do not exceed the values specified in appendix C to rule 3701:1-38-12 of the Administrative Code; and

(ii) If an individual were continuously present in an unrestricted area, the dose from external sources would not exceed 0.02 millisievert (0.002 rem) in an hour and 0.5 millisievert (0.05 rem) in a year.

(3) Upon approval from the department, the licensee may adjust the effluent concentration values in appendix C to rule 3701:1-38-12 of the Administrative Code for members of the public, to take into account the actual physical and chemical characteristics of the effluents, such as aerosol size distribution, solubility, density, radioactive decay equilibrium, or chemical form.

Last updated January 20, 2022 at 8:47 AM

History

• Effective: January 20, 2022
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-43-17

(A) Each person who receives TENORM under a license issued pursuant to the rules in Chapter 3701:1-43 and rule 3701:1-38-02 of the Administrative Code, will keep records showing the receipt, transfer, and disposal of the TENORM as follows:

(1) The licensee will retain each record of receipt of TENORM as long as the material is possessed and for three years following transfer or disposal of the material.

(2) The licensee who transferred the material will retain each record of transfer for three years after each transfer unless otherwise specified by rule for that particular licensed activity.

(3) The licensee who disposed of the material will retain each record of disposal of TENORM until the director terminates each license that authorizes disposal of the material.

(4) The licensee will keep records of information important to the safe and effective reclamation of a facility in an identified location until the license is terminated by the director. If records of relevant information are maintained for other purposes, reference to these records and their locations may be used. As used in this rule "reclaiming" means returning property to a condition or state such that the property no longer presents a health or safety hazard or threat to the environment. This includes, but is not limited to, those activities necessary to decommission the licensed facility such as safely removing a facility from service, reducing the residual radioactivity to a level that permits release of the property for unrestricted use, and termination of the license. Information important to reclaiming includes:

(a) Records of spills or other unusual occurrences involving the spread of contamination in and around the facility, equipment or site. These records may be limited to instances when contamination remains after any cleanup procedures or when there is reasonable likelihood that contaminants may have spread to inaccessible areas as in the case of possible seepage into porous materials such as concrete. These records will include any known information on identification of involved radionuclides, quantities, forms and concentrations; and

(b) As-built drawings and modifications of structures and equipment in restricted areas where radioactive materials are used or stored, and of locations of possible inaccessible contamination, such as buried pipes which may be subject to contamination. If needed drawings are referenced, each relevant document need not be indexed individually. If drawings are not available, the licensee will substitute appropriate records of available information concerning these areas and locations.

(B) Except as provided in paragraph (C) of this rule, the licensee will retain each record that is prescribed by Chapter 3701:1-38 and Chapter 3701:1-43 of the Administrative Code, or by license condition for the period specified by the appropriate regulation or license condition. If a retention period is not otherwise specified by rule or license condition, the record will be retained until the director terminates each license that authorizes the activity that is subject to the record-keeping requirement. Such records may be either the original record or a reproduced copy or microform, provided that such copy or microform is duly authenticated by authorized personnel and the microform is capable of producing a clear and legible copy after storage for the period specified by the director. The record also may be stored in electronic media provided that the licensee is capable of producing legible, accurate, and complete records during the prescribed retention period. Records such as letters, drawings, specifications, will include all pertinent information such as stamps, initials, and signatures. The licensee will maintain adequate safeguards against record tampering and loss.

(C) In the case of a conflict between a record requirement specified in rule and that requirement specified as a license condition, the licensee will comply with the license condition.

Last updated May 15, 2023 at 1:06 AM

History

• Effective: May 15, 2023
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-38-12

(A) Except in the case of a planned special exposure pursuant to paragraph (F) of this rule, a licensee or registrant shall limit the occupational dose received by an individual adult, as follows:

(1) An annual limit, which is the more limiting of:

(a) The total effective dose equivalent being equal to 0.05 sievert (five rem); or

(b) The sum of the deep dose equivalent and the committed dose equivalent to any individual organ or tissue other than the lens of the eye being equal to 0.5 sievert (fifty rem).

(2) The annual limits to the lens of the eye, to the skin of the whole body, and to the skin of the extremities, which are:

(a) A lens dose equivalent of 0.15 sievert (fifteen rem), and

(b) A shallow-dose equivalent of 0.5 sievert (fifty rem) to the skin of the whole body or to the skin of any extremity.

(3) Doses received in excess of the annual limits, including doses received during accidents, emergencies, and planned special exposures, shall be subtracted from the limits for planned special exposures that the individual may receive during the current calendar year and during the individual's lifetime in accordance with paragraph (F)(5) of this rule.

(4) When the external exposure is determined by measurement with an external personal monitoring device, the deep-dose equivalent must be used in place of the effective dose equivalent, unless the effective dose equivalent is determined by a dosimetry method approved by the director. The assigned deep-dose equivalent must be for the part of the body receiving the highest exposure.

(a) The assigned shallow-dose equivalent must be the dose averaged over the contiguous ten square centimeters of skin receiving the highest exposure. The deep-dose equivalent, lens-dose equivalent, and shallow-dose equivalent may be assessed from surveys or other radiation measurements for the purpose of demonstrating compliance with the occupational dose limits, if the individual monitoring device was not in the region of highest potential exposure, or the results of individual monitoring are unavailable; or

(b) When a protective apron is worn while working with radiation-generating equipment and monitoring is conducted as specified in paragraph (C)(1) of rule 3701:1-38-14 of the Administrative Code, the effective dose equivalent for external radiation shall be determined as follows:

(i) When only one individual monitoring device is used and it is located at the neck outside the protective apron, the reported deep dose equivalent value multiplied by 0.3 shall be the effective dose equivalent for external radiation; or

(ii) When two individual monitoring devices are worn, one under the protective apron at the waist and the other outside the protective apron at the neck, the effective dose equivalent for external radiation shall be assigned the value of the sum of the deep dose equivalent reported for the individual monitoring device located at the waist under the protective apron multiplied by 1.5 and the deep dose equivalent reported for the individual monitoring device located at the neck outside the protective apron multiplied by 0.04; or

(iii) Through the use of computational methods endorsed by the "American National Standards Institute", recommended by the "National Council on Radiation Protection and Measurements", or approved by the director.

(5) Derived air concentration (DAC) and annual limit on intake (ALI) values are specified in appendix C to this rule and may be used by the licensee to determine the individual's dose and to demonstrate compliance with the occupational dose limits. Appendices A and B are explanatory supplements to appendix C to this rule. Notwithstanding the annual dose limits, the licensee shall limit the soluble uranium intake by an individual to ten milligrams in a week in consideration of chemical toxicity.

(6) In accordance with paragraph (E) of this rule, the licensee or registrant shall reduce the dose that an individual may be allowed to receive in the current year by the amount of occupational dose received while employed by any other person.

(B) Compliance with requirements for summation of external and internal doses shall be in accordance with the following:

(1) If the licensee is required to monitor under both paragraphs (B)(1) and (B)(2) of rule 3701:1-38-14 of the Administrative Code, the licensee shall demonstrate compliance with the dose limits by summing external and internal doses. If the licensee is required to monitor only under paragraph (B)(1) or only under paragraph (B)(2) of rule 3701:1-38-14 of the Administrative Code, then summation is not required to demonstrate compliance with the dose limits. The licensee may demonstrate compliance with the requirements for summation of external and internal doses by meeting one of the conditions specified in paragraph (B)(2) of this rule and the conditions in paragraphs (B)(3) and (B)(4) of this rule. The dose equivalents for the lens of the eye, the skin, and the extremities are not included in the summation, but are subject to separate limits.

(2) If the only intake of radionuclides is by inhalation, the total effective dose equivalent limit is not exceeded if the sum of the deep dose equivalent divided by the total effective dose equivalent limit, plus one of the following does not exceed unity:

(a) The sum of the fractions of the inhalation ALI for each radionuclide; or

(b) The total number of derived air concentration-hours, or DAC-hours, for all radionuclides divided by two thousand; or

(c) The sum of the calculated committed effective dose equivalents to all significantly irradiated organs or tissues (T) calculated from bioassay data using appropriate biological models and expressed as a fraction of the annual limit. For purposes of this requirement, an organ or tissue is deemed to be significantly irradiated if, for that organ or tissue, the product of the weighting factors, W_T, and the committed dose equivalent, H_T,50, per unit intake is greater than ten per cent of the maximum weighted value of H_T,50, that is, W_TH_T,50, per unit intake for any organ or tissue.

(3) If the occupationally exposed individual also receives an intake of radionuclides by oral ingestion greater than ten percent of the applicable oral ALI, the licensee shall account for this intake and include it in demonstrating compliance with the limits set forth in paragraph (A) of this rule.

(4) The licensee shall evaluate and, to the extent practical, account for intakes through wounds or skin absorption. The intake through intact skin has been included in the calculation of DAC for hydrogen-3 and does not need to be further evaluated or accounted for pursuant to this paragraph.

(C) Determination of external dose from airborne radioactive material shall be in accordance with the following:

(1) When determining the dose from airborne radioactive material, the licensee shall include the contribution to the deep dose equivalent, lens dose equivalent, and shallow dose equivalent from external exposure to the radioactive cloud as specified in appendix C to this rule, footnotes ^A and ^B.

(2) The licensee should not use airborne radioactivity measurements or DAC values as the primary means to assess the deep dose equivalent when the airborne radioactive material includes radionuclides other than noble gases, or if the cloud of airborne radioactive material is not relatively uniform. The determination of the deep dose equivalent to an individual should be based upon measurements using instruments or individual monitoring devices.

(D) Determination of internal exposure shall be in accordance with the following:

(1) For purposes of assessing dose used to determine compliance with occupational dose equivalent limits, the licensee shall, when required under paragraph (B) of rule 3701:1-38-14 of the Administrative Code, take suitable and timely measurements of:

(a) Concentrations of radioactive materials in air in work areas; or

(b) Quantities of radionuclides in the body; or

(c) Quantities of radionuclides excreted from the body; or

(d) Combinations of these measurements.

(2) Unless respiratory protective equipment is used, as provided in paragraph (C) of rule 3701:1-38-16 of the Administrative Code or the assessment of intake is based on bioassays, the licensee shall assume that an individual inhales radioactive material at the airborne concentration in which the individual is present.

(3) When specific information on the physical and biochemical properties of the radionuclides taken into the body or the behavior of the material in an individual is known, the licensee may:

(a) Use that information to calculate the committed effective dose equivalent, and, if used, the licensee shall document that information in the individual's record; and

(b) Upon prior approval of the department, adjust the DAC or ALI values to reflect the actual physical and chemical characteristics of airborne radioactive material, for example, aerosol size distribution or density; and

(c) Separately assess the contribution of fractional intakes of Class D, W, or Y compounds of a given radionuclide to the committed effective dose equivalent as specified in appendix A to this rule.

(4) If the licensee chooses to assess intakes of Class Y material using the measurements given in paragraph (D)(1)(b) or (D)(1)(c) of this rule in order to make additional measurements basic to the assessments, the licensee may delay the recording and reporting of the assessments for periods up to seven months, unless otherwise required by paragraph (B)(2) or (C) of rule 3701:1-38-21 of the Administrative Code.

(5) If the identity and concentration of each radionuclide in a mixture are known, the fraction of the DAC applicable to the mixture for use in calculating DAC-hours shall be either:

(a) The sum of the ratios of the concentration to the appropriate DAC value, that is, D, W, or Y, from appendix C to this rule for each radionuclide in the mixture; or

(b) The ratio of the total concentration for all radionuclides in the mixture to the most restrictive DAC value for any radionuclide in the mixture.

(6) If the identity of each radionuclide in a mixture is known, but the concentration of one or more of the radionuclides in the mixture is not known, the DAC for the mixture shall by the most restrictive DAC of any radionuclide in the mixture.

(7) When a mixture of radionuclides in air exists, a licensee may disregard certain radionuclides in the mixture if all of the following occur:

(a) The licensee uses the total activity of the mixture in demonstrating compliance with the dose limits in paragraph (A) of this rule and in complying with the monitoring requirements in paragraph (B) of rule 3701:1-38-14 of the Administrative Code;

(b) The concentration of any radionuclide disregarded is less than ten percent of its DAC; and

(c) The sum of these percentages for all of the radionuclides disregarded in the mixture does not exceed thirty percent.

(8) When determining the committed effective dose equivalent, the licensee may consider the following:

(a) In order to calculate the committed effective dose equivalent, the licensee may assume that the inhalation of one ALI, or an exposure of two thousand DAC-hours, results in a committed effective dose equivalent of 0.05 sievert (five rem), for radionuclides that have their ALIs or DACs based on the committed effective dose equivalent; or

(b) For an ALI and the associated DAC determined by the nonstochastic organ dose limit of 0.5 sievert (fifty rem), the intake of radionuclides that would result in a committed effective dose equivalent of 0.05 sievert (five rem), that is, the stochastic ALI, is listed in parentheses in table I of appendix C to this rule. The licensee may, as a simplifying assumption, use the stochastic ALI to determine committed effective dose equivalent. However, if the licensee uses the stochastic ALI, the licensee shall also demonstrate that the limit in paragraph (A)(1)(b) of this rule is met.

(E) Determination of prior occupational dose shall be made in accordance with the following:

(1) For each individual who is likely to receive an annual occupational dose requiring monitoring pursuant to paragraph (B) of rule 3701:1-38-14 of the Administrative Code, the licensee or registrant shall determine the occupational radiation dose received during the current year.

(2) Prior to permitting an individual to participate in a planned special exposure, the licensee shall determine:

(a) The internal and external doses from all previous planned special exposures; and

(b) All doses in excess of the limits, including doses received during accidents and emergencies, received during the lifetime of the individual.

(3) In complying with the requirements of paragraph (E)(1) or (E)(2) of this rule, a licensee or registrant may:

(a) Accept, as a record of the occupational dose that the individual received during the current year, a written signed statements from the individual, or from the individual's most recent employer for work involving radiation exposure, that discloses the nature and the amount of any occupational dose that the individual may have received during the current year;

(b) Accept, as the record of lifetime cumulative radiation dose, a current department form entitled "lifetime occupational exposure history" or equivalent, signed by the individual and countersigned by an appropriate official of the most recent employer for work involving radiation exposure, or the individual's current employer, if the individual is not employed by the licensee or registrant; and

(c) Obtain reports of the individual's dose equivalent from the most recent employer for work involving radiation exposure, or the individual's current employer, if the individual is not employed by the licensee or registrant, by telephone, telegram, facsimile, e-mail or letter. The licensee or registrant shall request a written verification of the dose data if the authenticity of the transmitted report cannot be established.

(4) The licensee or registrant shall record the exposure history, as required by paragraph (A) of this rule, on a form provided by the department or other clear and legible record, of all the information required on that form. The form or record shall show each period in which the individual received occupational exposure to radiation or radioactive material and shall be signed by the individual who received the exposure. For each period for which the licensee or registrant obtains reports, the licensee or registrant shall use the dose shown in the report in preparing the exposure history form. For any period in which the licensee or registrant does not obtain a report, the licensee or registrant shall place a notation on the exposure history form indicating the periods of time for which data are not available.

(5) If the licensee or registrant is unable to obtain a complete record of an individual's current and previously accumulated occupational dose, the licensee or registrant shall assume:

(a) In establishing administrative controls pursuant to paragraph (A)(6) of this rule for the current year, that the allowable dose limit for the individual is reduced by 12.5 millisievert (1.25 rem), for each quarter for which records were unavailable and the individual was engaged in activities that could have resulted in occupational radiation exposure; and

(b) That the individual is not available for planned special exposures.

(6) The licensee or registrant shall retain the records on the exposure history form until the department terminates each pertinent license or registration requiring this record. The licensee or registrant shall retain records used in preparing the exposure history form for three years after the record is made.

(F) A planned special exposure may be authorized by a licensee in accordance with this paragraph. A licensee may authorize an adult worker to receive doses in addition to and accounted for separately from the doses received under the limits specified in paragraph (A) of this rule provided that each of the following is satisfied:

(1) The licensee authorizes a planned special exposure only in an exceptional situation when alternatives that might avoid the higher exposure are unavailable or impractical;

(2) The licensee and employer, if the employer is not the licensee, specifically authorizes the planned special exposure, in writing, before the exposure occurs;

(3) Before a planned special exposure, the licensee ensures that each individual involved is:

(a) Informed of the purpose of the planned operation; and

(b) Informed of the estimated doses and associated potential risks and specific radiation levels or other conditions that might be involved in performing the task; and

(c) Instructed in the measures to be taken to keep the dose ALARA considering other risks that may be present;

(4) Prior to permitting an individual to participate in a planned special exposure, the licensee ascertains prior doses as required by paragraph (E)(2) of this rule during the lifetime of the individual for each individual involved;

(5) The licensee shall not authorize a planned special exposure that would cause an individual to receive a dose from all planned special exposures and all doses in excess of the limits to exceed:

(a) The numerical values of any of the dose limits in paragraph (A) of this rule in any calendar year; and

(b) Five times the annual dose limits specified in paragraph (A) of this rule during the individual's lifetime;

(6) The licensee maintains records of the conduct of a planned special exposure in accordance with paragraph (E) of rule 3701:1-38-20 of the Administrative Code and submits a written report in accordance with paragraph (D) of rule 3701:1-38-21 of the Administrative Code;

(7) The licensee records the best estimate of the dose resulting from the planned special exposure in the individual's record and informs the individual, in writing, of the dose within thirty days from the date of the planned special exposure. The dose from planned special exposures shall not be considered in controlling future occupational dose of the individual pursuant to paragraph (A)(1) of this rule, but shall be included in evaluations required by paragraphs (F)(4) and (F)(5) of this rule.

(G) Occupational dose limits for minors shall be ten per cent of the annual occupational dose limits specified for adult workers in paragraph (A) of this rule.

(H) Dose equivalent to an embryo or fetus shall be in accordance with the following:

(1) The licensee or registrant shall ensure that the dose equivalent to an embryo or fetus during the entire pregnancy, due to occupational exposure of a declared pregnant woman, does not exceed five millisievert (0.5 rem). Records shall be maintained in accordance with paragraph (I) of rule 3701:1-38-20 of the Administrative Code.

(2) The licensee or registrant shall make efforts to avoid substantial variation above a uniform monthly exposure rate to a declared pregnant woman so as to satisfy the limit in paragraph (H)(1) of this rule.

(3) The dose equivalent to the embryo or fetus is the sum of:

(a) The deep-dose equivalent to the declared pregnant woman; and

(b) The dose equivalent to the embryo or fetus resulting from radionuclides in the embryo or fetus and from radionuclides in the declared pregnant woman.

(4) If the declared pregnant woman's exposure includes exposure from radiation generating equipment and a protective apron is worn, the dose equivalent to an embryo or fetus shall be taken as the sum of:

(a) The dose equivalent to the embryo or fetus from radionuclides in the embryo or fetus and radionuclides in the declared pregnant woman; and

(b) The dose equivalent that is most representative of the dose to the embryo or fetus from external radiation, that is, in the mother's lower torso region.

(i) If multiple measurements have not been made, assignment of the highest deep dose equivalent for the declared pregnant woman shall be the dose to the embryo or fetus, in accordance with paragraph (A)(4) of this rule; or

(ii) If multiple measurements have been made, assignment of the deep dose equivalent for the declared pregnant woman from the individual monitoring device which is most representative of the dose to the embryo or fetus shall be the dose to the embryo or fetus. Assignment of the highest deep dose equivalent for the declared pregnant woman to the embryo or fetus is not required unless that dose is also the most representative deep dose equivalent for the region of the embryo or fetus.

(5) If by the time the woman declares pregnancy to the licensee or registrant, the dose equivalent to the embryo or fetus has exceeded five millisievert, or 0.5 rem, the licensee or registrant shall be deemed to be in compliance with paragraph (A) of this rule, provided that the additional dose equivalent to the embryo or fetus does not exceed 0.5 millisievert (0.05 rem), during the remainder of the pregnancy.

View AppendixView AppendixView Appendix

Last updated November 2, 2022 at 2:10 PM

History

• Effective: October 4, 2010
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-43-09 Application for specific licenses.

(A) An applicant for a license to receive and possess TENORM will apply in accordance with rule 3701:1-38-02 of the Administrative Code and this chapter on a form prescribed by the director. The original application will be filed with the director. Information contained in previous applications, statements or reports filed with the director may be incorporated by reference, provided that the reference is clear, specific, and has been on file with the director for not more than two licensing periods, and provided that the item being referenced in the document is being referenced without change.

(B) The director may at any time after the filing of the original application prescribe additional information from the applicant in order to determine whether a license should be issued or whether a current license should be modified or revoked.

(C) Each application will be signed by the applicant or a person duly authorized to act for the applicant and will be accompanied by the fee prescribed in rule 3701:1-38-02 of the Administrative Code.

(D) An application for a license filed pursuant to the requirements in Chapter 3701:1-43 of the Administrative Code will be considered also as an application for licenses authorizing other activities for which licenses are prescribed by Chapter 3748. of the Revised Code and the rules promulgated thereunder, provided that the application specifies the additional activities for which licenses are requested and complies with requirements of the director as to applications for such licenses.

(E) Each application for a specific license will be accompanied by the fee prescribed in rule 3701:1-38-02 of the Administrative Code.

(F) Information provided by a licensee or applicant for a license or license renewal that constitutes a "trade secret" as defined in section 1333.61 of the Revised Code is not subject to public disclosure in accordance with sections 1333.61 to 1333.69 of the Revised Code.

(G) As provided by rule 3701:1-43-13 of the Administrative Code, certain applications for specific licenses filed under Chapter 3701:1-43 of the Administrative Code will contain a proposed decommissioning funding plan or a certification of financial assurance for decommissioning.

(H) An application for a license to receive and possess TENORM for the conduct of any activity which the director has determined pursuant to rule 3701:1-40-30 of the Administrative Code, could potentially affect the quality of the environment will be filed at least nine months prior to commencement of construction of the plant or facility in which the activity will be conducted and will be accompanied by any environmental report prescribed pursuant to rule 3701:1-40-30 of the Administrative Code.

Last updated May 15, 2023 at 1:06 AM

History

• Effective: May 15, 2023
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-43-13

Each licensee or applicant for a license subject to the requirements of rule 3701:1-43-10 of the Administrative Code will post with the director, financial assurance, or security, to ensure the protection of the public health and safety and the environment in the event of abandonment, default, or other inability or unwillingness of the licensee to meet the requirements of Chapter 3748. of the Revised Code. Financial assurance arrangements will:

(A) Consist of financial assurance for decommissioning, either by a decommissioning funding plan or certification of financial assurance, provided by the licensee and approved by the director prior to the issuance of the license and provided by one or more of the following methods:

(1) Prepayment by depositing into an account segregated from licensee assets and outside the licensee's administrative control, cash or liquid assets such that the amount of funds will be sufficient to pay decommissioning costs. Prepayment may be in the form of a trust, escrow account, government fund, certificate of deposit, or deposit of government securities.

(2) Surety, insurance, or other method in accordance with paragraph (F) of rule 3701:1-40-17 of the Administrative Code, that guarantees that decommissioning costs will be paid. A surety method may be in the form of a surety bond, letter of credit, or line of credit. A guarantee by the applicant or licensee will not be used in combination with any other financial methods used to satisfy the requirements of this paragraph or in any situation where the applicant or licensee has a parent company holding majority control of the voting stock of the company.

(3) A parent company guarantee of funds for decommissioning costs based on a financial test may be used provided that the parent company meets the requirements specified in appendix B to rule 3701:1-40-17 of the Administrative Code. A parent company guarantee will not be used in combination with other financial methods to satisfy the requirements of this rule.

(4) For commercial corporations that issue bonds, a guarantee of funds by the applicant or licensee for decommissioning costs based on a financial test may be used provided that the guarantee meets the requirements of appendix C to rule 3701:1-40-17 of the Administrative Code.

(5) For commercial companies that do not issue bonds, a guarantee of funds for decommissioning costs may be used provided that the guarantee meets the requirements of appendix D to rule 3701:1-40-17 of the Administrative Code.

(6) For nonprofit colleges, universities, hospitals, or research and development entities, a guarantee of funds for decommissioning costs may be used provided that the guarantee meets the requirements of appendix E to rule 3701:1-40-17 of the Administrative Code. The director may need proof of nonprofit status.

(7) An external sinking fund in which deposits are made at least annually, coupled with a surety method or insurance, the value of which may decrease by the amount being accumulated in the sinking fund. An external sinking fund is a fund established and maintained by setting aside funds periodically in an account segregated from licensee assets and outside the licensee's administrative control in which the total amount of funds would be sufficient to pay decommissioning costs at the time termination of operation is expected. An external sinking fund may be in the form of a trust, escrow account, government fund, certificate of deposit, or deposit of government securities. The surety or insurance provisions will be as stated in paragraph (A)(2) of this rule.

(8) In the case of state or local government licensee, a statement of intent containing a cost estimate for decommissioning or an amount specified in paragraphs (C)(1) to (C)(3) of rule 3701:1-40-17 of the Administrative Code, and indicating that funds for decommissioning will be obtained when necessary. As used in this rule, "state or local government licensee" does not include government owned or assisted colleges, universities or hospitals.

(B) Each decommissioning funding plan will contain a cost estimate for decommissioning and a description of the method of assuring funds for decommissioning in accordance with paragraph (A) of this rule, including the means for adjusting cost estimates and associated funding levels at each renewal over the life of the facility. The decommissioning funding plan will also contain a certification by the licensee that financial assurance for decommissioning has been provided in the amount of the cost estimate for decommissioning and a signed original of the financial instrument obtained to satisfy the requirements of paragraph (A) of this rule.

(C) Be established prior to issuance of the license or the commencement of operations to assure that sufficient funds will be available to carry out the decontamination and decommissioning of the facility;

(D) Be continuous for the duration of the license and for a period coincident with the applicant or licensee's responsibility under Chapter 3748. of the Revised Code and the rules promulgated thereunder; and

(E) Be available in Ohio subject to judicial process and execution in the event needed for the purposes set forth.

Last updated May 15, 2023 at 1:06 AM

History

• Effective: May 15, 2023
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-40-30

(A) The department shall require an environmental report to be submitted with the license application and a bureau assessment report following the department review of the environmental report in the case of any of the following:

(1) The applicant proposes a major action that could potentially affect the environment as it relates to human health;

(2) Any other action which the director determines is a major action which could potentially affect the environment as it relates to human health;

(3) The applicant applies for a license to possess and use source material for uranium milling or production of uranium hexafluoride pursuant to Chapter 3701:1-44 of the Administrative Code;

(4) The applicant applies for a license or renewal authorizing receipt and disposal of radioactive waste from other persons pursuant to Chapter 3701:1-54 of the Administrative Code.

(5) The applicant applies for a license amendment pursuant to Chapter 3701:1-54 of the Administrative Code authorizing either of the following:

(a) Closure of a land disposal site; or

(b) Transfer of the license to the disposal site owner for the purpose of institutional control; or

(6) Notwithstanding paragraph (C) of this rule, and in accordance with paragraph (B) of this rule, the department may, in special circumstances, require the preparation of an environmental report and bureau assessment report on an action that is listed as a categorical exclusion.

(B) Except in special circumstances as determined by the director at his or her discretion, an environmental report and bureau assessment report is not required in the case of an action included in the list of categorical exclusions set forth in paragraph (C) of this rule. Notwithstanding paragraph (C) of this rule, the director, at his or her discretion, may require an environmental report and bureau assessment report if he or she determines that special circumstances exist because the proposed action involves an unreasonable or unnecessary individual or cumulative risk to the human environment.

(C) The following categories of actions are considered categorical exclusions:

(1) Issuance of an amendment to a license for a radioactive material waste disposal site or an amendment to a radioactive materials license if required by Chapter 3701:1-54 of the Administrative Code which are administrative, organizational, or procedural in nature, or which result in a change in process operations or equipment, provided that:

(a) There is no significant change in the type or significant increase in the amount of any effluent that may be released offsite;

(b) There is no significant increase in individual or cumulative occupational radiation exposure;

(c) There is no significant construction impact; and

(d) There is no significant increase in the potential for or consequences from radiological accidents.

(2) Issuance, amendment or renewal of radioactive materials licenses issued pursuant to this chapter and Chapters 3701:1-44, 3701:1-46, 3701:1-48, 3701:1-49, 3701:1-52, 3701:1-56 and 3701:1-58 of the Administrative Code affecting general licenses, manufacture and distribution, industrial radiography, well logging, irradiators, medical use, source material, special nuclear material of less than critical mass authorizing the following:

(a) Distribution of radioactive materials and devices or products containing radioactive material to general licensees and to persons exempt from licensing;

(b) Distribution of radiopharmaceuticals, generators, reagent kits, or sealed sources to persons licensed in accordance with Chapter 3701:1-58 of the Administrative Code;

(c) Nuclear pharmacies;

(d) Medical and veterinary facilities;

(e) Use of radioactive materials for research and development and for educational purposes;

(f) Industrial radiography;

(g) Irradiators;

(h) Use of sealed sources or gauging devices, analytical instruments or other devices containing sealed sources;

(i) Use of uranium as shielding material in containers or devices;

(j) Possession of radioactive material incident to performing services such as installation, maintenance, leak tests and calibration;

(k) Use of sealed sources or radioactive tracers in well-logging procedures;

(l) Acceptance of packaged radioactive wastes from others for transfer to a licensed disposal facility, provided that the interim storage period for any package does not exceed one hundred eighty days and the total possession limit for all packages held in interim storage at the same time does not exceed 1.85 terabecquerels (fifty curies);

(m) Manufacturing or processing of source, radioactive, or special nuclear materials for distribution to other licensees, except processing of source material for extraction of rare earth and other metals and processing of radioactive material for extraction of metals;

(n) Nuclear laundries;

(o) Possession, manufacturing, processing, shipment, testing, or other use of depleted uranium military munitions; or

(p) Any use of source, radioactive, or special nuclear material not listed in paragraphs (C)(2)(a) to (C)(2)(o) of this rule which involves quantities and forms of source, radioactive, or special nuclear material of quantities less than a critical mass, similar to those listed in paragraphs (C)(2)(a) to (C)(2)(o) of this rule.

Last updated April 19, 2022 at 8:36 AM

History

• Effective: April 17, 2022
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-43-12 Terms and conditions of licenses.

(A) General terms and conditions of licenses include:

(1) Each license issued pursuant to the rules in Chapter 3701:1-43 of the Administrative Code shall be subject to all the provisions of Chapter 3748. of the Revised Code and the rules adopted thereunder, now or hereafter in effect, and to all rules, requirements, and orders of the director.

(2) No license issued or granted pursuant to the rules in Chapter 3701:1-43 of the Administrative Code shall be transferred, assigned, or in any manner disposed of, either voluntarily or involuntarily, directly or indirectly, through transfer of control of any license to any person, unless the director shall, after securing full information, find that the transfer is in accordance with the provisions of Chapter 3748. of the Revised Code and rules promulgated thereunder, and shall give consent in writing.

(3) Neither the license, nor any right under the license, shall be assigned or otherwise transferred in violation of the provisions of Chapter 3748. of the Revised Code and the rules adopted thereunder.

(4) Each person licensed by the director pursuant to the rules in Chapter 3701:1-43 of the Administrative Code shall confine his possession and use of TENORM to the locations and purposes authorized in the license. Except as otherwise provided in the license, a license issued pursuant to the rules in Chapter 3701:1-43 of the Administrative Code shall carry with it the right to receive, possess, and use TENORM. Preparation for shipment and transport of TENORM shall be in accordance with the provisions of Chapter 3701:1-50 of the Administrative Code.

(5) The director may incorporate in any license at the time of issuance, or thereafter, by appropriate rule, regulation or order, such additional requirements and conditions with respect to the licensee's receipt, possession, use, and transfer of TENORM subject to this chapter as it deems appropriate or necessary in order to:

(a) Protect health or to minimize danger to life or property;

(b) Require such reports and the keeping of such records, and to provide for such inspections of activities under the license as may be necessary or appropriate to effectuate the purposes of Chapter 3748. of the Revised Code and the rules adopted thereunder; and

(c) Prevent loss, theft, or loss of control of TENORM subject to this chapter.

(6)

(a) Each licensee shall notify the director by certified mail within ten business days of the commencement of a voluntary or involuntary bankruptcy petition that has been filed by or against:

(i) The licensee;

(ii) An entity, defined in this rule as person, estate, trust, governmental unit, and United States trustee, controlling the licensee or listing the license or licensee as property of the estate; or

(iii) An affiliate of the licensee, defined in this rule as an entity that directly or indirectly owns, controls, or holds with power to vote, twenty per cent or more of the outstanding voting securities of the debtor, other than an entity that holds such securities:

(a) In a fiduciary or agency capacity without sole discretionary power to vote such securities; or

(b) Solely to secure a debt, if such entity has not in fact exercised such power to vote.

(b) This notification must indicate:

(i) The bankruptcy court in which the petition for bankruptcy was filed; and

(ii) The date of the filing of the petition.

(7) Each licensee shall notify the director in writing prior to commencing activities to reclaim the licensed facility and site.

(8) When a licensee has permanently ceased use of radioactive materials at a site or portion of a facility and the licensee has not decontaminated the area, or when an area has not been used for a period of two years, the licensee shall, within sixty days, provide the following information in writing to the director:

(a) The location of the facility, site, or area;

(b) The plan for reclaiming or decontaminating the facility, site or area; and

(c) An evaluation of any changes to the financial assurance submitted in accordance with rule 3701:1-43-13 of the Administrative Code.

(9) For temporary jobsites:

(a) When temporary jobsites are authorized on a specific license, TENORM may be used at temporary jobsites throughout the state of Ohio in accordance with the reciprocal recognition provisions of rule 3701:1-43-19 of the Administrative Code, in areas not under exclusive federal jurisdiction.

(b) Before TENORM can be used at a temporary jobsite at any federal facility within the state of Ohio, the jurisdictional status of the jobsite shall be determined as it pertains to the TENORM. Authorization for use of TENORM at jobsites under exclusive federal jurisdiction shall be obtained from the applicable federal agency.

(B) Each person licensed under rule 3701:1-43-10 of the Administrative Code shall:

(1) Carry out adequate control procedures in the manufacture of the product to assure that each production lot meets the quality control standards approved by the director;

(2) Label or mark each unit so that the manufacturer, processor, producer, or initial transferor of the product and the TENORM in the product can be identified; and

(3) Maintain records identifying, by name and address, each person to whom TENORM is transferred for use under paragraph (B) of rule 3701:1-43-07 of the Administrative Code, or the equivalent regulations of another licensing state, and stating the kinds, quantities, and uses of TENORM transferred. An annual summary report stating the total quantity of each radionuclide transferred under the specific license shall be filed with the director. Each report shall cover the year ending December thirty-first, and shall be filed within ninety days thereafter. If no transfers of TENORM have been made pursuant to paragraph (C) of rule 3701:1-43-10 of the Administrative Code during the reporting period, the report shall so indicate.

Last updated May 15, 2023 at 1:06 AM

History

• Effective: May 15, 2023
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-43-19

(A) Any person who holds a specific license from another state, issued by the department having jurisdiction where the licensee maintains an office for directing the licensed activity and at which radiation safety records are normally maintained, will be granted reciprocity in the state of Ohio to conduct the same licensed activity provided that:

(1) The reciprocity form is current;

(2) The person has not violated Chapter 3748. of the Revised Code or the rules adopted thereunder;

(3) The person applies for reciprocity as outlined in this rule;

(4) The person notifies the director at least three days in advance of each entry into the state after the reciprocity agreement has been granted unless all dates and locations are specified within the agreement document; and

(5) There is no permanent location in Ohio requiring a specific license for radioactive materials.

(B) The person will not transfer or dispose of TENORM possessed or used under the reciprocity agreement provided in paragraph (A) of this rule except by transfer to a person:

(1) Specifically licensed by the director or by another licensing state to receive such TENORM; or

(2) Exempt from the requirements for a license for such TENORM under rule 3701:1-43-07 of the Administrative Code.

(C) A person applying for reciprocity in the state of Ohio as specified in paragraph (A) of this rule will do the following:

(1) At least three days prior to engaging in each activity for the first time in a calendar year, the person will submit on a form provided by the director, an application for reciprocity to conduct the activity in the state of Ohio, a copy of his or her state specific license, and the appropriate fee as prescribed in rule 3701:1-38-02 of the Administrative Code. If the person, due to an emergency, is unable to file the submittal three days before engaging in activities under reciprocity, the director may waive the three-day time requirement provided that the licensee:

(a) Informs the director by telephone or facsimile of the information provided on the reciprocity application;

(b) Receives oral or written authorization for the activity from the director; and

(c) Within three days after the notification, files the reciprocity application form, a copy of the state license, and the appropriate fee.

(2) The person will file an amended reciprocity form with the appropriate fee with the director to request approval for changes in work locations, radioactive material, or work activities different from the information contained on the initial reciprocity application.

(D) An Ohio reciprocity agreement will expire on the last day of December of the same year that the reciprocity agreement was issued.

(E) A licensee that is engaging in activities authorized by an Ohio reciprocity agreement will comply with all terms and conditions of the specific license for which Ohio reciprocity was issued, except for such terms or conditions as are contrary to the requirements of this rule.

(F) No person will engage in the activities authorized by an Ohio reciprocity agreement for more than one hundred eighty days in any calendar year.

Last updated May 15, 2023 at 1:06 AM

History

• Effective: May 15, 2023
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-40-17

(A) Prior to the director issuing a radioactive materials license:

(1) Each applicant for a specific license or license renewal authorizing the possession and use of unsealed radioactive material of half-life greater than one hundred twenty days and in quantities exceeding ten thousand times the applicable quantities set forth in appendix A to this rule shall submit a decommissioning funding plan as described in paragraph (D) of this rule. The decommissioning funding plan must also be submitted when a combination of radionuclides is involved if R divided by ten thousand is greater than one, where R is defined here as the sum of the ratios of the quantity of each radionuclide to the applicable value in appendix A to this rule.

(2) Each applicant for a specific license or license renewal authorizing the possession and use of sealed sources or plated foils of half-life greater than one hundred twenty days and in quantities exceeding one trillion times the applicable quantities of appendix A to this rule, shall submit a decommissioning funding plan as described in paragraph (D) of this rule. The decommissioning funding plan must also be submitted when a combination of radionuclides is involved if R divided by one trillion is greater than one, where R is defined here as the sum of the ratios of the quantity of each radionuclide to the applicable value in appendix A to this rule.

(B) Prior to the director issuing a radioactive materials license, each applicant for a specific license or license renewal authorizing possession and use of radioactive material of half-life greater than one hundred twenty days and in quantities specified in paragraph (C) of this rule shall either:

(1) Submit a decommissioning funding plan as described in paragraph (D) of this rule; or

(2) Submit a certification that financial assurance for decommissioning has been provided in the amount prescribed by paragraph (C) of this rule using one of the methods described in paragraph (E) of this rule. The applicant shall submit to the director, as part of the certification, a signed original of the financial instrument obtained to satisfy the requirements of paragraph (E) of this rule.

(C) Prior to the director issuing a radioactive materials license, an applicant providing certification of financial assurance for decommissioning as specified in paragraph (B)(2) of this rule shall provide the certification in a monetary amount based upon the quantity of licensed material specified as follows:

(1) Greater than one thousand but less than or equal to ten thousand times the applicable quantities of appendix A to this rule in unsealed form. For a combination of radionuclides, if R, as defined in paragraph (A) of this rule, divided by one thousand is greater than one but R divided by ten thousand is less than or equal to one, the sum of three hundred thousand dollars.

(2) Greater than ten billion but less than one trillion times the applicable quantities of appendix A to this rule in sealed sources or plated foils. For a combination of radionuclides, if R, as defined in paragraph (A) of this rule, divided by ten billion is greater than one but R divided by one trillion is less than or equal to one, the sum of one hundred fifty thousand dollars.

(D) .

(1) Each decommissioning funding plan must be submitted for review and approval and must contain:

(a) A detailed cost estimate for decommissioning, in an amount reflecting:

(i) The cost of an independent contractor to perform all decommissioning activities;

(ii) The cost of meeting the criteria specified in paragraph (B) of rule 3701:1-38-22 of the Administrative Code for unrestricted use, provided that, if the applicant or licensee can demonstrate its ability to meet the provisions of paragraph (D) of rule 3701:1-38-22 of the Administrative Code, the cost estimate may be based on meeting this criteria;

(iii) The volume of onsite subsurface material containing residual radioactivity that will require remediation to meet the criteria for license termination; and

(iv) An adequate contingency factor.

(b) Identification of and justification for using the key assumptions contained in the decommissioning cost estimate;

(c) A description of the method of assuring funds for decommissioning from paragraph (E) of this rule, including means for adjusting cost estimates and associated funding levels periodically over the life of the facility;

(d) A certification by the licensee that financial assurance for decommissioning has been provided in the amount of the cost estimate for decommissioning; and

(e) A signed original of the financial instrument obtained to satisfy the requirements of paragraph (E) of this rule (unless a previously submitted and accepted financial instrument continues to cover the cost estimate for decommissioning).

(2) At the time of license renewal and at intervals not to exceed three years, the decommissioning funding plan must be resubmitted with adjustments as necessary to account for the changes in costs and the extent of contamination. If the amount of financial assurance will be adjusted downward, this cannot be done until the updated decommissioning funding plan is approved. The decommissioning funding plan must update the information submitted with the original or prior approved plan, and must specifically consider the effect of the following events on decommissioning costs:

(a) Spills of radioactive material producing additional residual radioactivity in onsite subsurface material;

(b) Waste inventory increasing above the amount previously estimated;

(c) Waste disposal costs increasing above the amount previously estimated;

(d) Facility modifications;

(e) Changes in authorized possession limits;

(f) Actual remediation costs that exceed the previous cost estimate;

(g) Onsite disposal; and

(h) Use of a settling pond.

(E) Financial assurance for decommissioning, either by a decommissioning funding plan or certification of financial assurance, shall be provided by the licensee and approved by the director prior to the issuance of the license and shall be provided by one or more of the following methods:

(1) Prepayment by depositing into an account segregated from licensee assets and outside the licensee's administrative control, cash or liquid assets such that the amount of funds will be sufficient to pay decommissioning costs. Prepayment may be in the form of a trust, escrow account, government fund, certificate of deposit, or deposit of government securities.

(2) Surety, insurance, or other method in accordance with paragraph (F) of this rule, that guarantees that decommissioning costs will be paid. A surety method may be in the form of a surety bond, letter of credit, or line of credit. A guarantee by the applicant or licensee may not be used in combination with any other financial methods used to satisfy the requirements of this paragraph or in any situation where the applicant or licensee has a parent company holding majority control of the voting stock of the company.

(3) A parent company guarantee of funds for decommissioning costs based on a financial test may be used provided that the parent company meets the requirements specified in appendix B of this rule. A parent company guarantee may not be used in combination with other financial methods to satisfy the requirements of this rule.

(4) For commercial corporations that issue bonds, a guarantee of funds by the applicant or licensee for decommissioning costs based on a financial test may be used provided that the guarantee meets the requirements of appendix C to this rule.

(5) For commercial companies that do not issue bonds, a guarantee of funds for decommissioning costs may be used provided that the guarantee meets the requirements of appendix D to this rule.

(6) For nonprofit colleges, universities, hospitals, or research and development entities, a guarantee of funds for decommissioning costs may be used provided that the guarantee meets the requirements of appendix E to this rule. The director may require proof of nonprofit status.

(7) An external sinking fund in which deposits are made at least annually, coupled with a surety method or insurance, the value of which may decrease by the amount being accumulated in the sinking fund. An external sinking fund is a fund established and maintained by setting aside funds periodically in an account segregated from licensee assets and outside the licensee's administrative control in which the total amount of funds would be sufficient to pay decommissioning costs at the time termination of operation is expected. An external sinking fund may be in the form of a trust, escrow account, government fund, certificate of deposit, or deposit of government securities. The surety or insurance provisions must be as stated in paragraph (F) of this rule.

(8) In the case of state or local government licensee, a statement of intent containing a cost estimate for decommissioning or an amount specified in paragraphs (C)(1) to (C)(2) of this rule, and indicating that funds for decommissioning will be obtained when necessary. As used in this rule, "state or local government licensee" does not include government owned or assisted colleges, universities or hospitals.

(F) Any surety method or insurance used to provide financial assurance for decommissioning shall be in the form of instruments that contain language as provided in appendix F to this rule, and shall contain the following conditions:

(1) The surety method or insurance must be open-ended or, if written for a specified term, such as five years, must be renewed automatically unless ninety days or more prior to the renewal date, the issuer notifies the director, the beneficiary, and the licensee of its intention not to renew. The surety method or insurance must also provide that the full face amount be paid to the beneficiary automatically prior to the expiration without proof of forfeiture if the licensee fails to provide a replacement acceptable to the director within thirty days after receipt of notification of cancellation.

(2) The surety method or insurance must be payable to a trust established for decommissioning costs. The trustee and trust must be acceptable to the director. An acceptable trustee includes an appropriate state or federal government agency or an entity which has the authority to act as a trustee and whose trust operations are regulated and examined by a federal or state agency.

(3) The surety method or insurance must remain in effect until the director has terminated the license.

(4) The surety company issuing the bond must, at a minimum, be among those listed as acceptable in the "Circular 570" of the United States department of the treasury (as in effect on the effective date of this rule).

(G) A licensee must notify the director by certified mail within ten business days of the commencement of a voluntary or involuntary bankruptcy proceeding under Title 11 of the United States Code (as amended April 20, 2005). A licensee who fulfills the financial assurance requirements by obtaining a trust fund, surety bond, or other acceptable financial assurance will be deemed to be without the required financial assurance or liability coverage in the event of bankruptcy of the trustee or issuing institution, or a suspension or revocation of the authority of the trustee institution issuing the instrument. The licensee shall establish other financial assurance within sixty days after such an event.

(H) Financial assurance for decommissioning, either by a decommissioning funding plan or certification of financial assurance, that is provided by a contract of insurance shall not include any arrangement that constitutes self-insurance. As used in this rule:

(1) "Insurance" means a contract issued or underwritten by an insurance company, insurance service, or insurance organization which is licensed to engage in the business of insurance in Ohio, that binds the insurer to indemnify another against a specified loss in return for premiums paid.

(2) "Self insurance" means a contract of insurance issued either by the licensee or by an insurer affiliated with or an affiliate of the licensee.

(3) "Affiliate of" or "affiliated with" means that the licensee, either directly or indirectly, through one or more intermediaries or subsidiaries, controls, is controlled by, or is under common control with the insurer.

(4) "Control", including "controlled by", and "under common control with" means the possession, direct or indirect, of the power to direct or cause the direction of the management and policies of a person, whether through the ownership of voting securities, by contract, proxy, membership on the board, or otherwise.

(I) Each person licensed under this chapter, and rule 3701:1-38-02 of the Administrative Code as well as chapters containing rules regarding manufacturing and distribution (Chapter 3701:1-46 of the Administrative Code), industrial radiography (Chapter 3701:1-48 of the Administrative Code), well logging Chapter 3701:1-49 of the Administrative Code), irradiators (Chapter 3701:1-52 of the Administrative Code), and medical use (Chapter 3701:1-58 of the Administrative Code) promulgated pursuant to Chapter 3748. of the Revised Code shall keep records of information important to the decommissioning of a facility in an identified location until the site is released for unrestricted use. Before licensed activities are transferred or assigned in accordance with paragraph (B) of rule 3701:1-40-20 of the Administrative Code, a licensee shall transfer all records described in this paragraph to the new licensee, which will be responsible for maintaining these records until the license is terminated. If records important to the decommissioning of a facility are kept for other purposes, reference to these records and their locations may be used. As used in this rule, "information important to the decommissioning of a facility" includes the following:

(1) Records of spills or other unusual occurrences involving the spread of contamination in and around the facility, equipment, or site. These records may be limited to instances when contamination remains after any cleanup procedures or when there is reasonable likelihood that contaminants may have spread to inaccessible areas as in the case of possible seepage into porous materials such as concrete. These records must include any known information on identification of involved radionuclides, quantities, forms, and concentrations.

(2) As-built drawings and modifications of structures and equipment in restricted areas where radioactive materials are used or stored, and of locations of possible inaccessible contamination such as buried pipes which may be subject to contamination. If required drawings are referenced, each relevant document need not be indexed individually. If drawings are not available, the licensee shall substitute appropriate records of available information concerning these areas and locations.

(3) Except in the case of an area that contains only a sealed source, provided the source has not leaked or no contamination remains after any leak, or in the case of a byproduct or accelerator produced material having only a half-life of less than sixty-five days, a list contained in a single document and updated every two years, of the following:

(a) All areas designated and formerly designated restricted areas as defined in rule 3701:1-38-01 of the Administrative Code.

(b) All areas outside of restricted areas that require documentation under paragraph (I)(1) of this rule.

(c) All areas outside of restricted areas where current and previous wastes have been buried as documented under rule 3701:1-38-20 of the Administrative Code; and

(d) All areas outside of restricted areas that contain material such that, if the license expired, the licensee would be required to either decontaminate the area to meet the criteria for decommissioning in rule 3701:1-38-22 of the Administrative Code, or apply for approval for disposal under rule 3701:1-38-19 of the Administrative Code.

(4) Records of the cost estimate performed for the decommissioning funding plan or of the amount certified for decommissioning, and records of the funding method used for assuring funds if either a funding plan or certification is used.

View AppendixView AppendixView AppendixView AppendixView AppendixView Appendix

Last updated April 19, 2022 at 8:35 AM

History

• Effective: April 17, 2022
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-43-14 Expiration and termination of specific licenses and decommissioning of sites and separate buildings or outdoor areas.

(A) Each specific license expires at the end of the day on the expiration date stated in the license unless the licensee has filed an application for renewal under rule 3701:1-38-02 of the Administrative Code not less than ninety days before the expiration date stated in the existing license. If an application for renewal has been filed at least ninety days before the expiration date stated in the existing license, the existing license expires at the end of the day on which the director makes a final determination to deny the renewal application or, if the determination states an expiration date, the expiration date stated in the determination.

(B) Each specific license revoked by the director expires at the end of the day on the date of the director's final determination to revoke the license, or on the expiration date stated in the determination, or as otherwise provided by director order.

(C) Each specific license will continue in effect and will be renewed during the decommissioning period until the director notifies the licensee in writing after decommissioning that the license is terminated. During this time, the licensee will:

(1) Limit actions involving TENORM to those related to decommissioning; and

(2) Continue to control entry to any restricted area until that area is suitable for release in accordance with director requirements as may be imposed by Chapter 3748. of the Revised Code or rules adopted thereunder.

(D) A licensee will provide written notice to the director within sixty days of the occurrence of any of the following, in accordance with rule 3701:1-43-04 of the Administrative Code:

(1) The license has expired;

(2) The licensee has decided to permanently cease licensed activities at the entire site or in any separate building, room, or outdoor area that is unsuitable for release in accordance with the definition of "decommissioning" in Chapter 3748. of the Revised Code and the regulations for decommissioning in rule 3701:1-38-22 of the Administrative Code;

(3) No licensed activities have been conducted for a period of twenty-four months; or

(4) No licensed activities have been conducted for a period of twenty-four months in any separate building, room, or outdoor area that contains residual radioactivity such that the building, room, or outdoor area is unsuitable for release in accordance with Chapter 3748. of the Revised Code and the rule adopted thereunder.

(E) In the event of an occurrence as set forth in paragraph (D) of this rule, the licensee will either:

(1) Begin decommissioning the site, and any separate building, room or outdoor area that contains residual radioactivity so that the site, building, room and outdoor area are suitable for release in accordance with Chapter 3748. of the Revised Code and the rules adopted thereunder; or

(2) If prescribed by paragraph (H)(1) of this rule, submit within twelve months of notification, a decommissioning plan and begin decommissioning upon the director's approval of that plan.

(F) In addition to written notification of an occurrence, the licensee will maintain all decommissioning financial assurances established by the licensee pursuant to rule 3701:1-43-12 of the Administrative Code in conjunction with a license issuance or renewal or as prescribed by this rule.

(G) The director may grant a request to extend the twelve-month time period to submit a decommissioning plan established in paragraph (E)(2) of this rule provided that the director determines that the alternative schedule is necessary to the effective conduct of decommissioning operations and that the extension is not detrimental to the public health and safety or the environment and is otherwise in the public interest. The extension request will be submitted no later than thirty days after the occurrence for which notification is prescribed. Decommissioning set forth in paragraph (E)(2) of this rule will not commence until the director has made a determination on the extension request.

(H) The licensee will submit a decommissioning plan to the director prior to commencing any decommissioning in the following cases:

(1) If prescribed by license condition; or

(2) If the procedures and activities necessary to carry out decommissioning of the site or separate building, room, or outdoor area have not been previously approved by the director and these procedures could increase potential health and safety risk to workers or to the public, such as in any of the following cases:

(a) Decommissioning procedures would involve techniques not applied routinely during cleanup or maintenance operations;

(b) Workers would be entering areas not normally occupied where surface contamination and radiation levels are significantly higher than routinely encountered during operation; or

(c) Decommissioning procedures could result in significantly greater releases of radioactive material to the environment than those associated with operation.

(I) A proposed decommissioning plan for a site or separate building, room or outdoor area will include the following:

(1) A description of the conditions of the site or separate building, room or outdoor area sufficient to evaluate the acceptability of the plan;

(2) A description of planned decommissioning activities;

(3) A description of methods used to ensure protection of workers and the environment against radiation hazards during decommissioning;

(4) A description of the planned final radiation survey;

(5) An updated detailed cost estimate for decommissioning, comparison of that estimate with present funds set aside for decommissioning, and a plan for assuring the availability of adequate funds for completion of decommissioning; and

(6) In the case of a decommissioning plan that results in the licensee completing decommissioning later than twenty-four months after plan approval, the plan will include a justification for the delay based on the criteria in paragraph (K) of this rule. The proposed decommissioning plan will be approved by the director if the information therein demonstrates compliance with Chapter 3748. of the Revised Code and the rules adopted thereunder, that the decommissioning will be completed as soon as practicable, and that the health and safety of workers and the public will be adequately protected.

(J) Except as provided in paragraph (K) of this rule, a licensee will:

(1) Complete decommissioning of the site or separate building or outdoor area as soon as practicable but no later than twenty-four months following the initiation of decommissioning; and

(2) When decommissioning involves the entire site, the licensee will request license termination as soon as practicable but no later than twenty-four months following the initiation of decommissioning, unless the decommissioning is still actively in progress.

(K) The director may approve a request for an alternative schedule for completion of decommissioning and license termination. In considering whether an alternative schedule is warranted, the director will consider the following:

(1) Whether it is technically feasible to complete decommissioning within a twenty-four month period;

(2) Whether sufficient waste disposal capacity is available to allow completion of decommissioning within a twenty-four month period;

(3) Whether a significant volume reduction in wastes requiring disposal will be achieved by allowing short-lived radionuclides to decay;

(4) Whether a significant reduction in radiation exposure to workers can be achieved by allowing short-lived radionuclides to decay; and

(5) Any other factor that the director finds is unique to the site, such as the regulatory requirements of other government agencies, lawsuits, groundwater treatment activities, monitored natural groundwater restoration, actions that could result in more environmental harm than deferred cleanup, and other factors beyond the control of the licensee.

(L) After decommissioning the site, the licensee will:

(1) Certify the disposition of all licensed material, including accumulated wastes, by submitting a completed form HEA 5119, disposition of radioactive materials, provided by the director; and

(2) Conduct a radiation survey of the premises where the licensed activities were carried out and submit a report of the results of this survey, unless the licensee demonstrates in some other manner that the premises are suitable for release in accordance with the criteria for decommissioning set forth in rules promulgated pursuant to Chapter 3748. of the Revised Code. The licensee will survey and report as follows:

(a) Levels of gamma radiation expressed in the SI unit of sieverts or in the special unit of rem, or their multiples, per unit of time at one meter from surfaces;

(b) Levels of removable and fixed surface radioactive contamination, including alpha and beta, expressed in the SI unit of becquerels, disintegrations per minute, or in the special unit of curies, or their multiples, per one hundred square centimeters;

(c) Levels of volumetric radioactive contamination as follows:

(i) For water, results should be expressed in the SI unit of becquerels, disintegrations per minute, or in the special unit of or curies, or their multiples, per milliliter of water; and

(ii) For solids such as soils or concrete, results should be expressed in the SI unit of becquerels, disintegrations per minute, or in the special unit of or curies, or their multiples, per gram; and

(d) Identification of any survey instrument used and a certification that each instrument was properly calibrated and tested prior to being used to measure radioactivity at the site.

(M) Specific licenses, including expired licenses, will be terminated by written notice to the licensee when the director determines that:

(1) TENORM has been properly disposed;

(2) Reasonable effort has been made to eliminate residual radioactive contamination, if present;

(3) A radiation survey has been performed which demonstrates that the premises are suitable for release in accordance with the criteria for decommissioning, or other information is submitted by the licensee that is sufficient to demonstrate that the premises are suitable for release in accordance with the criteria for decommissioning in this chapter and rule 3701:1-38-22 of the Administrative Code adopter pursuant to Chapter 3748. of the Revised Code; and

(4) All applicable fees have been paid.

Last updated May 15, 2023 at 1:06 AM

History

• Effective: May 15, 2023
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-38-22

(A) This rule applies to the decommissioning of facilities licensed under Chapter 3748. of the Revised Code. For low-level waste disposal facilities, this rule applies only to ancillary surface facilities that support radioactive waste disposal activities. This rule does not apply to uranium and thorium recovery facilities already subject to source material licensing requirements in Chapter 3701:1-44 of the Administrative Code or to uranium solution extraction facilities.

(B) Decommissioning with license termination shall be limited to sites considered acceptable for unrestricted release where the residual radioactivity that is distinguishable from background radiation results in a total effective dose equivalent (TEDE) to an average member of the critical group that does not exceed 0.25 millisievert (twenty-five millirem) per year, including that from groundwater sources of drinking water, and the residual radioactivity has been reduced to levels that are as low as reasonably achievable (ALARA). Determination of the levels which are ALARA must take into account consideration of detriments, such as deaths from transportation accidents, expected to potentially result from decontamination and waste disposal.

(C) After a facility has been decommissioned and the license terminated in accordance with the criteria in this rule, the director will require additional cleanup only if, based on new information, it is determined that the criteria of this rule were not met and residual radioactivity remaining at the site could result in a significant threat to public health and safety. When calculating TEDE to the average member of the critical group the licensee shall determine the peak annual TEDE dose expected within the first one thousand years after decommissioning.

(D) A licensee may decommission a facility and maintain a decommissioning possession only license using alternate criteria greater than the dose criterion specified in paragraph (B) of this rule, provided that the licensee:

(1) Provides assurance that public health and safety would continue to be protected, and that it is unlikely that the dose from all man-made sources combined, other than medical, would be more than the one millisievert (one hundred millirem) per year limit set forth in this chapter, by submitting an analysis of possible sources of exposure;

(2) Has employed, to the extent practicable, restrictions on site use in minimizing exposures at the site;

(3) Reduces doses to ALARA levels, taking into consideration any detriments, such as traffic accidents expected to potentially result from decontamination and waste disposal; and

(4) Has submitted a decommissioning plan or license termination plan (LTP) to the director indicating the licensee's intent to decommission in accordance with rule 3701:1-40-18 of the Administrative Code, and specifying that the licensee proposes to decommission by restricting use of the site. The licensee shall document in the decommissioning plan or LTP how the advice of individuals and institutions in the community who may be affected by the decommissioning has been sought and incorporated, as appropriate, following analysis of that advice. In seeking such advice, the licensee shall provide for:

(a) Participation by representatives of a broad cross section of community interests who may be affected by the decommissioning;

(b) An opportunity for a comprehensive, collective discussion on the issues by the participants represented; and

(c) A publicly available summary of the results of all such discussions, including a description of the individual viewpoints of the participants on the issues and the extent of agreement and disagreement among the participants on the issues.

(5) Has provided sufficient financial assurance in the form of a trust fund to enable an independent third party, including a governmental custodian of a site, to assume and carry out responsibilities for any necessary control and maintenance of the site.

(E) When a decommissioning with restrictions is proposed by a licensee, a decommissioning possession only license is required to assure that the provisions of the decommissioning plan as approved by the director remain effective. The license will contain a condition that the director will not require further cleanup unless he or she determines that the criteria of this rule or terms of the license were not met or that residual radioactivity at the site could result in a significant threat to public health and safety.

(F) Any facility that has been decommissioned and has had the United States nuclear regulatory commission license terminated in accordance with a plan approved by the commission on or before August 31, 1999, will not be required to obtain a license or conduct further cleanup unless the director determines that residual radioactivity at the site could result in a significant threat to the public health and safety.

(G) Applicants for licenses, other than renewals, shall describe in the application how facility design and procedures for operation will minimize, to the extent practical, contamination of the facility and the environment, facilitate eventual decommissioning, and minimize, to the extent practical, the generation of radioactive waste.

(H) Licensees shall, to the extent practical, conduct operations to minimize the introduction of residual radioactivity into the site, including the subsurface, in accordance with the existing radiation protection requirements in rule 3701:1-38-11 of the Administrative Code and radiological criteria for license termination in accordance with this rule.

Last updated November 2, 2022 at 2:10 PM

History

• Effective: August 30, 2015
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-43-16 Reporting requirements.

(A) Except as provided in paragraph (D) of this rule, each licensee shall notify the director as soon as possible, but not later than four hours after the discovery of an event that prevents immediate protective action necessary to avoid exposure to radiation or radioactive material that could exceed regulatory limits, or a release of licensed material that could exceed regulatory limits. An event that requires such an immediate report may include a fire, explosion, or toxic gas release.

(B) Each licensee shall notify the director within twenty-four hours after the discovery of any of the following events involving licensed material:

(1) An unplanned contamination event that involves:

(a) Access to the contaminated area, by workers or the public, to be restricted for more than twenty-four hours by imposing additional radiological controls or by prohibiting entry into the area;

(b) A quantity of material greater than five times the lowest annual limit on intake specified in the appendices to rule 3701:1-38-12 of the Administrative Code; and

(c) Access to the area restricted for a reason other than to allow radionuclides with a half-life of less than twenty-four hours to decay prior to decontamination;

(2) An event in which equipment is disabled or fails to function as designed when:

(a) The equipment is required by regulation or license condition to prevent a release exceeding regulatory limits, to prevent exposure to radiation or radioactive material exceeding regulatory limits, or to mitigate the consequences of an accident;

(b) The equipment is required to be available and operable when it is disabled or fails to function; and

(c) No redundant equipment is available and operable to perform the required safety function;

(3) An event that requires unplanned medical treatment of an individual with spreadable radioactive contamination on the individual's clothing or body; and

(4) An unplanned fire or explosion damaging any licensed material or any device, container, or equipment containing licensed material when:

(a) The quantity of material involved is greater than five times the lowest annual limit on intake specified in the appendices to rule 3701:1-38-12 of the Administrative Code; and

(b) The damage affects the integrity of the licensed material or its container.

(C) The licensee shall prepare and submit a report in response to the requirements of this rule as follows:

(1) Licensees shall make reports required by paragraphs (A) and (B) of this rule by telephone, to the director at the telephone number listed in the notice to employees required by paragraph (A)(1)(e) of rule 3701:1-38-10 of the Administrative Code. To the extent that the information is available at the time of notification, the information provided in these reports must include:

(a) The caller's name and call back telephone number;

(b) A description of the event, including date and time;

(c) The exact location of the event;

(d) The radionuclides, quantities, and chemical and physical form of the licensed material involved; and

(e) Any personnel radiation exposure data available.

(2) Each licensee who makes a report required by paragraph (A) or (B) of this rule shall submit a written follow-up report within thirty days of the initial report. Written reports prepared pursuant to other regulations may be submitted to fulfill this requirement if the report contains all of the necessary information and the appropriate distribution is made. These written reports shall be sent to the director in the manner specified in rule 3701:1-43-04 of the Administrative Code. The report must include the following:

(a) A description of the event, including the probable cause and the manufacturer and model number, if applicable, of any equipment that failed or malfunctioned;

(b) The exact location of the event;

(c) The radionuclides, quantities, and chemical and physical form of the licensed material involved;

(d) Date and time of the event;

(e) Corrective actions taken or planned and the results of any evaluations or assessments; and

(f) The extent of exposure of individuals to radiation or to radioactive materials without identification of individuals by name.

(D) This rule applies to all licensees possessing material licensed under rule 3701:1-38-02 of the Administrative Code. This rule does not apply to material under a license subject to the notification requirements in 10 C.F.R. 50.72 (as in effect on the effective date of this rule).

(E) An applicant for a license or a licensee shall notify the director within two working days of information identified by the applicant or licensee as having for the regulated activity, an active adverse impact on equipment or personnel readily obvious by human observation or instrumentation, or a radiological impact on personnel or the environment in excess of regulatory limits. An applicant or licensee violates this paragraph only if the applicant or licensee fails to notify the director of information that the applicant or licensee has or should have identified.

Last updated May 15, 2023 at 1:06 AM

History

• Effective: May 15, 2023
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-38-10

(A) Posting of notices to workers.

(1) Each licensee or registrant shall post current copies of the following documents:

(a) All applicable rules promulgated pursuant to Chapters 3748. and 4773. of the Revised Code;

(b) The license or certificate of registration, including, any conditions or documents incorporated by reference into a license and amendments thereto;

(c) The safe operating procedures applicable to activities under the license or registration; and

(d) Any notice of violation involving radiological working conditions, proposed imposition of civil or administrative monetary penalty, or order issued pursuant to rule 3701:1-38-06 of the Administrative Code and any response from the licensee or registrant. Such document shall be posted within five working days after receipt of the document. The licensee's or registrant's response, if any, shall be posted within five working days after dispatch of the document to the director. Such documents shall remain posted for a minimum of five working days or until action correcting the violation has been completed, whichever is later.

(e) The Ohio department of health, bureau of environmental health and radiation protection issued form titled "Notice to Employees."

(2) If posting of a document specified in paragraphs (A)(1)(a) to (A)(1)(c) of this rule is not practical, the licensee or registrant may post a notice which describes the document and states where it may be readily examined.

(3) Documents, notices, or forms posted pursuant to paragraph (A) of this rule shall appear in a sufficient number of places to permit individuals engaged in licensed or registered activity under the license or registration to observe them on the way to or from any particular work location to which the document applies, shall be conspicuous, and shall be replaced if defaced or altered.

(B) Instruction to workers.

(1) The licensee or registrant shall, with respect to all individuals likely to receive an annual TEDE occupational dose in excess of one millisievert (one hundred millirem):

(a) Keep such individuals informed of the storage, transfer, or use of sources of radiation in the licensee's or registrant's workplace;

(b) Instruct such individuals in the health effects associated with exposure to radiation or radioactive material to the individual and potential offspring, in precautions or procedures to minimize exposure, and in the purposes and functions of protective devices employed;

(c) Instruct such individuals in, and instruct such individuals to observe, to the extent within the individual's control, the applicable provisions of rules promulgated under Chapter 3748. of the Revised Code and any license conditions for the protection of personnel from exposures to radiation or radioactive material;

(d) Instruct each such individual of his or her responsibility to report promptly to the licensee or registrant any condition which may constitute, lead to, or cause a violation of Chapter 3748. of the Revised Code, the rules promulgated thereunder, any license condition, or order, and any unnecessary exposure to radiation or radioactive material;

(e) Instruct such individuals in the appropriate response to warnings made in the event of any unusual occurrence or malfunction that may involve exposure to radiation or radioactive material; and

(f) Advise such individuals of any radiation exposure reports furnished pursuant to paragraph (C) of this rule.

(2) In determining those individuals subject to the requirements of paragraph (B)(1) of this rule, licensees and registrants shall take into consideration assigned activities during normal and abnormal situations involving exposure to radiation and radioactive materials which can reasonably be expected to occur during the life of the facility. The extent of these instructions shall be commensurate with potential radiological health protection problems present in the workplace.

(C) Notifications and reports to individuals.

(1) Radiation exposure data for an individual and the results of any measurements, analyses, and calculations of radioactive material deposited or retained in the body of an individual shall be reported to the individual as specified in this rule. The information reported shall include data and results obtained pursuant to Chapter 3748. of the Revised Code or rules adopted thereunder, an order, or license condition as shown in records maintained by the licensee or registrant pursuant to paragraph (H) of rule 3701:1-38-20 of the Administrative Code. Each notification and report shall:

(a) Be in writing;

(b) Include appropriate identifying data such as the name of the licensee or registrant, the name of the individual, and the individual's identification number, preferably social security number;

(c) Include the individual's exposure information; and

(d) Contain the statement: "This report is furnished to you under the provisions of rule 3701:1-38-10 of the Administrative Code. You should preserve this report for further reference."

(2) Each licensee or registrant shall make dose information available to workers as shown in records maintained by the licensee under the provisions of paragraph (H) of rule 3701:1-38-20 of the Administrative Code. The licensee or registrant shall provide an annual report to each individual monitored under rule 3701:1-38-14 of the Administrative Code, of the dose received in that monitoring year if:

(a) The individual's occupational dose exceeds one millisievert (one hundred millirem) TEDE or one millisievert (one hundred millirem) to any individual organ or tissue; or

(b) The individual requests his or her annual dose report.

(3) Each licensee or registrant shall furnish reports to workers.

(a) At the request of a worker formerly engaged in activities controlled by the licensee or registrant, each licensee or registrant shall furnish to the worker a report of the worker's exposure to sources of radiation:

(i) As shown in records maintained by the licensee or registrant pursuant to rule 3701:1-38-20 of the Administrative Code for each year the worker was required to be monitored under the provisions of rule 3701:1-38-14 of the Administrative Code; and

(ii) For each year the worker was required to be monitored under the monitoring requirements in effect prior to August 31, 1999.

(b) This report must be furnished within thirty days from the time the request is made or within thirty days after the exposure of the individual has been determined by the licensee or registrant, whichever is later. This report must cover the period of time that the worker's activities involved exposure to sources of radiation licensed or registered by the director and must include the dates and locations of licensed or registered activities in which the worker participated during this period.

(4) When a licensee or registrant is required pursuant to paragraphs (A) to (C) of rule 3701:1-38-21 of the Administrative Code to report to the director any exposure of an individual to sources of radiation, the licensee or the registrant shall also provide the individual a written report on the exposure data included in the report to the director. This report must be transmitted no later than the transmittal to the director.

(5) At the request of a worker who is terminating employment with the licensee or registrant that involved exposure to sources of radiation during the current calendar quarter or the current year, each licensee or registrant shall provide at termination to each worker, or to the worker's designee, a written report regarding the radiation dose received by that worker from operations of the licensee or registrant during the current calendar year or fraction thereof. If the most recent individual monitoring results are not available at that time, a written estimate of the dose must be provided together with a clear indication that this is an estimate.

Last updated November 2, 2022 at 2:09 PM

History

• Effective: May 17, 2018
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-38-19

(A) A licensee shall dispose of licensed radioactive material in accordance with this rule. Licensed material shall be disposed of in one of the following manners:

(1) By transfer to an authorized recipient as provided in this chapter, Chapter 3701:1-40 of the Administrative Code, or to the United States department of energy;

(2) By decay in storage provided that the radionuclide has a half-life of one hundred twenty days or less, or as otherwise permitted by the license;

(3) By release in effluents within the limits set forth in rule 3701:1-38-13 of the Administrative Code; or

(4) As authorized pursuant to paragraphs (B) to (F) of this rule.

(B) A person shall be specifically licensed to receive waste containing licensed material from another person for:

(1) Treatment prior to disposal;

(2) Treatment or disposal by incineration;

(3) Decay in storage;

(4) Disposal at a land disposal facility licensed pursuant to rules 3701:1-54-06 to 3701:1-54-12 of the Administrative Code or equivalent United States nuclear regulatory commission or agreement state regulations; or

(5) Storage until transfer to a storage or disposal facility authorized to receive the waste.

(C) A licensee or applicant for a license may apply to the director for approval of proposed disposal procedures that are not otherwise authorized in these rules for the disposal of licensed material generated in the licensee's operations. Each application shall include:

(1) A description of the waste containing licensed material to be disposed of, including the physical and chemical properties that have an impact on risk evaluation, and the proposed manner and conditions of waste disposal;

(2) An analysis and evaluation of pertinent information on the nature of the environment;

(3) The nature and location of other potentially affected facilities; and

(4) An analysis and procedures to ensure that doses are maintained ALARA and within the dose limits in rules 3701:1-38-12 and 3701:1-38-13 of the Administrative Code.

(D) A licensee may discharge licensed material into sanitary sewerage as follows:

(1) The material is readily soluble in water or is a biological material that is readily dispersible in water;

(2) The quantity of licensed or other radioactive material that the licensee releases into the sewer in one month divided by the average monthly volume of water released into the sewer by the licensee does not exceed the concentration listed in table III of appendix C to rule 3701:1-38-12 of the Administrative Code; and

(3) If more than one radionuclide is to be released, the following conditions must also be satisfied:

(a) The licensee shall determine the fraction of the limit in table III of appendix C to rule 3701:1-38-12 of the Administrative Code represented by discharges into sanitary sewerage by dividing the actual monthly average concentration of each radionuclide released by the licensee into the sewer by the concentration of that radionuclide listed in table III of appendix C to rule 3701:1-38-12 of the Administrative Code; and

(b) The sum of the fractions for each radionuclide required by paragraph (D)(3)(a) of this rule does not exceed unity.

(4) The total quantity of licensed and other radioactive material that the licensee releases into the sanitary sewerage in a year does not exceed one hundred eighty-five gigabecquerels (five curies) of hydrogen-3, thirty-seven gigabecquerels (one curie) of carbon-14, and thirty-seven gigabecquerels (one curie) of all other radioactive materials combined.

(5) Excreta from an individual undergoing medical diagnosis or therapy with radioactive material is not subject to the limitations contained in paragraph (D) of this rule.

(E) A licensee may dispose of licensed material by decay in storage. A licensee may hold radioactive material with a physical half-life of one hundred twenty days or less for decay-in-storage before disposal as non-radioactive material provided the licensee does the following:

(1) Monitors the material at the container surface prior to disposal and determines that the radioactivity cannot be distinguished from the background radiation level with an appropriate radiation detection survey meter set on its most sensitive scale and with no interposing shielding;

(2) Removes or obliterates all radiation caution labels and symbols, unless otherwise specified in the license; and

(3) Retains a record of the disposal for three years.

(F) A licensee may treat or dispose of licensed material by incineration only in the form and concentration specified in paragraph (G) of this rule or as specifically approved by the director pursuant to paragraph (C) of this rule.

(G) A licensee may dispose of the following licensed material as if it were not radioactive. The licensee shall maintain records in accordance with paragraph (K) of rule 3701:1-38-20 of the Administrative Code.

(1) 1.85 kilobecquerels (0.05 microcurie) or less, of hydrogen-3 or carbon-14 per gram of medium used for liquid scintillation counting; or

(2) 1.85 kilobecquerels (0.05 microcurie) or less, of hydrogen-3 or carbon-14 per gram of animal tissue, averaged over the weight of the entire animal. A licensee shall not dispose of tissue pursuant to this paragraph in a manner that would permit its use either as food for humans or as animal feed.

(H) A licensee shall transfer and dispose of licensed material in accordance with the following:

(1) For transfer of radioactive waste intended for disposal at a licensed radioactive waste disposal facility, establish a manifest tracking system, and supplement existing requirements concerning transfers and recordkeeping for those wastes. Each shipment of radioactive waste designated for disposal at a licensed radioactive waste disposal facility shall be accompanied by a shipment manifest as specified in the appendix to this rule.

(2) Each shipment manifest shall include a certification by the waste generator in accordance with the appendix to this rule.

(3) Each person involved in the transfer of waste for disposal or in the disposal of waste, including the waste generator, waste collector, waste processor, and disposal facility operator, shall comply with the requirements specified in the appendix to this rule.

(I) Nothing in this rule relieves a licensee from complying with other applicable federal, state and local regulations governing any other toxic or hazardous properties of materials that may be disposed of under this rule.

View Appendix

Last updated January 20, 2022 at 8:48 AM

History

• Effective: January 20, 2022
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-38-20

(A) Each licensee or registrant shall use the SI units becquerel, gray, sievert and coulomb per kilogram, or the special units curie, rad, rem and roentgen, including multiples and subdivisions, and shall clearly indicate the units of all quantities on records required by this chapter. The licensee or registrant shall make a clear distinction among the quantities entered on the records such as, total effective dose equivalent, total organ dose equivalent, shallow dose equivalent, lens dose equivalent, deep dose equivalent, or committed effective dose equivalent.

(B) Each licensee or registrant shall maintain records of the radiation protection program, including the provisions of the program and audits and other reviews of program content and implementation. The licensee or registrant shall retain the records of the provisions of the program until the department terminates each license or registration pertinent to the record. The licensee or registrant shall retain all the other records required by this paragraph for three years after the record is made.

(C) Records of surveys showing the results of surveys and calibrations required by paragraph (A) of rule 3701:1-38-14 and paragraph (F) of rule 3701:1-38-18 of the Administrative Code shall be maintained and retained by the licensee or registrant for three years after the record is made.

(D) The licensee or registrant shall retain each of the following records until the department terminates each license or registration pertinent to the record:

(1) Records of the results of surveys to determine the dose from external sources of radiation used, in the absence of or in combination with individual monitoring data, in the assessment of individual dose equivalents;

(2) Records of the results of measurements and calculations used to determine individual intakes of radioactive material and used in the assessment of internal dose;

(3) Records showing the results of air sampling, surveys, and bioassays required pursuant to paragraphs (C)(2)(a) and (C)(2)(b) of rule 3701:1-38-16 of the Administrative Code; and

(4) Records of the results of measurements and calculations used to evaluate the release of radioactive effluents to the environment.

(E) Records of tests for leakage or contamination of sealed sources shall be kept in units of becquerel or microcurie, or multiples thereof, and maintained for inspection by the department for at least three years after the records are made.

(F) Records of prior occupational dose and exposure history as required in paragraph (E) of rule 3701:1-38-12 of the Administrative Code shall be recorded by the licensee or registrant on a form provided by the department entitled "lifetime occupational exposure history" in accordance with the instructions for completing this form, or in clear and legible records containing all the information required by the same form. The licensee or registrant shall maintain these records until the department terminates each license or registration pertinent to this record. The licensee or registrant shall retain records used in preparing the form for three years after the record is made.

(G) Records of planned special exposures as required in paragraph (F) of rule 3701:1-38-12 of the Administrative Code shall be maintained by the licensee:

(1) The licensee shall maintain records that describe the following:

(a) The exceptional circumstances requiring the use of a planned special exposure;

(b) The name of the management official who authorized the planned special exposure and a copy of the signed authorization;

(c) What actions were necessary;

(d) Why the actions were necessary;

(e) What precautions were taken to assure that doses were maintained ALARA;

(f) What individual and collective doses were expected to result; and

(g) The doses actually received in the planned special exposure.

(2) The licensee shall retain the records until the department terminates each license pertinent to these records.

(H) Records of individual dose monitoring results shall be maintained by each licensee or registrant for each individual for whom monitoring is required pursuant to paragraph (B) of rule 3701:1-38-14 of the Administrative Code, and records of doses received during planned special exposures, accidents, and emergency conditions. Assessments of dose equivalent and records made using units in effect before the effective date of these rules need not be changed.

(1) These records shall include, when applicable:

(a) The deep dose equivalent to the whole body, lens dose equivalent, shallow dose equivalent to the skin, and shallow dose equivalent to the extremities;

(b) The estimated intake or radionuclides as provided in paragraph (B) of rule 3701:1-38-12 of the Administrative Code;

(c) The committed effective dose equivalent assigned to the intake of radionuclides; and

(d) The specific information used to calculate the committed effective dose equivalent pursuant to paragraph (D)(8) of rule 3701:1-38-12 of the Administrative Code; and

(e) The total effective dose equivalent when required by paragraph (B) of rule 3701:1-38-12 of the Administrative Code; and

(f) The total of the deep dose equivalent and the committed dose to the organ receiving the highest total dose.

(2) The licensee or registrant shall make entries of the records specified in paragraph (H) of this rule at least annually.

(I) Each licensee or registrant shall maintain the records specified in paragraph (H) of this rule on department form entitled "occupational exposure record for a monitoring period" in accordance with the instructions for completing this form, or in clear and legible records containing all the information required by the same form. The licensee or registrant shall maintain the records of dose to an embryo or fetus with the records of dose to the declared pregnant woman. The declaration of pregnancy shall also be kept on file, but may be maintained separately from the dose records. The licensee or registrant shall retain each required form or record until the department terminates each license or registration pertinent to the record.

(J) Each licensee or registrant shall maintain records sufficient to demonstrate compliance with the dose limits for individual members of the public specified in paragraph (A) of rule 3701:1-38-13 of the Administrative Code. Each licensee or registrant shall retain the records required by paragraph (H) of this rule until the department terminates each license or registration pertinent to the record.

(K) Records of the disposal of licensed material shall be maintained by each licensee in accordance with paragraphs (C), (D), (F), and (G) of rule 3701:1-38-19, and Chapter 3701:1-54 of the Administrative Code. The licensee shall retain the records required by this paragraph until the department terminates each pertinent license that requires the record.

(L) Records of tests performed on entry control devices located in a very high radiation area shall be maintained by each licensee in accordance with Chapter 3701:1-52 of the Administrative Code or registrant in accordance with Chapters 3701:1-66, 3701:1-67, and 3701:1-68 of the Administrative Code. These records must include the date, time, and results of each such test of function. The licensee or registrant shall retain the records required by this paragraph for at least three years after the record is made.

(M) Each record required by this chapter shall be legible throughout the specified retention period. The record shall be the original or a reproduced copy or a microform, provided that the copy or microform is authenticated by authorized personnel and that the microform is capable of producing a clear copy throughout the required retention period. The record may also be stored in electronic media with the capability for producing legible, accurate, and complete records during the required retention period. Records, such as letters, drawings, and specifications, shall include all pertinent information, such as stamps, initials, and signatures. The licensee or registrant shall maintain adequate safeguards against tampering with and loss of records.

Last updated January 20, 2022 at 8:48 AM

History

• Effective: January 20, 2022
• Promulgated Under: 119.03

Chapter 3701:1-44 Issuance of Licenses

Ohio Adm.Code 3701:1-44-01 Definitions.

Terms defined in rule 3701:1-38-01 of the Administrative Code shall have the same meaning when used in this chapter except terms redefined within a given rule for use within that rule only, and additionally, as used in this chapter of the Administrative Code:

(A) "Act" means the Atomic Energy Act of 1954 (68 Stat. 919), including any amendments thereto.

(B) "Byproduct material," as used in this chapter, means the tailings or wastes produced by the extraction or concentration of uranium or thorium from any ore processed primarily for its source material content, including discrete surface wastes resulting from uranium solution extraction processes. Underground ore bodies depleted by such solution extraction operations do not constitute byproduct material within this definition. With the exception of "byproduct material" as defined in section 11e. of the act, other terms defined in section 11 of the act shall have the same meaning when used in the rules of this chapter.

(C) "Principal activities," as used in this part, means activities authorized by the license which are essential to achieving the purpose(s) for which the license was issued or amended. Storage during which no licensed material is accessed for use or disposal and activities incidental to decontamination or decommissioning are not principal activities.

(D) "Residual radioactive material" means:

(1) Waste (which the secretary of energy determines to be radioactive) in the form of tailings resulting from the processing of ores for the extraction of uranium and other valuable constituents of the ores; and

(2) Other waste (which the secretary of energy determines to be radioactive) at a processing site which relates to such processing, including any residual stock of unprocessed ores or low-grade materials. This term is used only with respect to materials at sites subject to remediation under title I of the Uranium Mill Tailings Radiation Control Act of 1978, as amended.

(E) "Unrefined and unprocessed ore" means ore in its natural form prior to any processing, such as grinding, roasting or beneficiating, or refining. Processing does not include sieving or encapsulation of ore or preparation of samples for laboratory analysis.

(F) "Uranium milling" means any activity that results in the production of byproduct material as defined in this rule.

Last updated November 2, 2022 at 2:14 PM

History

• Effective: December 10, 2015
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-38-01

(A) As used in this chapter and all other rules promulgated pursuant to Chapter 3748. of the Revised Code:

(1) "A₁" means the maximum activity of special form radioactive material permitted in a type A package. These values are listed in rule 3701:1-50-25 of the Administrative Code, or may be derived in accordance with the procedure prescribed in rule 3701:1-50-25 of the Administrative Code.

(2) "A₂" means the maximum activity of radioactive material, other than special form, low specific activity and surface contaminated object material, permitted in a type A package. These values are listed in rule 3701:1-50-25 of the Administrative Code, or may be derived in accordance with the procedure prescribed in rule 3701:1-50-25 of the Administrative Code.

(3) "Absorbed dose" means the energy imparted by ionizing radiation per unit mass of irradiated material. The units of absorbed dose are the gray, or Gy, and the rad.

(4) "Accelerator or charged particle accelerator" means any of a class of radiation generating equipment designed to electronically accelerate atomic or sub-atomic particles for subsequent bombardment of targets.

(5) "Accelerator-produced radioactive material" means any material made radioactive by a particle accelerator.

(6) "Activity" means the rate of disintegration or transformation or decay of radioactive material. The units of activity are the becquerel, or Bq, and the curie, or Ci.

(7) "Address of use" means the building or buildings that are identified on the license or registration and where the source of radiation may be received, used, prepared, or stored, except for temporary job sites.

(8) "Administrative controls" means mechanisms used to protect health and minimize damage to life and property through the use of written policies, procedures, instructions, training, observation of work practices, and related compliance audits.

(9) "Administrative monetary penalty" means a monetary penalty assessed by the director under section 3748.05 of the Revised Code and in compliance with rules adopted thereunder, to emphasize the need for lasting remedial action and to deter future violations.

(10) "Adult" means an individual eighteen or more years of age.

(11) "Agreement state" means any state with which the United States nuclear regulatory commission or the atomic energy commission has entered into an effective agreement under subsection 274B of the Atomic Energy Act of 1954, 68 Stat. 919, 42 U.S.C. 2021, as amended (1978). Non-agreement state means any other state.

(12) "Airborne radioactive material" means radioactive material dispersed in the air in the form of dusts, fumes, particulates, mists, vapors, or gases.

(13) "Airborne radioactivity area" means a room, enclosure, or area in which airborne radioactive materials, composed wholly or partly of licensed material, exist in concentrations:

(a) In excess of the derived air concentrations (DACs) specified in appendix C to rule 3701:1-38-12 of the Administrative Code, or

(b) To such a degree that an individual present in the area without respiratory protective equipment could exceed, during the hours an individual is present in a week, an intake of 0.6 per cent of the annual limit on intake or twelve DAC-hours.

(14) "Air-purifying respirator" means a respirator with an air-purifying filter, cartridge, or canister that removes specific air contaminants by passing ambient air through the air-purifying element.

(15) "ALARA" or "as low as is reasonably achievable" means every reasonable effort to maintain exposures to radiation as far below the dose limits as is practical consistent with the purpose for which the licensed or registered activity is undertaken, taking into account the state of technology, the economics of improvements in relation to benefits to the public health and safety, and other societal and socioeconomic considerations, and in relation to utilization of nuclear energy and licensed materials and registered activities in the public interest.

(16) "Alert" means events may occur, are in progress, or have occurred that could lead to a release of radioactive material but that the release is not expected to require a response by off-site response organizations to protect persons off-site.

(17) "Annual limit on intake" or "ALI" means the derived limit for the amount of radioactive material taken into the body of an adult worker by inhalation or ingestion in a year. ALI is the smaller value of intake of a given radionuclide in a year by the reference man that would result in a committed effective dose equivalent of 0.05 sievert (five rem) or a committed dose equivalent of 0.5 sievert (fifty rem) to any individual organ or tissue. ALI values for intake by ingestion and by inhalation of selected radionuclides are given in appendix C to rule 3701:1-38-12 of the Administrative Code.

(18) "Annually" means either

(a) At intervals not to exceed one year; or

(b) Once per year, at about the same time each year, plus or minus one month.

(19) "Area of use" means a portion of an address of use that has been set aside for the purpose of receiving, preparing, using, or storing sources of radiation.

(20) "Assigned protection factor" or "APF" means the expected workplace level of respiratory protection that would be provided by a properly functioning respirator or a class of respirators to properly fitted and trained users. Operationally, the inhaled concentration can be estimated by dividing the ambient airborne concentration by the APF.

(21) "Atmosphere-supplying respirator" means a respirator that supplies the respirator user with breathing air from a source independent of the ambient atmosphere, and includes supplied air respirators, or SARs, and self-contained breathing apparatus, or SCBA, units.

(22) "Atomic energy commission" or "AEC" means the federal agency created by the Atomic Energy Act of 1954, 68 Stat. 919, 42 U.S.C. 2011, as amended (1964), and was the predecessor agency to the current United States nuclear regulatory commission.

(23) "Background radiation" means radiation from cosmic sources; naturally occurring radioactive materials, including radon, except as a decay product of source or special nuclear material, and global fallout as it exists in the environment from the testing of nuclear explosive devices or from past nuclear accidents such as Chernobyl that contribute to background radiation and are not under the control of the licensee. "Background radiation" does not include radiation from radioactive materials regulated by the department.

(24) "Becquerel" or "Bq" means the SI unit of activity. One becquerel is equal to one disintegration per second.

(25) "Bioassay" or "radiobioassay" means the determination of kinds, quantities or concentrations, and, in some cases, the locations of radioactive material in the human body, whether by direct measurement, in vivo counting, or by analysis and evaluation of materials excreted or removed from the human body.

(26) "Byproduct material" means

(a) Any radioactive material, except special nuclear material, yielded in or made radioactive by exposure to the radiation incident to the process of producing or utilizing special nuclear materials; or

(b) The tailings or wastes produced by the extraction or concentration of uranium or thorium from any ore processed primarily for its source material content, including discrete surface wastes resulting from solution extraction processes. Underground ore bodies depleted by such solution extraction do not constitute byproduct material within the definition.

(27) "Chelating agent" means a chemical compound or mixture that enhances the removal of radioactive material from the body, water or similar applications. Typical chelating agents include amine polycarboxylic acids such as EDTA or DTPA; hydroxy-carboxylic acids; and polycarboxylic acids such as citric acid, carbolic acid, and gluconic acid.

(28) "Chiropractor" means an individual licensed by the state of Ohio to practice chiropractic medicine pursuant to Chapter 4734. of the Revised Code.

(29) "Class" or "lung class" or "inhalation class" means a classification scheme for inhaled material according to its rate of clearance from the pulmonary region of the lung. Materials are classified as D, W, or Y, which applies to a range of clearance half-times: for class D, days, of less than ten days, for class W, weeks, from ten to one hundred days, and for class Y, years, of greater than one hundred days.

(30) "Collective dose" means the sum of the individual doses received in a given period of time by a specified population from exposure to a specified source of radiation.

(31) "Commencement of construction" means taking any action defined as "construction" or any other activity at the site of a facility subject to the rules promulgated pursuant to Chapter 3748. of the Revised Code that has a reasonable nexus to radiological health and safety.

(32) "Committed dose equivalent" or "H_T,50" means the dose equivalent to organs or tissues of reference, T, that will be received from an intake of radioactive material by an individual during the fifty year period following the intake.

(33) "Committed effective dose equivalent" or "H_E,50" means the sum of the products of the weighting factors applicable to each of the body organs or tissues, W_T, that are irradiated and the committed dose equivalent to each of these organs or tissues (H_{E, 50} = W_TH_T,50).

(34) "Consortium" means an association of medical use licensees and a PET radionuclide production facility in the same geographical area that jointly own or share in the operation and maintenance cost of the PET radionuclide production facility that produces PET radionuclides for use in producing radioactive drugs within the consortium for noncommercial distributions among its associated members for medical use. The PET radionuclide production facility within the consortium must be located at an educational institution or a medical facility.

(35) "Constraint" or "dose constraint" means a value above which specified licensee actions are required.

(36) "Construction" means the installation of foundations, or in-place assembly, erection, fabrication, or testing for any structure, system, or component of a facility or activity subject to the rules promulgated pursuant to Chapter 3748. of the Revised Code that are related to radiological safety or security. The term "construction" does not include:

(a) Changes for temporary use of the land for public recreational purposes;

(b) Site exploration, including necessary borings to determine foundation conditions or other preconstruction monitoring to establish background information related to the suitability of the site, the environmental impacts of construction or operation, or the protection of environmental values;

(c) Preparation of the site for construction of the facility, including clearing of the site, grading, installation of drainage, erosion and other environmental mitigation measures, and construction of temporary roads and borrow areas;

(d) Erection of fences and other access control measures that are not related to the safe use of, or security of, radiological materials subject to the rules promulgated pursuant to Chapter 3748. of the Revised Code;

(e) Excavation;

(f) Erection of support buildings (e.g. construction equipment storage sheds, warehouse and shop facilities, utilities, concrete mixing plants, docking and unloading facilities, and office buildings) for use in connection with the construction of the facility;

(g) Building of service facilities (e.g. paved roads, parking lots, railroad spurs, exterior utility and lighting systems, potable water systems, sanitary sewerage treatment facilities, and transmission lines);

(h) Procurement or fabrication of components or portions of the proposed facility occurring at other than the final, in-place location at the facility; or

(i) Taking any other action that has no reasonable nexus to radiological health and safety.

(37) "Controlled area" means an area, outside of a restricted area but inside the site boundary, access to which can be limited by the licensee or registrant for any reason.

(38) "Critical group" means the group of individuals reasonably expected to receive the greatest exposure to residual radioactivity for any applicable set of circumstances.

(39) "Curie" or "Ci" means a unit of activity. One curie equals 3.7 x 10¹⁰ disintegrations per second equals 3.7 x 10¹⁰ becquerels equals 2.22 x 10¹² disintegrations per minute.

(40) "Cyclotron" means a particle accelerator in which the charged particles travel in an outward spiral or circular path. A cyclotron accelerates charged particles at energies usually in excess of ten megaelectron volts and is commonly used for production of short half-life radionuclides for medical use.

(41) "Declared pregnant woman" means a woman who has voluntarily informed the licensee or registrant, in writing, of her pregnancy and the estimated date of conception. The declaration remains in effect until the declared pregnant woman withdraws the declaration in writing or is no longer pregnant.

(42) "Decommission" means to safely remove any licensed operation from service and reduce residual radioactivity to a level that permits release of the licensee's property for unrestricted use and termination of the license.

(43) "Dedicated check source" means a radioactive source that is used to assure the consistent performance of a radiation detection or measurement device over several months or years.

(44) "Deep dose equivalent" or "H_d" applies to external whole body exposure, and means the dose equivalent at a tissue depth of one centimeter, one thousand milligram per square centimeter.

(45) "Demand respirator" means an atmosphere-supplying respirator that admits breathing air to the facepiece only when a negative pressure is created inside the facepiece by inhalation.

(46) "Dentist" means an individual licensed by the state of Ohio to practice dentistry under Chapter 4715. of the Revised Code.

(47) "Department" means the Ohio department of health.

(48) "Depleted uranium" means uranium containing less uranium-235 than the naturally occurring distribution of uranium isotopes.

(49) "Derived air concentration" or "DAC" means the concentration of a given radionuclide in air which, if breathed by the reference man for a working year of two thousand hours under conditions of light work, results in an intake of one ALI. The condition of light work is inhaling 1.2 cubic meters of air per hour for two thousand hours in a year. DAC values are given in appendix C to rule 3701:1-38-12 of the Administrative Code.

(50) "Derived air concentration-hour or DAC-hour" means the product of the concentration of radioactive material in air, which is expressed as a fraction or multiple of the derived air concentration for each radionuclide, and the time of exposure to that radionuclide, in hours. A licensee or registrant may take two thousand DAC-hours to represent one ALI, equivalent to a committed effective dose equivalent of 0.05 Sv (five rem).

(51) "Direct reading dosimeter" means a device that measures radiation dose that does not require another device to read the measured radiation dose. Examples of direct reading dosimeters include pocket dosimeters and electronic dosimeters.

(52) "Director" means the director of health or a designee or authorized representative of the director.

(53) "Discipline" means a branch of knowledge or of teaching.

(54) "Discrete source" means a radionuclide that has been processed so that its concentration within a material has been purposely increased for use for commercial, medical, or research activities.

(55) "Disposable respirator" means a respirator for which maintenance is not intended and that is designed to be discarded after excessive breathing resistance, sorbent exhaustion, physical damage, or end-of service-life renders it unsuitable for use. Examples of this type of respirator are a disposable half-mask respirator or a disposable escape-only self-contained breathing apparatus.

(56) "Dose" or "radiation dose" is a generic term that means absorbed dose, dose equivalent, effective dose equivalent, committed effective dose equivalent, or total effective dose equivalent as defined in other paragraphs of this rule.

(57) "Dose equivalent" or "H_T" means the product of the absorbed dose in tissue, quality factor, and all other necessary modifying factors at the location of interest. The units of dose equivalent are the sievert and rem.

(58) "Dose limits" or "limits" means the permissible upper bounds of radiation doses established in accordance with these regulations but excludes background radiation and medical exposure.

(59) "Dosimetry processor" means a person that processes and evaluates individual monitoring devices in order to determine the radiation dose delivered to the monitoring devices.

(60) "Effective dose equivalent" or "H_E" means the sum of the products of the dose equivalent to each organ or tissue, H_T, and the weighting factor, W_T, applicable to each of the body organs or tissues that are irradiated: (H_E = ∑W_TH_T).

(61) "Embryo" or "fetus" means the developing human organism from conception until time of birth.

(62) "Engineering controls" means mechanisms used to protect health and minimize damage to life and property through engineering specifications, design, and construction of the product or facility including all of the security and safety features. This includes, but is not limited to, auxiliary security and safety features such as additional external shielding, barriers, and operational interlocks with associated processes.

(63) "Entrance" or "access point" means any opening through which an individual or extremity of an individual could gain access to radiation areas or to licensed radioactive materials or registered radiation generating equipment. This includes entry or exit portals of sufficient size to permit human entry, irrespective of their intended use.

(64) "Explosive material" means any chemical compound, mixture or device which produces a substantial instantaneous release of gas and heat spontaneously or by contact with sparks or flame.

(65) "Exposure" means being exposed to sources of ionizing radiation.

(66) "External dose" means that portion of the dose equivalent received from radiation sources outside the body.

(67) "Extremity" means hand, elbow, arm below the elbow, foot, knee, or leg below the knee.

(68) "Eye dose equivalent" means the same as lens dose equivalent.

(69) "Facility" means all buildings, equipment, structures and other stationary items that, in addition to the meaning defined in division (H) of section 3748.01 of the Revised Code, are:

(a) Located on a single site or on contiguous or adjacent sites and are operated by the same person and have common corporate or business interests; or

(b) Portions of a building or structure which are operated by the same person and have common corporate or business interests.

(70) "Filtering facepiece" or "dust mask" means a negative pressure particulate respirator with a filter as an integral part of the facepiece or with the entire facepiece composed of the filtering medium, not equipped with elastomeric sealing surfaces and adjustable straps.

(71) "Fissile material" means the radionuclides uranium-233, uranium-235, plutonium-239, and plutonium-241, or any combination of these radionuclides. Fissile material means the fissile nuclides themselves, not material containing fissile nuclides. Unirradiated natural uranium and depleted uranium and natural uranium or depleted uranium that has been irradiated in thermal reactors only, are not included in this definition. Certain exclusions from fissile material controls are provided in rule 3701:1-50-13 of the Administrative Code.

(72) "Fit factor" means quantitative estimate of the fit of a particular respirator to a specific individual, and typically estimates the ratio of the concentration of a substance in ambient air to its concentration inside the respirator when worn.

(73) "Fit test" means the use of a protocol to qualitatively or quantitatively evaluate the fit of a respirator on an individual.

(74) "Generally applicable environmental radiation standards" means standards issued by the United States environmental protection agency under the authority of the Atomic Energy Act of 1954, 68 Stat. 919, 42 U.S.C. 2011, as amended (2005), that impose limits on radiation exposures or levels, or concentrations or quantities of radioactive material, in the general environment outside the boundaries of locations under the control of persons possessing or using radioactive material.

(75) "Gray" or "Gy" means the SI unit of absorbed dose. One gray is equal to an absorbed dose of one joule per kilogram (one hundred rads).

(76) "Handle" means receive, possess, use, store, transfer, install, service, or dispose of sources of radiation unless possession is solely for the purpose of transportation.

(77) "Handler" means a facility that handles sources of radiation unless possession is solely for the purpose of transportation.

(78) "Hazardous waste" means those wastes designated as hazardous by rule 3745-51-03 of the Administrative Code.

(79) "Helmet" means a rigid respiratory inlet covering that also provides head protection against impact and penetration.

(80) "High radiation area" means an area, accessible to individuals, in which radiation levels from radiation sources external to the body could result in an individual receiving a dose equivalent in excess of one millisievert (0.1 rem) in one hour at thirty centimeters from the radiation source or thirty centimeters from any surface that the radiation penetrates.

(81) "Hood" means a respiratory inlet covering that completely covers the head and neck and may also cover portions of the shoulders and torso.

(82) "Individual" means any human being.

(83) "Individual monitoring" means

(a) The assessment of dose equivalent by the use of devices designed to be worn by an individual;

(b) The assessment of committed effective dose equivalent by bioassay or by determination of the time-weighted air concentrations to which an individual has been exposed, i.e. DAC-hours; or

(c) The assessment of dose equivalent by the use of survey data.

(84) "Individual monitoring devices" means devices designed to be worn by a single individual for the assessment of dose equivalent such as film badges; thermoluminescent dosimeters; optically stimulated luminescent dosimeters; pocket ionization chambers; and personal air sampling devices.

(85) "Industrial radiography" means the examination of the structure of materials by nondestructive methods, utilizing sealed sources of radioactive material or radiation-generating equipment.

(86) "Internal dose" means that portion of the dose equivalent received from radioactive material taken into the body.

(87) "Irradiator" means a facility that uses radioactive sealed sources for the irradiation of objects or materials and in which radiation dose rates exceeding five grays (five hundred rads) per hour exist at one meter from the sealed radioactive source in air or water, as applicable for the irradiator type, but does not include irradiators in which both the sealed source and the area subject to irradiation are contained within a device and are not accessible to personnel.

(88) "Lens dose equivalent" or "eye dose equivalent" means the external exposure of the lens of the eye and is taken as the dose equivalent at a tissue depth of 0.3 centimeters; i.e. three hundred milligrams per square centimeter.

(89) "License" means a license issued by the nuclear regulatory commission, the director, or another agreement state in accordance with rules adopted by those organizations.

(90) "Licensee" means a person to whom a license is issued.

(91) "Licensed activity" means an activity authorized by a radioactive material license which is essential to achieving the purpose for which the license was issued or amended.

(92) "Licensed material" means radioactive material received, possessed, used, transferred or disposed of under a general or specific license.

(93) "Loose-fitting facepiece" means a respiratory inlet covering that is designed to form a partial seal with the face.

(94) "Lost or missing licensed source of radiation" means a licensed source of radiation whose location is unknown. It includes material that has been shipped but has not reached its destination and whose location cannot be readily traced in the transportation system.

(95) "Low-level radioactive waste" or "LLRW," also "low-level waste," or "LLW" means radioactive waste which is not high-level radioactive waste, spent nuclear fuel, NARM, or byproduct material as defined in section 11 E. (2) of the Atomic Energy Act of 1954 68 Stat. 919, 42 U.S.C. 2011, as amended (2005), but is radioactive material that the United States nuclear regulatory commission classifies as low-level radioactive waste.

(96) "Low specific activity material" or "LSA" means radioactive material with limited specific activity which is nonfissile or is excepted under rule 3701:1-50-13 of the Administrative Code, and which satisfies the descriptions and limits set forth below. Shielding materials surrounding the LSA material may not be considered in determining the estimated average specific activity of the package contents. LSA must be in one of three groups:

(a) LSA - I.

(i) Uranium and thorium ores, concentrates of uranium and thorium ores, and other ores containing naturally occurring radioactive radionuclides that are intended to be processed for the use of these radionuclides;

(ii) Natural uranium, depleted uranium, natural thorium or their compounds or mixtures, provided they are unirradiated and in solid or liquid form;

(iii) Radioactive material other than fissile material, for which the A₂ value is unlimited; or

(iv) Other radioactive material in which the activity is distributed throughout and the estimated average specific activity does not exceed thirty times the value for exempt material activity concentration determined in accordance with rule 3701:1-50-25 of the Administrative Code.

(b) LSA-II.

(i) Water with tritium concentration up to 0.8 terabecquerels per liter (twenty curies per liter); or

(ii) Other material in which the activity is distributed throughout and the estimated average specific activity does not exceed ( 10^-4 A₂) per gram for solids and gases, and (10^-5 A₂) per gram for liquids.

(c) LSA-III. Solids (e.g., consolidated wastes, activated materials), excluding powders, that satisfy the requirements of 10 C.F.R. 71.77 (as in effect on the effective date of this rule), in which:

(i) The radioactive material is distributed throughout a solid or a collection of solid objects, or is essentially uniformly distributed in a solid compact binding agent (such as concrete, bitumen, ceramic, etc.);

(ii) The radioactive material is relatively insoluble, or it is intrinsically contained in a relatively insoluble material, so that even under loss of packaging, the loss of radioactive material per package by leaching, when placed in water for seven days, would not exceed (0.1 x A₂); and

(iii) The estimated average specific activity of the solid, excluding any shielding material, does not exceed (0.002 x A₂) per gram.

(97) "Management" means the chief executive officer or other individual having the authority to manage, direct, or administer the licensee's activities, or those persons' delegate or delegates.

(98) "Medical institution" means an organization in which more than one medical discipline is practiced.

(99) "Medical use" means the intentional internal or external administration of radioactive material or the radiation therefrom to patients or human research subjects under the supervision of an authorized user.

(100) "Member of the public" means any individual except when that individual is receiving an occupational dose.

(101) "Minor" means an individual less than eighteen years of age.

(102) "Monitoring" or "radiation monitoring" or "radiation protection monitoring" means the measurement of radiation levels, concentrations, surface area concentrations or quantities of radioactive material and the use of the results of these measurements to evaluate potential exposures and doses.

(103) "NARM" or "naturally occurring or accelerator-produced radioactive material" means naturally occurring or accelerator-produced radioactive material, including naturally occurring material that is technologically enhanced, and those nuclides that are generated in a charged particle accelerator, but does not include source material, byproduct material, or special nuclear material.

(104) "NARM licensing state" means any state with regulations equivalent to the suggested state regulations for control of radiation relating to, and an effective program for, the regulatory control of NARM and which has been granted final designation by the conference of radiation control program directors, inc.

(105) "Nationally tracked source" means a sealed source containing a quantity equal to or greater than "Category 1" or "Category 2" levels of any radioactive material listed in the appendix to rule 3701:1-38-25 of the Administrative Code. In this context a sealed source is defined as radioactive material that is sealed in a capsule or closely bonded, in a solid form and which is not exempt from regulatory control. It does not mean material encapsulated solely for disposal, or nuclear material contained in any fuel assembly, subassembly, fuel rod, or fuel pellet. "Category 1" nationally tracked sources are those containing radioactive material at a quantity equal to or greater than the "Category 1" threshold. "Category 2" nationally tracked sources are those containing radioactive material at a quantity equal to or greater than the "Category 2" threshold but less than the "Category 1" threshold.

(106) "Negative pressure respirator" or "tight fitting respirator" means a respirator in which the air pressure inside the facepiece is negative during inhalation with respect to the ambient air pressure outside the respirator.

(107) "Nonstochastic effect" or "deterministic effect" means health effects, the severity of which varies with the dose and for which a threshold is believed to exist. Radiation-induced cataract formation is an example of a nonstochastic effect.

(108) "NORM" or "naturally occurring radioactive material" means any nuclide that is radioactive in its natural physical state, but does not include source material, byproduct material, or special nuclear material.

(109) "Normal form radioactive material" means radioactive material that has not been demonstrated to qualify as special form radioactive material.

(110) "Nuclear regulatory commission" means the federal agency established by Title II of the Energy Reorganization Act of 1974, 88 Stat. 1233, 42 U.S.C.A. 5801, as amended (2005), comprising the members of the commission and all offices, employees, and representatives authorized to act in any case or matter related to licensing and related regulatory function previously assigned to the AEC.

(111) "Occupational dose" means the dose received by an individual in the course of employment in which the individual's assigned duties involve exposure to radiation or radioactive material from licensed and unlicensed sources of radiation, whether in the possession of the licensee or other person. Occupational dose does not include doses received from background radiation, from any medical administration the individual has received, from exposures to individuals administered radioactive materials and released in accordance with rule 3701:1-58-30 of the Administrative Code or equivalent United States nuclear regulatory commission or agreement state regulations, from voluntary participation in medical research programs, or as a member of the public.

(112) "Package" means the packaging together with its radioactive contents as presented for transport.

(a) Fissile material package or type AF package, type BF package, type B(U)F package, or type B(M)F package means a fissile material packaging together with its fissile material contents.

(b) Type A package means a type A packaging together with its radioactive contents. A type A package is defined and must comply with the United States department of transportation regulations in 49 C.F.R. 173 (as in effect on the effective date of this rule).

(c) Type B package means a type B packaging together with its radioactive contents. On approval, a type B package design is designated by the United States nuclear regulatory commission as B(U) unless the package has a maximum normal operating pressure of more than seven hundred kilopascals (one hundred pounds per square inch) gauge or a pressure relief device that would allow the release of radioactive material to the environment under the tests specified in 10 C.F.R. 71.73 (hypothetical accident conditions) (as in effect on the effective date of this rule), in which case it will receive a designation B(M). B(U) refers to the need for unilateral approval of international shipments; B(M) refers to the need for multilateral approval of international shipments. There is no distinction made in how packages with these designations may be used in domestic transportation. To determine their distinction for international transportation, see United States department of transportation regulations in 49 C.F.R. 173 (as in effect on the effective date of this rule). A type B package approved before September 6, 1983, was designated only as type B. Limitations on its use are specified in 10 C.F.R. 71.19 (as in effect on the effective date of this rule).

(113) "Packaging" means the assembly of components necessary to ensure compliance with the packaging requirements of rule 49 C.F.R. 173 Subpart I (as in effect on the effective date of this rule). It may consist of one or more receptacles, absorbent materials, spacing structures, thermal insulation, radiation shielding, and devices for cooling or absorbing mechanical shocks. The vehicle, tie-down system and auxiliary equipment may be designated as part of the packaging.

(114) "Particle accelerator" means any machine capable of accelerating electrons, protons, deuterons, or other charged particles in a vacuum and of discharging the resultant particulate or other radiation into a medium at energies usually in excess of one megaelectron volt. For purposes of this definition, "accelerator" is an equivalent term.

(115) "Person" means any individual, corporation, association, business enterprise, or other legal entity either public or private and any legal successor, representative, agent, or agency of that individual, corporation, association, business enterprise, or other legal entity. Person also includes the United States, states, political subdivisions of states, and any department, agency, or instrumentality of the United States or a state, except the U.S. department of energy or the U.S. nuclear regulatory commission where the state regulation of radioactive material by either of those agencies is prohibited by federal law.

(116) "Personnel dosimeter", means a device that measures radiation dose that is processed and evaluated by an accredited "National Voluntary Laboratory Accreditation Program" (NVLAP) processor. Examples of personnel dosimeters include film badges, thermo-luminescent dosimeters (TLD), and optically stimulated luminescence (OSL) dosimeters.

(117) "Pharmacist" means a person who is licensed by the state of Ohio to practice pharmacy pursuant to Chapter 4731. of the Revised Code.

(118) "Physician" means a person who is licensed pursuant to Chapter 4731. of the Revised Code to practice medicine or surgery or osteopathic medicine or surgery.

(119) "Planned special exposure" means an infrequent exposure to radiation, separate from and in addition to the annual dose limits.

(120) "Podiatrist" means an individual licensed by the state of Ohio to practice podiatry pursuant to Chapter 4731. of the Revised Code.

(121) "Positive pressure respirator" means a respirator in which the pressure inside the respiratory inlet covering exceeds the ambient air pressure outside the respirator.

(122) "Positron Emission Tomography (PET) radionuclide production facility" means a facility operating a cyclotron or accelerator for the purpose of producing PET radionuclides.

(123) "Powered air-purifying respirator" or "PAPR" means an air-purifying respirator that uses a blower to force the ambient air through air purifying elements to the inlet covering.

(124) "Pressure demand respirator" means a positive pressure atmosphere supplying respirator that admits breathing air to the facepiece when the positive pressure is reduced inside the facepiece by inhalation.

(125) "Public dose" means the dose received by a member of the public from exposure to radiation and/or radioactive material released by the licensee, or to any other source of radiation under the control of a licensee or registrant. Public dose does not include occupational dose or doses received from background radiation, from any medical administration the individual has received, from exposures to individuals administered radioactive materials and released in accordance with rule 3701:1-58-30 of the Administrative Code or equivalent United States nuclear regulatory commission or agreement state regulations, or from voluntary participation in medical research programs.

(126) "Pyrophoric material" means any liquid that ignites spontaneously in dry or moist air at or below 54.4 degrees celsius (one hundred thirty degrees fahrenheit). A pyrophoric solid is any solid material, other than one classed as an explosive, which under normal conditions is liable to cause fires through friction, retained heat from manufacturing or processing, or which can be ignited readily and when ignited burns so vigorously and persistently as to create a serious transportation, handling, or disposal hazard. Included are spontaneously combustible and water-reactive materials.

(127) "Qualitative fit test" or "QLFT" means a pass/fail fit test to assess the adequacy of respirator fit that relies on the individual's response to the test agent.

(128) "Quality factor" or "Q" means the modifying factor, as listed in paragraphs (A) and (B) of rule 3701:1-38-11 of the Administrative Code, that is used to derive dose equivalent from absorbed dose.

(129) "Quantitative fit test" or "QNFT" means an assessment of the adequacy of respirator fit by numerically measuring the amount of leakage into the respirator.

(130) "Quarter" or "quarterly" means a period of time equal to one-fourth of the year observed by the licensee or registrant, approximately thirteen consecutive weeks, providing that the beginning of the first quarter in a year coincides with the starting date of the year and that no day is omitted or duplicated in consecutive quarters.

(131) "Rad" means the special unit of radiation absorbed dose. One rad is equal to an absorbed dose of one hundred ergs per gram, or 0.01 joule per kilogram, or 0.01 gray.

(132) "Radiation" or "ionizing radiation" means alpha particles, beta particles, gamma rays, x-rays, neutrons, high speed electrons, high speed protons, and other particles capable of producing ions. Radiation does not include nonionizing radiation, such as radio or microwaves, or visible, infrared or ultraviolet light.

(133) "Radiation area" means an area, accessible to individuals, in which radiation levels could result in an individual receiving a dose equivalent in excess of 0.05 millisievert (0.005 rem) in one hour at thirty centimeters from the source of radiation or from any surface that the radiation penetrates.

(134) "Radiation-generating equipment" or "RGE" means any manufactured product or device, or component of such a product or device, or any machine or system that during operation can generate or emit radiation, except those that emit radiation only from radioactive material. "Radiation-generating equipment" does not include either of the following:

(a) Diathermy machines;

(b) Microwave ovens, including food service microwave ovens used for commercial and industrial uses, television receivers, electric lamps, and other household appliances and products that generate very low levels of radiation.

(135) "Radiation Safety Officer" or "RSO" means an individual designated by the licensee who has the knowledge and responsibility for the overall radiation safety program at the facility, to include the implementation of the daily radiation safety operations and compliance with the rules.

(136) "Radioactive material" means any solid, liquid or gaseous material that emits ionizing radiation spontaneously. "Radioactive material" includes accelerator-produced and naturally occurring radioactive materials and byproduct, source, and special nuclear material.

(137) "Radioactive waste" means waste containing regulated radioactive material.

(138) "Radioactivity" means the transformation of unstable atoms by the emission of radiation.

(139) "Radiography" means the same as industrial radiography.

(140) "Reference man" means a hypothetical aggregation of human physical and physiological characteristics arrived at by international consensus. These characteristics may be used by researchers and public health workers to standardize results of experiments and to relate biological insult to a common base.

(141) "Registrant" means a person required by Chapter 3748. of the Revised Code to register radiation-generating equipment with the director.

(142) "Rem" means the special unit of any of the quantities expressed as dose equivalent. The dose equivalent in rem is equal to the absorbed dose in rads multiplied by the quality factor (one rem = 0.01 Sv).

(143) "Research and development" means

(a) Theoretical analysis, exploration, or experimentation; or

(b) The extension of investigative findings and theories of a scientific or technical nature into practical application for experimental and demonstration purposes, including the experimental production and testing of models, devices, equipment, materials and processes. "Research and development" does not include the internal or external administration of sources of radiation to human beings.

(144) "Residual radioactivity" means radioactivity in structures, materials, soils, groundwater, and other media at a site resulting from activities under the licensee's control. This includes radioactivity from all licensed and unlicensed sources used by the licensee, but excludes background radiation. It also includes radioactive materials remaining at the site as a result of routine or accidental releases of radioactive material at the site and previous burials at the site, even if those burials were made in accordance with the provisions of 10 C.F.R. 20 (as in effect on the effective date of this rule).

(145) "Respiratory protective equipment or device" means an apparatus, such as a respirator, used to reduce the individual's intake of airborne radioactive materials.

(146) "Restricted area" means an area access to which is limited by the licensee or registrant for the purpose of protecting individuals against undue risks from exposure to sources of radiation. Restricted area does not include areas used as residential quarters, but separate rooms in a residential building may be set apart as a restricted area.

(147) "Roentgen" means the amount of gamma or x-rays required to produce ions resulting in a charge of 0.000258 coulombs per kilogram of air under standard conditions.

(148) "Sanitary sewerage" means a system of public sewers for carrying off wastewater and refuse, but excluding sewage treatment facilities, septic tanks, and leach fields owned or operated by the licensee.

(149) "Sealed source" means radioactive material that is encased in a manner designed to prevent leakage or escape of the radioactive material.

(150) "Sealed source and device registry" means the national registry that contains all the registration certificates, generated by both the United States nuclear regulatory commission and the agreement states, that summarize the radiation safety information for the sealed sources and devices and describe the licensing and use conditions approved for the product.

(151) "Seismic area" means any area where the probability of a horizontal acceleration in rock of more than 0.3 times the acceleration of gravity in two hundred fifty years is greater than ten per cent, as designated by the United States geological survey.

(152) "Self-contained breathing apparatus" or "SCBA" means an atmosphere-supplying respirator for which the breathing air source is designed to be carried by the user.

(153) "Shallow dose equivalent" or "H_S" means the external exposure of the skin of the whole body or the skin of an extremity, is taken as the dose equivalent at a tissue depth of 0.007 centimeter, or seven milligrams per square centimeter.

(154) "Sievert" or "Sv" means the SI unit of any of the quantities expressed as dose equivalent. The dose equivalent in sieverts is equal to the absorbed dose in grays multiplied by the quality factor. One sievert equals one hundred rem.

(155) "Site area emergency" means events may occur, are in progress, or have occurred that could lead to a significant release of radioactive material and that could require a response by off-site response organizations to protect persons off-site.

(156) "Site boundary" means that line beyond which the land or property is not owned, leased, or otherwise controlled by the licensee or registrant.

(157) "Site closure and stabilization" means those actions that are taken upon completion of operations that prepare a disposal site for custodial care and that assure that the disposal site will remain stable and will not need ongoing active maintenance.

(158) "Source material" means uranium, thorium, or any combination thereof in any physical or chemical form, or any ores that contain by weight at least one-twentieth of one per cent (0.05 per cent) of uranium, thorium, or any combination thereof. Source material does not include special nuclear material.

(159) "Sources of radiation" means radioactive material or radiation generating equipment.

(160) "Special form radioactive material" means radioactive material that satisfies the following conditions:

(a) It is either a single solid piece or is contained in a sealed capsule that can be opened only by destroying the capsule;

(b) The piece or capsule has at least one dimension not less than five millimeters (0.2 inch); and

(c) It satisfies the test requirements specified by the United States nuclear regulatory commission in 10 C.F.R. 71.75 (as in effect on the effective date of this rule). A special form encapsulation designed in accordance with the United States nuclear regulatory commission requirements identified in 10 C.F.R. 71.4, in effect on June 30, 1983, and constructed prior to July 1, 1985; a special form encapsulation designed in accordance with the requirements of 10 C.F.R. 71.4 in effect on March 31, 1996, and constructed before April 1, 1998; and special form material that was successfully tested before September 10, 2015 in accordance with the requirements of 10 C.F.R. 71.75(d) of this section in effect before September 10, 2015 may continue to be used. Any other special form encapsulation must meet the specifications of this definition.

(161) "Special nuclear material" means either of the following:

(a) Plutonium, uranium-233, uranium enriched in the isotope 233, or in the isotope 235, and any other material that the United States nuclear regulatory commission determines to be special nuclear material, but does not include source material pursuant to section 51 of the Atomic Energy Act of 1954, 68 Stat 919, 42 USCA 2071, as amended (2005).

(b) Any material artificially enriched by any of the foregoing but does not include source material.

(162) "Special nuclear material in quantities not sufficient to form a critical mass" means uranium enriched in the isotope uranium-235 in quantities not exceeding three hundred fifty grams of contained uranium-235; uranium-233 in quantities not exceeding two hundred grams; plutonium in quantities not exceeding two hundred grams; or any combination of them in accordance with the following formula: for each kind of special nuclear material, determine the ratio between the quantity of that special nuclear material and the quantity specified in this paragraph for the same kind of special nuclear material. The sum of such ratios for all of the kinds of special nuclear material in combination shall not exceed unity.

(163) "Stochastic effect" means health effects that occur randomly and for which the probability of the effect occurring, rather than its severity, is assumed to be a linear function of dose without threshold. Hereditary effects and cancer incidence are examples of stochastic effects.

(164) "Supplied-air respirator" or "SAR" or "airline respirator" means an atmosphere-supplying respirator for which the source of breathing air is not designed to be carried by the user.

(165) "Surface contaminated object" or "SCO" means a solid object that is not itself classed as radioactive material, but which has radioactive material distributed on any of its surfaces. SCO must be in one of two groups with surface activity not exceeding the following limits:

(a) SCO-I: a solid object on which:

(i) The non-fixed contamination on the accessible surface averaged over three hundred square centimeters, or the area of the surface if less than three hundred square centimeters, does not exceed four becquerels per square centimeter (10^-4 microcurie per square centimeter) for beta and gamma and low toxicity alpha emitters, or 0.4 becquerels per square centimeter 10^-5 microcurie per square centimeter) for all other alpha emitters;

(ii) The fixed contamination on the accessible surface averaged over three hundred square centimeters, or the area of the surface if less than three hundred square centimeters, does not exceed forty thousand becquerels per square centimeter (one microcurie per square centimeter) for beta and gamma and low toxicity alpha emitters, or four thousand becquerels per square centimeter (0.1 microcurie per square centimeter) for all other alpha emitters; and

(iii) The non-fixed contamination plus the fixed contamination on the inaccessible surface averaged over three hundred square centimeters, or the area of the surface if less than three hundred square centimeters, does not exceed forty thousand becquerels per square centimeter (one microcurie per square centimeter) for beta and gamma and low toxicity alpha emitters, or four thousand becquerels per square centimeter (0.1 microcurie per square centimeter) for all other alpha emitters.

(b) SCO-II: a solid object on which the limits for SCO-I are exceeded and on which:

(i) The non-fixed contamination on the accessible surface averaged over three hundred square centimeters, or the area of the surface if less than three hundred square centimeter, does not exceed four hundred becquerels per square centimeter (10^-2 microcurie per square centimeter) for beta and gamma and low toxicity alpha emitters, or forty becquerels per square centimeter (10^-3 microcurie per square centimeter) for all other alpha emitters;

(ii) The fixed contamination on the accessible surface averaged over three hundred square centimeters, or the area of the surface if less than three hundred square centimeters, does not exceed eight hundred thousand becquerels per square centimeter (twenty microcuries per square centimeter) for beta and gamma and low toxicity alpha emitters, or eighty thousand becquerels per square centimeter (two microcuries per square centimeter) for all other alpha emitters; and

(iii) The non-fixed contamination plus the fixed contamination on the inaccessible surface averaged over three hundred square centimeters, or the area of the surface if less than three hundred square centimeters, does not exceed eight hundred thousand becquerels per square centimeter (twenty microcuries per square centimeter) for beta and gamma and low toxicity alpha emitters, or eighty thousand becquerels per square centimeter (two microcuries per square centimeter) for all other alpha emitters.

(166) "Survey" means an evaluation of the radiological conditions and potential hazards incident to the production, use, transfer, release, disposal or presence of radioactive material or other sources of radiation. When appropriate, such an evaluation includes a physical survey of the location of radioactive material, or the sources of radiation and measurements or calculations of levels of radiation, or concentrations or quantities of radioactive material present.

(167) "Tight-fitting facepiece" means a respiratory inlet covering that forms a complete seal with the face.

(168) "Total effective dose equivalent" or "TEDE" means the sum of the effective dose equivalent (for external exposures) and the committed effective dose equivalent (for internal exposures).

(169) "Transport index" means the dimensionless number, rounded up to the next tenth, placed on the label of a package, to designate the degree of control to be exercised by the carrier during transportation. The transport index is the number determined by multiplying the maximum radiation level in millisievert per hour at one meter (3.3 feet) from the external surface of the package by one hundred, which is equivalent to the maximum radiation level in millirem per hour at one meter (3.3 feet).

(170) "Type A quantity" means a quantity of radioactive material, the aggregate radioactivity of which does not exceed A₁ for special form radioactive material, or A₂ for normal form radioactive material, where A₁ and A₂ are given in rule 3701:1-50-25 of the Administrative Code.

(171) "Type B quantity" means a quantity of radioactive material greater than a type A quantity.

(172) "Type B package" is defined under "Package."

(173) "United States department of energy" means the department of energy established by the Department of Energy Organization Act, PL 95-91, 91 Stat. 565 (1977), 42 U.S.C. 7101 et seq., as amended (2006), to the extent that the department of energy or its duly authorized representatives, exercises functions formerly vested in the United States atomic energy commission, its chairman, members, officers and components and transferred to the United States energy research and development administration and to the administrator thereof pursuant to Sections 104(b) to (d) of the Energy Reorganization Act of 1974, PL 93-438, 88 Stat. 1233 at 1237 (1974), 42 U.S.C. 5814 and retransferred to the secretary of energy pursuant to Section 301(a) of the Department of Energy Organization Act, PL 95-91, 91 Stat. 565 at 577-578 (1977), 42 U.S.C. 7151.

(174) "Unrestricted area" or "uncontrolled area" means any area, access to which is neither restricted nor controlled by the licensee or registrant.

(175) "User seal check" or "fit check" means an action conducted by the respirator user to determine if the respirator is properly seated to the face. Examples include negative pressure check, positive pressure check, irritant smoke check, or isoamyl acetate check.

(176) "Very high radiation area" means an area, accessible to individuals, in which radiation levels from radiation sources external to the body could result in an individual receiving an absorbed dose in excess of five gray (five hundred rad) in one hour at one meter from a source of radiation or from any surface that the radiation penetrates. At very high doses received at high dose rates, units of absorbed dose, gray and rad, are appropriate, rather than units of dose equivalent, sievert and rem.

(177) "Veterinarian" means an individual licensed by the state of Ohio to practice veterinary medicine pursuant to Chapter 4741. of the Revised Code.

(178) "Waste" means those low-level radioactive wastes containing source, special nuclear, or byproduct material that are acceptable for disposal in a land disposal facility. For the purposes of this definition, low-level radioactive waste means radioactive waste not classified as high-level radioactive waste, transuranic waste, spent nuclear fuel, or byproduct material as defined in paragraph (A)(26)(b) of this rule, or byproduct material as defined in section 11 E. (3) and (4) of the Atomic Energy Act of 1954, 68 Stat. 919, 42 USC 2014, as amended (2005).

(179) "Week" means seven consecutive days starting on Sunday.

(180) "Weighting factor

• W_T" for an organ or tissue, (T), is the proportion of the risk of stochastic effects resulting from irradiation of that organ or tissue to the total risk of stochastic effects when the whole body is irradiated uniformly. For calculating the effective dose equivalent, the values of W_T are:

| Organ doseweighting factors | | | --- | --- | | Organ ortissue | W_T | | Gonads | 0.25 | | Breast | 0.15 | | Red bone marrow | 0.12 | | Lung | 0.12 | | Thyroid | 0.03 | | Bonesurfaces | 0.03 | | Remainder | 0.30^a | | Whole body | 1.00^b |

^\a 0.30 results from 0.06 for each of five "remainder" organs, excluding the skin and the lens of the eye, that receive the highest doses.

^\b for the purpose of weighting the external whole body dose (for adding it to the internal dose) a single weighting factor, W_T = 1.0, has been specified. The use of other weighting factors for external exposure will be approved on a case-by-case basis until such time as specific guidance is issued.

(181) "Whole body" means for purposes of external exposure, head; trunk, including male gonads; arms above the elbow; legs above the knee.

(182) "Worker" means an individual engaged in activities licensed or registered by the department and controlled by a licensee or registrant, but does not include the licensee or registrant.

(183) "Working level" or "WL" means any combination of short-lived radon decay products (for radon-222: polonium-218, lead-214, bismuth-214, and polonium-214; and for radon-220: polonium-216, lead-212, bismuth-212, and polonium-212) in one liter of air that will result in the ultimate emission of 1.3 x 10⁵ million electron volts alpha particle energy.

(184) "Working level month" or "WLM" means a cumulative exposure to one working level for one hundred seventy hours. (Two thousand working hours per year/twelve months per year equals approximately one hundred seventy hours per month.)

(185) "Year" means the period of time beginning in January used to determine compliance with the provisions of this rule. The licensee or registrant may change the starting date of the year used to determine compliance by the licensee or registrant provided that the change is made at the beginning of the year and that no day is omitted or duplicated in consecutive years.

(B) The terms set out in paragraph (A) of this rule may be redefined in other chapters as promulgated pursuant to Chapter 3748. of the Revised Code as used in that chapter only.

Last updated May 13, 2026 at 11:20 AM

History

• Effective: January 20, 2022
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-44-02 Purpose and scope.

(A) The rules in Chapter 3701:1-44 of the Administrative Code establish procedures and criteria for the issuance of licenses to receive title to, receive, possess, use, transfer, or deliver source and byproduct materials, as defined in rule 3701:1-44-01 of the Administrative Code, and establish and provide for the terms and conditions upon which the director will issue such licenses.

(B) Except as provided in rules 3701:1-44-07 to 3701:1-44-10 of the Administrative Code, the rules in Chapter 3701:1-44 of the Administrative Code apply to all persons in the state of Ohio.

Last updated November 2, 2022 at 2:14 PM

History

• Effective: December 10, 2015
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-44-07

(A) Except to the extent that United States department of energy facilities or activities of the types subject to licensing pursuant to section 202 of the "Energy Reorganization Act of 1974" (Pub.L. 93-438, 88 Stat. 1233, 42 U.S.C. 5842) or the "Uranium Mill Tailings Radiation Control Act of 1978" (Pub.L. 95-604, 92 Stat. 3021, 42 U.S.C. 7901 st seq.) as amended are involved, any prime contractor of the United States department of energy is exempt from the requirements for a license set forth in sections 62, 63, and 64 of the "Atomic Energy Act of 1954 (68 Stat. 919)" and from the rules in this chapter to the extent that such contractor, under his prime contract with the United States department of energy, receives, possesses, uses, transfers or delivers source material for:

(1) The performance of work for the United States department of energy at a United States government-owned or controlled site, including the transportation of source material to or from such site and the performance of contract services during temporary interruptions of such transportation;

(2) Research in, or development, manufacture, storage, testing or transportation of, atomic weapons or components thereof; or

(3) The use or operation of nuclear reactors or other nuclear devices in a United States government-owned vehicle or vessel.

(B) In addition to the foregoing exemptions, and subject to the requirement for licensing of United States department of energy facilities and activities pursuant to section 202 of the "Energy Reorganization Act of 1974" (Pub.L. 93-438, 88 Stat. 1233, 42 U.S.C. 5842) or the "Uranium Mill Tailings Radiation Control Act of 1978" (Pub.L. 95-604, 92 Stat. 3021, 42 U.S.C. 7901 et seq.) as amended, any prime contractor or subcontractor of the United States department of energy or the United States nuclear regulatory commission is exempt from the requirements for a license set forth in sections 62, 63, and 64 of the "Atomic Energy Act of 1954 (68 Stat. 919)" and from the rules in Chapter 3701:1-44 of the Administrative Code to the extent that such prime contractor or subcontractor receives, possesses, uses, transfers or delivers source material under his prime contract or subcontract when the department determines that the exemption of the prime contractor or subcontractor is authorized by law; and that, under the terms of the contract or subcontract, there is adequate assurance that the work thereunder can be accomplished without undue risk to the public health and safety.

Last updated May 23, 2022 at 7:57 AM

History

• Effective: May 23, 2022
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-44-10

(A) The director may, upon application of any interested person or upon the director's own initiative, grant such exemptions from the requirements of the rules in Chapter 3701:1-44 of the Administrative Code as the director determines are authorized by law and will not endanger life or property or the common defense and security and are otherwise in the public interest.

(B) The United States department of energy is exempt from the requirements of Chapter 3701:1-44 of the Administrative Code.

(C) Except as specifically provided in Chapter 3701:1-54 of the Administrative Code, any licensee is exempt from the requirements of Chapter 3701:1-44 of the Administrative Code to the extent that its activities are subject to the requirements of Chapter 3701:1-54 of the Administrative Code.

Last updated May 23, 2022 at 7:57 AM

History

• Effective: May 23, 2022
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-44-03 Coverage of inactive tailings sites.

(A) Prior to the completion of the remedial action, the United States nuclear regulatory commission will not require a license pursuant to 10 CFR chapter I for possession of residual radioactive materials as defined in rule 3701:1-44-01 of the Administrative Code that are located at a site where milling operations are no longer active, if the site is covered by the remedial action program of title I of the "Uranium Mill Tailings Radiation Control Act of 1978" (Pub.L. 95-604, 92 Stat. 3021, 42 U.S.C. 7911 to 7925), as amended. The United States nuclear regulatory commission will exert its regulatory role in remedial actions primarily through concurrence and consultation in the execution of the remedial action pursuant to title I of the "Uranium Mill Tailings Radiation Control Act of 1978" (Pub.L. 95-604, 92 Stat. 3021, 42 U.S.C. 7911 to 7925), as amended. After remedial actions are completed, the United States nuclear regulatory commission will license the long-term care of sites, where residual radioactive materials are disposed, under the requirements set out in 10 C.F.R. 40.27 (as in effect on the effective date of this rule).

(B) The United States nuclear regulatory commission will regulate byproduct material as defined in this part that is located at a site where milling operations are no longer active, if such site is not covered by the remedial action program of title I of the "Uranium Mill Tailings Radiation Control Act of 1978" (Pub.L. 95-604, 92 Stat. 3021, 42 U.S.C. 7911 to 7925), as amended. The criteria in appendix A of 10 C.F.R. 40 (as in effect on the effective date of this rule) will be applied to such sites.

Last updated May 23, 2022 at 7:56 AM

History

• Effective: May 23, 2022
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-44-04 License requirements and types of licenses.

(A) A person subject to the rules in Chapter 3701:1-44 of the Administrative Code may not receive title to, own, receive, possess, use, transfer, provide for long-term care, deliver or dispose of byproduct material or residual radioactive material as defined in rule 3701:1-44-01 of the Administrative Code or any source material after removal from its place of deposit in nature, unless authorized in a specific or general license issued by the director under the rules in Chapter 3701:1-44 of the Administrative Code.

(B) Licenses for source material and byproduct material are of two types: general and specific. Licenses for long-term care and custody of residual radioactive material at disposal sites are general licenses. The general licenses provided in Chapter 3701:1-44 of the Administrative Code are effective without the filing of applications with the department or the issuance of licensing documents to particular persons. Specific licenses are issued to named persons upon applications filed pursuant to the rules in Chapter 3701:1-44 of the Administrative Code.

Last updated November 2, 2022 at 2:14 PM

History

• Effective: December 10, 2015
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-44-05 Communications.

Except as otherwise provided, any communication or report required by Chapter 3701:1-44 of the Administrative Code shall be filed in accordance with Chapter 3748. of the Revised Code and rules promulgated thereunder. Documents pertaining to license application or any license matter, unless otherwise directed in writing, shall be submitted to the director at the following address or by electronic submission in a manner approved by the director:

"Ohio Department of Health

Bureau of Environmental Health and Radiation Protection

246 North High Street

Columbus, Ohio 43215"

Last updated November 2, 2022 at 2:15 PM

History

• Effective: December 10, 2015
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-44-06 Completeness and accuracy of information.

(A) Information provided to the director by an applicant for a license or by a licensee or information required by statute or by the department's rules, orders, or license conditions to be maintained by the applicant or the licensee shall be complete and accurate in all material respects.

(B) Each applicant or licensee shall notify the director of information identified by the applicant or licensee as having for the regulated activity a significant implication for public health and safety or common defense and security. An applicant or licensee violates this paragraph only if the applicant or licensee fails to notify the director of information that the applicant or licensee has identified as having a significant implication for public health and safety or common defense and security. Notification shall be provided to the director within two working days of identifying the information. This requirement is not applicable to information which is already required to be provided to the director by other reporting or updating requirements.

Last updated November 2, 2022 at 2:15 PM

History

• Effective: December 10, 2015
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-44-08 Carriers.

Common and contract carriers, freight forwarders, warehousemen, and the United States postal service are exempt from the requirements in Chapter 3701:1-44 of the Administrative Code to the extent that they are not required to be licensed as set forth in Chapter 3748. of the Revised Code and rules promulgated thereunder to the extent that they only transport or store source material in the regular course of the carriage for another or storage incident thereto.

Last updated November 2, 2022 at 2:15 PM

History

• Effective: February 6, 2006
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-44-09 Unimportant quantities of source material.

(A) Any person is exempt from the requirements in Chapter 3701:1-44 of the Administrative Code and from the requirements for a license set forth in Chapter 3748. of the Revised Code and the rules adopted thereunder to the extent that such person receives, possesses, uses, transfers or delivers source material in any chemical mixture, compound, solution, or alloy in which the source material is by weight less than one-twentieth of one per cent (0.05 per cent) of the mixture, compound, solution or alloy. The exemption contained in this paragraph does not include byproduct material as defined in Chapter 3701:1-44 of the Administrative Code.

(B) Any person is exempt from the requirements in Chapter 3701:1-44 of the Administrative Code and from the requirements for a license set forth in Chapter 3748. of the Revised Code and the rules adopted thereunder to the extent that such person receives, possesses, uses, or transfers unrefined and unprocessed ore containing source material; provided, that, except as authorized in a specific license, such person shall not refine or process such ore.

(C) Any person is exempt from the requirements in Chapter 3701:1-38 and Chapter 3701:1-44 of the Administrative Code and from the requirements for a license set forth in Chapter 3748. of the Revised Code and the rules adopted thereunder to the extent that such person receives, possesses, uses, or transfers:

(1) Any quantities of thorium contained in:

(a) Incandescent gas mantles;

(b) Vacuum tubes;

(c) Welding rods;

(d) Electric lamps for illuminating purposes, provided that each lamp does not contain more than fifty milligrams of thorium;

(e) Germicidal lamps, sunlamps, and lamps for outdoor or industrial lighting, provided that each lamp does not contain more than two grams of thorium;

(f) Rare earth metals and compounds, mixtures, and products containing not more than 0.25 per cent by weight thorium, uranium, or any combination of these; or

(g) Personnel neutron dosimeters, provided that each dosimeter does not contain more than fifty milligrams of thorium.

(2) Source material contained in the following products:

(a) Glazed ceramic tableware manufactured before August 27, 2013, provided that the glaze contains not more than twenty per cent by weight source material;

(b) Piezoelectric ceramic containing not more than two per cent by weight source material;

(c) Glassware containing not more than two per cent by weight source material or, for glass ware manufactured before August 27, 2013, ten per cent by weight source material; but not including commercially manufactured glass brick, pane glass, ceramic tile, or other glass or ceramic used in construction;

(d) Glass enamel or glass enamel frit containing not more than ten per cent by weight source material imported or ordered for importation into the United States, or initially distributed by manufacturers in the United States, before July 25, 1983.

(3) Photographic film, negatives, and prints containing uranium or thorium;

(4) Any finished product or part fabricated of, or containing tungsten or magnesium-thorium alloys, provided that the thorium content of the alloy does not exceed four per cent by weight and that the exemption contained in this subparagraph shall not be deemed to authorize the chemical, physical or metallurgical treatment or processing of any such product or part; and

(5) Uranium contained in counterweights installed in aircraft, rockets, projectiles, and missiles, or stored or handled in connection with installation or removal of such counterweights, provided that:

(a) Each counterweight has been impressed with the following legend clearly legible through any plating or other covering: "Depleted Uranium";

(b) Each counterweight is durably and legibly labeled or marked with the identification of the manufacturer, and the statement: "Unauthorized Alterations Prohibited"; and

(c) The exemption contained in this paragraph shall not be deemed to authorize the chemical, physical, or metallurgical treatment or processing of any such counterweights other than repair or restoration of any plating or other covering.

(d) The requirements specified in paragraphs (C)(5)(a) and (C)(5)(b) of this rule need not be met by counterweights manufactured prior to Dec. 31, 1969, provided that such counterweights were manufactured under a specific license issued by the atomic energy commission and were impressed with the legend required by 10 C.F.R. 40.13(c)(5)(ii) in effect on June 30, 1969.

(6) Natural or depleted uranium metal used as shielding constituting part of any shipping container, provided that:

(a) The shipping container is conspicuously and legibly impressed with the legend "CAUTION--RADIOACTIVE SHIELDING--URANIUM"; and

(b) The uranium metal is encased in mild steel or equally fire resistant metal of minimum wall thickness of 3.2 millimeter (0.125 inch).

(7) Thorium or uranium contained in or on finished optical lenses and mirrors, provided that each lens or mirror does not contain more than ten per cent by weight thorium or uranium or, for lenses manufactured before August 27, 2013, thirty per cent by weight of thorium; and that the exemption contained in this paragraph does not authorize either:

(a) The shaping, grinding or polishing of such lens or mirror or manufacturing processes other than the assembly of such lens or mirror into optical systems and devices without any alteration of the lens or mirror; or

(b) The receipt, possession, use, or transfer, of uranium or thorium contained in contact lenses, or in spectacles, or in eyepieces in binoculars or other optical instruments.

(8) Thorium contained in any finished aircraft engine part containing nickel-thoria alloy, provided that:

(a) The thorium is dispersed in the nickel-thoria alloy in the form of finely divided thoria (thorium dioxide); and

(b) The thorium content in the nickel-thoria alloy does not exceed four per cent by weight.

(9) The exemptions in paragraph (C) of this rule do not authorize the manufacture of any of the products described.

(10) No person may initially transfer for sale or distribution a product containing source material to persons exempt under this paragraph, or equivalent regulations of an "Agreement State," unless authorized by a license issued by the United States nuclear regulatory commission to initially transfer such products for sale or distribution. Persons authorized by a license issued by the director, the United States nuclear regulatory commission, or an agreement state to manufacture, process, or produce these materials or products containing source material by the director or an agreement state, and persons who import finished products or parts, for sale or distribution must be authorized by a license issued by the United States nuclear regulatory commission for distribution only and are exempt from the requirements of Chapter 3701:1-38 and paragraphs (A)(2) and (A)(3) of rule 3701:1-44-15 of the Administrative Code.

Last updated November 2, 2022 at 2:15 PM

History

• Effective: December 10, 2015
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-44-15

(A) An application for a specific license will be approved if:

(1) The application is for a purpose authorized by Chapter 3748. of the Revised Code and the rules promulgated thereunder;

(2) The applicant is qualified by reason of training and experience to use the source material for the purpose requested in such manner as to protect health and minimize danger to life or property;

(3) The applicant's proposed equipment, facilities and procedures are adequate to protect health and minimize danger to life or property;

(4) For an application to possess and use source and byproduct material for uranium milling or for the conduct of any other activity which the director determines will significantly affect the quality of the environment, the director has concluded that the action called for is the issuance of the proposed license, along with any appropriate conditions to protect environmental values, after:

(a) Reviewing filed information;

(b) Making evaluations pursuant to rule 3701:1-40-30 of the Administrative Code; and

(c) Weighing the environmental, economic, technical and other benefits against environmental costs and considering available alternatives; and

(5) The applicant satisfies any applicable special requirements contained in rule 3701:1-44-16 of the Administrative Code.

(B) Commencement of construction prior to this conclusion in paragraph (A)(4) of this rule is grounds for denial of a license to possess and use source and byproduct material in the plant or facility. The term "commencement of construction" is as defined in rule 3701:1-38-01 of the Administrative Code.

(C) All applicants shall prohibit commencement of construction with respect to such material listed in paragraph (A)(4) of this rule until the director has issued a license.

Last updated November 2, 2022 at 2:15 PM

History

• Effective: December 10, 2015
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-44-11 General license to receive title to source or byproduct material.

A general license is hereby issued authorizing the receipt of title to source or byproduct material, as defined in rule 3701:1-44-01 of the Administrative Code, without regard to quantity. This general license does not authorize any person to receive, possess, deliver, use, or transfer source or byproduct material.

Last updated November 2, 2022 at 2:15 PM

History

• Effective: February 6, 2006
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-44-12 Small quantities of source material.

(A) A general license is hereby issued authorizing commercial and industrial firms; research, educational and medical institutions; and federal, state, and local government agencies to receive, possess, use and transfer uranium and thorium, in their natural isotopic concentrations and in the form of depleted uranium for research, development, educational, commercial or operational purposes in the following forms and quantities:

(1) No more than 1.5 kilograms (3.3 pounds) of uranium and thorium in dispersible forms (e.g., gaseous, liquid, powder, etc.) at any one time. Any material processed by the general licensee that alters the chemical or physical form of the material containing source material must be accounted for as a dispersible form. A person authorized to possess, use, and transfer source material under this paragraph may not receive more than a total of seven kilograms (15.4 pounds) of uranium and thorium in any one calendar year; and

(2) No more than a total of seven kilograms (15.4 pounds) of uranium and thorium at any one time. A person authorized to possess, use, and transfer source material under this paragraph may not receive more than a total of seventy kilograms (one hundred fifty-four pounds) of uranium and thorium in any one calendar year. A person may not alter the chemical or physical form of the source material possessed under this paragraph unless it is accounted for under the limits of paragraph (A)(1) of this rule; or

(3) No more than seven kilograms (15.4 pounds) of uranium, removed during the treatment of drinking water, at any one time. A person may not remove more than seventy kilograms (one hundred fifty-four pounds) of uranium from drinking water during a calendar year under this paragraph; or

(4) No more than seven kilograms (15.4 pounds) of uranium and thorium at laboratories for the purpose of determining the concentration of uranium and thorium contained within the material being analyzed at any one time. A person authorized to possess, use, and transfer source material under this paragraph may not receive more than a total of seventy kilograms (one hundred fifty-four pounds) of source material in any one calendar year.

(B) Any person who receives, possesses, uses, or transfers source material in accordance with the general license in paragraph (A) of this rule:

(1) Is prohibited from administering source material, or the radiation therefrom, either externally or internally, to human beings except as may be authorized by the director in a specific license.

(2) Shall not abandon such source material. Source material may be disposed of as follows:

(a) A cumulative total of 0.5 kilograms (1.1 pounds) of source material in a solid, non-dispersible form may be transferred each calendar year, by a person authorized to receive, possess, use, and transfer source material under this general license to persons receiving the material for permanent disposal. The recipient of source material transferred under the provisions of this paragraph is exempt from the requirements to obtain a license under this chapter to the extent the source material is permanently disposed. This provision does not apply to any person who is in possession of source material under a specific license issued under Chapter 3701:1-44 of the Administrative Code; or

(b) In accordance with rule 3701:1-38-19 of the Administrative Code.

(3) Is subject to the provisions in rules 3701:1-44-01 to 3701:1-44-06, 3701:1-44-19 and 3701:1-44-21 to 3701:1-44-23 of the Administrative Code.

(4) Shall not export such source material except in accordance with 10 CFR 110, as published in Code of Federal Regulations (as in effect on the effective date of this rule).

(C) Any person who receives, possesses, uses, or transfers source material in accordance with paragraph (A) of this rule shall conduct activities so as to minimize contamination of the facility and the environment. When activities involving such source material are permanently ceased at any site, if evidence of significant contamination is identified, the general licensee shall notify the director by an appropriate method listed in rule 3701:1-44-05 of the Administrative Code about such contamination and may consult with the director as to the appropriateness of sampling and restoration activities to ensure that any contamination or residual source material remaining at the site where source material was used under this general license is not likely to result in exposures that exceed the limits in rule 3701:1-38-22 of the Administrative Code.

(D) Any person who receives, possesses, uses, or transfers source material in accordance with the general license granted in paragraph (A) of this rule is exempt from the provisions of Chapter 3701:1-38 of the Administrative Code to the extent that such receipt, possession, use, and transfer are within the terms of this general license, except that such person shall comply with the provisions of rules 3701:1-38-19 and 3701:1-38-22 of the Administrative Code to the extent necessary to meet the provisions of paragraphs (B)(2) and (C) of this rule. However, this exemption does not apply to any person who also holds a specific license issued under Chapter 3701:1-44 of the Administrative Code.

(E) No person may initially transfer or distribute source material to persons generally licensed under paragraph (A)(1) or (A)(2) of this rule, unless authorized by a specific license issued in accordance with rule 3701:1-44-26 of the Administrative Code. This prohibition does not apply to analytical laboratories returning processed samples to the client who initially provided the sample.

Last updated May 23, 2022 at 7:57 AM

History

• Effective: May 23, 2022
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-38-19

(A) A licensee shall dispose of licensed radioactive material in accordance with this rule. Licensed material shall be disposed of in one of the following manners:

(1) By transfer to an authorized recipient as provided in this chapter, Chapter 3701:1-40 of the Administrative Code, or to the United States department of energy;

(2) By decay in storage provided that the radionuclide has a half-life of one hundred twenty days or less, or as otherwise permitted by the license;

(3) By release in effluents within the limits set forth in rule 3701:1-38-13 of the Administrative Code; or

(4) As authorized pursuant to paragraphs (B) to (F) of this rule.

(B) A person shall be specifically licensed to receive waste containing licensed material from another person for:

(1) Treatment prior to disposal;

(2) Treatment or disposal by incineration;

(3) Decay in storage;

(4) Disposal at a land disposal facility licensed pursuant to rules 3701:1-54-06 to 3701:1-54-12 of the Administrative Code or equivalent United States nuclear regulatory commission or agreement state regulations; or

(5) Storage until transfer to a storage or disposal facility authorized to receive the waste.

(C) A licensee or applicant for a license may apply to the director for approval of proposed disposal procedures that are not otherwise authorized in these rules for the disposal of licensed material generated in the licensee's operations. Each application shall include:

(1) A description of the waste containing licensed material to be disposed of, including the physical and chemical properties that have an impact on risk evaluation, and the proposed manner and conditions of waste disposal;

(2) An analysis and evaluation of pertinent information on the nature of the environment;

(3) The nature and location of other potentially affected facilities; and

(4) An analysis and procedures to ensure that doses are maintained ALARA and within the dose limits in rules 3701:1-38-12 and 3701:1-38-13 of the Administrative Code.

(D) A licensee may discharge licensed material into sanitary sewerage as follows:

(1) The material is readily soluble in water or is a biological material that is readily dispersible in water;

(2) The quantity of licensed or other radioactive material that the licensee releases into the sewer in one month divided by the average monthly volume of water released into the sewer by the licensee does not exceed the concentration listed in table III of appendix C to rule 3701:1-38-12 of the Administrative Code; and

(3) If more than one radionuclide is to be released, the following conditions must also be satisfied:

(a) The licensee shall determine the fraction of the limit in table III of appendix C to rule 3701:1-38-12 of the Administrative Code represented by discharges into sanitary sewerage by dividing the actual monthly average concentration of each radionuclide released by the licensee into the sewer by the concentration of that radionuclide listed in table III of appendix C to rule 3701:1-38-12 of the Administrative Code; and

(b) The sum of the fractions for each radionuclide required by paragraph (D)(3)(a) of this rule does not exceed unity.

(4) The total quantity of licensed and other radioactive material that the licensee releases into the sanitary sewerage in a year does not exceed one hundred eighty-five gigabecquerels (five curies) of hydrogen-3, thirty-seven gigabecquerels (one curie) of carbon-14, and thirty-seven gigabecquerels (one curie) of all other radioactive materials combined.

(5) Excreta from an individual undergoing medical diagnosis or therapy with radioactive material is not subject to the limitations contained in paragraph (D) of this rule.

(E) A licensee may dispose of licensed material by decay in storage. A licensee may hold radioactive material with a physical half-life of one hundred twenty days or less for decay-in-storage before disposal as non-radioactive material provided the licensee does the following:

(1) Monitors the material at the container surface prior to disposal and determines that the radioactivity cannot be distinguished from the background radiation level with an appropriate radiation detection survey meter set on its most sensitive scale and with no interposing shielding;

(2) Removes or obliterates all radiation caution labels and symbols, unless otherwise specified in the license; and

(3) Retains a record of the disposal for three years.

(F) A licensee may treat or dispose of licensed material by incineration only in the form and concentration specified in paragraph (G) of this rule or as specifically approved by the director pursuant to paragraph (C) of this rule.

(G) A licensee may dispose of the following licensed material as if it were not radioactive. The licensee shall maintain records in accordance with paragraph (K) of rule 3701:1-38-20 of the Administrative Code.

(1) 1.85 kilobecquerels (0.05 microcurie) or less, of hydrogen-3 or carbon-14 per gram of medium used for liquid scintillation counting; or

(2) 1.85 kilobecquerels (0.05 microcurie) or less, of hydrogen-3 or carbon-14 per gram of animal tissue, averaged over the weight of the entire animal. A licensee shall not dispose of tissue pursuant to this paragraph in a manner that would permit its use either as food for humans or as animal feed.

(H) A licensee shall transfer and dispose of licensed material in accordance with the following:

(1) For transfer of radioactive waste intended for disposal at a licensed radioactive waste disposal facility, establish a manifest tracking system, and supplement existing requirements concerning transfers and recordkeeping for those wastes. Each shipment of radioactive waste designated for disposal at a licensed radioactive waste disposal facility shall be accompanied by a shipment manifest as specified in the appendix to this rule.

(2) Each shipment manifest shall include a certification by the waste generator in accordance with the appendix to this rule.

(3) Each person involved in the transfer of waste for disposal or in the disposal of waste, including the waste generator, waste collector, waste processor, and disposal facility operator, shall comply with the requirements specified in the appendix to this rule.

(I) Nothing in this rule relieves a licensee from complying with other applicable federal, state and local regulations governing any other toxic or hazardous properties of materials that may be disposed of under this rule.

View Appendix

Last updated January 20, 2022 at 8:48 AM

History

• Effective: January 20, 2022
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-44-19

(A) Each license issued pursuant to the rules in Chapter 3701:1-44 of the Administrative Code shall be subject to all the provisions of Chapter 3748. of the Revised Code and the rules adopted thereunder, now or hereafter in effect, and to all rules, requirements, and orders of the director.

(B) Neither the license nor any right under the license shall be assigned or otherwise transferred in violation of the provisions of Chapter 3748. of the Revised Code and the rules adopted thereunder.

(C) Each person licensed by the director pursuant to the rules in Chapter 3701:1-44 of the Administrative Code shall confine his possession and use of source or byproduct material to the locations and purposes authorized in the license. Except as otherwise provided in the license, a license issued pursuant to the rules in Chapter 3701:1-44 of the Administrative Code shall carry with it the right to receive, possess, and use source or byproduct material. Preparation for shipment and transport of source or byproduct material shall be in accordance with the provisions of Chapter 3701:1-50 of the Administrative Code.

(D) The director may incorporate in any license at the time of issuance, or thereafter, by appropriate rule, regulation or order, such additional requirements and conditions with respect to the licensee's receipt, possession, use, and transfer of source or byproduct material as it deems appropriate or necessary in order to:

(1) Protect health or to minimize danger to life or property; and

(2) Require such reports and the keeping of such records, and to provide for such inspections of activities under the license as may be necessary or appropriate to effectuate the purposes of Chapter 3748. of the Revised Code and the rules adopted thereunder.

(E)

(1) Each licensee shall notify the director, in writing, within ten days following the filing of a voluntary or involuntary petition for bankruptcy under any chapter of title 11 (bankruptcy) of the United States Code by or against:

(a) The licensee;

(b) An entity (as that term is defined in 11 U.S.C. 101(15)) controlling the licensee or listing the license or licensee as property of the estate; or

(c) An affiliate (as that term is defined in 11 U.S.C. 101(2)) of the licensee.

(2) This notification must indicate:

(a) The bankruptcy court in which the petition for bankruptcy was filed; and

(b) The date of the filing of the petition.

Last updated June 3, 2022 at 12:17 PM

History

• Effective: May 23, 2022
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-44-21

(A) No licensee shall transfer source or byproduct material except as authorized pursuant to this rule.

(B) Except as otherwise provided in his license and subject to the provisions of paragraphs (C) and (D) of this rule, any licensee may transfer source or byproduct material:

(1) To the United States department of energy;

(2) To the agency in any agreement state which regulates radioactive materials pursuant to an agreement with the United States nuclear regulatory commission or the atomic energy commission under section 274 of the "Atomic Energy Act of 1954 (68 Stat. 919)";

(3) To any person exempt from the licensing requirements of the act and regulations in this chapter, to the extent permitted under such exemption;

(4) To any person in an agreement state subject to the jurisdiction of that state who has been exempted from the licensing requirements and regulations of that state, to the extent permitted under such exemptions;

(5) To any person authorized to receive such source or byproduct material under terms of a specific license or a general license or their equivalents issued by the director, the United States nuclear regulatory commission or an agreement state; or

(6) As otherwise authorized by the director in writing.

(C) Before transferring source or byproduct material to a specific licensee of the state of Ohio, United States nuclear regulatory commission or an agreement state or to a general licensee who is required to submit form HEA 5115 or the equivalent, with the director, United States nuclear regulatory commission or with an agreement state prior to receipt of the source or byproduct material, the licensee transferring the material shall verify that the transferee's license authorizes receipt of the type, form, and quantity of source or byproduct material to be transferred.

(D) The following methods for the verification required by paragraph (C) of this rule are acceptable:

(1) The transferor may have in his possession, and read, a current copy of the transferee's specific license or form HEA 5115 or equivalent;

(2) The transferor may have in his possession a written certification by the transferee that he is authorized by license or form HEA 5115 or equivalent to receive the type, form, and quantity of source or byproduct material to be transferred, specifying the license or form HEA 5115 number, issuing agency and expiration date;

(3) For emergency shipments the transferor may accept oral certification by the transferee that the transferee is authorized by license or form HEA 5115 to receive the type, form, and quantity of source or byproduct material to be transferred, specifying the license or form HEA 5115 number, issuing agency and expiration date, provided that the oral certification is confirmed in writing within ten days;

(4) The transferor may obtain other sources of information compiled by a reporting service from official records of the director, United States nuclear regulatory commission or the licensing agency of an agreement state as to the identity of licensees and the scope and expiration dates of licenses and form HEA 5115; or

(5) When none of the methods of verification described in paragraphs (D)(1) to (D)(4) of this rule are readily available or when a transferor desires to verify that information received by one of such methods is correct or up-to-date, the transferor may obtain and record confirmation from the director, United States nuclear regulatory commission or the licensing agency of an agreement state that the transferee is licensed to receive the source or byproduct material.

Last updated June 3, 2022 at 12:17 PM

History

• Effective: May 23, 2022
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-38-22

(A) This rule applies to the decommissioning of facilities licensed under Chapter 3748. of the Revised Code. For low-level waste disposal facilities, this rule applies only to ancillary surface facilities that support radioactive waste disposal activities. This rule does not apply to uranium and thorium recovery facilities already subject to source material licensing requirements in Chapter 3701:1-44 of the Administrative Code or to uranium solution extraction facilities.

(B) Decommissioning with license termination shall be limited to sites considered acceptable for unrestricted release where the residual radioactivity that is distinguishable from background radiation results in a total effective dose equivalent (TEDE) to an average member of the critical group that does not exceed 0.25 millisievert (twenty-five millirem) per year, including that from groundwater sources of drinking water, and the residual radioactivity has been reduced to levels that are as low as reasonably achievable (ALARA). Determination of the levels which are ALARA must take into account consideration of detriments, such as deaths from transportation accidents, expected to potentially result from decontamination and waste disposal.

(C) After a facility has been decommissioned and the license terminated in accordance with the criteria in this rule, the director will require additional cleanup only if, based on new information, it is determined that the criteria of this rule were not met and residual radioactivity remaining at the site could result in a significant threat to public health and safety. When calculating TEDE to the average member of the critical group the licensee shall determine the peak annual TEDE dose expected within the first one thousand years after decommissioning.

(D) A licensee may decommission a facility and maintain a decommissioning possession only license using alternate criteria greater than the dose criterion specified in paragraph (B) of this rule, provided that the licensee:

(1) Provides assurance that public health and safety would continue to be protected, and that it is unlikely that the dose from all man-made sources combined, other than medical, would be more than the one millisievert (one hundred millirem) per year limit set forth in this chapter, by submitting an analysis of possible sources of exposure;

(2) Has employed, to the extent practicable, restrictions on site use in minimizing exposures at the site;

(3) Reduces doses to ALARA levels, taking into consideration any detriments, such as traffic accidents expected to potentially result from decontamination and waste disposal; and

(4) Has submitted a decommissioning plan or license termination plan (LTP) to the director indicating the licensee's intent to decommission in accordance with rule 3701:1-40-18 of the Administrative Code, and specifying that the licensee proposes to decommission by restricting use of the site. The licensee shall document in the decommissioning plan or LTP how the advice of individuals and institutions in the community who may be affected by the decommissioning has been sought and incorporated, as appropriate, following analysis of that advice. In seeking such advice, the licensee shall provide for:

(a) Participation by representatives of a broad cross section of community interests who may be affected by the decommissioning;

(b) An opportunity for a comprehensive, collective discussion on the issues by the participants represented; and

(c) A publicly available summary of the results of all such discussions, including a description of the individual viewpoints of the participants on the issues and the extent of agreement and disagreement among the participants on the issues.

(5) Has provided sufficient financial assurance in the form of a trust fund to enable an independent third party, including a governmental custodian of a site, to assume and carry out responsibilities for any necessary control and maintenance of the site.

(E) When a decommissioning with restrictions is proposed by a licensee, a decommissioning possession only license is required to assure that the provisions of the decommissioning plan as approved by the director remain effective. The license will contain a condition that the director will not require further cleanup unless he or she determines that the criteria of this rule or terms of the license were not met or that residual radioactivity at the site could result in a significant threat to public health and safety.

(F) Any facility that has been decommissioned and has had the United States nuclear regulatory commission license terminated in accordance with a plan approved by the commission on or before August 31, 1999, will not be required to obtain a license or conduct further cleanup unless the director determines that residual radioactivity at the site could result in a significant threat to the public health and safety.

(G) Applicants for licenses, other than renewals, shall describe in the application how facility design and procedures for operation will minimize, to the extent practical, contamination of the facility and the environment, facilitate eventual decommissioning, and minimize, to the extent practical, the generation of radioactive waste.

(H) Licensees shall, to the extent practical, conduct operations to minimize the introduction of residual radioactivity into the site, including the subsurface, in accordance with the existing radiation protection requirements in rule 3701:1-38-11 of the Administrative Code and radiological criteria for license termination in accordance with this rule.

Last updated November 2, 2022 at 2:10 PM

History

• Effective: August 30, 2015
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-44-26

An application for a specific license to initially transfer source material for use under rule 3701:1-44-12 of the Administrative Code, will be approved if:

(A) The applicant satisfies the general requirements specified in rule 3701:1-44-15 of the Administrative Code; and

(B) The applicant submits adequate information on, and the director approves the methods to be used for quality control, labeling, and providing safety instructions to recipients.

Last updated November 2, 2022 at 2:17 PM

History

• Effective: December 10, 2015
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-44-13 General license for use of certain industrial products or devices.

(A) A general license is hereby issued to receive, acquire, possess, use, or transfer, in accordance with the provisions of paragraphs (B), (C), (D), and (E) of this rule, depleted uranium contained in industrial products or devices for the purpose of providing a concentrated mass in a small volume of the product or device.

(B) The general license in paragraph (A) of this rule applies only to industrial products or devices which have been manufactured or initially transferred in accordance with a specific license issued pursuant to paragraph (A) of rule 3701:1-44-17 of the Administrative Code or in accordance with a specific license issued by the United States nuclear regulatory commission, or an agreement state which authorizes manufacture of the products or devices for distribution to persons generally licensed by the director, the United States nuclear regulatory commission or an agreement state.

(C)

(1) Persons who receive, acquire, possess, or use depleted uranium pursuant to the general license established by paragraph (A) of this rule shall file form HEA 5115, "Use of Depleted Uranium Under General License," with the director. The form shall be submitted within thirty days after the first receipt or acquisition of such depleted uranium. The person shall furnish on form HEA 5115 the following information and such other information as may be required by that form:

(a) Name and address of the person;

(b) A statement that the person has developed and will maintain procedures designed to establish physical control over the depleted uranium described in paragraph (A) of this rule and designed to prevent transfer of such depleted uranium in any form, including metal scrap, to persons not authorized to receive the depleted uranium; and

(c) Name and/or title, address, and telephone number of the individual duly authorized to act for and on behalf of the person in supervising the procedures identified in paragraph (C)(1)(b) of this rule.

(2) The person possessing or using depleted uranium under the general license established by paragraph (A) of this rule shall report in writing to the director any changes in information furnished by the person in the form HEA 5115 "Use of Depleted Uranium Under General License." The report shall be submitted within thirty days after the effective date of such change.

(D) A person who receives, acquires, possesses, or uses depleted uranium pursuant to the general license established by paragraph (A) of this rule:

(1) Shall not introduce such depleted uranium, in any form, into a chemical, physical, or metallurgical treatment or process, except a treatment or process for repair or restoration of any plating or other covering of the depleted uranium.

(2) Shall not abandon such depleted uranium.

(3) Shall transfer or dispose of such depleted uranium only by transfer in accordance with the provisions of rule 3701:1-44-22 of the Administrative Code. In the case where the transferee receives the depleted uranium pursuant to the general license established by paragraph (A) of this rule, the transferor shall furnish the transferee a copy of this rule and a copy of form HEA 5115. In the case where the transferee receives the depleted uranium pursuant to a general license contained in the United States nuclear regulatory commission regulations or an agreement state's regulation equivalent to this rule, the transferor shall furnish the transferee a copy of this rule and a copy of form HEA 5115 accompanied by a note explaining that use of the product or device is regulated by the United States nuclear regulatory commission or an agreement state under requirements substantially the same as those in this rule.

(4) Within thirty days of any transfer, shall report, in writing to the director, the name and address of the person receiving the source material pursuant to such transfer.

(E) Any person receiving, acquiring, possessing, using, or transferring depleted uranium pursuant to the general license established by paragraph (A) of this rule is exempt from the requirements of Chapter 3701:1-38 of the Administrative Code with respect to the depleted uranium covered by that general license.

Last updated July 10, 2025 at 12:13 PM

History

• Effective: December 10, 2015
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-44-17

Each person licensed pursuant to rule 3701:1-44-16 of the Administrative Code shall:

(A) Maintain the level of quality control required by the license in the manufacture of the industrial product or device, and in the installation of the depleted uranium into the product or device;

(B) Label or mark each unit to:

(1) Identify the manufacturer or initial transferor of the product or device and the number of the license under which the product or device was manufactured or initially transferred, the fact that the product or device contains depleted uranium, and the quantity of depleted uranium in each product or device; and

(2) State that the receipt, possession, use, and transfer of the product or device are subject to a general license or the equivalent and the rules of the state of Ohio or the United States nuclear regulatory commission or an agreement state;

(C) Assure that the depleted uranium before being installed in each product or device has been impressed with the following legend clearly legible through any plating or other covering: "Depleted Uranium";

(D) Furnish a copy of the general license contained in rule 3701:1-44-13 of the Administrative Code or a copy of the United States nuclear regulatory commission's or agreement state's equivalent regulation, and a copy of form HEA 5115 or the United States nuclear regulatory commission's or agreement state's equivalent certificate to each person whom the licensee transfers source material in a product or device for use pursuant to the general license contained in rule 3701:1-44-13 of the Administrative Code.

(E) Report to the director, by an appropriate method listed in rule 3701:1-44-05 of the Administrative Code, United States nuclear regulatory commission, or agreement state, all transfers of industrial products or devices to persons for use under the general license in rule 3701:1-44-13 of the Administrative Code. Such report shall identify each general licensee by name and address, an individual by name and/or position who may constitute a point of contact between the director and the general licensee, the type and model number of device transferred, and the quantity of depleted uranium contained in the product or device. The report shall be submitted within thirty days after the end of each calendar quarter in which such a product or device is transferred to the generally licensed person. If no transfers have been made to persons generally licensed under rule 3701:1-44-13 of the Administrative Code during the reporting period, the report shall so indicate.

(F) Keep records showing the name, address, and a point of contact for each general license to whom the person transfers depleted uranium in industrial products or devices for use pursuant to the general license provided in rule 3701:1-44-13 of the Administrative Code or equivalent regulations of the United States nuclear regulatory commission or agreement state. The records must be retained for three years from the date of transfer and must show the date of each transfer, the quantity of depleted uranium in each product or device transferred, and compliance with the report requirements of this rule.

Last updated November 2, 2022 at 2:16 PM

History

• Effective: December 10, 2015
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-44-22

(A) Each licensee shall notify the director as soon as possible but not later than four hours after the discovery of an event that prevents immediate protective actions necessary to avoid exposures to radiation or radioactive materials that could exceed regulatory limits or releases of licensed material that could exceed regulatory limits (events may include fires, explosions, toxic gas releases, etc.).

(B) Each licensee shall notify the director within twenty-four hours after the discovery of any of the following events involving licensed material:

(1) An unplanned contamination event that:

(a) Requires access to the contaminated area, by workers or the public, to be restricted for more than twenty-four hours by imposing additional radiological controls or by prohibiting entry into the area;

(b) Involves a quantity of material greater than five times the lowest annual limit on intake specified in appendix C to rule 3701:1-38-12 of the Administrative Code for the material; and

(c) Has access to the area restricted for a reason other than to allow radionuclides with a half-life of less than twenty-four hours to decay prior to decontamination.

(2) An event in which equipment is disabled or fails to function as designed when:

(a) The equipment is required by rule or license condition to prevent releases exceeding regulatory limits, to prevent exposures to radiation and radioactive materials exceeding regulatory limits, or to mitigate the consequences of an accident;

(b) The equipment is required to be available and operable when it is disabled or fails to function; and

(c) No redundant equipment is available and operable to perform the required safety function.

(3) An event that requires unplanned medical treatment at a medical facility of an individual with spreadable radioactive contamination on the individual's clothing or body.

(4) An unplanned fire or explosion damaging any licensed material or any device, container, or equipment containing licensed material when:

(a) The quantity of material involved is greater than five times the lowest annual limit on intake specified in appendix C to rule 3701:1-38-12 of the Administrative Code for the material; and

(b) The damage affects the integrity of the licensed material or its container.

(C) Reports made by licensees in response to the requirements of this rule must be made as follows:

(1) Licensees shall make reports required by paragraphs (A) and (B) of this rule by telephone to the director. To the extent that the information is available at the time of notification, the information provided in these reports must include:

(a) The caller's name and call back telephone number;

(b) A description of the event, including date and time;

(c) The exact location of the event;

(d) The radionuclides, quantities, and chemical and physical form of the licensed material involved; and

(e) Any personnel radiation exposure data available.

(2) Each licensee who makes a report required by paragraph (A) or (B) of this rule shall submit a written follow-up report within thirty days of the initial report. Written reports prepared pursuant to other rules may be submitted to fulfill this requirement if the reports contain all of the necessary information and the appropriate distribution is made. These written reports must be sent to the director by an appropriate method listed in rule 3701:1-44-05 of the Administrative Code. The reports must include the following:

(a) A description of the event, including the probable cause and the manufacturer and model number (if applicable) of any equipment that failed or malfunctioned;

(b) The exact location of the event;

(c) The radionuclides, quantities, and chemical and physical form of the licensed material involved;

(d) Date and time of the event;

(e) Corrective actions taken or planned and the results of any evaluations or assessments; and

(f) The extent of exposure of individuals to radiation or to radioactive materials without identification of individuals by name.

Last updated November 2, 2022 at 2:16 PM

History

• Effective: December 10, 2015
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-44-14 Application for specific licenses.

(A) A person may file an application for specific license in accordance with the instructions in rule 3701:1-44-05 of the Administrative Code. Information contained in previous applications, statements or reports filed with the director may be incorporated by reference provided that the reference is clear and specific.

(B) The director may at any time after the filing of the original application, and before the expiration of the license, require further statements in order to enable the director to determine whether the application should be granted or denied or whether a license should be modified or revoked. All applications and statements shall be signed by the applicant or licensee or a person duly authorized to act for and on his behalf.

(C) An application for a license filed pursuant to the requirements in Chapter 3701:1-44 of the Administrative Code will be considered also as an application for licenses authorizing other activities for which licenses are required by Chapter 3748. of the Revised Code and the rules promulgated thereunder, provided that the application specifies the additional activities for which licenses are requested and complies with requirements of the director as to applications for such licenses.

(D) Each application for a source material license shall be accompanied by the fee prescribed in rule 3701:1-38-02 of the Administrative Code.

(E) An application for a license to possess and use source material for uranium milling, production of uranium hexafluoride, or for the conduct of any other activity which the director has determined will significantly affect the quality of the environment shall be filed at least nine months prior to commencement of construction of the plant or facility in which the activity will be conducted and shall be accompanied by any environmental report required pursuant to rule 3701:1-40-36 of the Administrative Code.

(F) An application for a license to receive, possess, and use source material for uranium or thorium milling or byproduct material, as defined in rule 3701:1-44-01 of the Administrative Code, at sites formerly associated with such milling shall contain proposed written specifications relating to milling operations and the disposition of the byproduct material to achieve the requirements and objectives set forth in the appendix to rule 3701:1-44-14 of the Administrative Code. Each application must clearly demonstrate how the requirements and objectives set forth in the appendix to rule 3701:1-44-14 of the Administrative Code have been addressed. Failure to clearly demonstrate how the requirements and objectives in the appendix to rule 3701:1-44-14 of the Administrative Code have been addressed shall be grounds for refusing to accept an application.

(G) As provided by rule 3701:1-44-18 of the Administrative Code, certain applications for specific licenses filed under Chapter 3701:1-44 of the Administrative Code must contain a proposed decommissioning funding plan or a certification of financial assurance for decommissioning.

View Appendix

Last updated May 23, 2022 at 7:57 AM

History

• Effective: May 23, 2022
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-38-02

(A) As used in this rule, "facility" has the meaning defined in division (H) of section 3748.01 of the Revised Code and the following:

(1) All buildings, equipment, structures, and other stationary items that are located on a single site or on contiguous or adjacent sites and that are operated by the same person and have common corporate or business interests; and

(2) Portions of a building or structure which are operated by the same person and have common corporate or business interests.

(B) Notwithstanding the definition of "facility," the director may consider sites that are not contiguous or adjacent as one facility provided that:

(1) The sites are operated by the same person;

(2) The sites are in the same license category or categories;

(3) The applicant for a license provides for one radiation safety officer, and if applicable, one radiation safety committee, as responsible for all sites; and

(4) The director is reasonably satisfied from the information provided in the application that the applicant will adequately control radioactive material at all sites listed in the application.

(a) Unless the director has information of violations of Chapter 3748. of the Revised Code or the rules adopted thereunder at one or more sites, the director shall presume the applicant will adequately control radioactive material at all sites if the sites are located not more than twenty miles driving distance apart as documented by the licensee, and if all sites are within a twenty mile radius from the main site as designated on the license.

(b) The director shall continue to renew a license issued under this paragraph that contains all the sites listed thereon provided the licensee demonstrates continued compliance with this paragraph, Chapter 3748. of the Revised Code, and the rules adopted thereunder.

(C) Every facility that handles radioactive material in any license category as specified in appendix A to this rule for which licensure is required shall apply for a license, license amendment, or license renewal in accordance with this rule. Application for a license, license amendment, or license renewal shall be made on any format prescribed and provided by the director. Licenses shall be issued in accordance with the requirements of Chapter 3748. of the Revised Code, and the rules adopted thereunder. Except as otherwise provided in this rule, a license shall expire five years from the date of issuance.

(1) As used in this paragraph, site means an address of use listed on the license. Temporary job sites are exempted.

(a) Any individual applying for a new license with one or more additional sites or a current licensee amending a license to add one or more additional sites that are located more than twenty miles from the main site shall pay an additional site fee for each such site as follows:

(i) The additional site fee(s) shall be seventy-five percent of the applicable annual fee, as those fees are set forth in paragraphs (D), (F), and (J) of this rule.

(ii) Additional site fees will be invoiced annually with the annual fee.

(b) Broad scope licensees are exempt from paragraph (C)(1)(a) of this rule.

(2) As used in this paragraph, "service" means activities performed by a person, other than a worker as defined in rule 3701:1-38-01 of the Administrative Code, pursuant to an agreement with the facility to perform activities that deal with sources of radiation for the facility.

(a) These activities include, but are not limited to the following:

(i) Conduct leak tests;

(ii) Calibrate survey instruments;

(iii) Provide quality control tests;

(iv) Conduct surveys, characterization, and/or remediation activities;

(v) Manage the disposal of radioactive waste for other persons; or

(vi) Install sources or devices or change sources within a device.

(b) License categories affected are:

(i) 3219 - decontamination services;

(ii) 3220 - leak test service;

(iii) 3221 - instrument calibration service only - source less than 3.7 terabecquerels (one hundred curies);

(iv) 3222 - instrument calibration service only - source equal to or greater than 3.7 terabecquerels (one hundred curies);

(v) 3223 - leak test and instrument calibration - source less than 3.7 terabecquerels (one hundred curies);

(vi) 3224 - leak test and instrument calibration - source equal to or greater than 3.7 terabecquerels (one hundred curies);

(vii) 3225 - other services - including teletherapy, irradiator, and gauge service;

(viii) 3232 - waste disposal service prepackaged only;

(ix) 3233 - waste disposal service - incineration; and

(x) 3234 - waste disposal service processing and/or repackaging.

(D) A radioactive materials license issued by the department may, at the discretion of the director, have more than one license category on any one specific license. A licensee may have more than one radioactive materials license. Except as otherwise provided in paragraph (J) of this rule, the annual fee for a radioactive material license shall be in an amount in accordance with appendix A to this rule.

(1) Upon receipt of an application for a new radioactive material license, the department will issue an invoice for the appropriate fee specified in appendix A to this rule or paragraph (J) of this rule. Annual fees will be invoiced based on the month of the license expiration date and the invoice will state that the fee is due thirty days after the date of the invoice. License fees are not refundable.

(2) An applicant for a new or a renewal or amendment of a radioactive material license must submit a complete application before the director will finalize the review of the application. A complete application is one in which the applicant has provided all the information requested by the director, including any additional information requested after receipt of the application package.

(3) Upon receipt of an application for a license amendment, the department will issue an invoice for the appropriate fee for the proposed amendment as specified in appendix A to this rule. If the amendment is to change the license from operational phase to storage of sealed sources only incident to disposal of the sources, after the amendment the annual fee for the license shall be reduced to fifty per cent of the fee for the operational phase of the license, provided that the sources continue to be in safe storage and leak tested as provided by license condition for the specific sources in storage. The inspection frequency will remain the same as that for the operational phase of the license until after source disposal.

(4) The applicant for a new, or renewal or amendment of a radioactive materials license shall provide to the director all additional information requested within sixty days from the date of the information request. If the director does not receive the requested information within the stated time period, the director may consider the application abandoned. Any further consideration of a new license, or a renewal or amendment of a license shall be pursuant to another application.

(5) The director shall grant a new license, license amendment, or license renewal to any applicant who has submitted a complete application and is in compliance with Chapter 3748. of the Revised Code and the rules adopted thereunder.

(6) When an amendment to a license results in a change to a license category with a higher fee, the licensee will be charged the higher of the two amendment fees for that category. The annual fee for the licensee will escalate to the new category fee on the date of the next annual invoice.

(7) The director shall charge a fee for minor license amendments that do not require review by members of the technical staff at a rate of one hundred dollars per amendment provided that no licensee shall be required to pay more than one thousand dollars for minor amendments in any calendar year. Minor amendments include, but are not limited to, adding a new gauge of the same type already licensed unless that additional gauge increases the license or inspection fee, a corporate name change if the corporate ownership does not change, adding a user name that does not require review of education and experience, and corporate address change if the location of the use of the radioactive material does not change. Amendments to change the radiation safety officer or the chair or members of the radiation safety committee that require review of education or experience are not minor amendments.

(8) License terminations shall be handled as follows:

(a) Except as provided in paragraph (D)(8)(c) of this rule, a termination fee of five hundred dollars or fifty per cent of the annual fee, whichever is less, will be invoiced upon written request from the licensee for termination of the license. This fee is not refundable.

(b) Except as provided in paragraph (D)(8)(c) of this rule, if the termination cost, as determined by paragraph (M) of this rule, exceeds the termination fee in paragraph (D)(8)(a) of this rule, the remainder of the termination expense will be assessed at full cost.

(c) If the license termination would be covered under paragraph (D)(9) of this rule, that paragraph will be used for the termination process.

(d) The license termination process will not be completed until the licensee is in compliance with all rules, including payment of fees.

(9) Licenses, and other approvals related to the licensed activity requiring decommissioning, decontamination, reclamation, site restoration, or long-term care due to the continued presence of radioactive materials shall be charged an annual fee based on the approved decommissioning funding plan as specified in appendix B to this rule.

(a) A decommissioning plan must be approved by the department. Prior to approval of the decommissioning plan the licensee must submit an amendment requesting decommissioning. Until the amendment is approved the licensee's annualized license fee will be reduced by fifty per cent. After approval of the amendment containing the decommissioning plan, the licensee will be invoiced at the annual fee specified in appendix B to this rule.

(b) The annual fee specified in appendix B to this rule is based on the cost of decommissioning. The fee is payable within thirty days of mailing of an invoice by the department.

(c) Routine decommissioning oversight by the department will be charged against the annual amount received and additional invoices will not be issued unless the cost of activities exceeds the annual amount in any given year.

(d) The facility shall receive a monthly statement of items and amounts charged against the annual fee.

(e) If the cost of additional activities arise that require use of additional staff, including any consulting service that exceeds the amount of the annual fee paid by the licensee, these additional costs will be included in any invoice as separate items invoiced for the full cost of the oversight by additional staff or consultants. Oversight activities will be performed at a frequency which adequately monitors health, safety, and the environment.

(f) When the approved decommissioning plan is less than one hundred thousand dollars, the licensee will remain in the current license category and continue to pay the required annual fee specified in appendix A to this rule during decommissioning. Inspections of these licensees will be done as non-routine inspections. Non-routine inspection fees will not be applied until the number of decommissioning inspections performed exceed the inspections that would have been performed if the licensee had not chosen the decommissioning option.

(g) When the licensee has completed the decommissioning, and the director has determined that the licensee cannot terminate the license as provided by the Administrative Code, Chapter 3748. of the Revised Code or the rules adopted thereunder, but the licensee has successfully completed the decommissioning of the operation as required by the approved decommissioning plan, the director will amend the license to a decommissioning/possession only license. The annual fee for a decommissioning/possession only license is provided in appendix B to this rule.

(E) Licenses shall be renewed in accordance with the standard renewal procedure established in Chapter 4745. of the Revised Code, except that a licensee, other than a broad scope licensee, shall apply for renewal of the license ninety days prior to the expiration date of the current license and broad scope licensees shall apply for renewal of their license one hundred eighty days prior to expiration.

(F) The annual fee is listed in appendix A to this rule "column 5" for a new license or "column 6" for a renewal license. To recover the costs of oversight activities where radioactive material is found in the public domain and there is no evident individual that is determined to be responsible, a surcharge of 5.25 per cent has been included in the annual fee listed in "column 5" and "column 6" of appendix A to this rule.

(G) The department shall charge an inspection fee for all non-routine inspections. A non-routine inspection is defined as any inspection that the department conducts in addition to the scheduled routine inspections and one follow-up inspection if necessary. Non-routine inspections include, without limitation:

(1) An inspection performed as a result of an incident;

(2) Any pre-license inspections for a new license applicant when the director determines that an inspection is necessary to assess the adequacy of the information provided in the application;

(3) Inspections prior to license amendment, category change, or termination;

(4) An inspection performed at a facility that results in the issuance of an adjudication order by the director; or

(5) Other enforcement or regulatory inspections, not specified above, that the director determines is necessary to assess compliance with Chapter 3748. of the Revised Code.

(H) The fee for a non-routine inspection shall be based on the actual cost for conducting the inspection which shall include:

(1) An hourly charge of seventy dollars per staff person assigned to the inspection, except staff participating as training will not be included in the charges;

(2) An administrative fee of three hundred thirty dollars;

(3) All necessary laboratory analysis costs for samples collected by department personnel; and

(4) Any staff travel costs which shall be calculated in accordance with rule 126-01-02 of the Administrative Code.

(I) All fees invoiced as provided within this rule, including full cost, routine, and non-routine inspection fees, shall be paid within thirty days of the invoice date specified on the invoice. In accordance with sections 3748.07 and 3748.13 of the Revised Code, any fee that remains unpaid on the ninety-first day after the original invoice date shall be assessed an additional amount equal to ten per cent of the original fee.

(1) The department shall mail invoices by ordinary U.S. mail to the most recent address provided by the licensee.

(2) The department shall maintain a list of the invoices issued and date mailed.

(J) Notwithstanding paragraph (D) of this rule, the department shall charge the following types of licensees reduced license fees in the following specified amounts:

(1) A private entity that provides services, does not engage in manufacturing, and that has three hundred fifty thousand to two million dollars in gross annual receipts, shall pay a total license fee of seventy-five per cent of the amount specified for that use of radioactive materials in appendix A to this rule.

(2) A private entity that provides services, does not engage in manufacturing, and that has less than three hundred fifty thousand dollars in gross annual receipts shall pay a total license fee of fifty per cent of the amount specified for that use of radioactive material in appendix A to this rule.

(3) A private entity that engages in manufacturing and that has thirty-five to two hundred employees, irrespective of gross annual receipts, shall pay a total license fee of seventy-five per cent of the amount specified for that use of radioactive material in appendix A to this rule.

(4) A private entity that engages in manufacturing and that has less than thirty-five employees, irrespective of gross annual receipts, shall pay a total license fee of fifty per cent of the amount specified for that use of radioactive material in appendix A to this rule.

(5) A nonprofit entity that has gross annual receipts of three hundred fifty thousand dollars to two million dollars shall pay a total license fee of seventy-five per cent of the amount specified for that use of radioactive material in appendix A to this rule.

(6) A nonprofit entity that has gross annual receipts of less than three hundred fifty thousand dollars shall pay a total license fee of fifty per cent of the amount specified for that use of radioactive material in appendix A to this rule.

(7) A government jurisdiction or district with a population of twenty thousand to fifty thousand shall pay a total license fee of seventy-five per cent of the amount specified for that use of radioactive material as specified in appendix A to this rule.

(8) A government jurisdiction or district with a population of less than twenty thousand shall pay a total license fee of fifty per cent of the amount specified for that use of radioactive materials as specified in appendix A to this rule.

(9) A health district as defined in section 3709.01 of the Revised Code shall pay a total license fee of twenty-five per cent of the amount specified in appendix A to this rule.

(10) An accredited private or public college or university possessing or using radioactive material in a sealed or unsealed source solely as a part of a college or university course supported by tuition and leading to an accredited degree, but excluding clinical training, shall pay a total license fee as set forth for category "1129" as that amount is specified in appendix A to this rule.

The reduced annual fees specified in this paragraph do not apply to any other fees that a licensee may be required to pay under Chapter 3748. of the Revised Code or rules adopted thereunder. Licensees shall provide certification of their compliance with the provisions of paragraphs (J)(1) to (J)(6) of this rule upon initial application and renewal.

(K) The director may modify the inspection frequency of licensed facilities based upon the performance of the facility.

(L) In accordance with section 3748.22 of the Revised Code, the department shall charge fees sufficient to cover all costs of regulatory, administrative, and enforcement activities conducted pursuant to Chapter 3748. of the Revised Code. The director shall recommend to the radiation advisory council and the public health council changes in the radioactive materials fees if the director finds that fees do not meet the requirements of section 3748.22 of the Revised Code.

(M) Fees for those categories listed as "full cost" such as decommissioning activities, for either partial, building or selected area of a licensed site, or full decommissioning leading to license amendment, category change, or termination and for review of sources and/or devices shall be specified as "full cost" and shall be calculated as the sum of the seventy dollar hourly charge per staff member for the number of hours spent on document review and preparation, licensing, inspection, meetings, teleconferences, in travel, administrative time, the cost of any special contractors as determined necessary by the director, any environmental monitoring for radioactive materials and laboratory analysis, any other associated activities. The administrative fee from paragraph (H)(2) of this rule shall be used for administrative time. Travel expenses shall also be invoiced and shall be calculated at the rate determined by rule 126-1-02 of the Administrative Code. These fees will be invoiced monthly.

(N)

(1) Reciprocity to engage in activities in the state of Ohio which involve radioactive materials may be authorized provided:

(a) The person requesting reciprocity possesses a valid radioactive materials license issued by another agreement state or the United States nuclear regulatory commission which authorizes the same activities proposed to be conducted in Ohio;

(b) The request for reciprocity is made by submission of a completed reciprocity application provided by the director, a copy of the person's radioactive materials license, and payment of the reciprocity fee specified in appendix A to this rule;

(c) The duration of activities to be performed in Ohio under reciprocity does not exceed one hundred eighty days in any one calendar year.

(2) A person who has been granted reciprocity in Ohio shall notify the director at least three business days in advance of each time the person proposes to begin a new use of radioactive materials in the state of Ohio, with the notification made on a form provided by the director.

(3) Activities conducted in Ohio under reciprocity are subject to inspection by the department at any time and the department shall invoice a reciprocity inspection fee of one thousand dollars for each inspection of a person's authorized reciprocity activities.

(4) Reciprocity is authorized for one calendar year, beginning on January first or later date when reciprocity is initially applied for, and ending on December thirty-first.

(5) A person who is authorized reciprocity shall apply for an Ohio radioactive materials license at least thirty days prior to exceeding one hundred eighty days of activities in Ohio.

(O) Requests for safety evaluation of devices, products, or sealed sources used for radioactive materials either for commercial distribution or manufactured in accordance with the unique specifications of, and for use by, a single applicant shall be submitted to the director on a form provided by the director for that review prior to manufacture or commercial distribution.

(1) The application shall specify a license amendment for one of the areas listed below:

(a) Safety evaluation of sealed sources or devices or products containing NARM, byproduct material, source material, or special nuclear material (less than critical mass) for commercial distribution.

(b) Safety evaluation of sealed sources or devices or products containing NARM, byproduct material, source material, or special nuclear material (less than critical mass) manufactured in accordance with the unique specifications of, and for use by, a single applicant.

(2) The amendment fee for a source or device review shall be "full cost" as outlined in paragraph ((M) of this rule.

(3) The amendment fee in appendix A to this rule for categories under manufacturing and distribution shall be for amendments other than source or device reviews.

(4) Licensees for categories 3211, 3212, 3213, 3214, and 22162 shall pay an annual surcharge of six hundred fifty dollars to cover administrative costs of overall maintenance activities associated with source or device data submitted to the United States nuclear regulatory commission. This surcharge is included in the annual fee for the above listed categories in "column 5" and "column 6" of appendix A to this rule.

(P) When considered necessary by the director, the director may conduct a review of shielding plans or the adequacy of shielding. The director may also conduct such a review upon the request of the licensee or the applicant for a license. The applicant or licensee shall pay a fee for review of shielding plans or adequacy of shielding as specified in paragraph (M) of this rule.

(Q) Individuals with implanted pacemakers that have a radioactive source will not be charged an annual fee as an individual because of the necessity of possessing the device. Unless the director determines other provisions are required, the medical institution that implanted the device shall hold the license for the individual.

(R) If, because of the complexity of a review, such as that for a sealed source or device, decommissioning, license, or incident, it is necessary to obtain the services of a consultant to assist in a final determination, the licensee or applicant will be invoiced for the consulting services.

(S) Licensees with general licenses requiring an annual report to the director shall submit the report with a fee of four hundred twenty dollars within thirty days of mailing an invoice by the department and are subject to late penalties in paragraph (I) of this rule. If a facility has a specific license which is in a category that would include the generally licensed material, the facility may add the generally licensed material to the specific license and will not be charged the additional fee for that generally licensed material. Annual reports are required for devices under a general license containing radionuclides at or above activities listed in paragraph (C)(13) of rule 3701:1-46-05 of the Administrative Code.

View AppendixView Appendix

Last updated November 2, 2022 at 2:09 PM

History

• Effective: April 15, 2013
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-40-36

(A) If a final bureau assessment report is required, the report shall become part of the director's decision. The decision shall be clearly identified and shall include the following:

(1) A statement of the decision.

(2) Identification of all alternatives considered by the department, a statement that these alternatives were included in the range of alternatives discussed in the bureau assessment report, and a statement specifying any alternative that is considered to be environmentally preferable.

(3) A discussion of preferences among alternatives based on relevant factors including statutory requirements in Chapter 3748. of the Revised Code.

(4) A statement indicating whether the department has taken all practicable measures to avoid or minimize environmental harm from the alternative selected, and if not, to explain why those measures were not adopted. The statement also shall summarize any license conditions and monitoring programs adopted in connection with mitigation measures.

(B) The decision may be integrated into any other record prepared by the department in connection with the action.

(C) The decision may incorporate by reference material contained in a final bureau assessment report. The applicant may appeal a final decision as provided in rule 3701:1-38-06 of the Administrative Code.

Last updated November 2, 2022 at 2:14 PM

History

• Effective: July 22, 2001
• Promulgated Under: Ch 119.

Ohio Adm.Code 3701:1-44-18

Except for licenses authorizing the receipt, possession, and use of source material for uranium or thorium milling, or byproduct material at sites formerly associated with such milling, for which financial assurance requirements are set forth in the appendix to rule 3701:1-44-14 of the Administrative Code, criteria for providing financial assurance for decommissioning are as follows:

(A) Each applicant for a specific license authorizing the possession and use of more than 3.7 gigabecquerels (one hundred millicuries) of source material in a readily dispersible form shall submit a decommissioning funding plan as described in paragraph (D) of this rule.

(B) Each applicant for a specific license authorizing possession and use of quantities of source material greater than 0.37 gigabecquerels (ten millicuries) but less than or equal to 3.7 gigabecquerels (one hundred millicuries) in a readily dispersible form shall either:

(1) Submit a decommissioning funding plan as described in paragraph (D) of this rule; or

(2) Submit a certification that financial assurance for decommissioning has been provided in the amount of two hundred twenty-five thousand dollars using one of the methods described in paragraph (E) of this rule. For an applicant, this certification may state that the appropriate assurance will be obtained after the application has been approved and the license issued but before the receipt of licensed material. If the applicant defers execution of the financial instrument until after the license has been issued, a signed original of the financial instrument obtained to satisfy the requirements of paragraph (E) of this rule must be submitted to the director prior to receipt of licensed material. If the applicant does not defer execution of the financial instrument, the applicant shall submit to the director, as part of the certification, a signed original of the financial instrument obtained to satisfy the requirements of paragraph (E) of this rule.

(C)

(1) Each holder of a specific license issued on or after July 27, 1990, which is covered by paragraph (A) or (B) of this rule, shall provide financial assurance for decommissioning in accordance with the criteria set forth in this rule.

(2) Each holder of a specific license issued before July 27, 1990, and of a type described in paragraph (A) of this rule shall submit a decommissioning funding plan as described in paragraph (D) of this rule or a certification of financial assurance for decommissioning in an amount at least equal to one million one hundred twenty-five thousand dollars in accordance with the criteria set forth in this rule. If the licensee submits the certification of financial assurance rather than a decommissioning funding plan, the licensee shall include a decommissioning funding plan in any application for license renewal.

(3) Each holder of a specific license issued before July 27, 1990, and of a type described in paragraph (B) of this rule shall submit a decommissioning funding plan, as described in paragraph (D) of this rule, or a certification of financial assurance for decommissioning in accordance with the criteria set forth in this rule.

(4) Any licensee who has submitted an application for renewal of license in accordance with rule 3701:1-38-02 of the Administrative Code shall provide financial assurance for decommissioning in accordance with paragraphs (A) and (B) of this rule.

(D)

(1) Each decommissioning funding plan must be submitted for review and approval and must contain:

(a) A detailed cost estimate for decommissioning, in an amount reflecting:

(i) The cost of an independent contractor to perform all decommissioning activities;

(ii) The cost of meeting the criteria specified in paragraph (B) of rule 3701:1-38-22 of the Administrative Code for unrestricted use, provided that, if the applicant or licensee can demonstrate its ability to meet the provisions of paragraph (D) of rule 3701:1-38-22 of the Administrative Code, the cost estimate may be based on meeting this criteria;

(iii) The volume of onsite subsurface material containing residual radioactivity that will require remediation; and

(iv) An adequate contingency factor.

(b) Identification of and justification for using the key assumptions contained in the decommissioning cost estimate;

(c) A description of the method of assuring funds for decommissioning from paragraph (E) of this rule, including means for adjusting cost estimates and associated funding levels periodically over the life of the facility;

(d) A certification by the licensee that financial assurance for decommissioning has been provided in the amount of the cost estimate for decommissioning; and

(e) A signed original of the financial instrument obtained to satisfy the requirements of paragraph (E) of this rule (unless a previously submitted and accepted financial instrument continues to cover the cost estimate for decommissioning).

(2) At the time of license renewal and at intervals not to exceed three years, the decommissioning funding plan must be resubmitted with adjustments as necessary to account for the changes in costs and the extent of contamination. If the amount of financial assurance will be adjusted downward, this cannot be done until the updated decommissioning funding plan is approved. The decommissioning funding plan must update the information submitted with the original or prior approved plan, and must specifically consider the effect of the following events on decommissioning costs:

(a) Spills of radioactive material producing additional residual radioactivity in onsite subsurface material;

(b) Waste inventory increasing above the amount previously estimated;

(c) Waste disposal costs increasing above the amount previously estimated;

(d) Facility modifications;

(e) Changes in authorized possession limits;

(f) Actual remediation costs that exceed the previous cost estimate;

(g) Onsite disposal; and

(h) Use of a settling pond.

(E) Financial assurance for decommissioning must be provided by one or more of the following methods:

(1) Prepayment is the deposit prior to the start of operation into an account segregated from licensee assets and outside the licensee's administrative control of cash or liquid assets such that the amount of funds would be sufficient to pay decommissioning costs. Prepayment may be in the form of a trust, escrow account, government fund, certificate of deposit, or deposit of government securities.

(2) A surety method, insurance, or other guarantee method. These methods guarantee that decommissioning costs will be paid. A surety method may be in the form of a surety bond, letter of credit, or line of credit. A parent company guarantee of funds for decommissioning costs based on a financial test may be used if the guarantee and test are as contained in appendix B to rule 3701:1-40-17 of the Administrative Code. A parent company guarantee may not be used in combination with other financial methods to satisfy the requirements of this rule. For commercial corporations that issue bonds, a guarantee of funds by the applicant or licensee for decommissioning costs based on a financial test may be used if the guarantee and test are as contained in appendix C to rule 3701:1-40-17 of the Administrative Code. For commercial companies that do not issue bonds, a guarantee of funds by the applicant or licensee for decommissioning costs may be used if the guarantee and test are as contained in appendix D to rule 3701:1-40-17 of the Administrative Code. For nonprofit entities, such as colleges, universities, and nonprofit hospitals, a guarantee of funds by the applicant or licensee may be used if the guarantee and test are as contained in appendix E to rule 3701:1-40-17 of the Administrative Code. A guarantee by the applicant or licensee may not be used in combination with any other financial methods used to satisfy the requirements of this rule or in any situation where the applicant or licensee has a parent company holding majority control of the voting stock of the company. Any surety method or insurance used to provide financial assurance for decommissioning must contain the following conditions:

(a) The surety method or insurance must be open-ended or, if written for a specified term, such as five years, must be renewed automatically unless ninety days or more prior to the renewal date, the issuer notifies the director, the beneficiary, and the licensee of its intention not to renew. The surety method or insurance must also provide that the full face amount be paid to the beneficiary automatically prior to the expiration without proof of forfeiture if the licensee fails to provide a replacement acceptable to the director within thirty days after receipt of notification of cancellation.

(b) The surety method or insurance must be payable to a trust established for decommissioning costs. The trustee and trust must be acceptable to the director. An acceptable trustee includes an appropriate state or federal government agency or an entity which has the authority to act as a trustee and whose trust operations are regulated and examined by a federal or state agency.

(c) The surety method or insurance must remain in effect until the director has terminated the license.

(3) An external sinking fund in which deposits are made at least annually, coupled with a surety method or insurance, the value of which may decrease by the amount being accumulated in the sinking fund. An external sinking fund is a fund established and maintained by setting aside funds periodically in an account segregated from licensee assets and outside the licensee's administrative control in which the total amount of funds would be sufficient to pay decommissioning costs at the time termination of operation is expected. An external sinking fund may be in the form of a trust, escrow account, government fund, certificate of deposit, or deposit of government securities. The surety or insurance provision must be as stated in paragraph (E)(2) of this rule.

(4) In the case of federal, state, or local government licensees, a statement of intent containing a cost estimate for decommissioning or an amount based on paragraph (B) of this rule, and indicating that funds for decommissioning will be obtained when necessary.

(5) When a government entity is assuming custody and ownership of a site, an arrangement that is deemed acceptable by such government entity.

(F) Each person licensed under Chapter 3701:1-44 of the Administrative Code shall keep records of information important to the decommissioning of a facility in an identified location until the site is released for unrestricted use. Before licensed activities are transferred or assigned in accordance with paragraph (B) of rule 3701:1-44-19 of the Administrative Code licensees shall transfer all records described in this paragraph to the new licensee. In this case, the new licensee will be responsible for maintaining these records until the license is terminated. If records important to the decommissioning of a facility are kept for other purposes, reference to these records and their locations may be used. Information the director considers important to decommissioning consists of:

(1) Records of spills or other unusual occurrences involving the spread of contamination in and around the facility, equipment, or site. These records may be limited to instances when contamination remains after any cleanup procedures or when there is reasonable likelihood that contaminants may have spread to inaccessible areas as in the case of possible seepage into porous materials such as concrete. These records must include any known information on identification of involved nuclides, quantities, forms, and concentrations.

(2) As-built drawings and modifications of structures and equipment in restricted areas where radioactive materials are used and/or stored, and of locations of possible inaccessible contamination such as buried pipes which may be subject to contamination. If required drawings are referenced, each relevant document need not be indexed individually. If drawings are not available, the licensee shall substitute appropriate records of available information concerning these areas and locations.

(3) Except for areas containing depleted uranium used only for shielding or as penetrators in unused munitions, a list contained in a single document and updated every two years, of the following:

(a) All areas designated and formerly designated as restricted areas as defined in rule 3701:1-38-01 of the Administrative Code;

(b) All areas outside of restricted areas that require documentation under paragraph (F)(1) of this rule;

(c) All areas outside of restricted areas where current and previous wastes have been buried as documented under paragraph (K) of rule 3701:1-38-20 of the Administrative Code; and

(d) All areas outside of restricted areas that contain material such that, if the license expired, the licensee would be required to either decontaminate the area to meet the criteria for decommissioning in rule 3701:1-38-22 of the Administrative Code, or apply for approval for disposal under paragraph (C) of rule 3701:1-38-19 of the Administrative Code.

(4) Records of the cost estimate performed for the decommissioning funding plan or of the amount certified for decommissioning, and records of the funding method used for assuring funds if either a funding plan or certification is used.

Last updated July 10, 2025 at 12:13 PM

History

• Effective: November 22, 2013
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-40-30

(A) The department shall require an environmental report to be submitted with the license application and a bureau assessment report following the department review of the environmental report in the case of any of the following:

(1) The applicant proposes a major action that could potentially affect the environment as it relates to human health;

(2) Any other action which the director determines is a major action which could potentially affect the environment as it relates to human health;

(3) The applicant applies for a license to possess and use source material for uranium milling or production of uranium hexafluoride pursuant to Chapter 3701:1-44 of the Administrative Code;

(4) The applicant applies for a license or renewal authorizing receipt and disposal of radioactive waste from other persons pursuant to Chapter 3701:1-54 of the Administrative Code.

(5) The applicant applies for a license amendment pursuant to Chapter 3701:1-54 of the Administrative Code authorizing either of the following:

(a) Closure of a land disposal site; or

(b) Transfer of the license to the disposal site owner for the purpose of institutional control; or

(6) Notwithstanding paragraph (C) of this rule, and in accordance with paragraph (B) of this rule, the department may, in special circumstances, require the preparation of an environmental report and bureau assessment report on an action that is listed as a categorical exclusion.

(B) Except in special circumstances as determined by the director at his or her discretion, an environmental report and bureau assessment report is not required in the case of an action included in the list of categorical exclusions set forth in paragraph (C) of this rule. Notwithstanding paragraph (C) of this rule, the director, at his or her discretion, may require an environmental report and bureau assessment report if he or she determines that special circumstances exist because the proposed action involves an unreasonable or unnecessary individual or cumulative risk to the human environment.

(C) The following categories of actions are considered categorical exclusions:

(1) Issuance of an amendment to a license for a radioactive material waste disposal site or an amendment to a radioactive materials license if required by Chapter 3701:1-54 of the Administrative Code which are administrative, organizational, or procedural in nature, or which result in a change in process operations or equipment, provided that:

(a) There is no significant change in the type or significant increase in the amount of any effluent that may be released offsite;

(b) There is no significant increase in individual or cumulative occupational radiation exposure;

(c) There is no significant construction impact; and

(d) There is no significant increase in the potential for or consequences from radiological accidents.

(2) Issuance, amendment or renewal of radioactive materials licenses issued pursuant to this chapter and Chapters 3701:1-44, 3701:1-46, 3701:1-48, 3701:1-49, 3701:1-52, 3701:1-56 and 3701:1-58 of the Administrative Code affecting general licenses, manufacture and distribution, industrial radiography, well logging, irradiators, medical use, source material, special nuclear material of less than critical mass authorizing the following:

(a) Distribution of radioactive materials and devices or products containing radioactive material to general licensees and to persons exempt from licensing;

(b) Distribution of radiopharmaceuticals, generators, reagent kits, or sealed sources to persons licensed in accordance with Chapter 3701:1-58 of the Administrative Code;

(c) Nuclear pharmacies;

(d) Medical and veterinary facilities;

(e) Use of radioactive materials for research and development and for educational purposes;

(f) Industrial radiography;

(g) Irradiators;

(h) Use of sealed sources or gauging devices, analytical instruments or other devices containing sealed sources;

(i) Use of uranium as shielding material in containers or devices;

(j) Possession of radioactive material incident to performing services such as installation, maintenance, leak tests and calibration;

(k) Use of sealed sources or radioactive tracers in well-logging procedures;

(l) Acceptance of packaged radioactive wastes from others for transfer to a licensed disposal facility, provided that the interim storage period for any package does not exceed one hundred eighty days and the total possession limit for all packages held in interim storage at the same time does not exceed 1.85 terabecquerels (fifty curies);

(m) Manufacturing or processing of source, radioactive, or special nuclear materials for distribution to other licensees, except processing of source material for extraction of rare earth and other metals and processing of radioactive material for extraction of metals;

(n) Nuclear laundries;

(o) Possession, manufacturing, processing, shipment, testing, or other use of depleted uranium military munitions; or

(p) Any use of source, radioactive, or special nuclear material not listed in paragraphs (C)(2)(a) to (C)(2)(o) of this rule which involves quantities and forms of source, radioactive, or special nuclear material of quantities less than a critical mass, similar to those listed in paragraphs (C)(2)(a) to (C)(2)(o) of this rule.

Last updated April 19, 2022 at 8:36 AM

History

• Effective: April 17, 2022
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-44-16

(A) An application for a specific license to manufacture industrial products and devices containing depleted uranium, or to initially transfer such products or devices, for use pursuant to rule 3701:1-44-13 of the Administrative Code or equivalent regulations of the United States nuclear regulatory commission or an agreement state, will be approved if:

(1) The applicant satisfies the general requirements specified in rule 3701:1-44-15 of the Administrative Code;

(2) The applicant submits sufficient information relating to the design, manufacture, prototype testing, quality control procedures, labeling or marking, proposed uses, and potential hazards of the industrial product or device to provide reasonable assurance that possession, use, or transfer of the depleted uranium in the product or device is not likely to cause any individual to receive in one year a radiation dose in excess of ten per cent of the annual limits specified in rule 3701:1-38-12 of the Administrative Code; and

(3) The applicant submits sufficient information regarding the industrial product or device and the presence of depleted uranium for a mass-volume application in the product or device to provide reasonable assurance that unique benefits will accrue to the public because of the usefulness of the product or device.

(B) In the case of an industrial product or device whose unique benefits are questionable, the director will approve an application for a specific license under this paragraph only if the product or device is found to combine a high degree of utility and low probability of uncontrolled disposal and dispersal of significant quantities of depleted uranium into the environment.

(C) The director may deny an applicant for a specific license under this paragraph if the end uses of the industrial product or device cannot be reasonably foreseen.

Last updated November 2, 2022 at 2:16 PM

History

• Effective: December 10, 2015
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-38-12

(A) Except in the case of a planned special exposure pursuant to paragraph (F) of this rule, a licensee or registrant shall limit the occupational dose received by an individual adult, as follows:

(1) An annual limit, which is the more limiting of:

(a) The total effective dose equivalent being equal to 0.05 sievert (five rem); or

(b) The sum of the deep dose equivalent and the committed dose equivalent to any individual organ or tissue other than the lens of the eye being equal to 0.5 sievert (fifty rem).

(2) The annual limits to the lens of the eye, to the skin of the whole body, and to the skin of the extremities, which are:

(a) A lens dose equivalent of 0.15 sievert (fifteen rem), and

(b) A shallow-dose equivalent of 0.5 sievert (fifty rem) to the skin of the whole body or to the skin of any extremity.

(3) Doses received in excess of the annual limits, including doses received during accidents, emergencies, and planned special exposures, shall be subtracted from the limits for planned special exposures that the individual may receive during the current calendar year and during the individual's lifetime in accordance with paragraph (F)(5) of this rule.

(4) When the external exposure is determined by measurement with an external personal monitoring device, the deep-dose equivalent must be used in place of the effective dose equivalent, unless the effective dose equivalent is determined by a dosimetry method approved by the director. The assigned deep-dose equivalent must be for the part of the body receiving the highest exposure.

(a) The assigned shallow-dose equivalent must be the dose averaged over the contiguous ten square centimeters of skin receiving the highest exposure. The deep-dose equivalent, lens-dose equivalent, and shallow-dose equivalent may be assessed from surveys or other radiation measurements for the purpose of demonstrating compliance with the occupational dose limits, if the individual monitoring device was not in the region of highest potential exposure, or the results of individual monitoring are unavailable; or

(b) When a protective apron is worn while working with radiation-generating equipment and monitoring is conducted as specified in paragraph (C)(1) of rule 3701:1-38-14 of the Administrative Code, the effective dose equivalent for external radiation shall be determined as follows:

(i) When only one individual monitoring device is used and it is located at the neck outside the protective apron, the reported deep dose equivalent value multiplied by 0.3 shall be the effective dose equivalent for external radiation; or

(ii) When two individual monitoring devices are worn, one under the protective apron at the waist and the other outside the protective apron at the neck, the effective dose equivalent for external radiation shall be assigned the value of the sum of the deep dose equivalent reported for the individual monitoring device located at the waist under the protective apron multiplied by 1.5 and the deep dose equivalent reported for the individual monitoring device located at the neck outside the protective apron multiplied by 0.04; or

(iii) Through the use of computational methods endorsed by the "American National Standards Institute", recommended by the "National Council on Radiation Protection and Measurements", or approved by the director.

(5) Derived air concentration (DAC) and annual limit on intake (ALI) values are specified in appendix C to this rule and may be used by the licensee to determine the individual's dose and to demonstrate compliance with the occupational dose limits. Appendices A and B are explanatory supplements to appendix C to this rule. Notwithstanding the annual dose limits, the licensee shall limit the soluble uranium intake by an individual to ten milligrams in a week in consideration of chemical toxicity.

(6) In accordance with paragraph (E) of this rule, the licensee or registrant shall reduce the dose that an individual may be allowed to receive in the current year by the amount of occupational dose received while employed by any other person.

(B) Compliance with requirements for summation of external and internal doses shall be in accordance with the following:

(1) If the licensee is required to monitor under both paragraphs (B)(1) and (B)(2) of rule 3701:1-38-14 of the Administrative Code, the licensee shall demonstrate compliance with the dose limits by summing external and internal doses. If the licensee is required to monitor only under paragraph (B)(1) or only under paragraph (B)(2) of rule 3701:1-38-14 of the Administrative Code, then summation is not required to demonstrate compliance with the dose limits. The licensee may demonstrate compliance with the requirements for summation of external and internal doses by meeting one of the conditions specified in paragraph (B)(2) of this rule and the conditions in paragraphs (B)(3) and (B)(4) of this rule. The dose equivalents for the lens of the eye, the skin, and the extremities are not included in the summation, but are subject to separate limits.

(2) If the only intake of radionuclides is by inhalation, the total effective dose equivalent limit is not exceeded if the sum of the deep dose equivalent divided by the total effective dose equivalent limit, plus one of the following does not exceed unity:

(a) The sum of the fractions of the inhalation ALI for each radionuclide; or

(b) The total number of derived air concentration-hours, or DAC-hours, for all radionuclides divided by two thousand; or

(c) The sum of the calculated committed effective dose equivalents to all significantly irradiated organs or tissues (T) calculated from bioassay data using appropriate biological models and expressed as a fraction of the annual limit. For purposes of this requirement, an organ or tissue is deemed to be significantly irradiated if, for that organ or tissue, the product of the weighting factors, W_T, and the committed dose equivalent, H_T,50, per unit intake is greater than ten per cent of the maximum weighted value of H_T,50, that is, W_TH_T,50, per unit intake for any organ or tissue.

(3) If the occupationally exposed individual also receives an intake of radionuclides by oral ingestion greater than ten percent of the applicable oral ALI, the licensee shall account for this intake and include it in demonstrating compliance with the limits set forth in paragraph (A) of this rule.

(4) The licensee shall evaluate and, to the extent practical, account for intakes through wounds or skin absorption. The intake through intact skin has been included in the calculation of DAC for hydrogen-3 and does not need to be further evaluated or accounted for pursuant to this paragraph.

(C) Determination of external dose from airborne radioactive material shall be in accordance with the following:

(1) When determining the dose from airborne radioactive material, the licensee shall include the contribution to the deep dose equivalent, lens dose equivalent, and shallow dose equivalent from external exposure to the radioactive cloud as specified in appendix C to this rule, footnotes ^A and ^B.

(2) The licensee should not use airborne radioactivity measurements or DAC values as the primary means to assess the deep dose equivalent when the airborne radioactive material includes radionuclides other than noble gases, or if the cloud of airborne radioactive material is not relatively uniform. The determination of the deep dose equivalent to an individual should be based upon measurements using instruments or individual monitoring devices.

(D) Determination of internal exposure shall be in accordance with the following:

(1) For purposes of assessing dose used to determine compliance with occupational dose equivalent limits, the licensee shall, when required under paragraph (B) of rule 3701:1-38-14 of the Administrative Code, take suitable and timely measurements of:

(a) Concentrations of radioactive materials in air in work areas; or

(b) Quantities of radionuclides in the body; or

(c) Quantities of radionuclides excreted from the body; or

(d) Combinations of these measurements.

(2) Unless respiratory protective equipment is used, as provided in paragraph (C) of rule 3701:1-38-16 of the Administrative Code or the assessment of intake is based on bioassays, the licensee shall assume that an individual inhales radioactive material at the airborne concentration in which the individual is present.

(3) When specific information on the physical and biochemical properties of the radionuclides taken into the body or the behavior of the material in an individual is known, the licensee may:

(a) Use that information to calculate the committed effective dose equivalent, and, if used, the licensee shall document that information in the individual's record; and

(b) Upon prior approval of the department, adjust the DAC or ALI values to reflect the actual physical and chemical characteristics of airborne radioactive material, for example, aerosol size distribution or density; and

(c) Separately assess the contribution of fractional intakes of Class D, W, or Y compounds of a given radionuclide to the committed effective dose equivalent as specified in appendix A to this rule.

(4) If the licensee chooses to assess intakes of Class Y material using the measurements given in paragraph (D)(1)(b) or (D)(1)(c) of this rule in order to make additional measurements basic to the assessments, the licensee may delay the recording and reporting of the assessments for periods up to seven months, unless otherwise required by paragraph (B)(2) or (C) of rule 3701:1-38-21 of the Administrative Code.

(5) If the identity and concentration of each radionuclide in a mixture are known, the fraction of the DAC applicable to the mixture for use in calculating DAC-hours shall be either:

(a) The sum of the ratios of the concentration to the appropriate DAC value, that is, D, W, or Y, from appendix C to this rule for each radionuclide in the mixture; or

(b) The ratio of the total concentration for all radionuclides in the mixture to the most restrictive DAC value for any radionuclide in the mixture.

(6) If the identity of each radionuclide in a mixture is known, but the concentration of one or more of the radionuclides in the mixture is not known, the DAC for the mixture shall by the most restrictive DAC of any radionuclide in the mixture.

(7) When a mixture of radionuclides in air exists, a licensee may disregard certain radionuclides in the mixture if all of the following occur:

(a) The licensee uses the total activity of the mixture in demonstrating compliance with the dose limits in paragraph (A) of this rule and in complying with the monitoring requirements in paragraph (B) of rule 3701:1-38-14 of the Administrative Code;

(b) The concentration of any radionuclide disregarded is less than ten percent of its DAC; and

(c) The sum of these percentages for all of the radionuclides disregarded in the mixture does not exceed thirty percent.

(8) When determining the committed effective dose equivalent, the licensee may consider the following:

(a) In order to calculate the committed effective dose equivalent, the licensee may assume that the inhalation of one ALI, or an exposure of two thousand DAC-hours, results in a committed effective dose equivalent of 0.05 sievert (five rem), for radionuclides that have their ALIs or DACs based on the committed effective dose equivalent; or

(b) For an ALI and the associated DAC determined by the nonstochastic organ dose limit of 0.5 sievert (fifty rem), the intake of radionuclides that would result in a committed effective dose equivalent of 0.05 sievert (five rem), that is, the stochastic ALI, is listed in parentheses in table I of appendix C to this rule. The licensee may, as a simplifying assumption, use the stochastic ALI to determine committed effective dose equivalent. However, if the licensee uses the stochastic ALI, the licensee shall also demonstrate that the limit in paragraph (A)(1)(b) of this rule is met.

(E) Determination of prior occupational dose shall be made in accordance with the following:

(1) For each individual who is likely to receive an annual occupational dose requiring monitoring pursuant to paragraph (B) of rule 3701:1-38-14 of the Administrative Code, the licensee or registrant shall determine the occupational radiation dose received during the current year.

(2) Prior to permitting an individual to participate in a planned special exposure, the licensee shall determine:

(a) The internal and external doses from all previous planned special exposures; and

(b) All doses in excess of the limits, including doses received during accidents and emergencies, received during the lifetime of the individual.

(3) In complying with the requirements of paragraph (E)(1) or (E)(2) of this rule, a licensee or registrant may:

(a) Accept, as a record of the occupational dose that the individual received during the current year, a written signed statements from the individual, or from the individual's most recent employer for work involving radiation exposure, that discloses the nature and the amount of any occupational dose that the individual may have received during the current year;

(b) Accept, as the record of lifetime cumulative radiation dose, a current department form entitled "lifetime occupational exposure history" or equivalent, signed by the individual and countersigned by an appropriate official of the most recent employer for work involving radiation exposure, or the individual's current employer, if the individual is not employed by the licensee or registrant; and

(c) Obtain reports of the individual's dose equivalent from the most recent employer for work involving radiation exposure, or the individual's current employer, if the individual is not employed by the licensee or registrant, by telephone, telegram, facsimile, e-mail or letter. The licensee or registrant shall request a written verification of the dose data if the authenticity of the transmitted report cannot be established.

(4) The licensee or registrant shall record the exposure history, as required by paragraph (A) of this rule, on a form provided by the department or other clear and legible record, of all the information required on that form. The form or record shall show each period in which the individual received occupational exposure to radiation or radioactive material and shall be signed by the individual who received the exposure. For each period for which the licensee or registrant obtains reports, the licensee or registrant shall use the dose shown in the report in preparing the exposure history form. For any period in which the licensee or registrant does not obtain a report, the licensee or registrant shall place a notation on the exposure history form indicating the periods of time for which data are not available.

(5) If the licensee or registrant is unable to obtain a complete record of an individual's current and previously accumulated occupational dose, the licensee or registrant shall assume:

(a) In establishing administrative controls pursuant to paragraph (A)(6) of this rule for the current year, that the allowable dose limit for the individual is reduced by 12.5 millisievert (1.25 rem), for each quarter for which records were unavailable and the individual was engaged in activities that could have resulted in occupational radiation exposure; and

(b) That the individual is not available for planned special exposures.

(6) The licensee or registrant shall retain the records on the exposure history form until the department terminates each pertinent license or registration requiring this record. The licensee or registrant shall retain records used in preparing the exposure history form for three years after the record is made.

(F) A planned special exposure may be authorized by a licensee in accordance with this paragraph. A licensee may authorize an adult worker to receive doses in addition to and accounted for separately from the doses received under the limits specified in paragraph (A) of this rule provided that each of the following is satisfied:

(1) The licensee authorizes a planned special exposure only in an exceptional situation when alternatives that might avoid the higher exposure are unavailable or impractical;

(2) The licensee and employer, if the employer is not the licensee, specifically authorizes the planned special exposure, in writing, before the exposure occurs;

(3) Before a planned special exposure, the licensee ensures that each individual involved is:

(a) Informed of the purpose of the planned operation; and

(b) Informed of the estimated doses and associated potential risks and specific radiation levels or other conditions that might be involved in performing the task; and

(c) Instructed in the measures to be taken to keep the dose ALARA considering other risks that may be present;

(4) Prior to permitting an individual to participate in a planned special exposure, the licensee ascertains prior doses as required by paragraph (E)(2) of this rule during the lifetime of the individual for each individual involved;

(5) The licensee shall not authorize a planned special exposure that would cause an individual to receive a dose from all planned special exposures and all doses in excess of the limits to exceed:

(a) The numerical values of any of the dose limits in paragraph (A) of this rule in any calendar year; and

(b) Five times the annual dose limits specified in paragraph (A) of this rule during the individual's lifetime;

(6) The licensee maintains records of the conduct of a planned special exposure in accordance with paragraph (E) of rule 3701:1-38-20 of the Administrative Code and submits a written report in accordance with paragraph (D) of rule 3701:1-38-21 of the Administrative Code;

(7) The licensee records the best estimate of the dose resulting from the planned special exposure in the individual's record and informs the individual, in writing, of the dose within thirty days from the date of the planned special exposure. The dose from planned special exposures shall not be considered in controlling future occupational dose of the individual pursuant to paragraph (A)(1) of this rule, but shall be included in evaluations required by paragraphs (F)(4) and (F)(5) of this rule.

(G) Occupational dose limits for minors shall be ten per cent of the annual occupational dose limits specified for adult workers in paragraph (A) of this rule.

(H) Dose equivalent to an embryo or fetus shall be in accordance with the following:

(1) The licensee or registrant shall ensure that the dose equivalent to an embryo or fetus during the entire pregnancy, due to occupational exposure of a declared pregnant woman, does not exceed five millisievert (0.5 rem). Records shall be maintained in accordance with paragraph (I) of rule 3701:1-38-20 of the Administrative Code.

(2) The licensee or registrant shall make efforts to avoid substantial variation above a uniform monthly exposure rate to a declared pregnant woman so as to satisfy the limit in paragraph (H)(1) of this rule.

(3) The dose equivalent to the embryo or fetus is the sum of:

(a) The deep-dose equivalent to the declared pregnant woman; and

(b) The dose equivalent to the embryo or fetus resulting from radionuclides in the embryo or fetus and from radionuclides in the declared pregnant woman.

(4) If the declared pregnant woman's exposure includes exposure from radiation generating equipment and a protective apron is worn, the dose equivalent to an embryo or fetus shall be taken as the sum of:

(a) The dose equivalent to the embryo or fetus from radionuclides in the embryo or fetus and radionuclides in the declared pregnant woman; and

(b) The dose equivalent that is most representative of the dose to the embryo or fetus from external radiation, that is, in the mother's lower torso region.

(i) If multiple measurements have not been made, assignment of the highest deep dose equivalent for the declared pregnant woman shall be the dose to the embryo or fetus, in accordance with paragraph (A)(4) of this rule; or

(ii) If multiple measurements have been made, assignment of the deep dose equivalent for the declared pregnant woman from the individual monitoring device which is most representative of the dose to the embryo or fetus shall be the dose to the embryo or fetus. Assignment of the highest deep dose equivalent for the declared pregnant woman to the embryo or fetus is not required unless that dose is also the most representative deep dose equivalent for the region of the embryo or fetus.

(5) If by the time the woman declares pregnancy to the licensee or registrant, the dose equivalent to the embryo or fetus has exceeded five millisievert, or 0.5 rem, the licensee or registrant shall be deemed to be in compliance with paragraph (A) of this rule, provided that the additional dose equivalent to the embryo or fetus does not exceed 0.5 millisievert (0.05 rem), during the remainder of the pregnancy.

View AppendixView AppendixView Appendix

Last updated November 2, 2022 at 2:10 PM

History

• Effective: October 4, 2010
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-40-17

(A) Prior to the director issuing a radioactive materials license:

(1) Each applicant for a specific license or license renewal authorizing the possession and use of unsealed radioactive material of half-life greater than one hundred twenty days and in quantities exceeding ten thousand times the applicable quantities set forth in appendix A to this rule shall submit a decommissioning funding plan as described in paragraph (D) of this rule. The decommissioning funding plan must also be submitted when a combination of radionuclides is involved if R divided by ten thousand is greater than one, where R is defined here as the sum of the ratios of the quantity of each radionuclide to the applicable value in appendix A to this rule.

(2) Each applicant for a specific license or license renewal authorizing the possession and use of sealed sources or plated foils of half-life greater than one hundred twenty days and in quantities exceeding one trillion times the applicable quantities of appendix A to this rule, shall submit a decommissioning funding plan as described in paragraph (D) of this rule. The decommissioning funding plan must also be submitted when a combination of radionuclides is involved if R divided by one trillion is greater than one, where R is defined here as the sum of the ratios of the quantity of each radionuclide to the applicable value in appendix A to this rule.

(B) Prior to the director issuing a radioactive materials license, each applicant for a specific license or license renewal authorizing possession and use of radioactive material of half-life greater than one hundred twenty days and in quantities specified in paragraph (C) of this rule shall either:

(1) Submit a decommissioning funding plan as described in paragraph (D) of this rule; or

(2) Submit a certification that financial assurance for decommissioning has been provided in the amount prescribed by paragraph (C) of this rule using one of the methods described in paragraph (E) of this rule. The applicant shall submit to the director, as part of the certification, a signed original of the financial instrument obtained to satisfy the requirements of paragraph (E) of this rule.

(C) Prior to the director issuing a radioactive materials license, an applicant providing certification of financial assurance for decommissioning as specified in paragraph (B)(2) of this rule shall provide the certification in a monetary amount based upon the quantity of licensed material specified as follows:

(1) Greater than one thousand but less than or equal to ten thousand times the applicable quantities of appendix A to this rule in unsealed form. For a combination of radionuclides, if R, as defined in paragraph (A) of this rule, divided by one thousand is greater than one but R divided by ten thousand is less than or equal to one, the sum of three hundred thousand dollars.

(2) Greater than ten billion but less than one trillion times the applicable quantities of appendix A to this rule in sealed sources or plated foils. For a combination of radionuclides, if R, as defined in paragraph (A) of this rule, divided by ten billion is greater than one but R divided by one trillion is less than or equal to one, the sum of one hundred fifty thousand dollars.

(D) .

(1) Each decommissioning funding plan must be submitted for review and approval and must contain:

(a) A detailed cost estimate for decommissioning, in an amount reflecting:

(i) The cost of an independent contractor to perform all decommissioning activities;

(ii) The cost of meeting the criteria specified in paragraph (B) of rule 3701:1-38-22 of the Administrative Code for unrestricted use, provided that, if the applicant or licensee can demonstrate its ability to meet the provisions of paragraph (D) of rule 3701:1-38-22 of the Administrative Code, the cost estimate may be based on meeting this criteria;

(iii) The volume of onsite subsurface material containing residual radioactivity that will require remediation to meet the criteria for license termination; and

(iv) An adequate contingency factor.

(b) Identification of and justification for using the key assumptions contained in the decommissioning cost estimate;

(c) A description of the method of assuring funds for decommissioning from paragraph (E) of this rule, including means for adjusting cost estimates and associated funding levels periodically over the life of the facility;

(d) A certification by the licensee that financial assurance for decommissioning has been provided in the amount of the cost estimate for decommissioning; and

(e) A signed original of the financial instrument obtained to satisfy the requirements of paragraph (E) of this rule (unless a previously submitted and accepted financial instrument continues to cover the cost estimate for decommissioning).

(2) At the time of license renewal and at intervals not to exceed three years, the decommissioning funding plan must be resubmitted with adjustments as necessary to account for the changes in costs and the extent of contamination. If the amount of financial assurance will be adjusted downward, this cannot be done until the updated decommissioning funding plan is approved. The decommissioning funding plan must update the information submitted with the original or prior approved plan, and must specifically consider the effect of the following events on decommissioning costs:

(a) Spills of radioactive material producing additional residual radioactivity in onsite subsurface material;

(b) Waste inventory increasing above the amount previously estimated;

(c) Waste disposal costs increasing above the amount previously estimated;

(d) Facility modifications;

(e) Changes in authorized possession limits;

(f) Actual remediation costs that exceed the previous cost estimate;

(g) Onsite disposal; and

(h) Use of a settling pond.

(E) Financial assurance for decommissioning, either by a decommissioning funding plan or certification of financial assurance, shall be provided by the licensee and approved by the director prior to the issuance of the license and shall be provided by one or more of the following methods:

(1) Prepayment by depositing into an account segregated from licensee assets and outside the licensee's administrative control, cash or liquid assets such that the amount of funds will be sufficient to pay decommissioning costs. Prepayment may be in the form of a trust, escrow account, government fund, certificate of deposit, or deposit of government securities.

(2) Surety, insurance, or other method in accordance with paragraph (F) of this rule, that guarantees that decommissioning costs will be paid. A surety method may be in the form of a surety bond, letter of credit, or line of credit. A guarantee by the applicant or licensee may not be used in combination with any other financial methods used to satisfy the requirements of this paragraph or in any situation where the applicant or licensee has a parent company holding majority control of the voting stock of the company.

(3) A parent company guarantee of funds for decommissioning costs based on a financial test may be used provided that the parent company meets the requirements specified in appendix B of this rule. A parent company guarantee may not be used in combination with other financial methods to satisfy the requirements of this rule.

(4) For commercial corporations that issue bonds, a guarantee of funds by the applicant or licensee for decommissioning costs based on a financial test may be used provided that the guarantee meets the requirements of appendix C to this rule.

(5) For commercial companies that do not issue bonds, a guarantee of funds for decommissioning costs may be used provided that the guarantee meets the requirements of appendix D to this rule.

(6) For nonprofit colleges, universities, hospitals, or research and development entities, a guarantee of funds for decommissioning costs may be used provided that the guarantee meets the requirements of appendix E to this rule. The director may require proof of nonprofit status.

(7) An external sinking fund in which deposits are made at least annually, coupled with a surety method or insurance, the value of which may decrease by the amount being accumulated in the sinking fund. An external sinking fund is a fund established and maintained by setting aside funds periodically in an account segregated from licensee assets and outside the licensee's administrative control in which the total amount of funds would be sufficient to pay decommissioning costs at the time termination of operation is expected. An external sinking fund may be in the form of a trust, escrow account, government fund, certificate of deposit, or deposit of government securities. The surety or insurance provisions must be as stated in paragraph (F) of this rule.

(8) In the case of state or local government licensee, a statement of intent containing a cost estimate for decommissioning or an amount specified in paragraphs (C)(1) to (C)(2) of this rule, and indicating that funds for decommissioning will be obtained when necessary. As used in this rule, "state or local government licensee" does not include government owned or assisted colleges, universities or hospitals.

(F) Any surety method or insurance used to provide financial assurance for decommissioning shall be in the form of instruments that contain language as provided in appendix F to this rule, and shall contain the following conditions:

(1) The surety method or insurance must be open-ended or, if written for a specified term, such as five years, must be renewed automatically unless ninety days or more prior to the renewal date, the issuer notifies the director, the beneficiary, and the licensee of its intention not to renew. The surety method or insurance must also provide that the full face amount be paid to the beneficiary automatically prior to the expiration without proof of forfeiture if the licensee fails to provide a replacement acceptable to the director within thirty days after receipt of notification of cancellation.

(2) The surety method or insurance must be payable to a trust established for decommissioning costs. The trustee and trust must be acceptable to the director. An acceptable trustee includes an appropriate state or federal government agency or an entity which has the authority to act as a trustee and whose trust operations are regulated and examined by a federal or state agency.

(3) The surety method or insurance must remain in effect until the director has terminated the license.

(4) The surety company issuing the bond must, at a minimum, be among those listed as acceptable in the "Circular 570" of the United States department of the treasury (as in effect on the effective date of this rule).

(G) A licensee must notify the director by certified mail within ten business days of the commencement of a voluntary or involuntary bankruptcy proceeding under Title 11 of the United States Code (as amended April 20, 2005). A licensee who fulfills the financial assurance requirements by obtaining a trust fund, surety bond, or other acceptable financial assurance will be deemed to be without the required financial assurance or liability coverage in the event of bankruptcy of the trustee or issuing institution, or a suspension or revocation of the authority of the trustee institution issuing the instrument. The licensee shall establish other financial assurance within sixty days after such an event.

(H) Financial assurance for decommissioning, either by a decommissioning funding plan or certification of financial assurance, that is provided by a contract of insurance shall not include any arrangement that constitutes self-insurance. As used in this rule:

(1) "Insurance" means a contract issued or underwritten by an insurance company, insurance service, or insurance organization which is licensed to engage in the business of insurance in Ohio, that binds the insurer to indemnify another against a specified loss in return for premiums paid.

(2) "Self insurance" means a contract of insurance issued either by the licensee or by an insurer affiliated with or an affiliate of the licensee.

(3) "Affiliate of" or "affiliated with" means that the licensee, either directly or indirectly, through one or more intermediaries or subsidiaries, controls, is controlled by, or is under common control with the insurer.

(4) "Control", including "controlled by", and "under common control with" means the possession, direct or indirect, of the power to direct or cause the direction of the management and policies of a person, whether through the ownership of voting securities, by contract, proxy, membership on the board, or otherwise.

(I) Each person licensed under this chapter, and rule 3701:1-38-02 of the Administrative Code as well as chapters containing rules regarding manufacturing and distribution (Chapter 3701:1-46 of the Administrative Code), industrial radiography (Chapter 3701:1-48 of the Administrative Code), well logging Chapter 3701:1-49 of the Administrative Code), irradiators (Chapter 3701:1-52 of the Administrative Code), and medical use (Chapter 3701:1-58 of the Administrative Code) promulgated pursuant to Chapter 3748. of the Revised Code shall keep records of information important to the decommissioning of a facility in an identified location until the site is released for unrestricted use. Before licensed activities are transferred or assigned in accordance with paragraph (B) of rule 3701:1-40-20 of the Administrative Code, a licensee shall transfer all records described in this paragraph to the new licensee, which will be responsible for maintaining these records until the license is terminated. If records important to the decommissioning of a facility are kept for other purposes, reference to these records and their locations may be used. As used in this rule, "information important to the decommissioning of a facility" includes the following:

(1) Records of spills or other unusual occurrences involving the spread of contamination in and around the facility, equipment, or site. These records may be limited to instances when contamination remains after any cleanup procedures or when there is reasonable likelihood that contaminants may have spread to inaccessible areas as in the case of possible seepage into porous materials such as concrete. These records must include any known information on identification of involved radionuclides, quantities, forms, and concentrations.

(2) As-built drawings and modifications of structures and equipment in restricted areas where radioactive materials are used or stored, and of locations of possible inaccessible contamination such as buried pipes which may be subject to contamination. If required drawings are referenced, each relevant document need not be indexed individually. If drawings are not available, the licensee shall substitute appropriate records of available information concerning these areas and locations.

(3) Except in the case of an area that contains only a sealed source, provided the source has not leaked or no contamination remains after any leak, or in the case of a byproduct or accelerator produced material having only a half-life of less than sixty-five days, a list contained in a single document and updated every two years, of the following:

(a) All areas designated and formerly designated restricted areas as defined in rule 3701:1-38-01 of the Administrative Code.

(b) All areas outside of restricted areas that require documentation under paragraph (I)(1) of this rule.

(c) All areas outside of restricted areas where current and previous wastes have been buried as documented under rule 3701:1-38-20 of the Administrative Code; and

(d) All areas outside of restricted areas that contain material such that, if the license expired, the licensee would be required to either decontaminate the area to meet the criteria for decommissioning in rule 3701:1-38-22 of the Administrative Code, or apply for approval for disposal under rule 3701:1-38-19 of the Administrative Code.

(4) Records of the cost estimate performed for the decommissioning funding plan or of the amount certified for decommissioning, and records of the funding method used for assuring funds if either a funding plan or certification is used.

View AppendixView AppendixView AppendixView AppendixView AppendixView Appendix

Last updated April 19, 2022 at 8:35 AM

History

• Effective: April 17, 2022
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-38-20

(A) Each licensee or registrant shall use the SI units becquerel, gray, sievert and coulomb per kilogram, or the special units curie, rad, rem and roentgen, including multiples and subdivisions, and shall clearly indicate the units of all quantities on records required by this chapter. The licensee or registrant shall make a clear distinction among the quantities entered on the records such as, total effective dose equivalent, total organ dose equivalent, shallow dose equivalent, lens dose equivalent, deep dose equivalent, or committed effective dose equivalent.

(B) Each licensee or registrant shall maintain records of the radiation protection program, including the provisions of the program and audits and other reviews of program content and implementation. The licensee or registrant shall retain the records of the provisions of the program until the department terminates each license or registration pertinent to the record. The licensee or registrant shall retain all the other records required by this paragraph for three years after the record is made.

(C) Records of surveys showing the results of surveys and calibrations required by paragraph (A) of rule 3701:1-38-14 and paragraph (F) of rule 3701:1-38-18 of the Administrative Code shall be maintained and retained by the licensee or registrant for three years after the record is made.

(D) The licensee or registrant shall retain each of the following records until the department terminates each license or registration pertinent to the record:

(1) Records of the results of surveys to determine the dose from external sources of radiation used, in the absence of or in combination with individual monitoring data, in the assessment of individual dose equivalents;

(2) Records of the results of measurements and calculations used to determine individual intakes of radioactive material and used in the assessment of internal dose;

(3) Records showing the results of air sampling, surveys, and bioassays required pursuant to paragraphs (C)(2)(a) and (C)(2)(b) of rule 3701:1-38-16 of the Administrative Code; and

(4) Records of the results of measurements and calculations used to evaluate the release of radioactive effluents to the environment.

(E) Records of tests for leakage or contamination of sealed sources shall be kept in units of becquerel or microcurie, or multiples thereof, and maintained for inspection by the department for at least three years after the records are made.

(F) Records of prior occupational dose and exposure history as required in paragraph (E) of rule 3701:1-38-12 of the Administrative Code shall be recorded by the licensee or registrant on a form provided by the department entitled "lifetime occupational exposure history" in accordance with the instructions for completing this form, or in clear and legible records containing all the information required by the same form. The licensee or registrant shall maintain these records until the department terminates each license or registration pertinent to this record. The licensee or registrant shall retain records used in preparing the form for three years after the record is made.

(G) Records of planned special exposures as required in paragraph (F) of rule 3701:1-38-12 of the Administrative Code shall be maintained by the licensee:

(1) The licensee shall maintain records that describe the following:

(a) The exceptional circumstances requiring the use of a planned special exposure;

(b) The name of the management official who authorized the planned special exposure and a copy of the signed authorization;

(c) What actions were necessary;

(d) Why the actions were necessary;

(e) What precautions were taken to assure that doses were maintained ALARA;

(f) What individual and collective doses were expected to result; and

(g) The doses actually received in the planned special exposure.

(2) The licensee shall retain the records until the department terminates each license pertinent to these records.

(H) Records of individual dose monitoring results shall be maintained by each licensee or registrant for each individual for whom monitoring is required pursuant to paragraph (B) of rule 3701:1-38-14 of the Administrative Code, and records of doses received during planned special exposures, accidents, and emergency conditions. Assessments of dose equivalent and records made using units in effect before the effective date of these rules need not be changed.

(1) These records shall include, when applicable:

(a) The deep dose equivalent to the whole body, lens dose equivalent, shallow dose equivalent to the skin, and shallow dose equivalent to the extremities;

(b) The estimated intake or radionuclides as provided in paragraph (B) of rule 3701:1-38-12 of the Administrative Code;

(c) The committed effective dose equivalent assigned to the intake of radionuclides; and

(d) The specific information used to calculate the committed effective dose equivalent pursuant to paragraph (D)(8) of rule 3701:1-38-12 of the Administrative Code; and

(e) The total effective dose equivalent when required by paragraph (B) of rule 3701:1-38-12 of the Administrative Code; and

(f) The total of the deep dose equivalent and the committed dose to the organ receiving the highest total dose.

(2) The licensee or registrant shall make entries of the records specified in paragraph (H) of this rule at least annually.

(I) Each licensee or registrant shall maintain the records specified in paragraph (H) of this rule on department form entitled "occupational exposure record for a monitoring period" in accordance with the instructions for completing this form, or in clear and legible records containing all the information required by the same form. The licensee or registrant shall maintain the records of dose to an embryo or fetus with the records of dose to the declared pregnant woman. The declaration of pregnancy shall also be kept on file, but may be maintained separately from the dose records. The licensee or registrant shall retain each required form or record until the department terminates each license or registration pertinent to the record.

(J) Each licensee or registrant shall maintain records sufficient to demonstrate compliance with the dose limits for individual members of the public specified in paragraph (A) of rule 3701:1-38-13 of the Administrative Code. Each licensee or registrant shall retain the records required by paragraph (H) of this rule until the department terminates each license or registration pertinent to the record.

(K) Records of the disposal of licensed material shall be maintained by each licensee in accordance with paragraphs (C), (D), (F), and (G) of rule 3701:1-38-19, and Chapter 3701:1-54 of the Administrative Code. The licensee shall retain the records required by this paragraph until the department terminates each pertinent license that requires the record.

(L) Records of tests performed on entry control devices located in a very high radiation area shall be maintained by each licensee in accordance with Chapter 3701:1-52 of the Administrative Code or registrant in accordance with Chapters 3701:1-66, 3701:1-67, and 3701:1-68 of the Administrative Code. These records must include the date, time, and results of each such test of function. The licensee or registrant shall retain the records required by this paragraph for at least three years after the record is made.

(M) Each record required by this chapter shall be legible throughout the specified retention period. The record shall be the original or a reproduced copy or a microform, provided that the copy or microform is authenticated by authorized personnel and that the microform is capable of producing a clear copy throughout the required retention period. The record may also be stored in electronic media with the capability for producing legible, accurate, and complete records during the required retention period. Records, such as letters, drawings, and specifications, shall include all pertinent information, such as stamps, initials, and signatures. The licensee or registrant shall maintain adequate safeguards against tampering with and loss of records.

Last updated January 20, 2022 at 8:48 AM

History

• Effective: January 20, 2022
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-44-20 Expiration and termination of licenses and decommissioning of sites and separate buildings or outdoor areas.

(A) Each specific license expires at the end of the day on the expiration date stated in the license unless the licensee has filed an application for renewal under rule 3701:1-38-02 of the Administrative Code not less than ninety days before the expiration date stated in the existing license. If an application for renewal has been filed at least ninety days before the expiration date stated in the existing license, the existing license expires at the end of the day on which the director makes a final determination to deny the renewal application or, if the determination states an expiration date, the expiration date stated in the determination.

(B) Each specific license revoked by the director expires at the end of the day on the date of the director's final determination to revoke the license, or on the expiration date stated in the determination, or as otherwise provided by the director's order.

(C) Each specific license continues in effect, beyond the expiration date if necessary, with respect to possession of source material until the director notifies the licensee in writing that the license is terminated. During this time, the licensee shall:

(1) Limit actions involving source material to those related to decommissioning; and

(2) Continue to control entry to restricted areas until they are suitable for release in accordance with the director's requirements;

(D) Within sixty days of the occurrence of any of the following, consistent with the administrative directions in rule 3701:1-44-05 of the Administrative Code, each licensee shall provide notification to the department in writing and either begin decommissioning its site, or any separate building or outdoor area that contains residual radioactivity, so that the building or outdoor area is suitable for release in accordance with director's requirements, or submit within twelve months of notification a decommissioning plan, if required by paragraph (G)(1) of this rule, and begin decommissioning upon approval of that plan if:

(1) The license has expired pursuant to paragraph (A) or (B) of this rule; or

(2) The licensee has decided to permanently cease principal activities, as defined in this chapter, at the entire site or in any separate building or outdoor area; or

(3) No principal activities under the license have been conducted for a period of twenty-four months; or

(4) No principal activities have been conducted for a period of twenty-four months in any separate building or outdoor area that contains residual radioactivity such that the building or outdoor area is unsuitable for release in accordance with director's requirements.

(E) Coincident with the notification required by paragraph (D) of this rule, the licensee shall maintain in effect all decommissioning financial assurances established by the licensee pursuant to rule 3701:1-44-18 of the Administrative Code in conjunction with a license issuance or renewal or as required by this rule. The amount of the financial assurance must be increased, or may be decreased, as appropriate, to cover the detailed cost estimate for decommissioning established pursuant to paragraph (G)(4)(e) of this rule.

(F) The director may grant a request to delay or postpone initiation of the decommissioning process if the director determines that such relief is not detrimental to the public health and safety and is otherwise in the public interest. The request must be submitted no later than thirty days before notification pursuant to paragraph (D) of this rule. The schedule for decommissioning set forth in paragraph (D) of this rule may not commence until the director has made a determination on the request.

(G)

(1) A decommissioning plan must be submitted if required by license condition or if the procedures and activities necessary to carry out decommissioning of the site or separate building or outdoor area have not been previously approved by the director and these procedures could increase potential health and safety impacts to workers or to the public, such as in any of the following cases:

(a) Procedures would involve techniques not applied routinely during cleanup or maintenance operations;

(b) Workers would be entering areas not normally occupied where surface contamination and radiation levels are significantly higher than routinely encountered during operation;

(c) Procedures could result in significantly greater airborne concentrations of radioactive materials than are present during operation; or

(d) Procedures could result in significantly greater releases of radioactive material to the environment than those associated with operation.

(2) The director may approve an alternate schedule for submittal of a decommissioning plan required pursuant to paragraph (D) of this rule if the director determines that the alternative schedule is necessary to the effective conduct of decommissioning operations and presents no undue risk from radiation to the public health and safety and is otherwise in the public interest.

(3) The procedures listed in paragraph (G)(1) of this rule may not be carried out prior to approval of the decommissioning plan.

(4) The proposed decommissioning plan for the site or separate building or outdoor area must include:

(a) A description of the conditions of the site or separate building or outdoor area sufficient to evaluate the acceptability of the plan;

(b) A description of planned decommissioning activities;

(c) A description of methods used to ensure protection of workers and the environment against radiation hazards during decommissioning;

(d) A description of the planned final radiation survey; and

(e) An updated detailed cost estimate for decommissioning, comparison of that estimate with present funds set aside for decommissioning, and a plan for assuring the availability of adequate funds for completion of decommissioning.

(f) For decommissioning plans calling for completion of decommissioning later than twenty-four months after plan approval, a justification for the delay based on the criteria in paragraph (I) of this rule.

(5) The proposed decommissioning plan will be approved by the director if the information therein demonstrates that the decommissioning will be completed as soon as practicable and that the health and safety of workers and the public will be adequately protected.

(H)

(1) Except as provided in paragraph (I) of this rule, licensees shall complete decommissioning of the site or separate building or outdoor area as soon as practicable but no later than twenty-four months following the initiation of decommissioning.

(2) Except as provided in paragraph (I) of this rule, when decommissioning involves the entire site, the licensee shall request license termination as soon as practicable but no later than twenty-four months following the initiation of decommissioning.

(I) The director may approve a request for an alternate schedule for completion of decommissioning of the site or separate building or outdoor area, and license termination if appropriate, if the director determines that the alternative is warranted by consideration of the following:

(1) Whether it is technically feasible to complete decommissioning within the allotted twenty-four month period;

(2) Whether sufficient waste disposal capacity is available to allow completion of decommissioning within the allotted twenty-four month period;

(3) Whether a significant volume reduction in wastes requiring disposal will be achieved by allowing short-lived radionuclides to decay;

(4) Whether a significant reduction in radiation exposure to workers can be achieved by allowing short-lived radionuclides to decay; and

(5) Other site-specific factors which the department may consider appropriate on a case-by-case basis, such as the regulatory requirements of other government agencies, lawsuits, ground-water treatment activities, monitored natural ground-water restoration, actions that could result in more environmental harm than deferred cleanup, and other factors beyond the control of the licensee.

(J) As the final step in decommissioning, the licensee shall:

(1) Certify the disposition of all licensed material, including accumulated wastes, by submitting a completed form HEA 5119 "Certificate of Disposition of Materials" or equivalent information; and

(2) Conduct a radiation survey of the premises where the licensed activities were carried out and submit a report of the results of this survey, unless the licensee demonstrates in some other manner that the premises are suitable for release in accordance with the criteria for decommissioning in rule 3701:1-38-22 of the Administrative Code or, for uranium milling (uranium and thorium recovery) facilities, criterion 6(6) in the appendix to rule 3701:1-44-14 of the Administrative Code. The licensee shall, as appropriate:

(a) Report levels of gamma radiation in units of millisieverts (microroentgen) per hour at one meter from surfaces, and report levels of radioactivity, including alpha and beta, in units of megabecquerels (disintegrations per minute or microcuries) per one hundred square centimeters removable and fixed for surfaces, megabecquerels (microcuries) per milliliter for water, and becquerels (picocuries) per gram for solids such as soils or concrete; and

(b) Specify the survey instrument(s) used and certify that each instrument is properly calibrated and tested.

(K) Specific licenses, including expired licenses, will be terminated by written notice to the licensee when the director determines that:

(1) Source material has been properly disposed;

(2) Reasonable effort has been made to eliminate residual radioactive contamination, if present; and

(3)

(a) A radiation survey has been performed which demonstrates that the premises are suitable for release in accordance with the criteria for decommissioning in rule 3701:1-38-22 of the Administrative Code or, for (uranium and thorium recovery) facilities, criterion 6(6) in the appendix to rule 3701:1-44-14 of the Administrative Code; or

(b) Other information submitted by the licensee is sufficient to demonstrate that the premises are suitable for release in accordance with the criteria for decommissioning in rule 3701:1-38-22 of the Administrative Code or, for uranium milling (uranium and thorium recovery) facilities, criterion 6(6) in the appendix to rule 3701:1-44-14 of the Administrative Code.

(4) Records required by paragraphs (D) and (F) of rule 3701:1-44-23 of the Administrative Code have been received.

(L) Specific licenses for uranium and thorium milling are exempt from paragraphs (D)(4), (G) and (H) of this rule with respect to reclamation of tailings impoundments and/or waste disposal areas.

Last updated June 3, 2022 at 12:17 PM

History

• Effective: May 23, 2022
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-44-23

(A) Each person who receives source or byproduct material pursuant to a license issued pursuant to the rules under Chapter 3701:1-44 of the Administrative Code shall keep records showing the receipt, transfer, and disposal of this source or byproduct material as follows:

(1) The licensee shall retain each record of receipt of source or byproduct material as long as the material is possessed and for three years following transfer or disposition of the source or byproduct material.

(2) The licensee who transferred the material shall retain each record of transfer of source or byproduct material until the director terminates each license that authorizes the activity that is subject to the recordkeeping requirement.

(3) The licensee shall retain each record of disposal of source or byproduct material until the director terminates each license that authorizes the activity that is subject to the recordkeeping requirement.

(4) If source or byproduct material is combined or mixed with other licensed material and subsequently treated in a manner that makes direct correlation of a receipt record with a transfer, export, or disposition record impossible, the licensee may use evaluative techniques (such as first-in-first-out), to make the records that are required by Chapter 3701:1-44 of the Administrative Code account for one hundred per cent of the material received.

(B) The licensee shall retain each record that is required by the rules in Chapter 3701:1-44 of the Administrative Code or by license condition for the period specified by the appropriate rule or license condition. If a retention period is not otherwise specified by rule or license condition, each record must be maintained until the director terminates the license that authorizes the activity that is subject to the recordkeeping requirement.

(C)

(1) Records which must be maintained pursuant to Chapter 3701:1-44 of the Administrative Code may be the original or reproduced copy or microform if the reproduced copy or microform is duly authenticated by authorized personnel and the microform is capable of producing a clear and legible copy after storage for the period specified by Chapter 3748. of the Revised Code and rules promulgated thereunder. The record may also be stored in electronic media with the capability for producing legible, accurate, and complete records during the required retention period. Records such as letters, drawings, and specifications must include all pertinent information such as stamps, initials, and signatures. The licensee shall maintain adequate safeguards against tampering with and loss of records.

(2) If there is a conflict between the rules in Chapter 3701:1-44 of the Administrative Code, license condition, or other written director's approval or authorization pertaining to the retention period for the same type of record, the retention period specified in the rules in Chapter 3701:1-44 of the Administrative Code for such records shall apply unless the director, pursuant to rule 3701:1-44-10 of the Administrative Code, has granted a specific exemption from the record retention requirements specified in the rules in Chapter 3701:1-44 of the Administrative Code.

(D) Prior to license termination, each licensee authorized to possess source material, in an unsealed form, shall forward the following records to the director:

(1) Records of disposal of licensed material made under paragraphs (C) (including burials authorized before January 28, 1981), (D), (F), and (G) of rule 3701:1-38-19 of the Administrative Code; and

(2) Records required by paragraph (D)(4) of rule 3701:1-38-20 of the Administrative Code.

(E) If licensed activities are transferred or assigned in accordance with paragraph (B) of rule 3701:1-44-19 of the Administrative Code, each licensee authorized to possess source material, in an unsealed form, shall transfer the following records to the new licensee and the new licensee will be responsible for maintaining these records until the license is terminated:

(1) Records of disposal of licensed material made under paragraphs (C) (including burials authorized before January 28, 1981), (D), (F), and (G) of rule 3701:1-38-19 of the Administrative Code; and

(2) Records required by paragraph (D)(4) of rule 3701:1-38-20 of the Administrative Code.

(F) Prior to license termination, each licensee shall forward the records required by paragraph (F) of rule 3701:1-44-18 of the Administrative Code to the director.

Last updated July 10, 2025 at 12:13 PM

History

• Effective: December 10, 2015
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-44-24 Effluent monitoring reporting requirements.

Each licensee authorized to possess and use source material in uranium milling shall, within sixty days after January first and July first of each year, submit a report to the director using an appropriate method listed in rule 3701:1-44-05 of the Administrative Code. The report must specify the quantity of each of the principal radionuclides released to unrestricted areas in liquid and in gaseous effluents during the previous six months of operation, and such other information as the department may require to estimate maximum potential annual radiation doses to the public resulting from effluent releases. If quantities of radioactive materials released during the reporting period are significantly above the licensee's design objectives previously reviewed as part of the licensing action, the report shall cover this specifically. On the basis of such reports and any additional information the director may obtain from the licensee or others, the director may from time to time require the licensee to take such action as the director deems appropriate.

Last updated November 2, 2022 at 2:16 PM

History

• Effective: December 10, 2015
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-44-25 Inalienability of licenses.

(A) No license issued or granted pursuant to the rules in Chapter 3701:1-44 of the Administrative Code shall be transferred, assigned or in any manner disposed of, either voluntarily or involuntarily, directly or indirectly, through transfer of control of any license to any person, unless the director shall after securing full information, find that the transfer is in accordance with the provisions of Chapter 3748. of the Revised Code and rules promulgated thereunder, and shall give his consent in writing.

(B) An application for transfer of a license must include:

(1) The identity, technical and financial qualifications of the proposed transferee; and

(2) Financial assurance for decommissioning information required by rule 3701:1-44-18 of the Administrative Code.

Last updated November 2, 2022 at 2:16 PM

History

• Effective: November 22, 2013
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-44-27 Conditions of licenses to initially transfer source material for use under the "small quantities of source material" general license: quality control, labeling, safety instructions, and records and reports.

(A) Each person licensed under rule 3701:1-44-26 of the Administrative Code shall label the immediate container of each quantity of source material with the type of source material and quantity of material and the words, "radioactive material."

(B) Each person licensed under rule 3701:1-44-26 of the Administrative Code shall ensure that the quantities and concentrations of source material are as labeled and indicated in any transfer records.

(C) Each person licensed under rule 3701:1-44-26 of the Administrative Code shall provide the information specified in this paragraph to each person to whom source material is transferred for use under rule 3701:1-44-12 of the Administrative Code. This information must be transferred before the source material is transferred for the first time in each calendar year to the particular recipient. The required information includes:

(1) A copy of rules 3701:1-44-12 and 3701:1-44-21 of the Administrative Code or relevant equivalent regulation of the U.S. nuclear regulatory commission or an agreement state.

(2) Appropriate radiation safety precautions and instructions relating to handling, use, storage, and disposal of the material.

(D) Each person licensed under rule 3701:1-44-26 of the Administrative Code shall report transfers as follows:

(1) File a report with the director. The report shall include the following information:

(a) The name, address, and license number of the person who transferred the source material;

(b) For each general licensee under rule 3701:1-44-12 of the Administrative Code, to whom greater than fifty grams (0.11 pounds) of source material has been transferred in a single calendar quarter, the name and address of the general licensee to whom source material was distributed; a responsible agent, by name and/or position and phone number, of the general licensee to whom the material was sent; and the type, physical form, and quantity of source material transferred; and

(c) The total quantity of each type and physical form of source material transferred in the reporting period to all such generally licensed recipients.

(2) File a report with the U. S. nuclear regulatory commission for transfers in states in which the U. S. nuclear regulatory commission has regulatory authority or file a report with the responsible agreement state agency that identifies all persons, operating under provisions equivalent to rule 3701:1-44-12 of the Administrative Code, to whom greater than fifty grams (0.11 pounds) of source material has been transferred within a single calendar quarter. The report shall include the following information specific to those transfers made to the U. S. nuclear regulatory commission or agreement state being reported to:

(a) The name, address, and license number of the person who transferred the source material; and

(b) The name and address of the general licensee to whom source material was distributed; a responsible agent, by name and/or position and phone number, of the general licensee to whom the material was sent; and the type, physical form, and quantity of source material transferred.

(c) The total quantity of each type and physical form of source material transferred in the reporting period to all such generally licensed recipients within the agreement state.

(3) Submit each report by January thirty-first of each year covering all transfers for the previous calendar year. If no transfers were made to persons generally licensed under rule 3701:1-44-12 of the Administrative Code during the current period, a report shall be submitted to the director indicating so. If no transfers have been made to general licensees in a particular agreement state during the reporting period, this information shall be reported to the U.S. nuclear regulatory commission or responsible agreement state agency upon request of the agency.

(E) Each person licensed under rule 3701:1-44-26 of the Administrative Code shall maintain all information that supports the reports required by this section concerning each transfer to a general licensee for a period of one year after the event is included in a report to the director.

Last updated November 2, 2022 at 2:17 PM

History

• Effective: December 10, 2015
• Promulgated Under: 119.03

Chapter 3701:1-46 Byproduct, Accelerator Produced Material and Radium Licensing

Ohio Adm.Code 3701:1-46-01 Definitions.

Terms defined in rules 3701:1-38-01 and 3701:1-40-01 and Chapter 3701:1-50 of the Administrative Code shall have the same meaning when used in this chapter except terms redefined within a given rule for use within that rule only and additionally, as used in this chapter:

"Lot Tolerance Per Cent Defective" means, expressed in per cent defective, the poorest quality in an individual inspection lot that should be accepted.

Last updated November 2, 2022 at 2:17 PM

History

• Effective: June 16, 2017
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-38-01

(A) As used in this chapter and all other rules promulgated pursuant to Chapter 3748. of the Revised Code:

(1) "A₁" means the maximum activity of special form radioactive material permitted in a type A package. These values are listed in rule 3701:1-50-25 of the Administrative Code, or may be derived in accordance with the procedure prescribed in rule 3701:1-50-25 of the Administrative Code.

(2) "A₂" means the maximum activity of radioactive material, other than special form, low specific activity and surface contaminated object material, permitted in a type A package. These values are listed in rule 3701:1-50-25 of the Administrative Code, or may be derived in accordance with the procedure prescribed in rule 3701:1-50-25 of the Administrative Code.

(3) "Absorbed dose" means the energy imparted by ionizing radiation per unit mass of irradiated material. The units of absorbed dose are the gray, or Gy, and the rad.

(4) "Accelerator or charged particle accelerator" means any of a class of radiation generating equipment designed to electronically accelerate atomic or sub-atomic particles for subsequent bombardment of targets.

(5) "Accelerator-produced radioactive material" means any material made radioactive by a particle accelerator.

(6) "Activity" means the rate of disintegration or transformation or decay of radioactive material. The units of activity are the becquerel, or Bq, and the curie, or Ci.

(7) "Address of use" means the building or buildings that are identified on the license or registration and where the source of radiation may be received, used, prepared, or stored, except for temporary job sites.

(8) "Administrative controls" means mechanisms used to protect health and minimize damage to life and property through the use of written policies, procedures, instructions, training, observation of work practices, and related compliance audits.

(9) "Administrative monetary penalty" means a monetary penalty assessed by the director under section 3748.05 of the Revised Code and in compliance with rules adopted thereunder, to emphasize the need for lasting remedial action and to deter future violations.

(10) "Adult" means an individual eighteen or more years of age.

(11) "Agreement state" means any state with which the United States nuclear regulatory commission or the atomic energy commission has entered into an effective agreement under subsection 274B of the Atomic Energy Act of 1954, 68 Stat. 919, 42 U.S.C. 2021, as amended (1978). Non-agreement state means any other state.

(12) "Airborne radioactive material" means radioactive material dispersed in the air in the form of dusts, fumes, particulates, mists, vapors, or gases.

(13) "Airborne radioactivity area" means a room, enclosure, or area in which airborne radioactive materials, composed wholly or partly of licensed material, exist in concentrations:

(a) In excess of the derived air concentrations (DACs) specified in appendix C to rule 3701:1-38-12 of the Administrative Code, or

(b) To such a degree that an individual present in the area without respiratory protective equipment could exceed, during the hours an individual is present in a week, an intake of 0.6 per cent of the annual limit on intake or twelve DAC-hours.

(14) "Air-purifying respirator" means a respirator with an air-purifying filter, cartridge, or canister that removes specific air contaminants by passing ambient air through the air-purifying element.

(15) "ALARA" or "as low as is reasonably achievable" means every reasonable effort to maintain exposures to radiation as far below the dose limits as is practical consistent with the purpose for which the licensed or registered activity is undertaken, taking into account the state of technology, the economics of improvements in relation to benefits to the public health and safety, and other societal and socioeconomic considerations, and in relation to utilization of nuclear energy and licensed materials and registered activities in the public interest.

(16) "Alert" means events may occur, are in progress, or have occurred that could lead to a release of radioactive material but that the release is not expected to require a response by off-site response organizations to protect persons off-site.

(17) "Annual limit on intake" or "ALI" means the derived limit for the amount of radioactive material taken into the body of an adult worker by inhalation or ingestion in a year. ALI is the smaller value of intake of a given radionuclide in a year by the reference man that would result in a committed effective dose equivalent of 0.05 sievert (five rem) or a committed dose equivalent of 0.5 sievert (fifty rem) to any individual organ or tissue. ALI values for intake by ingestion and by inhalation of selected radionuclides are given in appendix C to rule 3701:1-38-12 of the Administrative Code.

(18) "Annually" means either

(a) At intervals not to exceed one year; or

(b) Once per year, at about the same time each year, plus or minus one month.

(19) "Area of use" means a portion of an address of use that has been set aside for the purpose of receiving, preparing, using, or storing sources of radiation.

(20) "Assigned protection factor" or "APF" means the expected workplace level of respiratory protection that would be provided by a properly functioning respirator or a class of respirators to properly fitted and trained users. Operationally, the inhaled concentration can be estimated by dividing the ambient airborne concentration by the APF.

(21) "Atmosphere-supplying respirator" means a respirator that supplies the respirator user with breathing air from a source independent of the ambient atmosphere, and includes supplied air respirators, or SARs, and self-contained breathing apparatus, or SCBA, units.

(22) "Atomic energy commission" or "AEC" means the federal agency created by the Atomic Energy Act of 1954, 68 Stat. 919, 42 U.S.C. 2011, as amended (1964), and was the predecessor agency to the current United States nuclear regulatory commission.

(23) "Background radiation" means radiation from cosmic sources; naturally occurring radioactive materials, including radon, except as a decay product of source or special nuclear material, and global fallout as it exists in the environment from the testing of nuclear explosive devices or from past nuclear accidents such as Chernobyl that contribute to background radiation and are not under the control of the licensee. "Background radiation" does not include radiation from radioactive materials regulated by the department.

(24) "Becquerel" or "Bq" means the SI unit of activity. One becquerel is equal to one disintegration per second.

(25) "Bioassay" or "radiobioassay" means the determination of kinds, quantities or concentrations, and, in some cases, the locations of radioactive material in the human body, whether by direct measurement, in vivo counting, or by analysis and evaluation of materials excreted or removed from the human body.

(26) "Byproduct material" means

(a) Any radioactive material, except special nuclear material, yielded in or made radioactive by exposure to the radiation incident to the process of producing or utilizing special nuclear materials; or

(b) The tailings or wastes produced by the extraction or concentration of uranium or thorium from any ore processed primarily for its source material content, including discrete surface wastes resulting from solution extraction processes. Underground ore bodies depleted by such solution extraction do not constitute byproduct material within the definition.

(27) "Chelating agent" means a chemical compound or mixture that enhances the removal of radioactive material from the body, water or similar applications. Typical chelating agents include amine polycarboxylic acids such as EDTA or DTPA; hydroxy-carboxylic acids; and polycarboxylic acids such as citric acid, carbolic acid, and gluconic acid.

(28) "Chiropractor" means an individual licensed by the state of Ohio to practice chiropractic medicine pursuant to Chapter 4734. of the Revised Code.

(29) "Class" or "lung class" or "inhalation class" means a classification scheme for inhaled material according to its rate of clearance from the pulmonary region of the lung. Materials are classified as D, W, or Y, which applies to a range of clearance half-times: for class D, days, of less than ten days, for class W, weeks, from ten to one hundred days, and for class Y, years, of greater than one hundred days.

(30) "Collective dose" means the sum of the individual doses received in a given period of time by a specified population from exposure to a specified source of radiation.

(31) "Commencement of construction" means taking any action defined as "construction" or any other activity at the site of a facility subject to the rules promulgated pursuant to Chapter 3748. of the Revised Code that has a reasonable nexus to radiological health and safety.

(32) "Committed dose equivalent" or "H_T,50" means the dose equivalent to organs or tissues of reference, T, that will be received from an intake of radioactive material by an individual during the fifty year period following the intake.

(33) "Committed effective dose equivalent" or "H_E,50" means the sum of the products of the weighting factors applicable to each of the body organs or tissues, W_T, that are irradiated and the committed dose equivalent to each of these organs or tissues (H_{E, 50} = W_TH_T,50).

(34) "Consortium" means an association of medical use licensees and a PET radionuclide production facility in the same geographical area that jointly own or share in the operation and maintenance cost of the PET radionuclide production facility that produces PET radionuclides for use in producing radioactive drugs within the consortium for noncommercial distributions among its associated members for medical use. The PET radionuclide production facility within the consortium must be located at an educational institution or a medical facility.

(35) "Constraint" or "dose constraint" means a value above which specified licensee actions are required.

(36) "Construction" means the installation of foundations, or in-place assembly, erection, fabrication, or testing for any structure, system, or component of a facility or activity subject to the rules promulgated pursuant to Chapter 3748. of the Revised Code that are related to radiological safety or security. The term "construction" does not include:

(a) Changes for temporary use of the land for public recreational purposes;

(b) Site exploration, including necessary borings to determine foundation conditions or other preconstruction monitoring to establish background information related to the suitability of the site, the environmental impacts of construction or operation, or the protection of environmental values;

(c) Preparation of the site for construction of the facility, including clearing of the site, grading, installation of drainage, erosion and other environmental mitigation measures, and construction of temporary roads and borrow areas;

(d) Erection of fences and other access control measures that are not related to the safe use of, or security of, radiological materials subject to the rules promulgated pursuant to Chapter 3748. of the Revised Code;

(e) Excavation;

(f) Erection of support buildings (e.g. construction equipment storage sheds, warehouse and shop facilities, utilities, concrete mixing plants, docking and unloading facilities, and office buildings) for use in connection with the construction of the facility;

(g) Building of service facilities (e.g. paved roads, parking lots, railroad spurs, exterior utility and lighting systems, potable water systems, sanitary sewerage treatment facilities, and transmission lines);

(h) Procurement or fabrication of components or portions of the proposed facility occurring at other than the final, in-place location at the facility; or

(i) Taking any other action that has no reasonable nexus to radiological health and safety.

(37) "Controlled area" means an area, outside of a restricted area but inside the site boundary, access to which can be limited by the licensee or registrant for any reason.

(38) "Critical group" means the group of individuals reasonably expected to receive the greatest exposure to residual radioactivity for any applicable set of circumstances.

(39) "Curie" or "Ci" means a unit of activity. One curie equals 3.7 x 10¹⁰ disintegrations per second equals 3.7 x 10¹⁰ becquerels equals 2.22 x 10¹² disintegrations per minute.

(40) "Cyclotron" means a particle accelerator in which the charged particles travel in an outward spiral or circular path. A cyclotron accelerates charged particles at energies usually in excess of ten megaelectron volts and is commonly used for production of short half-life radionuclides for medical use.

(41) "Declared pregnant woman" means a woman who has voluntarily informed the licensee or registrant, in writing, of her pregnancy and the estimated date of conception. The declaration remains in effect until the declared pregnant woman withdraws the declaration in writing or is no longer pregnant.

(42) "Decommission" means to safely remove any licensed operation from service and reduce residual radioactivity to a level that permits release of the licensee's property for unrestricted use and termination of the license.

(43) "Dedicated check source" means a radioactive source that is used to assure the consistent performance of a radiation detection or measurement device over several months or years.

(44) "Deep dose equivalent" or "H_d" applies to external whole body exposure, and means the dose equivalent at a tissue depth of one centimeter, one thousand milligram per square centimeter.

(45) "Demand respirator" means an atmosphere-supplying respirator that admits breathing air to the facepiece only when a negative pressure is created inside the facepiece by inhalation.

(46) "Dentist" means an individual licensed by the state of Ohio to practice dentistry under Chapter 4715. of the Revised Code.

(47) "Department" means the Ohio department of health.

(48) "Depleted uranium" means uranium containing less uranium-235 than the naturally occurring distribution of uranium isotopes.

(49) "Derived air concentration" or "DAC" means the concentration of a given radionuclide in air which, if breathed by the reference man for a working year of two thousand hours under conditions of light work, results in an intake of one ALI. The condition of light work is inhaling 1.2 cubic meters of air per hour for two thousand hours in a year. DAC values are given in appendix C to rule 3701:1-38-12 of the Administrative Code.

(50) "Derived air concentration-hour or DAC-hour" means the product of the concentration of radioactive material in air, which is expressed as a fraction or multiple of the derived air concentration for each radionuclide, and the time of exposure to that radionuclide, in hours. A licensee or registrant may take two thousand DAC-hours to represent one ALI, equivalent to a committed effective dose equivalent of 0.05 Sv (five rem).

(51) "Direct reading dosimeter" means a device that measures radiation dose that does not require another device to read the measured radiation dose. Examples of direct reading dosimeters include pocket dosimeters and electronic dosimeters.

(52) "Director" means the director of health or a designee or authorized representative of the director.

(53) "Discipline" means a branch of knowledge or of teaching.

(54) "Discrete source" means a radionuclide that has been processed so that its concentration within a material has been purposely increased for use for commercial, medical, or research activities.

(55) "Disposable respirator" means a respirator for which maintenance is not intended and that is designed to be discarded after excessive breathing resistance, sorbent exhaustion, physical damage, or end-of service-life renders it unsuitable for use. Examples of this type of respirator are a disposable half-mask respirator or a disposable escape-only self-contained breathing apparatus.

(56) "Dose" or "radiation dose" is a generic term that means absorbed dose, dose equivalent, effective dose equivalent, committed effective dose equivalent, or total effective dose equivalent as defined in other paragraphs of this rule.

(57) "Dose equivalent" or "H_T" means the product of the absorbed dose in tissue, quality factor, and all other necessary modifying factors at the location of interest. The units of dose equivalent are the sievert and rem.

(58) "Dose limits" or "limits" means the permissible upper bounds of radiation doses established in accordance with these regulations but excludes background radiation and medical exposure.

(59) "Dosimetry processor" means a person that processes and evaluates individual monitoring devices in order to determine the radiation dose delivered to the monitoring devices.

(60) "Effective dose equivalent" or "H_E" means the sum of the products of the dose equivalent to each organ or tissue, H_T, and the weighting factor, W_T, applicable to each of the body organs or tissues that are irradiated: (H_E = ∑W_TH_T).

(61) "Embryo" or "fetus" means the developing human organism from conception until time of birth.

(62) "Engineering controls" means mechanisms used to protect health and minimize damage to life and property through engineering specifications, design, and construction of the product or facility including all of the security and safety features. This includes, but is not limited to, auxiliary security and safety features such as additional external shielding, barriers, and operational interlocks with associated processes.

(63) "Entrance" or "access point" means any opening through which an individual or extremity of an individual could gain access to radiation areas or to licensed radioactive materials or registered radiation generating equipment. This includes entry or exit portals of sufficient size to permit human entry, irrespective of their intended use.

(64) "Explosive material" means any chemical compound, mixture or device which produces a substantial instantaneous release of gas and heat spontaneously or by contact with sparks or flame.

(65) "Exposure" means being exposed to sources of ionizing radiation.

(66) "External dose" means that portion of the dose equivalent received from radiation sources outside the body.

(67) "Extremity" means hand, elbow, arm below the elbow, foot, knee, or leg below the knee.

(68) "Eye dose equivalent" means the same as lens dose equivalent.

(69) "Facility" means all buildings, equipment, structures and other stationary items that, in addition to the meaning defined in division (H) of section 3748.01 of the Revised Code, are:

(a) Located on a single site or on contiguous or adjacent sites and are operated by the same person and have common corporate or business interests; or

(b) Portions of a building or structure which are operated by the same person and have common corporate or business interests.

(70) "Filtering facepiece" or "dust mask" means a negative pressure particulate respirator with a filter as an integral part of the facepiece or with the entire facepiece composed of the filtering medium, not equipped with elastomeric sealing surfaces and adjustable straps.

(71) "Fissile material" means the radionuclides uranium-233, uranium-235, plutonium-239, and plutonium-241, or any combination of these radionuclides. Fissile material means the fissile nuclides themselves, not material containing fissile nuclides. Unirradiated natural uranium and depleted uranium and natural uranium or depleted uranium that has been irradiated in thermal reactors only, are not included in this definition. Certain exclusions from fissile material controls are provided in rule 3701:1-50-13 of the Administrative Code.

(72) "Fit factor" means quantitative estimate of the fit of a particular respirator to a specific individual, and typically estimates the ratio of the concentration of a substance in ambient air to its concentration inside the respirator when worn.

(73) "Fit test" means the use of a protocol to qualitatively or quantitatively evaluate the fit of a respirator on an individual.

(74) "Generally applicable environmental radiation standards" means standards issued by the United States environmental protection agency under the authority of the Atomic Energy Act of 1954, 68 Stat. 919, 42 U.S.C. 2011, as amended (2005), that impose limits on radiation exposures or levels, or concentrations or quantities of radioactive material, in the general environment outside the boundaries of locations under the control of persons possessing or using radioactive material.

(75) "Gray" or "Gy" means the SI unit of absorbed dose. One gray is equal to an absorbed dose of one joule per kilogram (one hundred rads).

(76) "Handle" means receive, possess, use, store, transfer, install, service, or dispose of sources of radiation unless possession is solely for the purpose of transportation.

(77) "Handler" means a facility that handles sources of radiation unless possession is solely for the purpose of transportation.

(78) "Hazardous waste" means those wastes designated as hazardous by rule 3745-51-03 of the Administrative Code.

(79) "Helmet" means a rigid respiratory inlet covering that also provides head protection against impact and penetration.

(80) "High radiation area" means an area, accessible to individuals, in which radiation levels from radiation sources external to the body could result in an individual receiving a dose equivalent in excess of one millisievert (0.1 rem) in one hour at thirty centimeters from the radiation source or thirty centimeters from any surface that the radiation penetrates.

(81) "Hood" means a respiratory inlet covering that completely covers the head and neck and may also cover portions of the shoulders and torso.

(82) "Individual" means any human being.

(83) "Individual monitoring" means

(a) The assessment of dose equivalent by the use of devices designed to be worn by an individual;

(b) The assessment of committed effective dose equivalent by bioassay or by determination of the time-weighted air concentrations to which an individual has been exposed, i.e. DAC-hours; or

(c) The assessment of dose equivalent by the use of survey data.

(84) "Individual monitoring devices" means devices designed to be worn by a single individual for the assessment of dose equivalent such as film badges; thermoluminescent dosimeters; optically stimulated luminescent dosimeters; pocket ionization chambers; and personal air sampling devices.

(85) "Industrial radiography" means the examination of the structure of materials by nondestructive methods, utilizing sealed sources of radioactive material or radiation-generating equipment.

(86) "Internal dose" means that portion of the dose equivalent received from radioactive material taken into the body.

(87) "Irradiator" means a facility that uses radioactive sealed sources for the irradiation of objects or materials and in which radiation dose rates exceeding five grays (five hundred rads) per hour exist at one meter from the sealed radioactive source in air or water, as applicable for the irradiator type, but does not include irradiators in which both the sealed source and the area subject to irradiation are contained within a device and are not accessible to personnel.

(88) "Lens dose equivalent" or "eye dose equivalent" means the external exposure of the lens of the eye and is taken as the dose equivalent at a tissue depth of 0.3 centimeters; i.e. three hundred milligrams per square centimeter.

(89) "License" means a license issued by the nuclear regulatory commission, the director, or another agreement state in accordance with rules adopted by those organizations.

(90) "Licensee" means a person to whom a license is issued.

(91) "Licensed activity" means an activity authorized by a radioactive material license which is essential to achieving the purpose for which the license was issued or amended.

(92) "Licensed material" means radioactive material received, possessed, used, transferred or disposed of under a general or specific license.

(93) "Loose-fitting facepiece" means a respiratory inlet covering that is designed to form a partial seal with the face.

(94) "Lost or missing licensed source of radiation" means a licensed source of radiation whose location is unknown. It includes material that has been shipped but has not reached its destination and whose location cannot be readily traced in the transportation system.

(95) "Low-level radioactive waste" or "LLRW," also "low-level waste," or "LLW" means radioactive waste which is not high-level radioactive waste, spent nuclear fuel, NARM, or byproduct material as defined in section 11 E. (2) of the Atomic Energy Act of 1954 68 Stat. 919, 42 U.S.C. 2011, as amended (2005), but is radioactive material that the United States nuclear regulatory commission classifies as low-level radioactive waste.

(96) "Low specific activity material" or "LSA" means radioactive material with limited specific activity which is nonfissile or is excepted under rule 3701:1-50-13 of the Administrative Code, and which satisfies the descriptions and limits set forth below. Shielding materials surrounding the LSA material may not be considered in determining the estimated average specific activity of the package contents. LSA must be in one of three groups:

(a) LSA - I.

(i) Uranium and thorium ores, concentrates of uranium and thorium ores, and other ores containing naturally occurring radioactive radionuclides that are intended to be processed for the use of these radionuclides;

(ii) Natural uranium, depleted uranium, natural thorium or their compounds or mixtures, provided they are unirradiated and in solid or liquid form;

(iii) Radioactive material other than fissile material, for which the A₂ value is unlimited; or

(iv) Other radioactive material in which the activity is distributed throughout and the estimated average specific activity does not exceed thirty times the value for exempt material activity concentration determined in accordance with rule 3701:1-50-25 of the Administrative Code.

(b) LSA-II.

(i) Water with tritium concentration up to 0.8 terabecquerels per liter (twenty curies per liter); or

(ii) Other material in which the activity is distributed throughout and the estimated average specific activity does not exceed ( 10^-4 A₂) per gram for solids and gases, and (10^-5 A₂) per gram for liquids.

(c) LSA-III. Solids (e.g., consolidated wastes, activated materials), excluding powders, that satisfy the requirements of 10 C.F.R. 71.77 (as in effect on the effective date of this rule), in which:

(i) The radioactive material is distributed throughout a solid or a collection of solid objects, or is essentially uniformly distributed in a solid compact binding agent (such as concrete, bitumen, ceramic, etc.);

(ii) The radioactive material is relatively insoluble, or it is intrinsically contained in a relatively insoluble material, so that even under loss of packaging, the loss of radioactive material per package by leaching, when placed in water for seven days, would not exceed (0.1 x A₂); and

(iii) The estimated average specific activity of the solid, excluding any shielding material, does not exceed (0.002 x A₂) per gram.

(97) "Management" means the chief executive officer or other individual having the authority to manage, direct, or administer the licensee's activities, or those persons' delegate or delegates.

(98) "Medical institution" means an organization in which more than one medical discipline is practiced.

(99) "Medical use" means the intentional internal or external administration of radioactive material or the radiation therefrom to patients or human research subjects under the supervision of an authorized user.

(100) "Member of the public" means any individual except when that individual is receiving an occupational dose.

(101) "Minor" means an individual less than eighteen years of age.

(102) "Monitoring" or "radiation monitoring" or "radiation protection monitoring" means the measurement of radiation levels, concentrations, surface area concentrations or quantities of radioactive material and the use of the results of these measurements to evaluate potential exposures and doses.

(103) "NARM" or "naturally occurring or accelerator-produced radioactive material" means naturally occurring or accelerator-produced radioactive material, including naturally occurring material that is technologically enhanced, and those nuclides that are generated in a charged particle accelerator, but does not include source material, byproduct material, or special nuclear material.

(104) "NARM licensing state" means any state with regulations equivalent to the suggested state regulations for control of radiation relating to, and an effective program for, the regulatory control of NARM and which has been granted final designation by the conference of radiation control program directors, inc.

(105) "Nationally tracked source" means a sealed source containing a quantity equal to or greater than "Category 1" or "Category 2" levels of any radioactive material listed in the appendix to rule 3701:1-38-25 of the Administrative Code. In this context a sealed source is defined as radioactive material that is sealed in a capsule or closely bonded, in a solid form and which is not exempt from regulatory control. It does not mean material encapsulated solely for disposal, or nuclear material contained in any fuel assembly, subassembly, fuel rod, or fuel pellet. "Category 1" nationally tracked sources are those containing radioactive material at a quantity equal to or greater than the "Category 1" threshold. "Category 2" nationally tracked sources are those containing radioactive material at a quantity equal to or greater than the "Category 2" threshold but less than the "Category 1" threshold.

(106) "Negative pressure respirator" or "tight fitting respirator" means a respirator in which the air pressure inside the facepiece is negative during inhalation with respect to the ambient air pressure outside the respirator.

(107) "Nonstochastic effect" or "deterministic effect" means health effects, the severity of which varies with the dose and for which a threshold is believed to exist. Radiation-induced cataract formation is an example of a nonstochastic effect.

(108) "NORM" or "naturally occurring radioactive material" means any nuclide that is radioactive in its natural physical state, but does not include source material, byproduct material, or special nuclear material.

(109) "Normal form radioactive material" means radioactive material that has not been demonstrated to qualify as special form radioactive material.

(110) "Nuclear regulatory commission" means the federal agency established by Title II of the Energy Reorganization Act of 1974, 88 Stat. 1233, 42 U.S.C.A. 5801, as amended (2005), comprising the members of the commission and all offices, employees, and representatives authorized to act in any case or matter related to licensing and related regulatory function previously assigned to the AEC.

(111) "Occupational dose" means the dose received by an individual in the course of employment in which the individual's assigned duties involve exposure to radiation or radioactive material from licensed and unlicensed sources of radiation, whether in the possession of the licensee or other person. Occupational dose does not include doses received from background radiation, from any medical administration the individual has received, from exposures to individuals administered radioactive materials and released in accordance with rule 3701:1-58-30 of the Administrative Code or equivalent United States nuclear regulatory commission or agreement state regulations, from voluntary participation in medical research programs, or as a member of the public.

(112) "Package" means the packaging together with its radioactive contents as presented for transport.

(a) Fissile material package or type AF package, type BF package, type B(U)F package, or type B(M)F package means a fissile material packaging together with its fissile material contents.

(b) Type A package means a type A packaging together with its radioactive contents. A type A package is defined and must comply with the United States department of transportation regulations in 49 C.F.R. 173 (as in effect on the effective date of this rule).

(c) Type B package means a type B packaging together with its radioactive contents. On approval, a type B package design is designated by the United States nuclear regulatory commission as B(U) unless the package has a maximum normal operating pressure of more than seven hundred kilopascals (one hundred pounds per square inch) gauge or a pressure relief device that would allow the release of radioactive material to the environment under the tests specified in 10 C.F.R. 71.73 (hypothetical accident conditions) (as in effect on the effective date of this rule), in which case it will receive a designation B(M). B(U) refers to the need for unilateral approval of international shipments; B(M) refers to the need for multilateral approval of international shipments. There is no distinction made in how packages with these designations may be used in domestic transportation. To determine their distinction for international transportation, see United States department of transportation regulations in 49 C.F.R. 173 (as in effect on the effective date of this rule). A type B package approved before September 6, 1983, was designated only as type B. Limitations on its use are specified in 10 C.F.R. 71.19 (as in effect on the effective date of this rule).

(113) "Packaging" means the assembly of components necessary to ensure compliance with the packaging requirements of rule 49 C.F.R. 173 Subpart I (as in effect on the effective date of this rule). It may consist of one or more receptacles, absorbent materials, spacing structures, thermal insulation, radiation shielding, and devices for cooling or absorbing mechanical shocks. The vehicle, tie-down system and auxiliary equipment may be designated as part of the packaging.

(114) "Particle accelerator" means any machine capable of accelerating electrons, protons, deuterons, or other charged particles in a vacuum and of discharging the resultant particulate or other radiation into a medium at energies usually in excess of one megaelectron volt. For purposes of this definition, "accelerator" is an equivalent term.

(115) "Person" means any individual, corporation, association, business enterprise, or other legal entity either public or private and any legal successor, representative, agent, or agency of that individual, corporation, association, business enterprise, or other legal entity. Person also includes the United States, states, political subdivisions of states, and any department, agency, or instrumentality of the United States or a state, except the U.S. department of energy or the U.S. nuclear regulatory commission where the state regulation of radioactive material by either of those agencies is prohibited by federal law.

(116) "Personnel dosimeter", means a device that measures radiation dose that is processed and evaluated by an accredited "National Voluntary Laboratory Accreditation Program" (NVLAP) processor. Examples of personnel dosimeters include film badges, thermo-luminescent dosimeters (TLD), and optically stimulated luminescence (OSL) dosimeters.

(117) "Pharmacist" means a person who is licensed by the state of Ohio to practice pharmacy pursuant to Chapter 4731. of the Revised Code.

(118) "Physician" means a person who is licensed pursuant to Chapter 4731. of the Revised Code to practice medicine or surgery or osteopathic medicine or surgery.

(119) "Planned special exposure" means an infrequent exposure to radiation, separate from and in addition to the annual dose limits.

(120) "Podiatrist" means an individual licensed by the state of Ohio to practice podiatry pursuant to Chapter 4731. of the Revised Code.

(121) "Positive pressure respirator" means a respirator in which the pressure inside the respiratory inlet covering exceeds the ambient air pressure outside the respirator.

(122) "Positron Emission Tomography (PET) radionuclide production facility" means a facility operating a cyclotron or accelerator for the purpose of producing PET radionuclides.

(123) "Powered air-purifying respirator" or "PAPR" means an air-purifying respirator that uses a blower to force the ambient air through air purifying elements to the inlet covering.

(124) "Pressure demand respirator" means a positive pressure atmosphere supplying respirator that admits breathing air to the facepiece when the positive pressure is reduced inside the facepiece by inhalation.

(125) "Public dose" means the dose received by a member of the public from exposure to radiation and/or radioactive material released by the licensee, or to any other source of radiation under the control of a licensee or registrant. Public dose does not include occupational dose or doses received from background radiation, from any medical administration the individual has received, from exposures to individuals administered radioactive materials and released in accordance with rule 3701:1-58-30 of the Administrative Code or equivalent United States nuclear regulatory commission or agreement state regulations, or from voluntary participation in medical research programs.

(126) "Pyrophoric material" means any liquid that ignites spontaneously in dry or moist air at or below 54.4 degrees celsius (one hundred thirty degrees fahrenheit). A pyrophoric solid is any solid material, other than one classed as an explosive, which under normal conditions is liable to cause fires through friction, retained heat from manufacturing or processing, or which can be ignited readily and when ignited burns so vigorously and persistently as to create a serious transportation, handling, or disposal hazard. Included are spontaneously combustible and water-reactive materials.

(127) "Qualitative fit test" or "QLFT" means a pass/fail fit test to assess the adequacy of respirator fit that relies on the individual's response to the test agent.

(128) "Quality factor" or "Q" means the modifying factor, as listed in paragraphs (A) and (B) of rule 3701:1-38-11 of the Administrative Code, that is used to derive dose equivalent from absorbed dose.

(129) "Quantitative fit test" or "QNFT" means an assessment of the adequacy of respirator fit by numerically measuring the amount of leakage into the respirator.

(130) "Quarter" or "quarterly" means a period of time equal to one-fourth of the year observed by the licensee or registrant, approximately thirteen consecutive weeks, providing that the beginning of the first quarter in a year coincides with the starting date of the year and that no day is omitted or duplicated in consecutive quarters.

(131) "Rad" means the special unit of radiation absorbed dose. One rad is equal to an absorbed dose of one hundred ergs per gram, or 0.01 joule per kilogram, or 0.01 gray.

(132) "Radiation" or "ionizing radiation" means alpha particles, beta particles, gamma rays, x-rays, neutrons, high speed electrons, high speed protons, and other particles capable of producing ions. Radiation does not include nonionizing radiation, such as radio or microwaves, or visible, infrared or ultraviolet light.

(133) "Radiation area" means an area, accessible to individuals, in which radiation levels could result in an individual receiving a dose equivalent in excess of 0.05 millisievert (0.005 rem) in one hour at thirty centimeters from the source of radiation or from any surface that the radiation penetrates.

(134) "Radiation-generating equipment" or "RGE" means any manufactured product or device, or component of such a product or device, or any machine or system that during operation can generate or emit radiation, except those that emit radiation only from radioactive material. "Radiation-generating equipment" does not include either of the following:

(a) Diathermy machines;

(b) Microwave ovens, including food service microwave ovens used for commercial and industrial uses, television receivers, electric lamps, and other household appliances and products that generate very low levels of radiation.

(135) "Radiation Safety Officer" or "RSO" means an individual designated by the licensee who has the knowledge and responsibility for the overall radiation safety program at the facility, to include the implementation of the daily radiation safety operations and compliance with the rules.

(136) "Radioactive material" means any solid, liquid or gaseous material that emits ionizing radiation spontaneously. "Radioactive material" includes accelerator-produced and naturally occurring radioactive materials and byproduct, source, and special nuclear material.

(137) "Radioactive waste" means waste containing regulated radioactive material.

(138) "Radioactivity" means the transformation of unstable atoms by the emission of radiation.

(139) "Radiography" means the same as industrial radiography.

(140) "Reference man" means a hypothetical aggregation of human physical and physiological characteristics arrived at by international consensus. These characteristics may be used by researchers and public health workers to standardize results of experiments and to relate biological insult to a common base.

(141) "Registrant" means a person required by Chapter 3748. of the Revised Code to register radiation-generating equipment with the director.

(142) "Rem" means the special unit of any of the quantities expressed as dose equivalent. The dose equivalent in rem is equal to the absorbed dose in rads multiplied by the quality factor (one rem = 0.01 Sv).

(143) "Research and development" means

(a) Theoretical analysis, exploration, or experimentation; or

(b) The extension of investigative findings and theories of a scientific or technical nature into practical application for experimental and demonstration purposes, including the experimental production and testing of models, devices, equipment, materials and processes. "Research and development" does not include the internal or external administration of sources of radiation to human beings.

(144) "Residual radioactivity" means radioactivity in structures, materials, soils, groundwater, and other media at a site resulting from activities under the licensee's control. This includes radioactivity from all licensed and unlicensed sources used by the licensee, but excludes background radiation. It also includes radioactive materials remaining at the site as a result of routine or accidental releases of radioactive material at the site and previous burials at the site, even if those burials were made in accordance with the provisions of 10 C.F.R. 20 (as in effect on the effective date of this rule).

(145) "Respiratory protective equipment or device" means an apparatus, such as a respirator, used to reduce the individual's intake of airborne radioactive materials.

(146) "Restricted area" means an area access to which is limited by the licensee or registrant for the purpose of protecting individuals against undue risks from exposure to sources of radiation. Restricted area does not include areas used as residential quarters, but separate rooms in a residential building may be set apart as a restricted area.

(147) "Roentgen" means the amount of gamma or x-rays required to produce ions resulting in a charge of 0.000258 coulombs per kilogram of air under standard conditions.

(148) "Sanitary sewerage" means a system of public sewers for carrying off wastewater and refuse, but excluding sewage treatment facilities, septic tanks, and leach fields owned or operated by the licensee.

(149) "Sealed source" means radioactive material that is encased in a manner designed to prevent leakage or escape of the radioactive material.

(150) "Sealed source and device registry" means the national registry that contains all the registration certificates, generated by both the United States nuclear regulatory commission and the agreement states, that summarize the radiation safety information for the sealed sources and devices and describe the licensing and use conditions approved for the product.

(151) "Seismic area" means any area where the probability of a horizontal acceleration in rock of more than 0.3 times the acceleration of gravity in two hundred fifty years is greater than ten per cent, as designated by the United States geological survey.

(152) "Self-contained breathing apparatus" or "SCBA" means an atmosphere-supplying respirator for which the breathing air source is designed to be carried by the user.

(153) "Shallow dose equivalent" or "H_S" means the external exposure of the skin of the whole body or the skin of an extremity, is taken as the dose equivalent at a tissue depth of 0.007 centimeter, or seven milligrams per square centimeter.

(154) "Sievert" or "Sv" means the SI unit of any of the quantities expressed as dose equivalent. The dose equivalent in sieverts is equal to the absorbed dose in grays multiplied by the quality factor. One sievert equals one hundred rem.

(155) "Site area emergency" means events may occur, are in progress, or have occurred that could lead to a significant release of radioactive material and that could require a response by off-site response organizations to protect persons off-site.

(156) "Site boundary" means that line beyond which the land or property is not owned, leased, or otherwise controlled by the licensee or registrant.

(157) "Site closure and stabilization" means those actions that are taken upon completion of operations that prepare a disposal site for custodial care and that assure that the disposal site will remain stable and will not need ongoing active maintenance.

(158) "Source material" means uranium, thorium, or any combination thereof in any physical or chemical form, or any ores that contain by weight at least one-twentieth of one per cent (0.05 per cent) of uranium, thorium, or any combination thereof. Source material does not include special nuclear material.

(159) "Sources of radiation" means radioactive material or radiation generating equipment.

(160) "Special form radioactive material" means radioactive material that satisfies the following conditions:

(a) It is either a single solid piece or is contained in a sealed capsule that can be opened only by destroying the capsule;

(b) The piece or capsule has at least one dimension not less than five millimeters (0.2 inch); and

(c) It satisfies the test requirements specified by the United States nuclear regulatory commission in 10 C.F.R. 71.75 (as in effect on the effective date of this rule). A special form encapsulation designed in accordance with the United States nuclear regulatory commission requirements identified in 10 C.F.R. 71.4, in effect on June 30, 1983, and constructed prior to July 1, 1985; a special form encapsulation designed in accordance with the requirements of 10 C.F.R. 71.4 in effect on March 31, 1996, and constructed before April 1, 1998; and special form material that was successfully tested before September 10, 2015 in accordance with the requirements of 10 C.F.R. 71.75(d) of this section in effect before September 10, 2015 may continue to be used. Any other special form encapsulation must meet the specifications of this definition.

(161) "Special nuclear material" means either of the following:

(a) Plutonium, uranium-233, uranium enriched in the isotope 233, or in the isotope 235, and any other material that the United States nuclear regulatory commission determines to be special nuclear material, but does not include source material pursuant to section 51 of the Atomic Energy Act of 1954, 68 Stat 919, 42 USCA 2071, as amended (2005).

(b) Any material artificially enriched by any of the foregoing but does not include source material.

(162) "Special nuclear material in quantities not sufficient to form a critical mass" means uranium enriched in the isotope uranium-235 in quantities not exceeding three hundred fifty grams of contained uranium-235; uranium-233 in quantities not exceeding two hundred grams; plutonium in quantities not exceeding two hundred grams; or any combination of them in accordance with the following formula: for each kind of special nuclear material, determine the ratio between the quantity of that special nuclear material and the quantity specified in this paragraph for the same kind of special nuclear material. The sum of such ratios for all of the kinds of special nuclear material in combination shall not exceed unity.

(163) "Stochastic effect" means health effects that occur randomly and for which the probability of the effect occurring, rather than its severity, is assumed to be a linear function of dose without threshold. Hereditary effects and cancer incidence are examples of stochastic effects.

(164) "Supplied-air respirator" or "SAR" or "airline respirator" means an atmosphere-supplying respirator for which the source of breathing air is not designed to be carried by the user.

(165) "Surface contaminated object" or "SCO" means a solid object that is not itself classed as radioactive material, but which has radioactive material distributed on any of its surfaces. SCO must be in one of two groups with surface activity not exceeding the following limits:

(a) SCO-I: a solid object on which:

(i) The non-fixed contamination on the accessible surface averaged over three hundred square centimeters, or the area of the surface if less than three hundred square centimeters, does not exceed four becquerels per square centimeter (10^-4 microcurie per square centimeter) for beta and gamma and low toxicity alpha emitters, or 0.4 becquerels per square centimeter 10^-5 microcurie per square centimeter) for all other alpha emitters;

(ii) The fixed contamination on the accessible surface averaged over three hundred square centimeters, or the area of the surface if less than three hundred square centimeters, does not exceed forty thousand becquerels per square centimeter (one microcurie per square centimeter) for beta and gamma and low toxicity alpha emitters, or four thousand becquerels per square centimeter (0.1 microcurie per square centimeter) for all other alpha emitters; and

(iii) The non-fixed contamination plus the fixed contamination on the inaccessible surface averaged over three hundred square centimeters, or the area of the surface if less than three hundred square centimeters, does not exceed forty thousand becquerels per square centimeter (one microcurie per square centimeter) for beta and gamma and low toxicity alpha emitters, or four thousand becquerels per square centimeter (0.1 microcurie per square centimeter) for all other alpha emitters.

(b) SCO-II: a solid object on which the limits for SCO-I are exceeded and on which:

(i) The non-fixed contamination on the accessible surface averaged over three hundred square centimeters, or the area of the surface if less than three hundred square centimeter, does not exceed four hundred becquerels per square centimeter (10^-2 microcurie per square centimeter) for beta and gamma and low toxicity alpha emitters, or forty becquerels per square centimeter (10^-3 microcurie per square centimeter) for all other alpha emitters;

(ii) The fixed contamination on the accessible surface averaged over three hundred square centimeters, or the area of the surface if less than three hundred square centimeters, does not exceed eight hundred thousand becquerels per square centimeter (twenty microcuries per square centimeter) for beta and gamma and low toxicity alpha emitters, or eighty thousand becquerels per square centimeter (two microcuries per square centimeter) for all other alpha emitters; and

(iii) The non-fixed contamination plus the fixed contamination on the inaccessible surface averaged over three hundred square centimeters, or the area of the surface if less than three hundred square centimeters, does not exceed eight hundred thousand becquerels per square centimeter (twenty microcuries per square centimeter) for beta and gamma and low toxicity alpha emitters, or eighty thousand becquerels per square centimeter (two microcuries per square centimeter) for all other alpha emitters.

(166) "Survey" means an evaluation of the radiological conditions and potential hazards incident to the production, use, transfer, release, disposal or presence of radioactive material or other sources of radiation. When appropriate, such an evaluation includes a physical survey of the location of radioactive material, or the sources of radiation and measurements or calculations of levels of radiation, or concentrations or quantities of radioactive material present.

(167) "Tight-fitting facepiece" means a respiratory inlet covering that forms a complete seal with the face.

(168) "Total effective dose equivalent" or "TEDE" means the sum of the effective dose equivalent (for external exposures) and the committed effective dose equivalent (for internal exposures).

(169) "Transport index" means the dimensionless number, rounded up to the next tenth, placed on the label of a package, to designate the degree of control to be exercised by the carrier during transportation. The transport index is the number determined by multiplying the maximum radiation level in millisievert per hour at one meter (3.3 feet) from the external surface of the package by one hundred, which is equivalent to the maximum radiation level in millirem per hour at one meter (3.3 feet).

(170) "Type A quantity" means a quantity of radioactive material, the aggregate radioactivity of which does not exceed A₁ for special form radioactive material, or A₂ for normal form radioactive material, where A₁ and A₂ are given in rule 3701:1-50-25 of the Administrative Code.

(171) "Type B quantity" means a quantity of radioactive material greater than a type A quantity.

(172) "Type B package" is defined under "Package."

(173) "United States department of energy" means the department of energy established by the Department of Energy Organization Act, PL 95-91, 91 Stat. 565 (1977), 42 U.S.C. 7101 et seq., as amended (2006), to the extent that the department of energy or its duly authorized representatives, exercises functions formerly vested in the United States atomic energy commission, its chairman, members, officers and components and transferred to the United States energy research and development administration and to the administrator thereof pursuant to Sections 104(b) to (d) of the Energy Reorganization Act of 1974, PL 93-438, 88 Stat. 1233 at 1237 (1974), 42 U.S.C. 5814 and retransferred to the secretary of energy pursuant to Section 301(a) of the Department of Energy Organization Act, PL 95-91, 91 Stat. 565 at 577-578 (1977), 42 U.S.C. 7151.

(174) "Unrestricted area" or "uncontrolled area" means any area, access to which is neither restricted nor controlled by the licensee or registrant.

(175) "User seal check" or "fit check" means an action conducted by the respirator user to determine if the respirator is properly seated to the face. Examples include negative pressure check, positive pressure check, irritant smoke check, or isoamyl acetate check.

(176) "Very high radiation area" means an area, accessible to individuals, in which radiation levels from radiation sources external to the body could result in an individual receiving an absorbed dose in excess of five gray (five hundred rad) in one hour at one meter from a source of radiation or from any surface that the radiation penetrates. At very high doses received at high dose rates, units of absorbed dose, gray and rad, are appropriate, rather than units of dose equivalent, sievert and rem.

(177) "Veterinarian" means an individual licensed by the state of Ohio to practice veterinary medicine pursuant to Chapter 4741. of the Revised Code.

(178) "Waste" means those low-level radioactive wastes containing source, special nuclear, or byproduct material that are acceptable for disposal in a land disposal facility. For the purposes of this definition, low-level radioactive waste means radioactive waste not classified as high-level radioactive waste, transuranic waste, spent nuclear fuel, or byproduct material as defined in paragraph (A)(26)(b) of this rule, or byproduct material as defined in section 11 E. (3) and (4) of the Atomic Energy Act of 1954, 68 Stat. 919, 42 USC 2014, as amended (2005).

(179) "Week" means seven consecutive days starting on Sunday.

(180) "Weighting factor

• W_T" for an organ or tissue, (T), is the proportion of the risk of stochastic effects resulting from irradiation of that organ or tissue to the total risk of stochastic effects when the whole body is irradiated uniformly. For calculating the effective dose equivalent, the values of W_T are:

| Organ doseweighting factors | | | --- | --- | | Organ ortissue | W_T | | Gonads | 0.25 | | Breast | 0.15 | | Red bone marrow | 0.12 | | Lung | 0.12 | | Thyroid | 0.03 | | Bonesurfaces | 0.03 | | Remainder | 0.30^a | | Whole body | 1.00^b |

^\a 0.30 results from 0.06 for each of five "remainder" organs, excluding the skin and the lens of the eye, that receive the highest doses.

^\b for the purpose of weighting the external whole body dose (for adding it to the internal dose) a single weighting factor, W_T = 1.0, has been specified. The use of other weighting factors for external exposure will be approved on a case-by-case basis until such time as specific guidance is issued.

(181) "Whole body" means for purposes of external exposure, head; trunk, including male gonads; arms above the elbow; legs above the knee.

(182) "Worker" means an individual engaged in activities licensed or registered by the department and controlled by a licensee or registrant, but does not include the licensee or registrant.

(183) "Working level" or "WL" means any combination of short-lived radon decay products (for radon-222: polonium-218, lead-214, bismuth-214, and polonium-214; and for radon-220: polonium-216, lead-212, bismuth-212, and polonium-212) in one liter of air that will result in the ultimate emission of 1.3 x 10⁵ million electron volts alpha particle energy.

(184) "Working level month" or "WLM" means a cumulative exposure to one working level for one hundred seventy hours. (Two thousand working hours per year/twelve months per year equals approximately one hundred seventy hours per month.)

(185) "Year" means the period of time beginning in January used to determine compliance with the provisions of this rule. The licensee or registrant may change the starting date of the year used to determine compliance by the licensee or registrant provided that the change is made at the beginning of the year and that no day is omitted or duplicated in consecutive years.

(B) The terms set out in paragraph (A) of this rule may be redefined in other chapters as promulgated pursuant to Chapter 3748. of the Revised Code as used in that chapter only.

Last updated May 13, 2026 at 11:20 AM

History

• Effective: January 20, 2022
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-40-01

Terms defined in rule 3701:1-38-01 of the Administrative Code shall have the same meaning when used in Chapter 3701:1-40 of the Administrative Code except terms redefined within a given rule for use within that rule only, and additionally, as used in Chapter 3701:1-40 of the Administrative Code:

(A) "Bureau assessment report" means a document prepared by the department that briefly provides evidence and analysis of whether there is an adverse radiological impact on human health or the human environment or whether there is no significant impact.

(B) "Categorical exclusion" means a category of actions which do not individually or cumulatively have a significant effect on human health or the human environment.

(C) "Environmental report" means a document submitted to the department by an applicant for a license, renewal, or amendment thereof, that aids the department in completing the bureau assessment report.

Last updated November 2, 2022 at 2:11 PM

History

• Effective: October 4, 2010
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-46-02 Purpose and scope.

(A) This chapter establishes general licenses for the possession and use of radioactive material and a general license for ownership of radioactive material. Specific provisions of Chapter 3701:1-40 of the Administrative Code are applicable to general licenses established by this chapter. These provisions are specified in rule 3701:1-46-03 of the Administrative Code or in the particular general license.

(B) This chapter prescribes requirements for the issuance of specific licenses to persons who manufacture or initially transfer items containing radioactive material for sale or distribution to persons generally licensed under Chapter 3701:1-46 or 3701:1-58 of the Administrative Code or equivalent regulations of the United States nuclear regulatory commission or an agreement state.

(C) This chapter also prescribes certain rules governing holders of these licenses. In addition, this chapter prescribes requirements for the issuance of specific licenses to persons who introduce radioactive material into a product or material owned by or in the possession of the licensee or person and rules governing holders of such licenses. Further, this chapter describes procedures and prescribes requirements for the issuance of sealed source and device certificates (covering radiation safety information about a product) to manufacturers or initial transferors of sealed sources or devices containing sealed sources which are to be used by persons specifically licensed under Chapter 3701:1-40 of the Administrative Code or equivalent regulations of the United States nuclear regulatory commission or an agreement state.

(D) The provisions and requirements of this chapter are in addition to, and not in substitution for, other requirements of Chapter 3701:1-40 of the Administrative Code which apply to applications and licenses subject to this chapter.

Last updated November 2, 2022 at 2:17 PM

History

• Effective: December 1, 2012
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-46-03

The general licenses provided in this chapter are subject to the provisions of paragraph (D) of rule 3701:1-40-08, paragraphs (A) to (C) of rule 3701:1-40-16, rules 3701:1-40-19 to 3701:1-40-21, and Chapter 3701:1-38 of the Administrative Code unless indicated otherwise in the specific provision of the general license. Attention is directed particularly to the provisions of the rules in Chapter 3701:1-38 of the Administrative Code which relate to the labeling of containers.

Last updated November 2, 2022 at 2:31 PM

History

• Effective: April 22, 2013
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-40-08

(A) Except as may be required in paragraphs (C) and (D) of this rule, any person is exempt from the requirements for a license set forth in this chapter and Chapters 3701:1-46, 3701:1-48, 3701:1-49, 3701:1-52, and 3701:1-58 of the Administrative Code to the extent that such person receives, possesses, uses, transfers, owns, or acquires products or materials containing radioactive material in concentrations that do not exceed those listed in the appendix to this rule.

(B) This rule shall not be deemed to authorize the import of radioactive material or products containing radioactive material.

(C) A manufacturer, processor, or producer of a product or material is exempt from the rules in this chapter and Chapters 3701:1-46, 3701:1-48, 3701:1-49, 3701:1-52, and 3701:1-58 of the Administrative Code to the extent that the person transfers radioactive material contained in a product or material in concentrations not in excess of those specified in the appendix to this rule and introduced into the product or material by a licensee holding a specific license issued by an agreement state, the United States nuclear regulatory commission, or the director, expressly authorizing such introduction. This exemption does not apply to the transfer of radioactive material contained in any food, beverage, cosmetic, drug, or other commodity or product designed for ingestion or inhalation by, or application to, a human being.

(D) No person may introduce radioactive material into a product or material knowing or having reason to believe that it will be transferred to persons exempt under this rule, except in accordance with a license issued by the United States nuclear regulatory commission.

View Appendix

Last updated November 2, 2022 at 2:12 PM

History

• Effective: May 11, 2009
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-40-16

(A)

(1) A license, or any right under a license, shall not be transferred, assigned or in any manner disposed of, either voluntarily or involuntarily, directly or indirectly, through transfer of control of any license to any person, unless the director finds that the transfer is in accordance with this rule and Chapters 3701:1-46, 3701:1-48, 3701:1-49, 3701:1-52, and 3701:1-58 of the Administrative Code. A license or any right contained therein may not be transferred or conveyed without the written authorization of the director. If the director approves the transfer and receives payment of the appropriate licensing fee, a new license will be issued to the transferee.

(2) An application for transfer of license must include:

(a) The identity, technical and financial qualifications of the proposed transferee; and

(b) Financial assurance for decommissioning information required by rule 3701:1-40-17 of the Administrative Code.

(B) Each licensee shall confine possession and use of radioactive material to the locations and purposes authorized in the license. Preparation for shipment and transport of radioactive material shall be in accordance with Chapter 3701:1-50 of the Administrative Code.

(C) The director may incorporate at the time of issuance, or thereafter by appropriate rule, regulation, or order, such additional requirements or conditions with respect to the licensee's receipt, possession, use and transfer of radioactive material as the director deems appropriate or necessary in order to protect the environment, protect health, or minimize danger to life or property. The director may require such reports and the keeping of such records, and provide for such inspections of activities under the license as may be necessary to effectuate the purposes of Chapter 3748. of the Revised Code or rules adopted thereunder.

(D) A licensee that is required to submit an emergency plan pursuant to rule 3701:1-40-14 of the Administrative Code shall follow the emergency plan approved by the director. The licensee may amend the approved plan without approval of the director provided that the amendment does not decrease the effectiveness of the plan. Within six months after amending the emergency plan, the licensee shall furnish the amended plan to both the director and to affected offsite response organizations. Any proposed amendment to the emergency plan that decreases, or potentially decreases, the effectiveness of the approved emergency plan may not be implemented without prior approval by the director.

(E) Each licensee preparing technetium-99m radiopharmaceuticals from molybdenum-99/technetium-99m generators or rubidium-82 from strontium-82/rubidium-82 generators shall test the generator eluates for molybdenum-99 breakthrough or strontium-82 and strontium-85 contamination, respectively, in accordance with rule 3701:1-58-35 of the Administrative Code. The licensee shall record the results of each test and retain each record for three years after the record is made. The licensee shall report the results of any test that exceeds the permissible concentration listed in paragraph (A) of rule 3701:1-58-35 of the Administrative Code at the time of generator elution, in accordance with rule 3701:1-58-105 of the Administrative Code.

(F) Each licensee must notify the director by certified mail within ten business days of the commencement of a voluntary or involuntary bankruptcy petition that has been filed by or against:

(1) The licensee;

(2) An entity, defined in this rule as person, estate, trust, governmental unit, and United States trustee, controlling the licensee or listing the license or licensee as property of the estate; or

(3) An affiliate of the licensee defined in this rule as an entity that directly or indirectly owns, controls, or holds with power to vote, twenty per cent or more of the outstanding voting securities of the debtor, other than an entity that holds such securities:

(a) In a fiduciary or agency capacity without sole discretionary power to vote such securities; or

(b) Solely to secure a debt, if such entity has not in fact exercised such power to vote.

The notification shall specify the bankruptcy court in which the petition for bankruptcy was filed and the date of the filing petition.

(G) The director may, upon application including adequate documentation by a person or by his own initiative, grant such exemptions from the requirements of this chapter or other chapters of the Administrative Code involving radioactive materials promulgated under Chapter 3748. of the Revised Code that are authorized by law and will not result in undue hazard to life or property and are otherwise in the public interest.

(H) Each portable gauge licensee shall use a minimum of two independent physical controls that form tangible barriers to secure portable gauges from unauthorized removal, whenever portable gauges are not under the control and constant surveillance of the licensee.

(I)

(1) Authorization under paragraph (I) of rule 3701:1-40-14 of the Administrative Code to produce positron emission tomography (PET) radioactive drugs for noncommercial transfer to medical use licensees in its consortium does not relieve the licensee from complying with applicable United States federal drug administration, other federal, and state requirements governing radioactive drugs.

(2) Each licensee authorized under paragraph (I) of rule 3701:1-40-14 of the Administrative Code to produce PET radioactive drugs for noncommercial transfer to medical use licensees in its consortium shall:

(a) Satisfy the labeling requirements in paragraph (A)(4) of rule 3701:1-46-43 of the Administrative Code for each PET radioactive drug transport radiation shield and each syringe, vial, or other container used to hold a PET radioactive drug intended for noncommercial distribution to members of its consortium.

(b) Possess and use instrumentation to measure the radioactivity of the PET radioactive drugs intended for noncommercial distribution to members of its consortium and meet the procedural, radioactivity measurement, instrument test, instrument check, and instrument adjustment requirements in paragraph (C) of rule 3701:1-46-43 of the Administrative Code.

(3) A licensee that is a pharmacy authorized under paragraph (I) of rule 3701:1-40-14 of the Administrative Code to produce PET radioactive drugs for noncommercial transfer to medical use licensees in its consortium shall require that any individual that prepares PET radioactive drugs shall be:

(a) An authorized nuclear pharmacist that meets the requirements in paragraph (B)(2) of rule 3701:1-46-43 of the Administrative Code, or

(b) An individual under the supervision of an authorized nuclear pharmacist as specified in rule 3701:1-58-14 of the Administrative Code.

(4) A pharmacy, authorized under paragraph (I) of rule 3701:1-40-14 of the Administrative Code to produce PET radioactive drugs for noncommercial transfer to medical use licensees in its consortium that allows an individual to work as an authorized nuclear pharmacist, shall meet the requirements of paragraph (B)(5) of rule 3701:1-46-43 of the Administrative Code.

Last updated August 17, 2021 at 11:43 PM

History

• Effective: August 15, 2021
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-40-19

(A) No licensee shall transfer radioactive material except as authorized by this rule.

(B) Except as otherwise provided in the license and subject to the provisions of paragraph (C) of this rule, any licensee may transfer radioactive material:

(1) To the United States department of energy;

(2) To the agency in any agreement state which regulates radioactive material pursuant to an agreement under section 274 of the "Atomic Energy Act", as amended;

(3) To any person exempt from the licensing requirements of the act and regulations in this chapter, to the extent permitted under such exemption;

(4) To any person in an agreement state, subject to the jurisdiction of that state, who has been exempted from the licensing requirements and regulations of that state, to the extent permitted under such exemption;

(5) To any person authorized to receive such radioactive material under terms of a specific license or a general license or their equivalents issued by the United States atomic energy commission, the United States nuclear regulatory commission, or an agreement state; or

(6) As otherwise authorized by the director in writing.

(C) Before transferring radioactive material to an entity specified in paragraph (B) of this rule, the licensee transferring the material shall verify that the transferee's license authorizes the receipt of the type, form, and quantity of radioactive material to be transferred. The licensee may verify the transferee's authorization to accept the material by possessing one of the following:

(1) A current copy of the transferee's specific license or registration certificate specifying the type, form, and quantity of radioactive material to be transferred;

(2) A written certification by the receiving licensee certifying that the licensee is authorized by license or registration certificate to receive the type, form, and quantity of radioactive material to be transferred, and further specifying the license or registration certificate number, issuing agency, and expiration date;

(3) In the case of an emergency shipment, the transferring licensee may accept oral certification by the receiving licensee that the licensee is authorized by license or registration certificate to receive the type, form, and quantity of radioactive material to be transferred, and further, specifying the license or registration certificate number, issuing agency and expiration date. The transferring licensee shall obtain written confirmation detailing the oral certification within ten days of the emergency transfer; or

(4) The transferor may obtain other sources of information compiled by a reporting service from official records of the department, United States nuclear regulatory commission, or the licensing agency of an agreement state as to the identity of the receiving licensee, whether the licensee is authorized by license or registration certificate to receive the type, form, and quantity of radioactive material to be transferred, and the expiration date of the receiving licensee's license or registration.

Last updated November 2, 2022 at 2:12 PM

History

• Effective: October 4, 2010
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-40-21

(A) Each person who receives radioactive material under a license issued pursuant to the rules in this chapter, and other chapters of the Administrative Code adopted pursuant to Chapter 3748. of the Revised Code, and rule 3701:1-38-02 of the Administrative Code, shall keep records showing the receipt, transfer, and disposal of the radioactive material as follows:

(1) The licensee shall retain each record of receipt of radioactive material as long as the material is possessed and for three years following transfer or disposal of the material.

(2) The licensee who transferred the material shall retain each record of transfer for three years after each transfer unless otherwise specified by rule for that particular licensed activity.

(3) The licensee who disposed of the material shall retain each record of disposal of radioactive material until the director terminates each license that authorizes disposal of the material.

(B) Except as provided in paragraph (C) of this rule, the licensee shall retain each record that is required by this chapter, Chapters 3701:1-46, 3701:1-48, 3701:1-49, 3701:1-52, and 3701:1-58 of the Administrative Code, and rule 3701:1-38-02 of the Administrative Code, or by license condition for the period specified by the appropriate regulation or license condition. If a retention period is not otherwise specified by rule or license condition, the record must be retained until the director terminates each license that authorizes the activity that is subject to the record-keeping requirement. Such records may be either the original record or a reproduced copy or microform, provided that such copy or microform is duly authenticated by authorized personnel and the microform is capable of producing a clear and legible copy after storage for the period specified by the director. The record also may be stored in electronic media provided that the licensee is capable of producing legible, accurate, and complete records during the required retention period. Records such as letters, drawings, specifications, must include all pertinent information such as stamps, initials, and signatures. The licensee shall maintain adequate safeguards against record tampering and loss.

(C) In the case of a conflict between a record requirement specified in rule and that requirement specified as a license condition, the licensee shall comply with the license condition.

(D) Prior to license termination, each licensee authorized to possess radioactive material with a half-life greater than one hundred twenty days, in an unsealed form, shall forward to the department, records of disposal of radioactive material buried without specific state authority or buried without authorization from the United States nuclear regulatory commission prior to January 28, 1981, pursuant to 10 C.F.R. 20.304, as that section existed on January 1, 1981.

(E) If licensed activities are transferred or assigned in accordance with paragraph (B) of rule 3701:1-40-19 of the Administrative Code, each licensee authorized to possess radioactive material, with a half-life greater than one hundred twenty days, in an unsealed form, shall transfer the following records to the new licensee and the new licensee will be responsible for maintaining these records until the license is terminated:

(1) Records of disposal of licensed material made under rule 3701:1-38-19 of the Administrative Code, including any burial authorized under a United States nuclear regulatory commission license on or before January 28, 1981, or a previous "section 20.304" permitted burial of a small quantity of licensed material in soil by a United States nuclear regulatory commission licensee on or before January 28, 1981, without specific authorization, in accordance with 10 C.F.R. 20.304 as that section existed on January 1, 1981.

(2) Records required by rule 3701:1-38-20 of the Administrative Code.

(F) Prior to license termination, each licensee shall forward to the department all the records required by paragraph (I) of rule 3701:1-40-17 of the Administrative Code.

Last updated April 19, 2022 at 8:35 AM

History

• Effective: April 17, 2022
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-46-05 Certain measuring, gauging or controlling devices.

(A) A general license is hereby issued to commercial and industrial firms; research, educational, and medical institutions; individuals in the conduct of their business; and state or local government agencies to acquire, receive, possess, use or transfer, in accordance with the provisions of paragraphs (B) to (D) of this rule, radioactive material contained in devices designed and manufactured for the purpose of detecting, measuring, gauging or controlling thickness, density, level, interface location, radiation, leakage, or qualitative or quantitative chemical composition, or for producing light or an ionized atmosphere.

(B)

(1) The general license in paragraph (A) of this rule applies only to radioactive material contained in devices which have been manufactured or initially transferred and labeled in accordance with the specifications contained in:

(a) A specific license issued under rule 3701:1-46-30 of the Administrative Code;

(b) An equivalent specific license issued by an agreement state; or

(c) An equivalent specific license issued by the United States nuclear regulatory commission.

(2) The devices must have been received from one of the specific licensees described in paragraph (B)(1) of this rule or through a transfer made under paragraph (C)(9) of this rule.

(C) Any person who acquires, receives, possesses, uses or transfers radioactive material in a device pursuant to the general license in paragraph (A) of this rule:

(1) Shall assure that all labels affixed to the device at the time of receipt and bearing a statement that removal of the label is prohibited are maintained thereon and shall comply with all instructions and precautions provided by such labels;

(2) Shall assure that the device is tested for leakage of radioactive material and proper operation of the on-off mechanism and indicator, if any, at no longer than six-month intervals or at such other intervals as are specified in the label; however:

(a) Devices containing only krypton need not be tested for leakage of radioactive material, and

(b) Devices containing only tritium or not more than 3.7 megabecquerels (one hundred microcuries) of other beta and/or gamma emitting material or three hundred seventy kilobecquerels (ten microcuries) of alpha emitting material and devices held in storage in the original shipping container prior to initial installation need not be tested for any purpose;

(3) Shall assure that the tests required by paragraph (C)(2) of this rule and other testing, installation, servicing, and removal from installation involving the radioactive materials, its shielding or containment, are performed:

(a) In accordance with the instructions provided by the labels; or

(b) By a person holding a specific license pursuant to this chapter and Chapter 3701:1-40 of the Administrative Code or from an agreement state or the United States nuclear regulatory commission to perform such activities;

(4) Shall maintain records showing compliance with the requirements of paragraphs (C)(2) and (C)(3) of this rule. The records must show the results of tests. The records also must show the dates of performance of, and the names of persons performing, testing, installing, servicing, and removing from the installation radioactive material and its shielding or containment. The licensee shall retain these records as follows:

(a) Each record of a test for leakage or radioactive material required by paragraph (C)(2) of this rule must be retained for three years after the next required leak test is performed or until the sealed source is transferred or disposed of.

(b) Each record of a test of the on-off mechanism and indicator required by paragraph (C)(2) of this rule must be retained for three years after the next required test of the on-off mechanism and indicator is performed or until the sealed source is transferred or disposed of.

(c) Each record that is required by paragraph (C)(3) of this rule must be retained for three years from the date of the recorded event or until the device is transferred or disposed of.

(5) Shall immediately suspend operation of the device if there is a failure of, or damage to, or any indication of a possible failure of or damage to, the shielding of the radioactive material or the on-off mechanism or indicator, or upon the detection of one hundred eighty-five becquerels (0.005 microcurie) or more removable radioactive material. The device may not be operated until it has been repaired by the manufacturer or other person holding a specific license to repair such devices that was issued under Chapters 3701:1-40 and 3701:1-46 of the Administrative Code or by an agreement state or the United States nuclear regulatory commission. The device and any radioactive material from the device may only be disposed of by transfer to a person authorized by a specific license to receive the radioactive material in the device or as otherwise approved by the director. A report containing a brief description of the event and the remedial action taken; and, in the case of detection of one hundred eighty-five becquerels (0.005 microcurie) or more removable radioactive material or failure of or damage to a source likely to result in contamination of the premises or the environs, a plan for ensuring that the premises and environs are acceptable for unrestricted use, must be furnished to the director within thirty days.

(6) Shall not abandon the device containing radioactive material;

(7) Shall not export the device containing radioactive material except in accordance with applicable United States nuclear regulatory commission regulations;

(8)

(a) Shall transfer or dispose of the device containing radioactive material only by export as provided by paragraph (C)(7) of this rule, by transfer to another general licensee as authorized in paragraph (C)(9) of this rule, or to a person authorized to receive the device by a specific license issued under this chapter and Chapter 3701:1-40 of the Administrative Code, utilizing a licensed broker or other authorized waste collector, or equivalent regulations of an agreement state, United States nuclear regulatory commission, or as approved under paragraph (C)(8)(c) of this rule.

(b) Shall within thirty days after the transfer of a device to a specific licensee or export, furnish a report to the director by an appropriate method listed in rule 3701:1-40-04 of the Administrative Code, The report must contain:

(i) The identification of the device by manufacturer's (or initial transferor's) name, model number, and serial number;

(ii) The name, address, and license number of the person receiving the device; and

(iii) The date of the transfer.

(c) Shall obtain written director approval before transferring the device to any other specific licensee not specifically identified in paragraph (C)(8)(a) of this rule; however, a holder of a specific license may transfer a device for possession and use under its own specific license without prior approval, if the holder:

(i) Verifies that the specific license authorizes the possession and use, or applies for and obtains an amendment to the license authorizing the possession and use;

(ii) Removes, alters, covers, or clearly and unambiguously augments the existing label (otherwise required by paragraph (C)(1) of this rule) so that the device is labeled in compliance with rule 3701:1-38-18 of the Administrative Code; however the manufacturer, model number, and serial number must be retained;

(iii) Obtains the manufacturer's or initial transferor's information concerning maintenance that would be applicable under the specific license (such as leak testing procedures); and

(iv) Reports the transfer under paragraph (C)(8)(b) of this rule.

(9) Shall transfer the device to another general licensee only if:

(a) The device remains in use at a particular location. In this case, the transferor shall give the transferee a copy of this rule and any safety documents identified in the label of the device. Within thirty days of the transfer, the transferor shall report to the director:

(i) The manufacturer's (or initial transferor's) name;

(ii) The model number and the serial number of the device transferred;

(iii) The transferee's name and mailing address for the location of use; and

(iv) The name, title, and phone number of the responsible individual identified by the transferee in accordance with paragraph (C)(12) of this rule to have knowledge of and authority to take actions to ensure compliance with the appropriate rules and requirements; or

(b) The device is held in storage by an intermediate person in the original shipping container at its intended location of use prior to initial use by a general licensee.

(10) Shall comply with the provisions of paragraphs (A) and (B) of rule 3701:1-38-21 of the Administrative Code for reporting radiation incidents, theft or loss of licensed material, but shall be exempt from the other requirements of Chapter 3701:1-38 of the Administrative Code.

(11) Shall respond to written requests from the director to provide information relating to the general license within thirty calendar days of the date of the request, or other time specified in the request. If the general licensee cannot provide the requested information within the allotted time, it shall, within that same time period, request a longer period to supply the information by providing the director, by an appropriate method listed in rule 3701:1-40-04 of the Administrative Code, a written justification for the request.

(12) Shall appoint an individual responsible for having knowledge of the appropriate rules and requirements and the authority for taking required actions to comply with appropriate rules and requirements. The general licensee, through this individual, shall ensure the day-to-day compliance with appropriate rules and requirements. This appointment does not relieve the general licensee of responsibility in this regard.

(13)

(a) Shall report, in accordance with paragraphs (C)(13)(b) and (C)(13)(c) of this rule, devices containing at least three hundred seventy megabecquerels (ten millicuries) of cesium-137, 3.7 megabecquerels (0.1 millicurie) of strontium-90, thirty-seven megabecquerels (one millicurie) of cobalt-60, 3.7 megabecquerels (0.1 millicurie) of radium, or thirty-seven megabecquerels (one millicurie) of americium-241 or any other transuranic, i.e., element with atomic number greater than uranium (92), based on the activity indicated on the label. Each address for a location of use, as described under paragraph (C)(13)(c)(iv) of this rule, represents a separate general license and requires a separate registration and fee.

(b) If in possession of a device meeting the criteria of paragraph (C)(13)(a) of this rule, shall report these devices annually to the director and shall pay the fee required by paragraph (S) of rule 3701:1-38-02 of the Administrative Code. Reporting must be done by verifying, correcting, and/or adding to the information provided in a request received from the director. The information must be submitted to the director within thirty days of the date of the request for information or as otherwise indicated in the request. In addition, a general licensee holding devices meeting the criteria of paragraph (C)(13)(a) of this rule is subject to the bankruptcy notification requirement in Chapter 3701:1-40 of the Administrative Code.

(c) In reporting the devices, the general licensee shall furnish the following information and any other information specifically requested by the director:

(i) Name and mailing address of the general licensee;

(ii) Information about each device: the manufacturer (or initial transferor), model number, serial number, the radionuclide and activity (as indicated on the label);

(iii) Name, title, and telephone number of the responsible person designated as a representative of the general licensee under paragraph (C)(12) of this rule;

(iv) Address or location at which the device(s) are used and/or stored;

(v) Certification by the responsible representative of the general licensee that the information concerning the device(s) has been verified through a physical inventory and checking of label information; and

(vi) Certification by the responsible representative of the general licensee that they are aware of the requirements of the general license.

(14) Shall report changes to the mailing address for the location of use (including change in name of general licensee) to the director within thirty days of the effective date of the change.

(15) May not hold devices that are not in use for longer than two years. If devices with shutters are not being used, the shutter must be locked in the closed position. The testing required by paragraph (C)(2) of this rule need not be performed during the period of storage only. However, when devices are put back into service or transferred to another person, and have not been tested within the required test interval, they must be tested for leakage before use or transfer and the shutter tested before use. Devices kept in standby for future use are excluded from the two year time limit if the general licensee performs quarterly physical inventories of these devices while they are in standby.

(D) The director may order the inspection of any facility licensed under this rule if the director determines that an appropriate reason for the inspection exists. These inspections shall be considered as full cost inspections as defined in rule 3701:1-38-02 of the Administrative Code. The reasons the director may conduct for cause inspections include, but are not limited to;

(1) Failure to respond to official correspondence;

(2) Release of radioactive material to the environment;

(3) Investigations of alleged violations of department rules; or

(4) Failure to comply with the license application process.

(E) The general license in paragraph (A) of this rule does not authorize the manufacture or import of devices containing radioactive material.

Last updated July 10, 2025 at 12:13 PM

History

• Effective: December 1, 2012
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-46-30

(A) An application for a specific license to manufacture, or initially transfer devices containing radioactive material to persons generally licensed under rule 3701:1-46-05 of the Administrative Code or equivalent regulations of the United States nuclear regulatory commission or an agreement state will be approved if:

(1) The applicant satisfies the general requirements of rule 3701:1-40-15 of the Administrative Code;

(2) The applicant submits sufficient information relating to the design, manufacture, prototype testing, quality control, labels, proposed uses, installation, servicing, leak testing, operating and safety instructions, and potential hazards of the device to provide reasonable assurance that:

(a) The device can be safely operated by persons not having training in radiological protection;

(b) Under ordinary conditions of handling, storage, and use of the device, the radioactive material contained in the device will not be released or inadvertently removed from the device, and it is unlikely that any person will receive in one year a dose in excess of ten per cent of the annual limits specified in paragraph (A) of rule 3701:1-38-12 of the Administrative Code; and

(c) Under accident conditions (such as fire and explosion) associated with handling, storage and use of the device, it is unlikely that any person would receive an external radiation dose or dose commitment in excess of the dose to the appropriate organ as specified in the appendix to this rule.

(3) Each device bears a durable, legible, clearly visible label or labels approved by the director which contain in a clearly identified and separate statement:

(a) Instructions and precautions necessary to assure safe installation, operation, and servicing of the device (documents such as operating and service manuals may be identified in the label and used to provide this information);

(b) The requirements, or lack of requirement, for leak testing, or for testing any on-off mechanism and indicator, including the maximum time interval for such testing, and the identification of radioactive material by radionuclide, quantity of radioactivity, and date of determination of the quantity; and

(c) The information called for in the following statement in the same or substantially similar form. The receipt, possession, use, and transfer of this device model, serial no., are subject to a general license or the equivalent and the regulations of the United States nuclear regulatory commission or a state with which the United States nuclear regulatory commission has entered into an agreement for the exercise of regulatory authority. This label shall be maintained on the device in a legible condition. Removal of this label is prohibited.

"CAUTION-RADIOACTIVE MATERIAL"

(Name of manufacturer, or initial transferor)

Devices licensed by the United States nuclear regulatory commission prior to January 19, 1975, may bear labels authorized by the regulations in effect on January 1, 1975.

The model, serial number, and the name of the manufacturer, or initial transferor may be omitted from this label provided the information is elsewhere specified in labeling affixed to the device.

(4) Each device having a separable source housing that provides the primary shielding for the source also bears, on the source housing, a durable label containing the device model number and serial number, the radionuclide and quantity, the words, "Caution: Radioactive Material," the radiation symbol described in paragraph (A) of rule 3701:1-38-18 of the Administrative Code, and the name of the manufacturer or initial distributor.

(5) Each device meeting the criteria of paragraph (C)(13)(a) of rule 3701:1-46-05 of the Administrative Code, bears a permanent (e.g., embossed, etched, stamped, or engraved) label affixed to the source housing if separable, or the device if the source housing is not separable, that includes the words, "Caution: Radioactive Material," and, if practicable, the radiation symbol described in paragraph (A) of rule 3701:1-38-18 of the Administrative Code.

(B) In the event the applicant desires that the device be required to be tested at intervals longer than six months, either for proper operation of the on-off mechanism and indicator, if any, or for leakage of radioactive material or for both, the applicant shall include in this application sufficient information to demonstrate that such longer interval is justified by performance characteristics of the device or similar devices, and by design features which have a significant bearing on the probability or consequences of leakage of radioactive material from the device or failure of the on-off mechanism and indicator. In determining the acceptable interval for the test for leakage of radioactive material, the director will consider information which includes, but is not limited to:

(1) Primary containment (source capsule);

(2) Protection of primary containment;

(3) Method of sealing containment;

(4) Containment construction materials;

(5) Form of contained radioactive material;

(6) Maximum temperature withstood during prototype tests;

(7) Maximum pressure withstood during prototype tests;

(8) Maximum quantity of contained radioactive material;

(9) Radiotoxicity of contained radioactive material; and

(10) Operating experience with identical devices or similarly designed and constructed devices.

(C) In the event the applicant desires that the general licensee under rule 3701:1-46-05 of the Administrative Code, or under equivalent regulations of the United States nuclear regulatory commission or an agreement state be authorized to install the device, collect the sample to be analyzed by a specific licensee for leakage of radioactive material, service the device, test the on-off mechanism and indicator, or remove the device from installation, the applicant shall include in the application written instructions to be followed by the general licensee, estimated calendar quarter doses associated with such activity or activities, and the bases for these estimates. The submitted information must demonstrate that performance of this activity or activities by an individual untrained in radiological protection, in addition to other handling, storage, and use of devices under the general license, is unlikely to cause that individual to receive a dose in excess of ten per cent of the annual limits specified in paragraph (A) of rule 3701:1-38-12 of the Administrative Code.

View Appendix

Last updated November 2, 2022 at 2:33 PM

History

• Effective: December 1, 2012
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-40-04

(A) Except as otherwise provided, any communication or report required by this chapter shall be filed in accordance with Chapter 3748. of the Revised Code and rules promulgated thereunder. Documents pertaining to license application or any license matter, unless otherwise directed in writing, shall be submitted to the following address or by electronic submission in a manner approved by the director:

"Ohio Department of Health

Bureau of Environmental Health and Radiation Protection

246 North High Street

Columbus, Ohio 43215."

(B) If pemitted to submit via electronic mail, communications may be sent to the Ohio department of health at:

"BRadiation@odh.ohio.gov"

Last updated April 19, 2022 at 8:33 AM

History

• Effective: April 17, 2022
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-38-18

(A) Except as provided in paragraph (B) of this rule, caution signs and posting requirements for licensees and registrants are as follows:

(1) The standard radiation symbol, unless otherwise authorized by the department or as provided in paragraph (A)(2) of this rule, shall use the colors magenta, purple, or black on yellow background. The symbol prescribed is the three-bladed design as follows:

(2) Notwithstanding paragraph (A)(1) of this rule, licensees and registrants are authorized to label sources, source holders, or device components containing sources of radiation that are subjected to high temperatures, with conspicuously cast, etched or stamped radiation caution symbols and without a color requirement.

(3) In addition to the contents of signs and labels prescribed in this chapter, the licensee or registrant may provide, on or near the required signs and labels, additional information, as appropriate, to make individuals aware of potential radiation exposures and to minimize the exposures.

(4) Posting of radiation areas shall be accomplished as follows:

(a) The licensee or registrant shall post each radiation area with a conspicuous sign or signs bearing the radiation symbol and the words "Caution, Radiation Area".

(b) The licensee or registrant shall post each high radiation area with a conspicuous sign or signs bearing the radiation symbol and the words "Caution, High Radiation Area" or "Danger, High Radiation Area".

(c) The licensee or registrant shall post each very high radiation area with conspicuous sign or signs bearing the radiation symbol and words "Grave Danger, Very High Radiation Area".

(d) The licensee shall post each airborne radioactivity area with a conspicuous sign or signs bearing the radiation symbol and the words "Caution, Airborne Radioactivity Area" or "Danger, Airborne Radioactivity Area".

(e) The licensee shall post each area or room in which there is an amount of licensed material used or stored which exceeds ten times the quantity of such material specified in the appendix A ofto this rule with a conspicuous sign or signs bearing the radiation symbol and the words "Caution, Radioactive Material(s)" or "Danger, Radioactive Material(s)".

(f) The licensee shall post access openings to manufacturing or process equipment (such as tanks and vessels) on or in which radiation sources are mounted, if a person could gain access to the radiation beam and receive an annual dose to any part of their body which is greater than the applicable, permissible limits for individuals in rules 3701:1-38-12 and 3701:1-38-13 of the Administrative Code. The posting must include a conspicuous sign or signs bearing the radiation symbol and warning of the hazard.

(B) The following are exceptions to posting requirements set forth in paragraph (A) of this rule:

(1) A licensee or registrant is not required to post caution signs in an area or room that contains a source of radiation provided that the source is located in the area or room for a period of less than eight hours, and the source of radiation is continuously attended to during these periods by an individual who takes the precautions necessary to prevent the exposure of individuals to sources of radiation in excess of the limits established in rule 3701:1-38-13 of the Administrative Code, and the area or room is subject to licensee or registrant control.

(2) Rooms or other areas in hospitals that are occupied by patients are not required to be posted with caution signs pursuant to paragraph (A) of this rule provided that the patient could be released from licensee control in accordance with rule 3701:1-58-30 of the Administrative Code.

(3) A room or area is not required to be posted with a caution sign because of the presence of a sealed source provided the radiation level at thirty centimeters from the surface of the sealed source container or housing does not exceed 0.05 millisievert (0.005 rem) per hour.

(4) A room or area is not required to be posted with a caution sign because of the presence of radiation-generating equipment used solely for diagnosis in the healing arts.

(5) Rooms in hospitals or clinics that are used for teletherapy are exempt from the requirement to post caution signs if access to the room is controlled pursuant to rule 3701:1-58-59 of the Administrative Code and personnel in attendance take necessary precautions to prevent the inadvertent exposure of workers, other patients, and members of the public to radiation in excess of the limits established in this chapter.

(C) Except as provided in paragraph (E) of this rule, containers shall be labeled as follows:

(1) The licensee shall ensure that each container of licensed material bears a durable, clearly visible label bearing the radiation symbol and the words "Caution, Radioactive Material" or "Danger, Radioactive Material". The label shall also provide information, such as the radionuclides present, an estimate of the quantity of radioactivity, the date for which the activity is estimated, radiation levels, kinds of materials, and mass enrichment, to permit individuals handling or using the containers, or working in the vicinity of the containers, to take precautions to avoid or minimize exposures.

(2) Prior to removal or disposal of empty uncontaminated containers to unrestricted areas, each licensee shall, remove or deface the radioactive material label or otherwise clearly indicate that the container no longer contains radioactive materials.

(D) Each registrant shall ensure that each radiation-generating equipment is labeled in a conspicuous manner which cautions individuals that radiation is produced when it is energized.

(E) A licensee is not required to label the following:

(1) Containers holding licensed material in quantities less than the quantities listed in the appendix A to this rule;

(2) Containers holding licensed material in concentrations less than those specified in table III of appendix C to rule 3701:1-38-12 of the Administrative Code;

(3) Containers attended by an individual who takes the precautions necessary to prevent the exposure of individuals in excess of the limits established by rule 3701:1-38-13 of the Administrative Code;

(4) Containers when they are in transport and packaged and labeled in accordance with the regulations of the United States department of transportation;

(5) Containers that are accessible only to individuals authorized to handle or use them, or to work in the vicinity of the containers, if the contents are identified to these individuals by a readily available written record. Examples of containers of this type are containers in locations such as water-filled canals, storage vaults, or hot cells. The record shall be retained as long as the containers are in use for the purpose indicated on the record; or

(6) Manufacturing or processing equipment such as contaminated piping and tanks, and vessels on or in which radiation sources are installed.

(F) Each licensee shall:

(1) Monitor the external surfaces of a labeled package for radioactive contamination unless the package contains only radioactive material in the form of gas or in special form as defined in rule 3701:1-38-01 of the Administrative Code;

(2) Monitor the external surfaces of a labeled package for radiation levels unless the package contains quantities of radioactive material that are less than or equal to the type A quantity; and

(3) Monitor all packages known to contain radioactive material for radioactive contamination and radiation levels if there is evidence of degradation of package integrity, such as a package that is crushed, wet, or damaged.

(4) Perform the monitoring required by this paragraph as soon as practicable after receipt of the package, but not later than three hours after the package is received at the licensee's facility, if it is received during the licensee's normal working hours. If a package is received after working hours, the package shall be monitored no later than three hours from the beginning of the next working day.

(G) Each licensee who expects to receive a package containing quantities of radioactive material in excess of a type A quantity as defined in rule 3701:1-38-01 of the Administrative Code and as provided in rule 3701:1-50-25 of the Administrative Code, shall make arrangements to receive the package when the carrier offers it for delivery or expeditiously upon receiving notification that the package is available for pick-up.

(H) The licensee shall immediately notify the final delivery carrier and the department by telephone and either telegram, mailgram, or facsimile, when:

(1) Removable radioactive surface contamination exceeds the limits as provided in 49 C.F.R. 173.443 (as published in the October 1, 2009 Code of Federal Regulationsin effect on the effective date of this rule); or

(2) External radiation levels exceed the limits as provided in 49 C.F.R. 172.403 (as published in the October 1, 2009 Code of Federal Regulationsin effect on the effective date of this rule).

(I) Each licensee shall:

(1) Establish, maintain, and retain written procedures for safely opening packages in which radioactive material is received; and

(2) Ensure that the procedures are followed and that due consideration is given to special instructions for the type of package being opened.

(J) A licensee that transfers a special form source to and from a work site in a vehicle owned or operated by the licensee is exempt from the contamination monitoring requirements of this rule, but is not exempt from the monitoring requirement in this rule for measuring radiation levels that ensures that the source is still properly lodged in its shield.

View Appendix

Last updated June 6, 2022 at 9:29 AM

History

• Effective: June 4, 2022
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-38-21

(A) The licensee or registrant shall report stolen, lost, or missing licensed or registered sources of radiation to the director in accordance with the following:

(1) Telephone reports shall be made as follows:

(a) To the bureau of environmental health and radiation protection point of contact (POC) in accordance with the form "Notice to Employees" issued by the director.

(b) In the case of a licensee, he or she shall make contact:

(i) Immediately after the licensee determines that licensed radioactive material is stolen, lost, or missing in an aggregate quantity equal to or greater than one thousand times the quantity specified in the appendix to rule 3701:1-38-18 of the Administrative Code under such circumstances that it appears to the licensee that an exposure could result to individuals in unrestricted areas;

(ii) Within thirty days after its occurrence becomes known to the licensee, lost, stolen, or missing licensed radioactive material in an aggregate quantity greater than ten times the quantity specified in the appendix to rule 3701:1-38-18 of the Administrative Code that is still missing.

(c) In the case of a registrant, he or she shall make contact immediately after it becomes known that radiation-generating equipment has been stolen, lost, or is missing.

(2) Written reports shall be made as follows:

(a) Each licensee or registrant required to make a report pursuant to paragraph (A)(1) of this rule shall, within thirty days after making the telephone report, make a written report to the director setting forth the following information, where applicable:

(i) A description of the licensed or registered source of radiation involved, including, for radioactive material, the kind, quantity, and chemical and physical form, and in the case of radiation-generating equipment, the manufacturer, model and serial number, type and maximum energy of the radiation emitted;

(ii) A description of the circumstances under which the loss or theft occurred;

(iii) A statement of disposition, or probable disposition, of the licensed or registered source of radiation involved;

(iv) Exposures of individuals to radiation, circumstances under which the exposures occurred, and the possible total effective dose equivalent to persons in unrestricted areas;

(v) Actions that have been taken, or will be taken, to recover the source of radiation; and

(vi) Procedures or measures that have been, or will be, adopted to ensure against a recurrence of the loss or theft of licensed or registered sources of radiation.

(b) Subsequent to filing the written report, the licensee or registrant shall also report additional substantive information on the loss or theft within thirty days after the licensee or registrant learns of such information.

(c) The licensee or registrant shall prepare any report filed with the director pursuant to this rule so that names of individuals who may have received exposure to radiation are stated in a separate and detachable portion of the report.

(B) Notification of incidents shall be made as follows:

(1) Excluding prescribed medical doses to patients, each licensee or registrant shall immediately report each event involving a source of radiation possessed by the licensee or registrant that may have caused or threatens to cause any of the following conditions:

(a) An individual receiving:

(i) A total effective dose equivalent of 0.25 sievert (twenty-five rem) or more;

(ii) A lens dose equivalent of 0.75 sievert (seventy-five rem) or more; or

(iii) A shallow dose equivalent to the skin or extremities or a total organ dose equivalent of 2.5 sievert (two hundred fifty rem) or more; or

(b) The release of radioactive material, inside or outside of a restricted area that, had an individual been present for twenty-four hours, the individual could have received an intake five times the occupational ALI. This provision does not apply to locations where personnel are not normally stationed during routine operations, such as hot-cells or process enclosures.

(2) Each licensee or registrant shall report to the director, within twenty-four hours of discovery, each event involving loss of control of a licensed or registered source of radiation possessed by the licensee or registrant that may have caused, or threatens to cause, any of the following:

(a) An individual to receive, in a period of twenty-four hours:

(i) A total effective dose equivalent exceeding 0.05 sievert (five rem);

(ii) An lens dose equivalent exceeding 0.15 sievert (fifteen rem); or

(iii) A shallow dose equivalent to the skin or extremities or a total organ dose equivalent exceeding 0.5 sievert (fifty rem); or

(b) The release of radioactive material, inside or outside of a restricted area that, had an individual been present for twenty-four hours, the individual could have received an intake in excess of one occupational ALI. This provision does not apply to locations where personnel are not normally stationed during routine operations, such as hot-cells or process enclosures.

(3) Licensees or registrants shall make the reports required by paragraphs (B)(1) and (B)(2) of this rule to the POC by telephone to the department and shall confirm the initial contact by telegram, mailgram, electronic mail, or facsimile to the director.

(4) The licensee or registrant shall prepare each report filed with the director pursuant to this rule so that names of individuals who have received exposure to sources of radiation are stated in a separate and detachable portion of the report.

(5) The provisions of paragraph (B) of this rule do not apply to doses that result from planned special exposures, provided such doses are within the limits for planned special exposures and are reported in accordance with this paragraph.

(C) Reports of exposures, radiation levels, and concentrations of radioactive material exceeding the limits shall be made by the licensee or registrant as follows:

(1) Reportable events that are specified in this paragraph shall, in addition to the notification requirements in paragraph (B) of this rule, be reported to the director in writing within thirty days after learning of any of the following occurrences:

(a) Incidents for which notification is required by paragraph (B) of this rule and with doses in excess of any of the following:

(i) The occupational dose limits for adults in paragraphs (A)(1) and (A)(2) of rule 3701:1-38-12 of the Administrative Code;

(ii) The occupational dose limits for a minor in paragraph (G) of rule 3701:1-38-12 of the Administrative Code;

(iii) The limits for an embryo or fetus of a declared pregnant woman in paragraph (H) of rule 3701:1-38-12 of the Administrative Code;

(iv) The limits for an individual member of the public in paragraph (A) of rule 3701:1-38-13 of the Administrative Code;

(v) Any applicable limit in the license or registration; or

(vi) The ALARA constraints for air emissions established under paragraph (D)(4) of rule 3701:1-38-11 of the Administrative Code; or

(b) Levels of radiation or concentrations of radioactive material in:

(i) A restricted area in excess of applicable limits in the license or registration; or

(ii) An unrestricted area in excess of ten times the applicable limit set forth in this chapter or in the license or registration, whether or not involving exposure of any individual in excess of the limits in paragraph (A) of rule 3701:1-38-13 of the Administrative Code; or

(c) For licensees subject to the provisions of the United States environmental protection agency generally applicable environmental radiation standards in 40 C.F.R. 190 (as in effect on the effective date of this rule), levels of radiation or releases of radioactive material in excess of those standards, or of license conditions related to those standards.

(2) Each report required by this rule shall describe the extent of exposure of individuals to radiation and radioactive material, including, as appropriate:

(a) Estimates of each individual's dose, the level of radiation and concentration of radioactive material involved, and the cause of the elevated exposure, dose rate, or concentration; and

(b) Corrective steps taken or planned to ensure against a recurrence, including the schedule for achieving conformance with applicable limits, ALARA constraints, generally applicable environmental standards, and associated license or registration conditions.

(3) Each report filed pursuant to this rule shall include, for each occupationally overexposed individual, the name, social security account number, and date of birth of the individual. In the case of the limit for an embryo or fetus in paragraph (H) of rule 3701:1-38-12 of the Administrative Code, the identifiers should be those of the declared pregnant woman. The report shall be prepared so that information on each individual is stated in a separate and detachable portion of the report.

(4) All licensees or registrants who make reports pursuant to this rule shall submit the report in writing to the director.

(D) Reports of planned special exposures shall be submitted by the licensee in a written report to the director within thirty days following any planned special exposure conducted in accordance with paragraph (F) of rule 3701:1-38-12 of the Administrative Code, informing the director that a planned special exposure was conducted and indicating the date the planned special exposure occurred and the information required by paragraph (G) of rule 3701:1-38-20 of the Administrative Code.

(E) When a licensee or registrant is required pursuant to paragraph (C) or (D) of this rule to report to the director any exposure of an identified occupationally exposed individual, or an identified member of the public, to radiation or radioactive material, the licensee or registrant shall also provide the individual a report on his or her exposure data included in the report to the director. This report shall be transmitted no later than the transmittal to the director, and shall comply with the provisions of paragraph (C)(1) of rule 3701:1-38-10 of the Administrative Code.

(F) A report of a leaking or contaminated sealed source shall be filed by the licensee with the director within five days of the test results, if the test reveals the presence of one hundred eighty-five becquerels (0.005 microcurie) or more of removable contamination. The report shall include the equipment involved, the test results and the corrective action taken.

Last updated January 20, 2022 at 8:48 AM

History

• Effective: January 20, 2022
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-38-02

(A) As used in this rule, "facility" has the meaning defined in division (H) of section 3748.01 of the Revised Code and the following:

(1) All buildings, equipment, structures, and other stationary items that are located on a single site or on contiguous or adjacent sites and that are operated by the same person and have common corporate or business interests; and

(2) Portions of a building or structure which are operated by the same person and have common corporate or business interests.

(B) Notwithstanding the definition of "facility," the director may consider sites that are not contiguous or adjacent as one facility provided that:

(1) The sites are operated by the same person;

(2) The sites are in the same license category or categories;

(3) The applicant for a license provides for one radiation safety officer, and if applicable, one radiation safety committee, as responsible for all sites; and

(4) The director is reasonably satisfied from the information provided in the application that the applicant will adequately control radioactive material at all sites listed in the application.

(a) Unless the director has information of violations of Chapter 3748. of the Revised Code or the rules adopted thereunder at one or more sites, the director shall presume the applicant will adequately control radioactive material at all sites if the sites are located not more than twenty miles driving distance apart as documented by the licensee, and if all sites are within a twenty mile radius from the main site as designated on the license.

(b) The director shall continue to renew a license issued under this paragraph that contains all the sites listed thereon provided the licensee demonstrates continued compliance with this paragraph, Chapter 3748. of the Revised Code, and the rules adopted thereunder.

(C) Every facility that handles radioactive material in any license category as specified in appendix A to this rule for which licensure is required shall apply for a license, license amendment, or license renewal in accordance with this rule. Application for a license, license amendment, or license renewal shall be made on any format prescribed and provided by the director. Licenses shall be issued in accordance with the requirements of Chapter 3748. of the Revised Code, and the rules adopted thereunder. Except as otherwise provided in this rule, a license shall expire five years from the date of issuance.

(1) As used in this paragraph, site means an address of use listed on the license. Temporary job sites are exempted.

(a) Any individual applying for a new license with one or more additional sites or a current licensee amending a license to add one or more additional sites that are located more than twenty miles from the main site shall pay an additional site fee for each such site as follows:

(i) The additional site fee(s) shall be seventy-five percent of the applicable annual fee, as those fees are set forth in paragraphs (D), (F), and (J) of this rule.

(ii) Additional site fees will be invoiced annually with the annual fee.

(b) Broad scope licensees are exempt from paragraph (C)(1)(a) of this rule.

(2) As used in this paragraph, "service" means activities performed by a person, other than a worker as defined in rule 3701:1-38-01 of the Administrative Code, pursuant to an agreement with the facility to perform activities that deal with sources of radiation for the facility.

(a) These activities include, but are not limited to the following:

(i) Conduct leak tests;

(ii) Calibrate survey instruments;

(iii) Provide quality control tests;

(iv) Conduct surveys, characterization, and/or remediation activities;

(v) Manage the disposal of radioactive waste for other persons; or

(vi) Install sources or devices or change sources within a device.

(b) License categories affected are:

(i) 3219 - decontamination services;

(ii) 3220 - leak test service;

(iii) 3221 - instrument calibration service only - source less than 3.7 terabecquerels (one hundred curies);

(iv) 3222 - instrument calibration service only - source equal to or greater than 3.7 terabecquerels (one hundred curies);

(v) 3223 - leak test and instrument calibration - source less than 3.7 terabecquerels (one hundred curies);

(vi) 3224 - leak test and instrument calibration - source equal to or greater than 3.7 terabecquerels (one hundred curies);

(vii) 3225 - other services - including teletherapy, irradiator, and gauge service;

(viii) 3232 - waste disposal service prepackaged only;

(ix) 3233 - waste disposal service - incineration; and

(x) 3234 - waste disposal service processing and/or repackaging.

(D) A radioactive materials license issued by the department may, at the discretion of the director, have more than one license category on any one specific license. A licensee may have more than one radioactive materials license. Except as otherwise provided in paragraph (J) of this rule, the annual fee for a radioactive material license shall be in an amount in accordance with appendix A to this rule.

(1) Upon receipt of an application for a new radioactive material license, the department will issue an invoice for the appropriate fee specified in appendix A to this rule or paragraph (J) of this rule. Annual fees will be invoiced based on the month of the license expiration date and the invoice will state that the fee is due thirty days after the date of the invoice. License fees are not refundable.

(2) An applicant for a new or a renewal or amendment of a radioactive material license must submit a complete application before the director will finalize the review of the application. A complete application is one in which the applicant has provided all the information requested by the director, including any additional information requested after receipt of the application package.

(3) Upon receipt of an application for a license amendment, the department will issue an invoice for the appropriate fee for the proposed amendment as specified in appendix A to this rule. If the amendment is to change the license from operational phase to storage of sealed sources only incident to disposal of the sources, after the amendment the annual fee for the license shall be reduced to fifty per cent of the fee for the operational phase of the license, provided that the sources continue to be in safe storage and leak tested as provided by license condition for the specific sources in storage. The inspection frequency will remain the same as that for the operational phase of the license until after source disposal.

(4) The applicant for a new, or renewal or amendment of a radioactive materials license shall provide to the director all additional information requested within sixty days from the date of the information request. If the director does not receive the requested information within the stated time period, the director may consider the application abandoned. Any further consideration of a new license, or a renewal or amendment of a license shall be pursuant to another application.

(5) The director shall grant a new license, license amendment, or license renewal to any applicant who has submitted a complete application and is in compliance with Chapter 3748. of the Revised Code and the rules adopted thereunder.

(6) When an amendment to a license results in a change to a license category with a higher fee, the licensee will be charged the higher of the two amendment fees for that category. The annual fee for the licensee will escalate to the new category fee on the date of the next annual invoice.

(7) The director shall charge a fee for minor license amendments that do not require review by members of the technical staff at a rate of one hundred dollars per amendment provided that no licensee shall be required to pay more than one thousand dollars for minor amendments in any calendar year. Minor amendments include, but are not limited to, adding a new gauge of the same type already licensed unless that additional gauge increases the license or inspection fee, a corporate name change if the corporate ownership does not change, adding a user name that does not require review of education and experience, and corporate address change if the location of the use of the radioactive material does not change. Amendments to change the radiation safety officer or the chair or members of the radiation safety committee that require review of education or experience are not minor amendments.

(8) License terminations shall be handled as follows:

(a) Except as provided in paragraph (D)(8)(c) of this rule, a termination fee of five hundred dollars or fifty per cent of the annual fee, whichever is less, will be invoiced upon written request from the licensee for termination of the license. This fee is not refundable.

(b) Except as provided in paragraph (D)(8)(c) of this rule, if the termination cost, as determined by paragraph (M) of this rule, exceeds the termination fee in paragraph (D)(8)(a) of this rule, the remainder of the termination expense will be assessed at full cost.

(c) If the license termination would be covered under paragraph (D)(9) of this rule, that paragraph will be used for the termination process.

(d) The license termination process will not be completed until the licensee is in compliance with all rules, including payment of fees.

(9) Licenses, and other approvals related to the licensed activity requiring decommissioning, decontamination, reclamation, site restoration, or long-term care due to the continued presence of radioactive materials shall be charged an annual fee based on the approved decommissioning funding plan as specified in appendix B to this rule.

(a) A decommissioning plan must be approved by the department. Prior to approval of the decommissioning plan the licensee must submit an amendment requesting decommissioning. Until the amendment is approved the licensee's annualized license fee will be reduced by fifty per cent. After approval of the amendment containing the decommissioning plan, the licensee will be invoiced at the annual fee specified in appendix B to this rule.

(b) The annual fee specified in appendix B to this rule is based on the cost of decommissioning. The fee is payable within thirty days of mailing of an invoice by the department.

(c) Routine decommissioning oversight by the department will be charged against the annual amount received and additional invoices will not be issued unless the cost of activities exceeds the annual amount in any given year.

(d) The facility shall receive a monthly statement of items and amounts charged against the annual fee.

(e) If the cost of additional activities arise that require use of additional staff, including any consulting service that exceeds the amount of the annual fee paid by the licensee, these additional costs will be included in any invoice as separate items invoiced for the full cost of the oversight by additional staff or consultants. Oversight activities will be performed at a frequency which adequately monitors health, safety, and the environment.

(f) When the approved decommissioning plan is less than one hundred thousand dollars, the licensee will remain in the current license category and continue to pay the required annual fee specified in appendix A to this rule during decommissioning. Inspections of these licensees will be done as non-routine inspections. Non-routine inspection fees will not be applied until the number of decommissioning inspections performed exceed the inspections that would have been performed if the licensee had not chosen the decommissioning option.

(g) When the licensee has completed the decommissioning, and the director has determined that the licensee cannot terminate the license as provided by the Administrative Code, Chapter 3748. of the Revised Code or the rules adopted thereunder, but the licensee has successfully completed the decommissioning of the operation as required by the approved decommissioning plan, the director will amend the license to a decommissioning/possession only license. The annual fee for a decommissioning/possession only license is provided in appendix B to this rule.

(E) Licenses shall be renewed in accordance with the standard renewal procedure established in Chapter 4745. of the Revised Code, except that a licensee, other than a broad scope licensee, shall apply for renewal of the license ninety days prior to the expiration date of the current license and broad scope licensees shall apply for renewal of their license one hundred eighty days prior to expiration.

(F) The annual fee is listed in appendix A to this rule "column 5" for a new license or "column 6" for a renewal license. To recover the costs of oversight activities where radioactive material is found in the public domain and there is no evident individual that is determined to be responsible, a surcharge of 5.25 per cent has been included in the annual fee listed in "column 5" and "column 6" of appendix A to this rule.

(G) The department shall charge an inspection fee for all non-routine inspections. A non-routine inspection is defined as any inspection that the department conducts in addition to the scheduled routine inspections and one follow-up inspection if necessary. Non-routine inspections include, without limitation:

(1) An inspection performed as a result of an incident;

(2) Any pre-license inspections for a new license applicant when the director determines that an inspection is necessary to assess the adequacy of the information provided in the application;

(3) Inspections prior to license amendment, category change, or termination;

(4) An inspection performed at a facility that results in the issuance of an adjudication order by the director; or

(5) Other enforcement or regulatory inspections, not specified above, that the director determines is necessary to assess compliance with Chapter 3748. of the Revised Code.

(H) The fee for a non-routine inspection shall be based on the actual cost for conducting the inspection which shall include:

(1) An hourly charge of seventy dollars per staff person assigned to the inspection, except staff participating as training will not be included in the charges;

(2) An administrative fee of three hundred thirty dollars;

(3) All necessary laboratory analysis costs for samples collected by department personnel; and

(4) Any staff travel costs which shall be calculated in accordance with rule 126-01-02 of the Administrative Code.

(I) All fees invoiced as provided within this rule, including full cost, routine, and non-routine inspection fees, shall be paid within thirty days of the invoice date specified on the invoice. In accordance with sections 3748.07 and 3748.13 of the Revised Code, any fee that remains unpaid on the ninety-first day after the original invoice date shall be assessed an additional amount equal to ten per cent of the original fee.

(1) The department shall mail invoices by ordinary U.S. mail to the most recent address provided by the licensee.

(2) The department shall maintain a list of the invoices issued and date mailed.

(J) Notwithstanding paragraph (D) of this rule, the department shall charge the following types of licensees reduced license fees in the following specified amounts:

(1) A private entity that provides services, does not engage in manufacturing, and that has three hundred fifty thousand to two million dollars in gross annual receipts, shall pay a total license fee of seventy-five per cent of the amount specified for that use of radioactive materials in appendix A to this rule.

(2) A private entity that provides services, does not engage in manufacturing, and that has less than three hundred fifty thousand dollars in gross annual receipts shall pay a total license fee of fifty per cent of the amount specified for that use of radioactive material in appendix A to this rule.

(3) A private entity that engages in manufacturing and that has thirty-five to two hundred employees, irrespective of gross annual receipts, shall pay a total license fee of seventy-five per cent of the amount specified for that use of radioactive material in appendix A to this rule.

(4) A private entity that engages in manufacturing and that has less than thirty-five employees, irrespective of gross annual receipts, shall pay a total license fee of fifty per cent of the amount specified for that use of radioactive material in appendix A to this rule.

(5) A nonprofit entity that has gross annual receipts of three hundred fifty thousand dollars to two million dollars shall pay a total license fee of seventy-five per cent of the amount specified for that use of radioactive material in appendix A to this rule.

(6) A nonprofit entity that has gross annual receipts of less than three hundred fifty thousand dollars shall pay a total license fee of fifty per cent of the amount specified for that use of radioactive material in appendix A to this rule.

(7) A government jurisdiction or district with a population of twenty thousand to fifty thousand shall pay a total license fee of seventy-five per cent of the amount specified for that use of radioactive material as specified in appendix A to this rule.

(8) A government jurisdiction or district with a population of less than twenty thousand shall pay a total license fee of fifty per cent of the amount specified for that use of radioactive materials as specified in appendix A to this rule.

(9) A health district as defined in section 3709.01 of the Revised Code shall pay a total license fee of twenty-five per cent of the amount specified in appendix A to this rule.

(10) An accredited private or public college or university possessing or using radioactive material in a sealed or unsealed source solely as a part of a college or university course supported by tuition and leading to an accredited degree, but excluding clinical training, shall pay a total license fee as set forth for category "1129" as that amount is specified in appendix A to this rule.

The reduced annual fees specified in this paragraph do not apply to any other fees that a licensee may be required to pay under Chapter 3748. of the Revised Code or rules adopted thereunder. Licensees shall provide certification of their compliance with the provisions of paragraphs (J)(1) to (J)(6) of this rule upon initial application and renewal.

(K) The director may modify the inspection frequency of licensed facilities based upon the performance of the facility.

(L) In accordance with section 3748.22 of the Revised Code, the department shall charge fees sufficient to cover all costs of regulatory, administrative, and enforcement activities conducted pursuant to Chapter 3748. of the Revised Code. The director shall recommend to the radiation advisory council and the public health council changes in the radioactive materials fees if the director finds that fees do not meet the requirements of section 3748.22 of the Revised Code.

(M) Fees for those categories listed as "full cost" such as decommissioning activities, for either partial, building or selected area of a licensed site, or full decommissioning leading to license amendment, category change, or termination and for review of sources and/or devices shall be specified as "full cost" and shall be calculated as the sum of the seventy dollar hourly charge per staff member for the number of hours spent on document review and preparation, licensing, inspection, meetings, teleconferences, in travel, administrative time, the cost of any special contractors as determined necessary by the director, any environmental monitoring for radioactive materials and laboratory analysis, any other associated activities. The administrative fee from paragraph (H)(2) of this rule shall be used for administrative time. Travel expenses shall also be invoiced and shall be calculated at the rate determined by rule 126-1-02 of the Administrative Code. These fees will be invoiced monthly.

(N)

(1) Reciprocity to engage in activities in the state of Ohio which involve radioactive materials may be authorized provided:

(a) The person requesting reciprocity possesses a valid radioactive materials license issued by another agreement state or the United States nuclear regulatory commission which authorizes the same activities proposed to be conducted in Ohio;

(b) The request for reciprocity is made by submission of a completed reciprocity application provided by the director, a copy of the person's radioactive materials license, and payment of the reciprocity fee specified in appendix A to this rule;

(c) The duration of activities to be performed in Ohio under reciprocity does not exceed one hundred eighty days in any one calendar year.

(2) A person who has been granted reciprocity in Ohio shall notify the director at least three business days in advance of each time the person proposes to begin a new use of radioactive materials in the state of Ohio, with the notification made on a form provided by the director.

(3) Activities conducted in Ohio under reciprocity are subject to inspection by the department at any time and the department shall invoice a reciprocity inspection fee of one thousand dollars for each inspection of a person's authorized reciprocity activities.

(4) Reciprocity is authorized for one calendar year, beginning on January first or later date when reciprocity is initially applied for, and ending on December thirty-first.

(5) A person who is authorized reciprocity shall apply for an Ohio radioactive materials license at least thirty days prior to exceeding one hundred eighty days of activities in Ohio.

(O) Requests for safety evaluation of devices, products, or sealed sources used for radioactive materials either for commercial distribution or manufactured in accordance with the unique specifications of, and for use by, a single applicant shall be submitted to the director on a form provided by the director for that review prior to manufacture or commercial distribution.

(1) The application shall specify a license amendment for one of the areas listed below:

(a) Safety evaluation of sealed sources or devices or products containing NARM, byproduct material, source material, or special nuclear material (less than critical mass) for commercial distribution.

(b) Safety evaluation of sealed sources or devices or products containing NARM, byproduct material, source material, or special nuclear material (less than critical mass) manufactured in accordance with the unique specifications of, and for use by, a single applicant.

(2) The amendment fee for a source or device review shall be "full cost" as outlined in paragraph ((M) of this rule.

(3) The amendment fee in appendix A to this rule for categories under manufacturing and distribution shall be for amendments other than source or device reviews.

(4) Licensees for categories 3211, 3212, 3213, 3214, and 22162 shall pay an annual surcharge of six hundred fifty dollars to cover administrative costs of overall maintenance activities associated with source or device data submitted to the United States nuclear regulatory commission. This surcharge is included in the annual fee for the above listed categories in "column 5" and "column 6" of appendix A to this rule.

(P) When considered necessary by the director, the director may conduct a review of shielding plans or the adequacy of shielding. The director may also conduct such a review upon the request of the licensee or the applicant for a license. The applicant or licensee shall pay a fee for review of shielding plans or adequacy of shielding as specified in paragraph (M) of this rule.

(Q) Individuals with implanted pacemakers that have a radioactive source will not be charged an annual fee as an individual because of the necessity of possessing the device. Unless the director determines other provisions are required, the medical institution that implanted the device shall hold the license for the individual.

(R) If, because of the complexity of a review, such as that for a sealed source or device, decommissioning, license, or incident, it is necessary to obtain the services of a consultant to assist in a final determination, the licensee or applicant will be invoiced for the consulting services.

(S) Licensees with general licenses requiring an annual report to the director shall submit the report with a fee of four hundred twenty dollars within thirty days of mailing an invoice by the department and are subject to late penalties in paragraph (I) of this rule. If a facility has a specific license which is in a category that would include the generally licensed material, the facility may add the generally licensed material to the specific license and will not be charged the additional fee for that generally licensed material. Annual reports are required for devices under a general license containing radionuclides at or above activities listed in paragraph (C)(13) of rule 3701:1-46-05 of the Administrative Code.

View AppendixView Appendix

Last updated November 2, 2022 at 2:09 PM

History

• Effective: April 15, 2013
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-46-06 License to install devices that are generally licensed.

Any person who holds a specific license issued by the United States nuclear regulatory commission or an agreement state authorizing the holder to manufacture, install, or service a device described in rule 3701:1-46-05 of the Administrative Code is hereby granted a general license to install and service such device provided that:

(A) The device has been manufactured, labeled, installed, and serviced in accordance with applicable provisions of the specific license issued such person by the United States nuclear regulatory commission or an agreement state and requirements of paragraph (C)(2) of rule 3701:1-38-02 of the Administrative Code.

(B) Such person assures that any labels required to be affixed to the device under regulations of the United States nuclear regulatory commission or an agreement state which licensed the manufacturer of the device, bear a statement that removal of the label is prohibited.

Last updated November 2, 2022 at 2:32 PM

History

• Effective: January 20, 2008
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-46-07 Luminous safety devices for use in aircraft.

(A) A general license is hereby issued to own, receive, acquire, possess, and use tritium or promethium-147 contained in luminous safety devices for use in aircraft, provided each device contains not more than 0.37 terabecquerels (ten curies) of tritium or 11.1 gigabecquerels (three hundred millicuries) of promethium-147 and that each device has been manufactured, assembled or initially transferred in accordance with a license issued under the provisions of rule 3701:1-46-33 of the Administrative Code or manufactured or assembled in accordance with a specific license issued by the United States nuclear regulatory commission or an agreement state which authorizes manufacture or assembly of the device for distribution to persons generally licensed by the United States nuclear regulatory commission or an agreement state.

(B) Persons who own, receive, acquire, possess or use luminous safety devices pursuant to the general license in this rule are exempt from the requirements of Chapter 3701:1-38 of the Administrative Code except that they shall comply with the provisions of paragraphs (A) and (B) of rule 3701:1-38-21 of the Administrative Code.

(C) This general license does not authorize the manufacture, assembly, repair or import of luminous safety devices containing tritium or promethium-147.

(D) This general license does not authorize the export of luminous safety devices containing tritium or promethium-147.

(E) This general license does not authorize the ownership, receipt, acquisition, possession or use of promethium-147 contained in instrument dials.

Last updated November 2, 2022 at 2:32 PM

History

• Effective: October 20, 2002
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-46-33

An application for a specific license to manufacture, assemble, repair or initially transfer luminous safety devices containing tritium or promethium-147 for use in aircraft, for distribution to persons generally licensed under rule 3701:1-46-07 of the Administrative Code, will be approved if:

(A) The applicant satisfies the general requirements specified in rule 3701:1-40-15 of the Administrative Code;

(B) The applicant submits sufficient information regarding each device pertinent to evaluation of the potential radiation exposure, including:

(1) Chemical and physical form and maximum quantity of tritium or promethium-147 in each device;

(2) Details of construction and design;

(3) Details of the method of binding or containing the tritium or promethium-147;

(4) Procedures for and results of prototype testing to demonstrate that the tritium or promethium-147 will not be released to the environment under the most severe conditions likely to be encountered in normal use;

(5) Quality assurance procedures to be followed that are sufficient to ensure compliance with rule 3701:1-46-35 of the Administrative Code; and

(6) Any additional information, including experimental studies and tests, required by the director to facilitate a determination of the safety of the device.

(C) Each device will contain no more than three hundred seventy gigabecquerels (ten curies) of tritium or 11.1 gigabecquerels (three hundred millicuries) of promethium-147. The levels of radiation from each device containing promethium-147 will not exceed five microgray (0.5 millirad) per hour at ten centimeters from any surface when measured through fifty milligrams per square centimeter of absorber.

(D) The director determines that:

(1) The method of incorporation and binding of the tritium or promethium-147 in the device is such that the tritium or promethium-147 will not be released under the most severe conditions which are likely to be encountered in normal use and handling of the device;

(2) The tritium or promethium-147 is incorporated or enclosed so as to preclude direct physical contact by any person with it;

(3) The device is so designed that it cannot easily be disassembled; and

(4) Prototypes of the device have been subjected to and have satisfactorily passed the tests prescribed by rule 3701:1-46-45 of the Administrative Code.

(E) The applicant shall subject at least five prototypes of the device to tests as follows:

(1) The devices are subjected to tests that adequately take into account the individual, aggregate, and cumulative effects of environmental conditions expected in service that could adversely affect the effective containment of tritium or promethium-147, such as temperature, moisture, absolute pressure, water immersion, vibration, shock, and weathering.

(2) The devices are inspected for evidence of physical damage and for loss of tritium or promethium-147, after each stage of testing, using methods of inspection adequate for determining compliance with the criteria in paragraph (E)(3) of this rule.

(3) Device designs are rejected for which the following has been detected for any unit:

(a) A leak resulting in a loss of 0.1 per cent or more of the original amount of tritium or promethium-147 from the device; or

(b) Surface contamination of tritium or promethium-147 on the device of more than two thousand two hundred disintegrations per minute per one hundred square centimeters of surface area; or

(c) Any other evidence of physical damage.

(F) The device has been registered in the sealed source and device registry.

Last updated November 2, 2022 at 2:33 PM

History

• Effective: November 8, 2015
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-46-08 Americium-241 or radium-226 in the form of calibration or reference sources.

(A) A general license is hereby issued to those persons listed below to own, receive, acquire, possess, use and transfer, in accordance with the provisions of paragraphs (B) and (C) of this rule, americium-241 or radium-226 in the form of calibration or reference sources.

(1) Any person who holds a specific license issued by the director which authorizes the licensee to receive, possess, use, and transfer radioactive material; and

(2) Any person who holds a specific license issued by the United States nuclear regulatory commission which authorizes the licensee to receive, possess, use, and transfer byproduct material, source material or special nuclear material.

(B) The general license in paragraph (A) of this rule applies only to calibration or reference sources which have been manufactured or initially transferred in accordance with the specifications contained in a specific license issued pursuant to rule 3701:1-46-37 of the Administrative Code or in accordance with the specifications contained in a specific license issued to the manufacturer by the United States nuclear regulatory commission or another agreement state which authorizes manufacture of the sources for distribution to persons with a general license by the United States nuclear regulatory commission or another agreement state.

(C) The general license in paragraph (A) of this rule is subject to the provisions of paragraph (D) of 3701:1-40-08, paragraphs (A) to (C) of 3701:1-40-16, rules 3701:1-40-19 to 3701:1-40-21, and Chapter 3701:1-38 of the Administrative Code. In addition, persons who own, receive, acquire, possess, use and transfer one or more calibration or reference sources pursuant to this general license:

(1) Shall not possess at any one time, at any one location of storage or use, more than one hundred eighty-five kilobecquerels (five microcuries) of americium-241 or radium-226 in such sources:

(2) Shall not receive, possess, use or transfer such source unless the source, or the storage container, bears a label which includes the following statement or a substantially similar statement which contains the information called for in one of the following statements:

(a) For americium-241:

The receipt, possession, use and transfer of this source, model __, serial no. __, are subject to a general license and the regulations of the United States nuclear regulatory commission or of a state with which the commission has entered into an agreement for the exercise of regulatory authority. Do not remove this label.

"CAUTION-RADIOACTIVE MATERIAL-THIS SOURCE CONTAINS AMERICIUM-241. DO NOT TOUCH RADIOACTIVE PORTION OF THIS SOURCE"

(Name of manufacturer or initial transferor)

(b) For radium-226:

The receipt, possession, use and transfer of this source, model______, serial no. _____, are subject to a general license and the regulations of the United States nuclear regulatory commission or an agreement state. Do not remove this label.

"CAUTION - RADIOACTIVE MATERIAL-THIS SOURCE CONTAINS RADIUM-226. DO NOT TOUCH RADIOACTIVE PORTION OF THIS SOURCE."

(Name of manufacturer or initial transferor)

(c) Sources generally licensed under the United States nuclear regulatory commission or an agreement state prior to January 19, 1975, may bear labels authorized by the United States nuclear regulatory commission regulations in effect on January 1, 1975.

(3) Shall not transfer, abandon, or dispose of such source except by transfer to a person authorized by a license pursuant to this chapter or from an agreement state, or the United States nuclear regulatory commission to receive the source.

(4) Shall store such source, except when the source is being used, in a closed container adequately designed and constructed to contain either americium-241 or radium-226, as applicable, which might otherwise escape during storage.

(5) Shall not use such source for any purpose other than the calibration of radiation detectors or the standardization of other sources.

(D) This general license does not authorize the manufacture or import of calibration or reference sources containing americium-241 or radium-226.

(E) This general license does not authorize the export of calibration or reference sources containing americium-241 or radium-226.

Last updated November 2, 2022 at 2:32 PM

History

• Effective: June 16, 2017
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-46-37

An application for a specific license to manufacture or initially transfer calibration or reference sources containing americium-241 or radium-226, for distribution to persons generally licensed under rule 3701:1-46-08 of the Administrative Code, will be approved if:

(A) The applicant satisfies the general requirements of rule 3701:1-40-15 of the Administrative Code;

(B) The applicant submits sufficient information regarding each type of calibration or reference source pertinent to evaluation of the potential radiation exposure, including:

(1) Chemical and physical form and maximum quantity of americium-241 or radium-226 in the source;

(2) Details of construction and design;

(3) Details of the method of incorporation and binding of the americium-241 or radium-226 in the source;

(4) Procedures for and results of prototype testing of sources, which are designed to contain more than one hundred eighty-five becquerels (0.005 microcurie) of americium-241 or radium-226, to demonstrate that the americium-241 or radium-226 contained in each source will not be released or be removed from the source under normal conditions of use;

(5) Details of quality control procedures to be followed in manufacture of the source;

(6) Description of labeling to be affixed to the source or the storage container for the source;

(7) Any additional information, including experimental studies and tests, required by the director to facilitate a determination of the safety of the source.

(C) Each source will contain no more than one hundred eighty-five kilobecquerels (five microcuries) of americium-241 or radium-226.

(D) The director determines, with respect to any type of source containing more than one hundred eighty-five becquerels (0.005 microcurie) of americium-241, or radium-226 that:

(1) The method of incorporation and binding of the americium-241 or radium-226 in the source is such that the americium-241 or radium-226 will not be released or be removed from the source under normal conditions of use and handling of the source; and

(2) The source has been subjected to and has satisfactorily passed the prototype tests prescribed in paragraph (E) of this rule.

(E) The applicant shall subject at least five prototypes of each source that is designed to contain more than one hundred eighty-five becquerels (0.005 microcurie) of americium-241 or radium-226 to tests as follows:

(1) The initial quantity of radioactive material deposited on each source is measured by direct counting of the source.

(2) The sources are subjected to tests that adequately take into account the individual, aggregate, and cumulative effects of environmental conditions expected in service that could adversely affect the effective containment or binding of americium-241 or radium-226, such as physical handling, moisture, and water immersion.

(3) The sources are inspected for evidence of physical damage and for loss of americium-241 or radium-226, after each stage of testing, using methods of inspection adequate for determining compliance with the criteria in paragraph (E)(4) of this rule.

(4) Source designs are rejected for which the following has been detected for any unit: removal of more than one hundred eighty-five becquerels (0.005 microcurie) of americium-241 or radium-226 from the source or any other evidence of physical damage.

Last updated November 2, 2022 at 2:35 PM

History

• Effective: November 8, 2015
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-46-09 General license to own radioactive material.

A general license is hereby issued to own radioactive material without regard to quantity. Notwithstanding any other provision of this chapter, a general licensee under this paragraph is not authorized to manufacture, produce, transfer, receive, possess, use, import or export, radioactive material except as authorized in a specific license.

Last updated November 2, 2022 at 2:32 PM

History

• Effective: December 1, 2012
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-46-10 General license for strontium-90 in ice detection devices.

(A) A general license is hereby issued to own, receive, acquire, possess, use, and transfer strontium-90 contained in ice detection devices, provided each device contains not more than 1.85 megabecquerels (fifty microcuries) of strontium-90 and each device has been manufactured or initially transferred in accordance with the specifications contained in a license issued pursuant to rule 3701:1-46-40 of the Administrative Code or in accordance with the specifications contained in a specific license issued to the manufacturer by the United States nuclear regulatory commission or an agreement state which authorizes manufacture of the ice detection devices for distribution to persons with a general license issued by the United States nuclear regulatory commission or an agreement state.

(B) Persons who own, receive, acquire, possess, use, or transfer strontium-90 contained in ice detection devices pursuant to the general license in paragraph (A) of this rule:

(1) Shall, upon occurrence of visually observable damage, such as a bend or crack or discoloration from overheating, to the device, discontinue use of the device until it has been inspected, tested for leakage and repaired by a person holding a specific license pursuant to rule 3701:1-38-02 and Chapters 3701:1-40 and 3701:1-46 of the Administrative Code or from the United States nuclear regulatory commission or an agreement state to manufacture or service such devices; or shall dispose of the device pursuant to the provisions of paragraph (A) of rule 3701:1-38-19 of the Administrative Code.

(2) Shall assure that all labels affixed to the device at the time of receipt, and which bear a statement which prohibits removal of the labels, are maintained thereon;

(3) Are exempt from the requirements of Chapter 3701:1-38 of the Administrative Code except that such persons shall comply with the provisions of paragraph (A) of rule 3701:1-38-19 of the Administrative Code and paragraphs (A) and (B) of rule 3701:1-38-21 of the Administrative Code.

(C) The general license does not authorize the manufacture, assembly, disassembly, repair, or import of strontium-90 in ice detection devices.

Last updated November 2, 2022 at 2:32 PM

History

• Effective: October 20, 2002
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-46-40

An application for a specific license to manufacture or initially transfer ice detection devices containing strontium-90 for distribution to persons generally licensed under rule 3701:1-46-10 of the Administrative Code will be approved if:

(A) The applicant satisfies the general requirements specified in rule 3701:1-40-15 of the Administrative Code;

(B) The applicant submits sufficient information regarding each type of device pertinent to evaluation of the potential radiation exposure, including:

(1) Chemical and physical form and maximum quantity of strontium-90 in the device;

(2) Details of construction and design of the source of radiation and its shielding;

(3) Radiation profile of a prototype device;

(4) Procedures for and results of prototype testing of devices to demonstrate that the strontium-90 contained in each device will not be released or be removed from the device under the most severe conditions likely to be encountered in normal handling and use;

(5) Details of quality control procedures to be followed in manufacture of the device;

(6) Description of labeling to be affixed to the device;

(7) Instructions for handling and installation of the device;

(8) Any additional information, including experimental studies and tests, required by the director to facilitate a determination of the safety of the device;

(C) Each device will contain no more than 1.85 megabecquerels (fifty microcuries) of strontium-90 in an insoluble form;

(D) Each device will bear durable, legible labeling which includes the radiation symbol prescribed by paragraph (A) of rule 3701:1-38-18 of the Administrative Code, a statement that the device contains strontium-90 and the quantity thereof, instructions for disposal and statements that the device may be possessed pursuant to a general license, that the manufacturer or civil authorities should be notified if the device is found, that removal of the labeling is prohibited and that disassembly and repair of the device may be performed only by a person holding a specific license to manufacture or service such devices;

(E) The director determines that:

(1) The method of incorporation and binding of the strontium-90 in the device is such that the strontium-90 will not be released from the device under the most severe conditions which are likely to be encountered in normal use and handling of the device;

(2) The strontium-90 is incorporated or enclosed so as to preclude direct physical contact by any individual with it and is shielded so that no individual will receive a radiation exposure to a major portion of his body in excess of five millisieverts (0.5 rem) in a year under ordinary circumstances of use;

(3) The device is so designed that it cannot be easily disassembled;

(4) Prototypes of the device have been subjected to and have satisfactorily passed the tests required by paragraph (F) of this rule.

(5) Quality control procedures have been established to satisfy the requirements of rule 3701:1-46-41 of the Administrative Code.

(F) The applicant shall subject at least five prototypes of the device to tests as follows:

(1) The devices are subjected to tests that adequately take into account the individual, aggregate, and cumulative effects of environmental conditions expected in service that could adversely affect the effective containment of strontium-90, such as temperature, moisture, absolute pressure, water immersion, vibration, shock, and weathering.

(2) The devices are inspected for evidence of physical damage and for loss of strontium-90 after each stage of testing, using methods of inspection adequate for determining compliance with the criteria in paragraph (F)(3) of this rule.

(3) Device designs are rejected for which the following has been detected for any unit:

(a) A leak resulting in a loss of 0.1 per cent or more of the original amount of strontium-90 from the device;

(b) Surface contamination of strontium-90 on the device of more than two thousand two hundred disintegrations per minute per one hundred square centimeters of surface area; or

(c) Any other evidence of physical damage.

(G) The device has been registered in the sealed source and device registry.

Last updated November 2, 2022 at 2:35 PM

History

• Effective: November 8, 2015
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-38-19

(A) A licensee shall dispose of licensed radioactive material in accordance with this rule. Licensed material shall be disposed of in one of the following manners:

(1) By transfer to an authorized recipient as provided in this chapter, Chapter 3701:1-40 of the Administrative Code, or to the United States department of energy;

(2) By decay in storage provided that the radionuclide has a half-life of one hundred twenty days or less, or as otherwise permitted by the license;

(3) By release in effluents within the limits set forth in rule 3701:1-38-13 of the Administrative Code; or

(4) As authorized pursuant to paragraphs (B) to (F) of this rule.

(B) A person shall be specifically licensed to receive waste containing licensed material from another person for:

(1) Treatment prior to disposal;

(2) Treatment or disposal by incineration;

(3) Decay in storage;

(4) Disposal at a land disposal facility licensed pursuant to rules 3701:1-54-06 to 3701:1-54-12 of the Administrative Code or equivalent United States nuclear regulatory commission or agreement state regulations; or

(5) Storage until transfer to a storage or disposal facility authorized to receive the waste.

(C) A licensee or applicant for a license may apply to the director for approval of proposed disposal procedures that are not otherwise authorized in these rules for the disposal of licensed material generated in the licensee's operations. Each application shall include:

(1) A description of the waste containing licensed material to be disposed of, including the physical and chemical properties that have an impact on risk evaluation, and the proposed manner and conditions of waste disposal;

(2) An analysis and evaluation of pertinent information on the nature of the environment;

(3) The nature and location of other potentially affected facilities; and

(4) An analysis and procedures to ensure that doses are maintained ALARA and within the dose limits in rules 3701:1-38-12 and 3701:1-38-13 of the Administrative Code.

(D) A licensee may discharge licensed material into sanitary sewerage as follows:

(1) The material is readily soluble in water or is a biological material that is readily dispersible in water;

(2) The quantity of licensed or other radioactive material that the licensee releases into the sewer in one month divided by the average monthly volume of water released into the sewer by the licensee does not exceed the concentration listed in table III of appendix C to rule 3701:1-38-12 of the Administrative Code; and

(3) If more than one radionuclide is to be released, the following conditions must also be satisfied:

(a) The licensee shall determine the fraction of the limit in table III of appendix C to rule 3701:1-38-12 of the Administrative Code represented by discharges into sanitary sewerage by dividing the actual monthly average concentration of each radionuclide released by the licensee into the sewer by the concentration of that radionuclide listed in table III of appendix C to rule 3701:1-38-12 of the Administrative Code; and

(b) The sum of the fractions for each radionuclide required by paragraph (D)(3)(a) of this rule does not exceed unity.

(4) The total quantity of licensed and other radioactive material that the licensee releases into the sanitary sewerage in a year does not exceed one hundred eighty-five gigabecquerels (five curies) of hydrogen-3, thirty-seven gigabecquerels (one curie) of carbon-14, and thirty-seven gigabecquerels (one curie) of all other radioactive materials combined.

(5) Excreta from an individual undergoing medical diagnosis or therapy with radioactive material is not subject to the limitations contained in paragraph (D) of this rule.

(E) A licensee may dispose of licensed material by decay in storage. A licensee may hold radioactive material with a physical half-life of one hundred twenty days or less for decay-in-storage before disposal as non-radioactive material provided the licensee does the following:

(1) Monitors the material at the container surface prior to disposal and determines that the radioactivity cannot be distinguished from the background radiation level with an appropriate radiation detection survey meter set on its most sensitive scale and with no interposing shielding;

(2) Removes or obliterates all radiation caution labels and symbols, unless otherwise specified in the license; and

(3) Retains a record of the disposal for three years.

(F) A licensee may treat or dispose of licensed material by incineration only in the form and concentration specified in paragraph (G) of this rule or as specifically approved by the director pursuant to paragraph (C) of this rule.

(G) A licensee may dispose of the following licensed material as if it were not radioactive. The licensee shall maintain records in accordance with paragraph (K) of rule 3701:1-38-20 of the Administrative Code.

(1) 1.85 kilobecquerels (0.05 microcurie) or less, of hydrogen-3 or carbon-14 per gram of medium used for liquid scintillation counting; or

(2) 1.85 kilobecquerels (0.05 microcurie) or less, of hydrogen-3 or carbon-14 per gram of animal tissue, averaged over the weight of the entire animal. A licensee shall not dispose of tissue pursuant to this paragraph in a manner that would permit its use either as food for humans or as animal feed.

(H) A licensee shall transfer and dispose of licensed material in accordance with the following:

(1) For transfer of radioactive waste intended for disposal at a licensed radioactive waste disposal facility, establish a manifest tracking system, and supplement existing requirements concerning transfers and recordkeeping for those wastes. Each shipment of radioactive waste designated for disposal at a licensed radioactive waste disposal facility shall be accompanied by a shipment manifest as specified in the appendix to this rule.

(2) Each shipment manifest shall include a certification by the waste generator in accordance with the appendix to this rule.

(3) Each person involved in the transfer of waste for disposal or in the disposal of waste, including the waste generator, waste collector, waste processor, and disposal facility operator, shall comply with the requirements specified in the appendix to this rule.

(I) Nothing in this rule relieves a licensee from complying with other applicable federal, state and local regulations governing any other toxic or hazardous properties of materials that may be disposed of under this rule.

View Appendix

Last updated January 20, 2022 at 8:48 AM

History

• Effective: January 20, 2022
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-46-11 General license for use of radioactive material for certain in-vitro clinical or laboratory testing.

(A) A general license is hereby issued to any physician, veterinarian in the practice of veterinary medicine, clinical laboratory or hospital to receive, acquire, possess, transfer, or use, for any of the following stated tests, in accordance with the provisions of paragraphs (B) to (F) of this rule, the following radioactive materials in prepackaged units:

(1) Iodine-125, in units not exceeding three hundred seventy kilobecquerels (ten microcuries) each for use in in-vitro clinical or laboratory tests not involving internal or external administration of radioactive material, or the radiation therefrom, to human beings or animals.

(2) Iodine-131, in units not exceeding three hundred seventy kilobecquerels (ten microcuries) each for use in in-vitro clinical or laboratory tests not involving internal or external administration of radioactive material, or the radiation therefrom, to human beings or animals.

(3) Carbon-14, in units not exceeding three hundred seventy kilobecquerels (ten microcuries) each for use in in-vitro clinical or laboratory tests not involving internal or external administration of radioactive material, or the radiation therefrom, to human beings or animals.

(4) Hydrogen-3 (tritium), in units not exceeding 1.85 megabecquerels (fifty microcuries) each for use in in-vitro clinical or laboratory tests not involving internal or external administration of radioactive material, or the radiation therefrom, to human beings or animals.

(5) Iron-59, in units not exceeding seven hundred forty kilobecquerels (twenty microcuries) each for use in in-vitro clinical or laboratory tests not involving internal or external administration of radioactive material, or the radiation therefrom, to human beings, or animals.

(6) Selenium-75, in units not exceeding three hundred seventy kilobecquerels (ten microcuries) each for use in in-vitro clinical or laboratory tests not involving internal or external administration of radioactive material, or the radiation therefrom, to human beings or animals.

(7) Mock iodine-125 reference or calibration sources, in units not exceeding 1.85 kilobecquerels (0.05 microcurie) of iodine-129 and one hundred eighty-five becquerels (0.005 microcurie) of americium-241 each for use in in-vitro clinical or laboratory tests not involving internal or external administration of radioactive material, or the radiation therefrom, to human beings or animals.

(8) Cobalt-57, in units not exceeding three hundred seventy kilobecquerels (ten microcuries) each for use in in-vitro clinical or laboratory tests not involving internal or external administration of radioactive material, or the radiation therefrom, to human beings or animals.

(B) A person shall not receive, acquire, possess, use, or transfer radioactive material under the general license established by paragraph (A) of this rule unless that person:

(1) Has filed the radioactive materials in-vitro testing form with the director; or

(2) Has a license that authorizes the medical use of radioactive material that was issued under rules for medical uses of radioactive material.

(C) A person who receives, acquires, possesses, or uses radioactive material pursuant to the general license established by paragraph (A) of this rule shall comply with the following:

(1) The general licensee shall not possess at any one time, pursuant to the general license in paragraph (A) of this rule, at any one location of storage or use, a total amount of iodine-125, iodine-131, selenium-75, iron-59, and/or cobalt-57 in excess of 7.4 megabecquerels (two hundred microcuries).

(2) The general licensee shall store the radioactive material, until used, in the original shipping container or in a container providing equivalent radiation protection.

(3) The general licensee shall use the radioactive material only for the uses authorized by paragraph (A) of this rule.

(4) The general licensee shall not transfer the radioactive material except by transfer to a person authorized to receive it by a license pursuant to this chapter, from the United States nuclear regulatory commission, or from an agreement state or transfer the radioactive material in any manner other than in the unopened, labeled shipping container as received from the supplier.

(5) The general licensee shall dispose of the mock iodine-125 reference or calibration sources described in paragraph (A)(7) of this rule as required by rule 3701:1-38-19 of the Administrative Code.

(D) The general licensee shall not receive, acquire, possess or use radioactive material pursuant to paragraph (A) of this rule:

(1) Except as prepackaged units which are labeled in accordance with the provisions of a specific license issued under the provisions of rule 3701:1-46-42 of the Administrative Code or in accordance with the provisions of a specific license issued by the United States nuclear regulatory commission or an agreement state that authorizes manufacture and distribution of iodine-125, iodine-131, carbon-14, hydrogen-3 (tritium), selenium-75, iron-59, mock iodine-125, or cobalt-57 for distribution to persons generally licensed by the United States nuclear regulatory commission or an agreement state.

(2) Unless the following statement, or a substantially similar statement which contains the information called for in the following statement, appears on a label affixed to each prepackaged unit or appears in a leaflet or brochure which accompanies the package: This radioactive material may be received, acquired, possessed, and used only by physicians, veterinarians in the practice of veterinary medicine, clinical laboratories or hospitals and only for in- vitro clinical or laboratory tests not involving internal or external administration of the material, or the radiation therefrom, to human beings or animals. Its receipt, acquisition, possession, use, and transfer are subject to the regulations and a general license of the United States nuclear regulatory commission or of a state with which the commission has entered into an agreement for the exercise of regulatory authority ________________________(name of manufacturer)

(E) The licensee possessing or using radioactive materials under the general license of paragraph (A) of this rule shall report in writing to the director any changes in the information furnished by the licensee in department form HEA-5518, "In-Vitro Testing With Radioactive Material Form." The report shall be furnished within thirty days after the effective date of such change.

(F) Any person using radioactive material pursuant to the general license of paragraph (A) of this rule is exempt from the requirements of Chapter 3701:1-38 of the Administrative Code with respect to radioactive materials covered by that general license, except that such persons using the mock iodine-125 described in paragraph (A)(7) of this rule shall comply with the provisions of paragraph (A) of rule 3701:1-38-19 of the Administrative Code and paragraphs (A) and (B) of rule 3701:1-38-21 of the Administrative Code.

Last updated November 2, 2022 at 2:32 PM

History

• Effective: October 4, 2010
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-46-42

An application for a specific license to manufacture or distribute radioactive material for use under the general license in rule 3701:1-46-11 of the Administrative Code will be approved if:

(A) The applicant satisfies the general requirements specified in rule 3701:1-40-15 of the Administrative Code.

(B) The radioactive material is to be prepared for distribution in prepackaged units of:

(1) Iodine-125 in units not exceeding 0.37 megabecquerel (ten microcuries) each.

(2) Iodine-131 in units not exceeding 0.37 megabecquerel (ten microcuries) each.

(3) Carbon-14 in units not exceeding 0.37 megabecquerel (ten microcuries) each.

(4) Hydrogen-3 (tritium) in units not exceeding 1.85 megabecquerels (fifty microcuries) each.

(5) Iron-59 in units not exceeding 0.74 megabecquerel (twenty microcuries) each.

(6) Selenium-75 in units not exceeding 0.37 megabecquerel (ten microcuries) each.

(7) Mock iodine-125 in units not exceeding 1.85 kilobecquerels (0.05 microcurie) of iodine-129 and 0.185 kilobecquerel (0.005 microcurie) of americium-241 each.

(8) Cobalt-57 in units not exceeding 0.37 megabecquerel (ten microcuries) each.

(C) Each prepackaged unit bears a durable, clearly visible label:

(1) Identifying the radioactive contents as to chemical form and radionuclide, and indicating that the amount of radioactivity does not exceed 0.37 megabecquerel (ten microcuries) of iodine-131, iodine-125, selenium-75, cobalt-57, or carbon-14; 1.85 megabecquerels (fifty microcuries) of hydrogen-3 (tritium); or 0.74 megabecquerel (twenty microcuries) of iron-59; or mock iodine-125 in units not exceeding 1.85 kilobecquerels (0.05 microcurie) of iodine-129 and 0.185 kilobecquerel (0.005 microcurie) of americium-241 each; and

(2) Displaying the radiation symbol described in paragraph (A) of rule 3701:1-38-18 of the Administrative Code and the words, "Caution, Radioactive Material", and "Not for Internal or External Use in Humans or Animals."

(D) The following statement, or a substantially similar statement which contains the information called for in the following statement, appears on a label affixed to each prepackaged unit or appears in a leaflet or brochure which accompanies the package:

"The radioactive material may be received, acquired, possessed, and used only by physicians, veterinarians in the practice of veterinary medicine, clinical laboratories or hospitals and only for in-vitro clinical or laboratory tests not involving internal or external administration of the material, or the radiation therefrom, to human beings or animals. Its receipt, acquisition, possession, use, and transfer are subject to the regulations and a general license of the United States nuclear regulatory commission or of a state with which the commission has entered into an agreement for the exercise of regulatory authority.

(Name of manufacturer)"

(E) The label affixed to the unit, or the leaflet or brochure which accompanies the package, contains adequate information as to the precautions to be observed in handling and storing such radioactive material. In the case of the mock iodine-125 reference or calibration source, the information accompanying the source must also contain directions to the licensee regarding the waste disposal requirements set out in paragraph (A) of rule 3701:1-38-19 of the Administrative Code.

Last updated May 23, 2022 at 7:58 AM

History

• Effective: May 23, 2022
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-46-12 Maintenance of records.

Each record required by this chapter must be legible throughout the retention period specified by the director. The record may be the original or a reproduced copy or a microform provided that the copy or microform is authenticated by authorized personnel and that the microform is capable of producing a clear copy throughout the required retention period. The record may also be stored in electronic media with the capability for producing legible, accurate, and complete records during the required retention period. Records such as letters, drawings, specifications, must include all pertinent information such as letters, stamps, initials, and signatures. The licensee shall maintain adequate safeguards against tampering with and loss of records.

Last updated November 2, 2022 at 2:33 PM

History

• Effective: October 20, 2002
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-46-15 Introduction of radioactive material in exempt concentrations into products or materials, and transfer of ownership or possession of radioactive material in exempt concentrations: prohibition of introduction.

No person may introduce radioactive material in exempt concentration into a product or material knowing or having reason to believe that it will be transferred to persons exempt under rule 3701:1-40-08 of the Administrative Code or equivalent regulations of the United States nuclear regulatory commission or an agreement state, except in accordance with a license issued by the United States nuclear regulatory commission.

Last updated November 2, 2022 at 2:33 PM

History

• Effective: December 1, 2012
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-40-15

(A) An application for a specific license will be approved if:

(1) The application is for a purpose authorized by Chapter 3748. of the Revised Code and the rules adopted thereunder;

(2) The applicant's proposed equipment and facilities are adequate to protect health and minimize danger to life or property or the environment;

(3) The applicant is qualified by training and experience to use the radioactive material for the purpose requested in such manner as to protect health and minimize danger to life or property or the environment;

(4) The applicant satisfies any special requirements contained in rule 3701:1-38-02 of the Administrative Code, and Chapters 3701:1-46, 3701:1-48, 3701:1-49, 3701:1-52, and 3701:1-58 of the Administrative Code; and

(5) In the case of an application for a license to receive and possess radioactive material for the conduct of any activity which the director determines could potentially affect the quality of the environment, the department, before commencement of construction of the plant or facility in which the activity will be conducted, on the basis of information filed and evaluations made pursuant to rule 3701:1-40-30 of the Administrative Code, has concluded, after weighing the environmental, economic, technical, and other benefits against environmental costs and considering available alternatives, shall conclude that the action called for is the issuance of the proposed license, with any appropriate conditions to protect environmental values. Commencement of construction prior to such conclusion shall be grounds for denial of a license to receive and possess radioactive material in such plant or facility. As used in this paragraph the term "commencement of construction" is as defined in rule 3701:1-38-01 of the Administrative Code.

(B) Upon a determination that an application meets the requirements of Chapter 3748. of the Revised Code and the rules adopted thereunder, the director will issue a specific license authorizing the possession and use of radioactive material.

Last updated November 2, 2022 at 2:12 PM

History

• Effective: July 25, 2013
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-38-12

(A) Except in the case of a planned special exposure pursuant to paragraph (F) of this rule, a licensee or registrant shall limit the occupational dose received by an individual adult, as follows:

(1) An annual limit, which is the more limiting of:

(a) The total effective dose equivalent being equal to 0.05 sievert (five rem); or

(b) The sum of the deep dose equivalent and the committed dose equivalent to any individual organ or tissue other than the lens of the eye being equal to 0.5 sievert (fifty rem).

(2) The annual limits to the lens of the eye, to the skin of the whole body, and to the skin of the extremities, which are:

(a) A lens dose equivalent of 0.15 sievert (fifteen rem), and

(b) A shallow-dose equivalent of 0.5 sievert (fifty rem) to the skin of the whole body or to the skin of any extremity.

(3) Doses received in excess of the annual limits, including doses received during accidents, emergencies, and planned special exposures, shall be subtracted from the limits for planned special exposures that the individual may receive during the current calendar year and during the individual's lifetime in accordance with paragraph (F)(5) of this rule.

(4) When the external exposure is determined by measurement with an external personal monitoring device, the deep-dose equivalent must be used in place of the effective dose equivalent, unless the effective dose equivalent is determined by a dosimetry method approved by the director. The assigned deep-dose equivalent must be for the part of the body receiving the highest exposure.

(a) The assigned shallow-dose equivalent must be the dose averaged over the contiguous ten square centimeters of skin receiving the highest exposure. The deep-dose equivalent, lens-dose equivalent, and shallow-dose equivalent may be assessed from surveys or other radiation measurements for the purpose of demonstrating compliance with the occupational dose limits, if the individual monitoring device was not in the region of highest potential exposure, or the results of individual monitoring are unavailable; or

(b) When a protective apron is worn while working with radiation-generating equipment and monitoring is conducted as specified in paragraph (C)(1) of rule 3701:1-38-14 of the Administrative Code, the effective dose equivalent for external radiation shall be determined as follows:

(i) When only one individual monitoring device is used and it is located at the neck outside the protective apron, the reported deep dose equivalent value multiplied by 0.3 shall be the effective dose equivalent for external radiation; or

(ii) When two individual monitoring devices are worn, one under the protective apron at the waist and the other outside the protective apron at the neck, the effective dose equivalent for external radiation shall be assigned the value of the sum of the deep dose equivalent reported for the individual monitoring device located at the waist under the protective apron multiplied by 1.5 and the deep dose equivalent reported for the individual monitoring device located at the neck outside the protective apron multiplied by 0.04; or

(iii) Through the use of computational methods endorsed by the "American National Standards Institute", recommended by the "National Council on Radiation Protection and Measurements", or approved by the director.

(5) Derived air concentration (DAC) and annual limit on intake (ALI) values are specified in appendix C to this rule and may be used by the licensee to determine the individual's dose and to demonstrate compliance with the occupational dose limits. Appendices A and B are explanatory supplements to appendix C to this rule. Notwithstanding the annual dose limits, the licensee shall limit the soluble uranium intake by an individual to ten milligrams in a week in consideration of chemical toxicity.

(6) In accordance with paragraph (E) of this rule, the licensee or registrant shall reduce the dose that an individual may be allowed to receive in the current year by the amount of occupational dose received while employed by any other person.

(B) Compliance with requirements for summation of external and internal doses shall be in accordance with the following:

(1) If the licensee is required to monitor under both paragraphs (B)(1) and (B)(2) of rule 3701:1-38-14 of the Administrative Code, the licensee shall demonstrate compliance with the dose limits by summing external and internal doses. If the licensee is required to monitor only under paragraph (B)(1) or only under paragraph (B)(2) of rule 3701:1-38-14 of the Administrative Code, then summation is not required to demonstrate compliance with the dose limits. The licensee may demonstrate compliance with the requirements for summation of external and internal doses by meeting one of the conditions specified in paragraph (B)(2) of this rule and the conditions in paragraphs (B)(3) and (B)(4) of this rule. The dose equivalents for the lens of the eye, the skin, and the extremities are not included in the summation, but are subject to separate limits.

(2) If the only intake of radionuclides is by inhalation, the total effective dose equivalent limit is not exceeded if the sum of the deep dose equivalent divided by the total effective dose equivalent limit, plus one of the following does not exceed unity:

(a) The sum of the fractions of the inhalation ALI for each radionuclide; or

(b) The total number of derived air concentration-hours, or DAC-hours, for all radionuclides divided by two thousand; or

(c) The sum of the calculated committed effective dose equivalents to all significantly irradiated organs or tissues (T) calculated from bioassay data using appropriate biological models and expressed as a fraction of the annual limit. For purposes of this requirement, an organ or tissue is deemed to be significantly irradiated if, for that organ or tissue, the product of the weighting factors, W_T, and the committed dose equivalent, H_T,50, per unit intake is greater than ten per cent of the maximum weighted value of H_T,50, that is, W_TH_T,50, per unit intake for any organ or tissue.

(3) If the occupationally exposed individual also receives an intake of radionuclides by oral ingestion greater than ten percent of the applicable oral ALI, the licensee shall account for this intake and include it in demonstrating compliance with the limits set forth in paragraph (A) of this rule.

(4) The licensee shall evaluate and, to the extent practical, account for intakes through wounds or skin absorption. The intake through intact skin has been included in the calculation of DAC for hydrogen-3 and does not need to be further evaluated or accounted for pursuant to this paragraph.

(C) Determination of external dose from airborne radioactive material shall be in accordance with the following:

(1) When determining the dose from airborne radioactive material, the licensee shall include the contribution to the deep dose equivalent, lens dose equivalent, and shallow dose equivalent from external exposure to the radioactive cloud as specified in appendix C to this rule, footnotes ^A and ^B.

(2) The licensee should not use airborne radioactivity measurements or DAC values as the primary means to assess the deep dose equivalent when the airborne radioactive material includes radionuclides other than noble gases, or if the cloud of airborne radioactive material is not relatively uniform. The determination of the deep dose equivalent to an individual should be based upon measurements using instruments or individual monitoring devices.

(D) Determination of internal exposure shall be in accordance with the following:

(1) For purposes of assessing dose used to determine compliance with occupational dose equivalent limits, the licensee shall, when required under paragraph (B) of rule 3701:1-38-14 of the Administrative Code, take suitable and timely measurements of:

(a) Concentrations of radioactive materials in air in work areas; or

(b) Quantities of radionuclides in the body; or

(c) Quantities of radionuclides excreted from the body; or

(d) Combinations of these measurements.

(2) Unless respiratory protective equipment is used, as provided in paragraph (C) of rule 3701:1-38-16 of the Administrative Code or the assessment of intake is based on bioassays, the licensee shall assume that an individual inhales radioactive material at the airborne concentration in which the individual is present.

(3) When specific information on the physical and biochemical properties of the radionuclides taken into the body or the behavior of the material in an individual is known, the licensee may:

(a) Use that information to calculate the committed effective dose equivalent, and, if used, the licensee shall document that information in the individual's record; and

(b) Upon prior approval of the department, adjust the DAC or ALI values to reflect the actual physical and chemical characteristics of airborne radioactive material, for example, aerosol size distribution or density; and

(c) Separately assess the contribution of fractional intakes of Class D, W, or Y compounds of a given radionuclide to the committed effective dose equivalent as specified in appendix A to this rule.

(4) If the licensee chooses to assess intakes of Class Y material using the measurements given in paragraph (D)(1)(b) or (D)(1)(c) of this rule in order to make additional measurements basic to the assessments, the licensee may delay the recording and reporting of the assessments for periods up to seven months, unless otherwise required by paragraph (B)(2) or (C) of rule 3701:1-38-21 of the Administrative Code.

(5) If the identity and concentration of each radionuclide in a mixture are known, the fraction of the DAC applicable to the mixture for use in calculating DAC-hours shall be either:

(a) The sum of the ratios of the concentration to the appropriate DAC value, that is, D, W, or Y, from appendix C to this rule for each radionuclide in the mixture; or

(b) The ratio of the total concentration for all radionuclides in the mixture to the most restrictive DAC value for any radionuclide in the mixture.

(6) If the identity of each radionuclide in a mixture is known, but the concentration of one or more of the radionuclides in the mixture is not known, the DAC for the mixture shall by the most restrictive DAC of any radionuclide in the mixture.

(7) When a mixture of radionuclides in air exists, a licensee may disregard certain radionuclides in the mixture if all of the following occur:

(a) The licensee uses the total activity of the mixture in demonstrating compliance with the dose limits in paragraph (A) of this rule and in complying with the monitoring requirements in paragraph (B) of rule 3701:1-38-14 of the Administrative Code;

(b) The concentration of any radionuclide disregarded is less than ten percent of its DAC; and

(c) The sum of these percentages for all of the radionuclides disregarded in the mixture does not exceed thirty percent.

(8) When determining the committed effective dose equivalent, the licensee may consider the following:

(a) In order to calculate the committed effective dose equivalent, the licensee may assume that the inhalation of one ALI, or an exposure of two thousand DAC-hours, results in a committed effective dose equivalent of 0.05 sievert (five rem), for radionuclides that have their ALIs or DACs based on the committed effective dose equivalent; or

(b) For an ALI and the associated DAC determined by the nonstochastic organ dose limit of 0.5 sievert (fifty rem), the intake of radionuclides that would result in a committed effective dose equivalent of 0.05 sievert (five rem), that is, the stochastic ALI, is listed in parentheses in table I of appendix C to this rule. The licensee may, as a simplifying assumption, use the stochastic ALI to determine committed effective dose equivalent. However, if the licensee uses the stochastic ALI, the licensee shall also demonstrate that the limit in paragraph (A)(1)(b) of this rule is met.

(E) Determination of prior occupational dose shall be made in accordance with the following:

(1) For each individual who is likely to receive an annual occupational dose requiring monitoring pursuant to paragraph (B) of rule 3701:1-38-14 of the Administrative Code, the licensee or registrant shall determine the occupational radiation dose received during the current year.

(2) Prior to permitting an individual to participate in a planned special exposure, the licensee shall determine:

(a) The internal and external doses from all previous planned special exposures; and

(b) All doses in excess of the limits, including doses received during accidents and emergencies, received during the lifetime of the individual.

(3) In complying with the requirements of paragraph (E)(1) or (E)(2) of this rule, a licensee or registrant may:

(a) Accept, as a record of the occupational dose that the individual received during the current year, a written signed statements from the individual, or from the individual's most recent employer for work involving radiation exposure, that discloses the nature and the amount of any occupational dose that the individual may have received during the current year;

(b) Accept, as the record of lifetime cumulative radiation dose, a current department form entitled "lifetime occupational exposure history" or equivalent, signed by the individual and countersigned by an appropriate official of the most recent employer for work involving radiation exposure, or the individual's current employer, if the individual is not employed by the licensee or registrant; and

(c) Obtain reports of the individual's dose equivalent from the most recent employer for work involving radiation exposure, or the individual's current employer, if the individual is not employed by the licensee or registrant, by telephone, telegram, facsimile, e-mail or letter. The licensee or registrant shall request a written verification of the dose data if the authenticity of the transmitted report cannot be established.

(4) The licensee or registrant shall record the exposure history, as required by paragraph (A) of this rule, on a form provided by the department or other clear and legible record, of all the information required on that form. The form or record shall show each period in which the individual received occupational exposure to radiation or radioactive material and shall be signed by the individual who received the exposure. For each period for which the licensee or registrant obtains reports, the licensee or registrant shall use the dose shown in the report in preparing the exposure history form. For any period in which the licensee or registrant does not obtain a report, the licensee or registrant shall place a notation on the exposure history form indicating the periods of time for which data are not available.

(5) If the licensee or registrant is unable to obtain a complete record of an individual's current and previously accumulated occupational dose, the licensee or registrant shall assume:

(a) In establishing administrative controls pursuant to paragraph (A)(6) of this rule for the current year, that the allowable dose limit for the individual is reduced by 12.5 millisievert (1.25 rem), for each quarter for which records were unavailable and the individual was engaged in activities that could have resulted in occupational radiation exposure; and

(b) That the individual is not available for planned special exposures.

(6) The licensee or registrant shall retain the records on the exposure history form until the department terminates each pertinent license or registration requiring this record. The licensee or registrant shall retain records used in preparing the exposure history form for three years after the record is made.

(F) A planned special exposure may be authorized by a licensee in accordance with this paragraph. A licensee may authorize an adult worker to receive doses in addition to and accounted for separately from the doses received under the limits specified in paragraph (A) of this rule provided that each of the following is satisfied:

(1) The licensee authorizes a planned special exposure only in an exceptional situation when alternatives that might avoid the higher exposure are unavailable or impractical;

(2) The licensee and employer, if the employer is not the licensee, specifically authorizes the planned special exposure, in writing, before the exposure occurs;

(3) Before a planned special exposure, the licensee ensures that each individual involved is:

(a) Informed of the purpose of the planned operation; and

(b) Informed of the estimated doses and associated potential risks and specific radiation levels or other conditions that might be involved in performing the task; and

(c) Instructed in the measures to be taken to keep the dose ALARA considering other risks that may be present;

(4) Prior to permitting an individual to participate in a planned special exposure, the licensee ascertains prior doses as required by paragraph (E)(2) of this rule during the lifetime of the individual for each individual involved;

(5) The licensee shall not authorize a planned special exposure that would cause an individual to receive a dose from all planned special exposures and all doses in excess of the limits to exceed:

(a) The numerical values of any of the dose limits in paragraph (A) of this rule in any calendar year; and

(b) Five times the annual dose limits specified in paragraph (A) of this rule during the individual's lifetime;

(6) The licensee maintains records of the conduct of a planned special exposure in accordance with paragraph (E) of rule 3701:1-38-20 of the Administrative Code and submits a written report in accordance with paragraph (D) of rule 3701:1-38-21 of the Administrative Code;

(7) The licensee records the best estimate of the dose resulting from the planned special exposure in the individual's record and informs the individual, in writing, of the dose within thirty days from the date of the planned special exposure. The dose from planned special exposures shall not be considered in controlling future occupational dose of the individual pursuant to paragraph (A)(1) of this rule, but shall be included in evaluations required by paragraphs (F)(4) and (F)(5) of this rule.

(G) Occupational dose limits for minors shall be ten per cent of the annual occupational dose limits specified for adult workers in paragraph (A) of this rule.

(H) Dose equivalent to an embryo or fetus shall be in accordance with the following:

(1) The licensee or registrant shall ensure that the dose equivalent to an embryo or fetus during the entire pregnancy, due to occupational exposure of a declared pregnant woman, does not exceed five millisievert (0.5 rem). Records shall be maintained in accordance with paragraph (I) of rule 3701:1-38-20 of the Administrative Code.

(2) The licensee or registrant shall make efforts to avoid substantial variation above a uniform monthly exposure rate to a declared pregnant woman so as to satisfy the limit in paragraph (H)(1) of this rule.

(3) The dose equivalent to the embryo or fetus is the sum of:

(a) The deep-dose equivalent to the declared pregnant woman; and

(b) The dose equivalent to the embryo or fetus resulting from radionuclides in the embryo or fetus and from radionuclides in the declared pregnant woman.

(4) If the declared pregnant woman's exposure includes exposure from radiation generating equipment and a protective apron is worn, the dose equivalent to an embryo or fetus shall be taken as the sum of:

(a) The dose equivalent to the embryo or fetus from radionuclides in the embryo or fetus and radionuclides in the declared pregnant woman; and

(b) The dose equivalent that is most representative of the dose to the embryo or fetus from external radiation, that is, in the mother's lower torso region.

(i) If multiple measurements have not been made, assignment of the highest deep dose equivalent for the declared pregnant woman shall be the dose to the embryo or fetus, in accordance with paragraph (A)(4) of this rule; or

(ii) If multiple measurements have been made, assignment of the deep dose equivalent for the declared pregnant woman from the individual monitoring device which is most representative of the dose to the embryo or fetus shall be the dose to the embryo or fetus. Assignment of the highest deep dose equivalent for the declared pregnant woman to the embryo or fetus is not required unless that dose is also the most representative deep dose equivalent for the region of the embryo or fetus.

(5) If by the time the woman declares pregnancy to the licensee or registrant, the dose equivalent to the embryo or fetus has exceeded five millisievert, or 0.5 rem, the licensee or registrant shall be deemed to be in compliance with paragraph (A) of this rule, provided that the additional dose equivalent to the embryo or fetus does not exceed 0.5 millisievert (0.05 rem), during the remainder of the pregnancy.

View AppendixView AppendixView Appendix

Last updated November 2, 2022 at 2:10 PM

History

• Effective: October 4, 2010
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-46-31 Radioactive material contained in devices for use under rule 3701:1-46-05 of the Administrative Code: conditions of licenses.

(A) If a device containing radioactive material is to be transferred for use under the general license contained in rule 3701:1-46-05 of the Administrative Code, each person that is licensed under rule 3701:1-46-30 of the Administrative Code shall provide the information specified in this paragraph to each person to whom a device is to be transferred. This information must be provided before the device may be transferred. In the case of a transfer through an intermediate person, the information must also be provided to the intended user prior to the initial transfer to the intermediate person. The required information includes:

(1) A copy of rule 3701:1-46-05 of the Administrative Code; if paragraphs (C)(2) to (C)(4), or (C)(13) of rule 3701:1-46-05 of the Administrative Code do not apply to the particular device, those paragraphs may be omitted;

(2) A copy of rule 3701:1-46-03, paragraphs (A) and (B) of rule 3701:1-38-21, and rule 3701:1-40-21 of the Administrative Code;

(3) A list of the services that can only be performed by a specific licensee;

(4) Information on acceptable disposal options including estimated costs of disposal at the time of the purchase;

(5) A copy of rule 3701:1-38-05 of the Administrative Code which provides for penalties for improper disposal; and

(6) The device has been registered in the sealed source and device registry.

(B) If radioactive material is to be transferred in a device for use under an equivalent general license of the United States nuclear regulatory commission or an agreement state, each person that is licensed under rule 3701:1-46-30 of the Administrative Code shall provide the information specified in this paragraph to each person to whom a device is to be transferred. This information must be provided before the device may be transferred. In the case of a transfer through an intermediate person, the information must also be provided to the intended user prior to initial transfer to the intermediate person. The required information includes:

(1) A copy of paragraphs (A) and (B) of rule 3701:1-38-21, and rules 3701:1-40-21, 3701:1-46-03, and 3701:1-46-05 of the Administrative Code or equivalent United States nuclear regulatory commission or agreement state regulations;

(2) A list of the services that can only be performed by a specific licensee;

(3) Information on acceptable disposal options including estimated costs of disposal at the time of the purchase; and

(4) The name, address, and phone number of the contact at the United States nuclear regulatory commission or the agreement state regulatory agency from which additional information may be obtained.

(C) An alternate approach to informing customers may be proposed by the licensee for approval by the director.

(D) If a notification of bankruptcy has been made under paragraph (F) of rule 3701:1-40-16 of the Administrative Code, or the license is to be terminated, each person licensed under rule 3701:1-46-30 of the Administrative Code shall provide, upon request, to the director, and if appropriate, to the United States nuclear regulatory commission and any appropriate agreement state records of final disposition required under paragraph (C) of rule 3701:1-46-32 of the Administrative Code.

Last updated May 23, 2022 at 7:58 AM

History

• Effective: May 23, 2022
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-38-05

(A) As used in this rule:

(1) "Repetitive violation" means a same or similar violation that reasonably could have been prevented by a facility's corrective action for the previous violation normally occurring either within the past two years of the inspection at issue or the period within the last two inspections, whichever is longer.

(2) "Event" means a situation involving licensable material and characterized by:

(a) An active adverse impact on equipment or personnel readily obvious by human observation or instrumentation; or

(b) A radiological impact on personnel, the general public, or the environment in excess of regulatory limits, such as an overexposure, a release of radioactive material above the limits set forth in rule 3701:1-38-21 of the Administrative Code or a loss of radioactive material in quantities reportable pursuant to rule 3701:1-38-21 of the Administrative Code.

(B) The director may assess an administrative monetary penalty for failure of any facility required to be licensed under Chapter 3748. of the Revised Code to comply with that chapter or rules adopted thereunder. Any administrative monetary penalty imposed shall be assessed in accordance with this rule. Unless otherwise provided in this rule, the director may issue an order imposing an administrative penalty in addition to and concurrent or subsequent to issuing a written notice of violation as provided in rule 3701:1-38-06 of the Administrative Code. The director may assess an administrative monetary penalty independent of any and all other remedies that may be asserted by the department. Any orders issued or payments or other requirements imposed shall not affect any civil, criminal or administrative enforcement proceedings brought under this chapter or any other provision of state or local law.

(C) Administrative monetary penalties specified in this rule are based upon the level of severity of the violation which includes factors such as the importance or significance of the violation, the length or duration of the violation, whether the violation is repetitive in nature or is similar to previous violations, and the time period between the current violation and any previous violation. The director may issue an administrative monetary penalty as follows:

| Severity Level of Violation | Penalty | | --- | --- | | I | $5,000 | | II | $4,000 | | III | $2,500 | | IV | up to $500 |

(D) In addition to the issuance of a notice of violation, in the case of a severity level IV violation the director shall do either of the following:

(1) If within thirty days of the issuance of the notice of violation, or such greater time as the director may determine, the facility remedies the violation and documents to the satisfaction of the director that the facility is in compliance, the director shall withdraw the assessment of an administrative monetary penalty; or

(2) If there remain any items of non-compliance thirty days or such greater time as the director may determine after the issuance of the notice of violation, the director shall maintain the administrative monetary penalty for the items of non-compliance. The director shall reduce the administrative monetary penalty in an amount up to fifty per cent of the penalty assessed for the violation or violations found at severity level IV provided that the facility has corrected at least fifty per cent of the violations.

A group of severity level IV violations may be evaluated in the aggregate and assigned a single severity level III, if the violations have the same or similar underlying cause or program deficiencies, or the violations contributed to or were unavoidable consequences of the underlying problem or program deficiencies.

(E) In addition to the issuance of a notice of violation, in the case of a severity level III violation the director shall assess an administrative monetary penalty in accordance with the following:

(1) If within thirty days of the issuance of the notice of violation or such greater time as the director may determine the facility remedies the violation and documents to the satisfaction of the director that the facility is in compliance, the director may determine to withdraw the assessment of the administrative monetary penalty; or

(2) If there remain any items of non-compliance thirty days after the issuance of the notice of violation or such greater time as the director may determine, the director shall reduce the administrative monetary penalty in an amount up to fifty per cent of the penalty assessed for the violation or violations found at severity level III provided that the facility has corrected at least fifty per cent of the violations.

(F) In the case of a severity level I or II violation, the director shall issue an administrative monetary penalty. The director may reduce the penalty up to fifty per cent of the assessed amount if it is a non-repetitive violation and the facility achieves and documents compliance to the satisfaction of the director within thirty days of receiving the notice of violation.

(G) Notwithstanding paragraphs (C) to (F) of this rule, in the case of a repetitive violation, the director shall not reduce the administrative monetary penalty specified in paragraph (C) of this rule. In the case of a third or subsequent occurrence of the repetitive violation, the director may increase the administrative monetary penalty specified in paragraph (C) of this rule by an additional twenty-five per cent and continue to increase the penalty by an additional twenty-five per cent for each subsequent occurrence.

(H) When a violation occurs and the facility identifies the violation before it results in an event or is cited by the department, the director may reduce the penalty specified in paragraph (C) of this rule as follows:

(1) In the case of a facility that identified the violation as a result of observation, the director may reduce the administrative monetary penalty assessed in accordance with paragraph (C) of this rule in an amount of up to twenty-five per cent.

(2) In the case of a facility that discovered the violation as a result of a self-monitoring effort, such as an audit, test, surveillance, design review, or trouble shooting, the director may reduce the administrative monetary penalty assessed in accordance with paragraph (C) of this rule in an amount up to fifty per cent.

(3) In the case of a facility that self-corrects a severity III or IV violation in a manner and time period approved by director, the director shall not issue an administrative monetary penalty.

(I) Notwithstanding any other provision in this rule, after determination of the severity level of a violation found by the department, the director may increase the amount of the administrative monetary penalty as follows:

(1) In the case of overall past poor facility performance the administrative monetary penalty assessed in accordance with paragraph (C) of this rule may be increased up to one hundred per cent.

(2) In the case of a violation that is flagrant or reckless and that results in a substantial increase in risk to personnel, the general public or the environment, including cases in which the duration of the violation has contributed to the substantial increase in risk, the administrative monetary penalty assessed in accordance with paragraph (C) of this rule may be increased up to one hundred per cent.

(3) In the case of a willful violation within the administrative control of the licensee, the administrative monetary penalty assessed in accordance with paragraph (C) of this rule may be increased up to one hundred per cent.

(J) The facility may appeal the assessment of an administrative monetary penalty in accordance with Chapter 119. of the Revised Code, provided that the facility requests a hearing within thirty days of the time of mailing the notice of the administrative penalty assessment. The director may consolidate a hearing on an administrative monetary penalty assessed under this rule with any other complaint or finding of the director where the director determines that there are one or more issues of fact or law in common. No more than one hearing will be conducted with respect to each violation alleged.

Last updated January 20, 2022 at 8:46 AM

History

• Effective: January 20, 2022
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-46-32

Each person licensed under rule 3701:1-46-30 of the Administrative Code to initially transfer devices to generally licensed persons shall:

(A) Report all transfers of devices to persons for use under the general license in rule 3701:1-46-05 of the Administrative Code and all receipts of devices from persons licensed under rule 3701:1-46-05 of the Administrative Code to the director in a clear and legible report containing all of the data required by the form.

(1) The required information includes:

(a) The identity of each general licensee by name and mailing address for the location of use; if there is no mailing address for the location of use, an alternate address for the general licensee shall be submitted along with information on the actual location of use.

(b) The name, title, and phone number of the person identified by the general licensee as having knowledge of and authority to take required actions to ensure compliance with the appropriate rules and requirements;

(c) The date of transfer;

(d) The type, model number, and serial number of the device transferred; and

(e) The quantity and type of radioactive material contained in the device.

(2) If one or more intermediate persons will temporarily possess the device at the intended place of use before its possession by the user, the report must include the same information for both the intended user and each intermediate person, and clearly designate the intermediate person(s).

(3) For devices received from a general licensee under rule 3701:1-46-05 of the Administrative Code, the report must include the identity of the general licensee by name and address, the type, model number, and serial number of the device received, the date of receipt, and, in the case of devices not initially transferred by the reporting licensee, the name of the manufacturer or initial transferor.

(4) If the licensee makes changes to a device possessed by a general licensee under rule 3701:1-46-05 of the Administrative Code, such that the label must be changed to update required information, the report must identify the general licensee, the device, and the changes to information on the device label.

(5) The report must cover each calendar quarter, must be filed within thirty days of the end of the calendar quarter, and must clearly indicate the period covered by the report.

(6) The report must clearly identify the specific licensee submitting the report and include the license number of the specific licensee.

(7) If no transfers have been made to or from persons generally licensed under rule 3701:1-46-05 of the Administrative Code during the reporting period, the report must so indicate.

(B) Report to the responsible regulatory agency, United States nuclear regulatory commission, or agreement state all transfers of devices to persons for use under a general license issued in accordance with the regulations of the United States nuclear regulatory commission, or an agreement state that are equivalent to rule 3701:1-46-05 of the Administrative Code and all receipts of devices from general licensees under the jurisdiction of the United States nuclear regulatory commission, or an agreement state. The report must be in a clear and legible format containing all of the data required by the form.

(1) The required information for transfers to general licensees includes:

(a) The identity of each general licensee by name and mailing address for the location of use; if there is no mailing address for the location of use, an alternate address for the general licensee shall be submitted along with information on the actual location of use.

(b) The name, title, and phone number of the person identified by the general licensee as having knowledge of and authority to take required actions to ensure compliance with the appropriate rules and requirements;

(c) The date of transfer;

(d) The type, model number, and serial number of the device transferred; and

(e) The quantity and type of radioactive material contained in the device.

(2) If one or more intermediate persons will temporarily possess the device at the intended place of use before its possession by the user, the report must include the same information for both the intended user and each intermediate person, and clearly designate the intermediate person(s).

(3) For devices received from a general licensee, the report must include the identity of the general licensee by name and address, the type, model number, and serial number of the device received, the date of receipt, and, in the case of devices not initially transferred by the reporting licensee, the name of the manufacturer or initial transferor.

(4) If the licensee makes changes to a device possessed by a general licensee, such that the label must be changed to update required information, the report must identify the general licensee, the device, and the changes to information on the device label.

(5) The report must cover each calendar quarter, must be filed within thirty days of the end of the calendar quarter, and must clearly indicate the period covered by the report.

(6) The report must clearly identify the specific licensee submitting the report and must include the license number of the specific licensee.

(7) If no transfers have been made to or from the United States nuclear regulatory commission or a particular agreement state jurisdiction during the reporting period, this information shall be reported to the United States nuclear regulatory commission or the responsible agreement state agency upon request of the agency.

(C) Maintain all information concerning transfers and receipts of devices that supports the reports required by this rule. Records required by this paragraph must be kept for a period of three years following the date of the recorded event.

Last updated November 2, 2022 at 2:33 PM

History

• Effective: December 10, 2012
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-46-35

(A) Each person licensed under rule 3701:1-46-33 of the Administrative Code shall visually inspect each device and shall reject any which has an observable physical defect that could affect containment of the tritium or promethium-147.

(B) Each person licensed under rule 3701:1-46-33 of the Administrative Code shall:

(1) Maintain quality assurance systems in the manufacture of the luminous safety device in a manner sufficient to provide reasonable assurance that the safety-related components if the distributed devices are capable of performing their intended functions; and

(2) Subject inspection lots to acceptance sampling procedures, by procedures specified in paragraph (C) of this rule and in a license issued under rule 3701:1-46-33 of the Administrative Code, to provide at least ninety five per cent confidence that the lot tolerance per cent defective of five per cent will not be exceeded.

(C) The licensee shall subject each inspection lot to:

(1) Tests that adequately take into account the individual, aggregate, and cumulative effects of the environmental conditions expected in service that could adversely affect the effective containment of tritium or promethium-147, such as absolute pressure and water immersion.

(2) Inspection for evidence of physical damage, containment failure, or for loss of tritium or promethium-147 after each stage of testing, using methods of inspection adequate for applying the following criteria for defective:

(a) A leak test resulting in a loss of 0.1 per cent or more of the original amount of tritium or promethium-147 from the device;

(b) Levels of radiation in excess of five microgray (0.5 millirad) per hour at ten centimeters from any surface when measured through fifty milligrams per square centimeter of absorber, if the device contains promethium-147; and

(c) Any other criteria specified in the license issued under rule 3701:1-46-33 of the Administrative Code.

(D) No person licensed under rule 3701:1-46-33 of the Administrative Code shall transfer to persons generally licensed under rule 3701:1-46-07 of the Administrative Code, or under an equivalent general license from an agreement state or the United States nuclear regulatory commission:

(1) Any luminous safety device tested and found defective under any condition of a license issued under rule 3701:1-46-33 of the Administrative Code, or paragraph (B) of this rule, unless the defective luminous safety device has been repaired or reworked, retested, and determined by an independent inspector to meet the applicable acceptance criteria; or

(2) Any luminous safety device contained within any lot that has been sampled and rejected as a result of the procedures in paragraph (B)(2) of this rule, unless:

(a) A procedure for defining sub-lot size, independence, and additional testing procedures is contained in the license issued under rule 3701:1-46-33 of the Administrative Code; and

(b) Each individual sub-lot is sampled, tested, and accepted in accordance with paragraphs (B)(2) and (D)(2)(a) of this rule and any other criteria that may be required as a condition of the license issued under rule 3701:1-46-33 of the Administrative Code.

Last updated November 2, 2022 at 2:34 PM

History

• Effective: November 8, 2015
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-46-34 Luminous safety devices for use in aircraft: labeling of devices.

(A) A person licensed under rule 3701:1-46-33 of the Administrative Code to manufacture, assemble, or initially transfer devices containing tritium or promethium-147 for distribution to persons generally licensed under rule 3701:1-46-07 of the Administrative Code shall, except as provided in paragraph (B) of this rule, affix to each device a label containing the radiation symbol prescribed by rule 3701:1-38-18 of the Administrative Code, such other information as may be required by the director including disposal instructions when appropriate, and the following or a substantially similar statement which contains the information called for in the following statement:

(1) Devices licensed by the United States nuclear regulatory commission prior to January 19, 1975, may bear labels authorized by the regulations in effect on January 1, 1975.

(2) The receipt, possession, use, and transfer of this device, model _______, serial no. ___, containing ______ (identity and quantity of radioactive material) are subject to a general license or the equivalent and the regulations of the United States nuclear regulatory commission or of a state with which the United States nuclear regulatory commission has entered into an agreement for the exercise of regulatory authority. Do not remove this label.

"CAUTION-RADIOACTIVE MATERIAL"

(Name of manufacturer, assembler, or initial transferor.) The model, serial number, and name of manufacturer, assembler, or initial transferor may be omitted from this label provided they are elsewhere specified in labeling affixed to the device.

(B) If the director determines that it is not feasible to affix a label to the device containing all the information called for in paragraph (A) of this rule, the director may waive the requirements of that paragraph and require in lieu thereof that:

(1) A label be affixed to the device identifying:

(a) The manufacturer, assembler, or initial transferor; and

(b) The type of radioactive material; and

(2) A leaflet bearing the following information be enclosed in or accompany the container in which the device is shipped:

(a) The name of the manufacturer, assembler, or initial transferor,

(b) The type and quantity of radioactive material,

(c) The model number,

(d) A statement that the receipt, possession, use, and transfer of the device are subject to a general license or the equivalent and the regulations of the United States nuclear regulatory commission or of an agreement state, and

(e) Such other information as may be required by the director, including disposal instructions when appropriate.

Last updated November 2, 2022 at 2:34 PM

History

• Effective: January 20, 2008
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-46-36 Luminous safety devices for use in aircraft: material transfer reports.

(A) Each person licensed under rule 3701:1-46-33 of the Administrative Code shall file an annual report with the director at the following address:

"Ohio Department of Health

Bureau of Environmental Health and Radiation Protection

246 North High Street

Columbus, Ohio 43215"

which must state the total quantity of tritium or promethium-147 transferred to persons generally licensed under rule 3701:1-46-07 of the Administrative Code. The report must identify each general licensee by name, state the kinds and numbers of luminous devices transferred, and specify the quantity of tritium or promethium-147 in each kind of device. Each report must cover the year ending June 30 and must be filed within thirty days thereafter. If no transfers have been made to persons generally licensed under rule 3701:1-46-07 of the Administrative Code during the reporting period, the report must so indicate.

(B) Each person licensed under rule 3701:1-46-33 of the Administrative Code shall report annually all transfers of devices to persons for use under a general license in an agreement state or the United States nuclear regulatory commission's regulations that are equivalent to rule 3701:1-46-07 of the Administrative Code to the responsible agreement state or United States nuclear regulatory commission. The report must state the total quantity of tritium or promethium-147 transferred, identify each general licensee by name, state the kinds and numbers of luminous devices transferred, and specify the quantity of tritium or promethium-147 in each kind of device. If no transfers have been made to a particular agreement state or the United States nuclear regulatory commission during the reporting period, this information must be reported to the responsible agreement state agency or to the United States nuclear regulatory commission upon request of the agency.

Last updated November 2, 2022 at 2:35 PM

History

• Effective: June 16, 2017
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-46-38 Calibration or reference sources containing americium-241 or radium-226: labeling of devices.

(A) Each person licensed under rule 3701:1-46-37 of the Administrative Code shall affix to each source, or storage container for the source, a label which shall contain sufficient information relative to safe use and storage of the source and shall include one of the following statements or a substantially similar statement which contains the information called for in one of the following statements:

(1) For americium-241:

The receipt, possession, use and transfer of this source, model __, serial no. __, are subject to a general license and the regulations of the United States nuclear regulatory commission or of a state with which the commission has entered into an agreement for the exercise of regulatory authority. Do not remove this label.

"CAUTION-RADIOACTIVE MATERIAL-THIS SOURCE CONTAINS AMERICIUM-241.

DO NOT TOUCH RADIOACTIVE PORTION OF THIS SOURCE."

Name of manufacturer or initial transferor.

(2) For radium-226:

The receipt, possession, use and transfer of this source, model __, serial no. __, are subject to a general license and the regulations of the United States nuclear regulatory commission or of a state with which the commission has entered into an agreement for the exercise of regulatory authority. Do not remove this label.

"CAUTION-RADIOACTIVE MATERIAL-THIS SOURCE CONTAINS RADIUM-226.

DO NOT TOUCH RADIOACTIVE PORTION OF THIS SOURCE."

Name of manufacturer or initial transferor.

(B) Sources licensed by the United States nuclear regulatory commission prior to January 19, 1975, may bear labels authorized by the regulations in effect on January 1, 1975.

Last updated November 2, 2022 at 2:35 PM

History

• Effective: December 1, 2012
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-46-39 Calibration or reference sources containing americium-241 or radium-226: leak testing of each source.

Each person licensed under rule 3701:1-46-37 of the Administrative Code shall perform a dry wipe test upon each source containing more than 3.7 kilobecquerels (0.1 microcurie) of americium-241 or radium-226 prior to transferring the source to a general licensee under rule 3701:1-46-08 of the Administrative Code. This test shall be performed by wiping the entire radioactive surface of the source with a filter paper with the application of moderate finger pressure. The radioactivity on the paper shall be measured by using radiation detection instrumentation capable of detecting one hundred eighty-five becquerels (0.005 microcurie) of americium-241 or radium-226. If a source has been shown to be leaking or losing more than one hundred eighty-five becquerels (0.005 microcurie) of americium-241 or radium-226 by the methods described in this rule, the source shall not be transferred to a general licensee under rule 3701:1-46-08 of the Administrative Code, or under an equivalent general license from an agreement state or the United States nuclear regulatory commission.

Last updated November 2, 2022 at 2:35 PM

History

• Effective: November 8, 2015
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-46-41

(A) Each person licensed under rule 3701:1-46-40 of the Administrative Code shall visually inspect each device and shall reject any which has an observable physical defect that could affect containment of the strontium-90.

(B) Each person licensed under rule 3701:1-46-40 of the Administrative Code shall test each device for possible loss of strontium-90 or for contamination by wiping with filter paper an area of at least one hundred square centimeters on the outside surface of the device, or by wiping the entire surface area if it is less than one hundred square centimeters. The detection on the filter paper of more than two thousand two hundred disintegrations per minute of radioactive material per one hundred square centimeters of surface wiped shall be cause for rejection of the tested device.

(C) Each person licensed under rule 3701:1-46-40 of the Administrative Code shall :

(1) Maintain quality assurance systems in the manufacture of the ice detection device containing strontium-90 in a manner sufficient to provide reasonable assurance that the safety-related components of the distributed devices are capable of performing their intended functions; and

(2) Subject inspection lots to acceptance sampling procedures, by procedures specified in paragraph (D) of this rule and in a license issued under the rule 3701:1-46-40 of the Administrative Code, to provide at least ninety five per cent confidence that the lot tolerance per cent defective of five per cent will not be exceeded.

(D) Each person licensed under rule 3701:1-46-40 of the Administrative Code shall subject each inspection lot to:

(1) Tests that adequately take into account the individual, aggregate, and cumulative effects of environmental conditions expected in service that could possibly affect the effective containment of strontium-90, such as absolute pressure and water immersion.

(2) Inspection for evidence of physical damage, containment failure, or for loss of strontium-90 after each stage of testing, using methods of inspection adequate to determine compliance with the following criteria for defective: a leak resulting in a loss of 0.1 per cent or more of the original amount of strontium-90 from the device and any other criteria specified in the license issued under rule 3701:1-46-40 of the Administrative Code.

(E) No person licensed under rule 3701:1-46-40 of the Administrative Code shall transfer to persons generally licensed under rule 3701:1-46-10 of the Administrative Code, or under an equivalent general license of an agreement state or the United States nuclear regulatory commission:

(1) Any ice detection device containing strontium-90 tested and found defective under the criteria specified in a license issued under rule 3701:1-46-40 of the Administrative Code, unless the defective ice detection device has been repaired or reworked, retested, and determined by an independent inspector to meet the applicable acceptance criteria; or

(2) Any ice detection device containing strontium-90 contained within any lot that has been sampled and rejected as a result of the procedures in paragraph (C)(2) of this rule, unless:

(a) A procedure for defining sub-lot size, independence, and additional testing procedures is contained in the license issued under rule 3701:1-46-40 of the Administrative Code; and

(b) Each individual sub-lot is sampled, tested, and accepted in accordance with paragraphs (C)(2) and (E)(2)(a) of this rule and any other criteria as may be required as a condition of the license issued under rule 3701:1-46-40 of the Administrative Code.

Last updated November 2, 2022 at 2:36 PM

History

• Effective: November 8, 2015
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-46-43 Manufacture, preparation, or transfer for commercial distribution of radioactive drugs containing radioactive material for medical use.

(A) An application for a specific license to manufacture, prepare, or transfer for commercial distribution radioactive drugs containing radioactive material for use by persons authorized pursuant to Chapter 3701:1-58 of the Administrative Code or equivalent regulations of an agreement state will be approved if:

(1) The applicant satisfies the general requirements specified in rule 3701:1-40-15 of the Administrative Code;

(2) The applicant submits evidence that the applicant is at least one of the following:

(a) Registered with the United States food and drug administration as the owner or operator of a drug establishment that engages in the manufacture, preparation, propagation, compounding, or processing of a drug under 21 C.F.R. 207.20(a) (as in effect on the effective date of this rule);

(b) Registered or licensed with a state agency as a drug manufacturer;

(c) Licensed as a pharmacy by a state board of pharmacy;

(d) Operating as a nuclear pharmacy within a federal medical institution; or

(e) A positron emission tomography (PET) drug production facility registered with a state agency.

(3) The applicant submits information on the radionuclide; the chemical and physical form; the maximum activity per vial, syringe, generator, or other container of the radioactive drug; and the shielding provided by the packaging to show it is appropriate for the safe handling and storage of the radioactive drugs by medical use licensees; and

(4) The applicant commits to the following labeling requirements:

(a) A label is affixed to each transport radiation shield, whether it is constructed of lead, glass, plastic, or other material, of a radioactive drug to be transferred for commercial distribution. The label must include the radiation symbol and the words "CAUTION, RADIOACTIVE MATERIAL" or "DANGER, RADIOACTIVE MATERIAL"; the name of the radioactive drug or its abbreviation; and the quantity of radioactivity at a specified date and time. For radioactive drugs with a half-life greater than one hundred days, the time may be omitted.

(b) A label is affixed to each syringe, vial, or other container used to hold a radioactive drug to be transferred for commercial distribution. The label must include the radiation symbol and the words "CAUTION, RADIOACTIVE MATERIAL" or "DANGER, RADIOACTIVE MATERIAL" and an identifier that ensures that the syringe, vial, or other container can be correlated with the information on the transport radiation shield label.

(B) A licensee described by paragraph (A)(2)(c) or (A)(2)(d) of this rule:

(1) May prepare radioactive drugs for medical use, as defined in rule 3701:1-38-01 of the Administrative Code, provided that the radioactive drug is prepared by either an authorized nuclear pharmacist, as specified in paragraphs (B)(2) and (B)(3) of this rule, or an individual under the supervision of an authorized nuclear pharmacist as specified in rule 3701:1-58-14 of the Administrative Code.

(2) May allow a pharmacist to work as an authorized nuclear pharmacist if:

(a) This individual qualifies as an authorized nuclear pharmacist as defined in rule 3701:1-58-01 of the Administrative Code,

(b) This individual meets the requirements specified in paragraph (B) of rule 3701:1-58-20 of the Administrative Code and rule 3701:1-58-22 of the Administrative Code and the licensee has received an approved license amendment identifying this individual as an authorized nuclear pharmacist, or

(c) This individual is designated as an authorized nuclear pharmacist in accordance with paragraph (B)(4) of this rule.

(3) The actions authorized in paragraphs (B)(1) and (B)(2) of this rule are permitted in spite of more restrictive language in license conditions.

(4) May designate a pharmacist as an authorized nuclear pharmacist if:

(a) The individual was a nuclear pharmacist preparing only radioactive drugs containing accelerator-produced radioactive material, and

(b) The individual practiced at a pharmacy at a government agency or federally recognized indian tribe before November 30, 2007 or at all other pharmacies before August 8, 2009, or an earlier date as noticed by the United States nuclear regulatory commission.

(5) Shall provide to the director a copy of:

(a) A copy of each individual's certification by a specialty board whose certification process has been recognized by the United States nuclear regulatory commission or an agreement state as specified in paragraph (A) of rule 3701:1-58-20 of the Administrative Code; or

(b) The United States nuclear regulatory commission or agreement state license; or

(c) The permit issued by a United States nuclear regulatory commission master materials licensee; or

(d) The permit issued by a licensee or United States nuclear regulatory commission master materials permittee of broad scope; or

(e) The authorization from a commercial nuclear pharmacy authorized to list its own authorized nuclear pharmacist; or

(f) Documentation that only accelerator-produced radioactive materials were used in the practice of nuclear pharmacy at a government agency or federally recognized indian tribe before November 30, 2007, or at all other locations of use before August 8, 2009, or an earlier date as noticed by the United States nuclear regulatory commission; and

(g) State pharmacy licensure or registration, no later than thirty days after the date that the licensee allows, under paragraphs (B)(2)(a) and (B)(2)(c) of this rule, the individual to work as an authorized nuclear pharmacist.

(C) A licensee shall possess and use instrumentation to measure the radioactivity of radioactive drugs. The licensee shall have procedures for use of the instrumentation. The licensee shall measure, by direct measurement or by combination of measurements and calculations, the amount of radioactivity in dosages of alpha-, beta-, or photon-emitting radioactive drugs prior to transfer for commercial distribution. In addition, the licensee shall:

(1) Perform tests before initial use, periodically, and following repair, on each instrument for accuracy, linearity, and geometry dependence, as appropriate for the use of the instrument; and make adjustments when necessary; and

(2) Check each instrument for constancy and proper operation at the beginning of each day of use.

(D) A licensee shall satisfy the labeling requirements in paragraph (A)(4) of this rule.

(E) Nothing in this rule relieves the licensee from complying with applicable United States food and drug administration, other federal, and state requirements governing radioactive drugs.

Last updated August 1, 2023 at 2:36 PM

History

• Effective: August 15, 2021
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-58-14

(A) A licensee that permits the receipt, possession, use, or transfer of radioactive material by an individual under the supervision of an authorized user, as allowed by paragraph (B)(1) of rule 3701:1-58-06 of the Administrative Code, shall:

(1) In addition to the requirements in rule 3701:1-38-10 of the Administrative Code, instruct the supervised individual in the licensee's written radiation protection procedures, written directive procedures, regulations of this chapter, and license conditions with respect to the use of radioactive material; and

(2) Require the supervised individual to follow the instructions of the supervising authorized user for medical uses of radioactive material, written radiation protection procedures established by the licensee, written directive procedures, regulations of this chapter, and license conditions with respect to the medical use of radioactive material.

(B) A licensee that permits the preparation of radioactive material for medical use by an individual under the supervision of an authorized nuclear pharmacist or physician who is an authorized user, as allowed by paragraph (B)(2) of rule 3701:1-58-06 of the Administrative Code shall:

(1) In addition to the requirements in rule 3701:1-38-10 of the Administrative Code, instruct the supervised individual in the preparation of radioactive material for medical use, as appropriate to that individual's involvement with radioactive material; and

(2) Require the supervised individual to follow the instructions of the supervising authorized user or authorized nuclear pharmacist regarding the preparation of radioactive material for medical use, written radiation protection procedures established by the licensee, the rules of this chapter, and license conditions.

(C) A licensee that permits supervised activities under paragraphs (A) and (B) of this rule is responsible for the acts and omissions of the supervised individual.

Last updated November 18, 2022 at 8:30 AM

History

• Effective: August 15, 2005
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-58-01

The terms used in this chapter have the same meaning as found in rule 3701:1-38-01 of the Administrative Code, unless an alternative definition is provided in this rule or in another rules of this chapter:

(A) "Associate radiation safety officer" means an individual who:

(1) Meets the requirements in rules 3701:1-58-18 and 3701:1-58-22 of the Administrative Code; and

(2) Is currently identified as an associate radiation safety officer for the types of use of radioactive material for which the individual has been assigned duties and tasks by the radiation safety officer on:

(a) A specific medical use license issued by the director, the United States nuclear regulatory commission, or an agreement state; or

(b) A medical use permit issued by a United States nuclear regulatory commission master material licensee.

(B) "Authorized medical physicist" means an individual who:

(1) Meets the requirements in paragraph (A) of rule 3701:1-58-19 and in rule 3701:1-58-22 of the Administrative Code; or

(2) Is identified as an authorized medical physicist or teletherapy physicist on:

(a) A specific medical use license issued by the director, the United States nuclear regulatory commission, or an agreement state;

(b) A medical use permit issued by a United States nuclear regulatory commission master material licensee;

(c) A permit issued by a United States nuclear regulatory commission or agreement state broad scope medical use licensee; or

(d) A permit issued by a United States nuclear regulatory commission master material license broad scope medical use permittee.

(C) "Authorized nuclear pharmacist" means a pharmacist who:

(1) Meets the requirements in paragraph (A) of rule 3701:1-58-20 and in rule 3701:1-58-22 of the Administrative Code; or

(2) Is identified as an authorized nuclear pharmacist on:

(a) A specific license issued by the director, the United States nuclear regulatory commission, or an agreement state that authorizes medical use or the practice of nuclear pharmacy;

(b) A permit issued by a United States nuclear regulatory commission master material licensee that authorizes medical use or the practice of nuclear pharmacy;

(c) A permit issued by a United States nuclear regulatory commission or agreement state broad scope medical use licensee that authorizes medical use or the practice of nuclear pharmacy; or

(d) A permit issued by a United States nuclear regulatory commission master material license broad scope medical use permittee that authorizes medical use or the practice of nuclear pharmacy; or

(3) Is identified as an authorized nuclear pharmacist by a commercial nuclear pharmacy that has been authorized to identify authorized nuclear pharmacists; or

(4) Is designated as an authorized nuclear pharmacist in accordance with rule 3701:1-46-43 of the Administrative Code.

(D) "Authorized user" means a physician, dentist, or podiatrist who:

(1) Meets the requirements in rule 3701:1-58-22 of the Administrative Code and paragraph (A) of rule 3701:1-58-33, paragraph (A) of rule 3701:1-58-36, paragraph (A) of rule 3701:1-58-40, paragraph (A) of rule 3701:1-58-41, paragraph (A) of rule 3701:1-58-42, paragraph (A) of rule 3701:1-58-51, paragraph (A) of rule 3701:1-58-54, or paragraph (A) of rule 3701:1-58-71 of the Administrative Code; or

(2) Is identified as an authorized user on:

(a) A license issued by the director, the United States nuclear regulatory commission, or an agreement state that authorizes the medical use of radioactive material;

(b) A permit issued by a United States nuclear regulatory commission master material licensee that is authorized to permit the medical use of radioactive material;

(c) A permit issued by a United States nuclear regulatory commission or agreement state specific licensee of broad scope that is authorized to permit the medical use of radioactive material; or

(d) A permit issued by a United States nuclear regulatory commission master material license broad scope permittee that is authorized to permit the medical use of radioactive material.

(E) "Brachytherapy" means a method of radiation therapy in which sources are used to deliver a radiation dose at a distance of up to a few centimeters by surface, intracavitary, intraluminal, or interstitial application.

(F) "Brachytherapy source" means a radioactive source or a manufacturer-assembled source train or a combination of these sources that is designed to deliver a therapeutic dose within a distance of a few centimeters.

(G) "Client's address" means the area of use or a temporary job site, as defined in this rule, for the purpose of providing mobile medical service in accordance with rule 3701:1-58-31 of the Administrative Code.

(H) "High dose-rate remote afterloader," as used in this chapter, means a brachytherapy device that remotely delivers a dose rate in excess of twelve gray (one thousand two hundred rads) per hour at the point or surface where the dose is prescribed.

(I) "Low dose-rate remote afterloader," as used in this chapter, means a brachytherapy device that remotely delivers a dose rate of less than or equal to two gray (two hundred rads) per hour at the point or surface where the dose is prescribed.

(J) "Manual brachytherapy," as used in this chapter, means a type of brachytherapy in which the brachytherapy sources, such as seeds or ribbons are manually placed topically on or inserted either into the body cavities that are in close proximity to a treatment site or directly into the tissue volume.

(K) "Medical event" means an event that meets the criteria in paragraph (A) or (B) of rule 3701:1-58-101 of the Administrative Code.

(L) "Medium dose-rate remote afterloader," as used in this chapter, means a brachytherapy device that remotely delivers a dose rate of greater than two gray (two hundred rads) per hour, but less than or equal to twelve gray (one thousand two hundred rads) per hour at the point or surface where the dose is prescribed.

(M) "Mobile medical service" means the transportation of radioactive material to and its medical use at the client's address.

(N) "Ophthalmic physicist" means an individual who:

(1) Meets the requirements in paragraph (A)(2) of rule 3701:1-58-49 and in rule 3701:1-58-22 of the Administrative Code; and

(2) Is identified as an ophthalmic physicist on a:

(a) Specific medical use license issued by the director, the United States nuclear regulatory commission, or an agreement state;

(b) Permit issued by a United States nuclear regulatory commission or agreement state broad scope medical use licensee;

(c) Medical use permit issued by a United States nuclear regulatory commission master material licensee; or

(d) Permit issued by a United States nuclear regulatory commission master material licensee broad scope medical use permittee.

(O) "Output" means the exposure rate, dose rate, or a quantity related in a known manner to these rates from a brachytherapy source or a teletherapy, remote afterloader, or gamma stereotactic radiosurgery unit for a specified set of exposure conditions.

(P) "Patient intervention" means actions by the patient or human research subject, whether intentional or unintentional, such as dislodging or removing treatment devices or prematurely terminating the administration.

(Q) "Personal Representative" means:

(1) A person who has authority to act on behalf of an individual who is an adult or an emancipated minor in making decisions related to health care, or

(2) A parent, guardian, or other person acting in loco parentis who has authority to act on behalf of an individual who is an unemancipated minor in making decisions related to health care.

(R) "Preceptor" means an individual who provides, directs, or verifies the training and experience required for an individual to become an authorized user, an authorized medical physicist, an authorized nuclear pharmacist, a radiation safety officer, or an associate radiation safety officer.

(S) "Prescribed dosage" means the specified activity or range of activity of unsealed radioactive material as documented:

(1) In a written directive; or

(2) In accordance with the directions of the authorized user for procedures performed pursuant to rules 3701:1-58-32 and 3701:1-58-34 of the Administrative Code.

(T) "Prescribed dose" means:

(1) For gamma stereotactic radiosurgery, the total dose as documented in the written directive;

(2) For teletherapy, the total dose and dose per fraction as documented in the written directive;

(3) For manual brachytherapy, either the total source strength and exposure time or the total dose, as documented in the written directive; or

(4) For remote brachytherapy afterloaders, the total dose and dose per fraction as documented in the written directive.

(U) "Pulsed dose-rate remote afterloader," as used in this chapter, means a special type of remote afterloading brachytherapy device that uses a single source capable of delivering dose rates in the "high dose-rate'' range, but:

(1) Is approximately one-tenth of the activity of typical high dose-rate remote afterloader sources; and

(2) Is used to simulate the radiobiology of a low dose-rate treatment by inserting the source for a given fraction of each hour.

(V) "Radiation safety officer," as used in this chapter, means an individual who:

(1) Meets the requirements in paragraph (A) or (C)(1) of rule 3701:1-58-18 and in rule 3701:1-58-22 of the Administrative Code, or

(2) Is identified as a radiation safety officer on:

(a) A specific medical use license issued by the director, the United States nuclear regulatory commission, or an agreement state that authorizes the medical use of radioactive material; or

(b) A medical use permit issued by a United States nuclear regulatory commission master material licensee.

(W) "Stereotactic radiosurgery" means the use of external radiation in conjunction with a stereotactic guidance device to very precisely deliver a therapeutic dose to a tissue volume.

(X) "Structured educational program" means an educational program designed to impart particular knowledge and practical education through interrelated studies and supervised training.

(Y) "Teletherapy," as used in this chapter, means a method of radiation therapy in which collimated gamma rays are delivered at a distance from the patient or human research subject.

(Z) "Teletherapy Physicist" means the individual identified as the teletherapy physicist on a radioactive material license issued by the state of Ohio.

(AA) "Temporary job site," as used in this chapter, means a location where mobile medical services are conducted other than those location(s) of use authorized on the license.

(BB) "Therapeutic dosage" means a dosage of unsealed radioactive material that is intended to deliver a radiation dose to a patient or human research subject for palliative or curative treatment.

(CC) "Therapeutic dose" means a radiation dose delivered from a source containing radioactive material to a patient or human research subject for palliative or curative treatment.

(DD) "Treatment site" means the anatomical description of the tissue intended to receive a radiation dose, as described in a written directive.

(EE) "Type of use" means use of radioactive material under rule 3701:1-58-32, 3701:1-58-34, 3701:1-58-37, 3701:1-58-43, 3701:1-58-53, 3701:1-58-55 or 3701:1-58-72 of the Administrative Code.

(FF) "Unit dosage" means a dosage prepared for medical use for administration as a single dosage to a patient or human research subject without any further manipulation of the dosage after it is initially prepared.

(GG) "Written directive," as specified in rule 3701:1-58-15 of the Administrative Code, means an authorized user's written order for the administration of radioactive material or radiation from radioactive material to a specific patient or human research subject.

Last updated November 18, 2022 at 8:27 AM

History

• Effective: August 15, 2021
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-58-20

Except as provided in rule 3701:1-58-21 of the Administrative Code, the licensee shall require the authorized nuclear pharmacist to be a pharmacist who:

(A) Is certified by a specialty board whose certification process has been recognized by the director, United States nuclear regulatory commission, or an agreement state. The names of board certifications which have been recognized by the director, United States nuclear regulatory commission, or an agreement state will be posted on the United States nuclear regulatory commission's "Medical Uses Licensee Toolkit" web page at www.nrc.gov. To have its certification process recognized, a specialty board shall require all candidates for certification to:

(1) Have graduated from a pharmacy program accredited by the "Accreditation Council on Pharmaceutical Education" (ACPE) (previously named the "American Council on Pharmaceutical Education") or have passed the "Foreign Pharmacy Graduate Examination Committee" (FPGEC) examination;

(2) Hold a current, active license to practice pharmacy;

(3) Provide evidence of having acquired at least four thousand hours of training/experience in nuclear pharmacy practice. Academic training may be substituted for no more than two thousand hours of the required training and experience; and

(4) Pass an examination in nuclear pharmacy administered by diplomates of the specialty board, that assesses knowledge and competency in procurement, compounding, quality assurance, dispensing, distribution, health and safety, radiation safety, provision of information and consultation, monitoring patient outcomes, research and development; or

(B) Has achieved the following requirements:

(1) Has completed seven hundred hours in a structured educational program consisting of both:

(a) Two hundred hours of classroom and laboratory training in the following areas:

(i) Radiation physics and instrumentation;

(ii) Radiation protection;

(iii) Mathematics pertaining to the use and measurement of radioactivity;

(iv) Chemistry of radioactive material for medical use; and

(v) Radiation biology; and

(b) Supervised practical experience in a nuclear pharmacy involving:

(i) Shipping, receiving, and performing related radiation surveys;

(ii) Using and performing checks for proper operation of instruments used to determine the activity of dosages, survey meters, and, if appropriate, instruments used to measure alpha- or beta-emitting radionuclides;

(iii) Calculating, assaying, and safely preparing dosages for patients or human research subjects;

(iv) Using administrative controls to avoid medical events in the administration of radioactive material; and

(v) Using procedures to prevent or minimize radioactive contamination and using proper decontamination procedures; and

(2) Has obtained written attestation, signed by a preceptor authorized nuclear pharmacist, that the individual has satisfactorily completed the requirements in paragraph (B)(1) of this rule and is able to independently fulfill the radiation safety-related duties as an authorized nuclear pharmacist.

Last updated January 9, 2026 at 8:01 AM

History

• Effective: May 15, 2023
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-58-22

The training and experience specified in rules 3701:1-58-12 to 3701:1-58-21, 3701:1-58-32 to 3701:1-58-71, and 3701:1-58-104 of the Administrative Code must have been obtained within the seven years preceding the date of application or the individual must have had related continuing education and experience since the required training and experience was completed.

Last updated November 18, 2022 at 8:31 AM

History

• Effective: December 22, 2008
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-46-44 Manufacture and distribution of sources or devices containing radioactive material for medical use.

(A) An application for a specific license to manufacture and distribute sources and devices containing radioactive material to persons licensed pursuant to Chapter 3701:1-58 of the Administrative Code or equivalent regulations of the United States nuclear regulatory commission or agreement state for use as a calibration, transmission, or reference source or for the uses listed in rules 3701:1-58-43, 3701:1-58-53, 3701:1-58-55, and 3701:1-58-72 of the Administrative Code or equivalent regulations of the United States nuclear regulatory commission or agreement state will be approved if:

(1) The applicant satisfies the general requirements in rule 3701:1-40-15 of the Administrative Code;

(2) The applicant submits sufficient information regarding each type of source or device pertinent to an evaluation of its radiation safety, including:

(a) The radioactive material contained, its chemical and physical form, and amount;

(b) Details of design and construction of the source or device;

(c) Procedures for, and results of, prototype tests to demonstrate that the source or device will maintain its integrity under stresses likely to be encountered in normal use and accidents;

(d) For devices containing radioactive material, the radiation profile of a prototype device;

(e) Details of quality control procedures to assure that production sources and devices meet the standards of the design and prototype tests;

(f) Procedures and standards for calibrating sources and devices;

(g) Legend and methods for labeling sources and devices as to their radioactive content;

(h) Instructions for handling and storing the source or device from the radiation safety standpoint; these instructions are to be included on a durable label attached to the source or device or attached to a permanent storage container for the source or device: provided, that instructions which are too lengthy for such label may be summarized on the label and printed in detail on a brochure which is referenced on the label;

(3) The label affixed to the source or device, or to the permanent storage container for the source or device, contains information on the radionuclide, quantity and date of assay, and a statement that the director has approved distribution of the (name of source or device) to persons licensed to use radioactive material identified in rules 3701:1-58-26, 3701:1-58-43, 3701:1-58-53, and 3701:1-58-55 of the Administrative Code, as appropriate, and to persons who hold an equivalent license issued by the United States nuclear regulatory commission or an agreement state; and

(4) The source or device has been registered in the sealed source and device registry.

(B) The following is applicable:

(1) In the event the applicant desires that the source or device be required to be tested for leakage of radioactive material at intervals longer than six months, he/she shall include in his/her application sufficient information to demonstrate that such longer interval is justified by performance characteristics of the source or device or similar sources or devices and by design features that have a significant bearing on the probability or consequences of leakage of radioactive material from the source.

(2) In determining the acceptable interval for test of leakage of radioactive material, the director will consider information that includes, but is not limited to:

(a) Primary containment (source capsule);

(b) Protection of primary containment;

(c) Method of sealing containment;

(d) Containment construction materials;

(e) Form of contained radioactive material;

(f) Maximum temperature withstood during prototype tests;

(g) Maximum pressure withstood during prototype tests;

(h) Maximum quantity of contained radioactive material;

(i) Radiotoxicity of contained radioactive material;

(j) Operating experience with identical sources or devices or similarly designed and constructed sources or devices.

Last updated November 2, 2022 at 2:36 PM

History

• Effective: November 8, 2015
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-58-43

A licensee shall use only brachytherapy sources:

(A) As approved in the sealed source and device registry for manual brachytherapy medical use. The manual brachytherapy sources may be used for manual brachytherapy uses that are not explicitly listed in the sealed source and device registry, but must be used in accordance with the radiation safety conditions and limitations described in the sealed source and device registry; or

(B) In research to deliver therapeutic doses for medical use in accordance with an active investigational device exemption application accepted by the United States food and drug administration provided the requirements of paragraph (A) of rule 3701:1-58-17 of the Administrative Code are met.

Last updated November 18, 2022 at 8:34 AM

History

• Effective: August 15, 2021
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-58-53

(A) A licensee must use only sealed sources that are not in medical devices for diagnostic medical uses if the sealed sources are approved in the sealed source and device registry for diagnostic medicine. The sealed sources may be used for diagnostic medical uses that are not explicitly listed in the sealed source and device registry but must be used in accordance with the radiation safety conditions and limitations described in the sealed source and device registry.

(B) A licensee must only use medical devices containing sealed sources for diagnostic medical uses if both the sealed sources and medical devices are approved in the sealed source and device registry for diagnostic medical uses. The diagnostic medical devices may be used for diagnostic medical uses that are not explicitly listed in the sealed source and device registry but must be used in accordance with the radiation safety conditions and limitations described in the sealed source and device registry.

(C) Sealed sources and devices for diagnostic medical uses may be used in research in accordance with an active investigational device exemption (IDE) application accepted by the United States food and drug administration provided the requirements of paragraph (A) of rule 3701:1-58-17 of the Administrative Code are met.

Last updated November 18, 2022 at 8:36 AM

History

• Effective: August 15, 2021
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-58-55

(A) A licensee must only use sealed sources:

(1) Approved and as provided for in the sealed source and device registry in photon emitting remote afterloader units, teletherapy units, or gamma stereotactic radiosurgery units to deliver therapeutic doses for medical uses; or

(2) In research involving photon-emitting remote afterloader units, teletherapy units, or gamma stereotactic radiosurgery units in accordance with an active investigational device exemption (IDE) application accepted by the United States food and drug administration provided the requirements of paragraph (A) of rule 3701:1-58-17 of the Administrative Code are met.

(B) A licensee must use photon-emitting remote afterloader units, teletherapy units, or gamma stereotactic radiosurgery units:

(1) Approved in the sealed source and device registry to deliver a therapeutic dose for medical use. These devices may be used for therapeutic medical treatments that are not explicitly provided for in the sealed source and device registry, but must be used in accordance with radiation safety conditions and limitations described in the sealed source and device registry; or

(2) In research in accordance with an active investigational device exemption (IDE) application accepted by the United States food and drug administration provided the requirements of paragraph (A) of rule 3701:1-58-17 of the Administrative Code are met.

Last updated November 18, 2022 at 8:36 AM

History

• Effective: August 15, 2021
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-58-72

A licensee may use radioactive material or a radiation source approved for medical use which is not specifically addressed in rules 3701:1-58-32, 3701:1-58-34, 3701:1-58-37, 3701:1-58-43, 3701:1-58-53 and 3701:1-58-55 of the Administrative Code if:

(A) The applicant or licensee has submitted the information required by paragraphs (B) to (D) of rule 3701:1-58-07 of the Administrative Code; and

(B) The applicant or licensee has received written approval from the director in a license or license amendment and uses the material in accordance with the regulations and specific conditions the director considers necessary for the medical use of the material.

Last updated November 18, 2022 at 8:39 AM

History

• Effective: August 15, 2005
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-58-26

(A) Any person authorized by rule 3701:1-58-06 of the Administrative Code for medical use of radioactive material may receive, possess, and use any of the following radioactive material for check, calibration, transmission, and reference use:

(1) Sealed sources, not exceeding 1.11 gigabecquerels (thirty millicuries) each, manufactured and distributed by a person licensed under rule 3701:1-46-44 of the Administrative Code or equivalent United States nuclear regulatory commission, or agreement state regulations.

(2) Sealed sources, not exceeding 1.11 gigabecquerels (thirty millicuries) each, redistributed by a licensee authorized to redistribute the sealed sources manufactured and distributed by a person licensed under rule 3701:1-46-44 of the Administrative Code or equivalent United States nuclear regulatory commission or agreement state regulations, providing the redistributed sealed sources are in the original packaging and shielding and are accompanied by the manufacturer's approved instructions.

(3) Any radioactive material with a half-life not longer than one hundred twenty days in individual amounts not to exceed 0.56 gigabecquerels (fifteen millicuries).

(4) Any radioactive material with a half-life longer than one hundred twenty days in individual amounts not to exceed the smaller of 7.4 megabecquerels (two hundred microcuries) or one thousand times the quantities in appendix A to rule 3701:1-40-17 of the Administrative Code.

(5) Technetium-99m in amounts as needed.

(B) Radioactive material in sealed sources authorized by this provision shall not be:

(1) Used for medical use as defined in rule 3701:1-38-01 of the Adminstrative Code except in accordance with the requirements in rule 3701:1-58-53 of the Adminstrative Code; or

(2) Combined (i.e., bundled or aggregated) to create an activity greater than the maximum activity of any single sealed source authorized under this chapter.

(C) A licensee using calibration, transmission, and reference sources in accordance with the requirements in paragraph (A) or (B) of this rule need not list these sources on a specific medical use license.

Last updated October 6, 2022 at 8:25 AM

History

• Effective: October 6, 2022
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-46-49 Registration of product information.

(A) Any manufacturer or initial distributor of a sealed source or device containing a sealed source may submit a request to the director for evaluation of radiation safety information about its product and for its registration.

(B) The request for review must be made in duplicate and sent to the director at the following address:

"Ohio Department of Health

Bureau of Environmental Health and Radiation Protection

246 North High Street

Columbus, Ohio 43215"

(C) The request for review of a sealed source or a device must include sufficient information about the design, manufacture, prototype testing, quality control program, labeling, proposed uses and leak testing and, for a device, the request must also include sufficient information about installation, service and maintenance, operating and safety instructions, and its potential hazards, to provide reasonable assurance that the radiation safety properties of the source or device are adequate to protect health and minimize danger to life and property.

(D) The director normally evaluates a sealed source or a device using radiation safety criteria in accepted industry standards. If these standards and criteria do not readily apply to a particular case, the director formulates reasonable standards and criteria with the help of the manufacturer or distributor. The director shall use criteria and standards sufficient to ensure that the radiation safety properties of the device or sealed source are adequate to protect health and minimize danger to life and property.

(E) After completion of the evaluation, the director issues a certificate of registration to the person making the request. The certificate of registration acknowledges the availability of the submitted information for inclusion in an application for a specific license proposing use of the product, or concerning use under an exemption from licensing or general license as applicable for the category of certificate.

(F) The person submitting the request for evaluation and registration of safety information about the product shall manufacture and distribute the product in accordance with:

(1) The statements and representations, including quality control program, contained in the request; and

(2) The provisions of the registration certificate.

(G) Authority to manufacture or initially distribute a sealed source or device to specific licensees may be provided in the license without the issuance of a certificate of registration in the following cases:

(1) Calibration and reference sources containing no more than:

(a) Thirty seven megabecquerels (one millicurie), for beta and/or gamma emitting radionuclides; or

(b) 0.37 megabecquerels (10 microcuries), for alpha emitting radionuclides; or

(2) The intended recipients are qualified by training and experience and have sufficient facilities and equipment to safely use and handle the requested quantity of radioactive material in any form in the case of unregistered sources or, for registered sealed sources contained in unregistered devices, are qualified by training and experience and have sufficient facilities and equipment to safely use and handle the requested quantity of radioactive material in unshielded form, as specified in their licenses; and

(a) The intended recipients are licensed under chapter 3701:1-40 of the Administrative Code or comparable provisions of another agreement state or the United States nuclear regulatory commission; or

(b) The recipients are authorized for research and development; or

(c) The sources and devices are to be built to the unique specifications of the particular recipient and contain no more than seven hundred forty gigabecquerels (twenty curies) of tritium or 7.4 gigabecquerels (two hundred millicuries) of any other radionuclide.

(H) After the certificate is issued, the director may conduct an additional review as he/she determines is necessary to ensure compliance with current regulatory standards. In conducting the review, the director will complete his/her evaluation in accordance with criteria specified in this rule. The director may request such additional information as he/she considers necessary to conduct his/her review and the certificate holder shall provide the information as requested.

(I) A certificate holder who no longer manufactures or initially transfers any of the sealed source(s) or device(s) covered by a particular certificate issued by the director shall request inactivation of the registration certificate. Such a request must be made to the director by an appropriate method listed in rule 3701:1-40-04 of the Administrative Code and must normally be made no later than two years after the initial distribution of all of the source(s) or device(s) covered by the certificate has ceased. However, if the certificate holder determines that an initial transfer was in fact the last initial transfer more than two years after that transfer, the certificate holder shall request inactivation of the certificate within ninety days of this determination and briefly describe the circumstances of the delay.

(J) If a distribution license is to be terminated in accordance with rule 3701:1-40-18 of the Administrative Code, the licensee shall request inactivation of its registration certificates associated with that distribution license before the director will terminate the license. Such a request for inactivation of certificate(s) must indicate that the license is being terminated and include the associated specific license number.

(K) A specific license to manufacture or initially transfer a source or device covered only by an inactivated certificate no longer authorizes the licensee to initially transfer such sources or devices for use. Servicing of devices must be in accordance with any conditions in the certificate, including in the case of an inactive certificate.

Last updated November 2, 2022 at 2:36 PM

History

• Effective: November 8, 2015
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-40-18

(A) Each specific license expires at the end of the day on the expiration date stated in the license unless the licensee has filed an application for renewal in accordance with paragraph (E) of rule 3701:1-38-02 of the Administrative Code. If an application for renewal has been filed at least ninety days, or in the case of a broad scope license, at least one hundred eighty days prior to the expiration date stated in the existing license, the existing license expires at the later of the end of the day on which the director makes a final determination to deny the renewal application or, if the determination states an expiration date, the expiration date stated in the determination.

(B) Each specific license for the possession of radioactive material that requires a decommissioning plan shall continue in effect and shall be renewed during the decommissioning period, until the director notifies the licensee in writing after decommissioning that the license is terminated. During this time, the licensee shall:

(1) Limit actions involving radioactive material to those related to decommissioning; and

(2) Continue to control entry to any restricted area until that area is suitable for release in accordance with department requirements as may be imposed by rule 3701:1-38-22 of the Administrative Code.

(C) A licensee shall provide written notice to the director within sixty days of the occurrence of any of the following, in accordance with rule 3701:1-40-04 of the Administrative Code:

(1) The license has expired;

(2) The licensee has decided to permanently cease licensed activities at the entire site or in any separate building, room or outdoor area that contains residual radioactivity such that the building, room or outdoor area is unsuitable for release in accordance with the definition of "decommissioning" in Chapter 3748. of the Revised Code and the regulations for decommissioning in rule 3701:1-38-22 of the Administrative Code.

(3) No licensed activities have been conducted for a period of twenty-four months; or

(4) No licensed activities have been conducted for a period of twenty-four months in any separate building, room or outdoor area that contains residual radioactivity such that the building, room or outdoor area is unsuitable for release in accordance with rule 3701:1-38-22 of the Administrative Code.

(D) In the event of an occurrence as set forth in paragraph (C) of this rule, the licensee shall either:

(1) Begin decommissioning the site, and any separate building, room or outdoor area that contains residual radioactivity so that the site, building, room and outdoor area are suitable for release in accordance with rule 3701:1-38-22 of the Administrative Code; or

(2) If required by paragraph (G)(1) of this rule, submit within twelve months of notification, a decommissioning plan and begin decommissioning upon the director's approval of that plan.

(E) In addition to written notification of an occurrence, the licensee shall maintain all decommissioning financial assurances established by the licensee pursuant to rule 3701:1-40-17 of the Administrative Code in conjunction with a license issuance or renewal or as required by this rule.

(F) The director may grant a request to extend the twelve-month time period to submit a decommissioning plan established in paragraph (D)(2) of this rule provided that the director determines that the alternative schedule is necessary to the effective conduct of decommissioning operations and that the extension is not detrimental to the public health and safety or the environment and is otherwise in the public interest. The extension request must be submitted no later than thirty days after the occurrence for which notification is required. Decommissioning set forth in paragraph (D)(2) of this rule may not commence until the director has made a determination on the extension request.

(G) The licensee shall submit a decommissioning plan to the director prior to commencing any decommissioning in the following cases:

(1) If required by license condition; or

(2) If the procedures and activities necessary to carry out decommissioning of the site or separate building, room or outdoor area have not been previously approved by the director and these procedures could increase potential health and safety risk to workers or to the public, such as in any of the following cases:

(a) Decommissioning procedures would involve techniques not applied routinely during cleanup or maintenance operations;

(b) Workers would be entering areas not normally occupied where surface contamination and radiation levels are significantly higher than routinely encountered during operation;

(c) Decommissioning procedures could result in significantly greater airborne concentrations of radioactive materials than are present during operation; or

(d) Decommissioning procedures could result in significantly greater releases of radioactive material to the environment than those associated with operation.

(H) A proposed decommissioning plan for a site or separate building, room or outdoor area shall include the following:

(1) A description of the conditions of the site or separate building, room or outdoor area sufficient to evaluate the acceptability of the plan;

(2) A description of planned decommissioning activities;

(3) A description of methods used to ensure protection of workers and the environment against radiation hazards during decommissioning;

(4) A description of the planned final radiation survey;

(5) An updated detailed cost estimate for decommissioning, comparison of that estimate with present funds set aside for decommissioning, and a plan for assuring the availability of adequate funds for completion of decommissioning; and

(6) In the case of a decommissioning plan that results in the licensee completing decommissioning later than twenty-four months after plan approval, the plan shall include a justification for the delay based on the criteria in paragraph (J) of this rule.

The proposed decommissioning plan will be approved by the director if the information therein demonstrates compliance with rule 3701:1-38-22 of the Administrative Code, that the decommissioning will be completed as soon as practicable, and that the health and safety of workers and the public will be adequately protected.

(I) Except as provided in paragraph (J) of this rule, a licensee shall:

(1) Complete decommissioning of the site or separate building or outdoor area as soon as practicable but no later than twenty-four months following the initiation of decommissioning; and

(2) When decommissioning involves the entire site, request license termination as soon as practicable but no later than twenty-four months following the initiation of decommissioning, unless the decommissioning is still actively in progress.

(J) The director may approve a request for an alternative schedule for completion of decommissioning and license termination. In considering whether an alternative schedule is warranted, the director shall consider the following:

(1) Whether it is technically feasible to complete decommissioning within twenty-four months;

(2) Whether sufficient waste disposal capacity is available to allow completion of decommissioning within twenty-four months;

(3) Whether a significant volume reduction in wastes requiring disposal will be achieved by allowing short-lived radionuclides to decay;

(4) Whether a significant reduction in radiation exposure to workers can be achieved by allowing short-lived radionuclides to decay; and

(5) Any other factor that the director finds is unique to the site, such as the regulatory requirements of other government agencies, lawsuits, ground-water treatment activities, monitored natural ground-water restoration, actions that could result in more environmental harm than deferred cleanup, and other factors beyond the control of the licensee.

(K) After decommissioning the site, the licensee shall:

(1) Certify the disposition of all licensed material, including accumulated wastes, by submitting a completed disposition of radioactive materials form provided by the director; and

(2) Conduct a radiation survey of the premises where the licensed activities were carried out and submit a report of the results of this survey, unless the licensee demonstrates in some other manner that the premises are suitable for release in accordance with the criteria for decommissioning set forth in rule 3701:1-38-22 of the Administrative Code. The licensee shall survey and report as follows:

(a) Levels of gamma radiation in units of millisieverts (microroentgen) per hour at one meter from surfaces and radioactivity, including alpha and beta, in units of megabecquerels (disintegrations per minute or microcuries) per one hundred square centimeters, removable and fixed, for surfaces, megabecquerels (microcuries) per milliliter for water, and becquerels (picocuries) per gram for solids such as soils or concrete; and

(b) Identification of any survey instrument used and a certification that each instrument was properly calibrated and tested prior to being used to measure radioactivity at the site.

(L) Specific licenses, including expired licenses, will be terminated by written notice to the licensee when the director determines that:

(1) Radioactive material has been properly disposed;

(2) Reasonable effort has been made to eliminate residual radioactive contamination, if present;

(3) A radiation survey has been performed which demonstrates that the premises are suitable for release in accordance with the criteria for decommissioning, or other information is submitted by the licensee that is sufficient to demonstrate that the premises are suitable for release in accordance with the criteria for decommissioning in this chapter and rule 3701:1-38-22 of the Administrative Code; and

(4) All applicable fees have been paid.

Last updated April 19, 2022 at 8:35 AM

History

• Effective: April 17, 2022
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-46-50 Serialization of nationally tracked sources.

Each licensee who manufactures a nationally tracked source after February 6, 2007, shall assign a unique serial number to each nationally tracked source. Serial numbers must be composed only of alpha-numeric characters.

Last updated November 2, 2022 at 2:36 PM

History

• Effective: October 27, 2008
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-46-51 General license for certain items and self-luminous products containing radium-226.

(A) A general license is hereby issued to any person to acquire, receive, possess, use, or transfer, in accordance with the provisions of paragraphs (B), (C), and (D) of this rule, radium-226 contained in the following products manufactured prior to November 30, 2007:

(1) Antiquities originally intended for use by the general public. For the purposes of this paragraph, antiquities mean products originally intended for use by the general public and distributed in the late nineteenth and early twentieth centuries, such as radium emanator jars, revigators, radium water jars, radon generators, refrigerator cards, radium bath salts, and healing pads;

(2) Intact timepieces containing greater than 0.037 megabecquerel (one microcurie), nonintact timepieces, and timepiece hands and dials no longer installed in timepieces;

(3) Luminous items installed in air, marine, or land vehicles;

(4) All other luminous products, provided that no more than one hundred items are used or stored at the same location at any one time; and

(5) Small radium sources containing no more than 0.037 megabecquerel (one microcurie) of radium-226. For the purposes of this paragraph, "small radium sources" means discrete survey instrument check sources, sources contained in radiation measuring instruments, sources used in educational demonstrations (such as cloud chambers and spinthariscopes), electron tubes, lightning rods, ionization sources, static eliminators, or as designated by the director or the United States nuclear regulatory commission.

(B) Persons who acquire, receive, possess, use, or transfer radium-226 under the general license issued in paragraph (A) of this rule are exempt from the provisions of rules 3701:1-38-07, 3701:1-38-09 to 3701:1-38-18, 3701:1-38-20 to 3701:1-38-25 of the Administrative Code, to the extent that the receipt, possession, use, or transfer of radium-226 is within the terms of the general license; provided, however, that this exemption shall not be deemed to apply to any such person specifically licensed in accordance with rule 3701:1-38-02 of the Administrative Code.

(C) Any person who acquires, receives, possesses, uses, or transfers radium-226 in accordance with the general license in paragraph (A) of this rule:

(1) Shall notify the director should there be any indication of possible damage to the product so that it appears it could result in a loss of the radioactive material. A report containing a brief description of the event, and the remedial action taken, must be furnished to the director in the manner specified in rule 3701:1-40-04 of the Administrative Code within thirty days.

(2) Shall not abandon products containing radium-226. The product, and any radioactive material from the product, may only be disposed of in accordance with rule 3701:1-38-19 of the Administrative Code, or by transfer to a person authorized by a specific license to receive the radium-226 in the product or as otherwise approved by the director.

(3) Shall not export products containing radium-226 except in accordance with United States nuclear regulatory commission regulations.

(4) Shall dispose of products containing radium-226:

(a) At a disposal facility authorized to dispose of radioactive material in accordance with Chapter 3701:1-54 of the Administrative Code or equivalent regulation of an agreement state or the United States nuclear regulatory commission;

(b) By transfer to a person authorized to receive radium-226 by a specific license issued in accordance with rule 3701:1-38-02 of the Administrative Code or equivalent regulations of an agreement state or the United States nuclear regulatory commission; or

(c) As otherwise approved by the director.

(5) Shall respond to written requests from the director to provide information relating to the general license within thirty calendar days of the date of the request, or other time specified in the request. If the general licensee cannot provide the requested information within the allotted time, it shall, within that same time period, request a longer period to supply the information by providing the director, in the manner specified in rule 3701:1-40-04 of the Administrative Code, a written justification for the request.

(D) The general license in paragraph (A) of this rule does not authorize the manufacture, assembly, disassembly, repair, or import of products containing radium-226, except that timepieces may be disassembled and repaired.

Last updated November 2, 2022 at 2:36 PM

History

• Effective: December 1, 2012
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-38-07

(A) Chapter 3701:1-38 of the Administrative Code establishes standards for protection against ionizing radiation resulting from activities conducted under licenses and registrations issued by the director. It is the purpose of Chapter 3701:1-38 of the Administrative Code to control the receipt, possession, use, transfer, and disposal of radiation sources by any licensee or registrant in such a manner that the total dose to an individual, including doses resulting from licensed and unlicensed radioactive material and from radiation sources other than background radiation, does not exceed the standards for protection against radiation prescribed in this chapter. The rules in Chapter 3701:1-38 of the Administrative Code apply to facilities that receive, possess, use, transfer, or dispose of radioactive material, and to handlers of radiation-generating equipment. Nothing in this chapter shall be construed as limiting actions of the director that may be necessary to protect health, safety or the environment. The limits in Chapter 3701:1-38 of the Administrative Code do not apply to doses due to background radiation, any medical administration the individual has received, from exposures to individuals administered radioactive materials and released in accordance with rule 3701:1-58-30 of the Administrative Code, or equivalent United States nuclear regulatory commission or agreement state regulations, or voluntary participation in medical research programs.

(B) Communications and reports, unless otherwise specified in Chapter 3701:1-38 of the Administrative Code, shall be addressed to "Ohio Department of Health, Bureau of Environmental Health and Radiation Protection, 246 North High Street, Columbus, Ohio 43215."

Last updated January 20, 2022 at 8:47 AM

History

• Effective: January 20, 2022
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-38-09

(A) Each licensee or registrant shall afford to the department at all reasonable times, the opportunity to inspect materials, machines, activities, facilities, premises, and records and any other matters relative to the handling of radioactive material or radiation-generating equipment.

(1) During an inspection, department inspectors may consult privately with workers as specified in paragraph (B) of this rule. The licensee or registrant may accompany department inspectors at any other time during the inspection.

(2) If, at the time of inspection, an individual has been authorized by the workers to represent them during department inspections, the licensee or registrant shall notify the inspector of such authorization and shall give the worker's representative an opportunity to accompany the inspector during the inspection of physical working conditions. Each worker's representative shall be routinely engaged in licensed or registered activity under control of the licensee or registrant and shall have received instructions as to the provisions specified in paragraph (B) of rule 3701:1-38-10 of the Administrative Code. Different representatives of licensees or registrants and workers may accompany the inspectors during different phases of an inspection if there is no resulting interference with the conduct of the inspection. However, only one worker's representative at a time may accompany an inspector.

(3) With the approval of the licensee or registrant and the worker's representative, an individual who is not routinely engaged in work under control of the licensee or registrant, for example, a consultant to the licensee or registrant or to the worker's representative, shall be afforded the opportunity to accompany the department inspector during the inspection of physical working conditions.

(4) Notwithstanding any other provision in paragraph (A) of this rule, a department inspector may refuse to permit accompaniment by any individual who deliberately interferes with a fair and orderly inspection. With regard to areas containing information classified by an agency of the United States government in the interest of national security, an individual who accompanies an inspector may have access to such information only if properly authorized. With regard to any area containing proprietary information or trade secrets, the worker's representative for that area shall be an individual previously authorized by the licensee or registrant to enter that area.

(B) Private consultation between a department inspector and a worker during inspections shall be subject to the following:

(1) A department inspector may consult privately with workers concerning matters of occupational radiation protection and other matters related to applicable provisions of a license condition, order, or rules adopted pursuant to Chapter 3748. of the Revised Code.

(2) During the course of an inspection, any worker privately may bring to the attention of a department inspector, either orally or in writing, any past or present condition which the worker has reason to believe may have contributed to or caused any violation of rules adopted pursuant to Chapter 3748. of the Revised Code, license condition, order, or any unnecessary exposure of an individual to sources of radiation under the licensee's or registrant's control. Any such notice in writing shall comply with the requirements specified in paragraph (C) of this rule. The provisions of this paragraph shall not be interpreted as authorization to disregard instructions pursuant to paragraph (B) of rule 3701:1-38-10 of the Administrative Code.

(C) Requests by workers for a department inspection shall be in accordance with the following:

(1) Any worker or representative of workers believing that a violation of Chapter 3748. of the Revised Code or rules adopted thereunder, license condition or order, or any unnecessary exposure of an individual to sources of radioactive material or radiation-generating equipment under the licensee's or registrant's control has occurred in the handling of radioactive material or radiation-generating equipment relative to working conditions may request an inspection by giving notice of the alleged violation to the director. Any such notice shall be in writing, shall set forth the specific grounds for the notice, and shall be signed by the worker or representative of the workers. A copy shall be provided to the licensee or registrant by the department no later than at the time of inspection except that, upon the request of the worker giving such notice, such worker's name and the name of individuals referred to therein shall not appear in such copy or on any record published, released, or made available by the department, except for good cause shown.

(2) If, upon receipt of such notice, the director determines that the written complaint meets the requirements specified in paragraph (C)(1) of this rule and that the director determines that there are reasonable grounds to believe that the alleged violation exists or has occurred or that further investigation is necessary, the department shall inspect the facility as soon as practicable to determine if such alleged violation exists or has occurred. Any such inspection is not limited to matters referred to in the written complaint.

(3) The department shall notify the complainant in writing of the results of the investigation. The complainant may resubmit the written complaint without prejudice.

(D) If the department determines under paragraph (C) of this rule that an inspection is not warranted by a written complaint, such determination shall be in accordance with the following:

(1) If the department determines that an inspection is not warranted because there are no reasonable grounds to believe that a violation exists or has occurred, the department shall notify the complainant in writing of such determination. The complainant may obtain review of such determination by submitting a written statement of position with the department. The department will provide the licensee or registrant with a copy of such statement, excluding, at the request of the complainant, the name of the complainant. The licensee or registrant may submit an opposing written statement of position with the department. The department will provide any opposing statement to the complainant.

(2) Upon the request of the complainant, the director may hold an informal conference in which the complainant and the licensee or registrant may orally present their views. An informal conference may also be held at the request of the licensee or registrant, but disclosure of the identity of the complainant will be made only following receipt of written authorization from the complainant. The director shall consider all written and oral views presented and shall notify the parties in writing of his or her decision on whether an inspection is warranted and the reason therefore.

(E) No licensee or registrant, or contractor or subcontractor of a licensee or registrant shall instruct any employee to withhold information from a department inspector or retaliate or discriminate against any employee or former employee for exercising rights or engaging in activities protected under rules adopted pursuant to Chapter 3748. of the Revised Code.

Last updated November 2, 2022 at 2:09 PM

History

• Effective: August 30, 2015
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-38-20

(A) Each licensee or registrant shall use the SI units becquerel, gray, sievert and coulomb per kilogram, or the special units curie, rad, rem and roentgen, including multiples and subdivisions, and shall clearly indicate the units of all quantities on records required by this chapter. The licensee or registrant shall make a clear distinction among the quantities entered on the records such as, total effective dose equivalent, total organ dose equivalent, shallow dose equivalent, lens dose equivalent, deep dose equivalent, or committed effective dose equivalent.

(B) Each licensee or registrant shall maintain records of the radiation protection program, including the provisions of the program and audits and other reviews of program content and implementation. The licensee or registrant shall retain the records of the provisions of the program until the department terminates each license or registration pertinent to the record. The licensee or registrant shall retain all the other records required by this paragraph for three years after the record is made.

(C) Records of surveys showing the results of surveys and calibrations required by paragraph (A) of rule 3701:1-38-14 and paragraph (F) of rule 3701:1-38-18 of the Administrative Code shall be maintained and retained by the licensee or registrant for three years after the record is made.

(D) The licensee or registrant shall retain each of the following records until the department terminates each license or registration pertinent to the record:

(1) Records of the results of surveys to determine the dose from external sources of radiation used, in the absence of or in combination with individual monitoring data, in the assessment of individual dose equivalents;

(2) Records of the results of measurements and calculations used to determine individual intakes of radioactive material and used in the assessment of internal dose;

(3) Records showing the results of air sampling, surveys, and bioassays required pursuant to paragraphs (C)(2)(a) and (C)(2)(b) of rule 3701:1-38-16 of the Administrative Code; and

(4) Records of the results of measurements and calculations used to evaluate the release of radioactive effluents to the environment.

(E) Records of tests for leakage or contamination of sealed sources shall be kept in units of becquerel or microcurie, or multiples thereof, and maintained for inspection by the department for at least three years after the records are made.

(F) Records of prior occupational dose and exposure history as required in paragraph (E) of rule 3701:1-38-12 of the Administrative Code shall be recorded by the licensee or registrant on a form provided by the department entitled "lifetime occupational exposure history" in accordance with the instructions for completing this form, or in clear and legible records containing all the information required by the same form. The licensee or registrant shall maintain these records until the department terminates each license or registration pertinent to this record. The licensee or registrant shall retain records used in preparing the form for three years after the record is made.

(G) Records of planned special exposures as required in paragraph (F) of rule 3701:1-38-12 of the Administrative Code shall be maintained by the licensee:

(1) The licensee shall maintain records that describe the following:

(a) The exceptional circumstances requiring the use of a planned special exposure;

(b) The name of the management official who authorized the planned special exposure and a copy of the signed authorization;

(c) What actions were necessary;

(d) Why the actions were necessary;

(e) What precautions were taken to assure that doses were maintained ALARA;

(f) What individual and collective doses were expected to result; and

(g) The doses actually received in the planned special exposure.

(2) The licensee shall retain the records until the department terminates each license pertinent to these records.

(H) Records of individual dose monitoring results shall be maintained by each licensee or registrant for each individual for whom monitoring is required pursuant to paragraph (B) of rule 3701:1-38-14 of the Administrative Code, and records of doses received during planned special exposures, accidents, and emergency conditions. Assessments of dose equivalent and records made using units in effect before the effective date of these rules need not be changed.

(1) These records shall include, when applicable:

(a) The deep dose equivalent to the whole body, lens dose equivalent, shallow dose equivalent to the skin, and shallow dose equivalent to the extremities;

(b) The estimated intake or radionuclides as provided in paragraph (B) of rule 3701:1-38-12 of the Administrative Code;

(c) The committed effective dose equivalent assigned to the intake of radionuclides; and

(d) The specific information used to calculate the committed effective dose equivalent pursuant to paragraph (D)(8) of rule 3701:1-38-12 of the Administrative Code; and

(e) The total effective dose equivalent when required by paragraph (B) of rule 3701:1-38-12 of the Administrative Code; and

(f) The total of the deep dose equivalent and the committed dose to the organ receiving the highest total dose.

(2) The licensee or registrant shall make entries of the records specified in paragraph (H) of this rule at least annually.

(I) Each licensee or registrant shall maintain the records specified in paragraph (H) of this rule on department form entitled "occupational exposure record for a monitoring period" in accordance with the instructions for completing this form, or in clear and legible records containing all the information required by the same form. The licensee or registrant shall maintain the records of dose to an embryo or fetus with the records of dose to the declared pregnant woman. The declaration of pregnancy shall also be kept on file, but may be maintained separately from the dose records. The licensee or registrant shall retain each required form or record until the department terminates each license or registration pertinent to the record.

(J) Each licensee or registrant shall maintain records sufficient to demonstrate compliance with the dose limits for individual members of the public specified in paragraph (A) of rule 3701:1-38-13 of the Administrative Code. Each licensee or registrant shall retain the records required by paragraph (H) of this rule until the department terminates each license or registration pertinent to the record.

(K) Records of the disposal of licensed material shall be maintained by each licensee in accordance with paragraphs (C), (D), (F), and (G) of rule 3701:1-38-19, and Chapter 3701:1-54 of the Administrative Code. The licensee shall retain the records required by this paragraph until the department terminates each pertinent license that requires the record.

(L) Records of tests performed on entry control devices located in a very high radiation area shall be maintained by each licensee in accordance with Chapter 3701:1-52 of the Administrative Code or registrant in accordance with Chapters 3701:1-66, 3701:1-67, and 3701:1-68 of the Administrative Code. These records must include the date, time, and results of each such test of function. The licensee or registrant shall retain the records required by this paragraph for at least three years after the record is made.

(M) Each record required by this chapter shall be legible throughout the specified retention period. The record shall be the original or a reproduced copy or a microform, provided that the copy or microform is authenticated by authorized personnel and that the microform is capable of producing a clear copy throughout the required retention period. The record may also be stored in electronic media with the capability for producing legible, accurate, and complete records during the required retention period. Records, such as letters, drawings, and specifications, shall include all pertinent information, such as stamps, initials, and signatures. The licensee or registrant shall maintain adequate safeguards against tampering with and loss of records.

Last updated January 20, 2022 at 8:48 AM

History

• Effective: January 20, 2022
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-38-25

Each licensee who manufactures, transfers, receives, disassembles, or disposes of a nationally tracked source shall complete and submit a national source tracking transaction report as specified in paragraphs (A) to (E) of this rule for each type of transaction.

(A) Each licensee who manufactures a nationally tracked source shall complete and submit a national source tracking transaction report. The report must include the following information:

(1) The name, address, and license number of the reporting licensee;

(2) The name of the individual preparing the report;

(3) The manufacturer, model, and serial number of the source;

(4) The radioactive material in the source;

(5) The initial source strength in becquerels (curies) at the time of manufacture; and

(6) The manufacture date of the source.

(B) Each licensee that transfers a nationally tracked source to another person shall complete and submit a national source tracking transaction report. The report must include the following information:

(1) The name, address, and license number of the reporting licensee;

(2) The name of the individual preparing the report;

(3) The name and license number of the recipient facility and the shipping address;

(4) The manufacturer, model, and serial number of the source or, if not available, other information to uniquely identify the source;

(5) The radioactive material in the source;

(6) The initial or current source strength in becquerels (curies);

(7) The date for which the source strength is reported;

(8) The shipping date;

(9) The estimated arrival date; and

(10) For nationally tracked sources transferred as waste under a uniform low-level radioactive waste manifest, the waste manifest number and the container identification of the container with the nationally tracked source.

(C) Each licensee that receives a nationally tracked source shall complete and submit a national source tracking transaction report. The report must include the following information:

(1) The name, address, and license number of the reporting licensee;

(2) The name of the individual preparing the report;

(3) The name, address, and license number of the person that provided the source;

(4) The manufacturer, model, and serial number of the source or, if not available, other information to uniquely identify the source;

(5) The radioactive material in the source;

(6) The initial or current source strength in becquerels (curies);

(7) The date for which the source strength is reported;

(8) The date of receipt; and

(9) For material received under a uniform low-level radioactive waste manifest, the waste manifest number and the container identification with the nationally tracked source.

(D) Each licensee that disassembles a nationally tracked source shall complete and submit a national source tracking transaction report. The report must include the following information:

(1) The name, address, and license number of the reporting licensee;

(2) The name of the individual preparing the report;

(3) The manufacturer, model, and serial number of the source or, if not available, other information to uniquely identify the source;

(4) The radioactive material in the source;

(5) The initial or current source strength in becquerels (curies);

(6) The date for which the source strength is reported; and

(7) The disassemble date of the source.

(E) Each licensee who disposes of a nationally tracked source shall complete and submit a national source tracking transaction report. The report must include the following information:

(1) The name, address, and license number of the reporting licensee;

(2) The name of the individual preparing the report;

(3) The waste manifest number;

(4) The container identification with the nationally tracked source;

(5) The date of disposal; and

(6) The method of disposal.

(F) The reports discussed in paragraphs (A) to (E) of this rule must be submitted by the close of the next business day after the transaction. A single report may be submitted for multiple sources and transactions. The reports must be submitted to the national source tracking system by using:

(1) The on-line national source tracking system;

(2) Electronically using a computer readable format;

(3) By facsimile;

(4) By mail to the address on the national source tracking transaction report form (NRC form 748); or

(5) By telephone with followup by facsimile or mail.

(G) Each licensee shall correct any error in previously filed reports or file a new report for any missed transaction within five business days of the discovery of the error or missed transaction. Such errors may be detected by a variety of methods such as administrative reviews or by physical inventories required by regulation. In addition, each licensee shall reconcile the inventory of nationally tracked sources possessed by the licensee against that licensee's data in the national source tracking system. The reconciliation must be conducted during the month of January in each year. The reconciliation process must include resolving any discrepancies between the national source tracking system and the actual inventory by filing the reports identified by paragraphs (A) to (E) of this rule. By January thirty-first, of each year, each licensee must submit to the national source tracking system confirmation that the data in the national source tracking system is correct.

View Appendix

Last updated November 2, 2022 at 2:11 PM

History

• Effective: November 14, 2013
• Promulgated Under: 119.03

Chapter 3701:1-48 Licensing and Safety Requirements for Industrial Radiography

Ohio Adm.Code 3701:1-48-01 Definitions.

Terms defined in rule 3701:1-38-01 of the Administrative Code shall have the same meaning when used in this chapter except terms redefined within a given rule for use within that rule only, and additionally, as used in this chapter:

(A) "Annual Refresher Safety Training" means a review conducted or provided by the licensee for its employees on radiation safety aspects of industrial radiography. The review may include, as appropriate, the results of internal inspections, new procedures or equipment, new or revised regulations, accidents or errors that have been observed, and should also provide opportunities for employees to ask safety questions.

(B) "Associated Equipment" means equipment that is used in conjunction with a radiographic exposure device to make radiographic exposures that drives, guides, or comes in contact with the source, (e.g., guide tube, control tube, control (drive) cable, removable source stop, "j" tube and collimator when it is used as an exposure head.)

(C) "Certifying Entity" means an independent certifying organization meeting the requirements in appendix A to rule 3701:1-48-16 of the Administrative Code or equivalent United States nuclear regulatory commission or agreement state regulations meeting the requirements in appendix A to rule 3701:1-48-16 of the Administrative Code.

(D) "Collimator" means a radiation shield that is placed on the end of the guide tube or directly onto a radiographic exposure device to restrict the size of the radiation beam when the sealed source is cranked into position to make a radiographic exposure.

(E) "Control (Drive) Cable" means the cable that is connected to the source assembly and used to drive the source to and from the exposure location.

(F) "Control Drive Mechanism" means a device that enables the source assembly to be moved to and from the exposure device.

(G) "Control Tube" means a protective sheath for guiding the control cable. The control tube connects the control drive mechanism to the radiographic exposure device.

(H) "Exposure Head" means a device that locates the gamma radiography sealed source in the selected working position. (An exposure head is also known as a source stop.)

(I) "Field Station" means a facility where licensed material may be stored or used and from which equipment is dispatched.

(J) "Guide Tube (Projection Sheath)" means a flexible or rigid tube (i.e. "j" tube) for guiding the source assembly and the attached control cable from the exposure device to the exposure head. The guide tube may also include the connections necessary for attachment to the exposure device and to the exposure head.

(K) "Hands-On Experience" means experience in all of those areas considered to be directly involved in the radiography process.

(L) "Independent Certifying Organization" means an independent organization that meets all of the criteria of appendix A to rule 3701:1-48-16 of the Administrative Code.

(M) "Industrial Radiography (Radiography)" means an examination of the structure of materials by nondestructive methods, utilizing sealed sources of radioactive material.

(N) "Lay-Barge Radiography" means industrial radiography performed on any water vessel used for laying pipe.

(O) "Offshore Platform Radiography" means industrial radiography conducted from a platform over a body of water.

(P) "Permanent Radiographic Installation" means an enclosed shielded room, cell, or vault, not located at a temporary job site, in which radiography is performed.

(Q) "Practical Examination" means a demonstration through practical application of the safety rules and principles in industrial radiography including use of all appropriate equipment and procedures.

(R) "Radiation Safety Officer for Industrial Radiography" means an individual with the responsibility for the overall radiation safety program on behalf of the licensee and who meets the requirements of rule 3701:1-48-15 of the Administrative Code.

(S) "Radiographer" means any individual who performs or who, in attendance at the site where the sealed source or sources are being used, personally supervises industrial radiographic operations and who is responsible to the licensee for assuring compliance with the requirements of Chapter 3748. of the Revised Code and rules promulgated thereunder in addition to the conditions of the license.

(T) "Radiographer Certification" means written approval received from a certifying entity stating that an individual has satisfactorily met certain established radiation safety, testing, and experience criteria.

(U) "Radiographer's Assistant" means any individual who, under the personal supervision (physical presence of the radiographer) of a radiographer, uses radiographic exposure devices, sealed sources or related handling tools, or radiation survey instruments in industrial radiography.

(V) "Radiographic Exposure Device (also called a Camera, or a Projector)" means any instrument containing a sealed source fastened or contained therein, in which the sealed source or shielding thereof may be moved, or otherwise changed, from a shielded to unshielded position for purposes of making a radiographic exposure.

(W) "Radiographic Operations" means all activities associated with the presence of radioactive sources in a radiographic exposure device during use of the device or transport (except when being transported by a common or contract transport), to include surveys to confirm the adequacy of boundaries, setting up equipment and any activity inside restricted area boundaries.

(X) "S-Tube" means a tube through which the radioactive source travels when inside a radiographic exposure device.

(Y) "Shielded Position" means the location within the radiographic exposure device or source changer where the sealed source is secured and restricted from movement.

(Z) "Source Assembly" means an assembly that consists of the sealed source and a connector that attaches the source to the control cable. The source assembly may also include a stop ball used to secure the source in the shielded position.

(AA) "Source Changer" means a device designed and used for replacement of sealed sources in radiographic exposure devices, including those also used for transporting and storage of sealed sources.

(BB) "Storage Area" means any location, facility, or vehicle which is used to store or to secure a radiographic exposure device, a storage container, or a sealed source when it is not in use and which is locked or has a physical barrier to prevent accidental exposure, tampering with, or unauthorized removal of the device, container, or source.

(CC) "Storage Container" means a container in which sealed sources are secured and stored.

(DD) "Temporary Job Site" means a location where radiographic operations are conducted and where licensed material may be stored other than those location(s) of use authorized on the license.

(EE) "Underwater Radiography" means industrial radiography performed when the radiographic exposure device and/or related equipment are beneath the surface of the water.

Last updated November 2, 2022 at 2:36 PM

History

• Effective: January 1, 2012
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-38-01

(A) As used in this chapter and all other rules promulgated pursuant to Chapter 3748. of the Revised Code:

(1) "A₁" means the maximum activity of special form radioactive material permitted in a type A package. These values are listed in rule 3701:1-50-25 of the Administrative Code, or may be derived in accordance with the procedure prescribed in rule 3701:1-50-25 of the Administrative Code.

(2) "A₂" means the maximum activity of radioactive material, other than special form, low specific activity and surface contaminated object material, permitted in a type A package. These values are listed in rule 3701:1-50-25 of the Administrative Code, or may be derived in accordance with the procedure prescribed in rule 3701:1-50-25 of the Administrative Code.

(3) "Absorbed dose" means the energy imparted by ionizing radiation per unit mass of irradiated material. The units of absorbed dose are the gray, or Gy, and the rad.

(4) "Accelerator or charged particle accelerator" means any of a class of radiation generating equipment designed to electronically accelerate atomic or sub-atomic particles for subsequent bombardment of targets.

(5) "Accelerator-produced radioactive material" means any material made radioactive by a particle accelerator.

(6) "Activity" means the rate of disintegration or transformation or decay of radioactive material. The units of activity are the becquerel, or Bq, and the curie, or Ci.

(7) "Address of use" means the building or buildings that are identified on the license or registration and where the source of radiation may be received, used, prepared, or stored, except for temporary job sites.

(8) "Administrative controls" means mechanisms used to protect health and minimize damage to life and property through the use of written policies, procedures, instructions, training, observation of work practices, and related compliance audits.

(9) "Administrative monetary penalty" means a monetary penalty assessed by the director under section 3748.05 of the Revised Code and in compliance with rules adopted thereunder, to emphasize the need for lasting remedial action and to deter future violations.

(10) "Adult" means an individual eighteen or more years of age.

(11) "Agreement state" means any state with which the United States nuclear regulatory commission or the atomic energy commission has entered into an effective agreement under subsection 274B of the Atomic Energy Act of 1954, 68 Stat. 919, 42 U.S.C. 2021, as amended (1978). Non-agreement state means any other state.

(12) "Airborne radioactive material" means radioactive material dispersed in the air in the form of dusts, fumes, particulates, mists, vapors, or gases.

(13) "Airborne radioactivity area" means a room, enclosure, or area in which airborne radioactive materials, composed wholly or partly of licensed material, exist in concentrations:

(a) In excess of the derived air concentrations (DACs) specified in appendix C to rule 3701:1-38-12 of the Administrative Code, or

(b) To such a degree that an individual present in the area without respiratory protective equipment could exceed, during the hours an individual is present in a week, an intake of 0.6 per cent of the annual limit on intake or twelve DAC-hours.

(14) "Air-purifying respirator" means a respirator with an air-purifying filter, cartridge, or canister that removes specific air contaminants by passing ambient air through the air-purifying element.

(15) "ALARA" or "as low as is reasonably achievable" means every reasonable effort to maintain exposures to radiation as far below the dose limits as is practical consistent with the purpose for which the licensed or registered activity is undertaken, taking into account the state of technology, the economics of improvements in relation to benefits to the public health and safety, and other societal and socioeconomic considerations, and in relation to utilization of nuclear energy and licensed materials and registered activities in the public interest.

(16) "Alert" means events may occur, are in progress, or have occurred that could lead to a release of radioactive material but that the release is not expected to require a response by off-site response organizations to protect persons off-site.

(17) "Annual limit on intake" or "ALI" means the derived limit for the amount of radioactive material taken into the body of an adult worker by inhalation or ingestion in a year. ALI is the smaller value of intake of a given radionuclide in a year by the reference man that would result in a committed effective dose equivalent of 0.05 sievert (five rem) or a committed dose equivalent of 0.5 sievert (fifty rem) to any individual organ or tissue. ALI values for intake by ingestion and by inhalation of selected radionuclides are given in appendix C to rule 3701:1-38-12 of the Administrative Code.

(18) "Annually" means either

(a) At intervals not to exceed one year; or

(b) Once per year, at about the same time each year, plus or minus one month.

(19) "Area of use" means a portion of an address of use that has been set aside for the purpose of receiving, preparing, using, or storing sources of radiation.

(20) "Assigned protection factor" or "APF" means the expected workplace level of respiratory protection that would be provided by a properly functioning respirator or a class of respirators to properly fitted and trained users. Operationally, the inhaled concentration can be estimated by dividing the ambient airborne concentration by the APF.

(21) "Atmosphere-supplying respirator" means a respirator that supplies the respirator user with breathing air from a source independent of the ambient atmosphere, and includes supplied air respirators, or SARs, and self-contained breathing apparatus, or SCBA, units.

(22) "Atomic energy commission" or "AEC" means the federal agency created by the Atomic Energy Act of 1954, 68 Stat. 919, 42 U.S.C. 2011, as amended (1964), and was the predecessor agency to the current United States nuclear regulatory commission.

(23) "Background radiation" means radiation from cosmic sources; naturally occurring radioactive materials, including radon, except as a decay product of source or special nuclear material, and global fallout as it exists in the environment from the testing of nuclear explosive devices or from past nuclear accidents such as Chernobyl that contribute to background radiation and are not under the control of the licensee. "Background radiation" does not include radiation from radioactive materials regulated by the department.

(24) "Becquerel" or "Bq" means the SI unit of activity. One becquerel is equal to one disintegration per second.

(25) "Bioassay" or "radiobioassay" means the determination of kinds, quantities or concentrations, and, in some cases, the locations of radioactive material in the human body, whether by direct measurement, in vivo counting, or by analysis and evaluation of materials excreted or removed from the human body.

(26) "Byproduct material" means

(a) Any radioactive material, except special nuclear material, yielded in or made radioactive by exposure to the radiation incident to the process of producing or utilizing special nuclear materials; or

(b) The tailings or wastes produced by the extraction or concentration of uranium or thorium from any ore processed primarily for its source material content, including discrete surface wastes resulting from solution extraction processes. Underground ore bodies depleted by such solution extraction do not constitute byproduct material within the definition.

(27) "Chelating agent" means a chemical compound or mixture that enhances the removal of radioactive material from the body, water or similar applications. Typical chelating agents include amine polycarboxylic acids such as EDTA or DTPA; hydroxy-carboxylic acids; and polycarboxylic acids such as citric acid, carbolic acid, and gluconic acid.

(28) "Chiropractor" means an individual licensed by the state of Ohio to practice chiropractic medicine pursuant to Chapter 4734. of the Revised Code.

(29) "Class" or "lung class" or "inhalation class" means a classification scheme for inhaled material according to its rate of clearance from the pulmonary region of the lung. Materials are classified as D, W, or Y, which applies to a range of clearance half-times: for class D, days, of less than ten days, for class W, weeks, from ten to one hundred days, and for class Y, years, of greater than one hundred days.

(30) "Collective dose" means the sum of the individual doses received in a given period of time by a specified population from exposure to a specified source of radiation.

(31) "Commencement of construction" means taking any action defined as "construction" or any other activity at the site of a facility subject to the rules promulgated pursuant to Chapter 3748. of the Revised Code that has a reasonable nexus to radiological health and safety.

(32) "Committed dose equivalent" or "H_T,50" means the dose equivalent to organs or tissues of reference, T, that will be received from an intake of radioactive material by an individual during the fifty year period following the intake.

(33) "Committed effective dose equivalent" or "H_E,50" means the sum of the products of the weighting factors applicable to each of the body organs or tissues, W_T, that are irradiated and the committed dose equivalent to each of these organs or tissues (H_{E, 50} = W_TH_T,50).

(34) "Consortium" means an association of medical use licensees and a PET radionuclide production facility in the same geographical area that jointly own or share in the operation and maintenance cost of the PET radionuclide production facility that produces PET radionuclides for use in producing radioactive drugs within the consortium for noncommercial distributions among its associated members for medical use. The PET radionuclide production facility within the consortium must be located at an educational institution or a medical facility.

(35) "Constraint" or "dose constraint" means a value above which specified licensee actions are required.

(36) "Construction" means the installation of foundations, or in-place assembly, erection, fabrication, or testing for any structure, system, or component of a facility or activity subject to the rules promulgated pursuant to Chapter 3748. of the Revised Code that are related to radiological safety or security. The term "construction" does not include:

(a) Changes for temporary use of the land for public recreational purposes;

(b) Site exploration, including necessary borings to determine foundation conditions or other preconstruction monitoring to establish background information related to the suitability of the site, the environmental impacts of construction or operation, or the protection of environmental values;

(c) Preparation of the site for construction of the facility, including clearing of the site, grading, installation of drainage, erosion and other environmental mitigation measures, and construction of temporary roads and borrow areas;

(d) Erection of fences and other access control measures that are not related to the safe use of, or security of, radiological materials subject to the rules promulgated pursuant to Chapter 3748. of the Revised Code;

(e) Excavation;

(f) Erection of support buildings (e.g. construction equipment storage sheds, warehouse and shop facilities, utilities, concrete mixing plants, docking and unloading facilities, and office buildings) for use in connection with the construction of the facility;

(g) Building of service facilities (e.g. paved roads, parking lots, railroad spurs, exterior utility and lighting systems, potable water systems, sanitary sewerage treatment facilities, and transmission lines);

(h) Procurement or fabrication of components or portions of the proposed facility occurring at other than the final, in-place location at the facility; or

(i) Taking any other action that has no reasonable nexus to radiological health and safety.

(37) "Controlled area" means an area, outside of a restricted area but inside the site boundary, access to which can be limited by the licensee or registrant for any reason.

(38) "Critical group" means the group of individuals reasonably expected to receive the greatest exposure to residual radioactivity for any applicable set of circumstances.

(39) "Curie" or "Ci" means a unit of activity. One curie equals 3.7 x 10¹⁰ disintegrations per second equals 3.7 x 10¹⁰ becquerels equals 2.22 x 10¹² disintegrations per minute.

(40) "Cyclotron" means a particle accelerator in which the charged particles travel in an outward spiral or circular path. A cyclotron accelerates charged particles at energies usually in excess of ten megaelectron volts and is commonly used for production of short half-life radionuclides for medical use.

(41) "Declared pregnant woman" means a woman who has voluntarily informed the licensee or registrant, in writing, of her pregnancy and the estimated date of conception. The declaration remains in effect until the declared pregnant woman withdraws the declaration in writing or is no longer pregnant.

(42) "Decommission" means to safely remove any licensed operation from service and reduce residual radioactivity to a level that permits release of the licensee's property for unrestricted use and termination of the license.

(43) "Dedicated check source" means a radioactive source that is used to assure the consistent performance of a radiation detection or measurement device over several months or years.

(44) "Deep dose equivalent" or "H_d" applies to external whole body exposure, and means the dose equivalent at a tissue depth of one centimeter, one thousand milligram per square centimeter.

(45) "Demand respirator" means an atmosphere-supplying respirator that admits breathing air to the facepiece only when a negative pressure is created inside the facepiece by inhalation.

(46) "Dentist" means an individual licensed by the state of Ohio to practice dentistry under Chapter 4715. of the Revised Code.

(47) "Department" means the Ohio department of health.

(48) "Depleted uranium" means uranium containing less uranium-235 than the naturally occurring distribution of uranium isotopes.

(49) "Derived air concentration" or "DAC" means the concentration of a given radionuclide in air which, if breathed by the reference man for a working year of two thousand hours under conditions of light work, results in an intake of one ALI. The condition of light work is inhaling 1.2 cubic meters of air per hour for two thousand hours in a year. DAC values are given in appendix C to rule 3701:1-38-12 of the Administrative Code.

(50) "Derived air concentration-hour or DAC-hour" means the product of the concentration of radioactive material in air, which is expressed as a fraction or multiple of the derived air concentration for each radionuclide, and the time of exposure to that radionuclide, in hours. A licensee or registrant may take two thousand DAC-hours to represent one ALI, equivalent to a committed effective dose equivalent of 0.05 Sv (five rem).

(51) "Direct reading dosimeter" means a device that measures radiation dose that does not require another device to read the measured radiation dose. Examples of direct reading dosimeters include pocket dosimeters and electronic dosimeters.

(52) "Director" means the director of health or a designee or authorized representative of the director.

(53) "Discipline" means a branch of knowledge or of teaching.

(54) "Discrete source" means a radionuclide that has been processed so that its concentration within a material has been purposely increased for use for commercial, medical, or research activities.

(55) "Disposable respirator" means a respirator for which maintenance is not intended and that is designed to be discarded after excessive breathing resistance, sorbent exhaustion, physical damage, or end-of service-life renders it unsuitable for use. Examples of this type of respirator are a disposable half-mask respirator or a disposable escape-only self-contained breathing apparatus.

(56) "Dose" or "radiation dose" is a generic term that means absorbed dose, dose equivalent, effective dose equivalent, committed effective dose equivalent, or total effective dose equivalent as defined in other paragraphs of this rule.

(57) "Dose equivalent" or "H_T" means the product of the absorbed dose in tissue, quality factor, and all other necessary modifying factors at the location of interest. The units of dose equivalent are the sievert and rem.

(58) "Dose limits" or "limits" means the permissible upper bounds of radiation doses established in accordance with these regulations but excludes background radiation and medical exposure.

(59) "Dosimetry processor" means a person that processes and evaluates individual monitoring devices in order to determine the radiation dose delivered to the monitoring devices.

(60) "Effective dose equivalent" or "H_E" means the sum of the products of the dose equivalent to each organ or tissue, H_T, and the weighting factor, W_T, applicable to each of the body organs or tissues that are irradiated: (H_E = ∑W_TH_T).

(61) "Embryo" or "fetus" means the developing human organism from conception until time of birth.

(62) "Engineering controls" means mechanisms used to protect health and minimize damage to life and property through engineering specifications, design, and construction of the product or facility including all of the security and safety features. This includes, but is not limited to, auxiliary security and safety features such as additional external shielding, barriers, and operational interlocks with associated processes.

(63) "Entrance" or "access point" means any opening through which an individual or extremity of an individual could gain access to radiation areas or to licensed radioactive materials or registered radiation generating equipment. This includes entry or exit portals of sufficient size to permit human entry, irrespective of their intended use.

(64) "Explosive material" means any chemical compound, mixture or device which produces a substantial instantaneous release of gas and heat spontaneously or by contact with sparks or flame.

(65) "Exposure" means being exposed to sources of ionizing radiation.

(66) "External dose" means that portion of the dose equivalent received from radiation sources outside the body.

(67) "Extremity" means hand, elbow, arm below the elbow, foot, knee, or leg below the knee.

(68) "Eye dose equivalent" means the same as lens dose equivalent.

(69) "Facility" means all buildings, equipment, structures and other stationary items that, in addition to the meaning defined in division (H) of section 3748.01 of the Revised Code, are:

(a) Located on a single site or on contiguous or adjacent sites and are operated by the same person and have common corporate or business interests; or

(b) Portions of a building or structure which are operated by the same person and have common corporate or business interests.

(70) "Filtering facepiece" or "dust mask" means a negative pressure particulate respirator with a filter as an integral part of the facepiece or with the entire facepiece composed of the filtering medium, not equipped with elastomeric sealing surfaces and adjustable straps.

(71) "Fissile material" means the radionuclides uranium-233, uranium-235, plutonium-239, and plutonium-241, or any combination of these radionuclides. Fissile material means the fissile nuclides themselves, not material containing fissile nuclides. Unirradiated natural uranium and depleted uranium and natural uranium or depleted uranium that has been irradiated in thermal reactors only, are not included in this definition. Certain exclusions from fissile material controls are provided in rule 3701:1-50-13 of the Administrative Code.

(72) "Fit factor" means quantitative estimate of the fit of a particular respirator to a specific individual, and typically estimates the ratio of the concentration of a substance in ambient air to its concentration inside the respirator when worn.

(73) "Fit test" means the use of a protocol to qualitatively or quantitatively evaluate the fit of a respirator on an individual.

(74) "Generally applicable environmental radiation standards" means standards issued by the United States environmental protection agency under the authority of the Atomic Energy Act of 1954, 68 Stat. 919, 42 U.S.C. 2011, as amended (2005), that impose limits on radiation exposures or levels, or concentrations or quantities of radioactive material, in the general environment outside the boundaries of locations under the control of persons possessing or using radioactive material.

(75) "Gray" or "Gy" means the SI unit of absorbed dose. One gray is equal to an absorbed dose of one joule per kilogram (one hundred rads).

(76) "Handle" means receive, possess, use, store, transfer, install, service, or dispose of sources of radiation unless possession is solely for the purpose of transportation.

(77) "Handler" means a facility that handles sources of radiation unless possession is solely for the purpose of transportation.

(78) "Hazardous waste" means those wastes designated as hazardous by rule 3745-51-03 of the Administrative Code.

(79) "Helmet" means a rigid respiratory inlet covering that also provides head protection against impact and penetration.

(80) "High radiation area" means an area, accessible to individuals, in which radiation levels from radiation sources external to the body could result in an individual receiving a dose equivalent in excess of one millisievert (0.1 rem) in one hour at thirty centimeters from the radiation source or thirty centimeters from any surface that the radiation penetrates.

(81) "Hood" means a respiratory inlet covering that completely covers the head and neck and may also cover portions of the shoulders and torso.

(82) "Individual" means any human being.

(83) "Individual monitoring" means

(a) The assessment of dose equivalent by the use of devices designed to be worn by an individual;

(b) The assessment of committed effective dose equivalent by bioassay or by determination of the time-weighted air concentrations to which an individual has been exposed, i.e. DAC-hours; or

(c) The assessment of dose equivalent by the use of survey data.

(84) "Individual monitoring devices" means devices designed to be worn by a single individual for the assessment of dose equivalent such as film badges; thermoluminescent dosimeters; optically stimulated luminescent dosimeters; pocket ionization chambers; and personal air sampling devices.

(85) "Industrial radiography" means the examination of the structure of materials by nondestructive methods, utilizing sealed sources of radioactive material or radiation-generating equipment.

(86) "Internal dose" means that portion of the dose equivalent received from radioactive material taken into the body.

(87) "Irradiator" means a facility that uses radioactive sealed sources for the irradiation of objects or materials and in which radiation dose rates exceeding five grays (five hundred rads) per hour exist at one meter from the sealed radioactive source in air or water, as applicable for the irradiator type, but does not include irradiators in which both the sealed source and the area subject to irradiation are contained within a device and are not accessible to personnel.

(88) "Lens dose equivalent" or "eye dose equivalent" means the external exposure of the lens of the eye and is taken as the dose equivalent at a tissue depth of 0.3 centimeters; i.e. three hundred milligrams per square centimeter.

(89) "License" means a license issued by the nuclear regulatory commission, the director, or another agreement state in accordance with rules adopted by those organizations.

(90) "Licensee" means a person to whom a license is issued.

(91) "Licensed activity" means an activity authorized by a radioactive material license which is essential to achieving the purpose for which the license was issued or amended.

(92) "Licensed material" means radioactive material received, possessed, used, transferred or disposed of under a general or specific license.

(93) "Loose-fitting facepiece" means a respiratory inlet covering that is designed to form a partial seal with the face.

(94) "Lost or missing licensed source of radiation" means a licensed source of radiation whose location is unknown. It includes material that has been shipped but has not reached its destination and whose location cannot be readily traced in the transportation system.

(95) "Low-level radioactive waste" or "LLRW," also "low-level waste," or "LLW" means radioactive waste which is not high-level radioactive waste, spent nuclear fuel, NARM, or byproduct material as defined in section 11 E. (2) of the Atomic Energy Act of 1954 68 Stat. 919, 42 U.S.C. 2011, as amended (2005), but is radioactive material that the United States nuclear regulatory commission classifies as low-level radioactive waste.

(96) "Low specific activity material" or "LSA" means radioactive material with limited specific activity which is nonfissile or is excepted under rule 3701:1-50-13 of the Administrative Code, and which satisfies the descriptions and limits set forth below. Shielding materials surrounding the LSA material may not be considered in determining the estimated average specific activity of the package contents. LSA must be in one of three groups:

(a) LSA - I.

(i) Uranium and thorium ores, concentrates of uranium and thorium ores, and other ores containing naturally occurring radioactive radionuclides that are intended to be processed for the use of these radionuclides;

(ii) Natural uranium, depleted uranium, natural thorium or their compounds or mixtures, provided they are unirradiated and in solid or liquid form;

(iii) Radioactive material other than fissile material, for which the A₂ value is unlimited; or

(iv) Other radioactive material in which the activity is distributed throughout and the estimated average specific activity does not exceed thirty times the value for exempt material activity concentration determined in accordance with rule 3701:1-50-25 of the Administrative Code.

(b) LSA-II.

(i) Water with tritium concentration up to 0.8 terabecquerels per liter (twenty curies per liter); or

(ii) Other material in which the activity is distributed throughout and the estimated average specific activity does not exceed ( 10^-4 A₂) per gram for solids and gases, and (10^-5 A₂) per gram for liquids.

(c) LSA-III. Solids (e.g., consolidated wastes, activated materials), excluding powders, that satisfy the requirements of 10 C.F.R. 71.77 (as in effect on the effective date of this rule), in which:

(i) The radioactive material is distributed throughout a solid or a collection of solid objects, or is essentially uniformly distributed in a solid compact binding agent (such as concrete, bitumen, ceramic, etc.);

(ii) The radioactive material is relatively insoluble, or it is intrinsically contained in a relatively insoluble material, so that even under loss of packaging, the loss of radioactive material per package by leaching, when placed in water for seven days, would not exceed (0.1 x A₂); and

(iii) The estimated average specific activity of the solid, excluding any shielding material, does not exceed (0.002 x A₂) per gram.

(97) "Management" means the chief executive officer or other individual having the authority to manage, direct, or administer the licensee's activities, or those persons' delegate or delegates.

(98) "Medical institution" means an organization in which more than one medical discipline is practiced.

(99) "Medical use" means the intentional internal or external administration of radioactive material or the radiation therefrom to patients or human research subjects under the supervision of an authorized user.

(100) "Member of the public" means any individual except when that individual is receiving an occupational dose.

(101) "Minor" means an individual less than eighteen years of age.

(102) "Monitoring" or "radiation monitoring" or "radiation protection monitoring" means the measurement of radiation levels, concentrations, surface area concentrations or quantities of radioactive material and the use of the results of these measurements to evaluate potential exposures and doses.

(103) "NARM" or "naturally occurring or accelerator-produced radioactive material" means naturally occurring or accelerator-produced radioactive material, including naturally occurring material that is technologically enhanced, and those nuclides that are generated in a charged particle accelerator, but does not include source material, byproduct material, or special nuclear material.

(104) "NARM licensing state" means any state with regulations equivalent to the suggested state regulations for control of radiation relating to, and an effective program for, the regulatory control of NARM and which has been granted final designation by the conference of radiation control program directors, inc.

(105) "Nationally tracked source" means a sealed source containing a quantity equal to or greater than "Category 1" or "Category 2" levels of any radioactive material listed in the appendix to rule 3701:1-38-25 of the Administrative Code. In this context a sealed source is defined as radioactive material that is sealed in a capsule or closely bonded, in a solid form and which is not exempt from regulatory control. It does not mean material encapsulated solely for disposal, or nuclear material contained in any fuel assembly, subassembly, fuel rod, or fuel pellet. "Category 1" nationally tracked sources are those containing radioactive material at a quantity equal to or greater than the "Category 1" threshold. "Category 2" nationally tracked sources are those containing radioactive material at a quantity equal to or greater than the "Category 2" threshold but less than the "Category 1" threshold.

(106) "Negative pressure respirator" or "tight fitting respirator" means a respirator in which the air pressure inside the facepiece is negative during inhalation with respect to the ambient air pressure outside the respirator.

(107) "Nonstochastic effect" or "deterministic effect" means health effects, the severity of which varies with the dose and for which a threshold is believed to exist. Radiation-induced cataract formation is an example of a nonstochastic effect.

(108) "NORM" or "naturally occurring radioactive material" means any nuclide that is radioactive in its natural physical state, but does not include source material, byproduct material, or special nuclear material.

(109) "Normal form radioactive material" means radioactive material that has not been demonstrated to qualify as special form radioactive material.

(110) "Nuclear regulatory commission" means the federal agency established by Title II of the Energy Reorganization Act of 1974, 88 Stat. 1233, 42 U.S.C.A. 5801, as amended (2005), comprising the members of the commission and all offices, employees, and representatives authorized to act in any case or matter related to licensing and related regulatory function previously assigned to the AEC.

(111) "Occupational dose" means the dose received by an individual in the course of employment in which the individual's assigned duties involve exposure to radiation or radioactive material from licensed and unlicensed sources of radiation, whether in the possession of the licensee or other person. Occupational dose does not include doses received from background radiation, from any medical administration the individual has received, from exposures to individuals administered radioactive materials and released in accordance with rule 3701:1-58-30 of the Administrative Code or equivalent United States nuclear regulatory commission or agreement state regulations, from voluntary participation in medical research programs, or as a member of the public.

(112) "Package" means the packaging together with its radioactive contents as presented for transport.

(a) Fissile material package or type AF package, type BF package, type B(U)F package, or type B(M)F package means a fissile material packaging together with its fissile material contents.

(b) Type A package means a type A packaging together with its radioactive contents. A type A package is defined and must comply with the United States department of transportation regulations in 49 C.F.R. 173 (as in effect on the effective date of this rule).

(c) Type B package means a type B packaging together with its radioactive contents. On approval, a type B package design is designated by the United States nuclear regulatory commission as B(U) unless the package has a maximum normal operating pressure of more than seven hundred kilopascals (one hundred pounds per square inch) gauge or a pressure relief device that would allow the release of radioactive material to the environment under the tests specified in 10 C.F.R. 71.73 (hypothetical accident conditions) (as in effect on the effective date of this rule), in which case it will receive a designation B(M). B(U) refers to the need for unilateral approval of international shipments; B(M) refers to the need for multilateral approval of international shipments. There is no distinction made in how packages with these designations may be used in domestic transportation. To determine their distinction for international transportation, see United States department of transportation regulations in 49 C.F.R. 173 (as in effect on the effective date of this rule). A type B package approved before September 6, 1983, was designated only as type B. Limitations on its use are specified in 10 C.F.R. 71.19 (as in effect on the effective date of this rule).

(113) "Packaging" means the assembly of components necessary to ensure compliance with the packaging requirements of rule 49 C.F.R. 173 Subpart I (as in effect on the effective date of this rule). It may consist of one or more receptacles, absorbent materials, spacing structures, thermal insulation, radiation shielding, and devices for cooling or absorbing mechanical shocks. The vehicle, tie-down system and auxiliary equipment may be designated as part of the packaging.

(114) "Particle accelerator" means any machine capable of accelerating electrons, protons, deuterons, or other charged particles in a vacuum and of discharging the resultant particulate or other radiation into a medium at energies usually in excess of one megaelectron volt. For purposes of this definition, "accelerator" is an equivalent term.

(115) "Person" means any individual, corporation, association, business enterprise, or other legal entity either public or private and any legal successor, representative, agent, or agency of that individual, corporation, association, business enterprise, or other legal entity. Person also includes the United States, states, political subdivisions of states, and any department, agency, or instrumentality of the United States or a state, except the U.S. department of energy or the U.S. nuclear regulatory commission where the state regulation of radioactive material by either of those agencies is prohibited by federal law.

(116) "Personnel dosimeter", means a device that measures radiation dose that is processed and evaluated by an accredited "National Voluntary Laboratory Accreditation Program" (NVLAP) processor. Examples of personnel dosimeters include film badges, thermo-luminescent dosimeters (TLD), and optically stimulated luminescence (OSL) dosimeters.

(117) "Pharmacist" means a person who is licensed by the state of Ohio to practice pharmacy pursuant to Chapter 4731. of the Revised Code.

(118) "Physician" means a person who is licensed pursuant to Chapter 4731. of the Revised Code to practice medicine or surgery or osteopathic medicine or surgery.

(119) "Planned special exposure" means an infrequent exposure to radiation, separate from and in addition to the annual dose limits.

(120) "Podiatrist" means an individual licensed by the state of Ohio to practice podiatry pursuant to Chapter 4731. of the Revised Code.

(121) "Positive pressure respirator" means a respirator in which the pressure inside the respiratory inlet covering exceeds the ambient air pressure outside the respirator.

(122) "Positron Emission Tomography (PET) radionuclide production facility" means a facility operating a cyclotron or accelerator for the purpose of producing PET radionuclides.

(123) "Powered air-purifying respirator" or "PAPR" means an air-purifying respirator that uses a blower to force the ambient air through air purifying elements to the inlet covering.

(124) "Pressure demand respirator" means a positive pressure atmosphere supplying respirator that admits breathing air to the facepiece when the positive pressure is reduced inside the facepiece by inhalation.

(125) "Public dose" means the dose received by a member of the public from exposure to radiation and/or radioactive material released by the licensee, or to any other source of radiation under the control of a licensee or registrant. Public dose does not include occupational dose or doses received from background radiation, from any medical administration the individual has received, from exposures to individuals administered radioactive materials and released in accordance with rule 3701:1-58-30 of the Administrative Code or equivalent United States nuclear regulatory commission or agreement state regulations, or from voluntary participation in medical research programs.

(126) "Pyrophoric material" means any liquid that ignites spontaneously in dry or moist air at or below 54.4 degrees celsius (one hundred thirty degrees fahrenheit). A pyrophoric solid is any solid material, other than one classed as an explosive, which under normal conditions is liable to cause fires through friction, retained heat from manufacturing or processing, or which can be ignited readily and when ignited burns so vigorously and persistently as to create a serious transportation, handling, or disposal hazard. Included are spontaneously combustible and water-reactive materials.

(127) "Qualitative fit test" or "QLFT" means a pass/fail fit test to assess the adequacy of respirator fit that relies on the individual's response to the test agent.

(128) "Quality factor" or "Q" means the modifying factor, as listed in paragraphs (A) and (B) of rule 3701:1-38-11 of the Administrative Code, that is used to derive dose equivalent from absorbed dose.

(129) "Quantitative fit test" or "QNFT" means an assessment of the adequacy of respirator fit by numerically measuring the amount of leakage into the respirator.

(130) "Quarter" or "quarterly" means a period of time equal to one-fourth of the year observed by the licensee or registrant, approximately thirteen consecutive weeks, providing that the beginning of the first quarter in a year coincides with the starting date of the year and that no day is omitted or duplicated in consecutive quarters.

(131) "Rad" means the special unit of radiation absorbed dose. One rad is equal to an absorbed dose of one hundred ergs per gram, or 0.01 joule per kilogram, or 0.01 gray.

(132) "Radiation" or "ionizing radiation" means alpha particles, beta particles, gamma rays, x-rays, neutrons, high speed electrons, high speed protons, and other particles capable of producing ions. Radiation does not include nonionizing radiation, such as radio or microwaves, or visible, infrared or ultraviolet light.

(133) "Radiation area" means an area, accessible to individuals, in which radiation levels could result in an individual receiving a dose equivalent in excess of 0.05 millisievert (0.005 rem) in one hour at thirty centimeters from the source of radiation or from any surface that the radiation penetrates.

(134) "Radiation-generating equipment" or "RGE" means any manufactured product or device, or component of such a product or device, or any machine or system that during operation can generate or emit radiation, except those that emit radiation only from radioactive material. "Radiation-generating equipment" does not include either of the following:

(a) Diathermy machines;

(b) Microwave ovens, including food service microwave ovens used for commercial and industrial uses, television receivers, electric lamps, and other household appliances and products that generate very low levels of radiation.

(135) "Radiation Safety Officer" or "RSO" means an individual designated by the licensee who has the knowledge and responsibility for the overall radiation safety program at the facility, to include the implementation of the daily radiation safety operations and compliance with the rules.

(136) "Radioactive material" means any solid, liquid or gaseous material that emits ionizing radiation spontaneously. "Radioactive material" includes accelerator-produced and naturally occurring radioactive materials and byproduct, source, and special nuclear material.

(137) "Radioactive waste" means waste containing regulated radioactive material.

(138) "Radioactivity" means the transformation of unstable atoms by the emission of radiation.

(139) "Radiography" means the same as industrial radiography.

(140) "Reference man" means a hypothetical aggregation of human physical and physiological characteristics arrived at by international consensus. These characteristics may be used by researchers and public health workers to standardize results of experiments and to relate biological insult to a common base.

(141) "Registrant" means a person required by Chapter 3748. of the Revised Code to register radiation-generating equipment with the director.

(142) "Rem" means the special unit of any of the quantities expressed as dose equivalent. The dose equivalent in rem is equal to the absorbed dose in rads multiplied by the quality factor (one rem = 0.01 Sv).

(143) "Research and development" means

(a) Theoretical analysis, exploration, or experimentation; or

(b) The extension of investigative findings and theories of a scientific or technical nature into practical application for experimental and demonstration purposes, including the experimental production and testing of models, devices, equipment, materials and processes. "Research and development" does not include the internal or external administration of sources of radiation to human beings.

(144) "Residual radioactivity" means radioactivity in structures, materials, soils, groundwater, and other media at a site resulting from activities under the licensee's control. This includes radioactivity from all licensed and unlicensed sources used by the licensee, but excludes background radiation. It also includes radioactive materials remaining at the site as a result of routine or accidental releases of radioactive material at the site and previous burials at the site, even if those burials were made in accordance with the provisions of 10 C.F.R. 20 (as in effect on the effective date of this rule).

(145) "Respiratory protective equipment or device" means an apparatus, such as a respirator, used to reduce the individual's intake of airborne radioactive materials.

(146) "Restricted area" means an area access to which is limited by the licensee or registrant for the purpose of protecting individuals against undue risks from exposure to sources of radiation. Restricted area does not include areas used as residential quarters, but separate rooms in a residential building may be set apart as a restricted area.

(147) "Roentgen" means the amount of gamma or x-rays required to produce ions resulting in a charge of 0.000258 coulombs per kilogram of air under standard conditions.

(148) "Sanitary sewerage" means a system of public sewers for carrying off wastewater and refuse, but excluding sewage treatment facilities, septic tanks, and leach fields owned or operated by the licensee.

(149) "Sealed source" means radioactive material that is encased in a manner designed to prevent leakage or escape of the radioactive material.

(150) "Sealed source and device registry" means the national registry that contains all the registration certificates, generated by both the United States nuclear regulatory commission and the agreement states, that summarize the radiation safety information for the sealed sources and devices and describe the licensing and use conditions approved for the product.

(151) "Seismic area" means any area where the probability of a horizontal acceleration in rock of more than 0.3 times the acceleration of gravity in two hundred fifty years is greater than ten per cent, as designated by the United States geological survey.

(152) "Self-contained breathing apparatus" or "SCBA" means an atmosphere-supplying respirator for which the breathing air source is designed to be carried by the user.

(153) "Shallow dose equivalent" or "H_S" means the external exposure of the skin of the whole body or the skin of an extremity, is taken as the dose equivalent at a tissue depth of 0.007 centimeter, or seven milligrams per square centimeter.

(154) "Sievert" or "Sv" means the SI unit of any of the quantities expressed as dose equivalent. The dose equivalent in sieverts is equal to the absorbed dose in grays multiplied by the quality factor. One sievert equals one hundred rem.

(155) "Site area emergency" means events may occur, are in progress, or have occurred that could lead to a significant release of radioactive material and that could require a response by off-site response organizations to protect persons off-site.

(156) "Site boundary" means that line beyond which the land or property is not owned, leased, or otherwise controlled by the licensee or registrant.

(157) "Site closure and stabilization" means those actions that are taken upon completion of operations that prepare a disposal site for custodial care and that assure that the disposal site will remain stable and will not need ongoing active maintenance.

(158) "Source material" means uranium, thorium, or any combination thereof in any physical or chemical form, or any ores that contain by weight at least one-twentieth of one per cent (0.05 per cent) of uranium, thorium, or any combination thereof. Source material does not include special nuclear material.

(159) "Sources of radiation" means radioactive material or radiation generating equipment.

(160) "Special form radioactive material" means radioactive material that satisfies the following conditions:

(a) It is either a single solid piece or is contained in a sealed capsule that can be opened only by destroying the capsule;

(b) The piece or capsule has at least one dimension not less than five millimeters (0.2 inch); and

(c) It satisfies the test requirements specified by the United States nuclear regulatory commission in 10 C.F.R. 71.75 (as in effect on the effective date of this rule). A special form encapsulation designed in accordance with the United States nuclear regulatory commission requirements identified in 10 C.F.R. 71.4, in effect on June 30, 1983, and constructed prior to July 1, 1985; a special form encapsulation designed in accordance with the requirements of 10 C.F.R. 71.4 in effect on March 31, 1996, and constructed before April 1, 1998; and special form material that was successfully tested before September 10, 2015 in accordance with the requirements of 10 C.F.R. 71.75(d) of this section in effect before September 10, 2015 may continue to be used. Any other special form encapsulation must meet the specifications of this definition.

(161) "Special nuclear material" means either of the following:

(a) Plutonium, uranium-233, uranium enriched in the isotope 233, or in the isotope 235, and any other material that the United States nuclear regulatory commission determines to be special nuclear material, but does not include source material pursuant to section 51 of the Atomic Energy Act of 1954, 68 Stat 919, 42 USCA 2071, as amended (2005).

(b) Any material artificially enriched by any of the foregoing but does not include source material.

(162) "Special nuclear material in quantities not sufficient to form a critical mass" means uranium enriched in the isotope uranium-235 in quantities not exceeding three hundred fifty grams of contained uranium-235; uranium-233 in quantities not exceeding two hundred grams; plutonium in quantities not exceeding two hundred grams; or any combination of them in accordance with the following formula: for each kind of special nuclear material, determine the ratio between the quantity of that special nuclear material and the quantity specified in this paragraph for the same kind of special nuclear material. The sum of such ratios for all of the kinds of special nuclear material in combination shall not exceed unity.

(163) "Stochastic effect" means health effects that occur randomly and for which the probability of the effect occurring, rather than its severity, is assumed to be a linear function of dose without threshold. Hereditary effects and cancer incidence are examples of stochastic effects.

(164) "Supplied-air respirator" or "SAR" or "airline respirator" means an atmosphere-supplying respirator for which the source of breathing air is not designed to be carried by the user.

(165) "Surface contaminated object" or "SCO" means a solid object that is not itself classed as radioactive material, but which has radioactive material distributed on any of its surfaces. SCO must be in one of two groups with surface activity not exceeding the following limits:

(a) SCO-I: a solid object on which:

(i) The non-fixed contamination on the accessible surface averaged over three hundred square centimeters, or the area of the surface if less than three hundred square centimeters, does not exceed four becquerels per square centimeter (10^-4 microcurie per square centimeter) for beta and gamma and low toxicity alpha emitters, or 0.4 becquerels per square centimeter 10^-5 microcurie per square centimeter) for all other alpha emitters;

(ii) The fixed contamination on the accessible surface averaged over three hundred square centimeters, or the area of the surface if less than three hundred square centimeters, does not exceed forty thousand becquerels per square centimeter (one microcurie per square centimeter) for beta and gamma and low toxicity alpha emitters, or four thousand becquerels per square centimeter (0.1 microcurie per square centimeter) for all other alpha emitters; and

(iii) The non-fixed contamination plus the fixed contamination on the inaccessible surface averaged over three hundred square centimeters, or the area of the surface if less than three hundred square centimeters, does not exceed forty thousand becquerels per square centimeter (one microcurie per square centimeter) for beta and gamma and low toxicity alpha emitters, or four thousand becquerels per square centimeter (0.1 microcurie per square centimeter) for all other alpha emitters.

(b) SCO-II: a solid object on which the limits for SCO-I are exceeded and on which:

(i) The non-fixed contamination on the accessible surface averaged over three hundred square centimeters, or the area of the surface if less than three hundred square centimeter, does not exceed four hundred becquerels per square centimeter (10^-2 microcurie per square centimeter) for beta and gamma and low toxicity alpha emitters, or forty becquerels per square centimeter (10^-3 microcurie per square centimeter) for all other alpha emitters;

(ii) The fixed contamination on the accessible surface averaged over three hundred square centimeters, or the area of the surface if less than three hundred square centimeters, does not exceed eight hundred thousand becquerels per square centimeter (twenty microcuries per square centimeter) for beta and gamma and low toxicity alpha emitters, or eighty thousand becquerels per square centimeter (two microcuries per square centimeter) for all other alpha emitters; and

(iii) The non-fixed contamination plus the fixed contamination on the inaccessible surface averaged over three hundred square centimeters, or the area of the surface if less than three hundred square centimeters, does not exceed eight hundred thousand becquerels per square centimeter (twenty microcuries per square centimeter) for beta and gamma and low toxicity alpha emitters, or eighty thousand becquerels per square centimeter (two microcuries per square centimeter) for all other alpha emitters.

(166) "Survey" means an evaluation of the radiological conditions and potential hazards incident to the production, use, transfer, release, disposal or presence of radioactive material or other sources of radiation. When appropriate, such an evaluation includes a physical survey of the location of radioactive material, or the sources of radiation and measurements or calculations of levels of radiation, or concentrations or quantities of radioactive material present.

(167) "Tight-fitting facepiece" means a respiratory inlet covering that forms a complete seal with the face.

(168) "Total effective dose equivalent" or "TEDE" means the sum of the effective dose equivalent (for external exposures) and the committed effective dose equivalent (for internal exposures).

(169) "Transport index" means the dimensionless number, rounded up to the next tenth, placed on the label of a package, to designate the degree of control to be exercised by the carrier during transportation. The transport index is the number determined by multiplying the maximum radiation level in millisievert per hour at one meter (3.3 feet) from the external surface of the package by one hundred, which is equivalent to the maximum radiation level in millirem per hour at one meter (3.3 feet).

(170) "Type A quantity" means a quantity of radioactive material, the aggregate radioactivity of which does not exceed A₁ for special form radioactive material, or A₂ for normal form radioactive material, where A₁ and A₂ are given in rule 3701:1-50-25 of the Administrative Code.

(171) "Type B quantity" means a quantity of radioactive material greater than a type A quantity.

(172) "Type B package" is defined under "Package."

(173) "United States department of energy" means the department of energy established by the Department of Energy Organization Act, PL 95-91, 91 Stat. 565 (1977), 42 U.S.C. 7101 et seq., as amended (2006), to the extent that the department of energy or its duly authorized representatives, exercises functions formerly vested in the United States atomic energy commission, its chairman, members, officers and components and transferred to the United States energy research and development administration and to the administrator thereof pursuant to Sections 104(b) to (d) of the Energy Reorganization Act of 1974, PL 93-438, 88 Stat. 1233 at 1237 (1974), 42 U.S.C. 5814 and retransferred to the secretary of energy pursuant to Section 301(a) of the Department of Energy Organization Act, PL 95-91, 91 Stat. 565 at 577-578 (1977), 42 U.S.C. 7151.

(174) "Unrestricted area" or "uncontrolled area" means any area, access to which is neither restricted nor controlled by the licensee or registrant.

(175) "User seal check" or "fit check" means an action conducted by the respirator user to determine if the respirator is properly seated to the face. Examples include negative pressure check, positive pressure check, irritant smoke check, or isoamyl acetate check.

(176) "Very high radiation area" means an area, accessible to individuals, in which radiation levels from radiation sources external to the body could result in an individual receiving an absorbed dose in excess of five gray (five hundred rad) in one hour at one meter from a source of radiation or from any surface that the radiation penetrates. At very high doses received at high dose rates, units of absorbed dose, gray and rad, are appropriate, rather than units of dose equivalent, sievert and rem.

(177) "Veterinarian" means an individual licensed by the state of Ohio to practice veterinary medicine pursuant to Chapter 4741. of the Revised Code.

(178) "Waste" means those low-level radioactive wastes containing source, special nuclear, or byproduct material that are acceptable for disposal in a land disposal facility. For the purposes of this definition, low-level radioactive waste means radioactive waste not classified as high-level radioactive waste, transuranic waste, spent nuclear fuel, or byproduct material as defined in paragraph (A)(26)(b) of this rule, or byproduct material as defined in section 11 E. (3) and (4) of the Atomic Energy Act of 1954, 68 Stat. 919, 42 USC 2014, as amended (2005).

(179) "Week" means seven consecutive days starting on Sunday.

(180) "Weighting factor

• W_T" for an organ or tissue, (T), is the proportion of the risk of stochastic effects resulting from irradiation of that organ or tissue to the total risk of stochastic effects when the whole body is irradiated uniformly. For calculating the effective dose equivalent, the values of W_T are:

| Organ doseweighting factors | | | --- | --- | | Organ ortissue | W_T | | Gonads | 0.25 | | Breast | 0.15 | | Red bone marrow | 0.12 | | Lung | 0.12 | | Thyroid | 0.03 | | Bonesurfaces | 0.03 | | Remainder | 0.30^a | | Whole body | 1.00^b |

^\a 0.30 results from 0.06 for each of five "remainder" organs, excluding the skin and the lens of the eye, that receive the highest doses.

^\b for the purpose of weighting the external whole body dose (for adding it to the internal dose) a single weighting factor, W_T = 1.0, has been specified. The use of other weighting factors for external exposure will be approved on a case-by-case basis until such time as specific guidance is issued.

(181) "Whole body" means for purposes of external exposure, head; trunk, including male gonads; arms above the elbow; legs above the knee.

(182) "Worker" means an individual engaged in activities licensed or registered by the department and controlled by a licensee or registrant, but does not include the licensee or registrant.

(183) "Working level" or "WL" means any combination of short-lived radon decay products (for radon-222: polonium-218, lead-214, bismuth-214, and polonium-214; and for radon-220: polonium-216, lead-212, bismuth-212, and polonium-212) in one liter of air that will result in the ultimate emission of 1.3 x 10⁵ million electron volts alpha particle energy.

(184) "Working level month" or "WLM" means a cumulative exposure to one working level for one hundred seventy hours. (Two thousand working hours per year/twelve months per year equals approximately one hundred seventy hours per month.)

(185) "Year" means the period of time beginning in January used to determine compliance with the provisions of this rule. The licensee or registrant may change the starting date of the year used to determine compliance by the licensee or registrant provided that the change is made at the beginning of the year and that no day is omitted or duplicated in consecutive years.

(B) The terms set out in paragraph (A) of this rule may be redefined in other chapters as promulgated pursuant to Chapter 3748. of the Revised Code as used in that chapter only.

Last updated May 13, 2026 at 11:20 AM

History

• Effective: January 20, 2022
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-48-16

(A) The licensee may not permit any individual to act as a radiographer until the individual:

Has received training in the subjects in paragraph (G) of this rule, in addition to a minimum of two months of on-the-job training, is certified through a radiographer certification program by a certifying entity in accordance with the criteria specified in appendix A to this rule and is approved by the director.

(B) In addition, the licensee may not permit any individual to act as a radiographer until the individual:

(1) Has received copies of and instruction in the requirements described in this chapter, Chapter 3701:1-38, and rule 3701:1-40-05 of the Administrative Code; in applicable regulations as specified in Chapter 3701:1-50 of the Administrative Code; in the Ohio license(s) under which the radiographer will perform industrial radiography; and the licensee's operating and emergency procedures;

(2) Has demonstrated understanding of the licensee's license and operating and emergency procedures by successful completion of a written or oral examination covering this material;

(3) Has received training in the use of the licensee's radiographic exposure devices, sealed sources, in the daily inspection of devices and associated equipment, and in the use of radiation survey instruments; and

(4) Has demonstrated understanding of the use of radiographic exposure devices, sources, survey instruments and associated equipment described in paragraphs (B)(1) and (B)(3) of this rule by successful completion of a practical examination covering this material.

(C) The licensee may not permit any individual to act as a radiographer's assistant until the individual:

(1) Has received copies of and instruction in the requirements described in this chapter; Chapter 3701:1-38, and rule 3701:1-40-05 of the Administrative Code; in applicable regulations as specified in Chapter 3701:1-50 of the Administrative Code; in the Ohio license(s) under which the radiographer's assistant will perform industrial radiography; and the licensee's operating and emergency procedures;

(2) Has developed competence to use, under the personal supervision of the radiographer, the radiographic exposure devices, sealed sources, associated equipment, and radiation survey instruments that the assistant will use; and

(3) Has demonstrated understanding of the instructions provided under paragraph (C)(1) of this rule by successfully completing a written test on the subjects covered and has demonstrated competence in the use of hardware described in paragraph (C)(2) of this rule by successful completion of a practical examination on the use of such hardware.

(D) The licensee shall provide refresher safety training for each radiographer and radiographer's assistant at intervals not to exceed twelve months.

(E) Except as provided in paragraph (E)(3) of this rule, the radiation safety officer for industrial radiography or qualified designee shall conduct an inspection program of the job performance of each radiographer and radiographer's assistant to ensure that the department's rules, license requirements, and the applicant's operating and emergency procedures are followed.

(1) The inspection program must:

(a) Include observation of the performance of each radiographer and radiographer's assistant during an actual industrial radiographic operation, at intervals not to exceed six months; and

(b) Provide that, if a radiographer or a radiographer's assistant has not participated in an industrial radiographic operation for more than six months since the last inspection, the radiographer must demonstrate knowledge of the training requirements of paragraph (B)(3) of this rule and the radiographer's assistant must re-demonstrate knowledge of the training requirements of paragraph (C)(2) of this rule by a practical examination before these individuals can next participate in a radiographic operation.

(2) The director may consider alternatives in those situations where the individual serves as both radiographer and radiation safety officer for industrial radiography.

(3) In those operations where a single individual serves as both radiographer and radiation safety officer for industrial radiography, and performs all radiography operations, an inspection program is not required.

(F) The licensee shall maintain records of the above training to include certification documents, written and practical examinations, refresher safety training and inspections of job performance in accordance with paragraph (I) of rule 3701:1-48-23 of the Administrative Code.

(G) The licensee shall include the following subjects required in paragraph (A) of this rule:

(1) Fundamentals of radiation safety including:

(a) Characteristics of gamma radiation;

(b) Units of radiation dose and quantity of radioactivity;

(c) Hazards of exposure to radiation;

(d) Levels of radiation from licensed material; and

(e) Methods of controlling radiation dose (time, distance, and shielding);

(2) Radiation detection instruments including:

(a) Use, operation, calibration, and limitations of radiation survey instruments;

(b) Survey techniques; and

(c) Use of personnel monitoring equipment;

(3) Equipment to be used including:

(a) Operation and control of radiographic exposure equipment, remote handling equipment, and storage containers, including pictures or models of source assemblies (pigtails);

(b) Storage, control, and disposal of licensed material; and

(c) Inspection and maintenance of equipment;

(4) The requirements of pertinent federal and state regulations; and

(5) Case histories of accidents in radiography.

View Appendix

Last updated November 2, 2022 at 2:38 PM

History

• Effective: January 1, 2012
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-48-15

The radiation safety officer for industrial radiography shall ensure that radiation safety activities are being performed in accordance with approved procedures and regulatory requirements in the daily operation of the licensee's program.

(A) The minimum qualifications, training, and experience for radiation safety officers for industrial radiography are as follows:

(1) Completion of the training and testing requirements of paragraph (A) of rule 3701:1-48-16 of the Administrative Code;

(2) Two thousand hours of hands-on experience as a qualified radiographer in industrial radiographic operations; and

(3) Formal training in the establishment and maintenance of a radiation protection program.

(B) The director will consider alternatives to paragraph (A)(2) of this rule when the radiation safety officer for industrial radiography has appropriate training and/or experience in the field of ionizing radiation, and in addition, has adequate formal training with respect to the establishment and maintenance of a radiation safety protection program.

(C) The specific duties and authorities of the radiation safety officer for industrial radiography include, but are not limited to:

(1) Establishing and overseeing all operating, emergency, and ALARA procedures as required by Chapter 3701:1-38 of the Administrative Code, and reviewing them regularly to ensure that the procedures in use conform to current regulatory requirements, and to the license conditions.

(2) Overseeing and approving all phases of the training program for radiographic personnel, ensuring that appropriate and effective radiation protection practices are taught;

(3) Ensuring that required radiation surveys and leak tests are performed and documented in accordance with the regulations, including any corrective measures when levels of radiation exceed established limits;

(4) Ensuring that personnel monitoring devices are calibrated and used properly by occupationally-exposed personnel, that records are kept of the monitoring results, and that timely notifications are made as required by paragraph (C) of rule 3701:1-38-21 of the Administrative Code; and

(5) Ensuring that operations are conducted safely and to assume control for instituting corrective actions including stopping of operations when necessary.

Last updated November 2, 2022 at 2:38 PM

History

• Effective: January 1, 2012
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-48-02 Purpose and scope.

This chapter prescribes requirements for the issuance of licenses for the use of sealed sources containing radioactive material and radiation safety requirements for persons using these sealed sources in industrial radiography. The provisions and requirements of this chapter are in addition to, and not in substitution for, other requirements of Chapter 3748. of the Revised Code and rules promulgated thereunder. This chapter does not apply to medical uses of radioactive material.

Last updated November 2, 2022 at 2:37 PM

History

• Effective: January 1, 2012
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-48-03 Application for a specific license.

Application for a specific license for industrial radiography and the guidance document for completion of the license application is obtained by contacting:

"Ohio Department of Health

Bureau of Environmental Health and Radiation Protection

246 North High Street

Columbus, Ohio 43215"

Last updated November 2, 2022 at 2:37 PM

History

• Effective: June 27, 2016
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-48-04 Specific license for industrial radiography.

An application for a specific license for the use of licensed material in industrial radiography will be approved if the applicant meets the following requirements:

(A) The applicant satisfies the general requirements specified in rule 3701:1-40-15 of the Administrative Code for radioactive material, as appropriate, and any special requirements contained in this chapter.

(B) The applicant submits an adequate program for training radiographers and radiographers' assistants that meets the requirements of rule 3701:1-48-16 of the Administrative Code.

(C) The applicant submits procedures for verifying and documenting the certification status of radiographers and for ensuring that the certification of individuals acting as radiographers remains valid.

(D) The applicant submits written operating and emergency procedures as described in rule 3701:1-48-17 of the Administrative Code.

(E) The applicant submits a description of a program for inspections of the job performance of each radiographer and radiographer's assistant at intervals not to exceed six months as described in paragraph (E) of rule 3701:1-48-16 of the Administrative Code.

(F) The applicant submits a description of the applicant's overall organizational structure as it applies to the radiation safety responsibilities in industrial radiography, including specified delegation of authority and responsibility.

(G) The applicant identifies and lists the qualifications of the individual(s) designated as the radiation safety officer for industrial radiography in accordance with rule 3701:1-48-15 of the Administrative Code and potential designees responsible for ensuring that the licensee's radiation safety program is implemented in accordance with approved procedures.

(H) If an applicant intends to perform leak testing of sealed sources or exposure devices containing depleted uranium shielding, the applicant must describe the procedures for performing and the qualifications of the person(s) authorized to do the leak testing. If the applicant intends to analyze its own wipe samples, the application must include a description of the procedures to be followed. The description must include the:

(1) Instruments to be used;

(2) Methods of performing the analysis; and

(3) Pertinent experience of the person who will analyze the wipe samples.

(I) If the applicant intends to perform "in-house" calibrations of survey instruments the applicant must describe methods to be used and the relevant experience of the person(s) who will perform the calibrations. All calibrations must be performed according to the procedures described and at the intervals prescribed in rule 3701:1-48-08 of the Administrative Code.

(J) The applicant identifies and describes the location(s) of all field stations and permanent radiographic installations.

(K) The applicant identifies the locations where all records required by this and other chapters will be maintained.

Last updated November 2, 2022 at 2:37 PM

History

• Effective: January 1, 2012
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-40-15

(A) An application for a specific license will be approved if:

(1) The application is for a purpose authorized by Chapter 3748. of the Revised Code and the rules adopted thereunder;

(2) The applicant's proposed equipment and facilities are adequate to protect health and minimize danger to life or property or the environment;

(3) The applicant is qualified by training and experience to use the radioactive material for the purpose requested in such manner as to protect health and minimize danger to life or property or the environment;

(4) The applicant satisfies any special requirements contained in rule 3701:1-38-02 of the Administrative Code, and Chapters 3701:1-46, 3701:1-48, 3701:1-49, 3701:1-52, and 3701:1-58 of the Administrative Code; and

(5) In the case of an application for a license to receive and possess radioactive material for the conduct of any activity which the director determines could potentially affect the quality of the environment, the department, before commencement of construction of the plant or facility in which the activity will be conducted, on the basis of information filed and evaluations made pursuant to rule 3701:1-40-30 of the Administrative Code, has concluded, after weighing the environmental, economic, technical, and other benefits against environmental costs and considering available alternatives, shall conclude that the action called for is the issuance of the proposed license, with any appropriate conditions to protect environmental values. Commencement of construction prior to such conclusion shall be grounds for denial of a license to receive and possess radioactive material in such plant or facility. As used in this paragraph the term "commencement of construction" is as defined in rule 3701:1-38-01 of the Administrative Code.

(B) Upon a determination that an application meets the requirements of Chapter 3748. of the Revised Code and the rules adopted thereunder, the director will issue a specific license authorizing the possession and use of radioactive material.

Last updated November 2, 2022 at 2:12 PM

History

• Effective: July 25, 2013
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-48-17

(A) Operating and emergency procedures must include, as a minimum, instructions in the following:

(1) Appropriate handling and use of licensed sealed sources and radiographic exposure devices so that no person is likely to be exposed to radiation doses in excess of the limits established in Chapter 3701:1-38 of the Administrative Code;

(2) Methods and occasions for conducting radiation surveys;

(3) Methods for controlling access to radiographic areas;

(4) Methods and occasions for locking and securing radiographic exposure devices, transport and storage containers and sealed sources;

(5) Personnel monitoring and the use of personnel monitoring equipment;

(6) Transporting sealed sources to field locations, including packing of radiographic exposure devices and storage containers in the vehicles, placarding of vehicles when needed, and control of the sealed sources during transportation as specified in Chapter 3701:1-50 of the Administrative Code;

(7) The inspection, maintenance, and operability checks of radiographic exposure devices, survey instruments, transport containers, and storage containers;

(8) Steps that must be taken immediately by radiography personnel in the event a pocket dosimeter is found to be off-scale or an alarm rate meter alarms unexpectedly;

(9) The procedure(s) for identifying and reporting defects and noncompliance, as specified in rule 3701:1-38-23 of the Administrative Code;

(10) The procedure for notifying proper persons in the event of an accident;

(11) Minimizing exposure of persons in the event of an accident;

(12) Source recovery procedure if the licensee will perform source recovery; and

(13) Maintenance of records.

(B) The licensee shall maintain copies of current operating and emergency procedures in accordance with paragraphs (J) and (N) of rule 3701:1-48-23 of the Administrative Code.

Last updated November 2, 2022 at 2:39 PM

History

• Effective: June 27, 2016
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-48-08

(A) The licensee shall keep sufficient calibrated and operable radiation survey instruments at each location where radioactive material is present to make the radiation surveys required by this chapter and Chapter 3701:1-38 of the Administrative Code. Instrumentation required by this rule must be capable of measuring a range from 0.02 millisievert (two millirem) per hour through 0.01 sievert (one rem) per hour.

(B) The licensee shall have each radiation survey instrument required under paragraph (A) of this rule calibrated:

(1) At intervals not to exceed six months and after instrument servicing, except for battery changes;

(2) For linear scale instruments, at two points located approximately one-third and two-thirds of full-scale on each scale; for logarithmic scale instruments, at mid-range of each decade, and at two points of at least one decade; and for digital instruments, at three points between 0.02 and ten millisievert (two and one thousand millirem) per hour; and

(3) So that an accuracy within plus or minus twenty per cent of the calibration source strength can be demonstrated at each point checked.

(C) The licensee shall maintain records of the results of the instrument calibrations in accordance with paragraph (C) of rule 3701:1-48-23 of the Administrative Code.

Last updated November 2, 2022 at 2:37 PM

History

• Effective: March 22, 2007
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-48-05 Performance requirements for industrial radiography equipment.

Equipment used in industrial radiographic operations must meet the following minimum criteria:

(A)

(1) Each radiographic exposure device, source assembly or sealed source, and all associated equipment must meet the requirements specified in american national standards institute, N432-1980 "Radiological Safety for the Design and Construction of Apparatus for Gamma Radiography," (published as NBS handbook 136, issued January 1981). This publication may be purchased from the "American National Standards Institute, Inc., 25 West 43rd Street, New York, New York 10036, telephone (212) 642-4900."

(2) Engineering analysis may be submitted by an applicant or licensee to demonstrate the applicability of previously performed testing on similar individual radiography equipment components. Upon review, the director may find this an acceptable alternative to actual testing of the component pursuant to the above referenced standard.

(B) In addition to the requirements specified in paragraph (A) of this rule, the following requirements apply to radiographic exposure devices, source changers, source assemblies and sealed sources.

(1) The licensee shall ensure that each radiographic exposure device has attached to it a durable, legible, clearly visible label bearing the:

(a) Chemical symbol and mass number of the radionuclide in the device;

(b) Activity and the date on which this activity was last measured;

(c) Model (or product code) and serial number of the sealed source;

(d) Manufacturer's identity of the sealed source; and

(e) Licensee's name, address, and telephone number.

(2) Radiographic exposure devices intended for use as type B transport containers must meet the applicable requirements of Chapter 3701:1-50 of the Administrative Code.

(3) Modification of radiographic exposure devices, source changers, and source assemblies and associated equipment is prohibited, unless the design of any replacement component, including source holder, source assembly, controls or guide tubes would not compromise the design safety features of the system.

(C) In addition to the requirements specified in paragraphs (A) and (B) of this rule, the following requirements apply to radiographic exposure devices, source assemblies, and associated equipment that allow the source to be moved out of the device for radiographic operations or to source changers.

(1) The coupling between the source assembly and the control cable must be designed in such a manner that the source assembly will not become disconnected if cranked outside the guide tube. The coupling must be such that it cannot be unintentionally disconnected under normal and reasonably foreseeable abnormal conditions.

(2) The device must automatically secure the source assembly when it is cranked back into the fully shielded position within the device. This securing system may only be released by means of a deliberate operation on the exposure device.

(3) The outlet fittings, lock box, and drive cable fittings on each radiographic exposure device must be equipped with safety plugs or covers which must be installed during storage and transportation to protect the source assembly from water, mud, sand or other foreign matter.

(4)

(a) Each sealed source or source assembly must have attached to it or engraved on it, a durable, legible, visible label with the words: "DANGER-RADIOACTIVE."

(b) The label may not interfere with the safe operation of the exposure device or associated equipment.

(5) The guide tube must be able to withstand a crushing test that closely approximates the crushing forces that are likely to be encountered during use, and be able to withstand a kinking resistance test that closely approximates the kinking forces that are likely to be encountered during use.

(6) Guide tubes must be used when moving the source out of the device.

(7) An exposure head or similar device designed to prevent the source assembly from passing out of the end of the guide tube must be attached to the outermost end of the guide tube during industrial radiography operations.

(8) The guide tube exposure head connection must be able to withstand the tensile test for control units specified in american national standards institute, N432-1980 "Radiological Safety for the Design and Construction of Apparatus for Gamma Radiography," (published as NBS handbook 136, issued January 1981). This publication may be purchased from the "American National Standards Institute, Inc., 25 West 43rd Street, New York, New York 10036, telephone (212) 642-4900."

(9) Source changers must provide a system for ensuring that the source will not be accidentally withdrawn from the changer when connecting or disconnecting the drive cable to or from a source assembly.

(D) All radiographic exposure devices and associated equipment in use after January 10, 1996, must comply with the requirements of this rule.

(E) Notwithstanding paragraph (A)(1) of this rule, equipment used in industrial radiographic operations need not comply with the requirements of section 8.9.2(c) of the endurance test as specified in American national standards institute, N432-1980 "Radiological Safety for the Design and Construction of Apparatus for Gamma Radiography," (published as NBS handbook 136, issued January 1981), if the prototype equipment has been tested using a torque value representative of the torque that an individual using the radiography equipment can realistically exert on the lever or crankshaft of the drive mechanism. This publication may be purchased from the "American National Standards Institute, Inc., 25 West 43rd Street, New York, New York 10036, telephone (212) 642-4900."

Last updated July 10, 2025 at 12:13 PM

History

• Effective: June 27, 2016
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-48-06 Limits on external radiation levels from storage containers and source changers.

The maximum exposure rate limits for storage containers and source changers are two millisievert (two hundred millirem) per hour at any exterior surface, and 0.1 millisievert (ten millirem) per hour at one meter from any exterior surface with the sealed source in the shielded position.

Last updated November 2, 2022 at 2:37 PM

History

• Effective: March 22, 2007
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-48-07 Locking of radiographic exposure devices, storage containers and source containers.

(A) Each radiographic exposure device must have a lock or outer locked container designed to prevent unauthorized or accidental removal of the sealed source from its shielded position. The exposure device and/or its container must be kept locked (and if key-locked, with the key removed at all times) when not under the direct surveillance of a radiographer or a radiographer's assistant except at permanent radiographic installations as stated in rule 3701:1-48-21 of the Administrative Code. In addition, during radiographic operations the sealed source assembly must be secured in the shielded position each time the source is returned to that position.

(B) Each sealed source storage container and source changer must have a lock or outer locked container designed to prevent unauthorized or accidental removal of the sealed source from its shielded position. Storage containers and source changers must be kept locked (and if key-locked, with the key removed at all times) when containing sealed sources except when under the direct surveillance of a radiographer or a radiographer's assistant.

Last updated November 2, 2022 at 2:37 PM

History

• Effective: October 20, 2002
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-48-21

During each radiographic operation the radiographer, or the other qualified individual present, as required by rule 3701:1-48-14 of the Administrative Code, shall maintain continuous direct visual surveillance of the operation to protect against unauthorized entry into a high radiation area, as defined in rule 3701:1-38-01 of the Administrative Code, except at permanent radiographic installations where all entryways are locked and the requirements of rule 3701:1-48-12 of the Administrative Code are met.

Last updated November 2, 2022 at 2:39 PM

History

• Effective: January 1, 2012
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-48-23

(A) Each licensee shall maintain a copy of its license, license conditions, documents incorporated by reference, and amendments to each of these items until superseded by new documents approved by the director, or until the director terminates the license.

(B) Each licensee shall maintain records showing the receipts and transfers of all sealed sources and all devices using depleted uranium for shielding and retain each record for three years after it is made. These records must include the date, the name of the individual making the record, radionuclide, number of becquerels (curies) or mass (for depleted uranium), and manufacturer, model, and serial number of each sealed source and/or device, as appropriate.

(C) Each licensee shall maintain records of the calibrations of its radiation survey instruments that are required under rule 3701:1-48-08 of the Administrative Code and retain each record for three years after it is made.

(D) Each licensee shall maintain records of leak test results for sealed sources and also for devices containing depleted uranium. The results must be stated in units of becquerels (microcuries). The licensee shall retain each record for three years after it is made or until the source in storage is removed from storage.

(E) Each licensee shall maintain records of the quarterly inventory of sealed sources and of devices containing depleted uranium as required by rule 3701:1-48-10 of the Administrative Code and retain each record for three years after it is made. The record must include the date of the inventory, name of the individual conducting the inventory, radionuclide, number of becquerels (curies) or mass (for depleted uranium) in each device, location of sealed source and/or devices, and manufacturer, model, and serial number of each sealed source and/or device, as appropriate.

(F)

(1) Each licensee shall maintain utilization logs showing for each sealed source the following information:

(a) A description, including the make, model, and serial number of the radiographic exposure device or transport or storage container in which the sealed source is located;

(b) The identity and signature of the radiographer to whom assigned; and

(c) The plant or site where used and dates of use, including the dates removed and returned to storage.

(2) The licensee shall retain the logs required by paragraph (F)(1) of this rule for three years after the log is made.

(G) Each licensee shall maintain records specified in rule 3701:1-48-11 of the Administrative Code of equipment problems found in daily checks and quarterly inspections of radiographic exposure devices, transport and storage containers, associated equipment, source changers, and survey instruments; and retain each record for three years after it is made. The record must include the date of check or inspection, name of inspector, equipment involved, any problems found, and what repair and/or maintenance, if any, was done.

(H) Each licensee shall maintain records of alarm system and entrance control device tests required under rule 3701:1-48-12 of the Administrative Code and retain each record for three years after it is made.

(I) Each licensee shall maintain the following records of training and certification for three years after the record is made:

(1) Records of training of each radiographer and each radiographer's assistant. The record must include radiographer certification documents and verification of certification status, copies of written tests, dates of oral and practical examinations, and names of individuals conducting and receiving the oral and practical examinations; and

(2) Records of annual refresher safety training and semi-annual inspections of job performance for each radiographer and each radiographer's assistant. The records must list the topics discussed during the refresher safety training, the dates the annual refresher safety training was conducted, and names of the instructors and attendees. For inspections of job performance, the records must also include a list showing the items checked and any items of noncompliance observed by the radiation safety officer for industrial radiography.

(J) Each licensee shall maintain a copy of current operating and emergency procedures until the director terminates the license. Superseded material must be retained for three years after the change is made.

(K) Each licensee shall maintain the following exposure records specified in rule 3701:1-48-19 of the Administrative Code:

(1) Direct reading dosimeter readings and yearly operability checks required by paragraphs (B) and (C) of rule 3701:1-48-19 of the Administrative Code for three years after the record is made.

(2) Records of alarm rate meter calibrations for three years after the record is made.

(3) Personnel dosimeter results until the director terminates the license.

(4) Records of estimates of exposures as a result of off-scale personal direct reading dosimeters, or lost, or damaged personnel dosimeters until the director terminates the license.

(L) Each licensee shall maintain a record of each exposure device survey conducted before the device is placed in storage as specified in paragraph (C) of rule 3701:1-48-20 of the Administrative Code, if that survey is the last one performed in the workday. Each record must be maintained for three years after it is made.

(M) Each record required by this part must be legible throughout the specified retention period. The record may be the original or a reproduced copy or a microform provided that the copy or microform is authenticated by authorized personnel and that the microform is capable of reproducing a clear copy throughout the required retention period. The record may also be stored in electronic media with the capability for producing legible, accurate, and complete records during the required retention period. Records, such as letters, drawings, and specifications, must include all pertinent information, such as stamps, initials, and signatures. The licensee shall maintain adequate safeguards against tampering with and loss of records.

(N)

(1) Each licensee shall maintain copies of records required by this and other chapters at the location specified in paragraph (K) of rule 3701:1-48-04 of the Administrative Code.

(2) Each licensee shall also maintain copies of the following documents and records sufficient to demonstrate compliance at each applicable field station and each temporary job site:

(a) The license authorizing the use of licensed material;

(b) A copy of Chapters 3701:1-38 and 3701:1-48 of the Administrative Code;

(c) Utilization records for each radiographic exposure device dispatched from that location as required by paragraph (F) of this rule;

(d) Records of equipment problems identified in daily checks of equipment as required by paragraph (G) of this rule;

(e) Records of alarm system and entrance control checks required by paragraph (H) of this rule, if applicable;

(f) Records of direct reading dosimeters such as pocket dosimeter and/or electronic personal dosimeters readings as required by paragraph (K) of this rule;

(g) Operating and emergency procedures required by paragraph (J) of this rule;

(h) Evidence of the latest calibration of the radiation survey instruments in use at the site, as required by paragraph (C) of this rule;

(i) Evidence of the latest calibrations of alarm rate meters and operability checks of pocket dosimeters and/or electronic personal dosimeters as required by paragraph (K) of this rule;

(j) Latest survey records required by paragraph (L) of this rule;

(k) The shipping papers for the transportation of radioactive materials required by rule 3701:1-50-05 of the Administrative Code; and

(l) When operating under reciprocity, a copy of the agreement state or United States nuclear regulatory commission license authorizing the use of licensed materials.

Last updated April 19, 2022 at 8:38 AM

History

• Effective: April 17, 2022
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-48-09 Leak testing and replacement of sealed sources.

(A) The replacement of any sealed source fastened to or contained in a radiographic exposure device and leak testing of any sealed source must be performed by persons authorized by the director, the United States nuclear regulatory commission, or an agreement state to do so.

(B) The opening, repair, or modification of any sealed source must be performed by persons specifically authorized by the director, the United States nuclear regulatory commission, or an agreement state to do so.

(C)

(1) Each licensee who uses a sealed source shall have the source tested for leakage at intervals not to exceed six months. The leak testing of the source must be performed using a method approved by the director, the United States nuclear regulatory commission or by an agreement state. The wipe sample should be taken from the nearest accessible point to the sealed source where contamination might accumulate. The wipe sample must be analyzed for radioactive contamination. The analysis must be capable of detecting the presence of one hundred eighty-five becquerels (0.005 microcurie) of radioactive material on the test sample and must be performed by a person specifically authorized by the director, the United States nuclear regulatory commission, or an agreement state to perform the analysis.

(2) The licensee shall maintain records of the leak tests in accordance with paragraph (D) of rule 3701:1-48-23 of the Administrative Code.

(3) Unless a sealed source is accompanied by a certificate from the transferor that shows that it has been leak tested within six months before the transfer, it may not be used by the licensee until tested for leakage. Sealed sources that are in storage and not in use do not require leak testing, but must be tested before use or transfer to another person if the interval of storage exceeds six months.

(D) Any test conducted pursuant to paragraph (C) of this rule which reveals the presence of one hundred eighty-five becquerels (0.005 microcurie) or more of removable radioactive material must be considered evidence that the sealed source is leaking. The licensee shall immediately withdraw the equipment involved from use and shall have it decontaminated and repaired or disposed of in accordance with department rules. A report must be filed with the director, within five days of any test with results that exceed the threshold in this paragraph, describing the equipment involved, the test results, and the corrective action taken.

(E) Each exposure device using depleted uranium shielding and an S-tube configuration must be tested for depleted uranium contamination at intervals not to exceed twelve months. The analysis must be capable of detecting the presence of one hundred eighty-five becquerels (0.005 microcurie) of radioactive material on the test sample and must be performed by a person specifically authorized by the director, the United States nuclear regulatory commission or an agreement state to perform the analysis. Should such testing reveal the presence of one hundred eighty-five becquerels (0.005 microcurie) or more of removable depleted uranium contamination, the exposure device must be removed from use until an evaluation of the wear of the S-tube has been made. Should the evaluation reveal that the S-tube is worn through, the device may not be used again. Depleted uranium shielded devices do not have to be tested for depleted uranium contamination while in storage and not in use. Before using or transferring such a device, however, the device must be tested for depleted uranium contamination, if the interval of storage has exceeded twelve months. A record of the depleted uranium leak-test must be made in accordance with paragraph (D) of rule 3701:1-48-23 of the Administrative Code.

Last updated July 10, 2025 at 12:13 PM

History

• Effective: January 1, 2012
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-48-10 Quarterly inventory.

(A) Each licensee shall conduct a quarterly physical inventory to account for all sealed sources and for devices containing depleted uranium received and possessed under this license.

(B) The licensee shall maintain records of the quarterly inventory in accordance with paragraph (E) of rule 3701:1-48-23 of the Administrative Code.

Last updated November 2, 2022 at 2:38 PM

History

• Effective: October 20, 2002
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-48-11 Inspection and maintenance of radiographic exposure devices, transport and storage containers, associated equipment, source changers, and survey instruments.

(A) The licensee shall perform visual and operability checks on survey meters, radiographic exposure devices, transport and storage containers, associated equipment and source changers before use on each day the equipment is to be used to ensure that the equipment is in good working condition, that the sources are adequately shielded, and that required labeling is present. Survey instrument operability must be performed using check sources or other appropriate means. If equipment problems are found, the equipment must be removed from service until repaired.

(B) Each licensee shall have written procedures for:

(1) Inspection and routine maintenance of radiographic exposure devices, source changers, associated equipment, transport and storage containers, and survey instruments at intervals not to exceed three months or before the first use thereafter to ensure the proper functioning of components important to safety. Replacement components shall meet design specifications. If equipment problems are found, the equipment must be removed from service until repaired.

(2) Inspection and maintenance necessary to maintain the type B packaging used to transport radioactive materials. The inspection and maintenance program must include procedures to assure that type B packages are shipped and maintained in accordance with the certificate of compliance or other approval.

(C) Records of equipment problems and of any maintenance performed under paragraphs (A) and (B) of this rule must be made in accordance with paragraph (G) of rule 3701:1-48-23 of the Administrative Code.

Last updated November 2, 2022 at 2:38 PM

History

• Effective: October 20, 2002
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-48-12 Permanent radiographic installations.

(A) Each entrance that is used for personnel access to the high radiation area in a permanent radiographic installation must have either:

(1) An entrance control of the type described in paragraph (A) of rule 3701:1-38-15 of the Administrative Code that reduces the radiation level upon entry into the area; or

(2) Both conspicuously visible and audible warning signals to warn of the presence of radiation. The visible signal must be actuated by radiation whenever the source is exposed. The audible signal must be actuated when an attempt is made to enter the installation while the source is exposed.

(B) The alarm system must be tested for proper operation with a radiation source each day before the installation is used for radiographic operations. The test must include a check of both the visible and audible signals. Entrance control devices that reduce the radiation level upon entry (designated in paragraph (A)(1) of this rule) must be tested monthly. If an entrance control device or an alarm is operating improperly, it must be immediately labeled as defective and repaired within seven calendar days. The facility may continue to be used during this seven day period, provided the licensee implements the continuous surveillance requirements of rule 3701:1-48-21 of the Administrative Code and uses an alarming rate meter. Test records for entrance controls and audible and visual alarm must be maintained in accordance with paragraph (H) of rule 3701:1-48-23 of the Administrative Code.

Last updated November 2, 2022 at 2:38 PM

History

• Effective: October 20, 2002
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-38-15

(A) Control of access to high radiation areas shall be maintained by the licensee or registrant.

(1) Control of access shall be maintained by ensuring that each entrance or access point to a high radiation area has one or more of the following features:

(a) A control device that, upon entry into the area, causes the level of radiation to be reduced below that level at which an individual might receive a deep dose equivalent of one millisievert (0.1 rem) in one hour at thirty centimeters from the source of radiation or from any surface that the radiation penetrates; or

(b) A control device that energizes a conspicuous visible or audible alarm signal so that the individual entering the high radiation area and the supervisor of the activity are made aware of the entry; or

(c) Entryways that are locked, except during periods when access to the areas is required, with administrative and/or engineering control over each individual entry.

(2) In place of the controls required by paragraph (A)(1) of this rule, in the case of a high radiation area, the licensee or registrant may substitute continuous direct or electronic surveillance that is capable of preventing unauthorized entry.

(3) The licensee or registrant may apply to the department for approval of alternative methods for controlling access to high radiation areas.

(4) The licensee or registrant shall establish the controls required by paragraphs (A)(1) and (A)(3) of this rule in a way that does not prevent individuals from leaving a high radiation area.

(5) The licensee is not required to control each entrance or access point to a room or other area that is a high radiation area solely because of the presence of radioactive materials prepared for transport and packaged and labeled in accordance with the regulations of the United States department of transportation provided that:

(a) The packages do not remain in the area longer than three days; and

(b) The dose rate at one meter from the external surface of any package does not exceed 0.1 millisievert (0.01 rem) per hour.

(6) The licensee is not required to control entrance or access to rooms or other areas in hospitals solely because of the presence of patients containing radioactive material, provided that there are personnel in attendance who are taking the necessary precautions to prevent the exposure of individuals to radiation or radioactive material in excess of the established limits in paragraph (A) of rule 3701:1-38-13 of the Administrative Code and to operate within the ALARA provisions of the licensee's radiation protection program.

(7) The registrant is not required to control entrance or access to rooms or other areas containing sources of radiation capable of producing a high radiation area as described in paragraphs (A)(1) to (A)(4) of this rule if the registrant has met all the specific requirements for access and control specified in other applicable rules, such as, the requirements for industrial radiography, x-rays in the healing arts, and particle accelerators as provided in Chapters 3701:1-66, 3701:1-67, and 3701:1-68 of the Administrative Code.

(B) In the case of access to a very high radiation area, the licensee or registrant shall control access as follows:

(1) In addition to the requirements in paragraph (A) of this rule, and except as provided in paragraph (B)(2) of this rule, the licensee or registrant shall institute measures to ensure that an individual is not able to gain unauthorized or inadvertent access to a very high radiation area. This requirement does not apply to rooms or areas in which diagnostic x-ray systems are the only source of radiation.

(2) The registrant is not required to control entrance or access to rooms or other areas containing sources of radiation capable of producing a very high radiation area as provided in paragraph (B)(1) of this rule if the registrant has met all the specific requirements for access and control specified in other applicable rules, such as, requirements for industrial radiography, x-rays in the healing arts, and particle accelerators as provided in Chapters 3701:1-66, 3701:1-67, and 3701:1-68 of the Administrative Code.

Last updated January 20, 2022 at 8:47 AM

History

• Effective: January 20, 2022
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-48-13 Labeling, storage, and transportation.

(A) The licensee may not use a source changer or a container to store licensed material unless the source changer or the storage container has securely attached to it a durable, legible, and clearly visible label bearing the standard trefoil radiation caution symbol conventional colors, i.e., magenta, purple or black on a yellow background, having a minimum diameter of twenty-five millimeters, and the wording "CAUTION* RADIOACTIVE MATERIAL NOTIFY CIVIL AUTHORITIES (or "NAME OF COMPANY") *________ or "DANGER"."

(B) The licensee may not transport licensed material unless the material is packaged, and the package is labeled, marked, and accompanied with appropriate shipping papers in accordance with Chapter 3701:1-50 of the Administrative Code.

(C) Locked radiographic exposure devices and storage containers must be physically secured to prevent tampering or removal by unauthorized personnel. The licensee shall store licensed material in a manner which will minimize danger from explosion or fire.

(D) The licensee shall lock and physically secure the transport package containing licensed material in the transporting vehicle to prevent accidental loss, tampering, or unauthorized removal of the licensed material from the vehicle.

Last updated November 2, 2022 at 2:38 PM

History

• Effective: March 22, 2007
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-48-14 Conducting industrial radiographic operations.

(A) Whenever radiography is performed at a location other than a permanent radiographic installation, the radiographer must be accompanied by at least one other qualified radiographer or an individual who has at a minimum met the requirements of paragraph (C) of rule 3701:1-48-16 of the Administrative Code. The additional qualified individual shall observe the operations and be capable of providing immediate assistance to prevent unauthorized entry. Radiography may not be performed if only one qualified individual is present.

(B) All radiographic operations conducted at locations of use authorized on the license must be conducted in a permanent radiographic installation, unless specifically authorized by the director.

(C) A licensee may conduct lay-barge, offshore platform, or underwater radiography only if procedures have been approved by the director, the United States nuclear regulatory commission or an agreement state.

Last updated November 2, 2022 at 2:38 PM

History

• Effective: January 1, 2012
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-38-21

(A) The licensee or registrant shall report stolen, lost, or missing licensed or registered sources of radiation to the director in accordance with the following:

(1) Telephone reports shall be made as follows:

(a) To the bureau of environmental health and radiation protection point of contact (POC) in accordance with the form "Notice to Employees" issued by the director.

(b) In the case of a licensee, he or she shall make contact:

(i) Immediately after the licensee determines that licensed radioactive material is stolen, lost, or missing in an aggregate quantity equal to or greater than one thousand times the quantity specified in the appendix to rule 3701:1-38-18 of the Administrative Code under such circumstances that it appears to the licensee that an exposure could result to individuals in unrestricted areas;

(ii) Within thirty days after its occurrence becomes known to the licensee, lost, stolen, or missing licensed radioactive material in an aggregate quantity greater than ten times the quantity specified in the appendix to rule 3701:1-38-18 of the Administrative Code that is still missing.

(c) In the case of a registrant, he or she shall make contact immediately after it becomes known that radiation-generating equipment has been stolen, lost, or is missing.

(2) Written reports shall be made as follows:

(a) Each licensee or registrant required to make a report pursuant to paragraph (A)(1) of this rule shall, within thirty days after making the telephone report, make a written report to the director setting forth the following information, where applicable:

(i) A description of the licensed or registered source of radiation involved, including, for radioactive material, the kind, quantity, and chemical and physical form, and in the case of radiation-generating equipment, the manufacturer, model and serial number, type and maximum energy of the radiation emitted;

(ii) A description of the circumstances under which the loss or theft occurred;

(iii) A statement of disposition, or probable disposition, of the licensed or registered source of radiation involved;

(iv) Exposures of individuals to radiation, circumstances under which the exposures occurred, and the possible total effective dose equivalent to persons in unrestricted areas;

(v) Actions that have been taken, or will be taken, to recover the source of radiation; and

(vi) Procedures or measures that have been, or will be, adopted to ensure against a recurrence of the loss or theft of licensed or registered sources of radiation.

(b) Subsequent to filing the written report, the licensee or registrant shall also report additional substantive information on the loss or theft within thirty days after the licensee or registrant learns of such information.

(c) The licensee or registrant shall prepare any report filed with the director pursuant to this rule so that names of individuals who may have received exposure to radiation are stated in a separate and detachable portion of the report.

(B) Notification of incidents shall be made as follows:

(1) Excluding prescribed medical doses to patients, each licensee or registrant shall immediately report each event involving a source of radiation possessed by the licensee or registrant that may have caused or threatens to cause any of the following conditions:

(a) An individual receiving:

(i) A total effective dose equivalent of 0.25 sievert (twenty-five rem) or more;

(ii) A lens dose equivalent of 0.75 sievert (seventy-five rem) or more; or

(iii) A shallow dose equivalent to the skin or extremities or a total organ dose equivalent of 2.5 sievert (two hundred fifty rem) or more; or

(b) The release of radioactive material, inside or outside of a restricted area that, had an individual been present for twenty-four hours, the individual could have received an intake five times the occupational ALI. This provision does not apply to locations where personnel are not normally stationed during routine operations, such as hot-cells or process enclosures.

(2) Each licensee or registrant shall report to the director, within twenty-four hours of discovery, each event involving loss of control of a licensed or registered source of radiation possessed by the licensee or registrant that may have caused, or threatens to cause, any of the following:

(a) An individual to receive, in a period of twenty-four hours:

(i) A total effective dose equivalent exceeding 0.05 sievert (five rem);

(ii) An lens dose equivalent exceeding 0.15 sievert (fifteen rem); or

(iii) A shallow dose equivalent to the skin or extremities or a total organ dose equivalent exceeding 0.5 sievert (fifty rem); or

(b) The release of radioactive material, inside or outside of a restricted area that, had an individual been present for twenty-four hours, the individual could have received an intake in excess of one occupational ALI. This provision does not apply to locations where personnel are not normally stationed during routine operations, such as hot-cells or process enclosures.

(3) Licensees or registrants shall make the reports required by paragraphs (B)(1) and (B)(2) of this rule to the POC by telephone to the department and shall confirm the initial contact by telegram, mailgram, electronic mail, or facsimile to the director.

(4) The licensee or registrant shall prepare each report filed with the director pursuant to this rule so that names of individuals who have received exposure to sources of radiation are stated in a separate and detachable portion of the report.

(5) The provisions of paragraph (B) of this rule do not apply to doses that result from planned special exposures, provided such doses are within the limits for planned special exposures and are reported in accordance with this paragraph.

(C) Reports of exposures, radiation levels, and concentrations of radioactive material exceeding the limits shall be made by the licensee or registrant as follows:

(1) Reportable events that are specified in this paragraph shall, in addition to the notification requirements in paragraph (B) of this rule, be reported to the director in writing within thirty days after learning of any of the following occurrences:

(a) Incidents for which notification is required by paragraph (B) of this rule and with doses in excess of any of the following:

(i) The occupational dose limits for adults in paragraphs (A)(1) and (A)(2) of rule 3701:1-38-12 of the Administrative Code;

(ii) The occupational dose limits for a minor in paragraph (G) of rule 3701:1-38-12 of the Administrative Code;

(iii) The limits for an embryo or fetus of a declared pregnant woman in paragraph (H) of rule 3701:1-38-12 of the Administrative Code;

(iv) The limits for an individual member of the public in paragraph (A) of rule 3701:1-38-13 of the Administrative Code;

(v) Any applicable limit in the license or registration; or

(vi) The ALARA constraints for air emissions established under paragraph (D)(4) of rule 3701:1-38-11 of the Administrative Code; or

(b) Levels of radiation or concentrations of radioactive material in:

(i) A restricted area in excess of applicable limits in the license or registration; or

(ii) An unrestricted area in excess of ten times the applicable limit set forth in this chapter or in the license or registration, whether or not involving exposure of any individual in excess of the limits in paragraph (A) of rule 3701:1-38-13 of the Administrative Code; or

(c) For licensees subject to the provisions of the United States environmental protection agency generally applicable environmental radiation standards in 40 C.F.R. 190 (as in effect on the effective date of this rule), levels of radiation or releases of radioactive material in excess of those standards, or of license conditions related to those standards.

(2) Each report required by this rule shall describe the extent of exposure of individuals to radiation and radioactive material, including, as appropriate:

(a) Estimates of each individual's dose, the level of radiation and concentration of radioactive material involved, and the cause of the elevated exposure, dose rate, or concentration; and

(b) Corrective steps taken or planned to ensure against a recurrence, including the schedule for achieving conformance with applicable limits, ALARA constraints, generally applicable environmental standards, and associated license or registration conditions.

(3) Each report filed pursuant to this rule shall include, for each occupationally overexposed individual, the name, social security account number, and date of birth of the individual. In the case of the limit for an embryo or fetus in paragraph (H) of rule 3701:1-38-12 of the Administrative Code, the identifiers should be those of the declared pregnant woman. The report shall be prepared so that information on each individual is stated in a separate and detachable portion of the report.

(4) All licensees or registrants who make reports pursuant to this rule shall submit the report in writing to the director.

(D) Reports of planned special exposures shall be submitted by the licensee in a written report to the director within thirty days following any planned special exposure conducted in accordance with paragraph (F) of rule 3701:1-38-12 of the Administrative Code, informing the director that a planned special exposure was conducted and indicating the date the planned special exposure occurred and the information required by paragraph (G) of rule 3701:1-38-20 of the Administrative Code.

(E) When a licensee or registrant is required pursuant to paragraph (C) or (D) of this rule to report to the director any exposure of an identified occupationally exposed individual, or an identified member of the public, to radiation or radioactive material, the licensee or registrant shall also provide the individual a report on his or her exposure data included in the report to the director. This report shall be transmitted no later than the transmittal to the director, and shall comply with the provisions of paragraph (C)(1) of rule 3701:1-38-10 of the Administrative Code.

(F) A report of a leaking or contaminated sealed source shall be filed by the licensee with the director within five days of the test results, if the test reveals the presence of one hundred eighty-five becquerels (0.005 microcurie) or more of removable contamination. The report shall include the equipment involved, the test results and the corrective action taken.

Last updated January 20, 2022 at 8:48 AM

History

• Effective: January 20, 2022
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-40-05

All information provided to the director by an applicant for a license, or by a licensee, and all information required to be maintained by the applicant or the licensee in accordance with license conditions or by Chapter 3748. of the Revised Code or rules adopted thereunder, shall be complete and accurate in all material respects.

Last updated November 2, 2022 at 2:12 PM

History

• Effective: August 15, 2005
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-38-23

(A) As used in this rule:

(1) "Basic component" means:

(a) A structure, system, or component, or part thereof that affects their safety function, that is directly procured by the licensee or registrant of facility or activity subject to the rules promulgated pursuant to Chapter 3748. of the Revised Code and in which a defect or failure to comply with any rule promulgated pursuant to Chapter 3748. of the Revised Code, order issued by the director, or license issued by the department could create a substantial safety hazard; and

(b) Safety-related design, analysis, inspection, testing, fabrication, replacement of parts, or consulting services that are associated with the component hardware whether these services are performed by the component supplier or others.

(2) "Commercial grade item" means an item that is:

(a) Not subject to design or specification requirements that are unique to those facilities or activities;

(b) Used in applications other than those facilities or activities; and

(c) To be ordered from the manufacturer or supplier on the basis of specifications set forth in the manufacturer's published product description, such as a catalog.

(3) "Constructing" or "construction" means the analysis, design, manufacture, fabrication, placement, erection, installation, modification, inspection, or testing of a facility or activity which is subject to this rule and consulting services related to the facility or activity that are safety related.

(4) "Dedication" means an item has been received and designated for use as a basic component.

(5) "Defect" means:

(a) A deviation in a basic component delivered to a purchaser for use in a facility or an activity subject to this rule, if, on the basis of an evaluation, the deviation could create a substantial safety hazard; or

(b) The installation, use, or operation of a basic component containing a defect as defined in this paragraph.

(6) "Deviation" means a departure form the manufacturer's specification's or technical specifications as part of a license or registration issued by the department for a given safety device or safety system associated with that device.

(7) "Discovery" means the completion of the documentation first identifying the existence of a deviation or failure to comply potentially associated with a substantial safety hazard within the evaluation procedures discussed in paragraph (G) of this rule.

(8) "Evaluation" means the process of determining whether a particular deviation could create a substantial hazard or determining whether a failure to comply is associated with a substantial safety hazard.

(9) "Failure to comply" means a failure to meet the requirements of any of the following that could create a substantial safety hazard:

(a) A rule promulgated pursuant to Chapter 3748. of the Revised Code;

(b) An order issued by the director; or

(c) License issued by the department.

(10) "Operating" or "operation" means the operation of a facility or the conduct of a licensed or registered activity which is subject to this rule and consulting services related to operations that are safety related.

(11) "Responsible officer" means:

(a) The president, vice-president or other individual in the organization of a corporation, partnership, or other entity who is vested with executive authority over activities subject to this rule, or

(b) An individual who is appointed or elected according to law, who is authorized to manage and direct the affairs of a corporation, partnership or other entity. In the case of an individual proprietorship, responsible officer means the individual.

(12) "Substantial safety hazard" means a loss of safety function to the extent that there is a major reduction in the degree of protection provided to either public health and safety or the environment, for any facility or activity licensed or registered pursuant to Chapter 3748. of the Revised Code.

(13) "Supplying" or "supplies" means contractually responsible for a basic component used or to be used in a facility or activity which is subject to this rule.

(B) This rule establishes procedures and requirements for implementation of section 3748.04 of the Revised Code, which applies to reporting of defects in equipment used for licensed or registered activities. Any responsible corporate officer of a firm constructing, owning, operating or supplying the components of any facility or activity which is licensed, registered, or otherwise regulated pursuant to Chapter 3748. of the Revised Code, obtaining information reasonably indicating either of the following, shall notify the director within twenty-four hours:

(1) That the facility, activity or basic component supplied to such facility or activity fails to comply with any applicable rule, regulation, order, registration, or license of the department relating to substantial safety hazards; or

(2) That the facility, activity, or basic component supplied to such facility or activity contains defects, which could create a substantial safety hazard.

(C) This rule applies, except as specifically provided otherwise in Chapter 3748. of the Revised Code, to each individual, partnership, corporation, or other entity licensed or registered pursuant to Chapter 3748. of the Revised Code to possess, use, or transfer within the state of Ohio source material, radioactive material, special nuclear material, or to construct, manufacture, possess, own, operate or transfer within the state of Ohio any radiation-generating equipment and to each responsible officer of such a licensee or registrant. This rule applies also to each individual, corporation, partnership or other entity doing business within the state of Ohio, that supplies basic components for a facility or activity licensed, under Chapter 3748. of the Revised Code.

(D) Nothing in this rule should be deemed to preclude either an individual, a manufacturer, or a supplier of a commercial grade item not subject to this rule from reporting to the director, a known or suspected defect or failure to comply and, as authorized by law, the identity of anyone so reporting will be withheld from disclosure. The department will accept collect telephone calls from individuals who wish to speak to department representatives concerning radiation safety-related problems.

(E) Each individual, partnership, corporation, dedicating entity, or other entity subject to this rule shall post current copies of this rule and procedures adopted pursuant to this rule. These documents must be posted in a conspicuous position on any premises within the state of Ohio where the activities subject to this rule are conducted. If posting of this rule or the procedures adopted pursuant to this rule is not practicable, the licensee, registrant, or firm subject to this rule may post a notice which describes the rules and procedures, including the name of the individual to whom reports may be made, and where the rules and procedures may be examined.

(F) The director may, upon application of any interested person or upon the director's own initiative, grant such exemptions from the requirements of this rule as the director determines to be authorized by law and will not endanger public health and safety or the environment, and are otherwise in the public interest. Suppliers of commercial grade items are exempt from the provisions of this rule to the extent that they supply commercial grade items.

(G) Each individual, corporation, partnership, dedicating entity, or other entity subject to this rule shall adopt appropriate procedures to:

(1) Initiate evaluations of deviations and failures to comply that are associated with substantial safety hazards as soon as practicable, but no later than ten days from the date of discovery of the deviation or failure to comply. The director shall be notified of any such deviation or failure to comply in accordance with paragraph (B) of this rule.

(2) Evaluate a reportable defect or failure to comply that could create a substantial safety hazard, were it to remain uncorrected, within thirty days of its discovery, except as provided by paragraph (G)(3) of this rule.

(3) Ensure that if an evaluation of an identified deviation or failure to comply potentially associated with a substantial safety hazard cannot be completed within thirty days from discovery of the deviation or failure to comply, an interim report is prepared and submitted to the director through a responsible corporate officer. The interim report should describe the deviation or failure to comply that is being evaluated and should also state when the evaluation will be completed. This interim report must be submitted in writing within thirty days of discovery of the deviation or failure to comply; and

(4) Ensure that a responsible corporate officer subject to this rule is informed as soon as practicable, and, in all cases, within five working days after completion of the evaluation described in this paragraph if the construction or operation of a facility or activity, or a basic component supplied for such facility or activity either fails to comply with any applicable rule, regulation, order, or license or registration of the department relating to a substantial safety hazard, or contains a defect.

(H) If the deviation or failure to comply is discovered by a supplier of basic components, or services associated with basic components, and the supplier determines that it does not have the capability to perform the evaluation to determine if a defect exists, then the supplier must inform the purchasers or affected licensees or registrants within five working days of this determination so that the purchasers or affected licensees or registrants may evaluate the deviation or failure to comply, pursuant to paragraph (G) of this rule. Nothing in this rule shall be deemed to require manufacturers or suppliers to adopt or maintain procedures for defect identification and evaluation, where the item or service is not dedicated for purposes of licensed or registered activities or equipment. Instead, such is the responsibility of the registrant or licensee, in accordance with paragraph (B) of this rule.

(I) A responsible corporate officer subject to this rule must notify the director within thirty days when he or she obtains information reasonably indicating a failure to comply or a defect affecting:

(1) The construction or operation of a facility or any activity within the state of Ohio that is subject to the licensing or registration requirements under Chapter 3748. of the Revised Code and that is within the facility's responsibility; or

(2) A basic component that is within the facility's responsibility and is supplied for a facility or an activity within the state of Ohio that is subject to the licensing requirements of Chapter 3748. of the Revised Code.

(J) The notification required by paragraphs (B) and (I) of this rule shall include the following information, to the extent known:

(1) Name and address of the individual or individuals informing the director.

(2) Identification of the facility, the activity, or the basic component supplied for such facility or such activity within the state of Ohio which fails to comply or contains a defect.

(3) Identification of the firm constructing the facility or supplying the basic component which fails to comply or contains a defect.

(4) Nature of the defect or failure to comply and the safety hazard which is created or could be created by such defect or failure to comply.

(5) The date on which the information of such defect or failure to comply was obtained.

(6) In the case of a basic component which contains a defect or fails to comply, the number and location of all such components in use at, supplied for, or being supplied for one or more facilities or activities subject to this rule.

(7) The corrective action which has been, is being, or will be taken; the name of the individual or organization responsible for the action; and the length of time that has been or will be taken to complete the action.

(8) Any advice related to the defect or failure to comply about the facility, activity, or basic component that has been, is being, or will be given to purchasers or licensees.

(K) The responsible corporate officer may authorize an individual to provide the notification required by paragraph (J) of this rule, provided that, this shall not relieve the responsible corporate officer of his or her responsibility under this paragraph. Individuals subject to this rule may be required by the director to supply additional information related to a defect or failure to comply. Department action to obtain additional information may be based on reports of defects from other reporting entities.

(L) Each individual, corporation, partnership, or other entity subject to this rule shall prepare and maintain records necessary to accomplish the requirements of this rule, including retaining evaluations of all deviations and failures to comply for a minimum of five years after the date of the evaluation. Each individual, corporation, partnership, dedicating entity, or other entity subject to this rule shall permit the department the opportunity to inspect records pertaining to basic components that relate to the identification and evaluation of deviations, and the reporting of defects and failures to comply, including any advice given to purchasers or licensees on the placement, erection, installation, operation, maintenance, modification, or inspection of a basic component.

(M) Suppliers of basic components must retain any notifications sent to purchasers and affected licenses for a minimum of five years after the date of the notification. Suppliers of basic components must retain a record of the purchasers of basic components for ten years after delivery of the basic component or service associated with a basic component.

Last updated November 2, 2022 at 2:11 PM

History

• Effective: September 1, 2011
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-48-18 Supervision of radiographer's assistants.

Whenever a radiographer's assistant uses radiographic exposure devices, associated equipment or sealed sources or conducts radiation surveys required by paragraph (B) of rule 3701:1-48-20 of the Administrative Code to determine that the sealed source has returned to the shielded position after an exposure, the assistant shall be under the personal supervision of a radiographer. The personal supervision must include:

(A) The radiographer's physical presence at the site where the sealed sources are being used;

(B) The availability of the radiographer to give immediate assistance if required; and

(C) The radiographer's direct observation of the assistant's performance of the operations referred to in this rule.

Last updated November 2, 2022 at 2:39 PM

History

• Effective: October 20, 2002
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-48-20

The licensee shall:

(A) Conduct surveys with a calibrated and operable radiation survey instrument that meets the requirements of rule 3701:1-48-08 of the Administrative Code.

(B) Using a survey instrument meeting the requirements of paragraph (A) of this rule, conduct a survey of the radiographic exposure device and the guide tube after each exposure when approaching the device or the guide tube. The survey must determine that the sealed source has returned to its shielded position before exchanging films, repositioning the exposure head, or dismantling equipment.

(C) Conduct a survey of the radiographic exposure device with a calibrated radiation survey instrument any time the source is exchanged and whenever a radiographic exposure device is placed in a storage area (as defined in rule 3701:1-48-01 of the Administrative Code), to ensure that the sealed source is in its shielded position.

(D) Maintain records in accordance with paragraph (L) of rule 3701:1-48-23 of the Administrative Code.

Last updated November 2, 2022 at 2:39 PM

History

• Effective: October 20, 2002
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-48-19 Personnel monitoring.

(A) The licensee may not permit any individual to act as a radiographer or a radiographer's assistant unless, at all times during radiographic operations, each individual wears, on the trunk of the body, a direct reading dosimeter, an operating alarm rate meter, and a personnel dosimeter. At permanent radiography installations where other appropriate alarming or warning devices are in routine use, the wearing of an alarming rate meter is not required.

(1) Pocket dosimeters must have a range from zero to two millisievert (two hundred millirem) and must be recharged at the start of each shift. Electronic personal dosimeters may only be used in place of ion-chamber pocket dosimeters.

(2) Each personnel dosimeter must be assigned to and worn by only one individual.

(3) Film badges must be replaced at least monthly and all other personnel dosimeters that require replacement must be replaced at least quarterly. All personnel dosimeters must be evaluated at least quarterly or promptly after replacement, whichever is more frequent.

(B) Direct reading dosimeters such as pocket dosimeters or electronic personal dosimeters, must be read and the exposures recorded at the beginning and end of each shift, and records must be maintained in accordance with paragraph (K) of rule 3701:1-48-23 of the Administrative Code.

(C) Pocket dosimeters, or electronic personal dosimeters, must be checked at periods not to exceed twelve months for correct response to radiation, and records must be maintained in accordance with paragraph (K) of rule 3701:1-48-23 of the Administrative Code. Acceptable dosimeters must read within plus or minus twenty per cent of the true radiation exposure.

(D) If an individual's pocket dosimeter is found to be off-scale, or if his or her electronic personal dosimeter reads greater than two millisievert (two hundred millirem), and the possibility of radiation exposure cannot be ruled out as the cause, the individual's personnel dosimeter that requires processing must be sent for processing and evaluation within twenty-four hours. For personnel dosimeters that do not require processing, evaluation of the dosimeter must be started within twenty-four hours. In addition, the individual may not resume work associated with licensed material use until a determination of the individual's radiation exposure has been made. This determination must be made by the radiation safety officer or the radiation safety officer's designee. The results of this determination must be included in the records maintained in accordance with paragraph (K) of rule 3701:1-48-23 of the Administrative Code.

(E) If the personnel dosimeter that is required by paragraph (A) of this rule is lost or damaged, the worker shall cease work immediately until a replacement personnel dosimeter meeting the requirements in paragraph (A) of this rule is provided and the exposure is calculated for the time period from issuance to loss or damage of the personnel dosimeter. The results of the calculated exposure and the time period for which the personnel dosimeter was lost or damaged must be included in the records maintained in accordance with paragraph (K) of rule 3701:1-48-23 of the Administrative Code.

(F) Dosimetry reports must be retained in accordance with paragraph (K) of rule 3701:1-48-23 of the Administrative Code.

(G) Each alarm rate meter must:

(1) Be checked to ensure that the alarm functions properly (sounds) before using at the start of each shift;

(2) Be set to give an alarm signal at a preset dose rate of five millisievert (five hundred millirem) per hour; with an accuracy of plus or minus twenty per cent of the true radiation dose rate;

(3) Require special means to change the preset alarm function; and

(4) Be calibrated at periods not to exceed twelve months for correct response to radiation. The licensee shall maintain records of alarm rate meter calibrations in accordance with paragraph (K) of rule 3701:1-48-23 of the Administrative Code.

Last updated April 19, 2022 at 8:37 AM

History

• Effective: April 17, 2022
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-48-22 Posting.

All areas in which industrial radiography is being performed must be conspicuously posted as required by paragraphs (A)(4)(a) and (A)(4)(b) of rule 3701:1-38-18 of the Administrative Code. Exceptions listed in paragraph (B) of rule 3701:1-38-18 of the Administrative Code do not apply to industrial radiographic operations.

Last updated November 2, 2022 at 2:39 PM

History

• Effective: March 22, 2007
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-38-18

(A) Except as provided in paragraph (B) of this rule, caution signs and posting requirements for licensees and registrants are as follows:

(1) The standard radiation symbol, unless otherwise authorized by the department or as provided in paragraph (A)(2) of this rule, shall use the colors magenta, purple, or black on yellow background. The symbol prescribed is the three-bladed design as follows:

(2) Notwithstanding paragraph (A)(1) of this rule, licensees and registrants are authorized to label sources, source holders, or device components containing sources of radiation that are subjected to high temperatures, with conspicuously cast, etched or stamped radiation caution symbols and without a color requirement.

(3) In addition to the contents of signs and labels prescribed in this chapter, the licensee or registrant may provide, on or near the required signs and labels, additional information, as appropriate, to make individuals aware of potential radiation exposures and to minimize the exposures.

(4) Posting of radiation areas shall be accomplished as follows:

(a) The licensee or registrant shall post each radiation area with a conspicuous sign or signs bearing the radiation symbol and the words "Caution, Radiation Area".

(b) The licensee or registrant shall post each high radiation area with a conspicuous sign or signs bearing the radiation symbol and the words "Caution, High Radiation Area" or "Danger, High Radiation Area".

(c) The licensee or registrant shall post each very high radiation area with conspicuous sign or signs bearing the radiation symbol and words "Grave Danger, Very High Radiation Area".

(d) The licensee shall post each airborne radioactivity area with a conspicuous sign or signs bearing the radiation symbol and the words "Caution, Airborne Radioactivity Area" or "Danger, Airborne Radioactivity Area".

(e) The licensee shall post each area or room in which there is an amount of licensed material used or stored which exceeds ten times the quantity of such material specified in the appendix A ofto this rule with a conspicuous sign or signs bearing the radiation symbol and the words "Caution, Radioactive Material(s)" or "Danger, Radioactive Material(s)".

(f) The licensee shall post access openings to manufacturing or process equipment (such as tanks and vessels) on or in which radiation sources are mounted, if a person could gain access to the radiation beam and receive an annual dose to any part of their body which is greater than the applicable, permissible limits for individuals in rules 3701:1-38-12 and 3701:1-38-13 of the Administrative Code. The posting must include a conspicuous sign or signs bearing the radiation symbol and warning of the hazard.

(B) The following are exceptions to posting requirements set forth in paragraph (A) of this rule:

(1) A licensee or registrant is not required to post caution signs in an area or room that contains a source of radiation provided that the source is located in the area or room for a period of less than eight hours, and the source of radiation is continuously attended to during these periods by an individual who takes the precautions necessary to prevent the exposure of individuals to sources of radiation in excess of the limits established in rule 3701:1-38-13 of the Administrative Code, and the area or room is subject to licensee or registrant control.

(2) Rooms or other areas in hospitals that are occupied by patients are not required to be posted with caution signs pursuant to paragraph (A) of this rule provided that the patient could be released from licensee control in accordance with rule 3701:1-58-30 of the Administrative Code.

(3) A room or area is not required to be posted with a caution sign because of the presence of a sealed source provided the radiation level at thirty centimeters from the surface of the sealed source container or housing does not exceed 0.05 millisievert (0.005 rem) per hour.

(4) A room or area is not required to be posted with a caution sign because of the presence of radiation-generating equipment used solely for diagnosis in the healing arts.

(5) Rooms in hospitals or clinics that are used for teletherapy are exempt from the requirement to post caution signs if access to the room is controlled pursuant to rule 3701:1-58-59 of the Administrative Code and personnel in attendance take necessary precautions to prevent the inadvertent exposure of workers, other patients, and members of the public to radiation in excess of the limits established in this chapter.

(C) Except as provided in paragraph (E) of this rule, containers shall be labeled as follows:

(1) The licensee shall ensure that each container of licensed material bears a durable, clearly visible label bearing the radiation symbol and the words "Caution, Radioactive Material" or "Danger, Radioactive Material". The label shall also provide information, such as the radionuclides present, an estimate of the quantity of radioactivity, the date for which the activity is estimated, radiation levels, kinds of materials, and mass enrichment, to permit individuals handling or using the containers, or working in the vicinity of the containers, to take precautions to avoid or minimize exposures.

(2) Prior to removal or disposal of empty uncontaminated containers to unrestricted areas, each licensee shall, remove or deface the radioactive material label or otherwise clearly indicate that the container no longer contains radioactive materials.

(D) Each registrant shall ensure that each radiation-generating equipment is labeled in a conspicuous manner which cautions individuals that radiation is produced when it is energized.

(E) A licensee is not required to label the following:

(1) Containers holding licensed material in quantities less than the quantities listed in the appendix A to this rule;

(2) Containers holding licensed material in concentrations less than those specified in table III of appendix C to rule 3701:1-38-12 of the Administrative Code;

(3) Containers attended by an individual who takes the precautions necessary to prevent the exposure of individuals in excess of the limits established by rule 3701:1-38-13 of the Administrative Code;

(4) Containers when they are in transport and packaged and labeled in accordance with the regulations of the United States department of transportation;

(5) Containers that are accessible only to individuals authorized to handle or use them, or to work in the vicinity of the containers, if the contents are identified to these individuals by a readily available written record. Examples of containers of this type are containers in locations such as water-filled canals, storage vaults, or hot cells. The record shall be retained as long as the containers are in use for the purpose indicated on the record; or

(6) Manufacturing or processing equipment such as contaminated piping and tanks, and vessels on or in which radiation sources are installed.

(F) Each licensee shall:

(1) Monitor the external surfaces of a labeled package for radioactive contamination unless the package contains only radioactive material in the form of gas or in special form as defined in rule 3701:1-38-01 of the Administrative Code;

(2) Monitor the external surfaces of a labeled package for radiation levels unless the package contains quantities of radioactive material that are less than or equal to the type A quantity; and

(3) Monitor all packages known to contain radioactive material for radioactive contamination and radiation levels if there is evidence of degradation of package integrity, such as a package that is crushed, wet, or damaged.

(4) Perform the monitoring required by this paragraph as soon as practicable after receipt of the package, but not later than three hours after the package is received at the licensee's facility, if it is received during the licensee's normal working hours. If a package is received after working hours, the package shall be monitored no later than three hours from the beginning of the next working day.

(G) Each licensee who expects to receive a package containing quantities of radioactive material in excess of a type A quantity as defined in rule 3701:1-38-01 of the Administrative Code and as provided in rule 3701:1-50-25 of the Administrative Code, shall make arrangements to receive the package when the carrier offers it for delivery or expeditiously upon receiving notification that the package is available for pick-up.

(H) The licensee shall immediately notify the final delivery carrier and the department by telephone and either telegram, mailgram, or facsimile, when:

(1) Removable radioactive surface contamination exceeds the limits as provided in 49 C.F.R. 173.443 (as published in the October 1, 2009 Code of Federal Regulationsin effect on the effective date of this rule); or

(2) External radiation levels exceed the limits as provided in 49 C.F.R. 172.403 (as published in the October 1, 2009 Code of Federal Regulationsin effect on the effective date of this rule).

(I) Each licensee shall:

(1) Establish, maintain, and retain written procedures for safely opening packages in which radioactive material is received; and

(2) Ensure that the procedures are followed and that due consideration is given to special instructions for the type of package being opened.

(J) A licensee that transfers a special form source to and from a work site in a vehicle owned or operated by the licensee is exempt from the contamination monitoring requirements of this rule, but is not exempt from the monitoring requirement in this rule for measuring radiation levels that ensures that the source is still properly lodged in its shield.

View Appendix

Last updated June 6, 2022 at 9:29 AM

History

• Effective: June 4, 2022
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-50-05

(A) Each licensee who transports licensed material outside the site of usage, as specified in the United States nuclear regulatory commission or Ohio license, or where transport is on public highways, or who delivers licensed material to a carrier for transport, shall comply with the applicable requirements of the DOT regulations in 49 C.F.R. 107, 171 to 180, and 390 to 397 (as in effect on the effective date of this rule), appropriate to the mode of transport.

(1) The licensee shall particularly note DOT regulations (as in effect on the effective date of this rule) in the following areas:

(a) Packaging - 49 C.F.R. 173: subparts A, B, and I.

(b) Marking and labeling - 49 C.F.R. 172: subpart D; sections 172.400 to 172.407 and 172.436 to 172.441 of subpart E.

(c) Placarding - 49 C.F.R. 172: subpart F, especially sections 172.500 to 172.519 and 172.556; and appendices B and C.

(d) Accident reporting - 49 C.F.R. 171: sections 171.15 and 171.16.

(e) Shipping papers and emergency information - 49 C.F.R. 172: subparts C and G.

(f) Hazardous material employee training - 49 C.F.R. 172: subpart H.

(g) Security plans - 49 C.F.R. 172: subpart I.

(h) Hazardous material shipper/carrier registration - 49 C.F.R. 107: subpart G.

(2) The licensee shall also note DOT regulations (as in effect on the effective date of this rule) pertaining to the following modes of transportation:

(a) Rail - 49 C.F.R. 174: subparts A to D and K.

(b) Air - 49 C.F.R. 175.

(c) Vessel - 49 C.F.R. 176: subparts A to F and M.

(d) Public highway - 49 C.F.R. 177 and 390 to 397.

(B) If DOT regulations are not applicable to a shipment of licensed material, the licensee shall conform to the standards and requirements of the DOT specified in paragraph (A) of this rule to the same extent as if the shipment or transportation were subject to DOT regulations. A request for modification, waiver, or exemption from those requirements, and any notification referred to in those requirements, must be filed with, or made to, the director, Ohio department of health.

History

• Effective: February 15, 2021
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-48-24 Notifications.

(A) In addition to the reporting requirements specified in rules 3701:1-40-20 and 3701:1-38-23 of the Administrative Code, each licensee shall provide a written report to the director, within thirty days of the occurrence of any of the following incidents involving radiographic equipment:

(1) Unintentional disconnection of the source assembly from the control cable;

(2) Inability to retract the source assembly to its fully shielded position and secure it in this position; or

(3) Failure of any component (critical to safe operation of the device) to properly perform its intended function.

(B) The licensee shall include the following information in each report submitted under paragraph (A) of this rule, and in each report of overexposure submitted under paragraph (C) of rule 3701:1-38-21 of the Administrative Code which involves failure of safety components of radiography equipment:

(1) A description of the equipment problem;

(2) Cause of each incident, if known;

(3) Name of the manufacturer and model number of equipment involved in the incident;

(4) Place, date, and time of the incident;

(5) Actions taken to establish normal operations;

(6) Corrective actions taken or planned to prevent recurrence; and

(7) Qualifications of personnel involved in the incident.

(C) Any licensee conducting radiographic operations or storing radioactive material at any location or temporary job site not listed on the license for a period in excess of one hundred eighty days in a calendar year, shall notify the director prior to exceeding the one hundred eighty days.

Last updated November 2, 2022 at 2:39 PM

History

• Effective: January 1, 2012
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-40-20

(A) Except as provided in paragraph (D) of this rule, each licensee shall notify the department as soon as possible, but not later than four hours after the discovery of an event that prevents immediate protective action necessary to avoid exposure to radiation or radioactive material that could exceed regulatory limits, or a release of licensed material that could exceed regulatory limits. An event that requires such an immediate report may include a fire, explosion, or toxic gas release.

(B) Each licensee shall notify the department within twenty-four hours after the discovery of any of the following events involving licensed material:

(1) An unplanned contamination event that involves:

(a) Access to the contaminated area, by workers or the public, to be restricted for more than twenty-four hours by imposing additional radiological controls or by prohibiting entry into the area;

(b) A quantity of material greater than five times the lowest annual limit on intake specified in the appendices to rule 3701:1-38-12 of the Administrative Code; and

(c) Access to the area restricted for a reason other than to allow radionuclides with a half-life of less than twenty-four hours to decay prior to decontamination.

(2) An event in which equipment is disabled or fails to function as designed when:

(a) The equipment is required by regulation or license condition to prevent a release exceeding regulatory limits, to prevent exposure to radiation or radioactive material exceeding regulatory limits, or to mitigate the consequences of an accident;

(b) The equipment is required to be available and operable when it is disabled or fails to function; and

(c) No redundant equipment is available and operable to perform the required safety function.

(3) An event that requires unplanned medical treatment of an individual with spreadable radioactive contamination on the individual's clothing or body.

(4) An unplanned fire or explosion damaging any licensed material or any device, container, or equipment containing licensed material when:

(a) The quantity of material involved is greater than five times the lowest annual limit on intake specified in the appendices to rule 3701:1-38-12 of the Administrative Code; and

(b) The damage affects the integrity of the licensed material or its container.

(C) The licensee shall prepare and submit a report in response to the requirements of this rule as follows:

(1) Licensees shall make reports required by paragraphs (A) and (B) of this rule by telephone, to the department at the telephone number listed in the notice to employees required by paragraph (A)(1)(e) of rule 3701:1-38-10 of the Administrative Code. To the extent that the information is available at the time of notification, the information provided in these reports must include:

(a) The caller's name and call back telephone number;

(b) A description of the event, including date and time;

(c) The exact location of the event;

(d) The radionuclides, quantities, and chemical and physical form of the licensed material involved; and

(e) Any personnel radiation exposure data available.

(2) Each licensee who makes a report required by paragraph (A) or (B) of this rule shall submit a written follow-up report within thirty days of the initial report. Written reports prepared pursuant to other regulations may be submitted to fulfill this requirement if the report contains all of the necessary information and the appropriate distribution is made. These written reports shall be sent to the department in the manner specified in rule 3701:1-40-04 of the Administrative Code. The report must include the following:

(a) A description of the event, including the probable cause and the manufacturer and model number, if applicable, of any equipment that failed or malfunctioned;

(b) The exact location of the event;

(c) The radionuclides, quantities, and chemical and physical form of the licensed material involved;

(d) Date and time of the event;

(e) Corrective actions taken or planned and the results of any evaluations or assessments; and

(f) The extent of exposure of individuals to radiation or to radioactive materials without identification of individuals by name.

(D) This rule applies to all licensees possessing material licensed under rule 3701:1-38-02 of the Administrative Code. This rule does not apply to material under a license subject to the notification requirements in 10 C.F.R. 50.72 (as in effect on the effective date of this rule).

(E) An applicant for a license or a licensee shall notify the department within two working days of information identified by the applicant or licensee as having for the regulated activity, an active adverse impact on equipment or personnel readily obvious by human observation or instrumentation, or a radiological impact on personnel or the environment in excess of regulatory limits. An applicant or licensee violates this paragraph only if the applicant or licensee fails to notify the director of information that the applicant or licensee has or should have identified.

Last updated April 19, 2022 at 8:35 AM

History

• Effective: April 17, 2022
• Promulgated Under: 119.03

Chapter 3701:1-49 Licensing and Safety Requirements for Well Logging

Ohio Adm.Code 3701:1-49-01 Definitions.

Terms defined in rule 3701:1-38-01 of the Administrative Code shall have the same meaning when used in this chapter except terms redefined within a given rule for use within that rule only, and additionally, as used in this chapter of the Administrative Code:

(A) "Energy Compensation Source" (ECS) means a small sealed source, with an activity not exceeding 3.7 megabecquerels (one hundred microcuries), used within a logging tool, or other tool components, to provide a reference standard to maintain the tool's calibration when in use.

(B) "Field Station" means a facility where licensed material may be stored or used and from which equipment is dispatched to temporary job sites.

(C) "Fresh Water Aquifer", for the purpose of this chapter, means a geologic formation that is capable of yielding fresh water to a well or spring.

(D) "Injection Tool" means a device used for controlled subsurface injection of radioactive tracer material.

(E) "Irretrievable Well Logging Source" means any sealed source containing licensed material that is pulled off or not connected to the wireline that suspends the source in the well and for which all reasonable effort at recovery has been expended.

(F) "Logging Assistant" means any individual who, under the personal supervision of a logging supervisor, handles sealed sources or tracers that are not in logging tools or shipping containers or who performs surveys required by rule 3701:1-49-21 of the Administrative Code.

(G) "Logging Supervisor" means an individual who uses licensed material or provides personal supervision in the use of licensed material at a temporary job site and who is responsible to the licensee for assuring compliance with the requirements of Chapter 3748. of the Revised Code and rules promulgated thereunder and the conditions of the license.

(H) "Logging Tool" means a device used subsurface to perform well logging.

(I) "Personal Supervision" means guidance and instruction by a logging supervisor, who is physically present at a temporary job site, who is in personal contact with logging assistants, and who can give immediate assistance.

(J) "Radioactive Marker" means licensed material used for depth determination or direction orientation. For purposes of this chapter, this term includes radioactive collar markers and radioactive iron nails.

(K) "Reasonable Effort" means effort commensurate with an assessment, performed by the licensee and approved by the department, of the health and safety risks of a lost source considering the geological and hydrological location of the source, the source type, and risks and costs of attempted source retrieval.

(L) "Safety Review" means a periodic review provided by the licensee for its employees on radiation safety aspects of well logging. The review may include, as appropriate, the results of internal inspections, new procedures or equipment, accidents or errors that have been observed, and opportunities for employees to ask safety questions.

(M) "Source Holder" means a housing or assembly into which a sealed source is placed to facilitate the handling and use of the source in well logging.

(N) "Subsurface Tracer Study" means the release of unsealed licensed material or a substance labeled with licensed material in a single well for the purpose of tracing the movement or position of the material or substance in the well or adjacent formation.

(O) "Surface Casing For Protecting Fresh Water Aquifers" means a pipe or tube used as a lining in a well to isolate fresh water aquifers from the well.

(P) "Temporary Job Site" means a place where licensed materials are present for the purpose of performing well logging or subsurface tracer studies.

(Q) "Tritium Neutron Generator Target Source" means a tritium source used within a neutron generator tube to produce neutrons for use in well logging applications.

(R) "Uranium Sinker Bar" means a weight containing depleted uranium used to pull a logging tool toward the bottom of a well.

(S) "Well" means a drilled hole in which well logging may be performed. As used in this chapter, "well'' includes drilled holes for the purpose of oil, gas, mineral, groundwater, or geological exploration.

(T) "Well Logging" means all operations involving the lowering and raising of measuring devices or tools which contain licensed material or are used to detect licensed materials in wells for the purpose of obtaining information about the well or adjacent formations which may be used in oil, gas, mineral, groundwater, or geological exploration.

Last updated November 2, 2022 at 2:40 PM

History

• Effective: October 8, 2007
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-38-01

(A) As used in this chapter and all other rules promulgated pursuant to Chapter 3748. of the Revised Code:

(1) "A₁" means the maximum activity of special form radioactive material permitted in a type A package. These values are listed in rule 3701:1-50-25 of the Administrative Code, or may be derived in accordance with the procedure prescribed in rule 3701:1-50-25 of the Administrative Code.

(2) "A₂" means the maximum activity of radioactive material, other than special form, low specific activity and surface contaminated object material, permitted in a type A package. These values are listed in rule 3701:1-50-25 of the Administrative Code, or may be derived in accordance with the procedure prescribed in rule 3701:1-50-25 of the Administrative Code.

(3) "Absorbed dose" means the energy imparted by ionizing radiation per unit mass of irradiated material. The units of absorbed dose are the gray, or Gy, and the rad.

(4) "Accelerator or charged particle accelerator" means any of a class of radiation generating equipment designed to electronically accelerate atomic or sub-atomic particles for subsequent bombardment of targets.

(5) "Accelerator-produced radioactive material" means any material made radioactive by a particle accelerator.

(6) "Activity" means the rate of disintegration or transformation or decay of radioactive material. The units of activity are the becquerel, or Bq, and the curie, or Ci.

(7) "Address of use" means the building or buildings that are identified on the license or registration and where the source of radiation may be received, used, prepared, or stored, except for temporary job sites.

(8) "Administrative controls" means mechanisms used to protect health and minimize damage to life and property through the use of written policies, procedures, instructions, training, observation of work practices, and related compliance audits.

(9) "Administrative monetary penalty" means a monetary penalty assessed by the director under section 3748.05 of the Revised Code and in compliance with rules adopted thereunder, to emphasize the need for lasting remedial action and to deter future violations.

(10) "Adult" means an individual eighteen or more years of age.

(11) "Agreement state" means any state with which the United States nuclear regulatory commission or the atomic energy commission has entered into an effective agreement under subsection 274B of the Atomic Energy Act of 1954, 68 Stat. 919, 42 U.S.C. 2021, as amended (1978). Non-agreement state means any other state.

(12) "Airborne radioactive material" means radioactive material dispersed in the air in the form of dusts, fumes, particulates, mists, vapors, or gases.

(13) "Airborne radioactivity area" means a room, enclosure, or area in which airborne radioactive materials, composed wholly or partly of licensed material, exist in concentrations:

(a) In excess of the derived air concentrations (DACs) specified in appendix C to rule 3701:1-38-12 of the Administrative Code, or

(b) To such a degree that an individual present in the area without respiratory protective equipment could exceed, during the hours an individual is present in a week, an intake of 0.6 per cent of the annual limit on intake or twelve DAC-hours.

(14) "Air-purifying respirator" means a respirator with an air-purifying filter, cartridge, or canister that removes specific air contaminants by passing ambient air through the air-purifying element.

(15) "ALARA" or "as low as is reasonably achievable" means every reasonable effort to maintain exposures to radiation as far below the dose limits as is practical consistent with the purpose for which the licensed or registered activity is undertaken, taking into account the state of technology, the economics of improvements in relation to benefits to the public health and safety, and other societal and socioeconomic considerations, and in relation to utilization of nuclear energy and licensed materials and registered activities in the public interest.

(16) "Alert" means events may occur, are in progress, or have occurred that could lead to a release of radioactive material but that the release is not expected to require a response by off-site response organizations to protect persons off-site.

(17) "Annual limit on intake" or "ALI" means the derived limit for the amount of radioactive material taken into the body of an adult worker by inhalation or ingestion in a year. ALI is the smaller value of intake of a given radionuclide in a year by the reference man that would result in a committed effective dose equivalent of 0.05 sievert (five rem) or a committed dose equivalent of 0.5 sievert (fifty rem) to any individual organ or tissue. ALI values for intake by ingestion and by inhalation of selected radionuclides are given in appendix C to rule 3701:1-38-12 of the Administrative Code.

(18) "Annually" means either

(a) At intervals not to exceed one year; or

(b) Once per year, at about the same time each year, plus or minus one month.

(19) "Area of use" means a portion of an address of use that has been set aside for the purpose of receiving, preparing, using, or storing sources of radiation.

(20) "Assigned protection factor" or "APF" means the expected workplace level of respiratory protection that would be provided by a properly functioning respirator or a class of respirators to properly fitted and trained users. Operationally, the inhaled concentration can be estimated by dividing the ambient airborne concentration by the APF.

(21) "Atmosphere-supplying respirator" means a respirator that supplies the respirator user with breathing air from a source independent of the ambient atmosphere, and includes supplied air respirators, or SARs, and self-contained breathing apparatus, or SCBA, units.

(22) "Atomic energy commission" or "AEC" means the federal agency created by the Atomic Energy Act of 1954, 68 Stat. 919, 42 U.S.C. 2011, as amended (1964), and was the predecessor agency to the current United States nuclear regulatory commission.

(23) "Background radiation" means radiation from cosmic sources; naturally occurring radioactive materials, including radon, except as a decay product of source or special nuclear material, and global fallout as it exists in the environment from the testing of nuclear explosive devices or from past nuclear accidents such as Chernobyl that contribute to background radiation and are not under the control of the licensee. "Background radiation" does not include radiation from radioactive materials regulated by the department.

(24) "Becquerel" or "Bq" means the SI unit of activity. One becquerel is equal to one disintegration per second.

(25) "Bioassay" or "radiobioassay" means the determination of kinds, quantities or concentrations, and, in some cases, the locations of radioactive material in the human body, whether by direct measurement, in vivo counting, or by analysis and evaluation of materials excreted or removed from the human body.

(26) "Byproduct material" means

(a) Any radioactive material, except special nuclear material, yielded in or made radioactive by exposure to the radiation incident to the process of producing or utilizing special nuclear materials; or

(b) The tailings or wastes produced by the extraction or concentration of uranium or thorium from any ore processed primarily for its source material content, including discrete surface wastes resulting from solution extraction processes. Underground ore bodies depleted by such solution extraction do not constitute byproduct material within the definition.

(27) "Chelating agent" means a chemical compound or mixture that enhances the removal of radioactive material from the body, water or similar applications. Typical chelating agents include amine polycarboxylic acids such as EDTA or DTPA; hydroxy-carboxylic acids; and polycarboxylic acids such as citric acid, carbolic acid, and gluconic acid.

(28) "Chiropractor" means an individual licensed by the state of Ohio to practice chiropractic medicine pursuant to Chapter 4734. of the Revised Code.

(29) "Class" or "lung class" or "inhalation class" means a classification scheme for inhaled material according to its rate of clearance from the pulmonary region of the lung. Materials are classified as D, W, or Y, which applies to a range of clearance half-times: for class D, days, of less than ten days, for class W, weeks, from ten to one hundred days, and for class Y, years, of greater than one hundred days.

(30) "Collective dose" means the sum of the individual doses received in a given period of time by a specified population from exposure to a specified source of radiation.

(31) "Commencement of construction" means taking any action defined as "construction" or any other activity at the site of a facility subject to the rules promulgated pursuant to Chapter 3748. of the Revised Code that has a reasonable nexus to radiological health and safety.

(32) "Committed dose equivalent" or "H_T,50" means the dose equivalent to organs or tissues of reference, T, that will be received from an intake of radioactive material by an individual during the fifty year period following the intake.

(33) "Committed effective dose equivalent" or "H_E,50" means the sum of the products of the weighting factors applicable to each of the body organs or tissues, W_T, that are irradiated and the committed dose equivalent to each of these organs or tissues (H_{E, 50} = W_TH_T,50).

(34) "Consortium" means an association of medical use licensees and a PET radionuclide production facility in the same geographical area that jointly own or share in the operation and maintenance cost of the PET radionuclide production facility that produces PET radionuclides for use in producing radioactive drugs within the consortium for noncommercial distributions among its associated members for medical use. The PET radionuclide production facility within the consortium must be located at an educational institution or a medical facility.

(35) "Constraint" or "dose constraint" means a value above which specified licensee actions are required.

(36) "Construction" means the installation of foundations, or in-place assembly, erection, fabrication, or testing for any structure, system, or component of a facility or activity subject to the rules promulgated pursuant to Chapter 3748. of the Revised Code that are related to radiological safety or security. The term "construction" does not include:

(a) Changes for temporary use of the land for public recreational purposes;

(b) Site exploration, including necessary borings to determine foundation conditions or other preconstruction monitoring to establish background information related to the suitability of the site, the environmental impacts of construction or operation, or the protection of environmental values;

(c) Preparation of the site for construction of the facility, including clearing of the site, grading, installation of drainage, erosion and other environmental mitigation measures, and construction of temporary roads and borrow areas;

(d) Erection of fences and other access control measures that are not related to the safe use of, or security of, radiological materials subject to the rules promulgated pursuant to Chapter 3748. of the Revised Code;

(e) Excavation;

(f) Erection of support buildings (e.g. construction equipment storage sheds, warehouse and shop facilities, utilities, concrete mixing plants, docking and unloading facilities, and office buildings) for use in connection with the construction of the facility;

(g) Building of service facilities (e.g. paved roads, parking lots, railroad spurs, exterior utility and lighting systems, potable water systems, sanitary sewerage treatment facilities, and transmission lines);

(h) Procurement or fabrication of components or portions of the proposed facility occurring at other than the final, in-place location at the facility; or

(i) Taking any other action that has no reasonable nexus to radiological health and safety.

(37) "Controlled area" means an area, outside of a restricted area but inside the site boundary, access to which can be limited by the licensee or registrant for any reason.

(38) "Critical group" means the group of individuals reasonably expected to receive the greatest exposure to residual radioactivity for any applicable set of circumstances.

(39) "Curie" or "Ci" means a unit of activity. One curie equals 3.7 x 10¹⁰ disintegrations per second equals 3.7 x 10¹⁰ becquerels equals 2.22 x 10¹² disintegrations per minute.

(40) "Cyclotron" means a particle accelerator in which the charged particles travel in an outward spiral or circular path. A cyclotron accelerates charged particles at energies usually in excess of ten megaelectron volts and is commonly used for production of short half-life radionuclides for medical use.

(41) "Declared pregnant woman" means a woman who has voluntarily informed the licensee or registrant, in writing, of her pregnancy and the estimated date of conception. The declaration remains in effect until the declared pregnant woman withdraws the declaration in writing or is no longer pregnant.

(42) "Decommission" means to safely remove any licensed operation from service and reduce residual radioactivity to a level that permits release of the licensee's property for unrestricted use and termination of the license.

(43) "Dedicated check source" means a radioactive source that is used to assure the consistent performance of a radiation detection or measurement device over several months or years.

(44) "Deep dose equivalent" or "H_d" applies to external whole body exposure, and means the dose equivalent at a tissue depth of one centimeter, one thousand milligram per square centimeter.

(45) "Demand respirator" means an atmosphere-supplying respirator that admits breathing air to the facepiece only when a negative pressure is created inside the facepiece by inhalation.

(46) "Dentist" means an individual licensed by the state of Ohio to practice dentistry under Chapter 4715. of the Revised Code.

(47) "Department" means the Ohio department of health.

(48) "Depleted uranium" means uranium containing less uranium-235 than the naturally occurring distribution of uranium isotopes.

(49) "Derived air concentration" or "DAC" means the concentration of a given radionuclide in air which, if breathed by the reference man for a working year of two thousand hours under conditions of light work, results in an intake of one ALI. The condition of light work is inhaling 1.2 cubic meters of air per hour for two thousand hours in a year. DAC values are given in appendix C to rule 3701:1-38-12 of the Administrative Code.

(50) "Derived air concentration-hour or DAC-hour" means the product of the concentration of radioactive material in air, which is expressed as a fraction or multiple of the derived air concentration for each radionuclide, and the time of exposure to that radionuclide, in hours. A licensee or registrant may take two thousand DAC-hours to represent one ALI, equivalent to a committed effective dose equivalent of 0.05 Sv (five rem).

(51) "Direct reading dosimeter" means a device that measures radiation dose that does not require another device to read the measured radiation dose. Examples of direct reading dosimeters include pocket dosimeters and electronic dosimeters.

(52) "Director" means the director of health or a designee or authorized representative of the director.

(53) "Discipline" means a branch of knowledge or of teaching.

(54) "Discrete source" means a radionuclide that has been processed so that its concentration within a material has been purposely increased for use for commercial, medical, or research activities.

(55) "Disposable respirator" means a respirator for which maintenance is not intended and that is designed to be discarded after excessive breathing resistance, sorbent exhaustion, physical damage, or end-of service-life renders it unsuitable for use. Examples of this type of respirator are a disposable half-mask respirator or a disposable escape-only self-contained breathing apparatus.

(56) "Dose" or "radiation dose" is a generic term that means absorbed dose, dose equivalent, effective dose equivalent, committed effective dose equivalent, or total effective dose equivalent as defined in other paragraphs of this rule.

(57) "Dose equivalent" or "H_T" means the product of the absorbed dose in tissue, quality factor, and all other necessary modifying factors at the location of interest. The units of dose equivalent are the sievert and rem.

(58) "Dose limits" or "limits" means the permissible upper bounds of radiation doses established in accordance with these regulations but excludes background radiation and medical exposure.

(59) "Dosimetry processor" means a person that processes and evaluates individual monitoring devices in order to determine the radiation dose delivered to the monitoring devices.

(60) "Effective dose equivalent" or "H_E" means the sum of the products of the dose equivalent to each organ or tissue, H_T, and the weighting factor, W_T, applicable to each of the body organs or tissues that are irradiated: (H_E = ∑W_TH_T).

(61) "Embryo" or "fetus" means the developing human organism from conception until time of birth.

(62) "Engineering controls" means mechanisms used to protect health and minimize damage to life and property through engineering specifications, design, and construction of the product or facility including all of the security and safety features. This includes, but is not limited to, auxiliary security and safety features such as additional external shielding, barriers, and operational interlocks with associated processes.

(63) "Entrance" or "access point" means any opening through which an individual or extremity of an individual could gain access to radiation areas or to licensed radioactive materials or registered radiation generating equipment. This includes entry or exit portals of sufficient size to permit human entry, irrespective of their intended use.

(64) "Explosive material" means any chemical compound, mixture or device which produces a substantial instantaneous release of gas and heat spontaneously or by contact with sparks or flame.

(65) "Exposure" means being exposed to sources of ionizing radiation.

(66) "External dose" means that portion of the dose equivalent received from radiation sources outside the body.

(67) "Extremity" means hand, elbow, arm below the elbow, foot, knee, or leg below the knee.

(68) "Eye dose equivalent" means the same as lens dose equivalent.

(69) "Facility" means all buildings, equipment, structures and other stationary items that, in addition to the meaning defined in division (H) of section 3748.01 of the Revised Code, are:

(a) Located on a single site or on contiguous or adjacent sites and are operated by the same person and have common corporate or business interests; or

(b) Portions of a building or structure which are operated by the same person and have common corporate or business interests.

(70) "Filtering facepiece" or "dust mask" means a negative pressure particulate respirator with a filter as an integral part of the facepiece or with the entire facepiece composed of the filtering medium, not equipped with elastomeric sealing surfaces and adjustable straps.

(71) "Fissile material" means the radionuclides uranium-233, uranium-235, plutonium-239, and plutonium-241, or any combination of these radionuclides. Fissile material means the fissile nuclides themselves, not material containing fissile nuclides. Unirradiated natural uranium and depleted uranium and natural uranium or depleted uranium that has been irradiated in thermal reactors only, are not included in this definition. Certain exclusions from fissile material controls are provided in rule 3701:1-50-13 of the Administrative Code.

(72) "Fit factor" means quantitative estimate of the fit of a particular respirator to a specific individual, and typically estimates the ratio of the concentration of a substance in ambient air to its concentration inside the respirator when worn.

(73) "Fit test" means the use of a protocol to qualitatively or quantitatively evaluate the fit of a respirator on an individual.

(74) "Generally applicable environmental radiation standards" means standards issued by the United States environmental protection agency under the authority of the Atomic Energy Act of 1954, 68 Stat. 919, 42 U.S.C. 2011, as amended (2005), that impose limits on radiation exposures or levels, or concentrations or quantities of radioactive material, in the general environment outside the boundaries of locations under the control of persons possessing or using radioactive material.

(75) "Gray" or "Gy" means the SI unit of absorbed dose. One gray is equal to an absorbed dose of one joule per kilogram (one hundred rads).

(76) "Handle" means receive, possess, use, store, transfer, install, service, or dispose of sources of radiation unless possession is solely for the purpose of transportation.

(77) "Handler" means a facility that handles sources of radiation unless possession is solely for the purpose of transportation.

(78) "Hazardous waste" means those wastes designated as hazardous by rule 3745-51-03 of the Administrative Code.

(79) "Helmet" means a rigid respiratory inlet covering that also provides head protection against impact and penetration.

(80) "High radiation area" means an area, accessible to individuals, in which radiation levels from radiation sources external to the body could result in an individual receiving a dose equivalent in excess of one millisievert (0.1 rem) in one hour at thirty centimeters from the radiation source or thirty centimeters from any surface that the radiation penetrates.

(81) "Hood" means a respiratory inlet covering that completely covers the head and neck and may also cover portions of the shoulders and torso.

(82) "Individual" means any human being.

(83) "Individual monitoring" means

(a) The assessment of dose equivalent by the use of devices designed to be worn by an individual;

(b) The assessment of committed effective dose equivalent by bioassay or by determination of the time-weighted air concentrations to which an individual has been exposed, i.e. DAC-hours; or

(c) The assessment of dose equivalent by the use of survey data.

(84) "Individual monitoring devices" means devices designed to be worn by a single individual for the assessment of dose equivalent such as film badges; thermoluminescent dosimeters; optically stimulated luminescent dosimeters; pocket ionization chambers; and personal air sampling devices.

(85) "Industrial radiography" means the examination of the structure of materials by nondestructive methods, utilizing sealed sources of radioactive material or radiation-generating equipment.

(86) "Internal dose" means that portion of the dose equivalent received from radioactive material taken into the body.

(87) "Irradiator" means a facility that uses radioactive sealed sources for the irradiation of objects or materials and in which radiation dose rates exceeding five grays (five hundred rads) per hour exist at one meter from the sealed radioactive source in air or water, as applicable for the irradiator type, but does not include irradiators in which both the sealed source and the area subject to irradiation are contained within a device and are not accessible to personnel.

(88) "Lens dose equivalent" or "eye dose equivalent" means the external exposure of the lens of the eye and is taken as the dose equivalent at a tissue depth of 0.3 centimeters; i.e. three hundred milligrams per square centimeter.

(89) "License" means a license issued by the nuclear regulatory commission, the director, or another agreement state in accordance with rules adopted by those organizations.

(90) "Licensee" means a person to whom a license is issued.

(91) "Licensed activity" means an activity authorized by a radioactive material license which is essential to achieving the purpose for which the license was issued or amended.

(92) "Licensed material" means radioactive material received, possessed, used, transferred or disposed of under a general or specific license.

(93) "Loose-fitting facepiece" means a respiratory inlet covering that is designed to form a partial seal with the face.

(94) "Lost or missing licensed source of radiation" means a licensed source of radiation whose location is unknown. It includes material that has been shipped but has not reached its destination and whose location cannot be readily traced in the transportation system.

(95) "Low-level radioactive waste" or "LLRW," also "low-level waste," or "LLW" means radioactive waste which is not high-level radioactive waste, spent nuclear fuel, NARM, or byproduct material as defined in section 11 E. (2) of the Atomic Energy Act of 1954 68 Stat. 919, 42 U.S.C. 2011, as amended (2005), but is radioactive material that the United States nuclear regulatory commission classifies as low-level radioactive waste.

(96) "Low specific activity material" or "LSA" means radioactive material with limited specific activity which is nonfissile or is excepted under rule 3701:1-50-13 of the Administrative Code, and which satisfies the descriptions and limits set forth below. Shielding materials surrounding the LSA material may not be considered in determining the estimated average specific activity of the package contents. LSA must be in one of three groups:

(a) LSA - I.

(i) Uranium and thorium ores, concentrates of uranium and thorium ores, and other ores containing naturally occurring radioactive radionuclides that are intended to be processed for the use of these radionuclides;

(ii) Natural uranium, depleted uranium, natural thorium or their compounds or mixtures, provided they are unirradiated and in solid or liquid form;

(iii) Radioactive material other than fissile material, for which the A₂ value is unlimited; or

(iv) Other radioactive material in which the activity is distributed throughout and the estimated average specific activity does not exceed thirty times the value for exempt material activity concentration determined in accordance with rule 3701:1-50-25 of the Administrative Code.

(b) LSA-II.

(i) Water with tritium concentration up to 0.8 terabecquerels per liter (twenty curies per liter); or

(ii) Other material in which the activity is distributed throughout and the estimated average specific activity does not exceed ( 10^-4 A₂) per gram for solids and gases, and (10^-5 A₂) per gram for liquids.

(c) LSA-III. Solids (e.g., consolidated wastes, activated materials), excluding powders, that satisfy the requirements of 10 C.F.R. 71.77 (as in effect on the effective date of this rule), in which:

(i) The radioactive material is distributed throughout a solid or a collection of solid objects, or is essentially uniformly distributed in a solid compact binding agent (such as concrete, bitumen, ceramic, etc.);

(ii) The radioactive material is relatively insoluble, or it is intrinsically contained in a relatively insoluble material, so that even under loss of packaging, the loss of radioactive material per package by leaching, when placed in water for seven days, would not exceed (0.1 x A₂); and

(iii) The estimated average specific activity of the solid, excluding any shielding material, does not exceed (0.002 x A₂) per gram.

(97) "Management" means the chief executive officer or other individual having the authority to manage, direct, or administer the licensee's activities, or those persons' delegate or delegates.

(98) "Medical institution" means an organization in which more than one medical discipline is practiced.

(99) "Medical use" means the intentional internal or external administration of radioactive material or the radiation therefrom to patients or human research subjects under the supervision of an authorized user.

(100) "Member of the public" means any individual except when that individual is receiving an occupational dose.

(101) "Minor" means an individual less than eighteen years of age.

(102) "Monitoring" or "radiation monitoring" or "radiation protection monitoring" means the measurement of radiation levels, concentrations, surface area concentrations or quantities of radioactive material and the use of the results of these measurements to evaluate potential exposures and doses.

(103) "NARM" or "naturally occurring or accelerator-produced radioactive material" means naturally occurring or accelerator-produced radioactive material, including naturally occurring material that is technologically enhanced, and those nuclides that are generated in a charged particle accelerator, but does not include source material, byproduct material, or special nuclear material.

(104) "NARM licensing state" means any state with regulations equivalent to the suggested state regulations for control of radiation relating to, and an effective program for, the regulatory control of NARM and which has been granted final designation by the conference of radiation control program directors, inc.

(105) "Nationally tracked source" means a sealed source containing a quantity equal to or greater than "Category 1" or "Category 2" levels of any radioactive material listed in the appendix to rule 3701:1-38-25 of the Administrative Code. In this context a sealed source is defined as radioactive material that is sealed in a capsule or closely bonded, in a solid form and which is not exempt from regulatory control. It does not mean material encapsulated solely for disposal, or nuclear material contained in any fuel assembly, subassembly, fuel rod, or fuel pellet. "Category 1" nationally tracked sources are those containing radioactive material at a quantity equal to or greater than the "Category 1" threshold. "Category 2" nationally tracked sources are those containing radioactive material at a quantity equal to or greater than the "Category 2" threshold but less than the "Category 1" threshold.

(106) "Negative pressure respirator" or "tight fitting respirator" means a respirator in which the air pressure inside the facepiece is negative during inhalation with respect to the ambient air pressure outside the respirator.

(107) "Nonstochastic effect" or "deterministic effect" means health effects, the severity of which varies with the dose and for which a threshold is believed to exist. Radiation-induced cataract formation is an example of a nonstochastic effect.

(108) "NORM" or "naturally occurring radioactive material" means any nuclide that is radioactive in its natural physical state, but does not include source material, byproduct material, or special nuclear material.

(109) "Normal form radioactive material" means radioactive material that has not been demonstrated to qualify as special form radioactive material.

(110) "Nuclear regulatory commission" means the federal agency established by Title II of the Energy Reorganization Act of 1974, 88 Stat. 1233, 42 U.S.C.A. 5801, as amended (2005), comprising the members of the commission and all offices, employees, and representatives authorized to act in any case or matter related to licensing and related regulatory function previously assigned to the AEC.

(111) "Occupational dose" means the dose received by an individual in the course of employment in which the individual's assigned duties involve exposure to radiation or radioactive material from licensed and unlicensed sources of radiation, whether in the possession of the licensee or other person. Occupational dose does not include doses received from background radiation, from any medical administration the individual has received, from exposures to individuals administered radioactive materials and released in accordance with rule 3701:1-58-30 of the Administrative Code or equivalent United States nuclear regulatory commission or agreement state regulations, from voluntary participation in medical research programs, or as a member of the public.

(112) "Package" means the packaging together with its radioactive contents as presented for transport.

(a) Fissile material package or type AF package, type BF package, type B(U)F package, or type B(M)F package means a fissile material packaging together with its fissile material contents.

(b) Type A package means a type A packaging together with its radioactive contents. A type A package is defined and must comply with the United States department of transportation regulations in 49 C.F.R. 173 (as in effect on the effective date of this rule).

(c) Type B package means a type B packaging together with its radioactive contents. On approval, a type B package design is designated by the United States nuclear regulatory commission as B(U) unless the package has a maximum normal operating pressure of more than seven hundred kilopascals (one hundred pounds per square inch) gauge or a pressure relief device that would allow the release of radioactive material to the environment under the tests specified in 10 C.F.R. 71.73 (hypothetical accident conditions) (as in effect on the effective date of this rule), in which case it will receive a designation B(M). B(U) refers to the need for unilateral approval of international shipments; B(M) refers to the need for multilateral approval of international shipments. There is no distinction made in how packages with these designations may be used in domestic transportation. To determine their distinction for international transportation, see United States department of transportation regulations in 49 C.F.R. 173 (as in effect on the effective date of this rule). A type B package approved before September 6, 1983, was designated only as type B. Limitations on its use are specified in 10 C.F.R. 71.19 (as in effect on the effective date of this rule).

(113) "Packaging" means the assembly of components necessary to ensure compliance with the packaging requirements of rule 49 C.F.R. 173 Subpart I (as in effect on the effective date of this rule). It may consist of one or more receptacles, absorbent materials, spacing structures, thermal insulation, radiation shielding, and devices for cooling or absorbing mechanical shocks. The vehicle, tie-down system and auxiliary equipment may be designated as part of the packaging.

(114) "Particle accelerator" means any machine capable of accelerating electrons, protons, deuterons, or other charged particles in a vacuum and of discharging the resultant particulate or other radiation into a medium at energies usually in excess of one megaelectron volt. For purposes of this definition, "accelerator" is an equivalent term.

(115) "Person" means any individual, corporation, association, business enterprise, or other legal entity either public or private and any legal successor, representative, agent, or agency of that individual, corporation, association, business enterprise, or other legal entity. Person also includes the United States, states, political subdivisions of states, and any department, agency, or instrumentality of the United States or a state, except the U.S. department of energy or the U.S. nuclear regulatory commission where the state regulation of radioactive material by either of those agencies is prohibited by federal law.

(116) "Personnel dosimeter", means a device that measures radiation dose that is processed and evaluated by an accredited "National Voluntary Laboratory Accreditation Program" (NVLAP) processor. Examples of personnel dosimeters include film badges, thermo-luminescent dosimeters (TLD), and optically stimulated luminescence (OSL) dosimeters.

(117) "Pharmacist" means a person who is licensed by the state of Ohio to practice pharmacy pursuant to Chapter 4731. of the Revised Code.

(118) "Physician" means a person who is licensed pursuant to Chapter 4731. of the Revised Code to practice medicine or surgery or osteopathic medicine or surgery.

(119) "Planned special exposure" means an infrequent exposure to radiation, separate from and in addition to the annual dose limits.

(120) "Podiatrist" means an individual licensed by the state of Ohio to practice podiatry pursuant to Chapter 4731. of the Revised Code.

(121) "Positive pressure respirator" means a respirator in which the pressure inside the respiratory inlet covering exceeds the ambient air pressure outside the respirator.

(122) "Positron Emission Tomography (PET) radionuclide production facility" means a facility operating a cyclotron or accelerator for the purpose of producing PET radionuclides.

(123) "Powered air-purifying respirator" or "PAPR" means an air-purifying respirator that uses a blower to force the ambient air through air purifying elements to the inlet covering.

(124) "Pressure demand respirator" means a positive pressure atmosphere supplying respirator that admits breathing air to the facepiece when the positive pressure is reduced inside the facepiece by inhalation.

(125) "Public dose" means the dose received by a member of the public from exposure to radiation and/or radioactive material released by the licensee, or to any other source of radiation under the control of a licensee or registrant. Public dose does not include occupational dose or doses received from background radiation, from any medical administration the individual has received, from exposures to individuals administered radioactive materials and released in accordance with rule 3701:1-58-30 of the Administrative Code or equivalent United States nuclear regulatory commission or agreement state regulations, or from voluntary participation in medical research programs.

(126) "Pyrophoric material" means any liquid that ignites spontaneously in dry or moist air at or below 54.4 degrees celsius (one hundred thirty degrees fahrenheit). A pyrophoric solid is any solid material, other than one classed as an explosive, which under normal conditions is liable to cause fires through friction, retained heat from manufacturing or processing, or which can be ignited readily and when ignited burns so vigorously and persistently as to create a serious transportation, handling, or disposal hazard. Included are spontaneously combustible and water-reactive materials.

(127) "Qualitative fit test" or "QLFT" means a pass/fail fit test to assess the adequacy of respirator fit that relies on the individual's response to the test agent.

(128) "Quality factor" or "Q" means the modifying factor, as listed in paragraphs (A) and (B) of rule 3701:1-38-11 of the Administrative Code, that is used to derive dose equivalent from absorbed dose.

(129) "Quantitative fit test" or "QNFT" means an assessment of the adequacy of respirator fit by numerically measuring the amount of leakage into the respirator.

(130) "Quarter" or "quarterly" means a period of time equal to one-fourth of the year observed by the licensee or registrant, approximately thirteen consecutive weeks, providing that the beginning of the first quarter in a year coincides with the starting date of the year and that no day is omitted or duplicated in consecutive quarters.

(131) "Rad" means the special unit of radiation absorbed dose. One rad is equal to an absorbed dose of one hundred ergs per gram, or 0.01 joule per kilogram, or 0.01 gray.

(132) "Radiation" or "ionizing radiation" means alpha particles, beta particles, gamma rays, x-rays, neutrons, high speed electrons, high speed protons, and other particles capable of producing ions. Radiation does not include nonionizing radiation, such as radio or microwaves, or visible, infrared or ultraviolet light.

(133) "Radiation area" means an area, accessible to individuals, in which radiation levels could result in an individual receiving a dose equivalent in excess of 0.05 millisievert (0.005 rem) in one hour at thirty centimeters from the source of radiation or from any surface that the radiation penetrates.

(134) "Radiation-generating equipment" or "RGE" means any manufactured product or device, or component of such a product or device, or any machine or system that during operation can generate or emit radiation, except those that emit radiation only from radioactive material. "Radiation-generating equipment" does not include either of the following:

(a) Diathermy machines;

(b) Microwave ovens, including food service microwave ovens used for commercial and industrial uses, television receivers, electric lamps, and other household appliances and products that generate very low levels of radiation.

(135) "Radiation Safety Officer" or "RSO" means an individual designated by the licensee who has the knowledge and responsibility for the overall radiation safety program at the facility, to include the implementation of the daily radiation safety operations and compliance with the rules.

(136) "Radioactive material" means any solid, liquid or gaseous material that emits ionizing radiation spontaneously. "Radioactive material" includes accelerator-produced and naturally occurring radioactive materials and byproduct, source, and special nuclear material.

(137) "Radioactive waste" means waste containing regulated radioactive material.

(138) "Radioactivity" means the transformation of unstable atoms by the emission of radiation.

(139) "Radiography" means the same as industrial radiography.

(140) "Reference man" means a hypothetical aggregation of human physical and physiological characteristics arrived at by international consensus. These characteristics may be used by researchers and public health workers to standardize results of experiments and to relate biological insult to a common base.

(141) "Registrant" means a person required by Chapter 3748. of the Revised Code to register radiation-generating equipment with the director.

(142) "Rem" means the special unit of any of the quantities expressed as dose equivalent. The dose equivalent in rem is equal to the absorbed dose in rads multiplied by the quality factor (one rem = 0.01 Sv).

(143) "Research and development" means

(a) Theoretical analysis, exploration, or experimentation; or

(b) The extension of investigative findings and theories of a scientific or technical nature into practical application for experimental and demonstration purposes, including the experimental production and testing of models, devices, equipment, materials and processes. "Research and development" does not include the internal or external administration of sources of radiation to human beings.

(144) "Residual radioactivity" means radioactivity in structures, materials, soils, groundwater, and other media at a site resulting from activities under the licensee's control. This includes radioactivity from all licensed and unlicensed sources used by the licensee, but excludes background radiation. It also includes radioactive materials remaining at the site as a result of routine or accidental releases of radioactive material at the site and previous burials at the site, even if those burials were made in accordance with the provisions of 10 C.F.R. 20 (as in effect on the effective date of this rule).

(145) "Respiratory protective equipment or device" means an apparatus, such as a respirator, used to reduce the individual's intake of airborne radioactive materials.

(146) "Restricted area" means an area access to which is limited by the licensee or registrant for the purpose of protecting individuals against undue risks from exposure to sources of radiation. Restricted area does not include areas used as residential quarters, but separate rooms in a residential building may be set apart as a restricted area.

(147) "Roentgen" means the amount of gamma or x-rays required to produce ions resulting in a charge of 0.000258 coulombs per kilogram of air under standard conditions.

(148) "Sanitary sewerage" means a system of public sewers for carrying off wastewater and refuse, but excluding sewage treatment facilities, septic tanks, and leach fields owned or operated by the licensee.

(149) "Sealed source" means radioactive material that is encased in a manner designed to prevent leakage or escape of the radioactive material.

(150) "Sealed source and device registry" means the national registry that contains all the registration certificates, generated by both the United States nuclear regulatory commission and the agreement states, that summarize the radiation safety information for the sealed sources and devices and describe the licensing and use conditions approved for the product.

(151) "Seismic area" means any area where the probability of a horizontal acceleration in rock of more than 0.3 times the acceleration of gravity in two hundred fifty years is greater than ten per cent, as designated by the United States geological survey.

(152) "Self-contained breathing apparatus" or "SCBA" means an atmosphere-supplying respirator for which the breathing air source is designed to be carried by the user.

(153) "Shallow dose equivalent" or "H_S" means the external exposure of the skin of the whole body or the skin of an extremity, is taken as the dose equivalent at a tissue depth of 0.007 centimeter, or seven milligrams per square centimeter.

(154) "Sievert" or "Sv" means the SI unit of any of the quantities expressed as dose equivalent. The dose equivalent in sieverts is equal to the absorbed dose in grays multiplied by the quality factor. One sievert equals one hundred rem.

(155) "Site area emergency" means events may occur, are in progress, or have occurred that could lead to a significant release of radioactive material and that could require a response by off-site response organizations to protect persons off-site.

(156) "Site boundary" means that line beyond which the land or property is not owned, leased, or otherwise controlled by the licensee or registrant.

(157) "Site closure and stabilization" means those actions that are taken upon completion of operations that prepare a disposal site for custodial care and that assure that the disposal site will remain stable and will not need ongoing active maintenance.

(158) "Source material" means uranium, thorium, or any combination thereof in any physical or chemical form, or any ores that contain by weight at least one-twentieth of one per cent (0.05 per cent) of uranium, thorium, or any combination thereof. Source material does not include special nuclear material.

(159) "Sources of radiation" means radioactive material or radiation generating equipment.

(160) "Special form radioactive material" means radioactive material that satisfies the following conditions:

(a) It is either a single solid piece or is contained in a sealed capsule that can be opened only by destroying the capsule;

(b) The piece or capsule has at least one dimension not less than five millimeters (0.2 inch); and

(c) It satisfies the test requirements specified by the United States nuclear regulatory commission in 10 C.F.R. 71.75 (as in effect on the effective date of this rule). A special form encapsulation designed in accordance with the United States nuclear regulatory commission requirements identified in 10 C.F.R. 71.4, in effect on June 30, 1983, and constructed prior to July 1, 1985; a special form encapsulation designed in accordance with the requirements of 10 C.F.R. 71.4 in effect on March 31, 1996, and constructed before April 1, 1998; and special form material that was successfully tested before September 10, 2015 in accordance with the requirements of 10 C.F.R. 71.75(d) of this section in effect before September 10, 2015 may continue to be used. Any other special form encapsulation must meet the specifications of this definition.

(161) "Special nuclear material" means either of the following:

(a) Plutonium, uranium-233, uranium enriched in the isotope 233, or in the isotope 235, and any other material that the United States nuclear regulatory commission determines to be special nuclear material, but does not include source material pursuant to section 51 of the Atomic Energy Act of 1954, 68 Stat 919, 42 USCA 2071, as amended (2005).

(b) Any material artificially enriched by any of the foregoing but does not include source material.

(162) "Special nuclear material in quantities not sufficient to form a critical mass" means uranium enriched in the isotope uranium-235 in quantities not exceeding three hundred fifty grams of contained uranium-235; uranium-233 in quantities not exceeding two hundred grams; plutonium in quantities not exceeding two hundred grams; or any combination of them in accordance with the following formula: for each kind of special nuclear material, determine the ratio between the quantity of that special nuclear material and the quantity specified in this paragraph for the same kind of special nuclear material. The sum of such ratios for all of the kinds of special nuclear material in combination shall not exceed unity.

(163) "Stochastic effect" means health effects that occur randomly and for which the probability of the effect occurring, rather than its severity, is assumed to be a linear function of dose without threshold. Hereditary effects and cancer incidence are examples of stochastic effects.

(164) "Supplied-air respirator" or "SAR" or "airline respirator" means an atmosphere-supplying respirator for which the source of breathing air is not designed to be carried by the user.

(165) "Surface contaminated object" or "SCO" means a solid object that is not itself classed as radioactive material, but which has radioactive material distributed on any of its surfaces. SCO must be in one of two groups with surface activity not exceeding the following limits:

(a) SCO-I: a solid object on which:

(i) The non-fixed contamination on the accessible surface averaged over three hundred square centimeters, or the area of the surface if less than three hundred square centimeters, does not exceed four becquerels per square centimeter (10^-4 microcurie per square centimeter) for beta and gamma and low toxicity alpha emitters, or 0.4 becquerels per square centimeter 10^-5 microcurie per square centimeter) for all other alpha emitters;

(ii) The fixed contamination on the accessible surface averaged over three hundred square centimeters, or the area of the surface if less than three hundred square centimeters, does not exceed forty thousand becquerels per square centimeter (one microcurie per square centimeter) for beta and gamma and low toxicity alpha emitters, or four thousand becquerels per square centimeter (0.1 microcurie per square centimeter) for all other alpha emitters; and

(iii) The non-fixed contamination plus the fixed contamination on the inaccessible surface averaged over three hundred square centimeters, or the area of the surface if less than three hundred square centimeters, does not exceed forty thousand becquerels per square centimeter (one microcurie per square centimeter) for beta and gamma and low toxicity alpha emitters, or four thousand becquerels per square centimeter (0.1 microcurie per square centimeter) for all other alpha emitters.

(b) SCO-II: a solid object on which the limits for SCO-I are exceeded and on which:

(i) The non-fixed contamination on the accessible surface averaged over three hundred square centimeters, or the area of the surface if less than three hundred square centimeter, does not exceed four hundred becquerels per square centimeter (10^-2 microcurie per square centimeter) for beta and gamma and low toxicity alpha emitters, or forty becquerels per square centimeter (10^-3 microcurie per square centimeter) for all other alpha emitters;

(ii) The fixed contamination on the accessible surface averaged over three hundred square centimeters, or the area of the surface if less than three hundred square centimeters, does not exceed eight hundred thousand becquerels per square centimeter (twenty microcuries per square centimeter) for beta and gamma and low toxicity alpha emitters, or eighty thousand becquerels per square centimeter (two microcuries per square centimeter) for all other alpha emitters; and

(iii) The non-fixed contamination plus the fixed contamination on the inaccessible surface averaged over three hundred square centimeters, or the area of the surface if less than three hundred square centimeters, does not exceed eight hundred thousand becquerels per square centimeter (twenty microcuries per square centimeter) for beta and gamma and low toxicity alpha emitters, or eighty thousand becquerels per square centimeter (two microcuries per square centimeter) for all other alpha emitters.

(166) "Survey" means an evaluation of the radiological conditions and potential hazards incident to the production, use, transfer, release, disposal or presence of radioactive material or other sources of radiation. When appropriate, such an evaluation includes a physical survey of the location of radioactive material, or the sources of radiation and measurements or calculations of levels of radiation, or concentrations or quantities of radioactive material present.

(167) "Tight-fitting facepiece" means a respiratory inlet covering that forms a complete seal with the face.

(168) "Total effective dose equivalent" or "TEDE" means the sum of the effective dose equivalent (for external exposures) and the committed effective dose equivalent (for internal exposures).

(169) "Transport index" means the dimensionless number, rounded up to the next tenth, placed on the label of a package, to designate the degree of control to be exercised by the carrier during transportation. The transport index is the number determined by multiplying the maximum radiation level in millisievert per hour at one meter (3.3 feet) from the external surface of the package by one hundred, which is equivalent to the maximum radiation level in millirem per hour at one meter (3.3 feet).

(170) "Type A quantity" means a quantity of radioactive material, the aggregate radioactivity of which does not exceed A₁ for special form radioactive material, or A₂ for normal form radioactive material, where A₁ and A₂ are given in rule 3701:1-50-25 of the Administrative Code.

(171) "Type B quantity" means a quantity of radioactive material greater than a type A quantity.

(172) "Type B package" is defined under "Package."

(173) "United States department of energy" means the department of energy established by the Department of Energy Organization Act, PL 95-91, 91 Stat. 565 (1977), 42 U.S.C. 7101 et seq., as amended (2006), to the extent that the department of energy or its duly authorized representatives, exercises functions formerly vested in the United States atomic energy commission, its chairman, members, officers and components and transferred to the United States energy research and development administration and to the administrator thereof pursuant to Sections 104(b) to (d) of the Energy Reorganization Act of 1974, PL 93-438, 88 Stat. 1233 at 1237 (1974), 42 U.S.C. 5814 and retransferred to the secretary of energy pursuant to Section 301(a) of the Department of Energy Organization Act, PL 95-91, 91 Stat. 565 at 577-578 (1977), 42 U.S.C. 7151.

(174) "Unrestricted area" or "uncontrolled area" means any area, access to which is neither restricted nor controlled by the licensee or registrant.

(175) "User seal check" or "fit check" means an action conducted by the respirator user to determine if the respirator is properly seated to the face. Examples include negative pressure check, positive pressure check, irritant smoke check, or isoamyl acetate check.

(176) "Very high radiation area" means an area, accessible to individuals, in which radiation levels from radiation sources external to the body could result in an individual receiving an absorbed dose in excess of five gray (five hundred rad) in one hour at one meter from a source of radiation or from any surface that the radiation penetrates. At very high doses received at high dose rates, units of absorbed dose, gray and rad, are appropriate, rather than units of dose equivalent, sievert and rem.

(177) "Veterinarian" means an individual licensed by the state of Ohio to practice veterinary medicine pursuant to Chapter 4741. of the Revised Code.

(178) "Waste" means those low-level radioactive wastes containing source, special nuclear, or byproduct material that are acceptable for disposal in a land disposal facility. For the purposes of this definition, low-level radioactive waste means radioactive waste not classified as high-level radioactive waste, transuranic waste, spent nuclear fuel, or byproduct material as defined in paragraph (A)(26)(b) of this rule, or byproduct material as defined in section 11 E. (3) and (4) of the Atomic Energy Act of 1954, 68 Stat. 919, 42 USC 2014, as amended (2005).

(179) "Week" means seven consecutive days starting on Sunday.

(180) "Weighting factor

• W_T" for an organ or tissue, (T), is the proportion of the risk of stochastic effects resulting from irradiation of that organ or tissue to the total risk of stochastic effects when the whole body is irradiated uniformly. For calculating the effective dose equivalent, the values of W_T are:

| Organ doseweighting factors | | | --- | --- | | Organ ortissue | W_T | | Gonads | 0.25 | | Breast | 0.15 | | Red bone marrow | 0.12 | | Lung | 0.12 | | Thyroid | 0.03 | | Bonesurfaces | 0.03 | | Remainder | 0.30^a | | Whole body | 1.00^b |

^\a 0.30 results from 0.06 for each of five "remainder" organs, excluding the skin and the lens of the eye, that receive the highest doses.

^\b for the purpose of weighting the external whole body dose (for adding it to the internal dose) a single weighting factor, W_T = 1.0, has been specified. The use of other weighting factors for external exposure will be approved on a case-by-case basis until such time as specific guidance is issued.

(181) "Whole body" means for purposes of external exposure, head; trunk, including male gonads; arms above the elbow; legs above the knee.

(182) "Worker" means an individual engaged in activities licensed or registered by the department and controlled by a licensee or registrant, but does not include the licensee or registrant.

(183) "Working level" or "WL" means any combination of short-lived radon decay products (for radon-222: polonium-218, lead-214, bismuth-214, and polonium-214; and for radon-220: polonium-216, lead-212, bismuth-212, and polonium-212) in one liter of air that will result in the ultimate emission of 1.3 x 10⁵ million electron volts alpha particle energy.

(184) "Working level month" or "WLM" means a cumulative exposure to one working level for one hundred seventy hours. (Two thousand working hours per year/twelve months per year equals approximately one hundred seventy hours per month.)

(185) "Year" means the period of time beginning in January used to determine compliance with the provisions of this rule. The licensee or registrant may change the starting date of the year used to determine compliance by the licensee or registrant provided that the change is made at the beginning of the year and that no day is omitted or duplicated in consecutive years.

(B) The terms set out in paragraph (A) of this rule may be redefined in other chapters as promulgated pursuant to Chapter 3748. of the Revised Code as used in that chapter only.

Last updated May 13, 2026 at 11:20 AM

History

• Effective: January 20, 2022
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-49-21

(A) The licensee shall make radiation surveys, including but not limited to the surveys required under paragraphs (B) to (E) of this rule, of each area where licensed materials are used and stored.

(B) Before transporting licensed materials, the licensee shall make a radiation survey of the position occupied by each individual in the vehicle and of the exterior of each vehicle used to transport the licensed materials.

(C) If the sealed source assembly is removed from the logging tool before departure from the temporary job site, the licensee shall confirm that the logging tool is free of contamination by energizing the logging tool detector or by using a survey meter.

(D) If the licensee has reason to believe that, as a result of any operation involving a sealed source, the encapsulation of the sealed source could be damaged by the operation, the licensee shall conduct a radiation survey, including a contamination survey, during and after the operation.

(E) The licensee shall make a radiation survey at the temporary job site before and after each subsurface tracer study to confirm the absence of contamination.

(F) The results of surveys required under paragraphs (A) to (E) of this rule must be recorded and must include the date of the survey, the name of the individual making the survey, the identification of the survey, survey instrument used, and the location of the survey. The licensee shall retain records of surveys for inspection by the director for three years after they are made.

Last updated November 2, 2022 at 2:42 PM

History

• Effective: September 1, 2012
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-49-02 Purpose and scope.

Chapter 3701:1-49 of the Administrative Code covers requirements for the issuance of a license authorizing the use of licensed materials including sealed sources, radioactive tracers, radioactive markers, and uranium sinker bars in well logging in a single well. This chapter also prescribes radiation safety requirements for persons using licensed materials in these operations. The provisions and requirements of this chapter are in addition to, and not in substitution for, other requirements of Chapter 3748. of the Revised Code and rules promulgated thereunder. The requirements set out in this chapter do not apply to the issuance of a license authorizing the use of licensed material in tracer studies involving multiple wells, such as field flooding studies, or to the use of sealed sources auxiliary to well logging but not lowered into wells.

Last updated November 2, 2022 at 2:40 PM

History

• Effective: October 8, 2007
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-49-03 Application for a specific license for well logging.

(A) A person, as defined in rule 3701:1-38-01 of the Administrative Code, shall file an application for a specific license authorizing the use of licensed material in well logging on a form provided by the director. Each application for a license, must be accompanied by the fee prescribed in rule 3701:1-38-02 of the Administrative Code.

(B) The director will approve an application for a specific license for the use of licensed material in well logging if the applicant meets the following requirements:

(1) The applicant shall satisfy the general requirements specified in rule 3701:1-40-15 of the Administrative Code for byproduct and accelerator produced material, in rule 3701:1-44-15 of the Administrative Code for source material, and in rule 3701:1-56-18 of the Administrative Code for special nuclear material, as appropriate, and any special requirements contained in this chapter.

(2) The applicant shall develop a program for training logging supervisors and logging assistants and submit to the director a description of this program which specifies the:

(a) Initial training;

(b) On-the-job training;

(c) Annual safety reviews provided by the licensee;

(d) Means the applicant will use to demonstrate the logging supervisor's knowledge and understanding of and ability to comply with the department's rules and licensing requirements and the applicant's operating and emergency procedures; and

(e) Means the applicant will use to demonstrate the logging assistant's knowledge and understanding of and ability to comply with the applicant's operating and emergency procedures.

(3) The applicant shall submit to the director written operating and emergency procedures as described in rule 3701:1-49-19 of the Administrative Code or an outline or summary of the procedures that includes the important radiation safety aspects of the procedures.

(4) The applicant shall establish and submit to the director its program for annual inspections of the job performance of each logging supervisor to ensure that the department's rules, license requirements, and the applicant's operating and emergency procedures are followed. Inspection records must be retained for three years after each annual internal inspection.

(5) The applicant shall submit a description of its overall organizational structure as it applies to the radiation safety responsibilities in well logging, including specified delegations of authority and responsibility.

(6) If an applicant wants to perform leak testing of sealed sources, the applicant shall identify the manufacturers and the model numbers of the leak test kits to be used. If the applicant wants to analyze its own wipe samples, the applicant shall establish procedures to be followed and submit a description of these procedures to the director. The description must include the:

(a) Instruments to be used;

(b) Methods of performing the analysis; and

(c) Pertinent experience of the person who shall analyze the wipe samples.

(7) If the applicant does not perform the leak testing, leak tests shall be performed only by a company specifically licensed to perform the tests.

(C) Each license is issued with the condition that the licensee shall, at any time before expiration of the license, upon the director's request, submit written statements, signed under oath or affirmation, to enable the director to determine whether or not the license should be modified, suspended, or revoked.

Last updated November 2, 2022 at 2:40 PM

History

• Effective: July 27, 2013
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-38-02

(A) As used in this rule, "facility" has the meaning defined in division (H) of section 3748.01 of the Revised Code and the following:

(1) All buildings, equipment, structures, and other stationary items that are located on a single site or on contiguous or adjacent sites and that are operated by the same person and have common corporate or business interests; and

(2) Portions of a building or structure which are operated by the same person and have common corporate or business interests.

(B) Notwithstanding the definition of "facility," the director may consider sites that are not contiguous or adjacent as one facility provided that:

(1) The sites are operated by the same person;

(2) The sites are in the same license category or categories;

(3) The applicant for a license provides for one radiation safety officer, and if applicable, one radiation safety committee, as responsible for all sites; and

(4) The director is reasonably satisfied from the information provided in the application that the applicant will adequately control radioactive material at all sites listed in the application.

(a) Unless the director has information of violations of Chapter 3748. of the Revised Code or the rules adopted thereunder at one or more sites, the director shall presume the applicant will adequately control radioactive material at all sites if the sites are located not more than twenty miles driving distance apart as documented by the licensee, and if all sites are within a twenty mile radius from the main site as designated on the license.

(b) The director shall continue to renew a license issued under this paragraph that contains all the sites listed thereon provided the licensee demonstrates continued compliance with this paragraph, Chapter 3748. of the Revised Code, and the rules adopted thereunder.

(C) Every facility that handles radioactive material in any license category as specified in appendix A to this rule for which licensure is required shall apply for a license, license amendment, or license renewal in accordance with this rule. Application for a license, license amendment, or license renewal shall be made on any format prescribed and provided by the director. Licenses shall be issued in accordance with the requirements of Chapter 3748. of the Revised Code, and the rules adopted thereunder. Except as otherwise provided in this rule, a license shall expire five years from the date of issuance.

(1) As used in this paragraph, site means an address of use listed on the license. Temporary job sites are exempted.

(a) Any individual applying for a new license with one or more additional sites or a current licensee amending a license to add one or more additional sites that are located more than twenty miles from the main site shall pay an additional site fee for each such site as follows:

(i) The additional site fee(s) shall be seventy-five percent of the applicable annual fee, as those fees are set forth in paragraphs (D), (F), and (J) of this rule.

(ii) Additional site fees will be invoiced annually with the annual fee.

(b) Broad scope licensees are exempt from paragraph (C)(1)(a) of this rule.

(2) As used in this paragraph, "service" means activities performed by a person, other than a worker as defined in rule 3701:1-38-01 of the Administrative Code, pursuant to an agreement with the facility to perform activities that deal with sources of radiation for the facility.

(a) These activities include, but are not limited to the following:

(i) Conduct leak tests;

(ii) Calibrate survey instruments;

(iii) Provide quality control tests;

(iv) Conduct surveys, characterization, and/or remediation activities;

(v) Manage the disposal of radioactive waste for other persons; or

(vi) Install sources or devices or change sources within a device.

(b) License categories affected are:

(i) 3219 - decontamination services;

(ii) 3220 - leak test service;

(iii) 3221 - instrument calibration service only - source less than 3.7 terabecquerels (one hundred curies);

(iv) 3222 - instrument calibration service only - source equal to or greater than 3.7 terabecquerels (one hundred curies);

(v) 3223 - leak test and instrument calibration - source less than 3.7 terabecquerels (one hundred curies);

(vi) 3224 - leak test and instrument calibration - source equal to or greater than 3.7 terabecquerels (one hundred curies);

(vii) 3225 - other services - including teletherapy, irradiator, and gauge service;

(viii) 3232 - waste disposal service prepackaged only;

(ix) 3233 - waste disposal service - incineration; and

(x) 3234 - waste disposal service processing and/or repackaging.

(D) A radioactive materials license issued by the department may, at the discretion of the director, have more than one license category on any one specific license. A licensee may have more than one radioactive materials license. Except as otherwise provided in paragraph (J) of this rule, the annual fee for a radioactive material license shall be in an amount in accordance with appendix A to this rule.

(1) Upon receipt of an application for a new radioactive material license, the department will issue an invoice for the appropriate fee specified in appendix A to this rule or paragraph (J) of this rule. Annual fees will be invoiced based on the month of the license expiration date and the invoice will state that the fee is due thirty days after the date of the invoice. License fees are not refundable.

(2) An applicant for a new or a renewal or amendment of a radioactive material license must submit a complete application before the director will finalize the review of the application. A complete application is one in which the applicant has provided all the information requested by the director, including any additional information requested after receipt of the application package.

(3) Upon receipt of an application for a license amendment, the department will issue an invoice for the appropriate fee for the proposed amendment as specified in appendix A to this rule. If the amendment is to change the license from operational phase to storage of sealed sources only incident to disposal of the sources, after the amendment the annual fee for the license shall be reduced to fifty per cent of the fee for the operational phase of the license, provided that the sources continue to be in safe storage and leak tested as provided by license condition for the specific sources in storage. The inspection frequency will remain the same as that for the operational phase of the license until after source disposal.

(4) The applicant for a new, or renewal or amendment of a radioactive materials license shall provide to the director all additional information requested within sixty days from the date of the information request. If the director does not receive the requested information within the stated time period, the director may consider the application abandoned. Any further consideration of a new license, or a renewal or amendment of a license shall be pursuant to another application.

(5) The director shall grant a new license, license amendment, or license renewal to any applicant who has submitted a complete application and is in compliance with Chapter 3748. of the Revised Code and the rules adopted thereunder.

(6) When an amendment to a license results in a change to a license category with a higher fee, the licensee will be charged the higher of the two amendment fees for that category. The annual fee for the licensee will escalate to the new category fee on the date of the next annual invoice.

(7) The director shall charge a fee for minor license amendments that do not require review by members of the technical staff at a rate of one hundred dollars per amendment provided that no licensee shall be required to pay more than one thousand dollars for minor amendments in any calendar year. Minor amendments include, but are not limited to, adding a new gauge of the same type already licensed unless that additional gauge increases the license or inspection fee, a corporate name change if the corporate ownership does not change, adding a user name that does not require review of education and experience, and corporate address change if the location of the use of the radioactive material does not change. Amendments to change the radiation safety officer or the chair or members of the radiation safety committee that require review of education or experience are not minor amendments.

(8) License terminations shall be handled as follows:

(a) Except as provided in paragraph (D)(8)(c) of this rule, a termination fee of five hundred dollars or fifty per cent of the annual fee, whichever is less, will be invoiced upon written request from the licensee for termination of the license. This fee is not refundable.

(b) Except as provided in paragraph (D)(8)(c) of this rule, if the termination cost, as determined by paragraph (M) of this rule, exceeds the termination fee in paragraph (D)(8)(a) of this rule, the remainder of the termination expense will be assessed at full cost.

(c) If the license termination would be covered under paragraph (D)(9) of this rule, that paragraph will be used for the termination process.

(d) The license termination process will not be completed until the licensee is in compliance with all rules, including payment of fees.

(9) Licenses, and other approvals related to the licensed activity requiring decommissioning, decontamination, reclamation, site restoration, or long-term care due to the continued presence of radioactive materials shall be charged an annual fee based on the approved decommissioning funding plan as specified in appendix B to this rule.

(a) A decommissioning plan must be approved by the department. Prior to approval of the decommissioning plan the licensee must submit an amendment requesting decommissioning. Until the amendment is approved the licensee's annualized license fee will be reduced by fifty per cent. After approval of the amendment containing the decommissioning plan, the licensee will be invoiced at the annual fee specified in appendix B to this rule.

(b) The annual fee specified in appendix B to this rule is based on the cost of decommissioning. The fee is payable within thirty days of mailing of an invoice by the department.

(c) Routine decommissioning oversight by the department will be charged against the annual amount received and additional invoices will not be issued unless the cost of activities exceeds the annual amount in any given year.

(d) The facility shall receive a monthly statement of items and amounts charged against the annual fee.

(e) If the cost of additional activities arise that require use of additional staff, including any consulting service that exceeds the amount of the annual fee paid by the licensee, these additional costs will be included in any invoice as separate items invoiced for the full cost of the oversight by additional staff or consultants. Oversight activities will be performed at a frequency which adequately monitors health, safety, and the environment.

(f) When the approved decommissioning plan is less than one hundred thousand dollars, the licensee will remain in the current license category and continue to pay the required annual fee specified in appendix A to this rule during decommissioning. Inspections of these licensees will be done as non-routine inspections. Non-routine inspection fees will not be applied until the number of decommissioning inspections performed exceed the inspections that would have been performed if the licensee had not chosen the decommissioning option.

(g) When the licensee has completed the decommissioning, and the director has determined that the licensee cannot terminate the license as provided by the Administrative Code, Chapter 3748. of the Revised Code or the rules adopted thereunder, but the licensee has successfully completed the decommissioning of the operation as required by the approved decommissioning plan, the director will amend the license to a decommissioning/possession only license. The annual fee for a decommissioning/possession only license is provided in appendix B to this rule.

(E) Licenses shall be renewed in accordance with the standard renewal procedure established in Chapter 4745. of the Revised Code, except that a licensee, other than a broad scope licensee, shall apply for renewal of the license ninety days prior to the expiration date of the current license and broad scope licensees shall apply for renewal of their license one hundred eighty days prior to expiration.

(F) The annual fee is listed in appendix A to this rule "column 5" for a new license or "column 6" for a renewal license. To recover the costs of oversight activities where radioactive material is found in the public domain and there is no evident individual that is determined to be responsible, a surcharge of 5.25 per cent has been included in the annual fee listed in "column 5" and "column 6" of appendix A to this rule.

(G) The department shall charge an inspection fee for all non-routine inspections. A non-routine inspection is defined as any inspection that the department conducts in addition to the scheduled routine inspections and one follow-up inspection if necessary. Non-routine inspections include, without limitation:

(1) An inspection performed as a result of an incident;

(2) Any pre-license inspections for a new license applicant when the director determines that an inspection is necessary to assess the adequacy of the information provided in the application;

(3) Inspections prior to license amendment, category change, or termination;

(4) An inspection performed at a facility that results in the issuance of an adjudication order by the director; or

(5) Other enforcement or regulatory inspections, not specified above, that the director determines is necessary to assess compliance with Chapter 3748. of the Revised Code.

(H) The fee for a non-routine inspection shall be based on the actual cost for conducting the inspection which shall include:

(1) An hourly charge of seventy dollars per staff person assigned to the inspection, except staff participating as training will not be included in the charges;

(2) An administrative fee of three hundred thirty dollars;

(3) All necessary laboratory analysis costs for samples collected by department personnel; and

(4) Any staff travel costs which shall be calculated in accordance with rule 126-01-02 of the Administrative Code.

(I) All fees invoiced as provided within this rule, including full cost, routine, and non-routine inspection fees, shall be paid within thirty days of the invoice date specified on the invoice. In accordance with sections 3748.07 and 3748.13 of the Revised Code, any fee that remains unpaid on the ninety-first day after the original invoice date shall be assessed an additional amount equal to ten per cent of the original fee.

(1) The department shall mail invoices by ordinary U.S. mail to the most recent address provided by the licensee.

(2) The department shall maintain a list of the invoices issued and date mailed.

(J) Notwithstanding paragraph (D) of this rule, the department shall charge the following types of licensees reduced license fees in the following specified amounts:

(1) A private entity that provides services, does not engage in manufacturing, and that has three hundred fifty thousand to two million dollars in gross annual receipts, shall pay a total license fee of seventy-five per cent of the amount specified for that use of radioactive materials in appendix A to this rule.

(2) A private entity that provides services, does not engage in manufacturing, and that has less than three hundred fifty thousand dollars in gross annual receipts shall pay a total license fee of fifty per cent of the amount specified for that use of radioactive material in appendix A to this rule.

(3) A private entity that engages in manufacturing and that has thirty-five to two hundred employees, irrespective of gross annual receipts, shall pay a total license fee of seventy-five per cent of the amount specified for that use of radioactive material in appendix A to this rule.

(4) A private entity that engages in manufacturing and that has less than thirty-five employees, irrespective of gross annual receipts, shall pay a total license fee of fifty per cent of the amount specified for that use of radioactive material in appendix A to this rule.

(5) A nonprofit entity that has gross annual receipts of three hundred fifty thousand dollars to two million dollars shall pay a total license fee of seventy-five per cent of the amount specified for that use of radioactive material in appendix A to this rule.

(6) A nonprofit entity that has gross annual receipts of less than three hundred fifty thousand dollars shall pay a total license fee of fifty per cent of the amount specified for that use of radioactive material in appendix A to this rule.

(7) A government jurisdiction or district with a population of twenty thousand to fifty thousand shall pay a total license fee of seventy-five per cent of the amount specified for that use of radioactive material as specified in appendix A to this rule.

(8) A government jurisdiction or district with a population of less than twenty thousand shall pay a total license fee of fifty per cent of the amount specified for that use of radioactive materials as specified in appendix A to this rule.

(9) A health district as defined in section 3709.01 of the Revised Code shall pay a total license fee of twenty-five per cent of the amount specified in appendix A to this rule.

(10) An accredited private or public college or university possessing or using radioactive material in a sealed or unsealed source solely as a part of a college or university course supported by tuition and leading to an accredited degree, but excluding clinical training, shall pay a total license fee as set forth for category "1129" as that amount is specified in appendix A to this rule.

The reduced annual fees specified in this paragraph do not apply to any other fees that a licensee may be required to pay under Chapter 3748. of the Revised Code or rules adopted thereunder. Licensees shall provide certification of their compliance with the provisions of paragraphs (J)(1) to (J)(6) of this rule upon initial application and renewal.

(K) The director may modify the inspection frequency of licensed facilities based upon the performance of the facility.

(L) In accordance with section 3748.22 of the Revised Code, the department shall charge fees sufficient to cover all costs of regulatory, administrative, and enforcement activities conducted pursuant to Chapter 3748. of the Revised Code. The director shall recommend to the radiation advisory council and the public health council changes in the radioactive materials fees if the director finds that fees do not meet the requirements of section 3748.22 of the Revised Code.

(M) Fees for those categories listed as "full cost" such as decommissioning activities, for either partial, building or selected area of a licensed site, or full decommissioning leading to license amendment, category change, or termination and for review of sources and/or devices shall be specified as "full cost" and shall be calculated as the sum of the seventy dollar hourly charge per staff member for the number of hours spent on document review and preparation, licensing, inspection, meetings, teleconferences, in travel, administrative time, the cost of any special contractors as determined necessary by the director, any environmental monitoring for radioactive materials and laboratory analysis, any other associated activities. The administrative fee from paragraph (H)(2) of this rule shall be used for administrative time. Travel expenses shall also be invoiced and shall be calculated at the rate determined by rule 126-1-02 of the Administrative Code. These fees will be invoiced monthly.

(N)

(1) Reciprocity to engage in activities in the state of Ohio which involve radioactive materials may be authorized provided:

(a) The person requesting reciprocity possesses a valid radioactive materials license issued by another agreement state or the United States nuclear regulatory commission which authorizes the same activities proposed to be conducted in Ohio;

(b) The request for reciprocity is made by submission of a completed reciprocity application provided by the director, a copy of the person's radioactive materials license, and payment of the reciprocity fee specified in appendix A to this rule;

(c) The duration of activities to be performed in Ohio under reciprocity does not exceed one hundred eighty days in any one calendar year.

(2) A person who has been granted reciprocity in Ohio shall notify the director at least three business days in advance of each time the person proposes to begin a new use of radioactive materials in the state of Ohio, with the notification made on a form provided by the director.

(3) Activities conducted in Ohio under reciprocity are subject to inspection by the department at any time and the department shall invoice a reciprocity inspection fee of one thousand dollars for each inspection of a person's authorized reciprocity activities.

(4) Reciprocity is authorized for one calendar year, beginning on January first or later date when reciprocity is initially applied for, and ending on December thirty-first.

(5) A person who is authorized reciprocity shall apply for an Ohio radioactive materials license at least thirty days prior to exceeding one hundred eighty days of activities in Ohio.

(O) Requests for safety evaluation of devices, products, or sealed sources used for radioactive materials either for commercial distribution or manufactured in accordance with the unique specifications of, and for use by, a single applicant shall be submitted to the director on a form provided by the director for that review prior to manufacture or commercial distribution.

(1) The application shall specify a license amendment for one of the areas listed below:

(a) Safety evaluation of sealed sources or devices or products containing NARM, byproduct material, source material, or special nuclear material (less than critical mass) for commercial distribution.

(b) Safety evaluation of sealed sources or devices or products containing NARM, byproduct material, source material, or special nuclear material (less than critical mass) manufactured in accordance with the unique specifications of, and for use by, a single applicant.

(2) The amendment fee for a source or device review shall be "full cost" as outlined in paragraph ((M) of this rule.

(3) The amendment fee in appendix A to this rule for categories under manufacturing and distribution shall be for amendments other than source or device reviews.

(4) Licensees for categories 3211, 3212, 3213, 3214, and 22162 shall pay an annual surcharge of six hundred fifty dollars to cover administrative costs of overall maintenance activities associated with source or device data submitted to the United States nuclear regulatory commission. This surcharge is included in the annual fee for the above listed categories in "column 5" and "column 6" of appendix A to this rule.

(P) When considered necessary by the director, the director may conduct a review of shielding plans or the adequacy of shielding. The director may also conduct such a review upon the request of the licensee or the applicant for a license. The applicant or licensee shall pay a fee for review of shielding plans or adequacy of shielding as specified in paragraph (M) of this rule.

(Q) Individuals with implanted pacemakers that have a radioactive source will not be charged an annual fee as an individual because of the necessity of possessing the device. Unless the director determines other provisions are required, the medical institution that implanted the device shall hold the license for the individual.

(R) If, because of the complexity of a review, such as that for a sealed source or device, decommissioning, license, or incident, it is necessary to obtain the services of a consultant to assist in a final determination, the licensee or applicant will be invoiced for the consulting services.

(S) Licensees with general licenses requiring an annual report to the director shall submit the report with a fee of four hundred twenty dollars within thirty days of mailing an invoice by the department and are subject to late penalties in paragraph (I) of this rule. If a facility has a specific license which is in a category that would include the generally licensed material, the facility may add the generally licensed material to the specific license and will not be charged the additional fee for that generally licensed material. Annual reports are required for devices under a general license containing radionuclides at or above activities listed in paragraph (C)(13) of rule 3701:1-46-05 of the Administrative Code.

View AppendixView Appendix

Last updated November 2, 2022 at 2:09 PM

History

• Effective: April 15, 2013
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-40-15

(A) An application for a specific license will be approved if:

(1) The application is for a purpose authorized by Chapter 3748. of the Revised Code and the rules adopted thereunder;

(2) The applicant's proposed equipment and facilities are adequate to protect health and minimize danger to life or property or the environment;

(3) The applicant is qualified by training and experience to use the radioactive material for the purpose requested in such manner as to protect health and minimize danger to life or property or the environment;

(4) The applicant satisfies any special requirements contained in rule 3701:1-38-02 of the Administrative Code, and Chapters 3701:1-46, 3701:1-48, 3701:1-49, 3701:1-52, and 3701:1-58 of the Administrative Code; and

(5) In the case of an application for a license to receive and possess radioactive material for the conduct of any activity which the director determines could potentially affect the quality of the environment, the department, before commencement of construction of the plant or facility in which the activity will be conducted, on the basis of information filed and evaluations made pursuant to rule 3701:1-40-30 of the Administrative Code, has concluded, after weighing the environmental, economic, technical, and other benefits against environmental costs and considering available alternatives, shall conclude that the action called for is the issuance of the proposed license, with any appropriate conditions to protect environmental values. Commencement of construction prior to such conclusion shall be grounds for denial of a license to receive and possess radioactive material in such plant or facility. As used in this paragraph the term "commencement of construction" is as defined in rule 3701:1-38-01 of the Administrative Code.

(B) Upon a determination that an application meets the requirements of Chapter 3748. of the Revised Code and the rules adopted thereunder, the director will issue a specific license authorizing the possession and use of radioactive material.

Last updated November 2, 2022 at 2:12 PM

History

• Effective: July 25, 2013
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-44-15

(A) An application for a specific license will be approved if:

(1) The application is for a purpose authorized by Chapter 3748. of the Revised Code and the rules promulgated thereunder;

(2) The applicant is qualified by reason of training and experience to use the source material for the purpose requested in such manner as to protect health and minimize danger to life or property;

(3) The applicant's proposed equipment, facilities and procedures are adequate to protect health and minimize danger to life or property;

(4) For an application to possess and use source and byproduct material for uranium milling or for the conduct of any other activity which the director determines will significantly affect the quality of the environment, the director has concluded that the action called for is the issuance of the proposed license, along with any appropriate conditions to protect environmental values, after:

(a) Reviewing filed information;

(b) Making evaluations pursuant to rule 3701:1-40-30 of the Administrative Code; and

(c) Weighing the environmental, economic, technical and other benefits against environmental costs and considering available alternatives; and

(5) The applicant satisfies any applicable special requirements contained in rule 3701:1-44-16 of the Administrative Code.

(B) Commencement of construction prior to this conclusion in paragraph (A)(4) of this rule is grounds for denial of a license to possess and use source and byproduct material in the plant or facility. The term "commencement of construction" is as defined in rule 3701:1-38-01 of the Administrative Code.

(C) All applicants shall prohibit commencement of construction with respect to such material listed in paragraph (A)(4) of this rule until the director has issued a license.

Last updated November 2, 2022 at 2:15 PM

History

• Effective: December 10, 2015
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-56-18

An application for a specific license will be approved if:

(A) The application is for a purpose authorized by Chapter 3748. of the Revised Code and the rules promulgated thereunder;

(B) The applicant is qualified by reason of training and experience to use the material for the purpose requested in accordance with the rules in this chapter;

(C) The applicant's proposed equipment and facilities are adequate to protect health and minimize danger to life or property;

(D) The applicant's proposed procedures to protect health and to minimize danger to life or property are adequate; and

(E) Where the nature of the proposed activities is such as to require consideration by the director, the applicant is financially qualified to engage in the proposed activities in accordance with the rules in this chapter.

Last updated August 1, 2023 at 2:51 PM

History

• Effective: September 1, 2012
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-49-19

Each licensee shall develop and follow written operating and emergency procedures that cover:

(A) The handling and use of licensed materials including the use of sealed sources in wells without surface casing for protecting fresh water aquifers, if appropriate;

(B) The use of remote handling tools for handling sealed sources and radioactive tracer material except low-activity calibration sources;

(C) Methods and occasions for conducting radiation surveys, including surveys for detecting contamination, as required by paragraphs (C) to (E) of rule 3701:1-49-21 of the Administrative Code;

(D) Minimizing personnel exposure including exposures from inhalation and ingestion of licensed tracer materials;

(E) Methods and occasions for locking and securing stored licensed materials;

(F) Personnel monitoring and the use of personnel monitoring equipment;

(G) Transportation of licensed materials to field stations or temporary job sites, packaging of licensed materials for transport in vehicles, placarding of vehicles when needed, and physically securing licensed materials in transport vehicles during transportation to prevent accidental loss, tampering, or unauthorized removal;

(H) Picking up, receiving, and opening packages containing licensed materials, in accordance with rule 3701:1-38-18 of the Administrative Code;

(I) For the use of tracers, decontamination of the environment, equipment, and personnel;

(J) Maintenance of records generated by logging personnel at temporary job sites;

(K) The inspection and maintenance of sealed sources, source holders, logging tools, injection tools, source handling tools, storage containers, transport containers, and uranium sinker bars as required by rule 3701:1-49-11 of the Administrative Code;

(L) Identifying and reporting to the director defects and noncompliance as required by rule 3701:1-38-23 of the Administrative Code;

(M) Actions to be taken if a sealed source is lodged in a well;

(N) Notifying proper persons in the event of an accident; and

(O) Actions to be taken if a sealed source is ruptured including actions to prevent the spread of contamination and minimize inhalation and ingestion of licensed materials and actions to obtain suitable radiation survey instruments as required by paragraph (B) of rule 3701:1-49-06 of the Administrative Code.

Last updated November 2, 2022 at 2:42 PM

History

• Effective: September 1, 2012
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-49-04 Agreement with well owner or operator.

(A) A licensee may perform well logging with a sealed source only after the licensee has a written agreement with the employing well owner or operator. This written agreement must identify which party shall be responsible for meeting the following requirements:

(1) If a sealed source becomes lodged in the well, a reasonable effort will be made to recover it;

(2) A person may not attempt to recover a sealed source in a manner which, in the licensee's opinion, could result in its rupture;

(3) The radiation monitoring required in paragraph (A) of rule 3701:1-49-22 of the Administrative Code will be performed;

(4) If the environment, any equipment, or personnel are contaminated with licensed material, they must be decontaminated before release from the site or release for unrestricted use; and

(5) If the sealed source is classified as irretrievable after reasonable efforts at recovery have been expended, the following requirements must be implemented within thirty days:

(a) Each irretrievable well logging source must be immobilized and sealed in place with a cement plug;

(b) A means to prevent inadvertent intrusion on the source, unless the source is not accessible to any subsequent drilling operations; and

(c) A permanent identification plaque, constructed of long lasting material such as stainless steel, brass, bronze, or monel, must be mounted at the surface of the well, unless the mounting of the plaque is not practical. The size of the plaque must be at least seventeen centimeters (seven inches) square and three millimeters (0.125 inch) thick. The plaque must contain:

(i) The word "CAUTION";

(ii) The radiation symbol (the color requirement in paragraph (A) of rule 3701:1-38-18 of the Administrative Code need not be met);

(iii) The date the source was abandoned;

(iv) The name of the well owner or well operator, as appropriate;

(v) The well name and well identification number(s) or other designation;

(vi) An identification of the sealed source(s) by radionuclide and quantity;

(vii) The depth of the source and depth to the top of the plug; and

(viii) An appropriate warning, such as, "DO NOT RE-ENTER THIS WELL."

(B) The licensee shall retain a copy of the written agreement for three years after the completion of the well logging operation.

(C) A written agreement between the licensee and the well owner or operator is not required if the licensee and the well owner or operator are part of the same corporate structure or otherwise similarly affiliated. However, the licensee shall still otherwise meet the requirements in paragraphs (A)(1) to (A)(4) of this rule.

Last updated November 2, 2022 at 2:40 PM

History

• Effective: September 1, 2012
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-49-22

(A) If the licensee detects evidence that a sealed source has ruptured or licensed materials have caused contamination, the licensee shall initiate immediately the emergency procedures required by rule 3701:1-49-19 of the Administrative Code.

(B) If contamination results from the use of licensed material in well logging, the licensee shall decontaminate all work areas, equipment, and unrestricted areas.

(C) During efforts to recover a sealed source lodged in the well, the licensee shall continuously monitor, with an appropriate radiation detection instrument or a logging tool with a radiation detector, the circulating fluids from the well, if any, to check for contamination resulting from damage to the sealed source.

Last updated November 2, 2022 at 2:42 PM

History

• Effective: October 20, 2002
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-38-18

(A) Except as provided in paragraph (B) of this rule, caution signs and posting requirements for licensees and registrants are as follows:

(1) The standard radiation symbol, unless otherwise authorized by the department or as provided in paragraph (A)(2) of this rule, shall use the colors magenta, purple, or black on yellow background. The symbol prescribed is the three-bladed design as follows:

(2) Notwithstanding paragraph (A)(1) of this rule, licensees and registrants are authorized to label sources, source holders, or device components containing sources of radiation that are subjected to high temperatures, with conspicuously cast, etched or stamped radiation caution symbols and without a color requirement.

(3) In addition to the contents of signs and labels prescribed in this chapter, the licensee or registrant may provide, on or near the required signs and labels, additional information, as appropriate, to make individuals aware of potential radiation exposures and to minimize the exposures.

(4) Posting of radiation areas shall be accomplished as follows:

(a) The licensee or registrant shall post each radiation area with a conspicuous sign or signs bearing the radiation symbol and the words "Caution, Radiation Area".

(b) The licensee or registrant shall post each high radiation area with a conspicuous sign or signs bearing the radiation symbol and the words "Caution, High Radiation Area" or "Danger, High Radiation Area".

(c) The licensee or registrant shall post each very high radiation area with conspicuous sign or signs bearing the radiation symbol and words "Grave Danger, Very High Radiation Area".

(d) The licensee shall post each airborne radioactivity area with a conspicuous sign or signs bearing the radiation symbol and the words "Caution, Airborne Radioactivity Area" or "Danger, Airborne Radioactivity Area".

(e) The licensee shall post each area or room in which there is an amount of licensed material used or stored which exceeds ten times the quantity of such material specified in the appendix A ofto this rule with a conspicuous sign or signs bearing the radiation symbol and the words "Caution, Radioactive Material(s)" or "Danger, Radioactive Material(s)".

(f) The licensee shall post access openings to manufacturing or process equipment (such as tanks and vessels) on or in which radiation sources are mounted, if a person could gain access to the radiation beam and receive an annual dose to any part of their body which is greater than the applicable, permissible limits for individuals in rules 3701:1-38-12 and 3701:1-38-13 of the Administrative Code. The posting must include a conspicuous sign or signs bearing the radiation symbol and warning of the hazard.

(B) The following are exceptions to posting requirements set forth in paragraph (A) of this rule:

(1) A licensee or registrant is not required to post caution signs in an area or room that contains a source of radiation provided that the source is located in the area or room for a period of less than eight hours, and the source of radiation is continuously attended to during these periods by an individual who takes the precautions necessary to prevent the exposure of individuals to sources of radiation in excess of the limits established in rule 3701:1-38-13 of the Administrative Code, and the area or room is subject to licensee or registrant control.

(2) Rooms or other areas in hospitals that are occupied by patients are not required to be posted with caution signs pursuant to paragraph (A) of this rule provided that the patient could be released from licensee control in accordance with rule 3701:1-58-30 of the Administrative Code.

(3) A room or area is not required to be posted with a caution sign because of the presence of a sealed source provided the radiation level at thirty centimeters from the surface of the sealed source container or housing does not exceed 0.05 millisievert (0.005 rem) per hour.

(4) A room or area is not required to be posted with a caution sign because of the presence of radiation-generating equipment used solely for diagnosis in the healing arts.

(5) Rooms in hospitals or clinics that are used for teletherapy are exempt from the requirement to post caution signs if access to the room is controlled pursuant to rule 3701:1-58-59 of the Administrative Code and personnel in attendance take necessary precautions to prevent the inadvertent exposure of workers, other patients, and members of the public to radiation in excess of the limits established in this chapter.

(C) Except as provided in paragraph (E) of this rule, containers shall be labeled as follows:

(1) The licensee shall ensure that each container of licensed material bears a durable, clearly visible label bearing the radiation symbol and the words "Caution, Radioactive Material" or "Danger, Radioactive Material". The label shall also provide information, such as the radionuclides present, an estimate of the quantity of radioactivity, the date for which the activity is estimated, radiation levels, kinds of materials, and mass enrichment, to permit individuals handling or using the containers, or working in the vicinity of the containers, to take precautions to avoid or minimize exposures.

(2) Prior to removal or disposal of empty uncontaminated containers to unrestricted areas, each licensee shall, remove or deface the radioactive material label or otherwise clearly indicate that the container no longer contains radioactive materials.

(D) Each registrant shall ensure that each radiation-generating equipment is labeled in a conspicuous manner which cautions individuals that radiation is produced when it is energized.

(E) A licensee is not required to label the following:

(1) Containers holding licensed material in quantities less than the quantities listed in the appendix A to this rule;

(2) Containers holding licensed material in concentrations less than those specified in table III of appendix C to rule 3701:1-38-12 of the Administrative Code;

(3) Containers attended by an individual who takes the precautions necessary to prevent the exposure of individuals in excess of the limits established by rule 3701:1-38-13 of the Administrative Code;

(4) Containers when they are in transport and packaged and labeled in accordance with the regulations of the United States department of transportation;

(5) Containers that are accessible only to individuals authorized to handle or use them, or to work in the vicinity of the containers, if the contents are identified to these individuals by a readily available written record. Examples of containers of this type are containers in locations such as water-filled canals, storage vaults, or hot cells. The record shall be retained as long as the containers are in use for the purpose indicated on the record; or

(6) Manufacturing or processing equipment such as contaminated piping and tanks, and vessels on or in which radiation sources are installed.

(F) Each licensee shall:

(1) Monitor the external surfaces of a labeled package for radioactive contamination unless the package contains only radioactive material in the form of gas or in special form as defined in rule 3701:1-38-01 of the Administrative Code;

(2) Monitor the external surfaces of a labeled package for radiation levels unless the package contains quantities of radioactive material that are less than or equal to the type A quantity; and

(3) Monitor all packages known to contain radioactive material for radioactive contamination and radiation levels if there is evidence of degradation of package integrity, such as a package that is crushed, wet, or damaged.

(4) Perform the monitoring required by this paragraph as soon as practicable after receipt of the package, but not later than three hours after the package is received at the licensee's facility, if it is received during the licensee's normal working hours. If a package is received after working hours, the package shall be monitored no later than three hours from the beginning of the next working day.

(G) Each licensee who expects to receive a package containing quantities of radioactive material in excess of a type A quantity as defined in rule 3701:1-38-01 of the Administrative Code and as provided in rule 3701:1-50-25 of the Administrative Code, shall make arrangements to receive the package when the carrier offers it for delivery or expeditiously upon receiving notification that the package is available for pick-up.

(H) The licensee shall immediately notify the final delivery carrier and the department by telephone and either telegram, mailgram, or facsimile, when:

(1) Removable radioactive surface contamination exceeds the limits as provided in 49 C.F.R. 173.443 (as published in the October 1, 2009 Code of Federal Regulationsin effect on the effective date of this rule); or

(2) External radiation levels exceed the limits as provided in 49 C.F.R. 172.403 (as published in the October 1, 2009 Code of Federal Regulationsin effect on the effective date of this rule).

(I) Each licensee shall:

(1) Establish, maintain, and retain written procedures for safely opening packages in which radioactive material is received; and

(2) Ensure that the procedures are followed and that due consideration is given to special instructions for the type of package being opened.

(J) A licensee that transfers a special form source to and from a work site in a vehicle owned or operated by the licensee is exempt from the contamination monitoring requirements of this rule, but is not exempt from the monitoring requirement in this rule for measuring radiation levels that ensures that the source is still properly lodged in its shield.

View Appendix

Last updated June 6, 2022 at 9:29 AM

History

• Effective: June 4, 2022
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-49-05 Labels, security, and transportation precautions.

(A) The licensee may not use a source, source holder, or logging tool that contains licensed material unless the smallest component that is transported as a separate piece of equipment with the licensed material inside bears a durable, legible, and clearly visible marking or label. The marking or label must contain the radiation symbol specified in paragraph (A) of rule 3701:1-38-18 of the Administrative Code without the conventional color requirements, and the wording "DANGER (or CAUTION) RADIOACTIVE MATERIAL."

(B) The licensee may not use a container to store licensed material unless the container has securely attached to it a durable, legible, and clearly visible label. The label must contain the radiation symbol specified in paragraph (A) of rule 3701:1-38-18 of the Administrative Code and the wording "CAUTION (or DANGER), RADIOACTIVE MATERIAL, NOTIFY CIVIL AUTHORITIES (or NAME OF COMPANY)."

(C) The licensee may not transport licensed material unless the material is packaged, labeled, marked, and accompanied with appropriate shipping papers in accordance with rules set out in Chapter 3701:1-50 of the Administrative Code.

(D) The licensee shall store each source containing licensed material in a storage container or transportation package. The container or package must be locked and physically secured to prevent tampering or removal of licensed material from storage by unauthorized personnel. The licensee shall store licensed material in a manner which will minimize danger from explosion or fire.

(E) The licensee shall lock and physically secure the transport package containing licensed material in the transporting vehicle to prevent accidental loss, tampering, or unauthorized removal of the licensed material from the vehicle.

Last updated November 2, 2022 at 2:40 PM

History

• Effective: October 8, 2007
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-49-06 Radiation detection instruments.

(A) The licensee shall keep a calibrated and operable radiation survey instrument capable of detecting beta and gamma radiation at each field station and temporary job site to make the radiation surveys required by rules 3701:1-49-03 to 3701:1-49-24 of the Administrative Code and by Chapter 3701:1-38 of the Administrative Code. To satisfy this requirement, the radiation survey instrument must be capable of measuring 0.001 millisievert per hour (0.1 millirem per hour) through at least 0.5 millisievert per hour (fifty millirem per hour).

(B) The licensee shall have available additional calibrated and operable radiation detection instruments sensitive enough to detect the low radiation and contamination levels that could be encountered if a sealed source ruptured. The licensee may own the instruments or may have a procedure to obtain them immediately from a second party.

(C) The licensee shall have each radiation survey instrument required under paragraph (A) of this rule calibrated:

(1) After instrument servicing and at intervals not to exceed six months;

(2) For linear scale instruments, at two points located approximately one-third and two-thirds of full-scale on each scale; for logarithmic scale instruments, at midrange of each decade, and at two points of at least one decade; and for digital instruments, at appropriate points; and

(3) So that an accuracy within plus or minus twenty per cent of the calibration standard can be demonstrated on each scale.

(D) The licensee shall retain calibration records for a period of three years after the date of calibration for inspection by the director.

Last updated November 2, 2022 at 2:40 PM

History

• Effective: September 1, 2012
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-49-24

Each licensee shall maintain the following documents and records at the field station:

(A) A copy of Chapters 3701:1-38 and 3701:1-49 of the Administrative Code;

(B) The license authorizing the use of licensed material;

(C) Operating and emergency procedures required by rule 3701:1-49-19 of the Administrative Code;

(D) The record of radiation survey instrument calibrations required by rule 3701:1-49-06 of the Administrative Code;

(E) The record of leak test results required by rule 3701:1-49-07 of the Administrative Code;

(F) Physical inventory records required by rule 3701:1-49-08 of the Administrative Code;

(G) Utilization records required by rule 3701:1-49-09 of the Administrative Code;

(H) Records of inspection and maintenance required by rule 3701:1-49-11 of the Administrative Code;

(I) Training records required by paragraph (D) of rule 3701:1-49-18 of the Administrative Code; and

(J) Survey records required by rule 3701:1-49-21 of the Administrative Code.

Last updated November 2, 2022 at 2:42 PM

History

• Effective: October 20, 2002
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-49-07 Leak testing of sealed sources.

(A) Each licensee who uses a sealed source shall have the source tested for leakage. The licensee shall keep a record of leak test results in units of microcuries and retain the record for inspection by the director for three years after the leak test is performed.

(B) The wipe of a sealed source must be performed using a leak test kit or method approved by the director, the United States nuclear regulatory commission or an agreement state. The wipe sample must be taken from the nearest accessible point to the sealed source where contamination might accumulate. The wipe sample must be analyzed for radioactive contamination. The analysis must be capable of detecting the presence of one hundred eighty-five becquerels (0.005 microcurie) of radioactive material on the test sample and must be performed by a person approved by the director, the United States nuclear regulatory commission or an agreement state to perform the analysis.

(C) Sealed sources must be tested at the following frequencies:

(1) Each sealed source (except an energy compensation source (ECS)) must be tested at intervals not to exceed six months. In the absence of a certificate from a transferor that a test has been made within the six months before the transfer, the sealed source may not be used until tested.

(2) Each ECS that is not exempt from testing in accordance with paragraph (E) of this rule must be tested at intervals not to exceed three years. In the absence of a certificate from a transferor that a test has been made within the three years before the transfer, the ECS may not be used until tested.

(D) If a sealed source is found to be leaking the licensee shall:

(1) If the test conducted pursuant to paragraphs (A) and (B) of this rule reveals the presence of one hundred eighty-five becquerels (0.005 microcurie) or more of removable radioactive material, the licensee shall remove the sealed source from service immediately and have it decontaminated, repaired, or disposed of by a United States nuclear regulatory commission or agreement state licensee that is authorized to perform these functions. The licensee shall check the equipment associated with the leaking source for radioactive contamination and, if contaminated, have it decontaminated or disposed of by a United States nuclear regulatory commission or agreement state licensee that is authorized to perform these functions.

(2) The licensee shall submit a report to the director within five days of receiving the test results. The report must describe the equipment involved in the leak, the test results, any contamination which resulted from the leaking source, and the corrective actions taken up to the time the report is made.

(E) The following sealed sources are exempt from the periodic leak test requirements set out in paragraphs (A) to (D) of this rule:

(1) Hydrogen-3 (tritium) sources;

(2) Sources containing licensed material with a half-life of thirty days or less;

(3) Sealed sources containing licensed material in gaseous form;

(4) Sources of beta- or gamma-emitting radioactive material with an activity of 3.7 megabecquerels (one hundred microcuries) or less; and

(5) Sources of alpha- or neutron-emitting radioactive material with an activity of three hundred seventy kilobecquerels (ten microcuries) or less.

Last updated November 2, 2022 at 2:40 PM

History

• Effective: September 1, 2012
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-49-08 Physical inventory.

Each licensee shall conduct a physical inventory to account for all licensed material received and possessed under the license at intervals not to exceed six months. The licensee shall retain records of the inventory for three years from the date of the inventory for inspection by the director. The inventory must indicate the quantity and kind of licensed material, the location of the licensed material, the date of the inventory, and the name of the individual conducting the inventory. Physical inventory records may be combined with leak test records.

Last updated November 2, 2022 at 2:41 PM

History

• Effective: June 23, 2017
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-49-09 Records of material use.

(A) Each licensee shall maintain records for each use of licensed material showing:

(1) The make, model number, and a serial number or a description of each sealed source used;

(2) In the case of unsealed licensed material used for subsurface tracer studies, the radionuclide and quantity of activity used in a particular well and the disposition of any unused tracer materials;

(3) The identity of the logging supervisor who is responsible for the licensed material and the identity of logging assistants present; and

(4) The location and date of use of the licensed material.

(B) The licensee shall make the records required by paragraph (A) of this rule available for inspection by the director. The licensee shall retain the records for three years from the date of the recorded event.

Last updated November 2, 2022 at 2:41 PM

History

• Effective: September 1, 2012
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-49-10 Design and performance criteria for sealed sources.

(A) A licensee may use a sealed source in well logging applications if the sealed source:

(1) Is doubly encapsulated;

(2) Contains licensed material whose chemical and physical forms are as insoluble and non-dispersible as practical; and

(3) Meets the requirements of paragraph (B), (C), or (D) of this rule.

(B) For a sealed source manufactured on or before July 14, 1989, a licensee may use the sealed source for use in well logging applications if it meets the requirements of USASI N5.10-1968, "Classification of Sealed Sources," (this publication can be viewed at "the Bureau of Environmental Health and Radiation Protection library, 246 N. High Street Columbus, Ohio 43215") or the requirements in paragraph (C) or (D) of this rule.

(C) For a sealed source manufactured after July 14, 1989, a licensee may use the sealed source for use in well logging applications if it meets the oil-well logging requirements of ANSI/HPS N43.6-1997, "Sealed Radioactive Sources - Classification." (This publication can be viewed at "the Bureau of Environmental Health and Radiation Protection library, 246 N. High Street, Columbus, Ohio 43215"or may be obtained from the American National Standards Institute, 25 West 3rd Street, 4th Floor, New York, NY 10036, telephone 212-642-4900.)

(D) For a sealed source manufactured after July 14, 1989, a licensee may use the sealed source for use in well logging applications if:

(1) The sealed source's prototype has been tested and found to maintain its integrity after each of the following tests:

(a) The test source must be held at minus forty degrees celsius for twenty minutes, six hundred degrees celsius for one hour, and then be subject to a thermal shock test with a temperature drop from six hundred degrees celsius to twenty degrees celsius within fifteen seconds.

(b) A five kilogram steel hammer, 2.5 centimeter in diameter, must be dropped from a height of one meter onto the test source.

(c) The test source must be subject to a vibration from twenty-five hertz to five hundred hertz at five g (g is the acceleration of gravity and is equal to 9.8 meters per second squared) amplitude for thirty minutes.

(d) A one gram hammer and pin, 0.3 centimeter pin diameter, must be dropped from a height of one meter onto the test source.

(e) The test source must be subjected to an external pressure of 169.5 megapascals (twenty-four thousand six hundred pounds per square inch absolute).

(E) The requirements in paragraphs (A), (B), (C), and (D) of this rule do not apply to sealed sources that contain licensed material in gaseous form.

(F) The requirements in paragraphs (A), (B), (C), and (D) of this rule do not apply to energy compensation sources (ECS). Energy compensation sources must be registered with the director under rule 3701:1-46-49 of the Administrative Code, or with the United States nuclear regulatory commission or an agreement state under regulations equivalent to rule 3701:1-46-49 of the Administrative Code.

Last updated November 2, 2022 at 2:41 PM

History

• Effective: June 23, 2017
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-46-49

(A) Any manufacturer or initial distributor of a sealed source or device containing a sealed source may submit a request to the director for evaluation of radiation safety information about its product and for its registration.

(B) The request for review must be made in duplicate and sent to the director at the following address:

"Ohio Department of Health

Bureau of Environmental Health and Radiation Protection

246 North High Street

Columbus, Ohio 43215"

(C) The request for review of a sealed source or a device must include sufficient information about the design, manufacture, prototype testing, quality control program, labeling, proposed uses and leak testing and, for a device, the request must also include sufficient information about installation, service and maintenance, operating and safety instructions, and its potential hazards, to provide reasonable assurance that the radiation safety properties of the source or device are adequate to protect health and minimize danger to life and property.

(D) The director normally evaluates a sealed source or a device using radiation safety criteria in accepted industry standards. If these standards and criteria do not readily apply to a particular case, the director formulates reasonable standards and criteria with the help of the manufacturer or distributor. The director shall use criteria and standards sufficient to ensure that the radiation safety properties of the device or sealed source are adequate to protect health and minimize danger to life and property.

(E) After completion of the evaluation, the director issues a certificate of registration to the person making the request. The certificate of registration acknowledges the availability of the submitted information for inclusion in an application for a specific license proposing use of the product, or concerning use under an exemption from licensing or general license as applicable for the category of certificate.

(F) The person submitting the request for evaluation and registration of safety information about the product shall manufacture and distribute the product in accordance with:

(1) The statements and representations, including quality control program, contained in the request; and

(2) The provisions of the registration certificate.

(G) Authority to manufacture or initially distribute a sealed source or device to specific licensees may be provided in the license without the issuance of a certificate of registration in the following cases:

(1) Calibration and reference sources containing no more than:

(a) Thirty seven megabecquerels (one millicurie), for beta and/or gamma emitting radionuclides; or

(b) 0.37 megabecquerels (10 microcuries), for alpha emitting radionuclides; or

(2) The intended recipients are qualified by training and experience and have sufficient facilities and equipment to safely use and handle the requested quantity of radioactive material in any form in the case of unregistered sources or, for registered sealed sources contained in unregistered devices, are qualified by training and experience and have sufficient facilities and equipment to safely use and handle the requested quantity of radioactive material in unshielded form, as specified in their licenses; and

(a) The intended recipients are licensed under chapter 3701:1-40 of the Administrative Code or comparable provisions of another agreement state or the United States nuclear regulatory commission; or

(b) The recipients are authorized for research and development; or

(c) The sources and devices are to be built to the unique specifications of the particular recipient and contain no more than seven hundred forty gigabecquerels (twenty curies) of tritium or 7.4 gigabecquerels (two hundred millicuries) of any other radionuclide.

(H) After the certificate is issued, the director may conduct an additional review as he/she determines is necessary to ensure compliance with current regulatory standards. In conducting the review, the director will complete his/her evaluation in accordance with criteria specified in this rule. The director may request such additional information as he/she considers necessary to conduct his/her review and the certificate holder shall provide the information as requested.

(I) A certificate holder who no longer manufactures or initially transfers any of the sealed source(s) or device(s) covered by a particular certificate issued by the director shall request inactivation of the registration certificate. Such a request must be made to the director by an appropriate method listed in rule 3701:1-40-04 of the Administrative Code and must normally be made no later than two years after the initial distribution of all of the source(s) or device(s) covered by the certificate has ceased. However, if the certificate holder determines that an initial transfer was in fact the last initial transfer more than two years after that transfer, the certificate holder shall request inactivation of the certificate within ninety days of this determination and briefly describe the circumstances of the delay.

(J) If a distribution license is to be terminated in accordance with rule 3701:1-40-18 of the Administrative Code, the licensee shall request inactivation of its registration certificates associated with that distribution license before the director will terminate the license. Such a request for inactivation of certificate(s) must indicate that the license is being terminated and include the associated specific license number.

(K) A specific license to manufacture or initially transfer a source or device covered only by an inactivated certificate no longer authorizes the licensee to initially transfer such sources or devices for use. Servicing of devices must be in accordance with any conditions in the certificate, including in the case of an inactive certificate.

Last updated November 2, 2022 at 2:36 PM

History

• Effective: November 8, 2015
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-49-11 Inspection, maintenance, and opening of a source or source holder.

(A) Each licensee shall visually check source holders, logging tools, and source handling tools for defects before each use to ensure that the equipment is in good working condition and that required labeling is present. If defects are found, the equipment must be removed from service until repaired, and a record must be made listing: the date of check, name of inspector, equipment involved, defects found, and repairs made. These records must be retained for three years after the defect is found.

(B) Each licensee shall have a program for visual inspection and routine maintenance, at intervals not to exceed six months, of source holders, logging tools, injection tools, source handling tools, storage containers, transport containers, and uranium sinker bars to ensure that the required labeling is legible and that no physical damage is visible. If defects are found, the equipment must be removed from service until repaired, and a record must be made listing: date, equipment involved, inspection and maintenance operations performed, any defects found, and any actions taken to correct the defects. These records must be retained for three years after the defect is found.

(C) Removal of a sealed source from a source holder or logging tool, and maintenance on sealed sources or holders in which sealed sources are contained may not be performed by the licensee unless a written procedure developed pursuant to rule 3701:1-49-19 of the Administrative Code has been approved by the director, the United States nuclear regulatory commission or an agreement state.

(D) If a sealed source is stuck in the source holder, the licensee may not perform any operation, such as drilling, cutting, or chiseling, on the source holder unless the licensee is specifically approved by the director, the United States nuclear regulatory commission or an agreement state to perform this operation.

(E) The opening, repair, or modification of any sealed source must be performed by persons specifically approved to do so by the director, the United States nuclear regulatory commission or an agreement state.

Last updated November 2, 2022 at 2:41 PM

History

• Effective: June 23, 2017
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-49-12 Subsurface tracer studies.

(A) The licensee shall require all personnel handling radioactive tracer material to use protective gloves and, if required by the license, other protective clothing and equipment. The licensee shall take precautions to avoid ingestion or inhalation of radioactive tracer material and to avoid contamination of field stations and temporary job sites.

(B) A licensee may not knowingly inject licensed material into fresh water aquifers unless specifically authorized to do so by the director.

Last updated November 2, 2022 at 2:41 PM

History

• Effective: October 20, 2002
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-49-13 Radioactive markers.

The licensee may use radioactive markers in wells only if the individual markers contain quantities of licensed material not exceeding the quantities specified in rule 3701:1-40-11 of the Administrative Code. The use of markers is subject only to the requirements of rule 3701:1-49-08 of the Administrative Code.

Last updated November 2, 2022 at 2:41 PM

History

• Effective: October 20, 2002
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-40-11

(A) Except as provided in paragraphs (C) to (E) of this rule, any person is exempt from requirements set forth in this chapter and from the rules in Chapters 3701:1-46, 3701:1-48, 3701:1-49, and 3701:1-52 of the Administrative Code, to the extent that such person receives, possesses, uses, transfers, owns, or acquires radioactive material in individual quantities each of which does not exceed the applicable quantity set forth in the appendix to this rule.

(B) Any person who possesses radioactive material received or acquired before September 25, 1971, under the general license then provided in 10 C.F.R. 31.4 or similar general license of a state, is exempt from the requirements for a license set forth in this chapter and from the rules in Chapters 3701:1-46, 3701:1-48, 3701:1-49, and 3701:1-52 of the Administrative Code, to the extent that this person possesses, uses, transfers, or owns radioactive material.

(C) This rule does not authorize for purposes of commercial distribution the production, packaging, repackaging, or transfer of radioactive material or the incorporation of radioactive material into products intended for commercial distribution.

(D) No person may, for purposes of commercial distribution, transfer radioactive material in the individual quantities set forth in the appendix to this rule, knowing or having reason to believe that such quantities of radioactive material will be transferred to persons exempt under this chapter or equivalent regulations of an agreement state or the United States nuclear regulatory commission, except in accordance with a license, issued by the United States nuclear regulatory commission, which states that the radioactive material may be transferred by the licensee to persons exempt under this rule or the equivalent regulations of an agreement state or the United States nuclear regulatory commission.

(E) No person may, for purposes of producing an increased radiation level, combine quantities of radioactive material covered by this exemption so that the aggregate quantity exceeds the limits set forth in the appendix to this rule, except for radioactive material combined within a device placed in use before May 3, 1999, or as otherwise permitted by the rules in this chapter.

View Appendix

Last updated April 19, 2022 at 8:34 AM

History

• Effective: April 17, 2022
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-49-14 Uranium sinker bars.

The licensee may use a uranium sinker bar in well logging only if it is legibly impressed with the words "CAUTION - RADIOACTIVE-DEPLETED URANIUM" and "NOTIFY CIVIL AUTHORITIES (or COMPANY NAME) IF FOUND."

Last updated November 2, 2022 at 2:41 PM

History

• Effective: October 20, 2002
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-49-15 Use of a sealed source in a well without a surface casing.

The licensee may use a sealed source in a well without a surface casing for protecting fresh water aquifers only if the licensee follows a procedure for reducing the probability of the source becoming lodged in the well. The procedure must be approved by the director pursuant to paragraph (B)(3) of rule 3701:1-49-03 of the Administrative Code, the United States nuclear regulatory commission or an agreement state.

Last updated November 2, 2022 at 2:41 PM

History

• Effective: October 8, 2007
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-49-16 Energy compensation sources.

The licensee may use an energy compensation source (ECS) which is contained within a logging tool, or other tool components, only if the ECS contains quantities of licensed material not exceeding 3.7 megabecquerels (one hundred microcuries).

(A) For well logging applications with a surface casing for protecting fresh water aquifers, use of the ECS is only subject to the requirements of rules 3701:1-49-07, 3701:1-49-08, and 3701:1-49-09 of the Administrative Code.

(B) For well logging applications without a surface casing for protecting fresh water aquifers, use of the ECS is only subject to the requirements of rules 3701:1-49-04, 3701:1-49-07, 3701:1-49-08, 3701:1-49-09, 3701:1-49-15, and 3701:1-49-26 of the Administrative Code.

Last updated November 2, 2022 at 2:42 PM

History

• Effective: October 8, 2007
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-49-26

(A) The licensee shall immediately notify the director by telephone and subsequently, within thirty days, by confirmatory letter using an appropriate method listed in rule 3701:1-40-04 of the Administrative Code, if the licensee knows or has reason to believe that a sealed source has been ruptured. The letter must designate the well or other location, describe the magnitude and extent of the escape of licensed materials, assess the consequences of the rupture, and explain efforts planned or being taken to mitigate these consequences.

(B) The licensee shall notify the director of the theft or loss of radioactive materials, radiation overexposures, excessive levels and concentrations of radiation, and other accidents as required by rules 3701:1-38-21 and 3701:1-40-20 of the Administrative Code.

(C) If a sealed source becomes lodged in a well, and when it becomes apparent that efforts to recover the sealed source will not be successful, the licensee shall:

(1) Notify the director by telephone of the circumstances that resulted in the inability to retrieve the source; and

(a) Obtain the director's approval to implement abandonment procedures; or

(b) State or declare that the licensee implemented abandonment procedures before receiving the director's approval because the licensee believed there was an immediate threat to public health and safety; and

(2) Advise the well owner or operator, as appropriate, of the abandonment procedures under paragraph (A) or (C) of rule 3701:1-49-04 of the Administrative Code; and

(3) Either ensure that abandonment procedures are implemented within thirty days after the sealed source has been classified as irretrievable or request an extension of time if unable to complete the abandonment procedures.

(D) The licensee shall, within thirty days after a sealed source has been classified as irretrievable, make a report in writing to the director. The licensee shall send a copy of the report to each appropriate state or federal agency that issued permits or otherwise approved of the drilling operation. The report must contain the following information:

(1) Date of occurrence;

(2) A description of the irretrievable well logging source involved including the radionuclide and its quantity, chemical, and physical form;

(3) Surface location and identification of the well;

(4) Results of efforts to immobilize and seal the source in place;

(5) A brief description of the attempted recovery effort;

(6) Depth of the source;

(7) Depth of the top of the cement plug;

(8) Depth of the well;

(9) The immediate threat to public health and safety justification for implementing abandonment if prior approval from the director was not obtained in accordance with paragraph (C)(1)(b) of this rule;

(10) Any other information, such as a warning statement, contained on the permanent identification plaque; and

(11) State and federal agencies receiving copy of this report.

Last updated August 1, 2023 at 2:37 PM

History

• Effective: September 1, 2012
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-49-17 Tritium neutron generator target source.

(A) Use of a tritium neutron generator target source, containing quantities not exceeding one thousand one hundred ten gigabecquerels (thirty curies) and in a well with a surface casing to protect fresh water aquifers, is subject to the requirements of this chapter except rules 3701:1-49-04, 3701:1-49-10, and 3701:1-49-26 of the Administrative Code.

(B) Use of a tritium neutron generator target source, containing quantities exceeding one thousand one hundred ten gigabecquerels (thirty curies) or in a well without a surface casing to protect fresh water aquifers, is subject to the requirements of this chapter except rule 3701:1-49-10 of the Administrative Code.

Last updated November 2, 2022 at 2:42 PM

History

• Effective: October 8, 2007
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-49-18 Training.

(A) The licensee may not permit an individual to act as a logging supervisor until that person has:

(1) Completed training in the subjects outlined in paragraph (E) of this rule;

(2) Received copies of, and instruction in the:

(a) Applicable rules of Chapter 3701:1-38 of the Administrative Code and this chapter;

(b) License under which the logging supervisor will perform well logging; and

(c) Licensee's operating and emergency procedures required by rule 3701:1-49-19 of the Administrative Code;

(3) Completed on-the-job training and demonstrated competence in the use of licensed materials, remote handling tools, and radiation survey instruments by a field evaluation; and

(4) Demonstrated understanding of the requirements in paragraphs (A)(1) and (A)(2) of this rule by successfully completing a written test.

(B) The licensee may not permit an individual to act as a logging assistant until that person has:

(1) Received instruction in applicable rules of Chapter 3701:1-38 of the Administrative Code;

(2) Received copies of, and instruction in, the licensee's operating and emergency procedures required by rule 3701:1-49-19 of the Administrative Code;

(3) Demonstrated understanding of the materials listed in paragraphs (B)(1) and (B)(2) of this rule by successfully completing a written or oral test; and

(4) Received instruction in the use of licensed materials, remote handling tools, and radiation survey instruments, as appropriate for the logging assistant's intended job responsibilities.

(C) The licensee shall provide safety reviews for logging supervisors and logging assistants at least once during each calendar year.

(D) The licensee shall maintain a record on each logging supervisor's and logging assistant's training and annual safety review. The training records must include copies of written tests and dates of oral tests. The training records must be retained until three years following the termination of employment. Records of annual safety reviews must list the topics discussed and be retained for three years.

(E) The licensee shall include the following subjects in the training required in paragraph (A)(1) of this rule:

(1) Fundamentals of radiation safety including:

(a) Characteristics of radiation;

(b) Units of radiation dose and quantity of radioactivity;

(c) Hazards of exposure to radiation;

(d) Levels of radiation from licensed material;

(e) Methods of controlling radiation dose (time, distance, and shielding); and

(f) Radiation safety practices, including prevention of contamination, and methods of decontamination;

(2) Radiation detection instruments including:

(a) Use, operation, calibration, and limitations of radiation survey instruments;

(b) Survey techniques; and

(c) Use of personnel monitoring equipment;

(3) Equipment to be used including:

(a) Operation of equipment, including source handling equipment and remote handling tools;

(b) Storage, control, and disposal of licensed material; and

(c) Maintenance of equipment;

(4) The requirements of pertinent Ohio statutes and rules; and

(5) Case histories of accidents in well logging.

Last updated November 2, 2022 at 2:42 PM

History

• Effective: October 8, 2007
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-38-23

(A) As used in this rule:

(1) "Basic component" means:

(a) A structure, system, or component, or part thereof that affects their safety function, that is directly procured by the licensee or registrant of facility or activity subject to the rules promulgated pursuant to Chapter 3748. of the Revised Code and in which a defect or failure to comply with any rule promulgated pursuant to Chapter 3748. of the Revised Code, order issued by the director, or license issued by the department could create a substantial safety hazard; and

(b) Safety-related design, analysis, inspection, testing, fabrication, replacement of parts, or consulting services that are associated with the component hardware whether these services are performed by the component supplier or others.

(2) "Commercial grade item" means an item that is:

(a) Not subject to design or specification requirements that are unique to those facilities or activities;

(b) Used in applications other than those facilities or activities; and

(c) To be ordered from the manufacturer or supplier on the basis of specifications set forth in the manufacturer's published product description, such as a catalog.

(3) "Constructing" or "construction" means the analysis, design, manufacture, fabrication, placement, erection, installation, modification, inspection, or testing of a facility or activity which is subject to this rule and consulting services related to the facility or activity that are safety related.

(4) "Dedication" means an item has been received and designated for use as a basic component.

(5) "Defect" means:

(a) A deviation in a basic component delivered to a purchaser for use in a facility or an activity subject to this rule, if, on the basis of an evaluation, the deviation could create a substantial safety hazard; or

(b) The installation, use, or operation of a basic component containing a defect as defined in this paragraph.

(6) "Deviation" means a departure form the manufacturer's specification's or technical specifications as part of a license or registration issued by the department for a given safety device or safety system associated with that device.

(7) "Discovery" means the completion of the documentation first identifying the existence of a deviation or failure to comply potentially associated with a substantial safety hazard within the evaluation procedures discussed in paragraph (G) of this rule.

(8) "Evaluation" means the process of determining whether a particular deviation could create a substantial hazard or determining whether a failure to comply is associated with a substantial safety hazard.

(9) "Failure to comply" means a failure to meet the requirements of any of the following that could create a substantial safety hazard:

(a) A rule promulgated pursuant to Chapter 3748. of the Revised Code;

(b) An order issued by the director; or

(c) License issued by the department.

(10) "Operating" or "operation" means the operation of a facility or the conduct of a licensed or registered activity which is subject to this rule and consulting services related to operations that are safety related.

(11) "Responsible officer" means:

(a) The president, vice-president or other individual in the organization of a corporation, partnership, or other entity who is vested with executive authority over activities subject to this rule, or

(b) An individual who is appointed or elected according to law, who is authorized to manage and direct the affairs of a corporation, partnership or other entity. In the case of an individual proprietorship, responsible officer means the individual.

(12) "Substantial safety hazard" means a loss of safety function to the extent that there is a major reduction in the degree of protection provided to either public health and safety or the environment, for any facility or activity licensed or registered pursuant to Chapter 3748. of the Revised Code.

(13) "Supplying" or "supplies" means contractually responsible for a basic component used or to be used in a facility or activity which is subject to this rule.

(B) This rule establishes procedures and requirements for implementation of section 3748.04 of the Revised Code, which applies to reporting of defects in equipment used for licensed or registered activities. Any responsible corporate officer of a firm constructing, owning, operating or supplying the components of any facility or activity which is licensed, registered, or otherwise regulated pursuant to Chapter 3748. of the Revised Code, obtaining information reasonably indicating either of the following, shall notify the director within twenty-four hours:

(1) That the facility, activity or basic component supplied to such facility or activity fails to comply with any applicable rule, regulation, order, registration, or license of the department relating to substantial safety hazards; or

(2) That the facility, activity, or basic component supplied to such facility or activity contains defects, which could create a substantial safety hazard.

(C) This rule applies, except as specifically provided otherwise in Chapter 3748. of the Revised Code, to each individual, partnership, corporation, or other entity licensed or registered pursuant to Chapter 3748. of the Revised Code to possess, use, or transfer within the state of Ohio source material, radioactive material, special nuclear material, or to construct, manufacture, possess, own, operate or transfer within the state of Ohio any radiation-generating equipment and to each responsible officer of such a licensee or registrant. This rule applies also to each individual, corporation, partnership or other entity doing business within the state of Ohio, that supplies basic components for a facility or activity licensed, under Chapter 3748. of the Revised Code.

(D) Nothing in this rule should be deemed to preclude either an individual, a manufacturer, or a supplier of a commercial grade item not subject to this rule from reporting to the director, a known or suspected defect or failure to comply and, as authorized by law, the identity of anyone so reporting will be withheld from disclosure. The department will accept collect telephone calls from individuals who wish to speak to department representatives concerning radiation safety-related problems.

(E) Each individual, partnership, corporation, dedicating entity, or other entity subject to this rule shall post current copies of this rule and procedures adopted pursuant to this rule. These documents must be posted in a conspicuous position on any premises within the state of Ohio where the activities subject to this rule are conducted. If posting of this rule or the procedures adopted pursuant to this rule is not practicable, the licensee, registrant, or firm subject to this rule may post a notice which describes the rules and procedures, including the name of the individual to whom reports may be made, and where the rules and procedures may be examined.

(F) The director may, upon application of any interested person or upon the director's own initiative, grant such exemptions from the requirements of this rule as the director determines to be authorized by law and will not endanger public health and safety or the environment, and are otherwise in the public interest. Suppliers of commercial grade items are exempt from the provisions of this rule to the extent that they supply commercial grade items.

(G) Each individual, corporation, partnership, dedicating entity, or other entity subject to this rule shall adopt appropriate procedures to:

(1) Initiate evaluations of deviations and failures to comply that are associated with substantial safety hazards as soon as practicable, but no later than ten days from the date of discovery of the deviation or failure to comply. The director shall be notified of any such deviation or failure to comply in accordance with paragraph (B) of this rule.

(2) Evaluate a reportable defect or failure to comply that could create a substantial safety hazard, were it to remain uncorrected, within thirty days of its discovery, except as provided by paragraph (G)(3) of this rule.

(3) Ensure that if an evaluation of an identified deviation or failure to comply potentially associated with a substantial safety hazard cannot be completed within thirty days from discovery of the deviation or failure to comply, an interim report is prepared and submitted to the director through a responsible corporate officer. The interim report should describe the deviation or failure to comply that is being evaluated and should also state when the evaluation will be completed. This interim report must be submitted in writing within thirty days of discovery of the deviation or failure to comply; and

(4) Ensure that a responsible corporate officer subject to this rule is informed as soon as practicable, and, in all cases, within five working days after completion of the evaluation described in this paragraph if the construction or operation of a facility or activity, or a basic component supplied for such facility or activity either fails to comply with any applicable rule, regulation, order, or license or registration of the department relating to a substantial safety hazard, or contains a defect.

(H) If the deviation or failure to comply is discovered by a supplier of basic components, or services associated with basic components, and the supplier determines that it does not have the capability to perform the evaluation to determine if a defect exists, then the supplier must inform the purchasers or affected licensees or registrants within five working days of this determination so that the purchasers or affected licensees or registrants may evaluate the deviation or failure to comply, pursuant to paragraph (G) of this rule. Nothing in this rule shall be deemed to require manufacturers or suppliers to adopt or maintain procedures for defect identification and evaluation, where the item or service is not dedicated for purposes of licensed or registered activities or equipment. Instead, such is the responsibility of the registrant or licensee, in accordance with paragraph (B) of this rule.

(I) A responsible corporate officer subject to this rule must notify the director within thirty days when he or she obtains information reasonably indicating a failure to comply or a defect affecting:

(1) The construction or operation of a facility or any activity within the state of Ohio that is subject to the licensing or registration requirements under Chapter 3748. of the Revised Code and that is within the facility's responsibility; or

(2) A basic component that is within the facility's responsibility and is supplied for a facility or an activity within the state of Ohio that is subject to the licensing requirements of Chapter 3748. of the Revised Code.

(J) The notification required by paragraphs (B) and (I) of this rule shall include the following information, to the extent known:

(1) Name and address of the individual or individuals informing the director.

(2) Identification of the facility, the activity, or the basic component supplied for such facility or such activity within the state of Ohio which fails to comply or contains a defect.

(3) Identification of the firm constructing the facility or supplying the basic component which fails to comply or contains a defect.

(4) Nature of the defect or failure to comply and the safety hazard which is created or could be created by such defect or failure to comply.

(5) The date on which the information of such defect or failure to comply was obtained.

(6) In the case of a basic component which contains a defect or fails to comply, the number and location of all such components in use at, supplied for, or being supplied for one or more facilities or activities subject to this rule.

(7) The corrective action which has been, is being, or will be taken; the name of the individual or organization responsible for the action; and the length of time that has been or will be taken to complete the action.

(8) Any advice related to the defect or failure to comply about the facility, activity, or basic component that has been, is being, or will be given to purchasers or licensees.

(K) The responsible corporate officer may authorize an individual to provide the notification required by paragraph (J) of this rule, provided that, this shall not relieve the responsible corporate officer of his or her responsibility under this paragraph. Individuals subject to this rule may be required by the director to supply additional information related to a defect or failure to comply. Department action to obtain additional information may be based on reports of defects from other reporting entities.

(L) Each individual, corporation, partnership, or other entity subject to this rule shall prepare and maintain records necessary to accomplish the requirements of this rule, including retaining evaluations of all deviations and failures to comply for a minimum of five years after the date of the evaluation. Each individual, corporation, partnership, dedicating entity, or other entity subject to this rule shall permit the department the opportunity to inspect records pertaining to basic components that relate to the identification and evaluation of deviations, and the reporting of defects and failures to comply, including any advice given to purchasers or licensees on the placement, erection, installation, operation, maintenance, modification, or inspection of a basic component.

(M) Suppliers of basic components must retain any notifications sent to purchasers and affected licenses for a minimum of five years after the date of the notification. Suppliers of basic components must retain a record of the purchasers of basic components for ten years after delivery of the basic component or service associated with a basic component.

Last updated November 2, 2022 at 2:11 PM

History

• Effective: September 1, 2011
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-49-20 Personnel monitoring.

(A) The licensee may not permit an individual to act as a logging supervisor or logging assistant unless that person wears a personnel dosimeter at all times during the handling of licensed radioactive materials. Each personnel dosimeter must be assigned and worn by only one individual. Film badges must be replaced at least monthly and other personnel dosimeters that require replacement must be replaced at least quarterly. All personnel dosimeters must be evaluated at least quarterly or promptly after replacement, whichever is more frequent.

(B) The licensee shall provide bioassay services to individuals using licensed materials in subsurface tracer studies if required by the license.

(C) The licensee shall retain records of personnel dosimeters required by paragraph (A) of this rule and bioassay results for inspection until the director authorizes disposition of the records.

Last updated May 23, 2022 at 7:59 AM

History

• Effective: May 23, 2022
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-49-23 Security.

(A) A logging supervisor must be physically present at a temporary job site whenever licensed materials are being handled or are not stored and locked in a vehicle or storage place. The logging supervisor may leave the job site in order to obtain assistance if a source becomes lodged in a well.

(B) During well logging, except when radiation sources are below ground or in shipping or storage containers, the logging supervisor or other individual designated by the logging supervisor shall maintain direct surveillance of the operation to prevent unauthorized entry into a restricted area, as defined in rule 3701:1-38-01 of the Administrative Code.

Last updated November 2, 2022 at 2:42 PM

History

• Effective: October 20, 2002
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-49-25 Documents and records required at temporary job sites.

Each licensee conducting operations at a temporary job site shall maintain the following documents and records at the temporary job site until the well logging operation is completed:

(A) Operating and emergency procedures required by rule 3701:1-49-19 of the Administrative Code;

(B) Evidence of latest calibration of the radiation survey instruments in use at the site required by rule 3701:1-49-06 of the Administrative Code;

(C) Latest survey records required by paragraphs (B), (C), and (E) of rule 3701:1-49-21 of the Administrative Code;

(D) The shipping papers for the transportation of radioactive materials required by Chapter 3701:1-50 of the Administrative Code; and

(E) When operating under reciprocity a copy of the agreement state or United States nuclear regulatory commission license authorizing use of licensed materials.

Last updated November 2, 2022 at 2:43 PM

History

• Effective: October 20, 2002
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-40-04

(A) Except as otherwise provided, any communication or report required by this chapter shall be filed in accordance with Chapter 3748. of the Revised Code and rules promulgated thereunder. Documents pertaining to license application or any license matter, unless otherwise directed in writing, shall be submitted to the following address or by electronic submission in a manner approved by the director:

"Ohio Department of Health

Bureau of Environmental Health and Radiation Protection

246 North High Street

Columbus, Ohio 43215."

(B) If pemitted to submit via electronic mail, communications may be sent to the Ohio department of health at:

"BRadiation@odh.ohio.gov"

Last updated April 19, 2022 at 8:33 AM

History

• Effective: April 17, 2022
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-38-21

(A) The licensee or registrant shall report stolen, lost, or missing licensed or registered sources of radiation to the director in accordance with the following:

(1) Telephone reports shall be made as follows:

(a) To the bureau of environmental health and radiation protection point of contact (POC) in accordance with the form "Notice to Employees" issued by the director.

(b) In the case of a licensee, he or she shall make contact:

(i) Immediately after the licensee determines that licensed radioactive material is stolen, lost, or missing in an aggregate quantity equal to or greater than one thousand times the quantity specified in the appendix to rule 3701:1-38-18 of the Administrative Code under such circumstances that it appears to the licensee that an exposure could result to individuals in unrestricted areas;

(ii) Within thirty days after its occurrence becomes known to the licensee, lost, stolen, or missing licensed radioactive material in an aggregate quantity greater than ten times the quantity specified in the appendix to rule 3701:1-38-18 of the Administrative Code that is still missing.

(c) In the case of a registrant, he or she shall make contact immediately after it becomes known that radiation-generating equipment has been stolen, lost, or is missing.

(2) Written reports shall be made as follows:

(a) Each licensee or registrant required to make a report pursuant to paragraph (A)(1) of this rule shall, within thirty days after making the telephone report, make a written report to the director setting forth the following information, where applicable:

(i) A description of the licensed or registered source of radiation involved, including, for radioactive material, the kind, quantity, and chemical and physical form, and in the case of radiation-generating equipment, the manufacturer, model and serial number, type and maximum energy of the radiation emitted;

(ii) A description of the circumstances under which the loss or theft occurred;

(iii) A statement of disposition, or probable disposition, of the licensed or registered source of radiation involved;

(iv) Exposures of individuals to radiation, circumstances under which the exposures occurred, and the possible total effective dose equivalent to persons in unrestricted areas;

(v) Actions that have been taken, or will be taken, to recover the source of radiation; and

(vi) Procedures or measures that have been, or will be, adopted to ensure against a recurrence of the loss or theft of licensed or registered sources of radiation.

(b) Subsequent to filing the written report, the licensee or registrant shall also report additional substantive information on the loss or theft within thirty days after the licensee or registrant learns of such information.

(c) The licensee or registrant shall prepare any report filed with the director pursuant to this rule so that names of individuals who may have received exposure to radiation are stated in a separate and detachable portion of the report.

(B) Notification of incidents shall be made as follows:

(1) Excluding prescribed medical doses to patients, each licensee or registrant shall immediately report each event involving a source of radiation possessed by the licensee or registrant that may have caused or threatens to cause any of the following conditions:

(a) An individual receiving:

(i) A total effective dose equivalent of 0.25 sievert (twenty-five rem) or more;

(ii) A lens dose equivalent of 0.75 sievert (seventy-five rem) or more; or

(iii) A shallow dose equivalent to the skin or extremities or a total organ dose equivalent of 2.5 sievert (two hundred fifty rem) or more; or

(b) The release of radioactive material, inside or outside of a restricted area that, had an individual been present for twenty-four hours, the individual could have received an intake five times the occupational ALI. This provision does not apply to locations where personnel are not normally stationed during routine operations, such as hot-cells or process enclosures.

(2) Each licensee or registrant shall report to the director, within twenty-four hours of discovery, each event involving loss of control of a licensed or registered source of radiation possessed by the licensee or registrant that may have caused, or threatens to cause, any of the following:

(a) An individual to receive, in a period of twenty-four hours:

(i) A total effective dose equivalent exceeding 0.05 sievert (five rem);

(ii) An lens dose equivalent exceeding 0.15 sievert (fifteen rem); or

(iii) A shallow dose equivalent to the skin or extremities or a total organ dose equivalent exceeding 0.5 sievert (fifty rem); or

(b) The release of radioactive material, inside or outside of a restricted area that, had an individual been present for twenty-four hours, the individual could have received an intake in excess of one occupational ALI. This provision does not apply to locations where personnel are not normally stationed during routine operations, such as hot-cells or process enclosures.

(3) Licensees or registrants shall make the reports required by paragraphs (B)(1) and (B)(2) of this rule to the POC by telephone to the department and shall confirm the initial contact by telegram, mailgram, electronic mail, or facsimile to the director.

(4) The licensee or registrant shall prepare each report filed with the director pursuant to this rule so that names of individuals who have received exposure to sources of radiation are stated in a separate and detachable portion of the report.

(5) The provisions of paragraph (B) of this rule do not apply to doses that result from planned special exposures, provided such doses are within the limits for planned special exposures and are reported in accordance with this paragraph.

(C) Reports of exposures, radiation levels, and concentrations of radioactive material exceeding the limits shall be made by the licensee or registrant as follows:

(1) Reportable events that are specified in this paragraph shall, in addition to the notification requirements in paragraph (B) of this rule, be reported to the director in writing within thirty days after learning of any of the following occurrences:

(a) Incidents for which notification is required by paragraph (B) of this rule and with doses in excess of any of the following:

(i) The occupational dose limits for adults in paragraphs (A)(1) and (A)(2) of rule 3701:1-38-12 of the Administrative Code;

(ii) The occupational dose limits for a minor in paragraph (G) of rule 3701:1-38-12 of the Administrative Code;

(iii) The limits for an embryo or fetus of a declared pregnant woman in paragraph (H) of rule 3701:1-38-12 of the Administrative Code;

(iv) The limits for an individual member of the public in paragraph (A) of rule 3701:1-38-13 of the Administrative Code;

(v) Any applicable limit in the license or registration; or

(vi) The ALARA constraints for air emissions established under paragraph (D)(4) of rule 3701:1-38-11 of the Administrative Code; or

(b) Levels of radiation or concentrations of radioactive material in:

(i) A restricted area in excess of applicable limits in the license or registration; or

(ii) An unrestricted area in excess of ten times the applicable limit set forth in this chapter or in the license or registration, whether or not involving exposure of any individual in excess of the limits in paragraph (A) of rule 3701:1-38-13 of the Administrative Code; or

(c) For licensees subject to the provisions of the United States environmental protection agency generally applicable environmental radiation standards in 40 C.F.R. 190 (as in effect on the effective date of this rule), levels of radiation or releases of radioactive material in excess of those standards, or of license conditions related to those standards.

(2) Each report required by this rule shall describe the extent of exposure of individuals to radiation and radioactive material, including, as appropriate:

(a) Estimates of each individual's dose, the level of radiation and concentration of radioactive material involved, and the cause of the elevated exposure, dose rate, or concentration; and

(b) Corrective steps taken or planned to ensure against a recurrence, including the schedule for achieving conformance with applicable limits, ALARA constraints, generally applicable environmental standards, and associated license or registration conditions.

(3) Each report filed pursuant to this rule shall include, for each occupationally overexposed individual, the name, social security account number, and date of birth of the individual. In the case of the limit for an embryo or fetus in paragraph (H) of rule 3701:1-38-12 of the Administrative Code, the identifiers should be those of the declared pregnant woman. The report shall be prepared so that information on each individual is stated in a separate and detachable portion of the report.

(4) All licensees or registrants who make reports pursuant to this rule shall submit the report in writing to the director.

(D) Reports of planned special exposures shall be submitted by the licensee in a written report to the director within thirty days following any planned special exposure conducted in accordance with paragraph (F) of rule 3701:1-38-12 of the Administrative Code, informing the director that a planned special exposure was conducted and indicating the date the planned special exposure occurred and the information required by paragraph (G) of rule 3701:1-38-20 of the Administrative Code.

(E) When a licensee or registrant is required pursuant to paragraph (C) or (D) of this rule to report to the director any exposure of an identified occupationally exposed individual, or an identified member of the public, to radiation or radioactive material, the licensee or registrant shall also provide the individual a report on his or her exposure data included in the report to the director. This report shall be transmitted no later than the transmittal to the director, and shall comply with the provisions of paragraph (C)(1) of rule 3701:1-38-10 of the Administrative Code.

(F) A report of a leaking or contaminated sealed source shall be filed by the licensee with the director within five days of the test results, if the test reveals the presence of one hundred eighty-five becquerels (0.005 microcurie) or more of removable contamination. The report shall include the equipment involved, the test results and the corrective action taken.

Last updated January 20, 2022 at 8:48 AM

History

• Effective: January 20, 2022
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-40-20

(A) Except as provided in paragraph (D) of this rule, each licensee shall notify the department as soon as possible, but not later than four hours after the discovery of an event that prevents immediate protective action necessary to avoid exposure to radiation or radioactive material that could exceed regulatory limits, or a release of licensed material that could exceed regulatory limits. An event that requires such an immediate report may include a fire, explosion, or toxic gas release.

(B) Each licensee shall notify the department within twenty-four hours after the discovery of any of the following events involving licensed material:

(1) An unplanned contamination event that involves:

(a) Access to the contaminated area, by workers or the public, to be restricted for more than twenty-four hours by imposing additional radiological controls or by prohibiting entry into the area;

(b) A quantity of material greater than five times the lowest annual limit on intake specified in the appendices to rule 3701:1-38-12 of the Administrative Code; and

(c) Access to the area restricted for a reason other than to allow radionuclides with a half-life of less than twenty-four hours to decay prior to decontamination.

(2) An event in which equipment is disabled or fails to function as designed when:

(a) The equipment is required by regulation or license condition to prevent a release exceeding regulatory limits, to prevent exposure to radiation or radioactive material exceeding regulatory limits, or to mitigate the consequences of an accident;

(b) The equipment is required to be available and operable when it is disabled or fails to function; and

(c) No redundant equipment is available and operable to perform the required safety function.

(3) An event that requires unplanned medical treatment of an individual with spreadable radioactive contamination on the individual's clothing or body.

(4) An unplanned fire or explosion damaging any licensed material or any device, container, or equipment containing licensed material when:

(a) The quantity of material involved is greater than five times the lowest annual limit on intake specified in the appendices to rule 3701:1-38-12 of the Administrative Code; and

(b) The damage affects the integrity of the licensed material or its container.

(C) The licensee shall prepare and submit a report in response to the requirements of this rule as follows:

(1) Licensees shall make reports required by paragraphs (A) and (B) of this rule by telephone, to the department at the telephone number listed in the notice to employees required by paragraph (A)(1)(e) of rule 3701:1-38-10 of the Administrative Code. To the extent that the information is available at the time of notification, the information provided in these reports must include:

(a) The caller's name and call back telephone number;

(b) A description of the event, including date and time;

(c) The exact location of the event;

(d) The radionuclides, quantities, and chemical and physical form of the licensed material involved; and

(e) Any personnel radiation exposure data available.

(2) Each licensee who makes a report required by paragraph (A) or (B) of this rule shall submit a written follow-up report within thirty days of the initial report. Written reports prepared pursuant to other regulations may be submitted to fulfill this requirement if the report contains all of the necessary information and the appropriate distribution is made. These written reports shall be sent to the department in the manner specified in rule 3701:1-40-04 of the Administrative Code. The report must include the following:

(a) A description of the event, including the probable cause and the manufacturer and model number, if applicable, of any equipment that failed or malfunctioned;

(b) The exact location of the event;

(c) The radionuclides, quantities, and chemical and physical form of the licensed material involved;

(d) Date and time of the event;

(e) Corrective actions taken or planned and the results of any evaluations or assessments; and

(f) The extent of exposure of individuals to radiation or to radioactive materials without identification of individuals by name.

(D) This rule applies to all licensees possessing material licensed under rule 3701:1-38-02 of the Administrative Code. This rule does not apply to material under a license subject to the notification requirements in 10 C.F.R. 50.72 (as in effect on the effective date of this rule).

(E) An applicant for a license or a licensee shall notify the department within two working days of information identified by the applicant or licensee as having for the regulated activity, an active adverse impact on equipment or personnel readily obvious by human observation or instrumentation, or a radiological impact on personnel or the environment in excess of regulatory limits. An applicant or licensee violates this paragraph only if the applicant or licensee fails to notify the director of information that the applicant or licensee has or should have identified.

Last updated April 19, 2022 at 8:35 AM

History

• Effective: April 17, 2022
• Promulgated Under: 119.03

Chapter 3701:1-50 Packaging and Transportation of Radioactive Material

Ohio Adm.Code 3701:1-50-01 Definitions.

Terms defined in rule 3701:1-38-01 of the Administrative Code shall have the same meaning when used in this chapter except terms redefined within a given rule for use within that rule only, and additionally, as used in this chapter of the Administrative Code:

(A) "Carrier" means a person engaged in the transportation of passengers or property by land or water as a common, contract, or private carrier, or by civil aircraft.

(B) "Certificate holder" means a person who has been issued a certificate of compliance or other package approval by the United States nuclear regulatory commission.

(C) "Certificate of compliance (CoC)" means the certificate issued by the United States nuclear regulatory commission under subpart D of 10 C.F.R. 71 (as in effect on the effective date of this rule) which approves the design of a package for the transportation of radioactive material.

(D) "Closed transport vehicle" means a transport vehicle equipped with a securely attached exterior enclosure that during normal transportation restricts the access of unauthorized persons to the cargo space containing the radioactive material. The enclosure may be temporary or permanent but shall limit access from top, sides, and ends. In the case of packaged materials, it may be of the "see-through" type.

(E) "Close reflection by water" means immediate contact by water of sufficient thickness for maximum reflection of neutrons.

(F) "Consignment" means each shipment of a package or groups of packages or load of radioactive material offered by a shipper for transport.

(G) "Containment system" means the assembly of components of the packaging intended to retain the radioactive material during transport.

(H) "Contamination" means the presence of a radioactive substance on a surface in quantities in excess of 0.4 becquerel per square centimeter (1x10^-5microcurie per square centimeter) for beta and gamma emitters and low toxicity alpha emitters, or 0.04 becquerel per square centimeter (1x10^-6microcurie per square centimeter) for all other alpha emitters.

(1) Fixed contamination means contamination that cannot be removed from a surface during normal conditions of transport.

(2) Non-fixed contamination means contamination that can be removed from a surface during normal conditions of transport.

(I) "Conveyance" means:

(1) For transport by public highway or rail, any transport vehicle or large freight container;

(2) For transport by water, any vessel, or any hold, compartment, or defined deck area of a vessel including any transport vehicle on board the vessel; and

(3) For transport by air, any aircraft.

(J) "Criticality safety index (CSI)" means the dimensionless number (rounded up to the next tenth) assigned to and placed on the label of a fissile material package, to designate the degree of control of accumulation of packages, overpacks or freight containers containing fissile material during transportation. Determination of the criticality safety index is described in rules 3701:1-50-11 and 3701:1-50-12 of the Administrative Code and 10 C.F.R. 71.59 (as in effect on the effective date of this rule). The criticality safety index for an overpack, freight container, consignment or conveyance containing fissile material packages is the arithmetic sum of the criticality safety indices of all the fissile material packages contained within the overpack, freight container, consignment or conveyance.

(K) "Deuterium" means, for the purpose of rules 3701:1-50-11 and 3701:1-50-13 of the Administrative Code, deuterium and any deuterium compounds, including heavy water, in which the ratio of deuterium atoms to hydrogen atoms exceeds one to five thousand.

(L) "DOT" means United States department of transportation.

(M) "Enriched uranium" means uranium containing more uranium-235 than the naturally occurring distribution of uranium isotopes.

(N) "Exclusive use" means the sole use by a single consignor of a conveyance for which all initial, intermediate, and final loading and unloading are carried out in accordance with the direction of the consignor or consignee. The consignor and the carrier must ensure that any loading or unloading is performed by personnel having radiological training and resources appropriate for safe handling of the consignment. The consignor must issue specific instructions, in writing, for maintenance of exclusive use shipment controls, and include them with the shipping paper information provided to the carrier by the consignor.

(O) "Graphite" means, for the purposes of rules 3701:1-50-11 and 3701:1-50-13 of the Administrative Code, graphite with a boron equivalent content less than five parts per million and density greater than 1.5 grams per cubic centimeter.

(P) "Indian tribe" means an Indian or Alaska native tribe, band, nation, pueblo, village, or community that the secretary of the interior acknowledges to exist as an Indian tribe pursuant to the Federally Recognized Indian Tribe List Act of 1994, Pub.L. No. 103-454, 108 Stat. 4791, 25 U. S. C. 5130 (as in effect on the effective date of this rule).

(Q) "Low toxicity alpha emitters" means natural uranium, depleted uranium, natural thorium, uranium-235, uranium-238, thorium-232, thorium-228 or thorium-230 when contained in ores or physical or chemical concentrates or tailings; or alpha emitters with a half-life of less than ten days.

(R) "Maximum normal operating pressure" means the maximum gauge pressure that would develop in the containment system in a period of one year under the heat condition specified in 10 C.F.R. 71.71(C)(1) (as in effect on the effective date of this rule), in the absence of venting, external cooling by an ancillary system, or operational controls during transport.

(S) "Natural thorium" means thorium with the naturally occurring distribution of thorium isotopes or one hundred weight per cent thorium-232.

(T) "Natural uranium" means uranium (which may be chemically separated) with the naturally occurring distribution of uranium isotopes (approximately 0.711 weight per cent uranium-235, and the remainder by weight essentially uranium-238).

(U) "Optimum interspersed hydrogenous moderation" means the presence of hydrogenous material between packages to such an extent that the maximum nuclear reactivity results.

(V) "Specific activity of a radionuclide" means the radioactivity of the radionuclide per unit mass of that nuclide. The specific activity of a material in which the radionuclide is essentially uniformly distributed is the radioactivity per unit mass of the material.

(W) "Spent nuclear fuel or spent fuel" means fuel that has been withdrawn from a nuclear reactor following irradiation, has undergone at least one year's decay since being used as a source of energy in a power reactor, and has not been chemically separated into its constituent elements by reprocessing. Spent fuel includes the special nuclear material, byproduct material, source material, and other radioactive materials associated with fuel assemblies.

(X) "State" means a state of the United States, the District of Columbia, the Commonwealth of Puerto Rico, the Virgin Islands, Guam, American Samoa, and the Commonwealth of the Northern Mariana Islands.

(Y) "Tribal official" means the highest ranking individual that represents tribal leadership of an Indian tribe, such as the chief, president, or tribal council leadership.

(Z) "Unirradiated uranium" means uranium containing not more than two thousand becquerels (fifty-four nanocuries) of plutonium per gram of uranium-235, not more than nine megabecquerels (two hundred forty-three microcuries) of fission products per gram of uranium-235, and not more than 0.005 grams of uranium-236 per gram of uranium-235.

History

• Effective: February 15, 2021
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-38-01

(A) As used in this chapter and all other rules promulgated pursuant to Chapter 3748. of the Revised Code:

(1) "A₁" means the maximum activity of special form radioactive material permitted in a type A package. These values are listed in rule 3701:1-50-25 of the Administrative Code, or may be derived in accordance with the procedure prescribed in rule 3701:1-50-25 of the Administrative Code.

(2) "A₂" means the maximum activity of radioactive material, other than special form, low specific activity and surface contaminated object material, permitted in a type A package. These values are listed in rule 3701:1-50-25 of the Administrative Code, or may be derived in accordance with the procedure prescribed in rule 3701:1-50-25 of the Administrative Code.

(3) "Absorbed dose" means the energy imparted by ionizing radiation per unit mass of irradiated material. The units of absorbed dose are the gray, or Gy, and the rad.

(4) "Accelerator or charged particle accelerator" means any of a class of radiation generating equipment designed to electronically accelerate atomic or sub-atomic particles for subsequent bombardment of targets.

(5) "Accelerator-produced radioactive material" means any material made radioactive by a particle accelerator.

(6) "Activity" means the rate of disintegration or transformation or decay of radioactive material. The units of activity are the becquerel, or Bq, and the curie, or Ci.

(7) "Address of use" means the building or buildings that are identified on the license or registration and where the source of radiation may be received, used, prepared, or stored, except for temporary job sites.

(8) "Administrative controls" means mechanisms used to protect health and minimize damage to life and property through the use of written policies, procedures, instructions, training, observation of work practices, and related compliance audits.

(9) "Administrative monetary penalty" means a monetary penalty assessed by the director under section 3748.05 of the Revised Code and in compliance with rules adopted thereunder, to emphasize the need for lasting remedial action and to deter future violations.

(10) "Adult" means an individual eighteen or more years of age.

(11) "Agreement state" means any state with which the United States nuclear regulatory commission or the atomic energy commission has entered into an effective agreement under subsection 274B of the Atomic Energy Act of 1954, 68 Stat. 919, 42 U.S.C. 2021, as amended (1978). Non-agreement state means any other state.

(12) "Airborne radioactive material" means radioactive material dispersed in the air in the form of dusts, fumes, particulates, mists, vapors, or gases.

(13) "Airborne radioactivity area" means a room, enclosure, or area in which airborne radioactive materials, composed wholly or partly of licensed material, exist in concentrations:

(a) In excess of the derived air concentrations (DACs) specified in appendix C to rule 3701:1-38-12 of the Administrative Code, or

(b) To such a degree that an individual present in the area without respiratory protective equipment could exceed, during the hours an individual is present in a week, an intake of 0.6 per cent of the annual limit on intake or twelve DAC-hours.

(14) "Air-purifying respirator" means a respirator with an air-purifying filter, cartridge, or canister that removes specific air contaminants by passing ambient air through the air-purifying element.

(15) "ALARA" or "as low as is reasonably achievable" means every reasonable effort to maintain exposures to radiation as far below the dose limits as is practical consistent with the purpose for which the licensed or registered activity is undertaken, taking into account the state of technology, the economics of improvements in relation to benefits to the public health and safety, and other societal and socioeconomic considerations, and in relation to utilization of nuclear energy and licensed materials and registered activities in the public interest.

(16) "Alert" means events may occur, are in progress, or have occurred that could lead to a release of radioactive material but that the release is not expected to require a response by off-site response organizations to protect persons off-site.

(17) "Annual limit on intake" or "ALI" means the derived limit for the amount of radioactive material taken into the body of an adult worker by inhalation or ingestion in a year. ALI is the smaller value of intake of a given radionuclide in a year by the reference man that would result in a committed effective dose equivalent of 0.05 sievert (five rem) or a committed dose equivalent of 0.5 sievert (fifty rem) to any individual organ or tissue. ALI values for intake by ingestion and by inhalation of selected radionuclides are given in appendix C to rule 3701:1-38-12 of the Administrative Code.

(18) "Annually" means either

(a) At intervals not to exceed one year; or

(b) Once per year, at about the same time each year, plus or minus one month.

(19) "Area of use" means a portion of an address of use that has been set aside for the purpose of receiving, preparing, using, or storing sources of radiation.

(20) "Assigned protection factor" or "APF" means the expected workplace level of respiratory protection that would be provided by a properly functioning respirator or a class of respirators to properly fitted and trained users. Operationally, the inhaled concentration can be estimated by dividing the ambient airborne concentration by the APF.

(21) "Atmosphere-supplying respirator" means a respirator that supplies the respirator user with breathing air from a source independent of the ambient atmosphere, and includes supplied air respirators, or SARs, and self-contained breathing apparatus, or SCBA, units.

(22) "Atomic energy commission" or "AEC" means the federal agency created by the Atomic Energy Act of 1954, 68 Stat. 919, 42 U.S.C. 2011, as amended (1964), and was the predecessor agency to the current United States nuclear regulatory commission.

(23) "Background radiation" means radiation from cosmic sources; naturally occurring radioactive materials, including radon, except as a decay product of source or special nuclear material, and global fallout as it exists in the environment from the testing of nuclear explosive devices or from past nuclear accidents such as Chernobyl that contribute to background radiation and are not under the control of the licensee. "Background radiation" does not include radiation from radioactive materials regulated by the department.

(24) "Becquerel" or "Bq" means the SI unit of activity. One becquerel is equal to one disintegration per second.

(25) "Bioassay" or "radiobioassay" means the determination of kinds, quantities or concentrations, and, in some cases, the locations of radioactive material in the human body, whether by direct measurement, in vivo counting, or by analysis and evaluation of materials excreted or removed from the human body.

(26) "Byproduct material" means

(a) Any radioactive material, except special nuclear material, yielded in or made radioactive by exposure to the radiation incident to the process of producing or utilizing special nuclear materials; or

(b) The tailings or wastes produced by the extraction or concentration of uranium or thorium from any ore processed primarily for its source material content, including discrete surface wastes resulting from solution extraction processes. Underground ore bodies depleted by such solution extraction do not constitute byproduct material within the definition.

(27) "Chelating agent" means a chemical compound or mixture that enhances the removal of radioactive material from the body, water or similar applications. Typical chelating agents include amine polycarboxylic acids such as EDTA or DTPA; hydroxy-carboxylic acids; and polycarboxylic acids such as citric acid, carbolic acid, and gluconic acid.

(28) "Chiropractor" means an individual licensed by the state of Ohio to practice chiropractic medicine pursuant to Chapter 4734. of the Revised Code.

(29) "Class" or "lung class" or "inhalation class" means a classification scheme for inhaled material according to its rate of clearance from the pulmonary region of the lung. Materials are classified as D, W, or Y, which applies to a range of clearance half-times: for class D, days, of less than ten days, for class W, weeks, from ten to one hundred days, and for class Y, years, of greater than one hundred days.

(30) "Collective dose" means the sum of the individual doses received in a given period of time by a specified population from exposure to a specified source of radiation.

(31) "Commencement of construction" means taking any action defined as "construction" or any other activity at the site of a facility subject to the rules promulgated pursuant to Chapter 3748. of the Revised Code that has a reasonable nexus to radiological health and safety.

(32) "Committed dose equivalent" or "H_T,50" means the dose equivalent to organs or tissues of reference, T, that will be received from an intake of radioactive material by an individual during the fifty year period following the intake.

(33) "Committed effective dose equivalent" or "H_E,50" means the sum of the products of the weighting factors applicable to each of the body organs or tissues, W_T, that are irradiated and the committed dose equivalent to each of these organs or tissues (H_{E, 50} = W_TH_T,50).

(34) "Consortium" means an association of medical use licensees and a PET radionuclide production facility in the same geographical area that jointly own or share in the operation and maintenance cost of the PET radionuclide production facility that produces PET radionuclides for use in producing radioactive drugs within the consortium for noncommercial distributions among its associated members for medical use. The PET radionuclide production facility within the consortium must be located at an educational institution or a medical facility.

(35) "Constraint" or "dose constraint" means a value above which specified licensee actions are required.

(36) "Construction" means the installation of foundations, or in-place assembly, erection, fabrication, or testing for any structure, system, or component of a facility or activity subject to the rules promulgated pursuant to Chapter 3748. of the Revised Code that are related to radiological safety or security. The term "construction" does not include:

(a) Changes for temporary use of the land for public recreational purposes;

(b) Site exploration, including necessary borings to determine foundation conditions or other preconstruction monitoring to establish background information related to the suitability of the site, the environmental impacts of construction or operation, or the protection of environmental values;

(c) Preparation of the site for construction of the facility, including clearing of the site, grading, installation of drainage, erosion and other environmental mitigation measures, and construction of temporary roads and borrow areas;

(d) Erection of fences and other access control measures that are not related to the safe use of, or security of, radiological materials subject to the rules promulgated pursuant to Chapter 3748. of the Revised Code;

(e) Excavation;

(f) Erection of support buildings (e.g. construction equipment storage sheds, warehouse and shop facilities, utilities, concrete mixing plants, docking and unloading facilities, and office buildings) for use in connection with the construction of the facility;

(g) Building of service facilities (e.g. paved roads, parking lots, railroad spurs, exterior utility and lighting systems, potable water systems, sanitary sewerage treatment facilities, and transmission lines);

(h) Procurement or fabrication of components or portions of the proposed facility occurring at other than the final, in-place location at the facility; or

(i) Taking any other action that has no reasonable nexus to radiological health and safety.

(37) "Controlled area" means an area, outside of a restricted area but inside the site boundary, access to which can be limited by the licensee or registrant for any reason.

(38) "Critical group" means the group of individuals reasonably expected to receive the greatest exposure to residual radioactivity for any applicable set of circumstances.

(39) "Curie" or "Ci" means a unit of activity. One curie equals 3.7 x 10¹⁰ disintegrations per second equals 3.7 x 10¹⁰ becquerels equals 2.22 x 10¹² disintegrations per minute.

(40) "Cyclotron" means a particle accelerator in which the charged particles travel in an outward spiral or circular path. A cyclotron accelerates charged particles at energies usually in excess of ten megaelectron volts and is commonly used for production of short half-life radionuclides for medical use.

(41) "Declared pregnant woman" means a woman who has voluntarily informed the licensee or registrant, in writing, of her pregnancy and the estimated date of conception. The declaration remains in effect until the declared pregnant woman withdraws the declaration in writing or is no longer pregnant.

(42) "Decommission" means to safely remove any licensed operation from service and reduce residual radioactivity to a level that permits release of the licensee's property for unrestricted use and termination of the license.

(43) "Dedicated check source" means a radioactive source that is used to assure the consistent performance of a radiation detection or measurement device over several months or years.

(44) "Deep dose equivalent" or "H_d" applies to external whole body exposure, and means the dose equivalent at a tissue depth of one centimeter, one thousand milligram per square centimeter.

(45) "Demand respirator" means an atmosphere-supplying respirator that admits breathing air to the facepiece only when a negative pressure is created inside the facepiece by inhalation.

(46) "Dentist" means an individual licensed by the state of Ohio to practice dentistry under Chapter 4715. of the Revised Code.

(47) "Department" means the Ohio department of health.

(48) "Depleted uranium" means uranium containing less uranium-235 than the naturally occurring distribution of uranium isotopes.

(49) "Derived air concentration" or "DAC" means the concentration of a given radionuclide in air which, if breathed by the reference man for a working year of two thousand hours under conditions of light work, results in an intake of one ALI. The condition of light work is inhaling 1.2 cubic meters of air per hour for two thousand hours in a year. DAC values are given in appendix C to rule 3701:1-38-12 of the Administrative Code.

(50) "Derived air concentration-hour or DAC-hour" means the product of the concentration of radioactive material in air, which is expressed as a fraction or multiple of the derived air concentration for each radionuclide, and the time of exposure to that radionuclide, in hours. A licensee or registrant may take two thousand DAC-hours to represent one ALI, equivalent to a committed effective dose equivalent of 0.05 Sv (five rem).

(51) "Direct reading dosimeter" means a device that measures radiation dose that does not require another device to read the measured radiation dose. Examples of direct reading dosimeters include pocket dosimeters and electronic dosimeters.

(52) "Director" means the director of health or a designee or authorized representative of the director.

(53) "Discipline" means a branch of knowledge or of teaching.

(54) "Discrete source" means a radionuclide that has been processed so that its concentration within a material has been purposely increased for use for commercial, medical, or research activities.

(55) "Disposable respirator" means a respirator for which maintenance is not intended and that is designed to be discarded after excessive breathing resistance, sorbent exhaustion, physical damage, or end-of service-life renders it unsuitable for use. Examples of this type of respirator are a disposable half-mask respirator or a disposable escape-only self-contained breathing apparatus.

(56) "Dose" or "radiation dose" is a generic term that means absorbed dose, dose equivalent, effective dose equivalent, committed effective dose equivalent, or total effective dose equivalent as defined in other paragraphs of this rule.

(57) "Dose equivalent" or "H_T" means the product of the absorbed dose in tissue, quality factor, and all other necessary modifying factors at the location of interest. The units of dose equivalent are the sievert and rem.

(58) "Dose limits" or "limits" means the permissible upper bounds of radiation doses established in accordance with these regulations but excludes background radiation and medical exposure.

(59) "Dosimetry processor" means a person that processes and evaluates individual monitoring devices in order to determine the radiation dose delivered to the monitoring devices.

(60) "Effective dose equivalent" or "H_E" means the sum of the products of the dose equivalent to each organ or tissue, H_T, and the weighting factor, W_T, applicable to each of the body organs or tissues that are irradiated: (H_E = ∑W_TH_T).

(61) "Embryo" or "fetus" means the developing human organism from conception until time of birth.

(62) "Engineering controls" means mechanisms used to protect health and minimize damage to life and property through engineering specifications, design, and construction of the product or facility including all of the security and safety features. This includes, but is not limited to, auxiliary security and safety features such as additional external shielding, barriers, and operational interlocks with associated processes.

(63) "Entrance" or "access point" means any opening through which an individual or extremity of an individual could gain access to radiation areas or to licensed radioactive materials or registered radiation generating equipment. This includes entry or exit portals of sufficient size to permit human entry, irrespective of their intended use.

(64) "Explosive material" means any chemical compound, mixture or device which produces a substantial instantaneous release of gas and heat spontaneously or by contact with sparks or flame.

(65) "Exposure" means being exposed to sources of ionizing radiation.

(66) "External dose" means that portion of the dose equivalent received from radiation sources outside the body.

(67) "Extremity" means hand, elbow, arm below the elbow, foot, knee, or leg below the knee.

(68) "Eye dose equivalent" means the same as lens dose equivalent.

(69) "Facility" means all buildings, equipment, structures and other stationary items that, in addition to the meaning defined in division (H) of section 3748.01 of the Revised Code, are:

(a) Located on a single site or on contiguous or adjacent sites and are operated by the same person and have common corporate or business interests; or

(b) Portions of a building or structure which are operated by the same person and have common corporate or business interests.

(70) "Filtering facepiece" or "dust mask" means a negative pressure particulate respirator with a filter as an integral part of the facepiece or with the entire facepiece composed of the filtering medium, not equipped with elastomeric sealing surfaces and adjustable straps.

(71) "Fissile material" means the radionuclides uranium-233, uranium-235, plutonium-239, and plutonium-241, or any combination of these radionuclides. Fissile material means the fissile nuclides themselves, not material containing fissile nuclides. Unirradiated natural uranium and depleted uranium and natural uranium or depleted uranium that has been irradiated in thermal reactors only, are not included in this definition. Certain exclusions from fissile material controls are provided in rule 3701:1-50-13 of the Administrative Code.

(72) "Fit factor" means quantitative estimate of the fit of a particular respirator to a specific individual, and typically estimates the ratio of the concentration of a substance in ambient air to its concentration inside the respirator when worn.

(73) "Fit test" means the use of a protocol to qualitatively or quantitatively evaluate the fit of a respirator on an individual.

(74) "Generally applicable environmental radiation standards" means standards issued by the United States environmental protection agency under the authority of the Atomic Energy Act of 1954, 68 Stat. 919, 42 U.S.C. 2011, as amended (2005), that impose limits on radiation exposures or levels, or concentrations or quantities of radioactive material, in the general environment outside the boundaries of locations under the control of persons possessing or using radioactive material.

(75) "Gray" or "Gy" means the SI unit of absorbed dose. One gray is equal to an absorbed dose of one joule per kilogram (one hundred rads).

(76) "Handle" means receive, possess, use, store, transfer, install, service, or dispose of sources of radiation unless possession is solely for the purpose of transportation.

(77) "Handler" means a facility that handles sources of radiation unless possession is solely for the purpose of transportation.

(78) "Hazardous waste" means those wastes designated as hazardous by rule 3745-51-03 of the Administrative Code.

(79) "Helmet" means a rigid respiratory inlet covering that also provides head protection against impact and penetration.

(80) "High radiation area" means an area, accessible to individuals, in which radiation levels from radiation sources external to the body could result in an individual receiving a dose equivalent in excess of one millisievert (0.1 rem) in one hour at thirty centimeters from the radiation source or thirty centimeters from any surface that the radiation penetrates.

(81) "Hood" means a respiratory inlet covering that completely covers the head and neck and may also cover portions of the shoulders and torso.

(82) "Individual" means any human being.

(83) "Individual monitoring" means

(a) The assessment of dose equivalent by the use of devices designed to be worn by an individual;

(b) The assessment of committed effective dose equivalent by bioassay or by determination of the time-weighted air concentrations to which an individual has been exposed, i.e. DAC-hours; or

(c) The assessment of dose equivalent by the use of survey data.

(84) "Individual monitoring devices" means devices designed to be worn by a single individual for the assessment of dose equivalent such as film badges; thermoluminescent dosimeters; optically stimulated luminescent dosimeters; pocket ionization chambers; and personal air sampling devices.

(85) "Industrial radiography" means the examination of the structure of materials by nondestructive methods, utilizing sealed sources of radioactive material or radiation-generating equipment.

(86) "Internal dose" means that portion of the dose equivalent received from radioactive material taken into the body.

(87) "Irradiator" means a facility that uses radioactive sealed sources for the irradiation of objects or materials and in which radiation dose rates exceeding five grays (five hundred rads) per hour exist at one meter from the sealed radioactive source in air or water, as applicable for the irradiator type, but does not include irradiators in which both the sealed source and the area subject to irradiation are contained within a device and are not accessible to personnel.

(88) "Lens dose equivalent" or "eye dose equivalent" means the external exposure of the lens of the eye and is taken as the dose equivalent at a tissue depth of 0.3 centimeters; i.e. three hundred milligrams per square centimeter.

(89) "License" means a license issued by the nuclear regulatory commission, the director, or another agreement state in accordance with rules adopted by those organizations.

(90) "Licensee" means a person to whom a license is issued.

(91) "Licensed activity" means an activity authorized by a radioactive material license which is essential to achieving the purpose for which the license was issued or amended.

(92) "Licensed material" means radioactive material received, possessed, used, transferred or disposed of under a general or specific license.

(93) "Loose-fitting facepiece" means a respiratory inlet covering that is designed to form a partial seal with the face.

(94) "Lost or missing licensed source of radiation" means a licensed source of radiation whose location is unknown. It includes material that has been shipped but has not reached its destination and whose location cannot be readily traced in the transportation system.

(95) "Low-level radioactive waste" or "LLRW," also "low-level waste," or "LLW" means radioactive waste which is not high-level radioactive waste, spent nuclear fuel, NARM, or byproduct material as defined in section 11 E. (2) of the Atomic Energy Act of 1954 68 Stat. 919, 42 U.S.C. 2011, as amended (2005), but is radioactive material that the United States nuclear regulatory commission classifies as low-level radioactive waste.

(96) "Low specific activity material" or "LSA" means radioactive material with limited specific activity which is nonfissile or is excepted under rule 3701:1-50-13 of the Administrative Code, and which satisfies the descriptions and limits set forth below. Shielding materials surrounding the LSA material may not be considered in determining the estimated average specific activity of the package contents. LSA must be in one of three groups:

(a) LSA - I.

(i) Uranium and thorium ores, concentrates of uranium and thorium ores, and other ores containing naturally occurring radioactive radionuclides that are intended to be processed for the use of these radionuclides;

(ii) Natural uranium, depleted uranium, natural thorium or their compounds or mixtures, provided they are unirradiated and in solid or liquid form;

(iii) Radioactive material other than fissile material, for which the A₂ value is unlimited; or

(iv) Other radioactive material in which the activity is distributed throughout and the estimated average specific activity does not exceed thirty times the value for exempt material activity concentration determined in accordance with rule 3701:1-50-25 of the Administrative Code.

(b) LSA-II.

(i) Water with tritium concentration up to 0.8 terabecquerels per liter (twenty curies per liter); or

(ii) Other material in which the activity is distributed throughout and the estimated average specific activity does not exceed ( 10^-4 A₂) per gram for solids and gases, and (10^-5 A₂) per gram for liquids.

(c) LSA-III. Solids (e.g., consolidated wastes, activated materials), excluding powders, that satisfy the requirements of 10 C.F.R. 71.77 (as in effect on the effective date of this rule), in which:

(i) The radioactive material is distributed throughout a solid or a collection of solid objects, or is essentially uniformly distributed in a solid compact binding agent (such as concrete, bitumen, ceramic, etc.);

(ii) The radioactive material is relatively insoluble, or it is intrinsically contained in a relatively insoluble material, so that even under loss of packaging, the loss of radioactive material per package by leaching, when placed in water for seven days, would not exceed (0.1 x A₂); and

(iii) The estimated average specific activity of the solid, excluding any shielding material, does not exceed (0.002 x A₂) per gram.

(97) "Management" means the chief executive officer or other individual having the authority to manage, direct, or administer the licensee's activities, or those persons' delegate or delegates.

(98) "Medical institution" means an organization in which more than one medical discipline is practiced.

(99) "Medical use" means the intentional internal or external administration of radioactive material or the radiation therefrom to patients or human research subjects under the supervision of an authorized user.

(100) "Member of the public" means any individual except when that individual is receiving an occupational dose.

(101) "Minor" means an individual less than eighteen years of age.

(102) "Monitoring" or "radiation monitoring" or "radiation protection monitoring" means the measurement of radiation levels, concentrations, surface area concentrations or quantities of radioactive material and the use of the results of these measurements to evaluate potential exposures and doses.

(103) "NARM" or "naturally occurring or accelerator-produced radioactive material" means naturally occurring or accelerator-produced radioactive material, including naturally occurring material that is technologically enhanced, and those nuclides that are generated in a charged particle accelerator, but does not include source material, byproduct material, or special nuclear material.

(104) "NARM licensing state" means any state with regulations equivalent to the suggested state regulations for control of radiation relating to, and an effective program for, the regulatory control of NARM and which has been granted final designation by the conference of radiation control program directors, inc.

(105) "Nationally tracked source" means a sealed source containing a quantity equal to or greater than "Category 1" or "Category 2" levels of any radioactive material listed in the appendix to rule 3701:1-38-25 of the Administrative Code. In this context a sealed source is defined as radioactive material that is sealed in a capsule or closely bonded, in a solid form and which is not exempt from regulatory control. It does not mean material encapsulated solely for disposal, or nuclear material contained in any fuel assembly, subassembly, fuel rod, or fuel pellet. "Category 1" nationally tracked sources are those containing radioactive material at a quantity equal to or greater than the "Category 1" threshold. "Category 2" nationally tracked sources are those containing radioactive material at a quantity equal to or greater than the "Category 2" threshold but less than the "Category 1" threshold.

(106) "Negative pressure respirator" or "tight fitting respirator" means a respirator in which the air pressure inside the facepiece is negative during inhalation with respect to the ambient air pressure outside the respirator.

(107) "Nonstochastic effect" or "deterministic effect" means health effects, the severity of which varies with the dose and for which a threshold is believed to exist. Radiation-induced cataract formation is an example of a nonstochastic effect.

(108) "NORM" or "naturally occurring radioactive material" means any nuclide that is radioactive in its natural physical state, but does not include source material, byproduct material, or special nuclear material.

(109) "Normal form radioactive material" means radioactive material that has not been demonstrated to qualify as special form radioactive material.

(110) "Nuclear regulatory commission" means the federal agency established by Title II of the Energy Reorganization Act of 1974, 88 Stat. 1233, 42 U.S.C.A. 5801, as amended (2005), comprising the members of the commission and all offices, employees, and representatives authorized to act in any case or matter related to licensing and related regulatory function previously assigned to the AEC.

(111) "Occupational dose" means the dose received by an individual in the course of employment in which the individual's assigned duties involve exposure to radiation or radioactive material from licensed and unlicensed sources of radiation, whether in the possession of the licensee or other person. Occupational dose does not include doses received from background radiation, from any medical administration the individual has received, from exposures to individuals administered radioactive materials and released in accordance with rule 3701:1-58-30 of the Administrative Code or equivalent United States nuclear regulatory commission or agreement state regulations, from voluntary participation in medical research programs, or as a member of the public.

(112) "Package" means the packaging together with its radioactive contents as presented for transport.

(a) Fissile material package or type AF package, type BF package, type B(U)F package, or type B(M)F package means a fissile material packaging together with its fissile material contents.

(b) Type A package means a type A packaging together with its radioactive contents. A type A package is defined and must comply with the United States department of transportation regulations in 49 C.F.R. 173 (as in effect on the effective date of this rule).

(c) Type B package means a type B packaging together with its radioactive contents. On approval, a type B package design is designated by the United States nuclear regulatory commission as B(U) unless the package has a maximum normal operating pressure of more than seven hundred kilopascals (one hundred pounds per square inch) gauge or a pressure relief device that would allow the release of radioactive material to the environment under the tests specified in 10 C.F.R. 71.73 (hypothetical accident conditions) (as in effect on the effective date of this rule), in which case it will receive a designation B(M). B(U) refers to the need for unilateral approval of international shipments; B(M) refers to the need for multilateral approval of international shipments. There is no distinction made in how packages with these designations may be used in domestic transportation. To determine their distinction for international transportation, see United States department of transportation regulations in 49 C.F.R. 173 (as in effect on the effective date of this rule). A type B package approved before September 6, 1983, was designated only as type B. Limitations on its use are specified in 10 C.F.R. 71.19 (as in effect on the effective date of this rule).

(113) "Packaging" means the assembly of components necessary to ensure compliance with the packaging requirements of rule 49 C.F.R. 173 Subpart I (as in effect on the effective date of this rule). It may consist of one or more receptacles, absorbent materials, spacing structures, thermal insulation, radiation shielding, and devices for cooling or absorbing mechanical shocks. The vehicle, tie-down system and auxiliary equipment may be designated as part of the packaging.

(114) "Particle accelerator" means any machine capable of accelerating electrons, protons, deuterons, or other charged particles in a vacuum and of discharging the resultant particulate or other radiation into a medium at energies usually in excess of one megaelectron volt. For purposes of this definition, "accelerator" is an equivalent term.

(115) "Person" means any individual, corporation, association, business enterprise, or other legal entity either public or private and any legal successor, representative, agent, or agency of that individual, corporation, association, business enterprise, or other legal entity. Person also includes the United States, states, political subdivisions of states, and any department, agency, or instrumentality of the United States or a state, except the U.S. department of energy or the U.S. nuclear regulatory commission where the state regulation of radioactive material by either of those agencies is prohibited by federal law.

(116) "Personnel dosimeter", means a device that measures radiation dose that is processed and evaluated by an accredited "National Voluntary Laboratory Accreditation Program" (NVLAP) processor. Examples of personnel dosimeters include film badges, thermo-luminescent dosimeters (TLD), and optically stimulated luminescence (OSL) dosimeters.

(117) "Pharmacist" means a person who is licensed by the state of Ohio to practice pharmacy pursuant to Chapter 4731. of the Revised Code.

(118) "Physician" means a person who is licensed pursuant to Chapter 4731. of the Revised Code to practice medicine or surgery or osteopathic medicine or surgery.

(119) "Planned special exposure" means an infrequent exposure to radiation, separate from and in addition to the annual dose limits.

(120) "Podiatrist" means an individual licensed by the state of Ohio to practice podiatry pursuant to Chapter 4731. of the Revised Code.

(121) "Positive pressure respirator" means a respirator in which the pressure inside the respiratory inlet covering exceeds the ambient air pressure outside the respirator.

(122) "Positron Emission Tomography (PET) radionuclide production facility" means a facility operating a cyclotron or accelerator for the purpose of producing PET radionuclides.

(123) "Powered air-purifying respirator" or "PAPR" means an air-purifying respirator that uses a blower to force the ambient air through air purifying elements to the inlet covering.

(124) "Pressure demand respirator" means a positive pressure atmosphere supplying respirator that admits breathing air to the facepiece when the positive pressure is reduced inside the facepiece by inhalation.

(125) "Public dose" means the dose received by a member of the public from exposure to radiation and/or radioactive material released by the licensee, or to any other source of radiation under the control of a licensee or registrant. Public dose does not include occupational dose or doses received from background radiation, from any medical administration the individual has received, from exposures to individuals administered radioactive materials and released in accordance with rule 3701:1-58-30 of the Administrative Code or equivalent United States nuclear regulatory commission or agreement state regulations, or from voluntary participation in medical research programs.

(126) "Pyrophoric material" means any liquid that ignites spontaneously in dry or moist air at or below 54.4 degrees celsius (one hundred thirty degrees fahrenheit). A pyrophoric solid is any solid material, other than one classed as an explosive, which under normal conditions is liable to cause fires through friction, retained heat from manufacturing or processing, or which can be ignited readily and when ignited burns so vigorously and persistently as to create a serious transportation, handling, or disposal hazard. Included are spontaneously combustible and water-reactive materials.

(127) "Qualitative fit test" or "QLFT" means a pass/fail fit test to assess the adequacy of respirator fit that relies on the individual's response to the test agent.

(128) "Quality factor" or "Q" means the modifying factor, as listed in paragraphs (A) and (B) of rule 3701:1-38-11 of the Administrative Code, that is used to derive dose equivalent from absorbed dose.

(129) "Quantitative fit test" or "QNFT" means an assessment of the adequacy of respirator fit by numerically measuring the amount of leakage into the respirator.

(130) "Quarter" or "quarterly" means a period of time equal to one-fourth of the year observed by the licensee or registrant, approximately thirteen consecutive weeks, providing that the beginning of the first quarter in a year coincides with the starting date of the year and that no day is omitted or duplicated in consecutive quarters.

(131) "Rad" means the special unit of radiation absorbed dose. One rad is equal to an absorbed dose of one hundred ergs per gram, or 0.01 joule per kilogram, or 0.01 gray.

(132) "Radiation" or "ionizing radiation" means alpha particles, beta particles, gamma rays, x-rays, neutrons, high speed electrons, high speed protons, and other particles capable of producing ions. Radiation does not include nonionizing radiation, such as radio or microwaves, or visible, infrared or ultraviolet light.

(133) "Radiation area" means an area, accessible to individuals, in which radiation levels could result in an individual receiving a dose equivalent in excess of 0.05 millisievert (0.005 rem) in one hour at thirty centimeters from the source of radiation or from any surface that the radiation penetrates.

(134) "Radiation-generating equipment" or "RGE" means any manufactured product or device, or component of such a product or device, or any machine or system that during operation can generate or emit radiation, except those that emit radiation only from radioactive material. "Radiation-generating equipment" does not include either of the following:

(a) Diathermy machines;

(b) Microwave ovens, including food service microwave ovens used for commercial and industrial uses, television receivers, electric lamps, and other household appliances and products that generate very low levels of radiation.

(135) "Radiation Safety Officer" or "RSO" means an individual designated by the licensee who has the knowledge and responsibility for the overall radiation safety program at the facility, to include the implementation of the daily radiation safety operations and compliance with the rules.

(136) "Radioactive material" means any solid, liquid or gaseous material that emits ionizing radiation spontaneously. "Radioactive material" includes accelerator-produced and naturally occurring radioactive materials and byproduct, source, and special nuclear material.

(137) "Radioactive waste" means waste containing regulated radioactive material.

(138) "Radioactivity" means the transformation of unstable atoms by the emission of radiation.

(139) "Radiography" means the same as industrial radiography.

(140) "Reference man" means a hypothetical aggregation of human physical and physiological characteristics arrived at by international consensus. These characteristics may be used by researchers and public health workers to standardize results of experiments and to relate biological insult to a common base.

(141) "Registrant" means a person required by Chapter 3748. of the Revised Code to register radiation-generating equipment with the director.

(142) "Rem" means the special unit of any of the quantities expressed as dose equivalent. The dose equivalent in rem is equal to the absorbed dose in rads multiplied by the quality factor (one rem = 0.01 Sv).

(143) "Research and development" means

(a) Theoretical analysis, exploration, or experimentation; or

(b) The extension of investigative findings and theories of a scientific or technical nature into practical application for experimental and demonstration purposes, including the experimental production and testing of models, devices, equipment, materials and processes. "Research and development" does not include the internal or external administration of sources of radiation to human beings.

(144) "Residual radioactivity" means radioactivity in structures, materials, soils, groundwater, and other media at a site resulting from activities under the licensee's control. This includes radioactivity from all licensed and unlicensed sources used by the licensee, but excludes background radiation. It also includes radioactive materials remaining at the site as a result of routine or accidental releases of radioactive material at the site and previous burials at the site, even if those burials were made in accordance with the provisions of 10 C.F.R. 20 (as in effect on the effective date of this rule).

(145) "Respiratory protective equipment or device" means an apparatus, such as a respirator, used to reduce the individual's intake of airborne radioactive materials.

(146) "Restricted area" means an area access to which is limited by the licensee or registrant for the purpose of protecting individuals against undue risks from exposure to sources of radiation. Restricted area does not include areas used as residential quarters, but separate rooms in a residential building may be set apart as a restricted area.

(147) "Roentgen" means the amount of gamma or x-rays required to produce ions resulting in a charge of 0.000258 coulombs per kilogram of air under standard conditions.

(148) "Sanitary sewerage" means a system of public sewers for carrying off wastewater and refuse, but excluding sewage treatment facilities, septic tanks, and leach fields owned or operated by the licensee.

(149) "Sealed source" means radioactive material that is encased in a manner designed to prevent leakage or escape of the radioactive material.

(150) "Sealed source and device registry" means the national registry that contains all the registration certificates, generated by both the United States nuclear regulatory commission and the agreement states, that summarize the radiation safety information for the sealed sources and devices and describe the licensing and use conditions approved for the product.

(151) "Seismic area" means any area where the probability of a horizontal acceleration in rock of more than 0.3 times the acceleration of gravity in two hundred fifty years is greater than ten per cent, as designated by the United States geological survey.

(152) "Self-contained breathing apparatus" or "SCBA" means an atmosphere-supplying respirator for which the breathing air source is designed to be carried by the user.

(153) "Shallow dose equivalent" or "H_S" means the external exposure of the skin of the whole body or the skin of an extremity, is taken as the dose equivalent at a tissue depth of 0.007 centimeter, or seven milligrams per square centimeter.

(154) "Sievert" or "Sv" means the SI unit of any of the quantities expressed as dose equivalent. The dose equivalent in sieverts is equal to the absorbed dose in grays multiplied by the quality factor. One sievert equals one hundred rem.

(155) "Site area emergency" means events may occur, are in progress, or have occurred that could lead to a significant release of radioactive material and that could require a response by off-site response organizations to protect persons off-site.

(156) "Site boundary" means that line beyond which the land or property is not owned, leased, or otherwise controlled by the licensee or registrant.

(157) "Site closure and stabilization" means those actions that are taken upon completion of operations that prepare a disposal site for custodial care and that assure that the disposal site will remain stable and will not need ongoing active maintenance.

(158) "Source material" means uranium, thorium, or any combination thereof in any physical or chemical form, or any ores that contain by weight at least one-twentieth of one per cent (0.05 per cent) of uranium, thorium, or any combination thereof. Source material does not include special nuclear material.

(159) "Sources of radiation" means radioactive material or radiation generating equipment.

(160) "Special form radioactive material" means radioactive material that satisfies the following conditions:

(a) It is either a single solid piece or is contained in a sealed capsule that can be opened only by destroying the capsule;

(b) The piece or capsule has at least one dimension not less than five millimeters (0.2 inch); and

(c) It satisfies the test requirements specified by the United States nuclear regulatory commission in 10 C.F.R. 71.75 (as in effect on the effective date of this rule). A special form encapsulation designed in accordance with the United States nuclear regulatory commission requirements identified in 10 C.F.R. 71.4, in effect on June 30, 1983, and constructed prior to July 1, 1985; a special form encapsulation designed in accordance with the requirements of 10 C.F.R. 71.4 in effect on March 31, 1996, and constructed before April 1, 1998; and special form material that was successfully tested before September 10, 2015 in accordance with the requirements of 10 C.F.R. 71.75(d) of this section in effect before September 10, 2015 may continue to be used. Any other special form encapsulation must meet the specifications of this definition.

(161) "Special nuclear material" means either of the following:

(a) Plutonium, uranium-233, uranium enriched in the isotope 233, or in the isotope 235, and any other material that the United States nuclear regulatory commission determines to be special nuclear material, but does not include source material pursuant to section 51 of the Atomic Energy Act of 1954, 68 Stat 919, 42 USCA 2071, as amended (2005).

(b) Any material artificially enriched by any of the foregoing but does not include source material.

(162) "Special nuclear material in quantities not sufficient to form a critical mass" means uranium enriched in the isotope uranium-235 in quantities not exceeding three hundred fifty grams of contained uranium-235; uranium-233 in quantities not exceeding two hundred grams; plutonium in quantities not exceeding two hundred grams; or any combination of them in accordance with the following formula: for each kind of special nuclear material, determine the ratio between the quantity of that special nuclear material and the quantity specified in this paragraph for the same kind of special nuclear material. The sum of such ratios for all of the kinds of special nuclear material in combination shall not exceed unity.

(163) "Stochastic effect" means health effects that occur randomly and for which the probability of the effect occurring, rather than its severity, is assumed to be a linear function of dose without threshold. Hereditary effects and cancer incidence are examples of stochastic effects.

(164) "Supplied-air respirator" or "SAR" or "airline respirator" means an atmosphere-supplying respirator for which the source of breathing air is not designed to be carried by the user.

(165) "Surface contaminated object" or "SCO" means a solid object that is not itself classed as radioactive material, but which has radioactive material distributed on any of its surfaces. SCO must be in one of two groups with surface activity not exceeding the following limits:

(a) SCO-I: a solid object on which:

(i) The non-fixed contamination on the accessible surface averaged over three hundred square centimeters, or the area of the surface if less than three hundred square centimeters, does not exceed four becquerels per square centimeter (10^-4 microcurie per square centimeter) for beta and gamma and low toxicity alpha emitters, or 0.4 becquerels per square centimeter 10^-5 microcurie per square centimeter) for all other alpha emitters;

(ii) The fixed contamination on the accessible surface averaged over three hundred square centimeters, or the area of the surface if less than three hundred square centimeters, does not exceed forty thousand becquerels per square centimeter (one microcurie per square centimeter) for beta and gamma and low toxicity alpha emitters, or four thousand becquerels per square centimeter (0.1 microcurie per square centimeter) for all other alpha emitters; and

(iii) The non-fixed contamination plus the fixed contamination on the inaccessible surface averaged over three hundred square centimeters, or the area of the surface if less than three hundred square centimeters, does not exceed forty thousand becquerels per square centimeter (one microcurie per square centimeter) for beta and gamma and low toxicity alpha emitters, or four thousand becquerels per square centimeter (0.1 microcurie per square centimeter) for all other alpha emitters.

(b) SCO-II: a solid object on which the limits for SCO-I are exceeded and on which:

(i) The non-fixed contamination on the accessible surface averaged over three hundred square centimeters, or the area of the surface if less than three hundred square centimeter, does not exceed four hundred becquerels per square centimeter (10^-2 microcurie per square centimeter) for beta and gamma and low toxicity alpha emitters, or forty becquerels per square centimeter (10^-3 microcurie per square centimeter) for all other alpha emitters;

(ii) The fixed contamination on the accessible surface averaged over three hundred square centimeters, or the area of the surface if less than three hundred square centimeters, does not exceed eight hundred thousand becquerels per square centimeter (twenty microcuries per square centimeter) for beta and gamma and low toxicity alpha emitters, or eighty thousand becquerels per square centimeter (two microcuries per square centimeter) for all other alpha emitters; and

(iii) The non-fixed contamination plus the fixed contamination on the inaccessible surface averaged over three hundred square centimeters, or the area of the surface if less than three hundred square centimeters, does not exceed eight hundred thousand becquerels per square centimeter (twenty microcuries per square centimeter) for beta and gamma and low toxicity alpha emitters, or eighty thousand becquerels per square centimeter (two microcuries per square centimeter) for all other alpha emitters.

(166) "Survey" means an evaluation of the radiological conditions and potential hazards incident to the production, use, transfer, release, disposal or presence of radioactive material or other sources of radiation. When appropriate, such an evaluation includes a physical survey of the location of radioactive material, or the sources of radiation and measurements or calculations of levels of radiation, or concentrations or quantities of radioactive material present.

(167) "Tight-fitting facepiece" means a respiratory inlet covering that forms a complete seal with the face.

(168) "Total effective dose equivalent" or "TEDE" means the sum of the effective dose equivalent (for external exposures) and the committed effective dose equivalent (for internal exposures).

(169) "Transport index" means the dimensionless number, rounded up to the next tenth, placed on the label of a package, to designate the degree of control to be exercised by the carrier during transportation. The transport index is the number determined by multiplying the maximum radiation level in millisievert per hour at one meter (3.3 feet) from the external surface of the package by one hundred, which is equivalent to the maximum radiation level in millirem per hour at one meter (3.3 feet).

(170) "Type A quantity" means a quantity of radioactive material, the aggregate radioactivity of which does not exceed A₁ for special form radioactive material, or A₂ for normal form radioactive material, where A₁ and A₂ are given in rule 3701:1-50-25 of the Administrative Code.

(171) "Type B quantity" means a quantity of radioactive material greater than a type A quantity.

(172) "Type B package" is defined under "Package."

(173) "United States department of energy" means the department of energy established by the Department of Energy Organization Act, PL 95-91, 91 Stat. 565 (1977), 42 U.S.C. 7101 et seq., as amended (2006), to the extent that the department of energy or its duly authorized representatives, exercises functions formerly vested in the United States atomic energy commission, its chairman, members, officers and components and transferred to the United States energy research and development administration and to the administrator thereof pursuant to Sections 104(b) to (d) of the Energy Reorganization Act of 1974, PL 93-438, 88 Stat. 1233 at 1237 (1974), 42 U.S.C. 5814 and retransferred to the secretary of energy pursuant to Section 301(a) of the Department of Energy Organization Act, PL 95-91, 91 Stat. 565 at 577-578 (1977), 42 U.S.C. 7151.

(174) "Unrestricted area" or "uncontrolled area" means any area, access to which is neither restricted nor controlled by the licensee or registrant.

(175) "User seal check" or "fit check" means an action conducted by the respirator user to determine if the respirator is properly seated to the face. Examples include negative pressure check, positive pressure check, irritant smoke check, or isoamyl acetate check.

(176) "Very high radiation area" means an area, accessible to individuals, in which radiation levels from radiation sources external to the body could result in an individual receiving an absorbed dose in excess of five gray (five hundred rad) in one hour at one meter from a source of radiation or from any surface that the radiation penetrates. At very high doses received at high dose rates, units of absorbed dose, gray and rad, are appropriate, rather than units of dose equivalent, sievert and rem.

(177) "Veterinarian" means an individual licensed by the state of Ohio to practice veterinary medicine pursuant to Chapter 4741. of the Revised Code.

(178) "Waste" means those low-level radioactive wastes containing source, special nuclear, or byproduct material that are acceptable for disposal in a land disposal facility. For the purposes of this definition, low-level radioactive waste means radioactive waste not classified as high-level radioactive waste, transuranic waste, spent nuclear fuel, or byproduct material as defined in paragraph (A)(26)(b) of this rule, or byproduct material as defined in section 11 E. (3) and (4) of the Atomic Energy Act of 1954, 68 Stat. 919, 42 USC 2014, as amended (2005).

(179) "Week" means seven consecutive days starting on Sunday.

(180) "Weighting factor

• W_T" for an organ or tissue, (T), is the proportion of the risk of stochastic effects resulting from irradiation of that organ or tissue to the total risk of stochastic effects when the whole body is irradiated uniformly. For calculating the effective dose equivalent, the values of W_T are:

| Organ doseweighting factors | | | --- | --- | | Organ ortissue | W_T | | Gonads | 0.25 | | Breast | 0.15 | | Red bone marrow | 0.12 | | Lung | 0.12 | | Thyroid | 0.03 | | Bonesurfaces | 0.03 | | Remainder | 0.30^a | | Whole body | 1.00^b |

^\a 0.30 results from 0.06 for each of five "remainder" organs, excluding the skin and the lens of the eye, that receive the highest doses.

^\b for the purpose of weighting the external whole body dose (for adding it to the internal dose) a single weighting factor, W_T = 1.0, has been specified. The use of other weighting factors for external exposure will be approved on a case-by-case basis until such time as specific guidance is issued.

(181) "Whole body" means for purposes of external exposure, head; trunk, including male gonads; arms above the elbow; legs above the knee.

(182) "Worker" means an individual engaged in activities licensed or registered by the department and controlled by a licensee or registrant, but does not include the licensee or registrant.

(183) "Working level" or "WL" means any combination of short-lived radon decay products (for radon-222: polonium-218, lead-214, bismuth-214, and polonium-214; and for radon-220: polonium-216, lead-212, bismuth-212, and polonium-212) in one liter of air that will result in the ultimate emission of 1.3 x 10⁵ million electron volts alpha particle energy.

(184) "Working level month" or "WLM" means a cumulative exposure to one working level for one hundred seventy hours. (Two thousand working hours per year/twelve months per year equals approximately one hundred seventy hours per month.)

(185) "Year" means the period of time beginning in January used to determine compliance with the provisions of this rule. The licensee or registrant may change the starting date of the year used to determine compliance by the licensee or registrant provided that the change is made at the beginning of the year and that no day is omitted or duplicated in consecutive years.

(B) The terms set out in paragraph (A) of this rule may be redefined in other chapters as promulgated pursuant to Chapter 3748. of the Revised Code as used in that chapter only.

Last updated May 13, 2026 at 11:20 AM

History

• Effective: January 20, 2022
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-50-11

(A) A general license is issued to any licensee of the department to transport fissile material, or to deliver fissile material to a carrier for transport, if the material is shipped in accordance with this section. The fissile material need not be contained in a package which meets the standards of subparts E and F of 10 C.F.R. 71 (as in effect on the effective date of this rule); however, the material must be contained in a type A package. The type A package must also meet the DOT requirements of 49 C.F.R. 173.417(a) (as in effect on the effective date of this rule).

(B) The general license applies only to a licensee who has a quality assurance program approved by the department as satisfying the provisions of rule 3701:1-50-24 of the Administrative Code.

(C) The general license applies only when a package's contents:

(1) Contain no more than a type A quantity of radioactive material; and

(2) Contain less than five hundred total grams of beryllium, graphite, or hydrogenous material enriched in deuterium.

(D) The general license applies only to packages containing fissile material that are labeled with a CSI which:

(1) Has been determined in accordance with paragraph (E) of this rule;

(2) Has a value less than or equal to ten; and

(3) For a shipment of multiple packages containing fissile material, the sum of the CSIs must be less than or equal to fifty (for shipment on a nonexclusive use conveyance) and less than or equal to one hundred (for shipment on an exclusive use conveyance).

(E)

(1) The value for the CSI must be greater than or equal to the number calculated by the following equation:

CSI = 10((grams of U-235/X) + (grams of U-233/Y) + (grams of Pu/Z))

(2) The calculated CSI must be rounded up to the first decimal place;

(3) The values of X, Y, and Z used in the CSI equation must be taken from table 11-1 or table 11-2, as appropriate;

(4) If table 11-2 is used to obtain the value of X, then the values for the terms in the equation for uranium-233 and plutonium must be assumed to be zero; and

(5) Table 11-1 values for X, Y, and Z must be used to determine the CSI if:

(a) Uranium-233 is present in the package;

(b) The mass of plutonium exceeds one per cent of the mass of uranium-235;

(c) The uranium is of unknown uranium-235 enrichment or greater than twenty-four weight per cent enrichment; or

(d) Substances having a moderating effectiveness (i.e., an average hydrogen density greater than H₂O) (e.g., certain hydrocarbon oils or plastics) are present in any form, except as polyethylene used for packing or wrapping.

Table 11-1 Mass limits for general license packages containing mixed quantities of fissile material or uranium-235 of unknown enrichment per paragraph (E) of this rule

| Fissile material | Fissile material mass mixed with moderating substances having an average hydrogen density less than or equal to H₂O (grams) | Fissile material mass mixed with moderating substances having an average hydrogen density greater than H₂O^a(grams) | | --- | --- | --- | | U-235(X) | 60 | 38 | | U-233(Y) | 43 | 27 | | Pu-239 or Pu-241 (Z) | 37 | 24 |

^a When mixtures of moderating substances are present, the lower mass limits shall be used if more than fifteen per cent of the moderating substance has an average hydrogen density greater than H₂O.

Table 11-2 Mass limits for general license packages containing uranium-235 on known enrichment per paragraph (E) of this rule

| Uranium enrichment in weight per cent of U-235 not exceeding | Fissile material mass of U-235 (X) (grams) | | --- | --- | | 24 | 60 | | 20 | 63 | | 15 | 67 | | 11 | 72 | | 10 | 76 | | 9.5 | 78 | | 9 | 81 | | 8.5 | 82 | | 8 | 85 | | 7.5 | 88 | | 7 | 90 | | 6.5 | 93 | | 6 | 97 | | 5.5 | 102 | | 5 | 108 | | 4.5 | 114 | | 4 | 120 | | 3.5 | 132 | | 3 | 150 | | 2.5 | 180 | | 2 | 246 | | 1.5 | 408 | | 1.35 | 480 | | 1 | 1,020 | | 0.92 | 1,800 |

Last updated March 6, 2024 at 11:40 AM

History

• Effective: February 15, 2021
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-50-12

(A) A general license is issued to any licensee of the department to transport fissile material in the form of plutonium-beryllium (Pu-Be) special form sealed sources, or to deliver Pu-Be sealed sources to a carrier for transport, if the material is shipped in accordance with this section. This material need not be contained in a package which meets the standards of subparts E and F of 10 C.F.R. 71 (as in effect on the effective date of this rule); however, the material must be contained in a type A package. The type A package must also meet the DOT requirements of 49 C.F.R. 173.417(a) (as in effect on the effective date of this rule).

(B) The general license applies only to a licensee who has a quality assurance program approved by the department as satisfying the provisions of rule 3701:1-50-24 of the Administrative Code.

(C) The general license applies only when a package's contents:

(1) Contain no more than a type A quantity of radioactive material; and

(2) Contain less than one thousand grams of plutonium, provided that: plutonium-239, plutonium-241, or any combination of these radionuclides, constitutes less than two hundred forty grams of the total quantity of plutonium in the package.

(D) The general license applies only to packages labeled with a CSI which:

(1) Has been determined in accordance with paragraph (E) of this rule;

(2) Has a value less than or equal to one hundred; and

(3) For a shipment of multiple packages containing Pu-Be sealed sources, the sum of the CSIs must be less than or equal to fifty (for shipment on a nonexclusive use conveyance) and less than or equal to one hundred (for shipment on an exclusive use conveyance).

(E)

(1) The value for the CSI must be greater than or equal to the number calculated by the following equation:

CSI = 10 ((grams of Pu-239 + grams of Pu-241) / 24); and

(2) The calculated CSI must be rounded up to the first decimal place.

History

• Effective: February 15, 2021
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-50-13

Fissile material meeting the requirements of at least one of the paragraphs (A) to (F) of this rule are exempt from classification as fissile material and from the fissile material package standards of 10 C.F.R. 71.55 and 10 C.F.R. 71.59 (as in effect on the effective date of this rule), but are subject to all other requirements of this chapter, except as noted.

(A) Individual package containing two grams or less fissile material.

(B) Individual or bulk packaging containing fifteen grams or less of fissile material provided the package has at least two hundred grams of solid nonfissile material for every gram of fissile material. Lead, beryllium, graphite, and hydrogenous material enriched in deuterium may be present in the package but must not be included in determining the required mass for solid nonfissile material.

(C)

(1) Low concentrations of solid fissile material commingled with solid nonfissile material, provided that:

(a) There is at least two thousand grams of solid nonfissile material for every gram of fissile material, and

(b) There is no more than one hundred eighty grams of fissile material distributed within three hundred sixty kilograms of contiguous nonfissile material.

(2) Lead, beryllium, graphite, and hydrogenous material enriched in deuterium may be present in the package but must not be included in determining the required mass of solid nonfissile material.

(D) Uranium enriched in uranium-235 to a maximum of one per cent by weight, and with total plutonium and uranium-233 content of up to one per cent of the mass of uranium-235, provided that the mass of any beryllium, graphite, and hydrogenous material enriched in deuterium constitutes less than five per cent of the uranium mass, and that the fissile material is distributed homogeneously and does not form a lattice arrangement within the package.

(E) Liquid solutions of uranyl nitrate enriched in uranium-235 to a maximum of two per cent by mass, with a total plutonium and uranium-233 content not exceeding 0.002 per cent of the mass of uranium, and with a minimum nitrogen to uranium atomic ratio (N/U) of two. The material must be contained in at least DOT type A package.

(F) Packages containing, individually, a total plutonium mass of not more than one thousand grams, of which not more than twenty per cent by mass may consist of plutonium-239, plutonium-241, or any combination of these radionuclides.

History

• Effective: February 15, 2021
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-50-02 Purpose and scope.

(A) This chapter establishes requirements for packaging, preparation for shipment, and transportation of radioactive material.

(B) The packaging and transport of radioactive material are also subject to other chapters of the Administrative Code and to the regulations of other agencies (such as the DOT, the United States postal service and the United States nuclear regulatory commission) having jurisdiction over means of transport. The requirements of this chapter are in addition to, and not in substitution for, other requirements.

(C) This chapter applies to any licensee authorized by specific or general license issued by the director to receive, possess, use, or transfer licensed material, if the licensee delivers that material to a carrier for transport, transports the material outside the site of usage as specified in the Ohio license, or transports that material on public highways. No provision of this chapter authorizes possession of licensed material.

(D) Exemptions from the requirement for license in rule 3701:1-50-04 of the Administrative Code are specified in rule 3701:1-50-06 of the Administrative Code. General licenses for which no package approval is required are issued in rules 3701:1-50-10 to 3701:1-50-12 of the Administrative Code. The general license in rule 3701:1-50-07 of the Administrative Code requires that an United States nuclear regulatory commission CoC or other package approval be issued for the package to be used under the general license. The transport of licensed material or delivery of licensed material to a carrier for transport is subject to the operating controls and procedures requirements of rules 3701:1-50-15 to 3701:1-50-19 and rule 3701:1-50-23 of the Administrative Code, to the quality assurance requirements of rule 3701:1-50-24 of the Administrative Code or United States nuclear regulatory commission, and to the general provisions of rules 3701:1-50-01 to 3701:1-50-05 of the Administrative Code, including DOT regulations referenced in rule 3701:1-50-05 of the Administrative Code.

(E) These rules apply to any person required to obtain a CoC or an approved compliance plan from the United States nuclear regulatory commission pursuant to 10 C.F.R. 76 (as in effect on the effective date of this rule) if the person delivers radioactive material to a common or contract carrier for transport or transports the material outside the confines of the person's plant or other authorized place of use.

History

• Effective: February 15, 2021
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-50-04

Except as authorized in a general license or a specific license issued by the director, or as exempted in this chapter, no licensee may:

(A) Deliver licensed material to a carrier for transport; or

(B) Transport licensed material.

Last updated June 13, 2021 at 10:03 AM

History

• Effective: June 13, 2021
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-50-06

(A) A licensee is exempt from all the requirements of this chapter with respect to shipment or carriage of the following low-level materials:

(1) Natural material and ores containing naturally occurring radionuclides that are either in their natural state, or have only been processed for purposes other than for the extraction of the radionuclides, and which are not intended to be processed for the use of these radionuclides, provided the activity concentration of the material does not exceed ten times the applicable radionuclide activity concentration values specified in table 25-2 in appendix B to rule 3701:1-50-25 of the Administrative Code, or table 25-3 in appendix C to rule 3701:1-50-25 of the Administrative Code.

(2) Materials for which the activity concentration is not greater than the activity concentration values specified in table 25-2 in appendix B to rule 3701:1-50-25 of the Administrative Code, or table 25-3 in appendix C to rule 3701:1-50-25 of the Administrative Code, or for which the consignment activity is not greater than the limit for an exempt consignment found in table 25-2 in appendix B to rule 3701:1-50-25 of the Administrative Code, or table 25-3 in appendix C to rule 3701:1-50-25 of the Administrative Code.

(3) Non-radioactive solid objects with radioactive substances present on any surfaces in quantities not in excess of the levels cited in the definition of contamination in rule 3701:1-50-01 of the Administrative Code.

(B) A licensee is exempt from all the requirements of this chapter, other than rules 3701:1-50-05 and 3701:1-50-18 of the Administrative Code, with respect to shipment or carriage of the following packages, provided the packages do not contain any fissile material, or the material is exempt from classification as fissile material under 3701:1-50-13 of the Administrative Code:

(1) A package that contains no more than a Type A quantity of radioactive material;

(2) A package transported within the United States that contains no more than 0.74 terabecquerel (twenty curies) of special form plutonium-244; or

(3) The package contains only LSA or SCO radioactive material, provided:

(a) That the LSA or SCO material has an external radiation dose of less than or equal to ten millisievert per hour (one rem per hour), at a distance of three meters from the unshielded material; or

(b) That the package contains only LSA-I or SCO-I material.

Last updated November 2, 2022 at 2:43 PM

History

• Effective: April 20, 2018
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-50-10

(A) A general license is issued to any Ohio licensee to transport, or to deliver to a carrier for transport, licensed material in a package the design of which has been approved in a foreign national competent authority certificate that has been revalidated by DOT as meeting applicable requirements of 49 C.F.R. 171.23 (as in effect on the effective date of this rule).

(B) Except as otherwise provided in this chapter, the general license applies only to a Ohio licensee who has a quality assurance program approved by the director as satisfying the applicable provisions of this chapter.

(C) This general license applies to only shipments made to or from locations outside the United States.

(D) Each licensee issued a general license under paragraph (A) of this rule shall:

(1) Maintain a copy of the applicable certificate, the revalidation, and the drawings and other documents referenced in the certificate, relating to the use and maintenance of the packaging and to the actions to be taken before shipment; and

(2) Comply with the terms and conditions of the certificate and revalidation, and with the applicable requirements of this chapter.

History

• Effective: February 15, 2021
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-50-07

(A) A general license is hereby issued to any Ohio licensee to transport, or to deliver to a carrier for transport, licensed material in a package for which a license, CoC, or other approval has been issued by the United States nuclear regulatory commission.

(B) This general license applies only to a licensee who has a quality assurance program approved by the director as satisfying the provisions of this chapter.

(C) Each licensee issued a general license under paragraph (A) of this rule shall:

(1) Maintain a copy of the CoC, or other approval of the package, and the drawings and other documents referenced in the approval relating to the use and maintenance of the packaging and to the actions to be taken before shipment;

(2) Comply with the terms and conditions of the license, certificate, or other approval, as applicable, and the applicable requirements of this chapter; and

(3) Submit in writing before the first use of the package to:

"Attn: Document Control Desk

Director, Division of Fuel Management

Office of Nuclear Material Safety and Safeguards"

using an appropriate method listed in 10 C.F.R. 71.1(a) (as in effect on the effective date of this rule), the licensee's name and license number and the package identification number specified in the package approval.

(D) This general license applies only when the package approval authorizes use of the package under this general license.

(E) For a type B or fissile material package, the design of which was approved by the United States nuclear regulatory commission before April 1, 1996, the general license is subject to the additional restrictions of 10 C.F.R. 71.19 (as in effect on the effective date of this rule).

History

• Effective: February 15, 2021
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-50-15

When the isotopic abundance, mass, concentration, degree of irradiation, degree of moderation, or other pertinent property of fissile material in any package is not known, the licensee shall package the fissile material as if the unknown properties have credible values that will cause the maximum neutron multiplication.

Last updated June 13, 2021 at 10:04 AM

History

• Effective: June 13, 2021
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-50-19

Before delivery of a package to a carrier for transport, the licensee shall ensure that any special instructions needed to safely open the package have been sent to, or otherwise made available to, the consignee for the consignee's use in accordance with paragraph (I) of rule 3701:1-38-18 of the Administrative Code.

Last updated June 13, 2021 at 10:04 AM

History

• Effective: June 13, 2021
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-50-23

(A)

(1) As specified in paragraphs (B), (C) and (D) of this rule, each licensee shall provide advance notification to the governor of a state, or the governor's designee, of the shipment of licensed material, through, or across the boundary of the state, before the transport, or delivery to a carrier, for transport, of licensed material outside the confines of the licensee's plant or other place of use or storage in compliance with section 4163.07 of the Revised Code.

(2) As specified in paragraphs (B), (C), and (D) of this rule, each licensee shall provide advance notification to the tribal official of participating indian tribes referenced in paragraph (C)(3)(c) of this rule, or the official's designee, of the shipment of licensed material, within or across the boundary of the indian tribe's reservation, before the transport, or delivery to a carrier, for transport, of licensed material outside the confines of the licensee's plant or other place of use or storage in compliance with section 4163.07 of the Revised Code.

(B) Advance notification is also required under this rule for shipments of licensed material, other than irradiated reactor fuel, meeting the following three conditions:

(1) The licensed material is required by this part to be in type B packaging for transportation;

(2) The licensed material is being transported to or across a state boundary in route to a disposal facility or to a collection point for transport to a disposal facility; and

(3) The quantity of licensed material in a single package exceeds the least of the following:

(a) Three thousand times the A₁ value of the radionuclides as specified in rule 3701:1-50-25 of the Administrative Code for special form radioactive material;

(b) Three thousand times the A₂ value of the radionuclides as specified in rule 3701:1-50-25 of the Administrative Code for normal form radioactive material; or

(c) One thousand terabecquerels (twenty-seven thousand curies).

(C) Each licensee shall submit an advance notification as follows:

(1) The notification must be made in writing to the office of each appropriate governor or governor's designee, the office of each appropriate tribal official or tribal official's designee, and to the director, office of nuclear security and incident response, United States nuclear regulatory commission.

(2) A notification delivered by mail must be postmarked at least seven days before the beginning of the seven-day period during which departure of the shipment is estimated to occur.

(3) A notification delivered by any other means than mail must reach the office of the governor or of the governor's designee or the tribal official or tribal official's designee at least four days before the beginning of the seven-day period during which departure of the shipment is estimated to occur.

(a) Contact information for each state, including telephone and mailing addresses of governors and governors' designees, and participating tribes, including telephone and mailing addresses of tribal officials and tribal official's designees, is available on the United States nuclear regulatory commission's web site at: https://scp.nrc.gov/special/designee.pdf.

(b) A list of the names and mailing addresses of the governors' designees and tribal officials' designees of participating tribes is available on request from the "Director, Division of Material Safety, Security, State, and Tribal Programs, Office of Nuclear Material Safety and Safeguards, United States Nuclear Regulatory Commission, Washington, DC 20555-0001."

(4) The licensee shall retain a copy of the notification as a record for three years.

(D) Each advance notification of shipment of nuclear waste must contain the following information:

(1) The name, address, and telephone number of the shipper, carrier, and receiver of the nuclear waste shipment;

(2) A description of the nuclear waste contained in the shipment, as specified in the regulation of DOT in 49 C.F.R. 172.202 and 49 C.F.R. 172.203(D) (as in effect on the effective date of this rule);

(3) The point of origin of the shipment and the seven-day period during which departure of the shipment is estimated to occur;

(4) The seven-day period during which arrival of the shipment at state boundaries, or tribal reservation boundaries is estimated to occur;

(5) The destination of the shipment, and the seven-day period during which arrival at the destination of the shipment is estimated to occur; and

(6) A point of contact, with a telephone number, for current shipment information.

(E) Revision notice.

(1) A licensee who finds that schedule information previously furnished to a governor or governor's designee or a tribal official or tribal official's designee, in accordance with this section, will not be met, shall telephone a responsible individual in the office of the governor of the state or of the governor's designee or the tribal official or the tribal official's designee and inform that individual of the extent of the delay beyond the schedule originally reported. The licensee shall maintain a record of the name of the individual contacted for three years.

(F) Cancellation notice.

(1) Each licensee who cancels a nuclear waste shipment for which advance notification has been sent shall send a cancellation notice to the offices listed in paragraph (A) of this rule previously notified, and to the director, office of nuclear security and incident response, United States nuclear regulatory commission.

(2) The licensee shall state in the notice that it is a cancellation and identify the advance notification that is being canceled. The licensee shall retain a copy of the notice as a record for three years.

Last updated May 15, 2023 at 4:02 AM

History

• Effective: May 15, 2023
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-50-24

(A) This rule describes quality assurance requirements applying to design, purchase, fabrication, handling, shipping, storing, cleaning, assembly, inspection, testing, operation, maintenance, repair, and modification of components of packaging that are important to safety. As used in this rule, "quality assurance" comprises all those planned and systematic actions necessary to provide adequate confidence that a system or component will perform satisfactorily in service. Quality assurance includes quality control, which comprises those quality assurance actions related to control of the physical characteristics and quality of the material or component to predetermined requirements. Each licensee is responsible for satisfying the quality assurance requirements that apply to its use of a packaging for the shipment of licensed material subject to this rule.

(B) Each licensee shall establish, maintain, and execute a quality assurance program satisfying each of the applicable criteria of this chapter and satisfying any specific provisions that are applicable to the licensee's activities including procurement of packaging. The licensee shall execute the applicable criteria in a graded approach to an extent that is commensurate with the quality assurance requirement's importance to safety.

(C) Before the use of any package for the shipment of licensed material subject to this rule, each licensee shall obtain the director's approval of its quality assurance program. Each licensee shall file a description of its quality assurance program, including a discussion of which requirements of this chapter are applicable and how they will be satisfied, by submitting the description to the address in rule 3701:1-50-03 of the Administrative Code.

(D) A program for transport container inspection and maintenance limited to radiographic exposure devices, source changers, or packages transporting these devices and meeting the requirements of paragraph (B) of rule 3701:1-48-11 of the Administrative Code or equivalent United States nuclear regulatory commission or agreement state requirements, is deemed to satisfy the requirements of paragraph (B) of rule 3701:1-50-07 of the Administrative Code and paragraph (B) of this rule.

(E) The licensee shall be responsible for the establishment and execution of the quality assurance program. The licensee may delegate to others, such as contractors, agents, or consultants, the work of establishing and executing the quality assurance program, or any part of the quality assurance program, but shall retain responsibility for the program. These activities include performing the functions associated with attaining quality objectives and the quality assurance functions.

(F) The quality assurance functions are:

(1) Assuring that an appropriate quality assurance program is established and effectively executed; and

(2) Verifying, by procedures such as checking, auditing, and inspection, that activities affecting the functions that are important to safety have been correctly performed.

(G) The persons and organizations performing quality assurance functions must have sufficient authority and organizational freedom to:

(1) Identify quality problems;

(2) Initiate, recommend, or provide solutions; and

(3) Verify implementation of solutions.

(H) The persons and organizations performing quality assurance functions shall report to a management level that assures that the required authority and organizational freedom, including sufficient independence from cost and schedule, when opposed to safety considerations, are provided.

(I) Because of the many variables involved, such as the number of personnel, the type of activity being performed, and the location or locations where activities are performed, the organizational structure for executing the quality assurance program may take various forms, provided that the persons and organizations assigned the quality assurance functions have the required authority and organizational freedom.

(J) Irrespective of the organizational structure, the individual(s) assigned the responsibility for assuring effective execution of any portion of the quality assurance program, at any location where activities subject to this chapter are being performed, must have direct access to the levels of management necessary to perform this function.

(K) The licensee shall establish, at the earliest practicable time consistent with the schedule for accomplishing the activities, a quality assurance program that complies with the requirements of this chapter. The licensee shall document the quality assurance program by written procedures or instructions and shall carry out the program in accordance with those procedures throughout the period during which the packaging is used. The licensee shall identify the material and components to be covered by the quality assurance program, the major organizations participating in the program, and the designated functions of these organizations.

(L) The licensee, through its quality assurance program, shall provide control over activities affecting the quality of the identified materials and components to an extent consistent with their importance to safety, and as necessary to assure conformance to the approved design of each individual package used for the shipment of radioactive material. The licensee shall assure that activities affecting quality are accomplished under suitably controlled conditions. Controlled conditions include the use of appropriate equipment; suitable environmental conditions for accomplishing the activity, such as adequate cleanliness; and assurance that all prerequisites for the given activity have been satisfied. The licensee shall take into account the need for special controls, processes, test equipment, tools, and skills to attain the required quality, and the need for verification of quality by inspection and test.

(M) The licensee shall base the requirements and procedures of its quality assurance program on the following considerations concerning the complexity and proposed use of the package and its components:

(1) The impact of malfunction or failure of the item to safety;

(2) The design and fabrication complexity or uniqueness of the item;

(3) The need for special controls and surveillance over processes and equipment;

(4) The degree to which functional compliance can be demonstrated by inspection or test; and

(5) The quality history and degree of standardization of the item.

(N) The licensee shall provide for orientation and training of personnel performing activities affecting quality, as necessary to assure that suitable proficiency is achieved and maintained. The licensee shall review the status and adequacy of the quality assurance program at established intervals. Management of other organizations participating in the quality assurance program shall review regularly the status and adequacy of that part of the quality assurance program they are executing.

(O) Each quality assurance program approval holder shall submit, in accordance with rule 3701:1-50-03 of the Administrative Code, a description of a proposed change to its director approved quality assurance program that will reduce commitments in the program description as approved by the director. The quality assurance program approval holder shall not implement the change before receiving director approval. The description of a proposed change to the director approved quality assurance program must identify the change, the reason for the change, and the basis for concluding that the revised program incorporating the change continues to satisfy the applicable requirements of this chapter.

(P) Each quality assurance program approval holder may change a previously approved quality assurance program without prior director approval, if the change does not reduce the commitments in the quality assurance program previously approved by the director. Changes to the quality assurance program that do not reduce the commitments shall be submitted to the director every twenty four months, in accordance with rule 3701:1-50-03 of the Administrative Code. In addition to quality assurance program changes involving administrative improvements and clarifications, spelling corrections, and non-substantive changes to punctuation or editorial items, the following changes are not considered reductions in commitment:

(1) The use of a quality assurance standard approved by the director that is more recent than the quality assurance standard in the licensee's current quality assurance program at the time of the change. The use of a quality assurance standard approved by the director that is more recent than the quality assurance standard in the licensee's current quality assurance program at the time of the change;

(2) The use of generic organizational position titles that clearly denote the position function, supplemented as necessary by descriptive text, rather than specific titles, provided that there is no substantive change to either the functions of the position or reporting responsibilities;

(3) The use of generic organizational charts to indicate functional relationships, authorities, and responsibilities, or alternatively, the use of descriptive text, provided that there is no substantive change to the functional relationships, authorities, or responsibilities;

(4) The elimination of quality assurance program information that duplicates language in quality assurance regulatory guides and quality assurance standards to which the quality assurance program approval holder has committed to on record; and

(5) Organizational revisions that ensure that persons and organizations performing quality assurance functions continue to have the requisite authority and organizational freedom, including sufficient independence from cost and schedule when opposed to safety considerations.

(Q) Each quality assurance program approval holder shall maintain records of quality assurance program changes.

(R) The licensee shall maintain sufficient written records to describe the activities affecting quality. These records must include changes to the quality assurance program as required by this chapter, the instructions, procedures, and drawings required by 10 C.F.R. 71.111 (as in effect on the effective date of this rule) to prescribe quality assurance activities, and closely related specifications such as required qualifications of personnel, procedures, and equipment. The records must include the instructions or procedures that establish a records retention program that is consistent with applicable regulations and designates factors such as duration, location, and assigned responsibility. The licensee shall retain these records for three years beyond the date when the licensee last engage in the activity for which the quality assurance program was developed. If any portion of the quality assurance program, written procedures or instructions is superseded, the licensee shall retain the superseded material for three years after it is superseded.

History

• Effective: February 15, 2021
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-50-05

(A) Each licensee who transports licensed material outside the site of usage, as specified in the United States nuclear regulatory commission or Ohio license, or where transport is on public highways, or who delivers licensed material to a carrier for transport, shall comply with the applicable requirements of the DOT regulations in 49 C.F.R. 107, 171 to 180, and 390 to 397 (as in effect on the effective date of this rule), appropriate to the mode of transport.

(1) The licensee shall particularly note DOT regulations (as in effect on the effective date of this rule) in the following areas:

(a) Packaging - 49 C.F.R. 173: subparts A, B, and I.

(b) Marking and labeling - 49 C.F.R. 172: subpart D; sections 172.400 to 172.407 and 172.436 to 172.441 of subpart E.

(c) Placarding - 49 C.F.R. 172: subpart F, especially sections 172.500 to 172.519 and 172.556; and appendices B and C.

(d) Accident reporting - 49 C.F.R. 171: sections 171.15 and 171.16.

(e) Shipping papers and emergency information - 49 C.F.R. 172: subparts C and G.

(f) Hazardous material employee training - 49 C.F.R. 172: subpart H.

(g) Security plans - 49 C.F.R. 172: subpart I.

(h) Hazardous material shipper/carrier registration - 49 C.F.R. 107: subpart G.

(2) The licensee shall also note DOT regulations (as in effect on the effective date of this rule) pertaining to the following modes of transportation:

(a) Rail - 49 C.F.R. 174: subparts A to D and K.

(b) Air - 49 C.F.R. 175.

(c) Vessel - 49 C.F.R. 176: subparts A to F and M.

(d) Public highway - 49 C.F.R. 177 and 390 to 397.

(B) If DOT regulations are not applicable to a shipment of licensed material, the licensee shall conform to the standards and requirements of the DOT specified in paragraph (A) of this rule to the same extent as if the shipment or transportation were subject to DOT regulations. A request for modification, waiver, or exemption from those requirements, and any notification referred to in those requirements, must be filed with, or made to, the director, Ohio department of health.

History

• Effective: February 15, 2021
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-50-03 Communications and records.

(A) Except as otherwise specified, all communications required by this chapter shall be addressed to the bureau of environmental health and radiation protection at:

"Ohio Department of Health

246 North High Street

Bureau of Environmental Health and Radiation Protection

Columbus, Ohio 43215"

If communications are required to be submitted to the United States nuclear regulatory commission use the following address: the director, office of nuclear material safety and safeguards, United States nuclear regulatory commission, Washington, D.C. 20555-0001, or may be delivered in person, at the commission offices, at 11545 Rockville Pike, Rockville, Maryland.

(B) Each record required by this chapter must be legible throughout the retention period specified by each rule. The record may be the original or a reproduced copy or a microform provided that the copy or microform is authenticated by authorized personnel and that the microform is capable of producing a clear copy throughout the required retention period. The record may also be stored in electronic media with the capability for producing legible, accurate, and complete records during the required retention period. Records such as letters, drawings, specifications, must include all pertinent information such as stamps, initials, and signatures. The licensee shall maintain adequate safeguards against tampering with and loss of records.

Last updated November 2, 2022 at 2:43 PM

History

• Effective: February 18, 2016
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-50-25

This rule was filed with the Legislative Service Commission in PDF format and is presented here as filed.

View Rule Text

View AppendixView AppendixView AppendixView Appendix

Last updated May 18, 2023 at 11:21 AM

History

• Effective: May 15, 2023
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-50-18

(A) Notwithstanding the provisions of any general licenses and notwithstanding any exemptions stated directly in this chapter or included indirectly by citation of 49 C.F.R. chapter I (as in effect on the effective date of this rule), as may be applicable, the licensee shall assure that plutonium in any form, whether for import, export, or domestic shipment, is not transported by air or delivered to a carrier for air transport unless:

(1) The plutonium is contained in a medical device designed for individual human application; or

(2) The plutonium is contained in a material in which the specific activity is less than or equal to the activity concentration values for plutonium specified in table 25-2 in appendix B to rule 3701:1-50-25 of the Administrative Code, and in which the radioactivity is essentially uniformly distributed; or

(3) The plutonium is shipped in a single package containing no more than an A₂ quantity of plutonium in any isotope or form, and is shipped in accordance with rule 3701:1-50-05 of the Administrative Code; or

(4) The plutonium is shipped in a package specifically authorized for the shipment of plutonium by air in the CoC for that package issued by the United States nuclear regulatory commission.

(B) Nothing in paragraph (A) of this rule is to be interpreted as removing or diminishing the requirements of 10 C.F.R. 73.24 (as in effect on the effective date of this rule).

(C) For a shipment of plutonium by air which is subject to paragraph (A)(4) of this rule, the licensee shall, through special arrangement with the carrier, require compliance with 49 C.F.R. 175.704 (as in effect on the effective date of this rule), DOT regulations applicable to the air transport of plutonium.

History

• Effective: February 15, 2021
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-50-16 Preliminary determinations.

Before the first use of any packaging for the shipment of licensed material, the licensee shall ascertain that the determinations in paragraphs (a) through (c) of 10 C.F.R. 71.85 (as in effect on the effective date of this rule) have been made.

History

• Effective: February 15, 2021
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-50-17 Routine determinations.

Before each shipment of licensed material, the licensee shall ensure that the package with its contents satisfies the applicable requirements of this chapter and of the license. The licensee shall determine that:

(A) The package is proper for the contents to be shipped;

(B) The package is in unimpaired physical condition except for superficial defects such as marks or dents;

(C) Each closure device of the packaging, including any required gasket, is properly installed and secured and free of defects;

(D) Any system for containing liquid is adequately sealed and has adequate space or other specified provision for expansion of the liquid;

(E) Any pressure relief device is operable and set in accordance with written procedures;

(F) The package has been loaded and closed in accordance with written procedures;

(G) For fissile material, any moderator or neutron absorber, if required, is present and in proper condition;

(H) Any structural part of the package that could be used to lift or tie down the package during transport is rendered inoperable for that purpose, unless it satisfies the design requirements of 10 C.F.R. 71.45 (as in effect on the effective date of this rule).

(I) The level of non-fixed or removable radioactive contamination on the external surfaces of each package offered for shipment is as low as reasonably achievable and within the limits as specified in DOT regulations in 49 C.F.R. 173.443 (as in effect on the effective date of this rule).

(J) External radiation levels around the package, and around the vehicle if applicable, will not exceed the limits specified in this paragraph at any time during transportation:

(1) Except as provided in paragraph (J)(2) of this rule, each package of radioactive materials offered for transportation must be designed and prepared for shipment so that under conditions normally incident to transportation the radiation level does not exceed two millisievert per hour (two hundred millirem per hour) at any point on the external surface of the package, and the transport index does not exceed ten;

(2) A package that exceeds the radiation level limits specified in paragraph (J)(1) of this rule must be transported by exclusive use shipment only, and the radiation levels for such shipment must not exceed the following during transportation:

(a) Two millisievert per hour (two hundred millirem per hour) on the external surface of the package, unless the following conditions are met, in which case the limit is ten millisievert per hour (one thousand millirem per hour):

(i) The shipment is made in a closed transport vehicle;

(ii) The package is secured within the vehicle so that its position remains fixed during transportation; and

(iii) There are no loading or unloading operations between the beginning and end of the transportation;

(b) Two millisievert per hour (two hundred millirem per hour) at any point on the outer surface of the vehicle, including the top and underside of the vehicle; or in the case of a flat-bed style vehicle, at any point on the vertical planes projected from the outer edges of the vehicle, on the upper surface of the load or enclosure, if used, and on the lower external surface of the vehicle; and

(c) 0.1 millisievert per hour (ten millirem per hour) at any point two meters (6.6 feet) from the outer lateral surfaces of the vehicle (excluding the top and underside of the vehicle); or in the case of a flat-bed style vehicle, at any point two meters (6.6 feet) from the vertical planes projected by the outer edges of the vehicle (excluding the top and underside of the vehicle); and

(d) 0.02 millisievert per hour (two millirem per hour) in any normally occupied space, except that this provision does not apply to private carriers, if exposed personnel under their control wear radiation dosimetry devices in conformance with rule 3701:1-38-14 of the Administrative Code.

(3) For shipments made under the provisions of paragraph (J)(2) of this rule, the shipper shall provide specific written instructions to the carrier for maintenance of the exclusive use shipment controls. The instructions must be included with the shipping paper information.

(4) The written instructions required for exclusive use shipments must be sufficient so that, when followed, they will cause the carrier to avoid actions that will unnecessarily delay delivery or unnecessarily result in increased radiation levels or radiation exposures to transport workers or members of the general public; and

(K) Accessible package surface temperatures will not exceed the limits specified in 10 C.F.R. 71.43(g) (as in effect on the effective date of this rule) at any time during transportation.

History

• Effective: February 15, 2021
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-38-14

(A) Each licensee or registrant shall:

(1) Make, or cause to be made, surveys of areas, including the subsurface, that are:

(a) Necessary to comply with this chapter: and

(b) Reasonable under the circumstances to evaluate:

(i) Radiation levels;

(ii) Concentrations or quantities of residual radioactivity; and

(iii) The potential radiological hazards of the radiation levels and residual radioactivity detected.

(2) Notwithstanding paragraph (C) of rule 3701:1-38-20 of the Administrative Code, records from surveys describing the location and amount of subsurface residual radioactivity identified at the site must be kept with records important for decommissioning, and such records must be retained in accordance with paragraph (I) of rule 3701:1-40-17, paragraph (F) of rule 3701:1-44-18, and paragraph (D) of rule 3701:1-56-19 of the Administrative Code, as applicable.

(3) Ensure that instruments and equipment used for quantitative radiation measurements, such as dose rate and effluent monitoring, are calibrated annually for the radiation measured, except as otherwise specified in Chapter 3748. of the Revised Code, rules adopted thereunder, or a license condition.

(4) Ensure that all personnel dosimeters, except for direct and indirect reading dosimeters used to measure the dose to any extremity, that require processing to determine the radiation dose and that are used to comply with paragraph (A) of rule 3701:1-38-12 of the Administrative Code, with other applicable provisions of these regulations, or with conditions specified in a license or registration shall be processed and evaluated by a dosimetry processor that:

(a) Holds a current personnel dosimetry accreditation from the national voluntary laboratory accreditation program of the national institute of standards and technology; and

(b) Is approved in this accreditation process for the type of radiation or radiations included in the national voluntary laboratory accreditation program that most closely approximates the type of radiation or radiations for which the individual wearing the dosimeter is monitored; and

(5) Have procedures in place to minimize the likelihood of a deceptive exposure of an individual monitoring device, and in the event of a suspected deceptive exposure, an investigation should be conducted by the radiation safety officer for licensees or individual responsible for radiation protection for registrants which will lead to corrective action as necessary.

(B) Conditions requiring individual monitoring of external and internal occupational dose are as follows:

(1) Each licensee or registrant shall monitor exposures from sources of radiation at levels sufficient to demonstrate compliance with the occupational dose limits of rule 3701:1-38-12 of the Administrative Code. Each licensee or registrant shall monitor occupational exposure to radiation from sources of radiation under the control of the licensee or registrant and shall supply and require the use of individual monitoring devices by:

(a) Adults likely to receive, in one year from sources of radiation external to the body, a dose in excess of ten per cent of the limits in paragraph (A) of rule 3701:1-38-12 of the Administrative Code;

(b) Minors likely to receive, in one year, from radiation sources external to the body, a deep dose equivalent in excess of one millisievert (0.1 rem), a lens dose equivalent in excess of 1.5 millisievert (0.15 rem), or a shallow dose equivalent to the skin or to the extremities in excess of five millisievert (0.5 rem);

(c) Declared pregnant women likely to receive during the entire pregnancy, from radiation sources external to the body, a deep dose equivalent in excess of one millisievert (0.1 rem); and

(d) Individuals entering a high or very high radiation area.

(2) To determine compliance with paragraph (D) of rule 3701:1-38-12 of the Administrative Code, each licensee shall monitor the occupational intake of radioactive material by and assess the committed effective dose equivalent to:

(a) Adults likely to receive, in one year, an intake in excess of ten per cent of the applicable ALI in appendix C to rule 3701:1-38-12 of the Administrative Code;

(b) Minors likely to receive, in one year, a committed effective dose equivalent in excess of one millisievert (0.1 rem); and

(c) Declared pregnant women likely to receive, during the entire pregnancy, a committed effective dose equivalent in excess of one millisievert (0.1 rem).

(C) Each licensee or registrant shall ensure that any individual who is required to monitor occupational doses in accordance with paragraph (B)(1) of this rule wears an individual monitoring device as follows:

(1) An individual monitoring device, used for monitoring the dose to the whole body, shall be worn at the unshielded location of the whole body likely to receive the highest exposure. When a protective apron is worn, the location of the individual monitoring device is typically at the neck.

(2) An individual monitoring device, used for monitoring the dose to an embryo or fetus of a declared pregnant woman pursuant to paragraph (H) of rule 3701:1-38-12 of the Administrative Code, shall be located at the waist under any protective apron being worn by the woman.

(3) An individual monitoring device, used for monitoring the lens dose equivalent, to demonstrate compliance with paragraph (A) of rule 3701:1-38-12 of the Administrative Code, shall be located at the neck outside any protective apron being worn by the monitored individual, or at an unshielded location close to the eye.

(4) An individual monitoring device, used for monitoring the dose to the extremities, to demonstrate compliance with paragraph (A)(2) of rule 3701:1-38-12 of the Administrative Code, shall be worn on the extremity likely to receive the highest exposure. Each individual monitoring device shall be oriented to measure the highest dose to the extremity being monitored.

(5) When only one individual monitoring device is used to determine the effective dose equivalent for external radiation pursuant to paragraph (A)(4)(b) of rule 3701:1-38-12 of the Administrative Code, it shall be located at the neck outside the protective apron. When a second individual monitoring device is used for the same purpose, it shall be located under the protective apron at the waist. The second individual monitoring device is required for a declared pregnant woman.

Last updated November 2, 2022 at 2:10 PM

History

• Effective: August 30, 2015
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-38-18

(A) Except as provided in paragraph (B) of this rule, caution signs and posting requirements for licensees and registrants are as follows:

(1) The standard radiation symbol, unless otherwise authorized by the department or as provided in paragraph (A)(2) of this rule, shall use the colors magenta, purple, or black on yellow background. The symbol prescribed is the three-bladed design as follows:

(2) Notwithstanding paragraph (A)(1) of this rule, licensees and registrants are authorized to label sources, source holders, or device components containing sources of radiation that are subjected to high temperatures, with conspicuously cast, etched or stamped radiation caution symbols and without a color requirement.

(3) In addition to the contents of signs and labels prescribed in this chapter, the licensee or registrant may provide, on or near the required signs and labels, additional information, as appropriate, to make individuals aware of potential radiation exposures and to minimize the exposures.

(4) Posting of radiation areas shall be accomplished as follows:

(a) The licensee or registrant shall post each radiation area with a conspicuous sign or signs bearing the radiation symbol and the words "Caution, Radiation Area".

(b) The licensee or registrant shall post each high radiation area with a conspicuous sign or signs bearing the radiation symbol and the words "Caution, High Radiation Area" or "Danger, High Radiation Area".

(c) The licensee or registrant shall post each very high radiation area with conspicuous sign or signs bearing the radiation symbol and words "Grave Danger, Very High Radiation Area".

(d) The licensee shall post each airborne radioactivity area with a conspicuous sign or signs bearing the radiation symbol and the words "Caution, Airborne Radioactivity Area" or "Danger, Airborne Radioactivity Area".

(e) The licensee shall post each area or room in which there is an amount of licensed material used or stored which exceeds ten times the quantity of such material specified in the appendix A ofto this rule with a conspicuous sign or signs bearing the radiation symbol and the words "Caution, Radioactive Material(s)" or "Danger, Radioactive Material(s)".

(f) The licensee shall post access openings to manufacturing or process equipment (such as tanks and vessels) on or in which radiation sources are mounted, if a person could gain access to the radiation beam and receive an annual dose to any part of their body which is greater than the applicable, permissible limits for individuals in rules 3701:1-38-12 and 3701:1-38-13 of the Administrative Code. The posting must include a conspicuous sign or signs bearing the radiation symbol and warning of the hazard.

(B) The following are exceptions to posting requirements set forth in paragraph (A) of this rule:

(1) A licensee or registrant is not required to post caution signs in an area or room that contains a source of radiation provided that the source is located in the area or room for a period of less than eight hours, and the source of radiation is continuously attended to during these periods by an individual who takes the precautions necessary to prevent the exposure of individuals to sources of radiation in excess of the limits established in rule 3701:1-38-13 of the Administrative Code, and the area or room is subject to licensee or registrant control.

(2) Rooms or other areas in hospitals that are occupied by patients are not required to be posted with caution signs pursuant to paragraph (A) of this rule provided that the patient could be released from licensee control in accordance with rule 3701:1-58-30 of the Administrative Code.

(3) A room or area is not required to be posted with a caution sign because of the presence of a sealed source provided the radiation level at thirty centimeters from the surface of the sealed source container or housing does not exceed 0.05 millisievert (0.005 rem) per hour.

(4) A room or area is not required to be posted with a caution sign because of the presence of radiation-generating equipment used solely for diagnosis in the healing arts.

(5) Rooms in hospitals or clinics that are used for teletherapy are exempt from the requirement to post caution signs if access to the room is controlled pursuant to rule 3701:1-58-59 of the Administrative Code and personnel in attendance take necessary precautions to prevent the inadvertent exposure of workers, other patients, and members of the public to radiation in excess of the limits established in this chapter.

(C) Except as provided in paragraph (E) of this rule, containers shall be labeled as follows:

(1) The licensee shall ensure that each container of licensed material bears a durable, clearly visible label bearing the radiation symbol and the words "Caution, Radioactive Material" or "Danger, Radioactive Material". The label shall also provide information, such as the radionuclides present, an estimate of the quantity of radioactivity, the date for which the activity is estimated, radiation levels, kinds of materials, and mass enrichment, to permit individuals handling or using the containers, or working in the vicinity of the containers, to take precautions to avoid or minimize exposures.

(2) Prior to removal or disposal of empty uncontaminated containers to unrestricted areas, each licensee shall, remove or deface the radioactive material label or otherwise clearly indicate that the container no longer contains radioactive materials.

(D) Each registrant shall ensure that each radiation-generating equipment is labeled in a conspicuous manner which cautions individuals that radiation is produced when it is energized.

(E) A licensee is not required to label the following:

(1) Containers holding licensed material in quantities less than the quantities listed in the appendix A to this rule;

(2) Containers holding licensed material in concentrations less than those specified in table III of appendix C to rule 3701:1-38-12 of the Administrative Code;

(3) Containers attended by an individual who takes the precautions necessary to prevent the exposure of individuals in excess of the limits established by rule 3701:1-38-13 of the Administrative Code;

(4) Containers when they are in transport and packaged and labeled in accordance with the regulations of the United States department of transportation;

(5) Containers that are accessible only to individuals authorized to handle or use them, or to work in the vicinity of the containers, if the contents are identified to these individuals by a readily available written record. Examples of containers of this type are containers in locations such as water-filled canals, storage vaults, or hot cells. The record shall be retained as long as the containers are in use for the purpose indicated on the record; or

(6) Manufacturing or processing equipment such as contaminated piping and tanks, and vessels on or in which radiation sources are installed.

(F) Each licensee shall:

(1) Monitor the external surfaces of a labeled package for radioactive contamination unless the package contains only radioactive material in the form of gas or in special form as defined in rule 3701:1-38-01 of the Administrative Code;

(2) Monitor the external surfaces of a labeled package for radiation levels unless the package contains quantities of radioactive material that are less than or equal to the type A quantity; and

(3) Monitor all packages known to contain radioactive material for radioactive contamination and radiation levels if there is evidence of degradation of package integrity, such as a package that is crushed, wet, or damaged.

(4) Perform the monitoring required by this paragraph as soon as practicable after receipt of the package, but not later than three hours after the package is received at the licensee's facility, if it is received during the licensee's normal working hours. If a package is received after working hours, the package shall be monitored no later than three hours from the beginning of the next working day.

(G) Each licensee who expects to receive a package containing quantities of radioactive material in excess of a type A quantity as defined in rule 3701:1-38-01 of the Administrative Code and as provided in rule 3701:1-50-25 of the Administrative Code, shall make arrangements to receive the package when the carrier offers it for delivery or expeditiously upon receiving notification that the package is available for pick-up.

(H) The licensee shall immediately notify the final delivery carrier and the department by telephone and either telegram, mailgram, or facsimile, when:

(1) Removable radioactive surface contamination exceeds the limits as provided in 49 C.F.R. 173.443 (as published in the October 1, 2009 Code of Federal Regulationsin effect on the effective date of this rule); or

(2) External radiation levels exceed the limits as provided in 49 C.F.R. 172.403 (as published in the October 1, 2009 Code of Federal Regulationsin effect on the effective date of this rule).

(I) Each licensee shall:

(1) Establish, maintain, and retain written procedures for safely opening packages in which radioactive material is received; and

(2) Ensure that the procedures are followed and that due consideration is given to special instructions for the type of package being opened.

(J) A licensee that transfers a special form source to and from a work site in a vehicle owned or operated by the licensee is exempt from the contamination monitoring requirements of this rule, but is not exempt from the monitoring requirement in this rule for measuring radiation levels that ensures that the source is still properly lodged in its shield.

View Appendix

Last updated June 6, 2022 at 9:29 AM

History

• Effective: June 4, 2022
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-50-20 Records.

(A) Each licensee shall maintain, for a period of three years after shipment, a record of each shipment of licensed material not exempt under rule 3701:1-50-06 of the Administrative Code, showing where applicable:

(1) Identification of the packaging by model number and serial number;

(2) Verification that there are no significant defects in the packaging, as shipped;

(3) Volume and identification of coolant;

(4) Type and quantity of licensed material in each package, and the total quantity of each shipment;

(5) For each item of irradiated fissile material;

(a) Identification by model number and serial number;

(b) Irradiation and decay history to the extent appropriate to demonstrate that its nuclear and thermal characteristics comply with license conditions; and

(c) Any abnormal or unusual condition relevant to radiation safety;

(6) Date of the shipment;

(7) For fissile packages and for type B packages, any special controls exercised;

(8) Name and address of the transferee;

(9) Address to which the shipment was made; and

(10) Results of the determinations required by rule 3701:1-50-17 of the Administrative Code and by the conditions of the package approval.

(B) The licensee shall make available to the department for inspection, upon reasonable notice, all records required by this chapter. Records are only valid if stamped, initialed, or signed and dated by authorized personnel, or otherwise authenticated.

(C) The licensee shall maintain sufficient written records to furnish evidence of the quality of packaging. The records to be maintained include results of the determinations required by rule 3701:1-50-16 of the Administrative Code; design, fabrication, and assembly records; results of reviews, inspections, tests, and audits; results of monitoring work performance and materials analyses; and results of maintenance, modification, and repair activities. Inspection, test, and audit records must identify the inspector or data recorder, the type of observation, the results, the acceptability, and the action taken in connection with any deficiencies noted. These records must be retained for three years after the life of the packaging to which they apply.

Last updated November 2, 2022 at 2:44 PM

History

• Effective: April 20, 2018
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-48-11

(A) The licensee shall perform visual and operability checks on survey meters, radiographic exposure devices, transport and storage containers, associated equipment and source changers before use on each day the equipment is to be used to ensure that the equipment is in good working condition, that the sources are adequately shielded, and that required labeling is present. Survey instrument operability must be performed using check sources or other appropriate means. If equipment problems are found, the equipment must be removed from service until repaired.

(B) Each licensee shall have written procedures for:

(1) Inspection and routine maintenance of radiographic exposure devices, source changers, associated equipment, transport and storage containers, and survey instruments at intervals not to exceed three months or before the first use thereafter to ensure the proper functioning of components important to safety. Replacement components shall meet design specifications. If equipment problems are found, the equipment must be removed from service until repaired.

(2) Inspection and maintenance necessary to maintain the type B packaging used to transport radioactive materials. The inspection and maintenance program must include procedures to assure that type B packages are shipped and maintained in accordance with the certificate of compliance or other approval.

(C) Records of equipment problems and of any maintenance performed under paragraphs (A) and (B) of this rule must be made in accordance with paragraph (G) of rule 3701:1-48-23 of the Administrative Code.

Last updated November 2, 2022 at 2:38 PM

History

• Effective: October 20, 2002
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-50-26 Exemption of physicians.

Any physician licensed by a state to dispense drugs in the practice of medicine is exempt from rule 3701:1-50-05 of the Administrative Code with respect to transport by the physician of licensed material for use in the practice of medicine. However, any physician operating under this exemption must be licensed under Chapter 3701:1-58 of the Administrative Code, or equivalent regulations of the United States nuclear regulatory commission or an agreement state.

History

• Effective: February 15, 2021
• Promulgated Under: 119.03

Chapter 3701:1-52 Licensing and Safety Requirements for Irradiators

Ohio Adm.Code 3701:1-52-01 Definitions.

Terms defined in rule 3701:1-38-01 of the Administrative Code shall have the same meaning when used in this chapter except terms redefined within a given rule for use within that rule only, and additionally, as used in this chapter of the Administrative Code:

(A) "Doubly Encapsulated Sealed Source" means a sealed source in which the radioactive material is sealed within a capsule and that capsule is sealed within another capsule.

(B) "Irradiator Operator" means an individual who has successfully completed the training and testing described in rule 3701:1-52-18 of the Administrative Code and is authorized by the terms of the license to operate the irradiator without a supervisor present.

(C) "Panoramic Dry-Source-Storage Irradiator" means an irradiator in which the irradiations occur in air in areas potentially accessible to personnel and in which the sources are stored in shields made of solid materials. The term includes beam-type dry-source-storage irradiators in which only a narrow beam of radiation is produced for performing irradiations.

(D) "Panoramic Irradiator" means an irradiator in which the irradiations are done in air in areas potentially accessible to personnel. The term includes beam-type irradiators.

(E) "Panoramic Wet-Source-Storage Irradiator" means an irradiator in which the irradiations occur in air in areas potentially accessible to personnel and in which the sources are stored under water in a storage pool.

(F) "Pool Irradiator" means any irradiator at which the sources are stored or used in a pool of water including panoramic wet-source-storage irradiators and underwater irradiators.

(G) "Product Conveyor System" means a system for moving the product to be irradiated to, from, and within the area where irradiation takes place.

(H) "Radiation Room" means a shielded room in which irradiations take place. Underwater irradiators do not have radiation rooms.

(I) "Underwater Irradiator" means an irradiator in which the sources always remain shielded under water and humans do not have access to the sealed sources or the space subject to irradiation without entering the pool.

Last updated August 1, 2023 at 2:37 PM

History

• Effective: October 20, 2002
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-38-01

(A) As used in this chapter and all other rules promulgated pursuant to Chapter 3748. of the Revised Code:

(1) "A₁" means the maximum activity of special form radioactive material permitted in a type A package. These values are listed in rule 3701:1-50-25 of the Administrative Code, or may be derived in accordance with the procedure prescribed in rule 3701:1-50-25 of the Administrative Code.

(2) "A₂" means the maximum activity of radioactive material, other than special form, low specific activity and surface contaminated object material, permitted in a type A package. These values are listed in rule 3701:1-50-25 of the Administrative Code, or may be derived in accordance with the procedure prescribed in rule 3701:1-50-25 of the Administrative Code.

(3) "Absorbed dose" means the energy imparted by ionizing radiation per unit mass of irradiated material. The units of absorbed dose are the gray, or Gy, and the rad.

(4) "Accelerator or charged particle accelerator" means any of a class of radiation generating equipment designed to electronically accelerate atomic or sub-atomic particles for subsequent bombardment of targets.

(5) "Accelerator-produced radioactive material" means any material made radioactive by a particle accelerator.

(6) "Activity" means the rate of disintegration or transformation or decay of radioactive material. The units of activity are the becquerel, or Bq, and the curie, or Ci.

(7) "Address of use" means the building or buildings that are identified on the license or registration and where the source of radiation may be received, used, prepared, or stored, except for temporary job sites.

(8) "Administrative controls" means mechanisms used to protect health and minimize damage to life and property through the use of written policies, procedures, instructions, training, observation of work practices, and related compliance audits.

(9) "Administrative monetary penalty" means a monetary penalty assessed by the director under section 3748.05 of the Revised Code and in compliance with rules adopted thereunder, to emphasize the need for lasting remedial action and to deter future violations.

(10) "Adult" means an individual eighteen or more years of age.

(11) "Agreement state" means any state with which the United States nuclear regulatory commission or the atomic energy commission has entered into an effective agreement under subsection 274B of the Atomic Energy Act of 1954, 68 Stat. 919, 42 U.S.C. 2021, as amended (1978). Non-agreement state means any other state.

(12) "Airborne radioactive material" means radioactive material dispersed in the air in the form of dusts, fumes, particulates, mists, vapors, or gases.

(13) "Airborne radioactivity area" means a room, enclosure, or area in which airborne radioactive materials, composed wholly or partly of licensed material, exist in concentrations:

(a) In excess of the derived air concentrations (DACs) specified in appendix C to rule 3701:1-38-12 of the Administrative Code, or

(b) To such a degree that an individual present in the area without respiratory protective equipment could exceed, during the hours an individual is present in a week, an intake of 0.6 per cent of the annual limit on intake or twelve DAC-hours.

(14) "Air-purifying respirator" means a respirator with an air-purifying filter, cartridge, or canister that removes specific air contaminants by passing ambient air through the air-purifying element.

(15) "ALARA" or "as low as is reasonably achievable" means every reasonable effort to maintain exposures to radiation as far below the dose limits as is practical consistent with the purpose for which the licensed or registered activity is undertaken, taking into account the state of technology, the economics of improvements in relation to benefits to the public health and safety, and other societal and socioeconomic considerations, and in relation to utilization of nuclear energy and licensed materials and registered activities in the public interest.

(16) "Alert" means events may occur, are in progress, or have occurred that could lead to a release of radioactive material but that the release is not expected to require a response by off-site response organizations to protect persons off-site.

(17) "Annual limit on intake" or "ALI" means the derived limit for the amount of radioactive material taken into the body of an adult worker by inhalation or ingestion in a year. ALI is the smaller value of intake of a given radionuclide in a year by the reference man that would result in a committed effective dose equivalent of 0.05 sievert (five rem) or a committed dose equivalent of 0.5 sievert (fifty rem) to any individual organ or tissue. ALI values for intake by ingestion and by inhalation of selected radionuclides are given in appendix C to rule 3701:1-38-12 of the Administrative Code.

(18) "Annually" means either

(a) At intervals not to exceed one year; or

(b) Once per year, at about the same time each year, plus or minus one month.

(19) "Area of use" means a portion of an address of use that has been set aside for the purpose of receiving, preparing, using, or storing sources of radiation.

(20) "Assigned protection factor" or "APF" means the expected workplace level of respiratory protection that would be provided by a properly functioning respirator or a class of respirators to properly fitted and trained users. Operationally, the inhaled concentration can be estimated by dividing the ambient airborne concentration by the APF.

(21) "Atmosphere-supplying respirator" means a respirator that supplies the respirator user with breathing air from a source independent of the ambient atmosphere, and includes supplied air respirators, or SARs, and self-contained breathing apparatus, or SCBA, units.

(22) "Atomic energy commission" or "AEC" means the federal agency created by the Atomic Energy Act of 1954, 68 Stat. 919, 42 U.S.C. 2011, as amended (1964), and was the predecessor agency to the current United States nuclear regulatory commission.

(23) "Background radiation" means radiation from cosmic sources; naturally occurring radioactive materials, including radon, except as a decay product of source or special nuclear material, and global fallout as it exists in the environment from the testing of nuclear explosive devices or from past nuclear accidents such as Chernobyl that contribute to background radiation and are not under the control of the licensee. "Background radiation" does not include radiation from radioactive materials regulated by the department.

(24) "Becquerel" or "Bq" means the SI unit of activity. One becquerel is equal to one disintegration per second.

(25) "Bioassay" or "radiobioassay" means the determination of kinds, quantities or concentrations, and, in some cases, the locations of radioactive material in the human body, whether by direct measurement, in vivo counting, or by analysis and evaluation of materials excreted or removed from the human body.

(26) "Byproduct material" means

(a) Any radioactive material, except special nuclear material, yielded in or made radioactive by exposure to the radiation incident to the process of producing or utilizing special nuclear materials; or

(b) The tailings or wastes produced by the extraction or concentration of uranium or thorium from any ore processed primarily for its source material content, including discrete surface wastes resulting from solution extraction processes. Underground ore bodies depleted by such solution extraction do not constitute byproduct material within the definition.

(27) "Chelating agent" means a chemical compound or mixture that enhances the removal of radioactive material from the body, water or similar applications. Typical chelating agents include amine polycarboxylic acids such as EDTA or DTPA; hydroxy-carboxylic acids; and polycarboxylic acids such as citric acid, carbolic acid, and gluconic acid.

(28) "Chiropractor" means an individual licensed by the state of Ohio to practice chiropractic medicine pursuant to Chapter 4734. of the Revised Code.

(29) "Class" or "lung class" or "inhalation class" means a classification scheme for inhaled material according to its rate of clearance from the pulmonary region of the lung. Materials are classified as D, W, or Y, which applies to a range of clearance half-times: for class D, days, of less than ten days, for class W, weeks, from ten to one hundred days, and for class Y, years, of greater than one hundred days.

(30) "Collective dose" means the sum of the individual doses received in a given period of time by a specified population from exposure to a specified source of radiation.

(31) "Commencement of construction" means taking any action defined as "construction" or any other activity at the site of a facility subject to the rules promulgated pursuant to Chapter 3748. of the Revised Code that has a reasonable nexus to radiological health and safety.

(32) "Committed dose equivalent" or "H_T,50" means the dose equivalent to organs or tissues of reference, T, that will be received from an intake of radioactive material by an individual during the fifty year period following the intake.

(33) "Committed effective dose equivalent" or "H_E,50" means the sum of the products of the weighting factors applicable to each of the body organs or tissues, W_T, that are irradiated and the committed dose equivalent to each of these organs or tissues (H_{E, 50} = W_TH_T,50).

(34) "Consortium" means an association of medical use licensees and a PET radionuclide production facility in the same geographical area that jointly own or share in the operation and maintenance cost of the PET radionuclide production facility that produces PET radionuclides for use in producing radioactive drugs within the consortium for noncommercial distributions among its associated members for medical use. The PET radionuclide production facility within the consortium must be located at an educational institution or a medical facility.

(35) "Constraint" or "dose constraint" means a value above which specified licensee actions are required.

(36) "Construction" means the installation of foundations, or in-place assembly, erection, fabrication, or testing for any structure, system, or component of a facility or activity subject to the rules promulgated pursuant to Chapter 3748. of the Revised Code that are related to radiological safety or security. The term "construction" does not include:

(a) Changes for temporary use of the land for public recreational purposes;

(b) Site exploration, including necessary borings to determine foundation conditions or other preconstruction monitoring to establish background information related to the suitability of the site, the environmental impacts of construction or operation, or the protection of environmental values;

(c) Preparation of the site for construction of the facility, including clearing of the site, grading, installation of drainage, erosion and other environmental mitigation measures, and construction of temporary roads and borrow areas;

(d) Erection of fences and other access control measures that are not related to the safe use of, or security of, radiological materials subject to the rules promulgated pursuant to Chapter 3748. of the Revised Code;

(e) Excavation;

(f) Erection of support buildings (e.g. construction equipment storage sheds, warehouse and shop facilities, utilities, concrete mixing plants, docking and unloading facilities, and office buildings) for use in connection with the construction of the facility;

(g) Building of service facilities (e.g. paved roads, parking lots, railroad spurs, exterior utility and lighting systems, potable water systems, sanitary sewerage treatment facilities, and transmission lines);

(h) Procurement or fabrication of components or portions of the proposed facility occurring at other than the final, in-place location at the facility; or

(i) Taking any other action that has no reasonable nexus to radiological health and safety.

(37) "Controlled area" means an area, outside of a restricted area but inside the site boundary, access to which can be limited by the licensee or registrant for any reason.

(38) "Critical group" means the group of individuals reasonably expected to receive the greatest exposure to residual radioactivity for any applicable set of circumstances.

(39) "Curie" or "Ci" means a unit of activity. One curie equals 3.7 x 10¹⁰ disintegrations per second equals 3.7 x 10¹⁰ becquerels equals 2.22 x 10¹² disintegrations per minute.

(40) "Cyclotron" means a particle accelerator in which the charged particles travel in an outward spiral or circular path. A cyclotron accelerates charged particles at energies usually in excess of ten megaelectron volts and is commonly used for production of short half-life radionuclides for medical use.

(41) "Declared pregnant woman" means a woman who has voluntarily informed the licensee or registrant, in writing, of her pregnancy and the estimated date of conception. The declaration remains in effect until the declared pregnant woman withdraws the declaration in writing or is no longer pregnant.

(42) "Decommission" means to safely remove any licensed operation from service and reduce residual radioactivity to a level that permits release of the licensee's property for unrestricted use and termination of the license.

(43) "Dedicated check source" means a radioactive source that is used to assure the consistent performance of a radiation detection or measurement device over several months or years.

(44) "Deep dose equivalent" or "H_d" applies to external whole body exposure, and means the dose equivalent at a tissue depth of one centimeter, one thousand milligram per square centimeter.

(45) "Demand respirator" means an atmosphere-supplying respirator that admits breathing air to the facepiece only when a negative pressure is created inside the facepiece by inhalation.

(46) "Dentist" means an individual licensed by the state of Ohio to practice dentistry under Chapter 4715. of the Revised Code.

(47) "Department" means the Ohio department of health.

(48) "Depleted uranium" means uranium containing less uranium-235 than the naturally occurring distribution of uranium isotopes.

(49) "Derived air concentration" or "DAC" means the concentration of a given radionuclide in air which, if breathed by the reference man for a working year of two thousand hours under conditions of light work, results in an intake of one ALI. The condition of light work is inhaling 1.2 cubic meters of air per hour for two thousand hours in a year. DAC values are given in appendix C to rule 3701:1-38-12 of the Administrative Code.

(50) "Derived air concentration-hour or DAC-hour" means the product of the concentration of radioactive material in air, which is expressed as a fraction or multiple of the derived air concentration for each radionuclide, and the time of exposure to that radionuclide, in hours. A licensee or registrant may take two thousand DAC-hours to represent one ALI, equivalent to a committed effective dose equivalent of 0.05 Sv (five rem).

(51) "Direct reading dosimeter" means a device that measures radiation dose that does not require another device to read the measured radiation dose. Examples of direct reading dosimeters include pocket dosimeters and electronic dosimeters.

(52) "Director" means the director of health or a designee or authorized representative of the director.

(53) "Discipline" means a branch of knowledge or of teaching.

(54) "Discrete source" means a radionuclide that has been processed so that its concentration within a material has been purposely increased for use for commercial, medical, or research activities.

(55) "Disposable respirator" means a respirator for which maintenance is not intended and that is designed to be discarded after excessive breathing resistance, sorbent exhaustion, physical damage, or end-of service-life renders it unsuitable for use. Examples of this type of respirator are a disposable half-mask respirator or a disposable escape-only self-contained breathing apparatus.

(56) "Dose" or "radiation dose" is a generic term that means absorbed dose, dose equivalent, effective dose equivalent, committed effective dose equivalent, or total effective dose equivalent as defined in other paragraphs of this rule.

(57) "Dose equivalent" or "H_T" means the product of the absorbed dose in tissue, quality factor, and all other necessary modifying factors at the location of interest. The units of dose equivalent are the sievert and rem.

(58) "Dose limits" or "limits" means the permissible upper bounds of radiation doses established in accordance with these regulations but excludes background radiation and medical exposure.

(59) "Dosimetry processor" means a person that processes and evaluates individual monitoring devices in order to determine the radiation dose delivered to the monitoring devices.

(60) "Effective dose equivalent" or "H_E" means the sum of the products of the dose equivalent to each organ or tissue, H_T, and the weighting factor, W_T, applicable to each of the body organs or tissues that are irradiated: (H_E = ∑W_TH_T).

(61) "Embryo" or "fetus" means the developing human organism from conception until time of birth.

(62) "Engineering controls" means mechanisms used to protect health and minimize damage to life and property through engineering specifications, design, and construction of the product or facility including all of the security and safety features. This includes, but is not limited to, auxiliary security and safety features such as additional external shielding, barriers, and operational interlocks with associated processes.

(63) "Entrance" or "access point" means any opening through which an individual or extremity of an individual could gain access to radiation areas or to licensed radioactive materials or registered radiation generating equipment. This includes entry or exit portals of sufficient size to permit human entry, irrespective of their intended use.

(64) "Explosive material" means any chemical compound, mixture or device which produces a substantial instantaneous release of gas and heat spontaneously or by contact with sparks or flame.

(65) "Exposure" means being exposed to sources of ionizing radiation.

(66) "External dose" means that portion of the dose equivalent received from radiation sources outside the body.

(67) "Extremity" means hand, elbow, arm below the elbow, foot, knee, or leg below the knee.

(68) "Eye dose equivalent" means the same as lens dose equivalent.

(69) "Facility" means all buildings, equipment, structures and other stationary items that, in addition to the meaning defined in division (H) of section 3748.01 of the Revised Code, are:

(a) Located on a single site or on contiguous or adjacent sites and are operated by the same person and have common corporate or business interests; or

(b) Portions of a building or structure which are operated by the same person and have common corporate or business interests.

(70) "Filtering facepiece" or "dust mask" means a negative pressure particulate respirator with a filter as an integral part of the facepiece or with the entire facepiece composed of the filtering medium, not equipped with elastomeric sealing surfaces and adjustable straps.

(71) "Fissile material" means the radionuclides uranium-233, uranium-235, plutonium-239, and plutonium-241, or any combination of these radionuclides. Fissile material means the fissile nuclides themselves, not material containing fissile nuclides. Unirradiated natural uranium and depleted uranium and natural uranium or depleted uranium that has been irradiated in thermal reactors only, are not included in this definition. Certain exclusions from fissile material controls are provided in rule 3701:1-50-13 of the Administrative Code.

(72) "Fit factor" means quantitative estimate of the fit of a particular respirator to a specific individual, and typically estimates the ratio of the concentration of a substance in ambient air to its concentration inside the respirator when worn.

(73) "Fit test" means the use of a protocol to qualitatively or quantitatively evaluate the fit of a respirator on an individual.

(74) "Generally applicable environmental radiation standards" means standards issued by the United States environmental protection agency under the authority of the Atomic Energy Act of 1954, 68 Stat. 919, 42 U.S.C. 2011, as amended (2005), that impose limits on radiation exposures or levels, or concentrations or quantities of radioactive material, in the general environment outside the boundaries of locations under the control of persons possessing or using radioactive material.

(75) "Gray" or "Gy" means the SI unit of absorbed dose. One gray is equal to an absorbed dose of one joule per kilogram (one hundred rads).

(76) "Handle" means receive, possess, use, store, transfer, install, service, or dispose of sources of radiation unless possession is solely for the purpose of transportation.

(77) "Handler" means a facility that handles sources of radiation unless possession is solely for the purpose of transportation.

(78) "Hazardous waste" means those wastes designated as hazardous by rule 3745-51-03 of the Administrative Code.

(79) "Helmet" means a rigid respiratory inlet covering that also provides head protection against impact and penetration.

(80) "High radiation area" means an area, accessible to individuals, in which radiation levels from radiation sources external to the body could result in an individual receiving a dose equivalent in excess of one millisievert (0.1 rem) in one hour at thirty centimeters from the radiation source or thirty centimeters from any surface that the radiation penetrates.

(81) "Hood" means a respiratory inlet covering that completely covers the head and neck and may also cover portions of the shoulders and torso.

(82) "Individual" means any human being.

(83) "Individual monitoring" means

(a) The assessment of dose equivalent by the use of devices designed to be worn by an individual;

(b) The assessment of committed effective dose equivalent by bioassay or by determination of the time-weighted air concentrations to which an individual has been exposed, i.e. DAC-hours; or

(c) The assessment of dose equivalent by the use of survey data.

(84) "Individual monitoring devices" means devices designed to be worn by a single individual for the assessment of dose equivalent such as film badges; thermoluminescent dosimeters; optically stimulated luminescent dosimeters; pocket ionization chambers; and personal air sampling devices.

(85) "Industrial radiography" means the examination of the structure of materials by nondestructive methods, utilizing sealed sources of radioactive material or radiation-generating equipment.

(86) "Internal dose" means that portion of the dose equivalent received from radioactive material taken into the body.

(87) "Irradiator" means a facility that uses radioactive sealed sources for the irradiation of objects or materials and in which radiation dose rates exceeding five grays (five hundred rads) per hour exist at one meter from the sealed radioactive source in air or water, as applicable for the irradiator type, but does not include irradiators in which both the sealed source and the area subject to irradiation are contained within a device and are not accessible to personnel.

(88) "Lens dose equivalent" or "eye dose equivalent" means the external exposure of the lens of the eye and is taken as the dose equivalent at a tissue depth of 0.3 centimeters; i.e. three hundred milligrams per square centimeter.

(89) "License" means a license issued by the nuclear regulatory commission, the director, or another agreement state in accordance with rules adopted by those organizations.

(90) "Licensee" means a person to whom a license is issued.

(91) "Licensed activity" means an activity authorized by a radioactive material license which is essential to achieving the purpose for which the license was issued or amended.

(92) "Licensed material" means radioactive material received, possessed, used, transferred or disposed of under a general or specific license.

(93) "Loose-fitting facepiece" means a respiratory inlet covering that is designed to form a partial seal with the face.

(94) "Lost or missing licensed source of radiation" means a licensed source of radiation whose location is unknown. It includes material that has been shipped but has not reached its destination and whose location cannot be readily traced in the transportation system.

(95) "Low-level radioactive waste" or "LLRW," also "low-level waste," or "LLW" means radioactive waste which is not high-level radioactive waste, spent nuclear fuel, NARM, or byproduct material as defined in section 11 E. (2) of the Atomic Energy Act of 1954 68 Stat. 919, 42 U.S.C. 2011, as amended (2005), but is radioactive material that the United States nuclear regulatory commission classifies as low-level radioactive waste.

(96) "Low specific activity material" or "LSA" means radioactive material with limited specific activity which is nonfissile or is excepted under rule 3701:1-50-13 of the Administrative Code, and which satisfies the descriptions and limits set forth below. Shielding materials surrounding the LSA material may not be considered in determining the estimated average specific activity of the package contents. LSA must be in one of three groups:

(a) LSA - I.

(i) Uranium and thorium ores, concentrates of uranium and thorium ores, and other ores containing naturally occurring radioactive radionuclides that are intended to be processed for the use of these radionuclides;

(ii) Natural uranium, depleted uranium, natural thorium or their compounds or mixtures, provided they are unirradiated and in solid or liquid form;

(iii) Radioactive material other than fissile material, for which the A₂ value is unlimited; or

(iv) Other radioactive material in which the activity is distributed throughout and the estimated average specific activity does not exceed thirty times the value for exempt material activity concentration determined in accordance with rule 3701:1-50-25 of the Administrative Code.

(b) LSA-II.

(i) Water with tritium concentration up to 0.8 terabecquerels per liter (twenty curies per liter); or

(ii) Other material in which the activity is distributed throughout and the estimated average specific activity does not exceed ( 10^-4 A₂) per gram for solids and gases, and (10^-5 A₂) per gram for liquids.

(c) LSA-III. Solids (e.g., consolidated wastes, activated materials), excluding powders, that satisfy the requirements of 10 C.F.R. 71.77 (as in effect on the effective date of this rule), in which:

(i) The radioactive material is distributed throughout a solid or a collection of solid objects, or is essentially uniformly distributed in a solid compact binding agent (such as concrete, bitumen, ceramic, etc.);

(ii) The radioactive material is relatively insoluble, or it is intrinsically contained in a relatively insoluble material, so that even under loss of packaging, the loss of radioactive material per package by leaching, when placed in water for seven days, would not exceed (0.1 x A₂); and

(iii) The estimated average specific activity of the solid, excluding any shielding material, does not exceed (0.002 x A₂) per gram.

(97) "Management" means the chief executive officer or other individual having the authority to manage, direct, or administer the licensee's activities, or those persons' delegate or delegates.

(98) "Medical institution" means an organization in which more than one medical discipline is practiced.

(99) "Medical use" means the intentional internal or external administration of radioactive material or the radiation therefrom to patients or human research subjects under the supervision of an authorized user.

(100) "Member of the public" means any individual except when that individual is receiving an occupational dose.

(101) "Minor" means an individual less than eighteen years of age.

(102) "Monitoring" or "radiation monitoring" or "radiation protection monitoring" means the measurement of radiation levels, concentrations, surface area concentrations or quantities of radioactive material and the use of the results of these measurements to evaluate potential exposures and doses.

(103) "NARM" or "naturally occurring or accelerator-produced radioactive material" means naturally occurring or accelerator-produced radioactive material, including naturally occurring material that is technologically enhanced, and those nuclides that are generated in a charged particle accelerator, but does not include source material, byproduct material, or special nuclear material.

(104) "NARM licensing state" means any state with regulations equivalent to the suggested state regulations for control of radiation relating to, and an effective program for, the regulatory control of NARM and which has been granted final designation by the conference of radiation control program directors, inc.

(105) "Nationally tracked source" means a sealed source containing a quantity equal to or greater than "Category 1" or "Category 2" levels of any radioactive material listed in the appendix to rule 3701:1-38-25 of the Administrative Code. In this context a sealed source is defined as radioactive material that is sealed in a capsule or closely bonded, in a solid form and which is not exempt from regulatory control. It does not mean material encapsulated solely for disposal, or nuclear material contained in any fuel assembly, subassembly, fuel rod, or fuel pellet. "Category 1" nationally tracked sources are those containing radioactive material at a quantity equal to or greater than the "Category 1" threshold. "Category 2" nationally tracked sources are those containing radioactive material at a quantity equal to or greater than the "Category 2" threshold but less than the "Category 1" threshold.

(106) "Negative pressure respirator" or "tight fitting respirator" means a respirator in which the air pressure inside the facepiece is negative during inhalation with respect to the ambient air pressure outside the respirator.

(107) "Nonstochastic effect" or "deterministic effect" means health effects, the severity of which varies with the dose and for which a threshold is believed to exist. Radiation-induced cataract formation is an example of a nonstochastic effect.

(108) "NORM" or "naturally occurring radioactive material" means any nuclide that is radioactive in its natural physical state, but does not include source material, byproduct material, or special nuclear material.

(109) "Normal form radioactive material" means radioactive material that has not been demonstrated to qualify as special form radioactive material.

(110) "Nuclear regulatory commission" means the federal agency established by Title II of the Energy Reorganization Act of 1974, 88 Stat. 1233, 42 U.S.C.A. 5801, as amended (2005), comprising the members of the commission and all offices, employees, and representatives authorized to act in any case or matter related to licensing and related regulatory function previously assigned to the AEC.

(111) "Occupational dose" means the dose received by an individual in the course of employment in which the individual's assigned duties involve exposure to radiation or radioactive material from licensed and unlicensed sources of radiation, whether in the possession of the licensee or other person. Occupational dose does not include doses received from background radiation, from any medical administration the individual has received, from exposures to individuals administered radioactive materials and released in accordance with rule 3701:1-58-30 of the Administrative Code or equivalent United States nuclear regulatory commission or agreement state regulations, from voluntary participation in medical research programs, or as a member of the public.

(112) "Package" means the packaging together with its radioactive contents as presented for transport.

(a) Fissile material package or type AF package, type BF package, type B(U)F package, or type B(M)F package means a fissile material packaging together with its fissile material contents.

(b) Type A package means a type A packaging together with its radioactive contents. A type A package is defined and must comply with the United States department of transportation regulations in 49 C.F.R. 173 (as in effect on the effective date of this rule).

(c) Type B package means a type B packaging together with its radioactive contents. On approval, a type B package design is designated by the United States nuclear regulatory commission as B(U) unless the package has a maximum normal operating pressure of more than seven hundred kilopascals (one hundred pounds per square inch) gauge or a pressure relief device that would allow the release of radioactive material to the environment under the tests specified in 10 C.F.R. 71.73 (hypothetical accident conditions) (as in effect on the effective date of this rule), in which case it will receive a designation B(M). B(U) refers to the need for unilateral approval of international shipments; B(M) refers to the need for multilateral approval of international shipments. There is no distinction made in how packages with these designations may be used in domestic transportation. To determine their distinction for international transportation, see United States department of transportation regulations in 49 C.F.R. 173 (as in effect on the effective date of this rule). A type B package approved before September 6, 1983, was designated only as type B. Limitations on its use are specified in 10 C.F.R. 71.19 (as in effect on the effective date of this rule).

(113) "Packaging" means the assembly of components necessary to ensure compliance with the packaging requirements of rule 49 C.F.R. 173 Subpart I (as in effect on the effective date of this rule). It may consist of one or more receptacles, absorbent materials, spacing structures, thermal insulation, radiation shielding, and devices for cooling or absorbing mechanical shocks. The vehicle, tie-down system and auxiliary equipment may be designated as part of the packaging.

(114) "Particle accelerator" means any machine capable of accelerating electrons, protons, deuterons, or other charged particles in a vacuum and of discharging the resultant particulate or other radiation into a medium at energies usually in excess of one megaelectron volt. For purposes of this definition, "accelerator" is an equivalent term.

(115) "Person" means any individual, corporation, association, business enterprise, or other legal entity either public or private and any legal successor, representative, agent, or agency of that individual, corporation, association, business enterprise, or other legal entity. Person also includes the United States, states, political subdivisions of states, and any department, agency, or instrumentality of the United States or a state, except the U.S. department of energy or the U.S. nuclear regulatory commission where the state regulation of radioactive material by either of those agencies is prohibited by federal law.

(116) "Personnel dosimeter", means a device that measures radiation dose that is processed and evaluated by an accredited "National Voluntary Laboratory Accreditation Program" (NVLAP) processor. Examples of personnel dosimeters include film badges, thermo-luminescent dosimeters (TLD), and optically stimulated luminescence (OSL) dosimeters.

(117) "Pharmacist" means a person who is licensed by the state of Ohio to practice pharmacy pursuant to Chapter 4731. of the Revised Code.

(118) "Physician" means a person who is licensed pursuant to Chapter 4731. of the Revised Code to practice medicine or surgery or osteopathic medicine or surgery.

(119) "Planned special exposure" means an infrequent exposure to radiation, separate from and in addition to the annual dose limits.

(120) "Podiatrist" means an individual licensed by the state of Ohio to practice podiatry pursuant to Chapter 4731. of the Revised Code.

(121) "Positive pressure respirator" means a respirator in which the pressure inside the respiratory inlet covering exceeds the ambient air pressure outside the respirator.

(122) "Positron Emission Tomography (PET) radionuclide production facility" means a facility operating a cyclotron or accelerator for the purpose of producing PET radionuclides.

(123) "Powered air-purifying respirator" or "PAPR" means an air-purifying respirator that uses a blower to force the ambient air through air purifying elements to the inlet covering.

(124) "Pressure demand respirator" means a positive pressure atmosphere supplying respirator that admits breathing air to the facepiece when the positive pressure is reduced inside the facepiece by inhalation.

(125) "Public dose" means the dose received by a member of the public from exposure to radiation and/or radioactive material released by the licensee, or to any other source of radiation under the control of a licensee or registrant. Public dose does not include occupational dose or doses received from background radiation, from any medical administration the individual has received, from exposures to individuals administered radioactive materials and released in accordance with rule 3701:1-58-30 of the Administrative Code or equivalent United States nuclear regulatory commission or agreement state regulations, or from voluntary participation in medical research programs.

(126) "Pyrophoric material" means any liquid that ignites spontaneously in dry or moist air at or below 54.4 degrees celsius (one hundred thirty degrees fahrenheit). A pyrophoric solid is any solid material, other than one classed as an explosive, which under normal conditions is liable to cause fires through friction, retained heat from manufacturing or processing, or which can be ignited readily and when ignited burns so vigorously and persistently as to create a serious transportation, handling, or disposal hazard. Included are spontaneously combustible and water-reactive materials.

(127) "Qualitative fit test" or "QLFT" means a pass/fail fit test to assess the adequacy of respirator fit that relies on the individual's response to the test agent.

(128) "Quality factor" or "Q" means the modifying factor, as listed in paragraphs (A) and (B) of rule 3701:1-38-11 of the Administrative Code, that is used to derive dose equivalent from absorbed dose.

(129) "Quantitative fit test" or "QNFT" means an assessment of the adequacy of respirator fit by numerically measuring the amount of leakage into the respirator.

(130) "Quarter" or "quarterly" means a period of time equal to one-fourth of the year observed by the licensee or registrant, approximately thirteen consecutive weeks, providing that the beginning of the first quarter in a year coincides with the starting date of the year and that no day is omitted or duplicated in consecutive quarters.

(131) "Rad" means the special unit of radiation absorbed dose. One rad is equal to an absorbed dose of one hundred ergs per gram, or 0.01 joule per kilogram, or 0.01 gray.

(132) "Radiation" or "ionizing radiation" means alpha particles, beta particles, gamma rays, x-rays, neutrons, high speed electrons, high speed protons, and other particles capable of producing ions. Radiation does not include nonionizing radiation, such as radio or microwaves, or visible, infrared or ultraviolet light.

(133) "Radiation area" means an area, accessible to individuals, in which radiation levels could result in an individual receiving a dose equivalent in excess of 0.05 millisievert (0.005 rem) in one hour at thirty centimeters from the source of radiation or from any surface that the radiation penetrates.

(134) "Radiation-generating equipment" or "RGE" means any manufactured product or device, or component of such a product or device, or any machine or system that during operation can generate or emit radiation, except those that emit radiation only from radioactive material. "Radiation-generating equipment" does not include either of the following:

(a) Diathermy machines;

(b) Microwave ovens, including food service microwave ovens used for commercial and industrial uses, television receivers, electric lamps, and other household appliances and products that generate very low levels of radiation.

(135) "Radiation Safety Officer" or "RSO" means an individual designated by the licensee who has the knowledge and responsibility for the overall radiation safety program at the facility, to include the implementation of the daily radiation safety operations and compliance with the rules.

(136) "Radioactive material" means any solid, liquid or gaseous material that emits ionizing radiation spontaneously. "Radioactive material" includes accelerator-produced and naturally occurring radioactive materials and byproduct, source, and special nuclear material.

(137) "Radioactive waste" means waste containing regulated radioactive material.

(138) "Radioactivity" means the transformation of unstable atoms by the emission of radiation.

(139) "Radiography" means the same as industrial radiography.

(140) "Reference man" means a hypothetical aggregation of human physical and physiological characteristics arrived at by international consensus. These characteristics may be used by researchers and public health workers to standardize results of experiments and to relate biological insult to a common base.

(141) "Registrant" means a person required by Chapter 3748. of the Revised Code to register radiation-generating equipment with the director.

(142) "Rem" means the special unit of any of the quantities expressed as dose equivalent. The dose equivalent in rem is equal to the absorbed dose in rads multiplied by the quality factor (one rem = 0.01 Sv).

(143) "Research and development" means

(a) Theoretical analysis, exploration, or experimentation; or

(b) The extension of investigative findings and theories of a scientific or technical nature into practical application for experimental and demonstration purposes, including the experimental production and testing of models, devices, equipment, materials and processes. "Research and development" does not include the internal or external administration of sources of radiation to human beings.

(144) "Residual radioactivity" means radioactivity in structures, materials, soils, groundwater, and other media at a site resulting from activities under the licensee's control. This includes radioactivity from all licensed and unlicensed sources used by the licensee, but excludes background radiation. It also includes radioactive materials remaining at the site as a result of routine or accidental releases of radioactive material at the site and previous burials at the site, even if those burials were made in accordance with the provisions of 10 C.F.R. 20 (as in effect on the effective date of this rule).

(145) "Respiratory protective equipment or device" means an apparatus, such as a respirator, used to reduce the individual's intake of airborne radioactive materials.

(146) "Restricted area" means an area access to which is limited by the licensee or registrant for the purpose of protecting individuals against undue risks from exposure to sources of radiation. Restricted area does not include areas used as residential quarters, but separate rooms in a residential building may be set apart as a restricted area.

(147) "Roentgen" means the amount of gamma or x-rays required to produce ions resulting in a charge of 0.000258 coulombs per kilogram of air under standard conditions.

(148) "Sanitary sewerage" means a system of public sewers for carrying off wastewater and refuse, but excluding sewage treatment facilities, septic tanks, and leach fields owned or operated by the licensee.

(149) "Sealed source" means radioactive material that is encased in a manner designed to prevent leakage or escape of the radioactive material.

(150) "Sealed source and device registry" means the national registry that contains all the registration certificates, generated by both the United States nuclear regulatory commission and the agreement states, that summarize the radiation safety information for the sealed sources and devices and describe the licensing and use conditions approved for the product.

(151) "Seismic area" means any area where the probability of a horizontal acceleration in rock of more than 0.3 times the acceleration of gravity in two hundred fifty years is greater than ten per cent, as designated by the United States geological survey.

(152) "Self-contained breathing apparatus" or "SCBA" means an atmosphere-supplying respirator for which the breathing air source is designed to be carried by the user.

(153) "Shallow dose equivalent" or "H_S" means the external exposure of the skin of the whole body or the skin of an extremity, is taken as the dose equivalent at a tissue depth of 0.007 centimeter, or seven milligrams per square centimeter.

(154) "Sievert" or "Sv" means the SI unit of any of the quantities expressed as dose equivalent. The dose equivalent in sieverts is equal to the absorbed dose in grays multiplied by the quality factor. One sievert equals one hundred rem.

(155) "Site area emergency" means events may occur, are in progress, or have occurred that could lead to a significant release of radioactive material and that could require a response by off-site response organizations to protect persons off-site.

(156) "Site boundary" means that line beyond which the land or property is not owned, leased, or otherwise controlled by the licensee or registrant.

(157) "Site closure and stabilization" means those actions that are taken upon completion of operations that prepare a disposal site for custodial care and that assure that the disposal site will remain stable and will not need ongoing active maintenance.

(158) "Source material" means uranium, thorium, or any combination thereof in any physical or chemical form, or any ores that contain by weight at least one-twentieth of one per cent (0.05 per cent) of uranium, thorium, or any combination thereof. Source material does not include special nuclear material.

(159) "Sources of radiation" means radioactive material or radiation generating equipment.

(160) "Special form radioactive material" means radioactive material that satisfies the following conditions:

(a) It is either a single solid piece or is contained in a sealed capsule that can be opened only by destroying the capsule;

(b) The piece or capsule has at least one dimension not less than five millimeters (0.2 inch); and

(c) It satisfies the test requirements specified by the United States nuclear regulatory commission in 10 C.F.R. 71.75 (as in effect on the effective date of this rule). A special form encapsulation designed in accordance with the United States nuclear regulatory commission requirements identified in 10 C.F.R. 71.4, in effect on June 30, 1983, and constructed prior to July 1, 1985; a special form encapsulation designed in accordance with the requirements of 10 C.F.R. 71.4 in effect on March 31, 1996, and constructed before April 1, 1998; and special form material that was successfully tested before September 10, 2015 in accordance with the requirements of 10 C.F.R. 71.75(d) of this section in effect before September 10, 2015 may continue to be used. Any other special form encapsulation must meet the specifications of this definition.

(161) "Special nuclear material" means either of the following:

(a) Plutonium, uranium-233, uranium enriched in the isotope 233, or in the isotope 235, and any other material that the United States nuclear regulatory commission determines to be special nuclear material, but does not include source material pursuant to section 51 of the Atomic Energy Act of 1954, 68 Stat 919, 42 USCA 2071, as amended (2005).

(b) Any material artificially enriched by any of the foregoing but does not include source material.

(162) "Special nuclear material in quantities not sufficient to form a critical mass" means uranium enriched in the isotope uranium-235 in quantities not exceeding three hundred fifty grams of contained uranium-235; uranium-233 in quantities not exceeding two hundred grams; plutonium in quantities not exceeding two hundred grams; or any combination of them in accordance with the following formula: for each kind of special nuclear material, determine the ratio between the quantity of that special nuclear material and the quantity specified in this paragraph for the same kind of special nuclear material. The sum of such ratios for all of the kinds of special nuclear material in combination shall not exceed unity.

(163) "Stochastic effect" means health effects that occur randomly and for which the probability of the effect occurring, rather than its severity, is assumed to be a linear function of dose without threshold. Hereditary effects and cancer incidence are examples of stochastic effects.

(164) "Supplied-air respirator" or "SAR" or "airline respirator" means an atmosphere-supplying respirator for which the source of breathing air is not designed to be carried by the user.

(165) "Surface contaminated object" or "SCO" means a solid object that is not itself classed as radioactive material, but which has radioactive material distributed on any of its surfaces. SCO must be in one of two groups with surface activity not exceeding the following limits:

(a) SCO-I: a solid object on which:

(i) The non-fixed contamination on the accessible surface averaged over three hundred square centimeters, or the area of the surface if less than three hundred square centimeters, does not exceed four becquerels per square centimeter (10^-4 microcurie per square centimeter) for beta and gamma and low toxicity alpha emitters, or 0.4 becquerels per square centimeter 10^-5 microcurie per square centimeter) for all other alpha emitters;

(ii) The fixed contamination on the accessible surface averaged over three hundred square centimeters, or the area of the surface if less than three hundred square centimeters, does not exceed forty thousand becquerels per square centimeter (one microcurie per square centimeter) for beta and gamma and low toxicity alpha emitters, or four thousand becquerels per square centimeter (0.1 microcurie per square centimeter) for all other alpha emitters; and

(iii) The non-fixed contamination plus the fixed contamination on the inaccessible surface averaged over three hundred square centimeters, or the area of the surface if less than three hundred square centimeters, does not exceed forty thousand becquerels per square centimeter (one microcurie per square centimeter) for beta and gamma and low toxicity alpha emitters, or four thousand becquerels per square centimeter (0.1 microcurie per square centimeter) for all other alpha emitters.

(b) SCO-II: a solid object on which the limits for SCO-I are exceeded and on which:

(i) The non-fixed contamination on the accessible surface averaged over three hundred square centimeters, or the area of the surface if less than three hundred square centimeter, does not exceed four hundred becquerels per square centimeter (10^-2 microcurie per square centimeter) for beta and gamma and low toxicity alpha emitters, or forty becquerels per square centimeter (10^-3 microcurie per square centimeter) for all other alpha emitters;

(ii) The fixed contamination on the accessible surface averaged over three hundred square centimeters, or the area of the surface if less than three hundred square centimeters, does not exceed eight hundred thousand becquerels per square centimeter (twenty microcuries per square centimeter) for beta and gamma and low toxicity alpha emitters, or eighty thousand becquerels per square centimeter (two microcuries per square centimeter) for all other alpha emitters; and

(iii) The non-fixed contamination plus the fixed contamination on the inaccessible surface averaged over three hundred square centimeters, or the area of the surface if less than three hundred square centimeters, does not exceed eight hundred thousand becquerels per square centimeter (twenty microcuries per square centimeter) for beta and gamma and low toxicity alpha emitters, or eighty thousand becquerels per square centimeter (two microcuries per square centimeter) for all other alpha emitters.

(166) "Survey" means an evaluation of the radiological conditions and potential hazards incident to the production, use, transfer, release, disposal or presence of radioactive material or other sources of radiation. When appropriate, such an evaluation includes a physical survey of the location of radioactive material, or the sources of radiation and measurements or calculations of levels of radiation, or concentrations or quantities of radioactive material present.

(167) "Tight-fitting facepiece" means a respiratory inlet covering that forms a complete seal with the face.

(168) "Total effective dose equivalent" or "TEDE" means the sum of the effective dose equivalent (for external exposures) and the committed effective dose equivalent (for internal exposures).

(169) "Transport index" means the dimensionless number, rounded up to the next tenth, placed on the label of a package, to designate the degree of control to be exercised by the carrier during transportation. The transport index is the number determined by multiplying the maximum radiation level in millisievert per hour at one meter (3.3 feet) from the external surface of the package by one hundred, which is equivalent to the maximum radiation level in millirem per hour at one meter (3.3 feet).

(170) "Type A quantity" means a quantity of radioactive material, the aggregate radioactivity of which does not exceed A₁ for special form radioactive material, or A₂ for normal form radioactive material, where A₁ and A₂ are given in rule 3701:1-50-25 of the Administrative Code.

(171) "Type B quantity" means a quantity of radioactive material greater than a type A quantity.

(172) "Type B package" is defined under "Package."

(173) "United States department of energy" means the department of energy established by the Department of Energy Organization Act, PL 95-91, 91 Stat. 565 (1977), 42 U.S.C. 7101 et seq., as amended (2006), to the extent that the department of energy or its duly authorized representatives, exercises functions formerly vested in the United States atomic energy commission, its chairman, members, officers and components and transferred to the United States energy research and development administration and to the administrator thereof pursuant to Sections 104(b) to (d) of the Energy Reorganization Act of 1974, PL 93-438, 88 Stat. 1233 at 1237 (1974), 42 U.S.C. 5814 and retransferred to the secretary of energy pursuant to Section 301(a) of the Department of Energy Organization Act, PL 95-91, 91 Stat. 565 at 577-578 (1977), 42 U.S.C. 7151.

(174) "Unrestricted area" or "uncontrolled area" means any area, access to which is neither restricted nor controlled by the licensee or registrant.

(175) "User seal check" or "fit check" means an action conducted by the respirator user to determine if the respirator is properly seated to the face. Examples include negative pressure check, positive pressure check, irritant smoke check, or isoamyl acetate check.

(176) "Very high radiation area" means an area, accessible to individuals, in which radiation levels from radiation sources external to the body could result in an individual receiving an absorbed dose in excess of five gray (five hundred rad) in one hour at one meter from a source of radiation or from any surface that the radiation penetrates. At very high doses received at high dose rates, units of absorbed dose, gray and rad, are appropriate, rather than units of dose equivalent, sievert and rem.

(177) "Veterinarian" means an individual licensed by the state of Ohio to practice veterinary medicine pursuant to Chapter 4741. of the Revised Code.

(178) "Waste" means those low-level radioactive wastes containing source, special nuclear, or byproduct material that are acceptable for disposal in a land disposal facility. For the purposes of this definition, low-level radioactive waste means radioactive waste not classified as high-level radioactive waste, transuranic waste, spent nuclear fuel, or byproduct material as defined in paragraph (A)(26)(b) of this rule, or byproduct material as defined in section 11 E. (3) and (4) of the Atomic Energy Act of 1954, 68 Stat. 919, 42 USC 2014, as amended (2005).

(179) "Week" means seven consecutive days starting on Sunday.

(180) "Weighting factor

• W_T" for an organ or tissue, (T), is the proportion of the risk of stochastic effects resulting from irradiation of that organ or tissue to the total risk of stochastic effects when the whole body is irradiated uniformly. For calculating the effective dose equivalent, the values of W_T are:

| Organ doseweighting factors | | | --- | --- | | Organ ortissue | W_T | | Gonads | 0.25 | | Breast | 0.15 | | Red bone marrow | 0.12 | | Lung | 0.12 | | Thyroid | 0.03 | | Bonesurfaces | 0.03 | | Remainder | 0.30^a | | Whole body | 1.00^b |

^\a 0.30 results from 0.06 for each of five "remainder" organs, excluding the skin and the lens of the eye, that receive the highest doses.

^\b for the purpose of weighting the external whole body dose (for adding it to the internal dose) a single weighting factor, W_T = 1.0, has been specified. The use of other weighting factors for external exposure will be approved on a case-by-case basis until such time as specific guidance is issued.

(181) "Whole body" means for purposes of external exposure, head; trunk, including male gonads; arms above the elbow; legs above the knee.

(182) "Worker" means an individual engaged in activities licensed or registered by the department and controlled by a licensee or registrant, but does not include the licensee or registrant.

(183) "Working level" or "WL" means any combination of short-lived radon decay products (for radon-222: polonium-218, lead-214, bismuth-214, and polonium-214; and for radon-220: polonium-216, lead-212, bismuth-212, and polonium-212) in one liter of air that will result in the ultimate emission of 1.3 x 10⁵ million electron volts alpha particle energy.

(184) "Working level month" or "WLM" means a cumulative exposure to one working level for one hundred seventy hours. (Two thousand working hours per year/twelve months per year equals approximately one hundred seventy hours per month.)

(185) "Year" means the period of time beginning in January used to determine compliance with the provisions of this rule. The licensee or registrant may change the starting date of the year used to determine compliance by the licensee or registrant provided that the change is made at the beginning of the year and that no day is omitted or duplicated in consecutive years.

(B) The terms set out in paragraph (A) of this rule may be redefined in other chapters as promulgated pursuant to Chapter 3748. of the Revised Code as used in that chapter only.

Last updated May 13, 2026 at 11:20 AM

History

• Effective: January 20, 2022
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-52-18

(A) Before an individual is permitted to operate an irradiator without a supervisor present, the individual must be instructed in:

(1) The fundamentals of radiation protection applied to irradiators (including the differences between external radiation and radioactive contamination, units of radiation dose, department dose limits, why large radiation doses must be avoided, how shielding and access controls prevent large doses, how an irradiator is designed to prevent contamination, the proper use of survey meters and personnel dosimeters, other radiation safety features of an irradiator, and the basic function of the irradiator);

(2) The requirements of rules in Chapters 3701:1-38 and 3701:1-52 of the Administrative Code that are relevant to the irradiator;

(3) The operation of the irradiator;

(4) Those operating and emergency procedures listed in rule 3701:1-52-19 of the Administrative Code that the individual is responsible for performing; and

(5) Case histories of accidents or problems involving irradiators.

(B) Before an individual is permitted to operate an irradiator without a supervisor present, the individual shall pass a written test on the instruction received consisting primarily of questions based on the licensee's operating and emergency procedures that the individual is responsible for performing and other operations necessary to safely operate the irradiator without supervision.

(C) Before an individual is permitted to operate an irradiator without a supervisor present, the individual must have received on-the-job training or simulator training in the use of the irradiator as described in the license application. The individual shall also demonstrate the ability to perform those portions of the operating and emergency procedures that he or she is to perform.

(D) The licensee shall conduct safety reviews for irradiator operators at least annually. The licensee shall give each operator a brief written test on the information. Each safety review must include, to the extent appropriate, each of the following:

(1) Changes in operating and emergency procedures since the last review, if any;

(2) Changes in regulations and license conditions since the last review, if any;

(3) Reports on recent accidents, mistakes, or problems that have occurred at irradiators, if any;

(4) Relevant results of inspections of operator safety performance;

(5) Relevant results of the facility's inspection and maintenance checks; and

(6) A drill to practice an emergency or abnormal event procedure.

(E) The licensee shall evaluate the safety performance of each irradiator operator at least annually to ensure that regulations, license conditions, and operating and emergency procedures are followed. The licensee shall discuss the results of the evaluation with the operator and shall instruct the operator on how to correct any mistakes or deficiencies observed.

(F) Individuals who will be permitted unescorted access to the radiation room of the irradiator or the area around the pool of an underwater irradiator, but who have not received the training required for operators and the radiation safety officer, shall be instructed and tested in any precautions they should take to avoid radiation exposure, any procedures or parts of procedures listed in rule 3701:1-52-19 of the Administrative Code that they are expected to perform or comply with, and their proper response to alarms required in this part. Tests may be oral.

(G) Individuals who must be prepared to respond to alarms required by paragraphs (B) and (I) of rule 3701:1-52-08; paragraph (A) of 3701:1-52-10; paragraphs (A) and (B) of 3701:1-52-11; and paragraph (B) of 3701:1-52-22 of the Administrative Code, shall be trained and tested on how to respond. Each individual shall be retested at least once a year. Tests may be oral.

Last updated August 1, 2023 at 2:40 PM

History

• Effective: October 8, 2007
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-52-02 Purpose and scope.

(A) This chapter contains requirements for the issuance of a license authorizing the use of sealed sources containing radioactive materials in irradiators used to irradiate objects or materials using gamma radiation. This chapter also contains radiation safety requirements for operating irradiators. The requirements of this chapter are in addition to other requirements of Chapter 3748. of the Revised Code or any rules adopted pursuant to Chapter 3748. of the Revised Code which apply to applications and licenses pursuant to this chapter. Nothing in this chapter relieves the licensee from complying with other applicable federal, state and local regulations governing the siting, zoning, land use, and building code requirements for industrial facilities.

(B) The rules in this chapter apply to panoramic irradiators that have either dry or wet storage of the radioactive sealed sources and to underwater irradiators in which both the source and the product being irradiated are under water. Irradiators whose dose rates exceed five gray (five hundred rad) per hour at one meter from the radioactive sealed sources in air or in water, as applicable for the irradiator type, are covered by this chapter.

(C) The rules in this chapter do not apply to self-contained dry-source-storage irradiators (those in which both the source and the area subject to irradiation are contained within a device and are not accessible by personnel), medical radiology or teletherapy for human medical use, radiography (the irradiation of materials for nondestructive testing purposes), gauging, or open-field (agricultural) irradiations.

Last updated August 1, 2023 at 2:37 PM

History

• Effective: October 8, 2007
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-52-03 Application for a specific license.

A person, as defined in accordance with rule 3701:1-38-01 of the Administrative Code, may file an application for a specific license authorizing the use of sealed sources in an irradiator on an "Application for a License for Radioactive Material" form provided by the director. Each application for a license or license amendment must be submitted as prescribed in rule 3701:1-38-02 of the Administrative Code.

Last updated August 1, 2023 at 2:38 PM

History

• Effective: September 1, 2012
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-38-02

(A) As used in this rule, "facility" has the meaning defined in division (H) of section 3748.01 of the Revised Code and the following:

(1) All buildings, equipment, structures, and other stationary items that are located on a single site or on contiguous or adjacent sites and that are operated by the same person and have common corporate or business interests; and

(2) Portions of a building or structure which are operated by the same person and have common corporate or business interests.

(B) Notwithstanding the definition of "facility," the director may consider sites that are not contiguous or adjacent as one facility provided that:

(1) The sites are operated by the same person;

(2) The sites are in the same license category or categories;

(3) The applicant for a license provides for one radiation safety officer, and if applicable, one radiation safety committee, as responsible for all sites; and

(4) The director is reasonably satisfied from the information provided in the application that the applicant will adequately control radioactive material at all sites listed in the application.

(a) Unless the director has information of violations of Chapter 3748. of the Revised Code or the rules adopted thereunder at one or more sites, the director shall presume the applicant will adequately control radioactive material at all sites if the sites are located not more than twenty miles driving distance apart as documented by the licensee, and if all sites are within a twenty mile radius from the main site as designated on the license.

(b) The director shall continue to renew a license issued under this paragraph that contains all the sites listed thereon provided the licensee demonstrates continued compliance with this paragraph, Chapter 3748. of the Revised Code, and the rules adopted thereunder.

(C) Every facility that handles radioactive material in any license category as specified in appendix A to this rule for which licensure is required shall apply for a license, license amendment, or license renewal in accordance with this rule. Application for a license, license amendment, or license renewal shall be made on any format prescribed and provided by the director. Licenses shall be issued in accordance with the requirements of Chapter 3748. of the Revised Code, and the rules adopted thereunder. Except as otherwise provided in this rule, a license shall expire five years from the date of issuance.

(1) As used in this paragraph, site means an address of use listed on the license. Temporary job sites are exempted.

(a) Any individual applying for a new license with one or more additional sites or a current licensee amending a license to add one or more additional sites that are located more than twenty miles from the main site shall pay an additional site fee for each such site as follows:

(i) The additional site fee(s) shall be seventy-five percent of the applicable annual fee, as those fees are set forth in paragraphs (D), (F), and (J) of this rule.

(ii) Additional site fees will be invoiced annually with the annual fee.

(b) Broad scope licensees are exempt from paragraph (C)(1)(a) of this rule.

(2) As used in this paragraph, "service" means activities performed by a person, other than a worker as defined in rule 3701:1-38-01 of the Administrative Code, pursuant to an agreement with the facility to perform activities that deal with sources of radiation for the facility.

(a) These activities include, but are not limited to the following:

(i) Conduct leak tests;

(ii) Calibrate survey instruments;

(iii) Provide quality control tests;

(iv) Conduct surveys, characterization, and/or remediation activities;

(v) Manage the disposal of radioactive waste for other persons; or

(vi) Install sources or devices or change sources within a device.

(b) License categories affected are:

(i) 3219 - decontamination services;

(ii) 3220 - leak test service;

(iii) 3221 - instrument calibration service only - source less than 3.7 terabecquerels (one hundred curies);

(iv) 3222 - instrument calibration service only - source equal to or greater than 3.7 terabecquerels (one hundred curies);

(v) 3223 - leak test and instrument calibration - source less than 3.7 terabecquerels (one hundred curies);

(vi) 3224 - leak test and instrument calibration - source equal to or greater than 3.7 terabecquerels (one hundred curies);

(vii) 3225 - other services - including teletherapy, irradiator, and gauge service;

(viii) 3232 - waste disposal service prepackaged only;

(ix) 3233 - waste disposal service - incineration; and

(x) 3234 - waste disposal service processing and/or repackaging.

(D) A radioactive materials license issued by the department may, at the discretion of the director, have more than one license category on any one specific license. A licensee may have more than one radioactive materials license. Except as otherwise provided in paragraph (J) of this rule, the annual fee for a radioactive material license shall be in an amount in accordance with appendix A to this rule.

(1) Upon receipt of an application for a new radioactive material license, the department will issue an invoice for the appropriate fee specified in appendix A to this rule or paragraph (J) of this rule. Annual fees will be invoiced based on the month of the license expiration date and the invoice will state that the fee is due thirty days after the date of the invoice. License fees are not refundable.

(2) An applicant for a new or a renewal or amendment of a radioactive material license must submit a complete application before the director will finalize the review of the application. A complete application is one in which the applicant has provided all the information requested by the director, including any additional information requested after receipt of the application package.

(3) Upon receipt of an application for a license amendment, the department will issue an invoice for the appropriate fee for the proposed amendment as specified in appendix A to this rule. If the amendment is to change the license from operational phase to storage of sealed sources only incident to disposal of the sources, after the amendment the annual fee for the license shall be reduced to fifty per cent of the fee for the operational phase of the license, provided that the sources continue to be in safe storage and leak tested as provided by license condition for the specific sources in storage. The inspection frequency will remain the same as that for the operational phase of the license until after source disposal.

(4) The applicant for a new, or renewal or amendment of a radioactive materials license shall provide to the director all additional information requested within sixty days from the date of the information request. If the director does not receive the requested information within the stated time period, the director may consider the application abandoned. Any further consideration of a new license, or a renewal or amendment of a license shall be pursuant to another application.

(5) The director shall grant a new license, license amendment, or license renewal to any applicant who has submitted a complete application and is in compliance with Chapter 3748. of the Revised Code and the rules adopted thereunder.

(6) When an amendment to a license results in a change to a license category with a higher fee, the licensee will be charged the higher of the two amendment fees for that category. The annual fee for the licensee will escalate to the new category fee on the date of the next annual invoice.

(7) The director shall charge a fee for minor license amendments that do not require review by members of the technical staff at a rate of one hundred dollars per amendment provided that no licensee shall be required to pay more than one thousand dollars for minor amendments in any calendar year. Minor amendments include, but are not limited to, adding a new gauge of the same type already licensed unless that additional gauge increases the license or inspection fee, a corporate name change if the corporate ownership does not change, adding a user name that does not require review of education and experience, and corporate address change if the location of the use of the radioactive material does not change. Amendments to change the radiation safety officer or the chair or members of the radiation safety committee that require review of education or experience are not minor amendments.

(8) License terminations shall be handled as follows:

(a) Except as provided in paragraph (D)(8)(c) of this rule, a termination fee of five hundred dollars or fifty per cent of the annual fee, whichever is less, will be invoiced upon written request from the licensee for termination of the license. This fee is not refundable.

(b) Except as provided in paragraph (D)(8)(c) of this rule, if the termination cost, as determined by paragraph (M) of this rule, exceeds the termination fee in paragraph (D)(8)(a) of this rule, the remainder of the termination expense will be assessed at full cost.

(c) If the license termination would be covered under paragraph (D)(9) of this rule, that paragraph will be used for the termination process.

(d) The license termination process will not be completed until the licensee is in compliance with all rules, including payment of fees.

(9) Licenses, and other approvals related to the licensed activity requiring decommissioning, decontamination, reclamation, site restoration, or long-term care due to the continued presence of radioactive materials shall be charged an annual fee based on the approved decommissioning funding plan as specified in appendix B to this rule.

(a) A decommissioning plan must be approved by the department. Prior to approval of the decommissioning plan the licensee must submit an amendment requesting decommissioning. Until the amendment is approved the licensee's annualized license fee will be reduced by fifty per cent. After approval of the amendment containing the decommissioning plan, the licensee will be invoiced at the annual fee specified in appendix B to this rule.

(b) The annual fee specified in appendix B to this rule is based on the cost of decommissioning. The fee is payable within thirty days of mailing of an invoice by the department.

(c) Routine decommissioning oversight by the department will be charged against the annual amount received and additional invoices will not be issued unless the cost of activities exceeds the annual amount in any given year.

(d) The facility shall receive a monthly statement of items and amounts charged against the annual fee.

(e) If the cost of additional activities arise that require use of additional staff, including any consulting service that exceeds the amount of the annual fee paid by the licensee, these additional costs will be included in any invoice as separate items invoiced for the full cost of the oversight by additional staff or consultants. Oversight activities will be performed at a frequency which adequately monitors health, safety, and the environment.

(f) When the approved decommissioning plan is less than one hundred thousand dollars, the licensee will remain in the current license category and continue to pay the required annual fee specified in appendix A to this rule during decommissioning. Inspections of these licensees will be done as non-routine inspections. Non-routine inspection fees will not be applied until the number of decommissioning inspections performed exceed the inspections that would have been performed if the licensee had not chosen the decommissioning option.

(g) When the licensee has completed the decommissioning, and the director has determined that the licensee cannot terminate the license as provided by the Administrative Code, Chapter 3748. of the Revised Code or the rules adopted thereunder, but the licensee has successfully completed the decommissioning of the operation as required by the approved decommissioning plan, the director will amend the license to a decommissioning/possession only license. The annual fee for a decommissioning/possession only license is provided in appendix B to this rule.

(E) Licenses shall be renewed in accordance with the standard renewal procedure established in Chapter 4745. of the Revised Code, except that a licensee, other than a broad scope licensee, shall apply for renewal of the license ninety days prior to the expiration date of the current license and broad scope licensees shall apply for renewal of their license one hundred eighty days prior to expiration.

(F) The annual fee is listed in appendix A to this rule "column 5" for a new license or "column 6" for a renewal license. To recover the costs of oversight activities where radioactive material is found in the public domain and there is no evident individual that is determined to be responsible, a surcharge of 5.25 per cent has been included in the annual fee listed in "column 5" and "column 6" of appendix A to this rule.

(G) The department shall charge an inspection fee for all non-routine inspections. A non-routine inspection is defined as any inspection that the department conducts in addition to the scheduled routine inspections and one follow-up inspection if necessary. Non-routine inspections include, without limitation:

(1) An inspection performed as a result of an incident;

(2) Any pre-license inspections for a new license applicant when the director determines that an inspection is necessary to assess the adequacy of the information provided in the application;

(3) Inspections prior to license amendment, category change, or termination;

(4) An inspection performed at a facility that results in the issuance of an adjudication order by the director; or

(5) Other enforcement or regulatory inspections, not specified above, that the director determines is necessary to assess compliance with Chapter 3748. of the Revised Code.

(H) The fee for a non-routine inspection shall be based on the actual cost for conducting the inspection which shall include:

(1) An hourly charge of seventy dollars per staff person assigned to the inspection, except staff participating as training will not be included in the charges;

(2) An administrative fee of three hundred thirty dollars;

(3) All necessary laboratory analysis costs for samples collected by department personnel; and

(4) Any staff travel costs which shall be calculated in accordance with rule 126-01-02 of the Administrative Code.

(I) All fees invoiced as provided within this rule, including full cost, routine, and non-routine inspection fees, shall be paid within thirty days of the invoice date specified on the invoice. In accordance with sections 3748.07 and 3748.13 of the Revised Code, any fee that remains unpaid on the ninety-first day after the original invoice date shall be assessed an additional amount equal to ten per cent of the original fee.

(1) The department shall mail invoices by ordinary U.S. mail to the most recent address provided by the licensee.

(2) The department shall maintain a list of the invoices issued and date mailed.

(J) Notwithstanding paragraph (D) of this rule, the department shall charge the following types of licensees reduced license fees in the following specified amounts:

(1) A private entity that provides services, does not engage in manufacturing, and that has three hundred fifty thousand to two million dollars in gross annual receipts, shall pay a total license fee of seventy-five per cent of the amount specified for that use of radioactive materials in appendix A to this rule.

(2) A private entity that provides services, does not engage in manufacturing, and that has less than three hundred fifty thousand dollars in gross annual receipts shall pay a total license fee of fifty per cent of the amount specified for that use of radioactive material in appendix A to this rule.

(3) A private entity that engages in manufacturing and that has thirty-five to two hundred employees, irrespective of gross annual receipts, shall pay a total license fee of seventy-five per cent of the amount specified for that use of radioactive material in appendix A to this rule.

(4) A private entity that engages in manufacturing and that has less than thirty-five employees, irrespective of gross annual receipts, shall pay a total license fee of fifty per cent of the amount specified for that use of radioactive material in appendix A to this rule.

(5) A nonprofit entity that has gross annual receipts of three hundred fifty thousand dollars to two million dollars shall pay a total license fee of seventy-five per cent of the amount specified for that use of radioactive material in appendix A to this rule.

(6) A nonprofit entity that has gross annual receipts of less than three hundred fifty thousand dollars shall pay a total license fee of fifty per cent of the amount specified for that use of radioactive material in appendix A to this rule.

(7) A government jurisdiction or district with a population of twenty thousand to fifty thousand shall pay a total license fee of seventy-five per cent of the amount specified for that use of radioactive material as specified in appendix A to this rule.

(8) A government jurisdiction or district with a population of less than twenty thousand shall pay a total license fee of fifty per cent of the amount specified for that use of radioactive materials as specified in appendix A to this rule.

(9) A health district as defined in section 3709.01 of the Revised Code shall pay a total license fee of twenty-five per cent of the amount specified in appendix A to this rule.

(10) An accredited private or public college or university possessing or using radioactive material in a sealed or unsealed source solely as a part of a college or university course supported by tuition and leading to an accredited degree, but excluding clinical training, shall pay a total license fee as set forth for category "1129" as that amount is specified in appendix A to this rule.

The reduced annual fees specified in this paragraph do not apply to any other fees that a licensee may be required to pay under Chapter 3748. of the Revised Code or rules adopted thereunder. Licensees shall provide certification of their compliance with the provisions of paragraphs (J)(1) to (J)(6) of this rule upon initial application and renewal.

(K) The director may modify the inspection frequency of licensed facilities based upon the performance of the facility.

(L) In accordance with section 3748.22 of the Revised Code, the department shall charge fees sufficient to cover all costs of regulatory, administrative, and enforcement activities conducted pursuant to Chapter 3748. of the Revised Code. The director shall recommend to the radiation advisory council and the public health council changes in the radioactive materials fees if the director finds that fees do not meet the requirements of section 3748.22 of the Revised Code.

(M) Fees for those categories listed as "full cost" such as decommissioning activities, for either partial, building or selected area of a licensed site, or full decommissioning leading to license amendment, category change, or termination and for review of sources and/or devices shall be specified as "full cost" and shall be calculated as the sum of the seventy dollar hourly charge per staff member for the number of hours spent on document review and preparation, licensing, inspection, meetings, teleconferences, in travel, administrative time, the cost of any special contractors as determined necessary by the director, any environmental monitoring for radioactive materials and laboratory analysis, any other associated activities. The administrative fee from paragraph (H)(2) of this rule shall be used for administrative time. Travel expenses shall also be invoiced and shall be calculated at the rate determined by rule 126-1-02 of the Administrative Code. These fees will be invoiced monthly.

(N)

(1) Reciprocity to engage in activities in the state of Ohio which involve radioactive materials may be authorized provided:

(a) The person requesting reciprocity possesses a valid radioactive materials license issued by another agreement state or the United States nuclear regulatory commission which authorizes the same activities proposed to be conducted in Ohio;

(b) The request for reciprocity is made by submission of a completed reciprocity application provided by the director, a copy of the person's radioactive materials license, and payment of the reciprocity fee specified in appendix A to this rule;

(c) The duration of activities to be performed in Ohio under reciprocity does not exceed one hundred eighty days in any one calendar year.

(2) A person who has been granted reciprocity in Ohio shall notify the director at least three business days in advance of each time the person proposes to begin a new use of radioactive materials in the state of Ohio, with the notification made on a form provided by the director.

(3) Activities conducted in Ohio under reciprocity are subject to inspection by the department at any time and the department shall invoice a reciprocity inspection fee of one thousand dollars for each inspection of a person's authorized reciprocity activities.

(4) Reciprocity is authorized for one calendar year, beginning on January first or later date when reciprocity is initially applied for, and ending on December thirty-first.

(5) A person who is authorized reciprocity shall apply for an Ohio radioactive materials license at least thirty days prior to exceeding one hundred eighty days of activities in Ohio.

(O) Requests for safety evaluation of devices, products, or sealed sources used for radioactive materials either for commercial distribution or manufactured in accordance with the unique specifications of, and for use by, a single applicant shall be submitted to the director on a form provided by the director for that review prior to manufacture or commercial distribution.

(1) The application shall specify a license amendment for one of the areas listed below:

(a) Safety evaluation of sealed sources or devices or products containing NARM, byproduct material, source material, or special nuclear material (less than critical mass) for commercial distribution.

(b) Safety evaluation of sealed sources or devices or products containing NARM, byproduct material, source material, or special nuclear material (less than critical mass) manufactured in accordance with the unique specifications of, and for use by, a single applicant.

(2) The amendment fee for a source or device review shall be "full cost" as outlined in paragraph ((M) of this rule.

(3) The amendment fee in appendix A to this rule for categories under manufacturing and distribution shall be for amendments other than source or device reviews.

(4) Licensees for categories 3211, 3212, 3213, 3214, and 22162 shall pay an annual surcharge of six hundred fifty dollars to cover administrative costs of overall maintenance activities associated with source or device data submitted to the United States nuclear regulatory commission. This surcharge is included in the annual fee for the above listed categories in "column 5" and "column 6" of appendix A to this rule.

(P) When considered necessary by the director, the director may conduct a review of shielding plans or the adequacy of shielding. The director may also conduct such a review upon the request of the licensee or the applicant for a license. The applicant or licensee shall pay a fee for review of shielding plans or adequacy of shielding as specified in paragraph (M) of this rule.

(Q) Individuals with implanted pacemakers that have a radioactive source will not be charged an annual fee as an individual because of the necessity of possessing the device. Unless the director determines other provisions are required, the medical institution that implanted the device shall hold the license for the individual.

(R) If, because of the complexity of a review, such as that for a sealed source or device, decommissioning, license, or incident, it is necessary to obtain the services of a consultant to assist in a final determination, the licensee or applicant will be invoiced for the consulting services.

(S) Licensees with general licenses requiring an annual report to the director shall submit the report with a fee of four hundred twenty dollars within thirty days of mailing an invoice by the department and are subject to late penalties in paragraph (I) of this rule. If a facility has a specific license which is in a category that would include the generally licensed material, the facility may add the generally licensed material to the specific license and will not be charged the additional fee for that generally licensed material. Annual reports are required for devices under a general license containing radionuclides at or above activities listed in paragraph (C)(13) of rule 3701:1-46-05 of the Administrative Code.

View AppendixView Appendix

Last updated November 2, 2022 at 2:09 PM

History

• Effective: April 15, 2013
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-52-04 Specific licenses for irradiators.

The director will approve an application for a specific license for the use of licensed material in an irradiator if the applicant meets the requirements contained in this chapter.

(A) The applicant shall satisfy the general requirements specified in rule 3701:1-40-15 of the Administrative Code and the requirements contained in this chapter.

(B) The application must describe the training provided to irradiator operators as required by rule 3701:1-52-18 of the Administrative Code including:

(1) Classroom training;

(2) On-the-job or simulator training;

(3) Safety reviews;

(4) Method employed by the applicant to test each operator's understanding of the department's regulations and licensing requirements and the irradiator operating and emergency procedures; and

(5) Minimum training and experience of personnel who may provide training.

(C) The application must include an outline of the written operating and emergency procedures listed in rule 3701:1-52-19 of the Administrative Code that describes the radiation safety aspects of the procedures.

(D) The application must describe the organizational structure for managing the irradiator, specifically the radiation safety responsibilities and authorities of the radiation safety officer and those management personnel who have important radiation safety responsibilities or authorities. In particular, the application must specify who, within the management structure, has the authority to stop unsafe operations. The application must also describe the training and experience required for the position of radiation safety officer.

(E) The application must include a description of the access control systems required by rule 3701:1-52-08 of the Administrative Code, the radiation monitors required by rule 3701:1-52-11 of the Administrative Code, the method of detecting leaking sources required by rule 3701:1-52-22 of the Administrative Code including the sensitivity of the method, and a diagram of the facility that shows the locations of all required interlocks and radiation monitors.

(F) If the applicant intends to perform leak testing of dry-source-storage sealed sources, the applicant shall establish procedures for leak testing and submit a description of these procedures to the director. The description must include the:

(1) Instruments to be used;

(2) Methods of performing the analysis; and

(3) Pertinent experience of the individual who analyzes the samples.

(G) If licensee personnel are to load or unload sources, the applicant shall describe the qualifications and training of the personnel and the procedures to be used. If the applicant intends to contract for source loading or unloading at its facility, the loading or unloading must be done by an organization specifically licensed by the United States nuclear regulatory commission, the director, or an agreement state to load or unload irradiator sources.

(H) The applicant shall describe the inspection and maintenance checks, including the frequency of the checks, required by rule 3701:1-52-23 of the Administrative Code.

Last updated August 1, 2023 at 2:38 PM

History

• Effective: September 1, 2012
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-40-15

(A) An application for a specific license will be approved if:

(1) The application is for a purpose authorized by Chapter 3748. of the Revised Code and the rules adopted thereunder;

(2) The applicant's proposed equipment and facilities are adequate to protect health and minimize danger to life or property or the environment;

(3) The applicant is qualified by training and experience to use the radioactive material for the purpose requested in such manner as to protect health and minimize danger to life or property or the environment;

(4) The applicant satisfies any special requirements contained in rule 3701:1-38-02 of the Administrative Code, and Chapters 3701:1-46, 3701:1-48, 3701:1-49, 3701:1-52, and 3701:1-58 of the Administrative Code; and

(5) In the case of an application for a license to receive and possess radioactive material for the conduct of any activity which the director determines could potentially affect the quality of the environment, the department, before commencement of construction of the plant or facility in which the activity will be conducted, on the basis of information filed and evaluations made pursuant to rule 3701:1-40-30 of the Administrative Code, has concluded, after weighing the environmental, economic, technical, and other benefits against environmental costs and considering available alternatives, shall conclude that the action called for is the issuance of the proposed license, with any appropriate conditions to protect environmental values. Commencement of construction prior to such conclusion shall be grounds for denial of a license to receive and possess radioactive material in such plant or facility. As used in this paragraph the term "commencement of construction" is as defined in rule 3701:1-38-01 of the Administrative Code.

(B) Upon a determination that an application meets the requirements of Chapter 3748. of the Revised Code and the rules adopted thereunder, the director will issue a specific license authorizing the possession and use of radioactive material.

Last updated November 2, 2022 at 2:12 PM

History

• Effective: July 25, 2013
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-52-19

(A) The licensee shall have and follow written operating procedures for:

(1) Operation of the irradiator, including entering and leaving the radiation room;

(2) Use of personnel dosimeters;

(3) Surveying the shielding of panoramic irradiators;

(4) Monitoring pool water for contamination while the water is in the pool and before release of pool water to unrestricted areas;

(5) Leak testing of sources;

(6) Inspection and maintenance checks required by rule 3701:1-52-23 of the Administrative Code;

(7) Loading, unloading, and repositioning sources, if the operations will be performed by the licensee; and

(8) Inspection of movable shielding required by paragraph (H) of rule 3701:1-52-08 of the Administrative Code, if applicable.

(B) The licensee shall have and follow emergency or abnormal event procedures, appropriate for the irradiator type, for:

(1) Sources stuck in the unshielded position;

(2) Personnel overexposures;

(3) A radiation alarm from the product exit portal monitor or pool monitor;

(4) Detection of leaking sources, pool contamination, or alarm caused by contamination of pool water;

(5) A low or high water level indicator, an abnormal water loss, or leakage from the source storage pool;

(6) A prolonged loss of electrical power;

(7) A fire alarm or explosion in the radiation room;

(8) An alarm indicating unauthorized entry into the radiation room, area around pool, or another alarmed area;

(9) Natural phenomena, including an earthquake, a tornado, flooding, or other phenomena as appropriate for the geographical location of the facility; and

(10) The jamming of automatic conveyor systems.

(C) The licensee may revise operating and emergency procedures without director approval only if all of the following conditions are met:

(1) The revisions do not reduce the safety of the facility;

(2) The revisions are consistent with the outline or summary of procedures submitted with the license application;

(3) The revisions have been reviewed and approved by the radiation safety officer; and

(4) The users or operators are instructed and tested on the revised procedures before they are put into use.

Last updated August 1, 2023 at 2:40 PM

History

• Effective: September 1, 2012
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-52-08

(A) Each entrance to a radiation room at a panoramic irradiator must have a door or other physical barrier to prevent inadvertent entry of personnel if the sources are not in the shielded position. Product conveyor systems may serve as barriers as long as they reliably and consistently function as a barrier. It must not be possible to move the sources out of their shielded position if the door or barrier is open. Opening the door or barrier while the sources are exposed must cause the sources to return promptly to their shielded position. The personnel entrance door or barrier must have a lock that is operated by the same key used to move the sources. The doors and barriers must not prevent any individual in the radiation room from leaving.

(B) Each entrance to a radiation room at a panoramic irradiator must have an independent backup access control to detect personnel entry while the sources are exposed. Detection of entry while the sources are exposed must cause the sources to return to their fully shielded position and must also activate a visible and audible alarm to make the individual entering the room aware of the hazard. The alarm must also alert at least one other individual who is onsite of the entry. That individual shall be trained on how to respond to the alarm and prepared to promptly render or summon assistance.

(C) A radiation monitor must be provided to detect the presence of high radiation levels in the radiation room of a panoramic irradiator before personnel entry. The monitor must be integrated with personnel access door locks to prevent room access when radiation levels are high. Attempted personnel entry while the monitor measures high radiation levels must activate the alarm described in paragraph (B) of this rule. The monitor may be located in the entrance (normally referred to as the maze) but not in the direct radiation beam.

(D) Before the sources move from their shielded position in a panoramic irradiator, the source control must automatically activate conspicuous visible and audible alarms to alert people in the radiation room that the sources will be moved from their shielded position. The alarms must give individuals enough time to leave the room before the sources leave the shielded position.

(E) Each radiation room at a panoramic irradiator must have a clearly visible and readily accessible control that would allow an individual in the room to make the sources return to their fully shielded position.

(F) Each radiation room of a panoramic irradiator must contain a control that prevents the sources from moving from the shielded position unless the control has been activated and the door or barrier to the radiation room has been closed within a preset time after activation of the control.

(G) Each entrance to the radiation room of a panoramic irradiator and each entrance to the area within the personnel access barrier of an underwater irradiator must be posted as required in rule 3701:1-38-18 of the Administrative Code. Radiation postings for panoramic irradiators must comply with the posting requirements in rule 3701:1-38-18 of the Administrative Code except that signs may be removed, covered, or otherwise made inoperative when the sources are fully shielded.

(H) If the radiation room of a panoramic irradiator has roof plugs or other movable shielding, it must not be possible to operate the irradiator unless the shielding is in its proper location. This requirement may be met by interlocks that prevent operation if shielding is not placed properly or by an operating procedure requiring inspection of shielding before operating.

(I) Underwater irradiators must have a personnel access barrier around the pool which must be locked to prevent access when the irradiator is not attended. Only operators and facility management may have access to keys to the personnel access barrier. There must be an intrusion alarm to detect unauthorized entry when the personnel access barrier is locked. Activation of the intrusion alarm must alert an individual (not necessarily onsite) who is prepared to respond or summon assistance.

Last updated August 1, 2023 at 2:39 PM

History

• Effective: October 20, 2002
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-52-11

(A) Irradiators with automatic product conveyor systems must have a radiation monitor with an audible alarm located to detect loose radioactive sources that are carried toward the product exit. If the monitor detects a source, an alarm must sound and product conveyors must stop automatically. The alarm must be capable of alerting an individual in the facility who is prepared to summon assistance. Underwater irradiators in which the product moves within an enclosed stationary tube are exempt from the requirements of this paragraph.

(B) Underwater irradiators that are not in a shielded radiation room must have a radiation monitor over the pool to detect abnormal radiation levels. The monitor must have an audible alarm and a visible indicator at entrances to the personnel access barrier around the pool. The audible alarm may have a manual shut-off. The alarm must be capable of alerting an individual who is prepared to respond promptly.

Last updated August 1, 2023 at 2:39 PM

History

• Effective: October 20, 2002
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-52-22

(A) Each dry-source-storage sealed source must be tested for leakage at intervals not to exceed six months using a leak test kit or method approved by the United States nuclear regulatory commission, the director, or an agreement state. In the absence of a certificate from a transferor that a test has been made within the six months before the transfer, the sealed source may not be used until tested. The test must be capable of detecting the presence of one hundred eighty-five becquerels (0.005 microcurie) of radioactive material and must be performed by a person approved by the United States nuclear regulatory commission, the director, or an agreement state to perform the test.

(B) For pool irradiators, sources may not be put into the pool unless the licensee tests the sources for leaks or has a certificate from a transferor that a leak test has been done within the six months before the transfer. Water from the pool must be checked for contamination each day the irradiator operates. The check may be done either by using a radiation monitor on a pool water circulating system or by analysis of a sample of pool water. If a check for contamination is done by analysis of a sample of pool water, the results of the analysis must be available within twenty-four hours. If the licensee uses a radiation monitor on a pool water circulating system, the detection of above normal radiation levels must activate an alarm. The alarm set-point must be set as low as practical, but high enough to avoid false alarms. The licensee may reset the alarm set-point to a higher level if necessary to operate the pool water purification system to clean up contamination in the pool if specifically provided for in written emergency procedures.

(C) If a leaking source is detected, the licensee shall arrange to remove the leaking source from service and have it decontaminated, repaired, or disposed of by an organization licensed by the United States nuclear regulatory commission, the director, or an agreement state to perform these functions. The licensee shall promptly check its personnel, equipment, facilities, and irradiated product for radioactive contamination. No product may be shipped until the product has been checked and found free of contamination. If a product has been shipped that may have been inadvertently contaminated, the licensee shall arrange to locate and survey that product for contamination. If any personnel are found to be contaminated, decontamination must be performed promptly. If contaminated equipment, facilities, or products are found, the licensee shall arrange to have them decontaminated or disposed of by an organization licensed by the United States nuclear regulatory commission, the director, or an agreement state to perform these functions. If a pool is contaminated, the licensee shall arrange to clean the pool until the contamination levels do not exceed the appropriate concentration in accordance with table II of appendix C to rule 3701:1-38-12 of the Administrative Code, "Annual Limits on Intake (ALI) and Derived Air Concentrations (DAC) of Radionuclides for Occupational Exposure; Effluent Concentrations; Concentrations for Release to Sanitary Sewerage."

Last updated August 1, 2023 at 2:41 PM

History

• Effective: January 15, 2017
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-52-23

(A) The licensee shall perform inspection and maintenance checks that include, as a minimum, each of the following at the frequency specified in the license or license application:

(1) Operability of each aspect of the access control system required by rule 3701:1-52-08 of the Administrative Code.

(2) Functioning of the source position indicator required by paragraph (B) of rule 3701:1-52-12 of the Administrative Code.

(3) Operability of the radiation monitor for radioactive contamination in pool water required by paragraph (B) of rule 3701:1-52-22 of the Administrative Code using a radiation check source, if applicable.

(4) Operability of the over-pool radiation monitor at underwater irradiators as required by paragraph (B) of rule 3701:1-52-11 of the Administrative Code.

(5) Operability of the product exit monitor required by paragraph (A) of rule 3701:1-52-11 of the Administrative Code.

(6) Operability of the emergency source return control required by paragraph (C) of rule 3701:1-52-12 of the Administrative Code.

(7) A visual inspection of the leak-tightness of systems through which pool water circulates.

(8) Without turning extinguishers on, operability of the heat and smoke detectors and extinguisher system required by rule 3701:1-52-10 of the Administrative Code.

(9) Operability of the means of pool water replenishment required by paragraph (C) of rule 3701:1-52-13 of the Administrative Code.

(10) Operability of the indicators of high and low pool water levels required by paragraph (D) of rule 3701:1-52-13 of the Administrative Code.

(11) Operability of the intrusion alarm required by paragraph (I) of rule 3701:1-52-08 of the Administrative Code, if applicable.

(12) Functioning and wear of the system, mechanisms, and cables used to raise and lower sources.

(13) Condition of the barrier to prevent products from hitting the sources or source mechanism as required by rule 3701:1-52-14 of the Administrative Code.

(14) Amount of water added to the pool to determine if the pool is leaking.

(15) Electrical wiring on required safety systems for radiation damage.

(16) Pool water conductivity measurements and analysis as required by paragraph (B) of rule 3701:1-52-24 of the Administrative Code.

(B) Malfunctions and defects found during inspection and maintenance checks must be repaired without undue delay.

Last updated August 1, 2023 at 2:41 PM

History

• Effective: October 8, 2007
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-52-05 Start of construction.

The applicant may not begin construction of a new irradiator prior to the submission to the director of both an application for a license for the irradiator and the fee required by rule 3701:1-38-02 of the Administrative Code. As used in this chapter, the term "construction" includes the construction of any portion of the permanent irradiator structure on the site but does not include: engineering and design work, purchase of a site, site surveys or soil testing, site preparation, site excavation, construction of warehouse or auxiliary structures, and other similar tasks. Any activities undertaken prior to the issuance of a license are entirely at the risk of the applicant and have no bearing on the issuance of a license by the director.

Last updated August 1, 2023 at 2:38 PM

History

• Effective: September 1, 2012
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-52-06 Applications for exemptions.

Any application for a license or for amendment of a license authorizing use of a teletherapy-type unit for irradiation of materials or objects may include proposed alternatives for the requirements of this chapter. The director will approve the proposed alternatives if the applicant provides adequate rationale for the proposed alternatives and demonstrates that they are likely to provide an adequate level of safety for workers and the public.

Last updated August 1, 2023 at 2:38 PM

History

• Effective: October 20, 2002
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-52-07 Performance criteria for sealed sources.

(A) The requirements for sealed sources installed after July 1, 1993:

(1) Must have a certificate of registration issued in accordance with rule 3701:1-46-49 of the Administrative Code or equivalent United States nuclear regulatory commission or agreement state regulations;

(2) Must be doubly encapsulated;

(3) Must use radioactive material that is as nondispersible as practical and that is as insoluble as practical if the source is used in a wet-source-storage or wet-source-change irradiator;

(4) Must be encapsulated in a material resistant to general corrosion and to localized corrosion, such as 316L stainless steel or other material with equivalent resistance, if the sources are for use in irradiator pools; and

(5) Must, in prototype testing of the sealed source, have been leak tested and found leak-free after each of the tests described in paragraphs (B) to (G) of this rule.

(B) The test source must be held at minus forty degrees celsius for twenty minutes, six hundred degrees celsius for one hour, and then be subjected to a thermal shock test with a temperature drop from six hundred degrees celsius to twenty degrees celsius within fifteen seconds.

(C) The test source must be twice subjected for at least five minutes to an external pressure (absolute) of two megapascals.

(D) A two-kilogram steel weight, 2.5 centimeters in diameter, must be dropped from a height of one meter onto the test source.

(E) The test source must be subjected three times for ten minutes each to vibrations sweeping from twenty-five hertz to five hundred hertz with a peak amplitude of five times the acceleration of gravity. In addition, each test source must be vibrated for thirty minutes at each resonant frequency found.

(F) A fifty gram weight and pin, 0.3 centimeter pin diameter, must be dropped from a height of one meter onto the test source.

(G) If the length of the source is more than fifteen times larger than the minimum cross-sectional dimension, the test source must be subjected to a force of two thousand newtons at its center equidistant from two support cylinders, the distance between which is ten times the minimum cross-sectional dimension of the source.

Last updated August 1, 2023 at 2:39 PM

History

• Effective: January 15, 2017
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-46-49

(A) Any manufacturer or initial distributor of a sealed source or device containing a sealed source may submit a request to the director for evaluation of radiation safety information about its product and for its registration.

(B) The request for review must be made in duplicate and sent to the director at the following address:

"Ohio Department of Health

Bureau of Environmental Health and Radiation Protection

246 North High Street

Columbus, Ohio 43215"

(C) The request for review of a sealed source or a device must include sufficient information about the design, manufacture, prototype testing, quality control program, labeling, proposed uses and leak testing and, for a device, the request must also include sufficient information about installation, service and maintenance, operating and safety instructions, and its potential hazards, to provide reasonable assurance that the radiation safety properties of the source or device are adequate to protect health and minimize danger to life and property.

(D) The director normally evaluates a sealed source or a device using radiation safety criteria in accepted industry standards. If these standards and criteria do not readily apply to a particular case, the director formulates reasonable standards and criteria with the help of the manufacturer or distributor. The director shall use criteria and standards sufficient to ensure that the radiation safety properties of the device or sealed source are adequate to protect health and minimize danger to life and property.

(E) After completion of the evaluation, the director issues a certificate of registration to the person making the request. The certificate of registration acknowledges the availability of the submitted information for inclusion in an application for a specific license proposing use of the product, or concerning use under an exemption from licensing or general license as applicable for the category of certificate.

(F) The person submitting the request for evaluation and registration of safety information about the product shall manufacture and distribute the product in accordance with:

(1) The statements and representations, including quality control program, contained in the request; and

(2) The provisions of the registration certificate.

(G) Authority to manufacture or initially distribute a sealed source or device to specific licensees may be provided in the license without the issuance of a certificate of registration in the following cases:

(1) Calibration and reference sources containing no more than:

(a) Thirty seven megabecquerels (one millicurie), for beta and/or gamma emitting radionuclides; or

(b) 0.37 megabecquerels (10 microcuries), for alpha emitting radionuclides; or

(2) The intended recipients are qualified by training and experience and have sufficient facilities and equipment to safely use and handle the requested quantity of radioactive material in any form in the case of unregistered sources or, for registered sealed sources contained in unregistered devices, are qualified by training and experience and have sufficient facilities and equipment to safely use and handle the requested quantity of radioactive material in unshielded form, as specified in their licenses; and

(a) The intended recipients are licensed under chapter 3701:1-40 of the Administrative Code or comparable provisions of another agreement state or the United States nuclear regulatory commission; or

(b) The recipients are authorized for research and development; or

(c) The sources and devices are to be built to the unique specifications of the particular recipient and contain no more than seven hundred forty gigabecquerels (twenty curies) of tritium or 7.4 gigabecquerels (two hundred millicuries) of any other radionuclide.

(H) After the certificate is issued, the director may conduct an additional review as he/she determines is necessary to ensure compliance with current regulatory standards. In conducting the review, the director will complete his/her evaluation in accordance with criteria specified in this rule. The director may request such additional information as he/she considers necessary to conduct his/her review and the certificate holder shall provide the information as requested.

(I) A certificate holder who no longer manufactures or initially transfers any of the sealed source(s) or device(s) covered by a particular certificate issued by the director shall request inactivation of the registration certificate. Such a request must be made to the director by an appropriate method listed in rule 3701:1-40-04 of the Administrative Code and must normally be made no later than two years after the initial distribution of all of the source(s) or device(s) covered by the certificate has ceased. However, if the certificate holder determines that an initial transfer was in fact the last initial transfer more than two years after that transfer, the certificate holder shall request inactivation of the certificate within ninety days of this determination and briefly describe the circumstances of the delay.

(J) If a distribution license is to be terminated in accordance with rule 3701:1-40-18 of the Administrative Code, the licensee shall request inactivation of its registration certificates associated with that distribution license before the director will terminate the license. Such a request for inactivation of certificate(s) must indicate that the license is being terminated and include the associated specific license number.

(K) A specific license to manufacture or initially transfer a source or device covered only by an inactivated certificate no longer authorizes the licensee to initially transfer such sources or devices for use. Servicing of devices must be in accordance with any conditions in the certificate, including in the case of an inactive certificate.

Last updated November 2, 2022 at 2:36 PM

History

• Effective: November 8, 2015
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-38-18

(A) Except as provided in paragraph (B) of this rule, caution signs and posting requirements for licensees and registrants are as follows:

(1) The standard radiation symbol, unless otherwise authorized by the department or as provided in paragraph (A)(2) of this rule, shall use the colors magenta, purple, or black on yellow background. The symbol prescribed is the three-bladed design as follows:

(2) Notwithstanding paragraph (A)(1) of this rule, licensees and registrants are authorized to label sources, source holders, or device components containing sources of radiation that are subjected to high temperatures, with conspicuously cast, etched or stamped radiation caution symbols and without a color requirement.

(3) In addition to the contents of signs and labels prescribed in this chapter, the licensee or registrant may provide, on or near the required signs and labels, additional information, as appropriate, to make individuals aware of potential radiation exposures and to minimize the exposures.

(4) Posting of radiation areas shall be accomplished as follows:

(a) The licensee or registrant shall post each radiation area with a conspicuous sign or signs bearing the radiation symbol and the words "Caution, Radiation Area".

(b) The licensee or registrant shall post each high radiation area with a conspicuous sign or signs bearing the radiation symbol and the words "Caution, High Radiation Area" or "Danger, High Radiation Area".

(c) The licensee or registrant shall post each very high radiation area with conspicuous sign or signs bearing the radiation symbol and words "Grave Danger, Very High Radiation Area".

(d) The licensee shall post each airborne radioactivity area with a conspicuous sign or signs bearing the radiation symbol and the words "Caution, Airborne Radioactivity Area" or "Danger, Airborne Radioactivity Area".

(e) The licensee shall post each area or room in which there is an amount of licensed material used or stored which exceeds ten times the quantity of such material specified in the appendix A ofto this rule with a conspicuous sign or signs bearing the radiation symbol and the words "Caution, Radioactive Material(s)" or "Danger, Radioactive Material(s)".

(f) The licensee shall post access openings to manufacturing or process equipment (such as tanks and vessels) on or in which radiation sources are mounted, if a person could gain access to the radiation beam and receive an annual dose to any part of their body which is greater than the applicable, permissible limits for individuals in rules 3701:1-38-12 and 3701:1-38-13 of the Administrative Code. The posting must include a conspicuous sign or signs bearing the radiation symbol and warning of the hazard.

(B) The following are exceptions to posting requirements set forth in paragraph (A) of this rule:

(1) A licensee or registrant is not required to post caution signs in an area or room that contains a source of radiation provided that the source is located in the area or room for a period of less than eight hours, and the source of radiation is continuously attended to during these periods by an individual who takes the precautions necessary to prevent the exposure of individuals to sources of radiation in excess of the limits established in rule 3701:1-38-13 of the Administrative Code, and the area or room is subject to licensee or registrant control.

(2) Rooms or other areas in hospitals that are occupied by patients are not required to be posted with caution signs pursuant to paragraph (A) of this rule provided that the patient could be released from licensee control in accordance with rule 3701:1-58-30 of the Administrative Code.

(3) A room or area is not required to be posted with a caution sign because of the presence of a sealed source provided the radiation level at thirty centimeters from the surface of the sealed source container or housing does not exceed 0.05 millisievert (0.005 rem) per hour.

(4) A room or area is not required to be posted with a caution sign because of the presence of radiation-generating equipment used solely for diagnosis in the healing arts.

(5) Rooms in hospitals or clinics that are used for teletherapy are exempt from the requirement to post caution signs if access to the room is controlled pursuant to rule 3701:1-58-59 of the Administrative Code and personnel in attendance take necessary precautions to prevent the inadvertent exposure of workers, other patients, and members of the public to radiation in excess of the limits established in this chapter.

(C) Except as provided in paragraph (E) of this rule, containers shall be labeled as follows:

(1) The licensee shall ensure that each container of licensed material bears a durable, clearly visible label bearing the radiation symbol and the words "Caution, Radioactive Material" or "Danger, Radioactive Material". The label shall also provide information, such as the radionuclides present, an estimate of the quantity of radioactivity, the date for which the activity is estimated, radiation levels, kinds of materials, and mass enrichment, to permit individuals handling or using the containers, or working in the vicinity of the containers, to take precautions to avoid or minimize exposures.

(2) Prior to removal or disposal of empty uncontaminated containers to unrestricted areas, each licensee shall, remove or deface the radioactive material label or otherwise clearly indicate that the container no longer contains radioactive materials.

(D) Each registrant shall ensure that each radiation-generating equipment is labeled in a conspicuous manner which cautions individuals that radiation is produced when it is energized.

(E) A licensee is not required to label the following:

(1) Containers holding licensed material in quantities less than the quantities listed in the appendix A to this rule;

(2) Containers holding licensed material in concentrations less than those specified in table III of appendix C to rule 3701:1-38-12 of the Administrative Code;

(3) Containers attended by an individual who takes the precautions necessary to prevent the exposure of individuals in excess of the limits established by rule 3701:1-38-13 of the Administrative Code;

(4) Containers when they are in transport and packaged and labeled in accordance with the regulations of the United States department of transportation;

(5) Containers that are accessible only to individuals authorized to handle or use them, or to work in the vicinity of the containers, if the contents are identified to these individuals by a readily available written record. Examples of containers of this type are containers in locations such as water-filled canals, storage vaults, or hot cells. The record shall be retained as long as the containers are in use for the purpose indicated on the record; or

(6) Manufacturing or processing equipment such as contaminated piping and tanks, and vessels on or in which radiation sources are installed.

(F) Each licensee shall:

(1) Monitor the external surfaces of a labeled package for radioactive contamination unless the package contains only radioactive material in the form of gas or in special form as defined in rule 3701:1-38-01 of the Administrative Code;

(2) Monitor the external surfaces of a labeled package for radiation levels unless the package contains quantities of radioactive material that are less than or equal to the type A quantity; and

(3) Monitor all packages known to contain radioactive material for radioactive contamination and radiation levels if there is evidence of degradation of package integrity, such as a package that is crushed, wet, or damaged.

(4) Perform the monitoring required by this paragraph as soon as practicable after receipt of the package, but not later than three hours after the package is received at the licensee's facility, if it is received during the licensee's normal working hours. If a package is received after working hours, the package shall be monitored no later than three hours from the beginning of the next working day.

(G) Each licensee who expects to receive a package containing quantities of radioactive material in excess of a type A quantity as defined in rule 3701:1-38-01 of the Administrative Code and as provided in rule 3701:1-50-25 of the Administrative Code, shall make arrangements to receive the package when the carrier offers it for delivery or expeditiously upon receiving notification that the package is available for pick-up.

(H) The licensee shall immediately notify the final delivery carrier and the department by telephone and either telegram, mailgram, or facsimile, when:

(1) Removable radioactive surface contamination exceeds the limits as provided in 49 C.F.R. 173.443 (as published in the October 1, 2009 Code of Federal Regulationsin effect on the effective date of this rule); or

(2) External radiation levels exceed the limits as provided in 49 C.F.R. 172.403 (as published in the October 1, 2009 Code of Federal Regulationsin effect on the effective date of this rule).

(I) Each licensee shall:

(1) Establish, maintain, and retain written procedures for safely opening packages in which radioactive material is received; and

(2) Ensure that the procedures are followed and that due consideration is given to special instructions for the type of package being opened.

(J) A licensee that transfers a special form source to and from a work site in a vehicle owned or operated by the licensee is exempt from the contamination monitoring requirements of this rule, but is not exempt from the monitoring requirement in this rule for measuring radiation levels that ensures that the source is still properly lodged in its shield.

View Appendix

Last updated June 6, 2022 at 9:29 AM

History

• Effective: June 4, 2022
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-52-09 Shielding.

(A) The radiation dose rate in areas that are normally occupied during operation of a panoramic irradiator may not exceed 0.02 millisievert (two millirem) per hour at any location thirty centimeters or more from the wall of the room when the sources are exposed. The dose rate must be averaged over an area not to exceed one hundred square centimeters having no linear dimension greater than twenty centimeters. Areas where the radiation dose rate exceeds 0.02 millisievert (two millirem) per hour must be locked, roped off, or posted.

(B) The radiation dose rate at thirty centimeters over the edge of the containment pool of a pool irradiator may not exceed 0.02 millisievert (two millirem) per hour when the sources are in the fully shielded position.

(C) The radiation dose rate at one meter from the shield of a dry-source-storage panoramic irradiator when the source is shielded may not exceed 0.02 millisievert (two millirem) per hour and at five centimeters from the shield may not exceed 0.2 millisievert (twenty millirem) per hour.

Last updated August 1, 2023 at 2:39 PM

History

• Effective: October 8, 2007
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-52-10 Fire protection.

(A) The radiation room at a panoramic irradiator must have heat and smoke detectors. The detectors must activate an audible alarm. The alarm must be capable of alerting a person who is prepared to summon assistance promptly. The sources must automatically become fully shielded if a fire is detected.

(B) The radiation room at a panoramic irradiator must be equipped with a fire extinguishing system capable of extinguishing a fire without the entry of personnel into the room. The system for the radiation room must have a shut-off valve to control flooding into unrestricted areas.

Last updated August 1, 2023 at 2:39 PM

History

• Effective: October 20, 2002
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-52-12 Control of source movement.

(A) The mechanism that moves the sources of a panoramic irradiator must require a key to actuate. Actuation of the mechanism must cause an audible signal to indicate that the sources are leaving the shielded position. Only one key may be in use at any time, and only operators or facility management may possess it. The key must be attached to a portable radiation survey meter by a chain or cable. The lock for source control must be designed so that the key may not be removed if the sources are in an unshielded position. The door to the radiation room must require the same key.

(B) The console of a panoramic irradiator must have a source position indicator that indicates when the sources are in the fully shielded position, when they are in transit, and when the sources are exposed.

(C) The control console of a panoramic irradiator must have a control that promptly returns the sources to the shielded position.

(D) Each control for a panoramic irradiator must be clearly marked as to its function.

Last updated August 1, 2023 at 2:40 PM

History

• Effective: October 20, 2002
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-52-13 Irradiator pools.

(A) For licenses initially issued after July 1, 1993, irradiator pools must either:

(1) Have a water-tight stainless steel liner or a liner metallurgically compatible with other components in the pool; or

(2) Be constructed so that there is a low likelihood of substantial leakage and have a surface designed to facilitate decontamination. In either case, the licensee shall have a method to safely store the sources during repairs of the pool.

(B) For licenses initially issued after July 1, 1993, irradiator pools must have no outlets more than 0.5 meter below the normal low water level that could allow water to drain out of the pool. Pipes that have intakes more than 0.5 meter below the normal low water level and that could act as siphons must have siphon breakers to prevent the siphoning of pool water.

(C) A means must be provided to replenish water losses from the pool.

(D) A visible indicator must be provided in a clearly visible location to indicate if the pool water level is below the normal low water level or above the normal high water level.

(E) Irradiator pools must be equipped with a purification system designed to be capable of maintaining the water during normal operation at a conductivity of twenty microsiemens per centimeter or less and with a clarity so that the sources can be seen clearly.

(F) A physical barrier, such as a railing or cover, must be used around or over irradiator pools during normal operation to prevent personnel from accidentally falling into the pool. The barrier may be removed during maintenance, inspection, and service operations.

(G) If long-handled tools or poles are used in irradiator pools, the radiation dose rate on the handling areas of the tools may not exceed 0.02 millisievert (two millirem) per hour.

Last updated August 1, 2023 at 2:40 PM

History

• Effective: October 8, 2007
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-52-14 Source rack protection.

If the product to be irradiated moves on a product conveyor system, the source rack and the mechanism that moves the rack must be protected by a barrier or guides to prevent products and product carriers from hitting or touching the rack or mechanism.

Last updated August 1, 2023 at 2:40 PM

History

• Effective: October 20, 2002
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-52-15 Power failures.

(A) If electrical power at a panoramic irradiator is lost for longer than ten seconds, the sources must automatically return to the shielded position.

(B) The lock on the door of the radiation room of a panoramic irradiator may not be deactivated by a power failure.

(C) During a power failure, the area of any irradiator where sources are located may be entered only when using an operable and calibrated radiation survey meter.

Last updated August 1, 2023 at 2:40 PM

History

• Effective: October 20, 2002
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-52-16 Design requirements.

Irradiators whose construction begins after July 1, 1993, must meet the design requirements of this rule.

(A) For all irradiators, the licensee shall evaluate the location and sensitivity of the monitor to detect sources carried by the product conveyor system as required by paragraph (A) of rule 3701:1-52-11 of the Administrative Code. The licensee shall verify that the product conveyor is designed to stop before a source on the product conveyor would cause a radiation overexposure to any person.

(B) For panoramic irradiators the licensee shall:

(1) Design shielding walls to meet generally accepted building code requirements for reinforced concrete and design the walls, wall penetrations, and entranceways to meet the radiation shielding requirements of rule 3701:1-52-09 of the Administrative Code. If the irradiator will use more than 2 x 10¹⁷ becquerels (five million curies) of activity, evaluate the effects of heating of the shielding walls by the irradiator sources;

(2) Design the foundation, with consideration given to soil characteristics, to ensure it is adequate to support the weight of the facility shield walls;

(3) Verify from the design and logic diagram that the access control system will meet the requirements of rule 3701:1-52-08 of the Administrative Code;

(4) Verify that the number, location, and spacing of the smoke and heat detectors are appropriate to detect fires and that the detectors are protected from mechanical and radiation damage, and verify that the design of the fire extinguishing system provides the necessary discharge patterns, densities, and flow characteristics for complete coverage of the radiation room and that the system is protected from mechanical and radiation damage;

(5) Verify that the source rack will automatically return to the fully shielded position if offsite power is lost for more than ten seconds;

(6) If to be built in seismic areas, the licensee shall design the reinforced concrete radiation shields to retain their integrity in the event of an earthquake by designing to the seismic requirements of an appropriate source such as American Concrete Institute Standard ACI 318-89, "Building Code Requirements for Reinforced Concrete," Chapter 21, "Special Provisions for Seismic Design," revised 1992 (this publication may be obtained from the American Concrete Institute, PO Box 9094, Farmington Hills, MI 48331, telephone (248)848-3700, http://www.concrete.org/store.aspx) or local building codes, if current;

(7) Verify that electrical wiring and electrical equipment in the radiation room are selected to minimize failures due to prolonged exposure to radiation;

(8) Determine that source rack drops due to loss of power will not damage the source rack and that source rack drops due to failure of cables (or alternate means of support) will not cause loss of integrity of sealed sources; and

(9) Review the design of the mechanism that moves the sources to assure that the likelihood of a stuck source is low and that, if the rack sticks, a means exists to free it with minimal risk to personnel.

(C) For pool irradiators the licensee shall:

(1) Design the pool to assure that it is leak resistant, that it is strong enough to bear the weight of the pool water and shipping casks, that a dropped cask would not fall on sealed sources, that all outlets or pipes meet the requirements of paragraph (B) of rule 3701:1-52-13 of the Administrative Code, and that metal components are metallurgically compatible with other components in the pool;

(2) Verify that the design of the water purification system is adequate to meet the requirements of paragraph (E) of rule 3701:1-52-13 of the Administrative Code. The system must be designed so that water leaking from the system does not drain to unrestricted areas without being monitored;

(3) Verify that there are no crevices on the source or between the source and source holder that would promote corrosion on a critical area of the source; and

(4) If the licensee uses radiation monitors to detect contamination under paragraph (B) of rule 3701:1-52-22 of the Administrative Code, the licensee shall verify that the design of radiation monitoring systems to detect pool contamination includes sensitive detectors located close to where contamination is likely to concentrate.

Last updated April 29, 2022 at 2:12 PM

History

• Effective: April 29, 2022
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-52-17 Construction monitoring and acceptance testing.

The requirements of this rule must be met for irradiators under construction. The requirements must be met prior to loading sources.

(A) For all irradiators the licensee shall:

(1) Verify the proper operation of the monitor to detect sources carried on the product conveyor system and the related alarms and interlocks required by paragraph (A) of rule 3701:1-52-11 of the Administrative Code; and

(2) For all irradiators with product conveyor systems, observe and test the operation of the conveyor system to assure that the requirements in rule 3701:1-52-14 of the Administrative Code are met for protection of the source rack and the mechanism that moves the rack; testing must include tests of any limit switches and interlocks used to protect the source rack and mechanism that moves the rack from moving product carriers.

(B) For panoramic irradiators the licensee shall:

(1) Monitor the construction of the shielding to verify that its construction meets design specifications and generally accepted building code requirements for reinforced concrete;

(2) Monitor the construction of the foundations to verify that their construction meets design specifications;

(3) Test the movement of the source racks for proper operation prior to source loading; testing must include source rack lowering due to simulated loss of power;

(4) Test the completed access control system to assure that it functions as designed and that all alarms, controls, and interlocks work properly;

(5) Test the ability of the heat and smoke detectors to detect a fire, to activate alarms, and to cause the source rack to automatically become fully shielded;

(6) Test the operability of the fire extinguishing system;

(7) Demonstrate that the source racks can be returned to their fully shielded positions without offsite power;

(8) For panoramic irradiators that use a computer system to control the access control system, verify that the access control system will operate properly if offsite power is lost and verify that the computer has security features that prevent an irradiator operator from commanding the computer to override the access control system when it is required to be operable; and

(9) Verify that the electrical wiring and electrical equipment that were installed meet the design specifications.

(C) For pool irradiators the licensee shall:

(1) Verify that the pool meets design specifications and shall test the integrity of the pool, and verify that outlets and pipes meet the requirements of paragraph (B) of rule 3701:1-52-13 of the Administrative Code;

(2) Verify that the water purification system, the conductivity meter, and the water level indicators operate properly;

(3) Verify the proper operation of the radiation monitors and the related alarm if used to meet paragraph (B) of rule 3701:1-52-22 of the Administrative Code; and

(4) For underwater irradiators, verify the proper operation of the over-the-pool monitor, alarms, and interlocks required by paragraph (B) of rule 3701:1-52-11 of the Administrative Code.

Last updated August 1, 2023 at 2:40 PM

History

• Effective: September 1, 2012
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-52-20 Personnel monitoring.

(A) Irradiator operators shall wear a personnel dosimeter while operating a panoramic irradiator or while in the area around the pool of an underwater irradiator. The personnel dosimeter processor must be capable of detecting high energy photons in the normal and accident dose ranges. Each personnel dosimeter must be assigned to and worn by only one individual. Film badges must be processed at least monthly and all other personnel dosimeters that require replacement must be replaced at least quarterly. All personnel dosimeters must be evaluated at least quarterly or promptly after replacement, whichever is more frequent.

(B) Other individuals who enter the radiation room of a panoramic irradiator shall wear a dosimeter, which may be a pocket dosimeter. For groups of visitors, only two people who enter the radiation room are required to wear dosimeters. If pocket dosimeters are used to meet the requirements of this paragraph, a check of their response to radiation must be done at least annually. Acceptable dosimeters must read within plus or minus thirty per cent of the true radiation dose.

Last updated April 29, 2022 at 2:12 PM

History

• Effective: April 29, 2022
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-52-21 Radiation surveys.

(A) A radiation survey of the area outside the shielding of the radiation room of a panoramic irradiator must be conducted with the sources in the exposed position before the facility starts to operate. A radiation survey of the area above the pool for pool irradiators must be conducted after the sources are loaded but before the facility starts to operate. Additional radiation surveys of the shielding must be performed at intervals not to exceed three years and before resuming operation after addition of new sources or any modification to the radiation room shielding or structure that might increase dose rates.

(B) If the radiation levels specified in rule 3701:1-52-09 of the Administrative Code are exceeded, the facility must be modified to comply with the requirements in rule 3701:1-52-09 of the Administrative Code.

(C) Portable radiation survey meters must be calibrated at least annually to an accuracy of plus or minus twenty per cent for the gamma energy of the sources in use. The calibration must be done at two points on each scale or, for digital instruments, at one point per decade over the range that will be used. Portable radiation survey meters must be of a type that does not saturate and read zero at high radiation dose rates.

(D) Water from the irradiator pool, other potentially contaminated liquids, and sediments from pool vacuuming must be monitored for radioactive contamination before release to unrestricted areas. Radioactive concentrations must not exceed those specified in accordance with table II or table III of appendix C to rule 3701:1-38-12 of the Administrative Code, "Annual Limits on Intake (ALI) and Derived Air Concentrations (DAC) of Radionuclides for Occupational Exposure; Effluent Concentrations; Concentrations for Release to Sanitary Sewerage".

(E) Before releasing resins for unrestricted use, they must be monitored before release in an area with a background level less than 0.5 microsievert (0.05 millirem) per hour. The resins may be released only if the survey does not detect radiation levels above background radiation levels. The survey meter used must be capable of detecting radiation levels of 0.5 microsievert (0.05 millirem) per hour.

Last updated August 1, 2023 at 2:41 PM

History

• Effective: January 15, 2017
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-38-12

(A) Except in the case of a planned special exposure pursuant to paragraph (F) of this rule, a licensee or registrant shall limit the occupational dose received by an individual adult, as follows:

(1) An annual limit, which is the more limiting of:

(a) The total effective dose equivalent being equal to 0.05 sievert (five rem); or

(b) The sum of the deep dose equivalent and the committed dose equivalent to any individual organ or tissue other than the lens of the eye being equal to 0.5 sievert (fifty rem).

(2) The annual limits to the lens of the eye, to the skin of the whole body, and to the skin of the extremities, which are:

(a) A lens dose equivalent of 0.15 sievert (fifteen rem), and

(b) A shallow-dose equivalent of 0.5 sievert (fifty rem) to the skin of the whole body or to the skin of any extremity.

(3) Doses received in excess of the annual limits, including doses received during accidents, emergencies, and planned special exposures, shall be subtracted from the limits for planned special exposures that the individual may receive during the current calendar year and during the individual's lifetime in accordance with paragraph (F)(5) of this rule.

(4) When the external exposure is determined by measurement with an external personal monitoring device, the deep-dose equivalent must be used in place of the effective dose equivalent, unless the effective dose equivalent is determined by a dosimetry method approved by the director. The assigned deep-dose equivalent must be for the part of the body receiving the highest exposure.

(a) The assigned shallow-dose equivalent must be the dose averaged over the contiguous ten square centimeters of skin receiving the highest exposure. The deep-dose equivalent, lens-dose equivalent, and shallow-dose equivalent may be assessed from surveys or other radiation measurements for the purpose of demonstrating compliance with the occupational dose limits, if the individual monitoring device was not in the region of highest potential exposure, or the results of individual monitoring are unavailable; or

(b) When a protective apron is worn while working with radiation-generating equipment and monitoring is conducted as specified in paragraph (C)(1) of rule 3701:1-38-14 of the Administrative Code, the effective dose equivalent for external radiation shall be determined as follows:

(i) When only one individual monitoring device is used and it is located at the neck outside the protective apron, the reported deep dose equivalent value multiplied by 0.3 shall be the effective dose equivalent for external radiation; or

(ii) When two individual monitoring devices are worn, one under the protective apron at the waist and the other outside the protective apron at the neck, the effective dose equivalent for external radiation shall be assigned the value of the sum of the deep dose equivalent reported for the individual monitoring device located at the waist under the protective apron multiplied by 1.5 and the deep dose equivalent reported for the individual monitoring device located at the neck outside the protective apron multiplied by 0.04; or

(iii) Through the use of computational methods endorsed by the "American National Standards Institute", recommended by the "National Council on Radiation Protection and Measurements", or approved by the director.

(5) Derived air concentration (DAC) and annual limit on intake (ALI) values are specified in appendix C to this rule and may be used by the licensee to determine the individual's dose and to demonstrate compliance with the occupational dose limits. Appendices A and B are explanatory supplements to appendix C to this rule. Notwithstanding the annual dose limits, the licensee shall limit the soluble uranium intake by an individual to ten milligrams in a week in consideration of chemical toxicity.

(6) In accordance with paragraph (E) of this rule, the licensee or registrant shall reduce the dose that an individual may be allowed to receive in the current year by the amount of occupational dose received while employed by any other person.

(B) Compliance with requirements for summation of external and internal doses shall be in accordance with the following:

(1) If the licensee is required to monitor under both paragraphs (B)(1) and (B)(2) of rule 3701:1-38-14 of the Administrative Code, the licensee shall demonstrate compliance with the dose limits by summing external and internal doses. If the licensee is required to monitor only under paragraph (B)(1) or only under paragraph (B)(2) of rule 3701:1-38-14 of the Administrative Code, then summation is not required to demonstrate compliance with the dose limits. The licensee may demonstrate compliance with the requirements for summation of external and internal doses by meeting one of the conditions specified in paragraph (B)(2) of this rule and the conditions in paragraphs (B)(3) and (B)(4) of this rule. The dose equivalents for the lens of the eye, the skin, and the extremities are not included in the summation, but are subject to separate limits.

(2) If the only intake of radionuclides is by inhalation, the total effective dose equivalent limit is not exceeded if the sum of the deep dose equivalent divided by the total effective dose equivalent limit, plus one of the following does not exceed unity:

(a) The sum of the fractions of the inhalation ALI for each radionuclide; or

(b) The total number of derived air concentration-hours, or DAC-hours, for all radionuclides divided by two thousand; or

(c) The sum of the calculated committed effective dose equivalents to all significantly irradiated organs or tissues (T) calculated from bioassay data using appropriate biological models and expressed as a fraction of the annual limit. For purposes of this requirement, an organ or tissue is deemed to be significantly irradiated if, for that organ or tissue, the product of the weighting factors, W_T, and the committed dose equivalent, H_T,50, per unit intake is greater than ten per cent of the maximum weighted value of H_T,50, that is, W_TH_T,50, per unit intake for any organ or tissue.

(3) If the occupationally exposed individual also receives an intake of radionuclides by oral ingestion greater than ten percent of the applicable oral ALI, the licensee shall account for this intake and include it in demonstrating compliance with the limits set forth in paragraph (A) of this rule.

(4) The licensee shall evaluate and, to the extent practical, account for intakes through wounds or skin absorption. The intake through intact skin has been included in the calculation of DAC for hydrogen-3 and does not need to be further evaluated or accounted for pursuant to this paragraph.

(C) Determination of external dose from airborne radioactive material shall be in accordance with the following:

(1) When determining the dose from airborne radioactive material, the licensee shall include the contribution to the deep dose equivalent, lens dose equivalent, and shallow dose equivalent from external exposure to the radioactive cloud as specified in appendix C to this rule, footnotes ^A and ^B.

(2) The licensee should not use airborne radioactivity measurements or DAC values as the primary means to assess the deep dose equivalent when the airborne radioactive material includes radionuclides other than noble gases, or if the cloud of airborne radioactive material is not relatively uniform. The determination of the deep dose equivalent to an individual should be based upon measurements using instruments or individual monitoring devices.

(D) Determination of internal exposure shall be in accordance with the following:

(1) For purposes of assessing dose used to determine compliance with occupational dose equivalent limits, the licensee shall, when required under paragraph (B) of rule 3701:1-38-14 of the Administrative Code, take suitable and timely measurements of:

(a) Concentrations of radioactive materials in air in work areas; or

(b) Quantities of radionuclides in the body; or

(c) Quantities of radionuclides excreted from the body; or

(d) Combinations of these measurements.

(2) Unless respiratory protective equipment is used, as provided in paragraph (C) of rule 3701:1-38-16 of the Administrative Code or the assessment of intake is based on bioassays, the licensee shall assume that an individual inhales radioactive material at the airborne concentration in which the individual is present.

(3) When specific information on the physical and biochemical properties of the radionuclides taken into the body or the behavior of the material in an individual is known, the licensee may:

(a) Use that information to calculate the committed effective dose equivalent, and, if used, the licensee shall document that information in the individual's record; and

(b) Upon prior approval of the department, adjust the DAC or ALI values to reflect the actual physical and chemical characteristics of airborne radioactive material, for example, aerosol size distribution or density; and

(c) Separately assess the contribution of fractional intakes of Class D, W, or Y compounds of a given radionuclide to the committed effective dose equivalent as specified in appendix A to this rule.

(4) If the licensee chooses to assess intakes of Class Y material using the measurements given in paragraph (D)(1)(b) or (D)(1)(c) of this rule in order to make additional measurements basic to the assessments, the licensee may delay the recording and reporting of the assessments for periods up to seven months, unless otherwise required by paragraph (B)(2) or (C) of rule 3701:1-38-21 of the Administrative Code.

(5) If the identity and concentration of each radionuclide in a mixture are known, the fraction of the DAC applicable to the mixture for use in calculating DAC-hours shall be either:

(a) The sum of the ratios of the concentration to the appropriate DAC value, that is, D, W, or Y, from appendix C to this rule for each radionuclide in the mixture; or

(b) The ratio of the total concentration for all radionuclides in the mixture to the most restrictive DAC value for any radionuclide in the mixture.

(6) If the identity of each radionuclide in a mixture is known, but the concentration of one or more of the radionuclides in the mixture is not known, the DAC for the mixture shall by the most restrictive DAC of any radionuclide in the mixture.

(7) When a mixture of radionuclides in air exists, a licensee may disregard certain radionuclides in the mixture if all of the following occur:

(a) The licensee uses the total activity of the mixture in demonstrating compliance with the dose limits in paragraph (A) of this rule and in complying with the monitoring requirements in paragraph (B) of rule 3701:1-38-14 of the Administrative Code;

(b) The concentration of any radionuclide disregarded is less than ten percent of its DAC; and

(c) The sum of these percentages for all of the radionuclides disregarded in the mixture does not exceed thirty percent.

(8) When determining the committed effective dose equivalent, the licensee may consider the following:

(a) In order to calculate the committed effective dose equivalent, the licensee may assume that the inhalation of one ALI, or an exposure of two thousand DAC-hours, results in a committed effective dose equivalent of 0.05 sievert (five rem), for radionuclides that have their ALIs or DACs based on the committed effective dose equivalent; or

(b) For an ALI and the associated DAC determined by the nonstochastic organ dose limit of 0.5 sievert (fifty rem), the intake of radionuclides that would result in a committed effective dose equivalent of 0.05 sievert (five rem), that is, the stochastic ALI, is listed in parentheses in table I of appendix C to this rule. The licensee may, as a simplifying assumption, use the stochastic ALI to determine committed effective dose equivalent. However, if the licensee uses the stochastic ALI, the licensee shall also demonstrate that the limit in paragraph (A)(1)(b) of this rule is met.

(E) Determination of prior occupational dose shall be made in accordance with the following:

(1) For each individual who is likely to receive an annual occupational dose requiring monitoring pursuant to paragraph (B) of rule 3701:1-38-14 of the Administrative Code, the licensee or registrant shall determine the occupational radiation dose received during the current year.

(2) Prior to permitting an individual to participate in a planned special exposure, the licensee shall determine:

(a) The internal and external doses from all previous planned special exposures; and

(b) All doses in excess of the limits, including doses received during accidents and emergencies, received during the lifetime of the individual.

(3) In complying with the requirements of paragraph (E)(1) or (E)(2) of this rule, a licensee or registrant may:

(a) Accept, as a record of the occupational dose that the individual received during the current year, a written signed statements from the individual, or from the individual's most recent employer for work involving radiation exposure, that discloses the nature and the amount of any occupational dose that the individual may have received during the current year;

(b) Accept, as the record of lifetime cumulative radiation dose, a current department form entitled "lifetime occupational exposure history" or equivalent, signed by the individual and countersigned by an appropriate official of the most recent employer for work involving radiation exposure, or the individual's current employer, if the individual is not employed by the licensee or registrant; and

(c) Obtain reports of the individual's dose equivalent from the most recent employer for work involving radiation exposure, or the individual's current employer, if the individual is not employed by the licensee or registrant, by telephone, telegram, facsimile, e-mail or letter. The licensee or registrant shall request a written verification of the dose data if the authenticity of the transmitted report cannot be established.

(4) The licensee or registrant shall record the exposure history, as required by paragraph (A) of this rule, on a form provided by the department or other clear and legible record, of all the information required on that form. The form or record shall show each period in which the individual received occupational exposure to radiation or radioactive material and shall be signed by the individual who received the exposure. For each period for which the licensee or registrant obtains reports, the licensee or registrant shall use the dose shown in the report in preparing the exposure history form. For any period in which the licensee or registrant does not obtain a report, the licensee or registrant shall place a notation on the exposure history form indicating the periods of time for which data are not available.

(5) If the licensee or registrant is unable to obtain a complete record of an individual's current and previously accumulated occupational dose, the licensee or registrant shall assume:

(a) In establishing administrative controls pursuant to paragraph (A)(6) of this rule for the current year, that the allowable dose limit for the individual is reduced by 12.5 millisievert (1.25 rem), for each quarter for which records were unavailable and the individual was engaged in activities that could have resulted in occupational radiation exposure; and

(b) That the individual is not available for planned special exposures.

(6) The licensee or registrant shall retain the records on the exposure history form until the department terminates each pertinent license or registration requiring this record. The licensee or registrant shall retain records used in preparing the exposure history form for three years after the record is made.

(F) A planned special exposure may be authorized by a licensee in accordance with this paragraph. A licensee may authorize an adult worker to receive doses in addition to and accounted for separately from the doses received under the limits specified in paragraph (A) of this rule provided that each of the following is satisfied:

(1) The licensee authorizes a planned special exposure only in an exceptional situation when alternatives that might avoid the higher exposure are unavailable or impractical;

(2) The licensee and employer, if the employer is not the licensee, specifically authorizes the planned special exposure, in writing, before the exposure occurs;

(3) Before a planned special exposure, the licensee ensures that each individual involved is:

(a) Informed of the purpose of the planned operation; and

(b) Informed of the estimated doses and associated potential risks and specific radiation levels or other conditions that might be involved in performing the task; and

(c) Instructed in the measures to be taken to keep the dose ALARA considering other risks that may be present;

(4) Prior to permitting an individual to participate in a planned special exposure, the licensee ascertains prior doses as required by paragraph (E)(2) of this rule during the lifetime of the individual for each individual involved;

(5) The licensee shall not authorize a planned special exposure that would cause an individual to receive a dose from all planned special exposures and all doses in excess of the limits to exceed:

(a) The numerical values of any of the dose limits in paragraph (A) of this rule in any calendar year; and

(b) Five times the annual dose limits specified in paragraph (A) of this rule during the individual's lifetime;

(6) The licensee maintains records of the conduct of a planned special exposure in accordance with paragraph (E) of rule 3701:1-38-20 of the Administrative Code and submits a written report in accordance with paragraph (D) of rule 3701:1-38-21 of the Administrative Code;

(7) The licensee records the best estimate of the dose resulting from the planned special exposure in the individual's record and informs the individual, in writing, of the dose within thirty days from the date of the planned special exposure. The dose from planned special exposures shall not be considered in controlling future occupational dose of the individual pursuant to paragraph (A)(1) of this rule, but shall be included in evaluations required by paragraphs (F)(4) and (F)(5) of this rule.

(G) Occupational dose limits for minors shall be ten per cent of the annual occupational dose limits specified for adult workers in paragraph (A) of this rule.

(H) Dose equivalent to an embryo or fetus shall be in accordance with the following:

(1) The licensee or registrant shall ensure that the dose equivalent to an embryo or fetus during the entire pregnancy, due to occupational exposure of a declared pregnant woman, does not exceed five millisievert (0.5 rem). Records shall be maintained in accordance with paragraph (I) of rule 3701:1-38-20 of the Administrative Code.

(2) The licensee or registrant shall make efforts to avoid substantial variation above a uniform monthly exposure rate to a declared pregnant woman so as to satisfy the limit in paragraph (H)(1) of this rule.

(3) The dose equivalent to the embryo or fetus is the sum of:

(a) The deep-dose equivalent to the declared pregnant woman; and

(b) The dose equivalent to the embryo or fetus resulting from radionuclides in the embryo or fetus and from radionuclides in the declared pregnant woman.

(4) If the declared pregnant woman's exposure includes exposure from radiation generating equipment and a protective apron is worn, the dose equivalent to an embryo or fetus shall be taken as the sum of:

(a) The dose equivalent to the embryo or fetus from radionuclides in the embryo or fetus and radionuclides in the declared pregnant woman; and

(b) The dose equivalent that is most representative of the dose to the embryo or fetus from external radiation, that is, in the mother's lower torso region.

(i) If multiple measurements have not been made, assignment of the highest deep dose equivalent for the declared pregnant woman shall be the dose to the embryo or fetus, in accordance with paragraph (A)(4) of this rule; or

(ii) If multiple measurements have been made, assignment of the deep dose equivalent for the declared pregnant woman from the individual monitoring device which is most representative of the dose to the embryo or fetus shall be the dose to the embryo or fetus. Assignment of the highest deep dose equivalent for the declared pregnant woman to the embryo or fetus is not required unless that dose is also the most representative deep dose equivalent for the region of the embryo or fetus.

(5) If by the time the woman declares pregnancy to the licensee or registrant, the dose equivalent to the embryo or fetus has exceeded five millisievert, or 0.5 rem, the licensee or registrant shall be deemed to be in compliance with paragraph (A) of this rule, provided that the additional dose equivalent to the embryo or fetus does not exceed 0.5 millisievert (0.05 rem), during the remainder of the pregnancy.

View AppendixView AppendixView Appendix

Last updated November 2, 2022 at 2:10 PM

History

• Effective: October 4, 2010
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-52-24

(A) The pool water purification system must be run sufficiently to maintain the conductivity of the pool water below twenty microsiemens per centimeter under normal circumstances. If pool water conductivity rises above twenty microsiemens per centimeter, the licensee shall take prompt actions to lower the pool water conductivity and shall take corrective actions to prevent future recurrences.

(B) The licensee shall measure the pool water conductivity frequently enough, but no less than weekly, to assure that the conductivity remains below twenty microsiemens per centimeter. Conductivity meters must be calibrated at least annually.

Last updated August 1, 2023 at 2:41 PM

History

• Effective: October 20, 2002
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-52-25 Attendance during operation.

(A) Both an irradiator operator and at least one other individual, who is trained on how to respond and prepared to promptly render or summon assistance if the access control alarm sounds, shall be present onsite:

(1) Whenever the irradiator is operated using an automatic product conveyor system; and

(2) Whenever the product is moved into or out of the radiation room when the irradiator is operated in a batch mode.

(B) At a panoramic irradiator at which static irradiations (no movement of the product) are occurring, a person who has received the training on how to respond to alarms described in paragraph (G) of rule 3701:1-52-18 of the Administrative Code must be onsite.

(C) At an underwater irradiator, an irradiator operator must be present at the facility whenever the product is moved into or out of the pool. Individuals who move the product into or out of the pool of an underwater irradiator need not be qualified as irradiator operators; however, they must have received the training described in paragraphs (F) and (G) of rule 3701:1-52-18 of the Administrative Code. Static irradiations may be performed without a person present at the facility.

Last updated August 1, 2023 at 2:41 PM

History

• Effective: October 20, 2002
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-52-26 Entering and leaving the radiation room.

(A) Upon first entering the radiation room of a panoramic irradiator after an irradiation, the irradiator operator shall use a survey meter to determine that the source has returned to its fully shielded position. The operator shall check the functioning of the survey meter with a radiation check source prior to entry.

(B) Before exiting from and locking the door to the radiation room of a panoramic irradiator prior to a planned irradiation, the irradiator operator shall:

(1) Visually inspect the entire radiation room to verify that no one else is in it; and

(2) Activate a control in the radiation room that permits the sources to be moved from the shielded position only if the door to the radiation room is locked within a preset time after setting the control.

(C) During a power failure, the area around the pool of an underwater irradiator may not be entered without using an operable and calibrated radiation survey meter unless the over-the-pool monitor required by paragraph (B) of rule 3701:1-52-11 of the Administrative Code is operating with backup power.

Last updated August 1, 2023 at 2:41 PM

History

• Effective: October 20, 2002
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-52-27 Irradiation of explosive or flammable material.

(A) Irradiation of explosive material is prohibited unless the licensee has received prior written authorization from the director. Authorization will not be granted unless the licensee can demonstrate that detonation of the explosive would not rupture the sealed sources, injure personnel, damage safety systems, or cause radiation overexposures of personnel.

(B) Irradiation of flammable material with a flash point below sixty degrees celsius (one hundred forty degrees fahrenheit), is prohibited in panoramic irradiators unless the licensee has received prior written authorization from the director. Authorization will not be granted unless the licensee can demonstrate that a fire in the radiation room could be controlled without damage to sealed sources or safety systems and without radiation overexposures of personnel.

Last updated August 1, 2023 at 2:41 PM

History

• Effective: October 8, 2007
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-52-28 Records and retention periods.

The licensee shall maintain the following records at the irradiator for the periods specified.

(A) A copy of the license, license conditions, documents incorporated into a license by reference, and amendments thereto until superseded by new documents or until the director terminates the license.

(B) Records of each individual's training, tests, and safety reviews provided to meet the requirements of paragraphs (A), (B), (C), (D), (F), and (G) of rule 3701:1-52-18 of the Administrative Code until three years after the individual terminates work.

(C) Records of the annual evaluations of the safety performance of irradiator operators required by paragraph (E) of rule 3701:1-52-18 of the Administrative Code for three years after the evaluation.

(D) A copy of the current operating and emergency procedures required by rule 3701:1-52-19 of the Administrative Code until superseded or the director terminates the license. Records of the radiation safety officer's review and approval of changes in procedures as required by paragraph (C)(3) of rule 3701:1-52-19 of the Administrative Code retained for three years from the date of the change.

(E) Personnel dosimetry results required by rule 3701:1-52-20 of the Administrative Code until the director terminates the license.

(F) Records of radiation surveys required by rule 3701:1-52-21 of the Administrative Code for three years from the date of the survey.

(G) Records of radiation survey meter calibrations required by rule 3701:1-52-21 of the Administrative Code and pool water conductivity meter calibrations required by paragraph (B) of rule 3701:1-52-24 of the Administrative Code until three years from the date of calibration.

(H) Records of the results of leak tests required by paragraph (A) of rule 3701:1-52-22 of the Administrative Code and the results of contamination checks required by paragraph (B) of rule 3701:1-52-22 of the Administrative Code for three years from the date of each test.

(I) Records of inspection and maintenance checks required by rule 3701:1-52-23 of the Administrative Code for three years.

(J) Records of major malfunctions, significant defects, operating difficulties or irregularities, and major operating problems that involve required radiation safety equipment for three years after repairs are completed.

(K) Records of the receipt, transfer and disposal, of all licensed sealed sources as required by rules 3701:1-40-19 and 3701:1-40-21 of the Administrative Code.

(L) Records on the design checks required by rule 3701:1-52-16 of the Administrative Code and the construction control checks as required by rule 3701:1-52-17 of the Administrative Code until the license is terminated. The records must be signed and dated. The title or qualification of the person signing must be included.

(M) Records related to decommissioning of the irradiator as required by paragraph (I) of rule 3701:1-40-17 of the Administrative Code.

Last updated August 1, 2023 at 2:42 PM

History

• Effective: October 20, 2002
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-40-19

(A) No licensee shall transfer radioactive material except as authorized by this rule.

(B) Except as otherwise provided in the license and subject to the provisions of paragraph (C) of this rule, any licensee may transfer radioactive material:

(1) To the United States department of energy;

(2) To the agency in any agreement state which regulates radioactive material pursuant to an agreement under section 274 of the "Atomic Energy Act", as amended;

(3) To any person exempt from the licensing requirements of the act and regulations in this chapter, to the extent permitted under such exemption;

(4) To any person in an agreement state, subject to the jurisdiction of that state, who has been exempted from the licensing requirements and regulations of that state, to the extent permitted under such exemption;

(5) To any person authorized to receive such radioactive material under terms of a specific license or a general license or their equivalents issued by the United States atomic energy commission, the United States nuclear regulatory commission, or an agreement state; or

(6) As otherwise authorized by the director in writing.

(C) Before transferring radioactive material to an entity specified in paragraph (B) of this rule, the licensee transferring the material shall verify that the transferee's license authorizes the receipt of the type, form, and quantity of radioactive material to be transferred. The licensee may verify the transferee's authorization to accept the material by possessing one of the following:

(1) A current copy of the transferee's specific license or registration certificate specifying the type, form, and quantity of radioactive material to be transferred;

(2) A written certification by the receiving licensee certifying that the licensee is authorized by license or registration certificate to receive the type, form, and quantity of radioactive material to be transferred, and further specifying the license or registration certificate number, issuing agency, and expiration date;

(3) In the case of an emergency shipment, the transferring licensee may accept oral certification by the receiving licensee that the licensee is authorized by license or registration certificate to receive the type, form, and quantity of radioactive material to be transferred, and further, specifying the license or registration certificate number, issuing agency and expiration date. The transferring licensee shall obtain written confirmation detailing the oral certification within ten days of the emergency transfer; or

(4) The transferor may obtain other sources of information compiled by a reporting service from official records of the department, United States nuclear regulatory commission, or the licensing agency of an agreement state as to the identity of the receiving licensee, whether the licensee is authorized by license or registration certificate to receive the type, form, and quantity of radioactive material to be transferred, and the expiration date of the receiving licensee's license or registration.

Last updated November 2, 2022 at 2:12 PM

History

• Effective: October 4, 2010
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-40-21

(A) Each person who receives radioactive material under a license issued pursuant to the rules in this chapter, and other chapters of the Administrative Code adopted pursuant to Chapter 3748. of the Revised Code, and rule 3701:1-38-02 of the Administrative Code, shall keep records showing the receipt, transfer, and disposal of the radioactive material as follows:

(1) The licensee shall retain each record of receipt of radioactive material as long as the material is possessed and for three years following transfer or disposal of the material.

(2) The licensee who transferred the material shall retain each record of transfer for three years after each transfer unless otherwise specified by rule for that particular licensed activity.

(3) The licensee who disposed of the material shall retain each record of disposal of radioactive material until the director terminates each license that authorizes disposal of the material.

(B) Except as provided in paragraph (C) of this rule, the licensee shall retain each record that is required by this chapter, Chapters 3701:1-46, 3701:1-48, 3701:1-49, 3701:1-52, and 3701:1-58 of the Administrative Code, and rule 3701:1-38-02 of the Administrative Code, or by license condition for the period specified by the appropriate regulation or license condition. If a retention period is not otherwise specified by rule or license condition, the record must be retained until the director terminates each license that authorizes the activity that is subject to the record-keeping requirement. Such records may be either the original record or a reproduced copy or microform, provided that such copy or microform is duly authenticated by authorized personnel and the microform is capable of producing a clear and legible copy after storage for the period specified by the director. The record also may be stored in electronic media provided that the licensee is capable of producing legible, accurate, and complete records during the required retention period. Records such as letters, drawings, specifications, must include all pertinent information such as stamps, initials, and signatures. The licensee shall maintain adequate safeguards against record tampering and loss.

(C) In the case of a conflict between a record requirement specified in rule and that requirement specified as a license condition, the licensee shall comply with the license condition.

(D) Prior to license termination, each licensee authorized to possess radioactive material with a half-life greater than one hundred twenty days, in an unsealed form, shall forward to the department, records of disposal of radioactive material buried without specific state authority or buried without authorization from the United States nuclear regulatory commission prior to January 28, 1981, pursuant to 10 C.F.R. 20.304, as that section existed on January 1, 1981.

(E) If licensed activities are transferred or assigned in accordance with paragraph (B) of rule 3701:1-40-19 of the Administrative Code, each licensee authorized to possess radioactive material, with a half-life greater than one hundred twenty days, in an unsealed form, shall transfer the following records to the new licensee and the new licensee will be responsible for maintaining these records until the license is terminated:

(1) Records of disposal of licensed material made under rule 3701:1-38-19 of the Administrative Code, including any burial authorized under a United States nuclear regulatory commission license on or before January 28, 1981, or a previous "section 20.304" permitted burial of a small quantity of licensed material in soil by a United States nuclear regulatory commission licensee on or before January 28, 1981, without specific authorization, in accordance with 10 C.F.R. 20.304 as that section existed on January 1, 1981.

(2) Records required by rule 3701:1-38-20 of the Administrative Code.

(F) Prior to license termination, each licensee shall forward to the department all the records required by paragraph (I) of rule 3701:1-40-17 of the Administrative Code.

Last updated April 19, 2022 at 8:35 AM

History

• Effective: April 17, 2022
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-40-17

(A) Prior to the director issuing a radioactive materials license:

(1) Each applicant for a specific license or license renewal authorizing the possession and use of unsealed radioactive material of half-life greater than one hundred twenty days and in quantities exceeding ten thousand times the applicable quantities set forth in appendix A to this rule shall submit a decommissioning funding plan as described in paragraph (D) of this rule. The decommissioning funding plan must also be submitted when a combination of radionuclides is involved if R divided by ten thousand is greater than one, where R is defined here as the sum of the ratios of the quantity of each radionuclide to the applicable value in appendix A to this rule.

(2) Each applicant for a specific license or license renewal authorizing the possession and use of sealed sources or plated foils of half-life greater than one hundred twenty days and in quantities exceeding one trillion times the applicable quantities of appendix A to this rule, shall submit a decommissioning funding plan as described in paragraph (D) of this rule. The decommissioning funding plan must also be submitted when a combination of radionuclides is involved if R divided by one trillion is greater than one, where R is defined here as the sum of the ratios of the quantity of each radionuclide to the applicable value in appendix A to this rule.

(B) Prior to the director issuing a radioactive materials license, each applicant for a specific license or license renewal authorizing possession and use of radioactive material of half-life greater than one hundred twenty days and in quantities specified in paragraph (C) of this rule shall either:

(1) Submit a decommissioning funding plan as described in paragraph (D) of this rule; or

(2) Submit a certification that financial assurance for decommissioning has been provided in the amount prescribed by paragraph (C) of this rule using one of the methods described in paragraph (E) of this rule. The applicant shall submit to the director, as part of the certification, a signed original of the financial instrument obtained to satisfy the requirements of paragraph (E) of this rule.

(C) Prior to the director issuing a radioactive materials license, an applicant providing certification of financial assurance for decommissioning as specified in paragraph (B)(2) of this rule shall provide the certification in a monetary amount based upon the quantity of licensed material specified as follows:

(1) Greater than one thousand but less than or equal to ten thousand times the applicable quantities of appendix A to this rule in unsealed form. For a combination of radionuclides, if R, as defined in paragraph (A) of this rule, divided by one thousand is greater than one but R divided by ten thousand is less than or equal to one, the sum of three hundred thousand dollars.

(2) Greater than ten billion but less than one trillion times the applicable quantities of appendix A to this rule in sealed sources or plated foils. For a combination of radionuclides, if R, as defined in paragraph (A) of this rule, divided by ten billion is greater than one but R divided by one trillion is less than or equal to one, the sum of one hundred fifty thousand dollars.

(D) .

(1) Each decommissioning funding plan must be submitted for review and approval and must contain:

(a) A detailed cost estimate for decommissioning, in an amount reflecting:

(i) The cost of an independent contractor to perform all decommissioning activities;

(ii) The cost of meeting the criteria specified in paragraph (B) of rule 3701:1-38-22 of the Administrative Code for unrestricted use, provided that, if the applicant or licensee can demonstrate its ability to meet the provisions of paragraph (D) of rule 3701:1-38-22 of the Administrative Code, the cost estimate may be based on meeting this criteria;

(iii) The volume of onsite subsurface material containing residual radioactivity that will require remediation to meet the criteria for license termination; and

(iv) An adequate contingency factor.

(b) Identification of and justification for using the key assumptions contained in the decommissioning cost estimate;

(c) A description of the method of assuring funds for decommissioning from paragraph (E) of this rule, including means for adjusting cost estimates and associated funding levels periodically over the life of the facility;

(d) A certification by the licensee that financial assurance for decommissioning has been provided in the amount of the cost estimate for decommissioning; and

(e) A signed original of the financial instrument obtained to satisfy the requirements of paragraph (E) of this rule (unless a previously submitted and accepted financial instrument continues to cover the cost estimate for decommissioning).

(2) At the time of license renewal and at intervals not to exceed three years, the decommissioning funding plan must be resubmitted with adjustments as necessary to account for the changes in costs and the extent of contamination. If the amount of financial assurance will be adjusted downward, this cannot be done until the updated decommissioning funding plan is approved. The decommissioning funding plan must update the information submitted with the original or prior approved plan, and must specifically consider the effect of the following events on decommissioning costs:

(a) Spills of radioactive material producing additional residual radioactivity in onsite subsurface material;

(b) Waste inventory increasing above the amount previously estimated;

(c) Waste disposal costs increasing above the amount previously estimated;

(d) Facility modifications;

(e) Changes in authorized possession limits;

(f) Actual remediation costs that exceed the previous cost estimate;

(g) Onsite disposal; and

(h) Use of a settling pond.

(E) Financial assurance for decommissioning, either by a decommissioning funding plan or certification of financial assurance, shall be provided by the licensee and approved by the director prior to the issuance of the license and shall be provided by one or more of the following methods:

(1) Prepayment by depositing into an account segregated from licensee assets and outside the licensee's administrative control, cash or liquid assets such that the amount of funds will be sufficient to pay decommissioning costs. Prepayment may be in the form of a trust, escrow account, government fund, certificate of deposit, or deposit of government securities.

(2) Surety, insurance, or other method in accordance with paragraph (F) of this rule, that guarantees that decommissioning costs will be paid. A surety method may be in the form of a surety bond, letter of credit, or line of credit. A guarantee by the applicant or licensee may not be used in combination with any other financial methods used to satisfy the requirements of this paragraph or in any situation where the applicant or licensee has a parent company holding majority control of the voting stock of the company.

(3) A parent company guarantee of funds for decommissioning costs based on a financial test may be used provided that the parent company meets the requirements specified in appendix B of this rule. A parent company guarantee may not be used in combination with other financial methods to satisfy the requirements of this rule.

(4) For commercial corporations that issue bonds, a guarantee of funds by the applicant or licensee for decommissioning costs based on a financial test may be used provided that the guarantee meets the requirements of appendix C to this rule.

(5) For commercial companies that do not issue bonds, a guarantee of funds for decommissioning costs may be used provided that the guarantee meets the requirements of appendix D to this rule.

(6) For nonprofit colleges, universities, hospitals, or research and development entities, a guarantee of funds for decommissioning costs may be used provided that the guarantee meets the requirements of appendix E to this rule. The director may require proof of nonprofit status.

(7) An external sinking fund in which deposits are made at least annually, coupled with a surety method or insurance, the value of which may decrease by the amount being accumulated in the sinking fund. An external sinking fund is a fund established and maintained by setting aside funds periodically in an account segregated from licensee assets and outside the licensee's administrative control in which the total amount of funds would be sufficient to pay decommissioning costs at the time termination of operation is expected. An external sinking fund may be in the form of a trust, escrow account, government fund, certificate of deposit, or deposit of government securities. The surety or insurance provisions must be as stated in paragraph (F) of this rule.

(8) In the case of state or local government licensee, a statement of intent containing a cost estimate for decommissioning or an amount specified in paragraphs (C)(1) to (C)(2) of this rule, and indicating that funds for decommissioning will be obtained when necessary. As used in this rule, "state or local government licensee" does not include government owned or assisted colleges, universities or hospitals.

(F) Any surety method or insurance used to provide financial assurance for decommissioning shall be in the form of instruments that contain language as provided in appendix F to this rule, and shall contain the following conditions:

(1) The surety method or insurance must be open-ended or, if written for a specified term, such as five years, must be renewed automatically unless ninety days or more prior to the renewal date, the issuer notifies the director, the beneficiary, and the licensee of its intention not to renew. The surety method or insurance must also provide that the full face amount be paid to the beneficiary automatically prior to the expiration without proof of forfeiture if the licensee fails to provide a replacement acceptable to the director within thirty days after receipt of notification of cancellation.

(2) The surety method or insurance must be payable to a trust established for decommissioning costs. The trustee and trust must be acceptable to the director. An acceptable trustee includes an appropriate state or federal government agency or an entity which has the authority to act as a trustee and whose trust operations are regulated and examined by a federal or state agency.

(3) The surety method or insurance must remain in effect until the director has terminated the license.

(4) The surety company issuing the bond must, at a minimum, be among those listed as acceptable in the "Circular 570" of the United States department of the treasury (as in effect on the effective date of this rule).

(G) A licensee must notify the director by certified mail within ten business days of the commencement of a voluntary or involuntary bankruptcy proceeding under Title 11 of the United States Code (as amended April 20, 2005). A licensee who fulfills the financial assurance requirements by obtaining a trust fund, surety bond, or other acceptable financial assurance will be deemed to be without the required financial assurance or liability coverage in the event of bankruptcy of the trustee or issuing institution, or a suspension or revocation of the authority of the trustee institution issuing the instrument. The licensee shall establish other financial assurance within sixty days after such an event.

(H) Financial assurance for decommissioning, either by a decommissioning funding plan or certification of financial assurance, that is provided by a contract of insurance shall not include any arrangement that constitutes self-insurance. As used in this rule:

(1) "Insurance" means a contract issued or underwritten by an insurance company, insurance service, or insurance organization which is licensed to engage in the business of insurance in Ohio, that binds the insurer to indemnify another against a specified loss in return for premiums paid.

(2) "Self insurance" means a contract of insurance issued either by the licensee or by an insurer affiliated with or an affiliate of the licensee.

(3) "Affiliate of" or "affiliated with" means that the licensee, either directly or indirectly, through one or more intermediaries or subsidiaries, controls, is controlled by, or is under common control with the insurer.

(4) "Control", including "controlled by", and "under common control with" means the possession, direct or indirect, of the power to direct or cause the direction of the management and policies of a person, whether through the ownership of voting securities, by contract, proxy, membership on the board, or otherwise.

(I) Each person licensed under this chapter, and rule 3701:1-38-02 of the Administrative Code as well as chapters containing rules regarding manufacturing and distribution (Chapter 3701:1-46 of the Administrative Code), industrial radiography (Chapter 3701:1-48 of the Administrative Code), well logging Chapter 3701:1-49 of the Administrative Code), irradiators (Chapter 3701:1-52 of the Administrative Code), and medical use (Chapter 3701:1-58 of the Administrative Code) promulgated pursuant to Chapter 3748. of the Revised Code shall keep records of information important to the decommissioning of a facility in an identified location until the site is released for unrestricted use. Before licensed activities are transferred or assigned in accordance with paragraph (B) of rule 3701:1-40-20 of the Administrative Code, a licensee shall transfer all records described in this paragraph to the new licensee, which will be responsible for maintaining these records until the license is terminated. If records important to the decommissioning of a facility are kept for other purposes, reference to these records and their locations may be used. As used in this rule, "information important to the decommissioning of a facility" includes the following:

(1) Records of spills or other unusual occurrences involving the spread of contamination in and around the facility, equipment, or site. These records may be limited to instances when contamination remains after any cleanup procedures or when there is reasonable likelihood that contaminants may have spread to inaccessible areas as in the case of possible seepage into porous materials such as concrete. These records must include any known information on identification of involved radionuclides, quantities, forms, and concentrations.

(2) As-built drawings and modifications of structures and equipment in restricted areas where radioactive materials are used or stored, and of locations of possible inaccessible contamination such as buried pipes which may be subject to contamination. If required drawings are referenced, each relevant document need not be indexed individually. If drawings are not available, the licensee shall substitute appropriate records of available information concerning these areas and locations.

(3) Except in the case of an area that contains only a sealed source, provided the source has not leaked or no contamination remains after any leak, or in the case of a byproduct or accelerator produced material having only a half-life of less than sixty-five days, a list contained in a single document and updated every two years, of the following:

(a) All areas designated and formerly designated restricted areas as defined in rule 3701:1-38-01 of the Administrative Code.

(b) All areas outside of restricted areas that require documentation under paragraph (I)(1) of this rule.

(c) All areas outside of restricted areas where current and previous wastes have been buried as documented under rule 3701:1-38-20 of the Administrative Code; and

(d) All areas outside of restricted areas that contain material such that, if the license expired, the licensee would be required to either decontaminate the area to meet the criteria for decommissioning in rule 3701:1-38-22 of the Administrative Code, or apply for approval for disposal under rule 3701:1-38-19 of the Administrative Code.

(4) Records of the cost estimate performed for the decommissioning funding plan or of the amount certified for decommissioning, and records of the funding method used for assuring funds if either a funding plan or certification is used.

View AppendixView AppendixView AppendixView AppendixView AppendixView Appendix

Last updated April 19, 2022 at 8:35 AM

History

• Effective: April 17, 2022
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-52-29 Reports.

(A) In addition to the reporting requirements in other chapters of the Administrative Code adopted pursuant to Chapter 3748. of the Revised Code, the licensee shall report the following events to the director if not reported under other chapters of the Administrative Code adopted pursuant to Chapter 3748. of the Revised Code:

(1) Source stuck in an unshielded position.

(2) Any fire or explosion in a radiation room.

(3) Damage to the source racks.

(4) Failure of the cable or drive mechanism used to move the source racks.

(5) Inoperability of the access control system.

(6) Detection of radiation source by the product exit monitor.

(7) Detection of radioactive contamination attributable to licensed radioactive material.

(8) Structural damage to the pool liner or walls.

(9) Abnormal water loss or leakage from the source storage pool.

(10) Pool water conductivity exceeding one hundred microsiemens per centimeter.

(B) The report must include a telephone report within twenty-four hours as described in paragraph (C)(1) of rule 3701:1-40-20 of the Administrative Code, and a written report within thirty days as described in paragraph (C)(2) of rule 3701:1-40-20 of the Administrative Code.

Last updated August 1, 2023 at 2:42 PM

History

• Effective: January 15, 2017
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-40-20

(A) Except as provided in paragraph (D) of this rule, each licensee shall notify the department as soon as possible, but not later than four hours after the discovery of an event that prevents immediate protective action necessary to avoid exposure to radiation or radioactive material that could exceed regulatory limits, or a release of licensed material that could exceed regulatory limits. An event that requires such an immediate report may include a fire, explosion, or toxic gas release.

(B) Each licensee shall notify the department within twenty-four hours after the discovery of any of the following events involving licensed material:

(1) An unplanned contamination event that involves:

(a) Access to the contaminated area, by workers or the public, to be restricted for more than twenty-four hours by imposing additional radiological controls or by prohibiting entry into the area;

(b) A quantity of material greater than five times the lowest annual limit on intake specified in the appendices to rule 3701:1-38-12 of the Administrative Code; and

(c) Access to the area restricted for a reason other than to allow radionuclides with a half-life of less than twenty-four hours to decay prior to decontamination.

(2) An event in which equipment is disabled or fails to function as designed when:

(a) The equipment is required by regulation or license condition to prevent a release exceeding regulatory limits, to prevent exposure to radiation or radioactive material exceeding regulatory limits, or to mitigate the consequences of an accident;

(b) The equipment is required to be available and operable when it is disabled or fails to function; and

(c) No redundant equipment is available and operable to perform the required safety function.

(3) An event that requires unplanned medical treatment of an individual with spreadable radioactive contamination on the individual's clothing or body.

(4) An unplanned fire or explosion damaging any licensed material or any device, container, or equipment containing licensed material when:

(a) The quantity of material involved is greater than five times the lowest annual limit on intake specified in the appendices to rule 3701:1-38-12 of the Administrative Code; and

(b) The damage affects the integrity of the licensed material or its container.

(C) The licensee shall prepare and submit a report in response to the requirements of this rule as follows:

(1) Licensees shall make reports required by paragraphs (A) and (B) of this rule by telephone, to the department at the telephone number listed in the notice to employees required by paragraph (A)(1)(e) of rule 3701:1-38-10 of the Administrative Code. To the extent that the information is available at the time of notification, the information provided in these reports must include:

(a) The caller's name and call back telephone number;

(b) A description of the event, including date and time;

(c) The exact location of the event;

(d) The radionuclides, quantities, and chemical and physical form of the licensed material involved; and

(e) Any personnel radiation exposure data available.

(2) Each licensee who makes a report required by paragraph (A) or (B) of this rule shall submit a written follow-up report within thirty days of the initial report. Written reports prepared pursuant to other regulations may be submitted to fulfill this requirement if the report contains all of the necessary information and the appropriate distribution is made. These written reports shall be sent to the department in the manner specified in rule 3701:1-40-04 of the Administrative Code. The report must include the following:

(a) A description of the event, including the probable cause and the manufacturer and model number, if applicable, of any equipment that failed or malfunctioned;

(b) The exact location of the event;

(c) The radionuclides, quantities, and chemical and physical form of the licensed material involved;

(d) Date and time of the event;

(e) Corrective actions taken or planned and the results of any evaluations or assessments; and

(f) The extent of exposure of individuals to radiation or to radioactive materials without identification of individuals by name.

(D) This rule applies to all licensees possessing material licensed under rule 3701:1-38-02 of the Administrative Code. This rule does not apply to material under a license subject to the notification requirements in 10 C.F.R. 50.72 (as in effect on the effective date of this rule).

(E) An applicant for a license or a licensee shall notify the department within two working days of information identified by the applicant or licensee as having for the regulated activity, an active adverse impact on equipment or personnel readily obvious by human observation or instrumentation, or a radiological impact on personnel or the environment in excess of regulatory limits. An applicant or licensee violates this paragraph only if the applicant or licensee fails to notify the director of information that the applicant or licensee has or should have identified.

Last updated April 19, 2022 at 8:35 AM

History

• Effective: April 17, 2022
• Promulgated Under: 119.03

Chapter 3701:1-54 Radiation Generator and Broker Reporting Requirements

Ohio Adm.Code 3701:1-54-01 Definitions.

As used in Chapter 3701:1-54 of the Administrative Code:

(A) "Above grade construction" for the purposes of a disposal cell for radioactive waste, means the structural design such that the bottom of the waste is at or above the elevation of the native surface topography.

(B) "Active maintenance" as used in reference to an AIF, means any improvements or repairs to the physical features of an AIF that are intended to preserve the ability of the facility to perform its function of isolating radioactive waste.

"Active maintenance" as used in reference to land disposal of radioactive waste, means any significant remedial activity needed during the period of institutional control to maintain a reasonable assurance that the performance objectives are met. Such active maintenance includes, but is not limited to, ongoing activities such as the pumping and treatment of water from a disposal unit or one-time measures such as replacement of a disposal unit cover. Active maintenance does not include custodial activities such as repair of fencing, repair or replacement of monitoring equipment, revegetation, minor additions to soil cover, minor repair of disposal unit covers, and general disposal site upkeep such as mowing grass.

(C) "Assured isolation" means an integrated management system for isolating licensable radioactive waste for a period not to exceed one hundred years, while preserving options for its long term management through robust, accessible facilities, and planned preventative maintenance. The time limit starts from the date that the radioactive waste is received by the AIF.

(D) "Assured isolation facility (AIF)" means the structures and land containing the operational components of a site for the assured isolation of licensable radioactive waste. This includes, but is not limited to, support and administrative facilities, roads and staging areas.

(E) "Assured isolation site" means the entire plot of land on which an AIF is located, including that portion of the earth underlying the facility which is of significance to its structural stability, or is related to the environmental monitoring of the facility.

(F) "Broker" means any person who takes possession of radioactive waste solely for purposes of consolidation and shipment.

(G) "Buffer Zone" means a portion of a site that is controlled by the licensee and that lies under the storage or disposal units and between the structure containing the radioactive waste and the site boundary.

(H) "Carrier" means a person who is engaged in the transportation of radioactive waste by air, rail, road, highway, or water.

(I) "Disposal" or "dispose" means the permanent isolation of radioactive waste in accordance with Chapter 3748. of the Revised Code and the rules promulgated thereunder.

(J) "Disposal site" means that portion of a facility that is used for the disposal of low level radioactive waste and that consists of disposal units and a buffer zone.

(K) "Disposal unit" means a discrete portion of the facility into which low level radioactive waste is placed for disposal.

(L) "Engineered Barrier" means a man made structure or device that us intended to improve a facility's ability to meet the performance objectives.

(M) "Frequent earthquake activity" means more than three earthquakes of greater than Richter magnitude of 4.5, within an epicentral distance of less than 24.2 kilometers (fifteen miles), over a projected interval of one hundred years, based on currently available scientific analyses of the past one hundred years seismicity.

(N) "Generator" means a person who first produces radioactive waste, including, without limitation, any person who does so in the course of or incident to manufacturing, power generation, processing, waste treatment, waste storage, medical diagnosis or treatment, research, or other industrial or commercial activity. "Generator" does not include a patient who may discharge radioactive material in body wastes or fluids as the result of a medical procedure; however, the waste or fluids generated by such a patient are low-level radioactive waste. If the person who first produced an item or quantity of waste cannot be identified, "generator" means the person first possessing the waste who can be identified.

(O) "Inadvertent intruder" means a person who might occupy the disposal site after closure and engage in normal activities, such as agriculture, dwelling, construction, or other pursuits in which the person might be unknowingly exposed to radiation from the waste.

(P) "Inadvertent intrusion" means any activity performed by a person that would unknowingly expose or release radiation from the waste, or compromise barriers designed to meet the performance objectives of the disposal site.

(Q) "Isolation" means the segregation and impoundment of radioactive waste in a manner that protects the environment inhabited by humans, including, but not limited to, the human food chain.

(R) "Karst" means a terrain with an assemblage of landforms such as sinkholes and caves that are due to weathering of predominantly carbonate bedrock.

(S) "Land disposal" means disposal of radioactive waste in a land disposal facility.

(T) "Land disposal facility" means the land, buildings, and equipment that is intended to be used for the disposal of radioactive waste.

(U) "Mixed waste" is radioactive waste that contains a listed hazardous waste or exhibits a hazardous waste characteristic identified in 40 C.F.R. 261, Subpart C (as in effect on the effective date of this rule).

(V) "Monitoring" means activities undertaken by the licensee in evaluating the characteristics or performance of a facility or a site through systematic measurement and analysis of specific parameters.

(W) "Processor" means a person who treats or repackages radioactive material received from another person.

(X) "Quality assurance" (QA) or "quality assurance program" means a program providing for verification by written procedures such as testing, auditing, and inspection to ensure that deficiencies, deviations, defective equipment, or unsafe practices, or a combination thereof, relating to the use, disposal, management, or manufacture or radiation sources are identified, promptly corrected, and reported to the appropriate regulatory agencies.

(Y) "Recoverable" means the ability to physically collect and remove the waste from its present location.

(Z) "Retrievable" means the ability to remove a container and its contents as a single entity when used in reference to waste storage.

(AA) "Stability" means structural stability.

(BB) "Storage" or "store" means the retention of radioactive waste, prior to disposal in a manner that allows for surveillance, control, and subsequent retrieval.

(CC) "Surveillance" means activities undertaken by the licensee in monitoring and observation of a site for purposes of visual detection of a need for maintenance, custodial care, evidence of intrusion, and compliance with other license and regulatory requirements.

(DD) "Treatment" means any method, technique, or process, including storage for radioactive decay, that changes the physical, chemical, or biological characteristics or composition of any radioactive waste in order to render the waste safer for transport or management, amenable to recovery, convertible to another usable material, or reduced in volume.

(EE) "Waste management" means the storage, treatment, or disposal of radioactive waste.

(FF) "Waste processing" is the act or process of treating radioactive waste.

Last updated November 15, 2022 at 8:57 AM

History

• Effective: November 14, 2022
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-54-02 Generator reporting and fee requirements.

(A) Except as otherwise provided in paragraph (D) of this rule, on or before the thirtieth day of April each year, each generator shall submit to the director, on forms provided by the director at least ninety days prior, an annual report containing the following information for the previous calendar year:

(1) The name, address, and telephone number of the generator, including the name of the person responsible for low-level radioactive waste management;

(2) The types and amounts of low-level radioactive waste generated during the previous calendar year;

(3) The types and amounts of low-level radioactive waste first placed in storage during the previous calendar year, and the types and amounts of wastes remaining in storage from previous calendar years;

(4) The types and amounts of low-level radioactive waste shipped during the previous calendar year, including carrier or broker, and the means of shipment;

(5) A statement indicating whether or not additional low-level radioactive waste was stored or shipped or both and not reported to the director during the previous report period;

(6) A description of the methods used to treat, store, and dispose of low-level radioactive waste;

(7) A description of any actions taken or planned to be taken to reduce the low-level radioactive waste volume or production; and

(8) The types and amounts of low-level radioactive waste expected to be generated or placed in storage during the next calendar year.

(B) Except as otherwise provided in paragraphs (C) and (D) of this rule, within thirty days after the director issues an invoice, all generators shall pay a fee as follows:

(1) At least fifty dollars if any low-level radioactive waste was generated, or three dollars and fifty cents per cubic foot of low-level radioactive waste that was generated during the previous calendar year, whichever is greater, except that for waste generated by a uranium enrichment facility, the generator shall pay seventy-five cents per cubic foot rather than three dollars and fifty cents per cubic foot for such wastes; and

(2) Three dollars and fifty cents per cubic foot of low-level radioactive waste that was stored or held in storage for more than forty-two months, except that for such waste held in storage by a uranium enrichment facility, the generator shall pay seventy-five cents rather than three dollars and fifty cents per cubic foot for such wastes; and

(3) In addition to the minimum charge and the per cubic foot charge provided in paragraphs (B)(1) and (B)(2) of this rule, a generator shall pay a per cubic foot surcharge based on the activity of the waste as classified in rule 3701:1-54-10 of the Administrative Code. There is no surcharge for class A waste. The surcharge for class B waste is an additional fifty per cent of the amount charged under paragraph (B)(1) or (B)(2) of this rule. The per cubic foot surcharge for class C waste is an additional one hundred per cent of the amount charged under paragraph (B)(1) or (B)(2) of this rule.

(C) Notwithstanding paragraph (B) of this rule, if the low-level radioactive waste is high-volume radioactive waste which contains soil, building debris, or rubble typically resulting from decommissioning or decontamination efforts, in an amount containing at least fifty cubic feet, the fee shall be one dollar per cubic yard for such wastes generated during the previous calendar year or for such wastes that have been stored for more than twelve months.

(D) Notwithstanding paragraph (B) of this rule, radioactive waste generated and disposed of in accordance with paragraphs (D) to (G) of rule 3701:1-38-19 of the Administrative Code shall be exempt from the requirements of this rule.

(E) If the low-level radioactive waste is treated by the generator, the fees specified in paragraphs (B) and (C) of this rule shall be determined based on the volume of waste that remains after treatment. The generator shall certify on a form provided by the director the amount of waste that was sent to a processor and the amount of waste sent back to the generator or disposed of on behalf of the generator.

(F) Paragraphs (B) and (C) of this rule shall be applicable to low-level radioactive waste generated or first placed in storage on or after January 1, 1998.

(G) In accordance with division (H) of section 3748.04 of the Revised Code, any fee that remains unpaid on the ninety-first day after the original invoice date shall be assessed an additional amount equal to ten per cent of the original fee.

(H) The director may annually review, at the generator's location, documentation and information that the generator used to prepare the report and the certification required by paragraphs (A) and (E) of this rule. If the director determines that the documentation and information that the generator used to prepare the report is inadequate to determine the accuracy of the report, the director may issue an order pursuant to division (B)(4) of section 3748.05 of the Revised Code to require the generator to amend the report so that the report is accurate.

(I) Any generator shall, upon the request of the director, provide additional information as required.

(J) Reports generated in accordance with this rule must be maintained by the licensee for a period of five years after being submitted to the director.

Last updated November 15, 2022 at 8:57 AM

History

• Effective: November 14, 2022
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-54-10

(A) The criteria to use for classifying waste for disposal are recorded below.

(1) Determination of the classification of radioactive waste involves two considerations. First, consideration must be given to the concentration of long-lived radionuclides (and their shorter-lived precursors) whose potential hazard will persist long after such precautions as institutional controls and improved waste form have ceased to be effective. These precautions delay the time when long-lived radionuclides could cause exposures. In addition, the magnitude of the potential dose is limited by the concentration and availability of the radionuclide at the time of exposure. Second, consideration must be given to the concentration of shorter-lived radionuclides for which requirements on institutional controls, waste form, and disposal methods are effective.

(2) Determination of waste classes shall be performed using the following criteria.

(a) Class A waste is waste that is usually segregated from other waste classes at the disposal site. The physical form and characteristics of class A waste must meet the minimum requirements set forth in paragraph (B) of this rule. If class A waste also meets the stability requirements set forth in paragraph (B) of this rule, it is not necessary to segregate the waste for disposal.

(b) Class B waste is waste that must meet more rigorous requirements on waste form to ensure stability after disposal. The physical form and characteristics of class B waste must meet both the minimum and stability requirements set forth in paragraph (B) of this rule.

(c) Class C waste is waste that not only must meet more rigorous requirements on waste form to ensure stability but also requires additional measures at the disposal facility to protect against inadvertent intrusion. The physical form and characteristics of class C waste must meet both the minimum and stability requirements set forth in paragraph (B) of this rule.

(d) Waste that exceeds class C is not acceptable for disposal under rules 3701:1-54-06 to 3701:1-54-12 of the Administrative Code.

(3) If radioactive waste contains only radionuclides listed in table 1, classification shall be determined as follows:

(a) If the concentration does not exceed 0.1 times the value in table 1, the waste is class A.

(b) If the concentration exceeds 0.1 times the value in table 1 but does not exceed the value in table 1, the waste is class C.

(c) If the concentration exceeds the value in table 1, the waste is not acceptable for disposal under rules 3701:1-54-06 to 3701:1-54-12 of the Administrative Code.

(d) For wastes containing mixtures of radionuclides listed in table 1, the total concentration shall be determined by the sum of fractions rule described in paragraph (A)(7) of this rule.

Table 1

| Radionuclide | Concentration Gigabecquerels per cubic meter | Concentration curies per cubic meter | | --- | --- | --- | | C-14 | 296 | 8 | | C-14 in activated metal | 2960 | 80 | | Ni-59 in activated metal | 8140 | 220 | | Nb-94 in activated metal | 7.4 | 0.2 | | Tc-99 | 111 | 3 | | I-129 | 2.96 | 0.08 | | Alpha emitting transuranic radionuclides with half-life greater than five years | \1\ 0.0037 | \2\ 100 | | Pu-241 | \1\ 0.1295 | \2\ 3500 | | Cm-242 | \1\ 0.74 | \2\ 20,000 | | Ra-226 | \1\ 0.0037 | \2\ 100 |

\1\ Units are megabecquerels per gram.

\2\ Units are nanocuries per gram.

(4) If radioactive waste does not contain any of the radionuclides listed in table 1, classification shall be determined based on the concentrations shown in table 2. However, as specified in paragraph (A)(6) of this rule, if radioactive waste does not contain any radionuclides listed in either table 1 or table 2, it is class A.

(a) If the concentration does not exceed the value in column 1, the waste is class A.

(b) If the concentration exceeds the value in column 1, but does not exceed the value in column 2, the waste is class B.

(c) If the concentration exceeds the value in column 2, but does not exceed the value in column 3, the waste is class C.

(d) If the concentration exceeds the value in column 3, the waste is not acceptable for disposal under rules 3701:1-54-06 to 3701:1-54-12 of the Administrative Code.

(e) For wastes containing mixtures of the radionuclides listed in table 2, the total concentration shall be determined by the sum of fractions rule described in paragraph (A)(7) of this rule.

Table 2

| Radionuclide | Concentration Gigabecquerels per cubic meter | Concentration curies per cubic meter | | | | | | --- | --- | --- | --- | --- | --- | --- | | | Col. 1 | Col. 2 | Col. 3 | Col. 1 | Col. 2 | Col. 3 | | Total of all radionuclides with less than 5 year half-life | 25,900 | (\1) | (\1) | 700 | (\1) | (\1) | | H-3 | 1480 | (\1) | (\1) | 40 | (\1) | (\1) | | Co-60 | 25,900 | (\1) | (\1) | 700 | (\1) | (\1) | | Ni-63 | 129.5 | 2590 | 25,900 | 3.5 | 70 | 700 | | Ni-63 in activated metal | 1295 | 25,900 | 259,000 | 35 | 700 | 7000 | | Sr-90 | 1.48 | 5550 | 259,000 | 0.04 | 150 | 7000 | | Cs-137 | 37 | 1628 | 170,200 | 1 | 44 | 4600 |

\1\There are no limits established for these radionuclides in class B or C wastes. Practical considerations such as the effects of external radiation and internal heat generation on transportation, handling, and disposal will limit the concentrations for these wastes. These wastes shall be class B unless the concentrations of other nuclides in table 2 determine the waste to be class C independent of these radionuclides.

(5) If radioactive waste contains a mixture of radionuclides, some of which are listed in table 1, and some of which are listed in table 2, classification shall be determined as follows:

(a) If the concentration of a radionuclide listed in table 1 does not exceed 0.1 times the value listed in table 1, the class shall be that determined by the concentration of radionuclides listed in table 2.

(b) If the concentration of a radionuclide listed in table 1 exceeds 0.1 times the value listed in table 1 but does not exceed the value in table 1, the waste shall be class C, provided the concentration of radionuclides listed in table 2 does not exceed the value shown in column 3 of table 2.

(6) If radioactive waste does not contain any radionuclides listed in either table 1 or table 2, it is class A.

(7) This is the sum of the fractions rule for mixtures of radionuclides. For determining classification for waste that contains a mixture of radionuclides, it is necessary to determine the sum of fractions by dividing each radionuclide's concentration by the appropriate limit and adding the resulting values. The appropriate limits must all be taken from the same column of the same table. The sum of the fractions for the column must be less than one if the waste class is to be determined by that column.

(8) The concentration of a radionuclide may be determined by indirect methods such as use of scaling factors which relate the inferred concentration of one radionuclide to another that is measured, or radionuclide material accountability, if there is reasonable assurance that the indirect methods can be correlated with actual measurements. The concentration of a radionuclide may be averaged over the volume of the waste, or weight of the waste if the units are expressed as megabecquerels or nanocuries per gram.

(9) Each package of waste must be clearly labeled to identify whether it is class A waste, class B waste, or class C waste, in accordance with paragraphs (A)(1) to (A)(8) of this rule.

(B) The following waste characteristics are minimum requirements for all classes of waste and are intended to facilitate handling at the disposal site and provide protection of health and safety of personnel at the disposal site.

(1) Waste must not be packaged for disposal in cardboard or fiberboard boxes.

(2) Liquid waste must be solidified or packaged in sufficient absorbent material to absorb twice the volume of the liquid.

(3) Solid waste containing liquid shall contain as little free standing and noncorrosive liquid as is reasonably achievable, but in no case shall the liquid exceed one per cent of the volume.

(4) Waste must not be readily capable of detonation or of explosive decomposition or reaction at normal pressures and temperatures, or of explosive reaction with water.

(5) Waste must not contain, or be capable of generating, quantities of toxic gases, vapors, or fumes harmful to persons transporting, handling, or disposing of the waste. This does not apply to radioactive gaseous waste packaged in accordance with paragraph (B)(7) of this rule.

(6) Waste must not be pyrophoric. Pyrophoric materials contained in waste shall be treated, prepared, and packaged to be nonflammable.

(7) Waste in a gaseous form must be packaged at a pressure that does not exceed 1.5 atmospheres at twenty degrees celsius. Total activity must not exceed one hundred curies per container.

(8) Waste containing biological, pathogenic, or infectious material must be treated to reduce to the maximum extent practicable the potential hazard from the non-radiological materials.

(9) The requirements in this rule are intended to provide stability of the waste. Stability is intended to ensure that the waste does not structurally degrade and affect overall stability of the site through slumping, collapse, or other failure of the disposal unit and thereby lead to water infiltration. Stability is also a factor in limiting exposure to an inadvertent intruder, since it provides a recognizable and nondispersible waste.

(a) Waste must have structural stability. A structurally stable waste form will generally maintain its physical dimensions and its form, under the expected disposal conditions such as weight of overburden and compaction equipment, the presence of moisture, and microbial activity, and internal factors such as radiation effects and chemical changes. Structural stability can be provided by the waste form itself, processing the waste to a stable form, or placing the waste in a disposal container or structure that provides stability after disposal.

(b) Notwithstanding the provisions in paragraphs (B)(2) and (B)(3) of this rule, liquid wastes, or wastes containing liquid, must be converted into a form that contains as little free standing and noncorrosive liquid as is reasonably achievable, but in no case shall the liquid exceed one per cent of the volume of the waste when the waste is in a disposal container designed to ensure stability, or 0.5 per cent of the volume of the waste for waste processed to a stable form.

(c) Void spaces within the waste and between the waste and its package must be reduced to the extent practicable.

(C) The director may, upon request or on his or her own initiative, authorize other provisions for the classification and characteristics of waste on a specific basis, if, after evaluation of the specific characteristics of the waste, disposal site, and method of disposal, he or she finds reasonable assurance of compliance with the performance objectives specified in Chapter 3701:1-54 of the Administrative Code.

Last updated November 15, 2022 at 8:58 AM

History

• Effective: November 14, 2022
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-38-19

(A) A licensee shall dispose of licensed radioactive material in accordance with this rule. Licensed material shall be disposed of in one of the following manners:

(1) By transfer to an authorized recipient as provided in this chapter, Chapter 3701:1-40 of the Administrative Code, or to the United States department of energy;

(2) By decay in storage provided that the radionuclide has a half-life of one hundred twenty days or less, or as otherwise permitted by the license;

(3) By release in effluents within the limits set forth in rule 3701:1-38-13 of the Administrative Code; or

(4) As authorized pursuant to paragraphs (B) to (F) of this rule.

(B) A person shall be specifically licensed to receive waste containing licensed material from another person for:

(1) Treatment prior to disposal;

(2) Treatment or disposal by incineration;

(3) Decay in storage;

(4) Disposal at a land disposal facility licensed pursuant to rules 3701:1-54-06 to 3701:1-54-12 of the Administrative Code or equivalent United States nuclear regulatory commission or agreement state regulations; or

(5) Storage until transfer to a storage or disposal facility authorized to receive the waste.

(C) A licensee or applicant for a license may apply to the director for approval of proposed disposal procedures that are not otherwise authorized in these rules for the disposal of licensed material generated in the licensee's operations. Each application shall include:

(1) A description of the waste containing licensed material to be disposed of, including the physical and chemical properties that have an impact on risk evaluation, and the proposed manner and conditions of waste disposal;

(2) An analysis and evaluation of pertinent information on the nature of the environment;

(3) The nature and location of other potentially affected facilities; and

(4) An analysis and procedures to ensure that doses are maintained ALARA and within the dose limits in rules 3701:1-38-12 and 3701:1-38-13 of the Administrative Code.

(D) A licensee may discharge licensed material into sanitary sewerage as follows:

(1) The material is readily soluble in water or is a biological material that is readily dispersible in water;

(2) The quantity of licensed or other radioactive material that the licensee releases into the sewer in one month divided by the average monthly volume of water released into the sewer by the licensee does not exceed the concentration listed in table III of appendix C to rule 3701:1-38-12 of the Administrative Code; and

(3) If more than one radionuclide is to be released, the following conditions must also be satisfied:

(a) The licensee shall determine the fraction of the limit in table III of appendix C to rule 3701:1-38-12 of the Administrative Code represented by discharges into sanitary sewerage by dividing the actual monthly average concentration of each radionuclide released by the licensee into the sewer by the concentration of that radionuclide listed in table III of appendix C to rule 3701:1-38-12 of the Administrative Code; and

(b) The sum of the fractions for each radionuclide required by paragraph (D)(3)(a) of this rule does not exceed unity.

(4) The total quantity of licensed and other radioactive material that the licensee releases into the sanitary sewerage in a year does not exceed one hundred eighty-five gigabecquerels (five curies) of hydrogen-3, thirty-seven gigabecquerels (one curie) of carbon-14, and thirty-seven gigabecquerels (one curie) of all other radioactive materials combined.

(5) Excreta from an individual undergoing medical diagnosis or therapy with radioactive material is not subject to the limitations contained in paragraph (D) of this rule.

(E) A licensee may dispose of licensed material by decay in storage. A licensee may hold radioactive material with a physical half-life of one hundred twenty days or less for decay-in-storage before disposal as non-radioactive material provided the licensee does the following:

(1) Monitors the material at the container surface prior to disposal and determines that the radioactivity cannot be distinguished from the background radiation level with an appropriate radiation detection survey meter set on its most sensitive scale and with no interposing shielding;

(2) Removes or obliterates all radiation caution labels and symbols, unless otherwise specified in the license; and

(3) Retains a record of the disposal for three years.

(F) A licensee may treat or dispose of licensed material by incineration only in the form and concentration specified in paragraph (G) of this rule or as specifically approved by the director pursuant to paragraph (C) of this rule.

(G) A licensee may dispose of the following licensed material as if it were not radioactive. The licensee shall maintain records in accordance with paragraph (K) of rule 3701:1-38-20 of the Administrative Code.

(1) 1.85 kilobecquerels (0.05 microcurie) or less, of hydrogen-3 or carbon-14 per gram of medium used for liquid scintillation counting; or

(2) 1.85 kilobecquerels (0.05 microcurie) or less, of hydrogen-3 or carbon-14 per gram of animal tissue, averaged over the weight of the entire animal. A licensee shall not dispose of tissue pursuant to this paragraph in a manner that would permit its use either as food for humans or as animal feed.

(H) A licensee shall transfer and dispose of licensed material in accordance with the following:

(1) For transfer of radioactive waste intended for disposal at a licensed radioactive waste disposal facility, establish a manifest tracking system, and supplement existing requirements concerning transfers and recordkeeping for those wastes. Each shipment of radioactive waste designated for disposal at a licensed radioactive waste disposal facility shall be accompanied by a shipment manifest as specified in the appendix to this rule.

(2) Each shipment manifest shall include a certification by the waste generator in accordance with the appendix to this rule.

(3) Each person involved in the transfer of waste for disposal or in the disposal of waste, including the waste generator, waste collector, waste processor, and disposal facility operator, shall comply with the requirements specified in the appendix to this rule.

(I) Nothing in this rule relieves a licensee from complying with other applicable federal, state and local regulations governing any other toxic or hazardous properties of materials that may be disposed of under this rule.

View Appendix

Last updated January 20, 2022 at 8:48 AM

History

• Effective: January 20, 2022
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-54-03 Assured isolation facility.

(A) This rule covers the licensing of the storage and safe isolation of licensable radioactive waste, and not disposal of such waste as delineated in rules 3701:1-54-06 to 3701:1-54-12 of the Administrative Code, over the term of a license prior to disposal in accordance with Chapter 3701:1-38 of the Administrative Code, and other rules promulgated under Chapter 3748. of the Revised Code. The requirements of this rule are in addition to those in Chapters 3701:1-40, 3701:1-44 and 3701:1-56 of the Administrative Code, and other rules pursuant to Chapter 3748. of the Revised Code. The requirements of this rule apply to all generators of radioactive waste, and those that store radioactive waste, as follows:

(1) All of the requirements of this rule apply to an assured isolation facility (AIF) used by more than one licensee to hold radioactive waste for storage or any radioactive waste generator who proposes to store radioactive waste at a location other than their currently licensed facility.

(2) Licensees that continue to hold only their own radioactive waste beyond a five year period at their currently licensed facility shall apply for a license to operate an AIF and must comply with paragraphs (B), (C)(1), (C)(2), (C)(4), (C)(5), (C)(7), (C)(9), (D)(3), (D)(4), and (E) to (N) of this rule. Licensees undergoing license termination in accordance with rules 3701:1-38-22 and 3701:1-40-18 of the Administrative Code, or are undergoing decommissioning under an approved decommissioning plan in place as of the date of this rule, are exempt from the licensing requirements of this rule.

(3) Notwithstanding the requirements of paragraph (A)(2) of this rule, licensees that demonstrate a need to hold their own radioactive waste beyond a five year period at their currently licensed facility may apply for an amendment to the license under which the waste is currently stored. The license amendment will be based on the licensee's needs, but will not permit storage beyond a total of ten years from the date that the waste was generated. The amendment may be approved if the director finds that the licensee (a) provides good cause for the need for the extension, (b) demonstrates that the waste will continue to be safely stored during the extension, and (c) submits a planned schedule for the disposition of the waste.

(B) The performance objectives of an AIF are to:

(1) Protect the environment, the general public, and workers from unnecessary exposures to ionizing radiation.

(2) Keep radioactive material secure from unauthorized access or removal.

(3) Protect the waste and containers from the adverse effects of environmental conditions, including, but not limited to, temperature, humidity, and water.

(4) Use sound engineering designs and prudent procedural practices to maintain doses to workers and the general public, and radionuclide releases to the environment as low as reasonably achievable.

(5) Ensure the individual storage containers are individually inspectable and readily retrievable.

(C) The contents of a license application shall provide sufficient information on the AIF, its operators, and the types of waste held, to provide reasonable assurance that the performance objectives will be met. As a minimum, the applicant shall do the following:

(1) Submit a license application pursuant to Chapter 3701:1-40 of the Administrative Code.

(2) Provide a description of the licensed operating activities requested, including, but not limited to:

(a) The location of the proposed site;

(b) The licensed activities involving the transportation, storage, and handling of radioactive waste;

(c) The types, chemical and/or physical forms and quantities of radioactive waste to be received, possessed, and stored;

(d) The proposed time schedules for construction and receipt of radioactive waste at the proposed AIF; and

(e) The estimated maximum amount of radioactive waste to be stored, both in terms of volume and activity, by radionuclide.

(3) Describe the site suitability for storage of licensed radioactive materials for each of the following categories.

(a) Describe and justify the location of the AIF in terms of land use. Include in the description the nearby structures present, local land usage, local populations, public facilities, local roads and traffic.

(b) Define the characteristics of the site by identifying and describing applicable portions of paragraph (D)(1) of this rule.

(c) Provide a description of the site radiological environmental monitoring program to meet the criteria in paragraph (I) of this rule. Include baseline information for the data to be collected.

(d) Provide an environmental assessment report required by Chapter 3701:1-40 of the Administrative Code.

(4) Provide a complete description of the AIF, including drawings, to meet the applicable criteria of paragraphs (D) and (E) of this rule.

(5) Submit details on the operation of the AIF covering the topics listed in paragraph (F) of this rule.

(6) Provide a description of the community awareness and communication program to be used.

(a) Identify the means of communication, types of information to be provided, and when the information will be provided to:

(i) Notify the community of the proposed operation and licensing; and

(ii) Maintain community input on operational status, operational changes, and off-site emergency response capacity.

(b) Identify how the effectiveness of the communications will be monitored and ensured.

(7) Submit any applicable decommissioning funding plan and financial assurance in accordance with Chapter 3701:1-40, Chapter 3701:1-44 or Chapter 3701:1-56 of the Administrative Code.

(8) Submit an emergency response plan in accordance with Chapter 3701:1-40 of the Administrative Code.

(9) Submit the quality assurance program used in accordance with rule 3701:1-54-04 of the Administrative Code to ensure that the maintenance and operation of the AIF meets the performance objectives, is consistent with the contents of the license application, and satisfies the requirements for the receipt, handling, emplacement and retrieval of waste in this rule.

(D) The design of an AIF shall provide reasonable assurance that the radioactive waste will maintain its integrity and remain isolated from the environment as intended.

(1) The overall hydrogeologic environment of the site, in combination with engineering design, shall act to minimize and control potential radioactive waste migration into surface water and ground water in the event of an accidental release. Identification and consideration of the hydrogeologic environment shall include, but is not limited to:

(a) Upstream drainage features such as the potential for frequent ponding and slope stability;

(b) Characteristics of nearby rivers, streams, wetlands, or other bodies of water;

(c) Distance to, and nature of, the water table and aquifer;

(d) Analysis of earthquake potential or other land movement and its consequences;

(e) The proximity to creeks or culverts; and

(f) Soil types under the AIF with respect to compatibility with the foundation and structural design.

(2) No new AIF shall be located:

(a) In a one-hundred year flood plain or a wetland; or

(b) In the recharge area of a sole source aquifer unless it can be demonstrated with reasonable assurance the new AIF will be designed, constructed, operated, and decommissioned without an unreasonable risk to the aquifer.

(3) The AIF shall be constructed as designed to:

(a) Safely handle and store the waste commensurate with the characteristics of the waste;

(b) Aid in fire suppression, provide filtered air ventilation, maintain environmental controls, and to the extent possible be constructed of nonflammable building materials;

(c) Store waste such that each individual waste container is readily retrievable and inspectable; and

(d) Be made of materials, and use methods, considered to ease future decontamination and decommissioning efforts.

(4) The AIF shall include design features to aid in keeping the radioactive waste isolated. The design features must:

(a) Minimize water infiltration and prevent any waste container from contact with water.

(b) Preserve the structural integrity of each waste container.

(c) Ensure that the site drainage and slope stability preserves the integrity of the AIF's foundation.

(d) Ensure that the AIF shall meet the standards prescribed in ASCE/SEI 7-10 "Minimum Design Loads for Buildings and Other Structures" (3rd printing, 2013) for a Category II facility as defined in the standard. This publication may be purchased from the "American Society of Civil Engineers, 1801 Alexander Bell Drive, Reston, Virginia 20191-4400, telephone (800) 548-2723," or this publication can be viewed at "the Bureau of Environmental Health and Radiation Protection library, 246 N. High Street Columbus, Ohio 43215." Facilities that will have containers exceeding a Type A Quantity of radioactive material in normal form, as defined in Chapter 3701:1-50 of the Administrative Code, must meet the criteria for a category III facility as defined in the standard.

(e) Minimize occupational and non-occupational exposures.

(f) Provide for site and effluent monitoring as appropriate for the AIF.

(g) Ensure that buildings and areas used for the storage of radioactive wastes shall have appropriate ventilation and fire protection systems to minimize the release of radioactive materials into the soil, water, or atmosphere.

(h) Provide facilities and equipment for repackaging leaking or damaged containers.

(i) Ensure that the design and operation of the radioactive waste storage area shall be such that radiation levels, concentrations, and potential exposures due to airborne releases during operations are within the limits specified in Chapter 3701:1-38 of the Administrative Code and are maintained as low as reasonably achievable (ALARA).

(j) Ensure that the design and operation of the AIF shall be compatible with the objectives of the decommissioning funding plan for the AIF.

(k) Ensure that the AIF shall be designed to confine spills. Independent and diverse engineering barriers shall be provided as necessary to minimize potential releases from the AIF.

(E) The applicant shall provide a description of the site and accurate drawings of the AIF. The descriptions shall address the following features, and any design features used in support of the performance objectives:

(1) Describe the ventilation system and how it will ensure adequate environmental controls of the storage area, including, but not limited to, heating, cooling, and humidity. Describe any applicable exhaust air filtration used.

(2) Describe the fire protection and suppression system to minimize the likelihood and extent of fire.

(3) Describe any plumbing, pipes, and/or wiring that goes through the storage or handling areas.

(4) Describe the physical security of the radioactive waste areas and the AIF. Include how acts of sabotage or deliberate attacks, and the consequences thereof, will be minimized.

(5) Identify radioactive waste storage areas, demonstrating where radioactive waste will be stored and how radioactive waste containers will be accessible for routine inspections.

(6) Describe the locations of radioactive waste handling areas, air sampling stations, effluent filters and any sources of flammable or explosive material.

(7) Provide a description and accurate drawing of any required special handling equipment to be employed.

(8) Describe the equipment installed to maintain control over the maximum concentrations of radioactive materials in gaseous and liquid effluents produced during normal operation and the means employed to keep levels of radioactive material in effluents to unrestricted areas ALARA.

(9) Describe the building codes and standards applied to the design and construction of the AIF.

(10) Describe the AIF construction, including, but not limited to, the building materials and method of construction. Submit copies of required building and zoning permits.

(11) Describe the activity, volume, classification and specifications of the radioactive material to be received, possessed, and stored at the AIF.

(F) The applicant shall describe the operations of the AIF in accordance with the radioactive waste procedures to meet the performance objectives.

(1) Describe the procedures to secure radioactive materials from unauthorized access and removal, including the control of access to the AIF. Include how acts of sabotage or deliberate attacks, and the consequences thereof, will be minimized.

(2) The commingling of radioactive wastes from different generators into a single waste container is prohibited. Describe the procedures used to verify this requirement is met.

(3) Describe the radiation safety program for control and monitoring of radioactive effluents to ensure compliance with the occupational radiation exposure limits, and to control contamination of personnel, vehicles, equipment, buildings, and the AIF. Routine operations, inadvertent releases, and accidents must be addressed. The program description must include procedures, instrumentation, facilities, and equipment.

(4) Submit the procedures for receipt and acceptance of waste packages. The procedures shall include examination of shipping documents, visual check of waste package, survey for removable contamination and external radiation level, identification of packages requiring remediation, corrective actions, and disposition of unacceptable packages.

(5) Describe the program for safe placement and inspection of waste in storage and maintaining occupational exposures ALARA. The program should include periodic radiation and contamination surveys of individual packages and the storage area in general, as well as posting the storage area.

(6) Describe the system for maintaining accurate records of radioactive materials and a current inventory of radioactive waste.

(7) Characterize the radioactive waste to be stored in terms of:

(a) Volume of waste by class A, B, or C as defined in rule 3701:1-54-10 of the Administrative Code; and

(b) Physical form of the waste: solid, liquid, or gas.

(8) The AIF operator shall describe:

(a) The packages or containers to be used for storage of radioactive waste, any hazards the waste may pose to the packaging integrity, and the projected storage life of the packaging or containers;

(b) The program for periodic inspections of radioactive waste packages to ensure that they retain their integrity and containment of radioactive waste; and

(c) The procedures and equipment used for remote handling and repackaging damaged or leaking waste containers.

(9) Provide the following descriptions of the equipment and procedures:

(a) Provide a flow diagram of radioactive waste receipt and storage operations.

(b) Describe the equipment and procedures used to maintain control over on-site exposures to and releases of radioactive material. Include monitoring methods, containment mechanisms, accident mitigation methods and procedures, and the corrective action process used when deviations are discovered.

(c) Describe the spill detection equipment and cleanup plans for the site and associated transportation of radioactive material.

(10) Provide a description of the site radiological environmental monitoring program to meet the criteria in paragraph (I) of this rule. Include baseline information for the data to be collected.

(11) Provide a description of the personnel training and retraining program.

(12) Each licensee shall have emergency response procedures for radionuclide incidents.

(a) If an emergency response plan is required in paragraph (C)(8) of this rule, the applicant shall provide all offsite emergency response organizations that would respond in the event of an accident a copy of the plan and allow sixty days to comment on the applicant's emergency response plan prior to submitting the plan to the director.

(b) The applicant shall submit copies of any comments received during the comment period to the director with the emergency response plan.

(13) Describe the system for maintaining inventory of receipt, storage, and transfer of radioactive waste.

(14) Describe the disposition of radioactive material and the AIF upon termination of the license.

(G) To meet the radiation safety requirements the following must be met:

(1) The safety manual shall include a description of personnel monitoring methods, training and procedures to be followed to prevent employees from ingesting or inhaling radioactive materials, and methods to keep radiation exposures ALARA;

(2) The operating manual shall include procedures to protect the integrity of the waste and waste containers during normal handling and storage conditions, and shipping radioactive materials;

(3) An emergency response manual shall include procedures to address likely minor and major accident conditions, incident response command structures, and a description of procedures for responding to emergencies, including notification of and coordination with local fire, police and medical departments;

(4) The radiation safety program shall incorporate the requirements of Chapters 3701:1-38 and 3701:1-40 of the Administrative Code, and include topics on the ALARA policy, radiation safety procedures, training, ventilation systems, air sampling, contamination control, internal exposure control and assessments, external exposure control, and instrumentation used; and

(5) The applicant shall describe the program for training personnel in procedures for packaging, handling, placement, inspection, surveying and emergency response for radioactive waste storage and transportation.

(H) Radioactive waste and materials are to be transported, handled, and stored in a safe manner to meet the performance objectives in paragraph (B) of this rule.

(1) Radioactive waste shall contain only class A, B, or C waste, determined by radionuclide activity and concentration, as provided in rule 3701:1-54-10 of the Administrative Code.

(2) Radioactive waste shall meet the waste characteristics of rule 3701:1-54-10 of the Administrative Code.

(3) No individual waste container dose rate shall exceed one-tenth mSv/hr (ten mrem/hr) at one meter or two mSv/hr (two hundred mrem/hr) on the surface.

(4) The radioactive waste shall be secured from unauthorized access and removal by individuals, and maintained to prevent unintentional releases to the environment.

(I) A radiological environmental monitoring program shall be developed and used to measure and monitor radionuclides in all pathways to individuals and the general public from licensed radiological operations. All applicants shall:

(1) Describe the environmental monitoring program to provide data to evaluate potential health and environmental impacts in support of the performance objectives.

(2) Describe the action levels of radionuclides in the environment that will initiate an investigation or corrective action.

(3) Describe the plan for additional monitoring in the event of an unintentional release of radionuclides.

(J) Records and reports shall be developed and maintained in accordance with Chapters 3701:1-38, 3701:1-40, and other chapters of the Administrative Code promulgated pursuant to Chapter 3748. of the Revised Code, and the following:

(1) The licensee shall prepare and send statements to each generator of their own waste status, including but not limited to volume, radionuclides, activity, waste container condition, regarding prior year inventory balances, additions and withdrawals of waste from the AIF, and final inventory balance. Both the licensee and the generator shall retain copies of these reports for three years.

(2) The licensee shall prepare and send an annual summary report to the director and publish a local notice of the report's availability to the public. The report shall include, at a minimum, a summary of waste in the AIF (prior year inventory balances, additions, withdrawals, and final balances), capacity utilization (volume and radionuclide license limits), incidents, environmental monitoring results, radionuclide releases to the environment, and a fiscal annual report. The licensee shall retain copies of these reports until the license has been terminated.

(3) The annual report to the generators and the annual summary report shall be completed and submitted to the director within sixty days after the end of the calendar year.

(K) The institutional requirements include:

(1) The radioactive materials will remain under active licensee control throughout the term of the license so that the licensee performs an environmental monitoring program, maintains surveillance and custodial care of the radioactive materials and the facility, and satisfies other requirements as determined by the director.

(2) The generator of the radioactive waste shall retain title to the waste.

(3) The generator is responsible for the radioactive waste as shipped, including but not limited to the original containers and contents delivered, waste form, and radionuclide identification and quantification. The AIF operator is responsible for the waste handling and storage conditions after acceptance of the waste until its ultimate disposition.

(4) Each generator shall issue an irrevocable trust to the AIF operator to cover the cost of disposal in the event that the generator becomes bankrupt. The AIF operator must submit a copy of each trust agreement to the director. Each trust shall be reviewed and updated every five years.

(L) Financial assurance, decommissioning, and license termination requirements include:

(1) The licensee shall meet the applicable financial assurance and decommissioning requirements for unrestricted release in rules 3701:1-38-22 and 3701:1-40-17 of the Administrative Code.

(2) The AIF shall return radioactive materials to the generator or generator's designee upon the AIF's failure to renew a license or prior to license termination.

(3) In the event that the AIF cannot meet the financial assurance requirements as determined by the director, the waste held must be returned to the generators or their designees within ninety days after determination that the licensee financial assurance cannot be met.

(M) The limitations placed on an AIF include:

(1) Each license will place limitations on the aggregate radioactive waste volume as well as radionuclide quantities.

(2) An AIF license shall be renewed in accordance with Chapter 3701:1-40 of the Administrative Code. During the license renewal process, an existing licensed AIF shall verify compliance with the originally licensed structural design for the originally licensed usage. Any changes from the originally licensed usage or structural design will require a reevaluation of the entire AIF based on current standards.

(3) All users of the AIF shall contractually agree to the return of the radioactive waste to the generator, or transfer to the generator's designee licensed to receive such waste, at the end of the radioactive material storage, which may not exceed one hundred years from the time of the receipt of the waste.

(N) Commencement of construction prior to the director issuing a license or renewal for the AIF is at the economic risk of the applicant.

Last updated November 15, 2022 at 8:57 AM

History

• Effective: November 14, 2022
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-54-06

(A) The purpose of rules 3701:1-54-06 to 3701:1-54-12 of the Administrative Code is to establish procedures, criteria, and terms and conditions upon which the department issues licenses for the land disposal of radioactive waste received from another licensee and radioactive waste disposed of in accordance with paragraph (C) of rule 3701:1-38-19 of the Administrative Code.

(B) The requirements of rules 3701:1-54-06 to 3701:1-54-12 of the Administrative Code are in addition to those in Chapter 3701:1-40 of the Administrative Code, and other rules adopted pursuant to Chapter 3748. of the Revised Code.

(C) The requirements of rules 3701:1-54-06 to 3701:1-54-12 of the Administrative Code apply to a radioactive waste land disposal facility used by more than one licensee to dispose of radioactive waste or to a licensee that disposes of any radioactive waste at a location other than its currently licensed facility.

(1) Rules 3701:1-54-06 to 3701:1-54-12 of the Administrative Code establish performance objectives and technical requirements for the land disposal of radioactive waste received from another licensee.

(2) The objectives are to protect the public health and safety, to minimize exposures to ionizing radiation, and not to adversely affect the environment from the land disposal of radioactive wastes received from another licensee.

(3) The land disposal requirements in rules 3701:1-54-06 to 3701:1-54-12 of the Administrative Code are in addition to, and not a substitution for, other applicable rules.

(4) Rules 3701:1-54-06 to 3701:1-54-12 of the Administrative Code do not apply to byproduct material as defined in section 11e(2) of the Atomic Energy Act and codified in 42 U.S.C. 2014e(2).

(5) As used in rules 3701:1-54-06 to 3701:1-54-12 of the Administrative Code, "waste" means the same as "radioactive waste" as defined in rule 3701:1-38-01 of the Administrative Code.

(D) The requirements of rules 3701:1-54-06 to 3701:1-54-12 of the Administrative Code apply to radioactive waste disposal facilities utilizing an above grade engineered structure.

Last updated August 1, 2023 at 2:47 PM

History

• Effective: February 6, 2006
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-54-12

The licensee shall maintain records, reports, and transfers as recorded in this rule.

(A) Each licensee shall maintain any records and make any reports in connection with the licensed activities as may be required by the conditions of the license or by the rules, regulations, and orders of the department.

(B) Records which are required by the regulations in this chapter or by license conditions must be maintained for a period specified by the appropriate regulations in this chapter or by license condition. If a retention period is not otherwise specified, these records must be maintained and transferred to the officials specified in paragraph (E) of this rule as a condition of license termination unless the department otherwise authorizes their disposition.

(C) Records which must be maintained pursuant to this chapter may be the original or a reproduced copy or a microform if this reproduced copy or microform is capable of producing copy that is clear and legible at the end of the required retention period. The record may also be stored in electronic media with the capability for producing legible, accurate, and complete records during the required retention period. Records such as letters, drawings, or specifications, must include all pertinent information such as stamps, initials, and signatures. The licensee shall maintain adequate safeguards against tampering with and loss of records.

(D) If there is a conflict between the department's regulations in this chapter, license condition, or other written department approval or authorization pertaining to the retention period for the same type of record, the longest retention period specified takes precedence.

(E) Notwithstanding paragraphs (A) to (D) of this rule, the licensee shall record the location and the quantity of radioactive wastes contained in the disposal site and transfer these records upon license termination to the department and other agencies as designated by the department.

(F) Following receipt and acceptance of a shipment of radioactive waste, the licensee shall record the following information and retain these records until the department transfers or terminates the license that authorizes the activities described in this paragraph.

(1) The date that the shipment is received at the disposal facility;

(2) The date of disposal of the waste;

(3) A traceable shipment manifest number;

(4) A description of any engineered barrier or structural overpack provided for disposal of the waste;

(5) The location of disposal at the disposal site;

(6) The containment integrity of the waste disposal containers as received;

(7) Any discrepancies between materials listed on the manifest and those received;

(8) The volume of any pallets, bracing, or other shipping or onsite generated materials that are contaminated, and are disposed of as contaminated or suspect materials;

(9) Any evidence of leaking or damaged disposal containers or radiation or contamination levels in excess of limits specified in rule 3701:1-50-17 of the Administrative Code and United States department of transportation regulations of 49 C.F.R. 173.443 (as in effect on the effective date of this rule);

(10) A description of any repackaging operations of any of the disposal containers included in the shipment; and

(11) Any other information required by the department as a license condition.

(G) Each licensee shall comply with the safeguards reporting requirements of 10 C.F.R. 30.55, 40.64, 70.53 and 70.54 (as in effect on the effective date of this rule), if the quantities or activities of materials received or transferred exceed the limits of these sections. Inventory reports required by these sections are not required for materials after disposal.

(H) Each licensee authorized to dispose of radioactive waste received from other persons shall file a copy of its financial report or a certified financial statement annually with the department in order to update the information base for determining financial qualifications.

(I) Each licensee authorized to dispose of waste materials received from other persons, pursuant to this chapter, shall submit annual reports to the department. Reports must be submitted by the end of the first calendar quarter of each year for the preceding year. The reports shall include:

(1) Specification of the quantity of each of the principal radionuclides released to unrestricted areas in liquid and in airborne effluents during the preceding year;

(2) The results of the environmental monitoring program;

(3) A summary of licensee disposal unit survey and maintenance activities;

(4) A summary, by waste class, of activities and quantities of radionuclides disposed of;

(5) Any instances in which observed site characteristics were significantly different from those described in the application for a license; and

(6) Any other information the department may require. If the quantities of radioactive materials released during the reporting period, monitoring results, or maintenance performed are significantly different from those expected in the materials previously reviewed as part of the licensing action, the report must cover this specifically.

(J) Each licensee shall report in accordance with the requirements of 10 C.F.R. 70.52 (as in effect on the effective date of this rule), to the department and the United States nuclear regulatory commission.

(K) Any transfer of radioactive material by the licensee is subject to the requirements in rules 3701:1-40-19, 3701:1-44-21, and 3701:1-56-08 of the Administrative Code.

(L) In addition to the other requirements of this rule, the licensee shall store, or have stored, manifest and other information pertaining to receipt and disposal of radioactive waste in an electronic recordkeeping system.

(1) The manifest information that must be electronically stored is:

(a) That information required in appendix G to rule 3701:1-38-19 of the Administrative Code with the exception of shipper and carrier telephone numbers and shipper and consignee certifications; and

(b) That information required in paragraph (F) of this rule.

(2) As specified in facility license conditions, the licensee shall report the stored information, or subsets of this information, on a computer-readable medium.

Last updated November 15, 2022 at 8:58 AM

History

• Effective: November 14, 2022
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-38-22

(A) This rule applies to the decommissioning of facilities licensed under Chapter 3748. of the Revised Code. For low-level waste disposal facilities, this rule applies only to ancillary surface facilities that support radioactive waste disposal activities. This rule does not apply to uranium and thorium recovery facilities already subject to source material licensing requirements in Chapter 3701:1-44 of the Administrative Code or to uranium solution extraction facilities.

(B) Decommissioning with license termination shall be limited to sites considered acceptable for unrestricted release where the residual radioactivity that is distinguishable from background radiation results in a total effective dose equivalent (TEDE) to an average member of the critical group that does not exceed 0.25 millisievert (twenty-five millirem) per year, including that from groundwater sources of drinking water, and the residual radioactivity has been reduced to levels that are as low as reasonably achievable (ALARA). Determination of the levels which are ALARA must take into account consideration of detriments, such as deaths from transportation accidents, expected to potentially result from decontamination and waste disposal.

(C) After a facility has been decommissioned and the license terminated in accordance with the criteria in this rule, the director will require additional cleanup only if, based on new information, it is determined that the criteria of this rule were not met and residual radioactivity remaining at the site could result in a significant threat to public health and safety. When calculating TEDE to the average member of the critical group the licensee shall determine the peak annual TEDE dose expected within the first one thousand years after decommissioning.

(D) A licensee may decommission a facility and maintain a decommissioning possession only license using alternate criteria greater than the dose criterion specified in paragraph (B) of this rule, provided that the licensee:

(1) Provides assurance that public health and safety would continue to be protected, and that it is unlikely that the dose from all man-made sources combined, other than medical, would be more than the one millisievert (one hundred millirem) per year limit set forth in this chapter, by submitting an analysis of possible sources of exposure;

(2) Has employed, to the extent practicable, restrictions on site use in minimizing exposures at the site;

(3) Reduces doses to ALARA levels, taking into consideration any detriments, such as traffic accidents expected to potentially result from decontamination and waste disposal; and

(4) Has submitted a decommissioning plan or license termination plan (LTP) to the director indicating the licensee's intent to decommission in accordance with rule 3701:1-40-18 of the Administrative Code, and specifying that the licensee proposes to decommission by restricting use of the site. The licensee shall document in the decommissioning plan or LTP how the advice of individuals and institutions in the community who may be affected by the decommissioning has been sought and incorporated, as appropriate, following analysis of that advice. In seeking such advice, the licensee shall provide for:

(a) Participation by representatives of a broad cross section of community interests who may be affected by the decommissioning;

(b) An opportunity for a comprehensive, collective discussion on the issues by the participants represented; and

(c) A publicly available summary of the results of all such discussions, including a description of the individual viewpoints of the participants on the issues and the extent of agreement and disagreement among the participants on the issues.

(5) Has provided sufficient financial assurance in the form of a trust fund to enable an independent third party, including a governmental custodian of a site, to assume and carry out responsibilities for any necessary control and maintenance of the site.

(E) When a decommissioning with restrictions is proposed by a licensee, a decommissioning possession only license is required to assure that the provisions of the decommissioning plan as approved by the director remain effective. The license will contain a condition that the director will not require further cleanup unless he or she determines that the criteria of this rule or terms of the license were not met or that residual radioactivity at the site could result in a significant threat to public health and safety.

(F) Any facility that has been decommissioned and has had the United States nuclear regulatory commission license terminated in accordance with a plan approved by the commission on or before August 31, 1999, will not be required to obtain a license or conduct further cleanup unless the director determines that residual radioactivity at the site could result in a significant threat to the public health and safety.

(G) Applicants for licenses, other than renewals, shall describe in the application how facility design and procedures for operation will minimize, to the extent practical, contamination of the facility and the environment, facilitate eventual decommissioning, and minimize, to the extent practical, the generation of radioactive waste.

(H) Licensees shall, to the extent practical, conduct operations to minimize the introduction of residual radioactivity into the site, including the subsurface, in accordance with the existing radiation protection requirements in rule 3701:1-38-11 of the Administrative Code and radiological criteria for license termination in accordance with this rule.

Last updated November 2, 2022 at 2:10 PM

History

• Effective: August 30, 2015
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-40-18

(A) Each specific license expires at the end of the day on the expiration date stated in the license unless the licensee has filed an application for renewal in accordance with paragraph (E) of rule 3701:1-38-02 of the Administrative Code. If an application for renewal has been filed at least ninety days, or in the case of a broad scope license, at least one hundred eighty days prior to the expiration date stated in the existing license, the existing license expires at the later of the end of the day on which the director makes a final determination to deny the renewal application or, if the determination states an expiration date, the expiration date stated in the determination.

(B) Each specific license for the possession of radioactive material that requires a decommissioning plan shall continue in effect and shall be renewed during the decommissioning period, until the director notifies the licensee in writing after decommissioning that the license is terminated. During this time, the licensee shall:

(1) Limit actions involving radioactive material to those related to decommissioning; and

(2) Continue to control entry to any restricted area until that area is suitable for release in accordance with department requirements as may be imposed by rule 3701:1-38-22 of the Administrative Code.

(C) A licensee shall provide written notice to the director within sixty days of the occurrence of any of the following, in accordance with rule 3701:1-40-04 of the Administrative Code:

(1) The license has expired;

(2) The licensee has decided to permanently cease licensed activities at the entire site or in any separate building, room or outdoor area that contains residual radioactivity such that the building, room or outdoor area is unsuitable for release in accordance with the definition of "decommissioning" in Chapter 3748. of the Revised Code and the regulations for decommissioning in rule 3701:1-38-22 of the Administrative Code.

(3) No licensed activities have been conducted for a period of twenty-four months; or

(4) No licensed activities have been conducted for a period of twenty-four months in any separate building, room or outdoor area that contains residual radioactivity such that the building, room or outdoor area is unsuitable for release in accordance with rule 3701:1-38-22 of the Administrative Code.

(D) In the event of an occurrence as set forth in paragraph (C) of this rule, the licensee shall either:

(1) Begin decommissioning the site, and any separate building, room or outdoor area that contains residual radioactivity so that the site, building, room and outdoor area are suitable for release in accordance with rule 3701:1-38-22 of the Administrative Code; or

(2) If required by paragraph (G)(1) of this rule, submit within twelve months of notification, a decommissioning plan and begin decommissioning upon the director's approval of that plan.

(E) In addition to written notification of an occurrence, the licensee shall maintain all decommissioning financial assurances established by the licensee pursuant to rule 3701:1-40-17 of the Administrative Code in conjunction with a license issuance or renewal or as required by this rule.

(F) The director may grant a request to extend the twelve-month time period to submit a decommissioning plan established in paragraph (D)(2) of this rule provided that the director determines that the alternative schedule is necessary to the effective conduct of decommissioning operations and that the extension is not detrimental to the public health and safety or the environment and is otherwise in the public interest. The extension request must be submitted no later than thirty days after the occurrence for which notification is required. Decommissioning set forth in paragraph (D)(2) of this rule may not commence until the director has made a determination on the extension request.

(G) The licensee shall submit a decommissioning plan to the director prior to commencing any decommissioning in the following cases:

(1) If required by license condition; or

(2) If the procedures and activities necessary to carry out decommissioning of the site or separate building, room or outdoor area have not been previously approved by the director and these procedures could increase potential health and safety risk to workers or to the public, such as in any of the following cases:

(a) Decommissioning procedures would involve techniques not applied routinely during cleanup or maintenance operations;

(b) Workers would be entering areas not normally occupied where surface contamination and radiation levels are significantly higher than routinely encountered during operation;

(c) Decommissioning procedures could result in significantly greater airborne concentrations of radioactive materials than are present during operation; or

(d) Decommissioning procedures could result in significantly greater releases of radioactive material to the environment than those associated with operation.

(H) A proposed decommissioning plan for a site or separate building, room or outdoor area shall include the following:

(1) A description of the conditions of the site or separate building, room or outdoor area sufficient to evaluate the acceptability of the plan;

(2) A description of planned decommissioning activities;

(3) A description of methods used to ensure protection of workers and the environment against radiation hazards during decommissioning;

(4) A description of the planned final radiation survey;

(5) An updated detailed cost estimate for decommissioning, comparison of that estimate with present funds set aside for decommissioning, and a plan for assuring the availability of adequate funds for completion of decommissioning; and

(6) In the case of a decommissioning plan that results in the licensee completing decommissioning later than twenty-four months after plan approval, the plan shall include a justification for the delay based on the criteria in paragraph (J) of this rule.

The proposed decommissioning plan will be approved by the director if the information therein demonstrates compliance with rule 3701:1-38-22 of the Administrative Code, that the decommissioning will be completed as soon as practicable, and that the health and safety of workers and the public will be adequately protected.

(I) Except as provided in paragraph (J) of this rule, a licensee shall:

(1) Complete decommissioning of the site or separate building or outdoor area as soon as practicable but no later than twenty-four months following the initiation of decommissioning; and

(2) When decommissioning involves the entire site, request license termination as soon as practicable but no later than twenty-four months following the initiation of decommissioning, unless the decommissioning is still actively in progress.

(J) The director may approve a request for an alternative schedule for completion of decommissioning and license termination. In considering whether an alternative schedule is warranted, the director shall consider the following:

(1) Whether it is technically feasible to complete decommissioning within twenty-four months;

(2) Whether sufficient waste disposal capacity is available to allow completion of decommissioning within twenty-four months;

(3) Whether a significant volume reduction in wastes requiring disposal will be achieved by allowing short-lived radionuclides to decay;

(4) Whether a significant reduction in radiation exposure to workers can be achieved by allowing short-lived radionuclides to decay; and

(5) Any other factor that the director finds is unique to the site, such as the regulatory requirements of other government agencies, lawsuits, ground-water treatment activities, monitored natural ground-water restoration, actions that could result in more environmental harm than deferred cleanup, and other factors beyond the control of the licensee.

(K) After decommissioning the site, the licensee shall:

(1) Certify the disposition of all licensed material, including accumulated wastes, by submitting a completed disposition of radioactive materials form provided by the director; and

(2) Conduct a radiation survey of the premises where the licensed activities were carried out and submit a report of the results of this survey, unless the licensee demonstrates in some other manner that the premises are suitable for release in accordance with the criteria for decommissioning set forth in rule 3701:1-38-22 of the Administrative Code. The licensee shall survey and report as follows:

(a) Levels of gamma radiation in units of millisieverts (microroentgen) per hour at one meter from surfaces and radioactivity, including alpha and beta, in units of megabecquerels (disintegrations per minute or microcuries) per one hundred square centimeters, removable and fixed, for surfaces, megabecquerels (microcuries) per milliliter for water, and becquerels (picocuries) per gram for solids such as soils or concrete; and

(b) Identification of any survey instrument used and a certification that each instrument was properly calibrated and tested prior to being used to measure radioactivity at the site.

(L) Specific licenses, including expired licenses, will be terminated by written notice to the licensee when the director determines that:

(1) Radioactive material has been properly disposed;

(2) Reasonable effort has been made to eliminate residual radioactive contamination, if present;

(3) A radiation survey has been performed which demonstrates that the premises are suitable for release in accordance with the criteria for decommissioning, or other information is submitted by the licensee that is sufficient to demonstrate that the premises are suitable for release in accordance with the criteria for decommissioning in this chapter and rule 3701:1-38-22 of the Administrative Code; and

(4) All applicable fees have been paid.

Last updated April 19, 2022 at 8:35 AM

History

• Effective: April 17, 2022
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-54-04

(A) The purpose of this rule is to set quality assurance requirements for facilities licensed under Chapter 3701:1-54 of the Administrative Code. The quality assurance requirements of a licensee apply to the design, operation, and decommissioning, of a facility for items and activities that are important to safety. The quality assurance program must include the following elements: the design, purchase, fabrication, handling, shipping, storing, cleaning, assembly, inspection, testing, operation, maintenance, repair, modification of structures, systems, and components, that are important to safety. The quality assurance requirements also apply to the operational procedures for ensuring compliance with safety requirements.

(B) The quality assurance functions are to:

(1) Ensure that an appropriate quality assurance program is established and effectively executed;

(2) Verify, by procedures such as checking, auditing, and inspection, that activities affecting the functions that are important to safety have been correctly performed; and

(3) Ensure that the persons and organizations performing quality assurance functions have sufficient authority and organizational freedom to identify quality problems; to initiate, recommend, or provide solutions; and to verify implementation of solutions.

(C) The licensee, or applicant for a license, shall be responsible for the establishment and execution of the quality assurance program. The licensee may delegate to others, such as contractors, agents, or consultants, the work of establishing and executing the quality assurance program, but the licensee shall retain responsibility for the program. The licensee, or applicant for a license, shall clearly establish and delineate in writing the authority and duties of persons and organizations performing activities affecting the functions and structures, systems, and components, which are important to safety. These activities include performing the functions associated with attaining quality objectives and the quality assurance functions.

(D) A quality assurance program shall meet the following:

(1) The licensee, or applicant for a license, shall document the quality assurance program by written procedures or instructions and shall carry out the program in accordance with these procedures throughout the period during which the facility is licensed. The licensee, or applicant for a license, shall identify the structures, systems, and components to be covered by the quality assurance program, the major organizations participating in the program, and the designated functions of these organizations.

(2) The licensee, or applicant for a license, through their quality assurance programs, shall provide control over activities affecting the quality of the identified structures, systems, and components to an extent commensurate with the importance to safety and, as necessary, to ensure conformance with the approved design of each facility.

(3) The licensee, or applicant for a license, shall base the requirements and procedures of their quality assurance program(s) on the following considerations concerning the complexity and proposed use of the structures, systems, or components:

(a) The impact of malfunction or failure of the item on safety;

(b) The design and fabrication complexity or uniqueness of the item;

(c) The need for special controls and surveillance over processes and equipment;

(d) The degree to which functional compliance can be demonstrated by inspection or test; and

(e) The quality history and degree of standardization of the item.

(4) The licensee, or applicant for a license, shall provide for indoctrination and training of personnel performing activities affecting quality as necessary to ensure that suitable proficiency is achieved and maintained.

(5) The licensee, or applicant for a license, shall review the status and adequacy of the quality assurance program at established intervals. Management of other organizations participating in the quality assurance program must regularly review the status and adequacy of that part of the quality assurance program that they are executing.

(6) The persons and organizations performing quality assurance functions shall report to a management level that ensures that the required authority and organizational freedom, including sufficient independence from cost and schedule considerations when these considerations are opposed to safety considerations, are provided. The individual(s) assigned the responsibility for assuring effective execution of any portion of the quality assurance program, at any location where activities subject to this section are being performed, must have direct authority, freedom, and access to the levels of management necessary to perform this function.

(E) A quality assurance program shall establish measures to ensure that applicable regulatory requirements and the design basis, as specified in the license application for those structures, systems, and components to which this chapter applies, are correctly translated into specifications, drawings, procedures, and instructions. These measures must include provisions to ensure that appropriate quality standards are specified and included in design documents and that deviations from standards are controlled. Measures must be established for the selection and review for suitability of application of materials, parts, equipment, and processes that are essential to the functions of the structures, systems, and components which are important to safety.

(F) A quality assurance program shall establish requirements for:

(1) Procurement document control by establishing measures to assure that applicable regulatory requirements, design bases, and other requirements which are necessary to assure adequate quality or safety are included or referenced in the documents for procurement of material, equipment, and services, whether purchased by the licensee, or by the licensee's contractors or subcontractors. To the extent necessary, the licensee, or applicant for a license, shall require contractors or subcontractors to provide a quality assurance program consistent with the applicable provisions of this rule.

(2) Instructions, procedures and drawings prescribing activities affecting quality or safety by documented instructions, procedures, or drawings of a type appropriate to the circumstances and shall require that these instructions, procedures, and drawings be followed. The instructions, procedures, and drawings must include appropriate quantitative or qualitative acceptance criteria for determining that important activities have been satisfactorily accomplished.

(3) Document control by establishing measures to control the issuance of documents such as instructions, procedures, and drawings, including changes, which prescribe all activities affecting quality or safety. These measures must assure that documents, including changes, are reviewed for adequacy, approved for release by authorized personnel, and distributed and used at the location where the prescribed activity is performed. These measures must ensure that changes to documents are reviewed and approved.

(4) Control of purchased material, equipment, and services requirements:

(a) Establishing measures to ensure that purchased material, equipment, and services, whether purchased directly or through contractors and subcontractors, conform to the procurement documents. These measures must include provisions, as appropriate, for source evaluation and selection, objective evidence of quality furnished by the contractor or subcontractor, inspection at the contractor or subcontractor source, and examination of products upon delivery;

(b) The licensee, or applicant for a license, shall have available documentary evidence that material and equipment conform to the procurement specifications prior to installation or use of the material and equipment. The licensee shall retain or have available this documentary evidence for the life of the facility. The licensee shall ensure that the evidence is sufficient to identify the specific requirements met by the purchased material and equipment; and

(c) The licensee, or applicant for a license, or a designee of either, shall assess the effectiveness of the control of quality by contractors and subcontractors at intervals consistent with the importance, complexity, and quantity of the product or services.

(5) Identification and control of materials, parts, and components by establishing measures for the identification and control of materials, parts, and components. These measures must ensure that identification of the item is maintained either on the item or on records traceable to the item as required, throughout fabrication, installation, and use of the item. These identification and control measures must be designed to prevent the use of incorrect or defective materials, parts, and components.

(6) Control of special processes by establishing measures to ensure that special processes are controlled and accomplished by qualified personnel using qualified procedures in accordance with applicable codes, standards, specifications, criteria, and other special requirements.

(7) Licensee inspection by establishing and executing a program for inspection of quality or safety related activities by or for the organization performing the activity to verify conformance with the documented instructions, procedures, and drawings for accomplishing the activity. Individuals other than those who performed the activity being inspected must perform the inspection. Examinations, measurements, or tests of material or products processed must be performed for each work operation where necessary to assure quality. If direct inspection of processed material or products cannot be carried out, indirect control by monitoring processing methods, equipment, and personnel must be provided. Both inspection and process monitoring must be provided when quality control is inadequate without both.

(8) Test control by establishing a test program to ensure that all testing, required to demonstrate that the structures, systems, and components will perform satisfactorily in service, is identified and performed in accordance with written test procedures that incorporate the requirements of this chapter and the requirements and acceptance limits contained in the facility. The test procedures must include provisions to ensure that all prerequisites for the given test are met, that adequate test instrumentation is available and used, and that the test is performed under suitable environmental conditions. The licensee, or applicant for a license, shall document and evaluate the test results to ensure that test requirements have been satisfied.

(9) Control of measuring and test equipment requirements, the licensee, or applicant for a license, shall establish measures to ensure that tools, gauges, instruments, and other measuring and testing devices used in activities affecting quality are properly controlled, calibrated, and adjusted at specified periods to maintain accuracy within necessary limits.

(10) Handling, storage and shipping control by establishing measures to control, in accordance with work and inspection instructions, the handling, storage, shipping, cleaning, and preservation of materials and equipment to prevent damage or deterioration.

(11) Inspection, test and operating status:

(a) Establish measures to indicate, by the use of markings such as stamps, tags, labels, routing cards, or other suitable means, the status of inspections and tests performed upon individual items of the facility. These measures must provide for the identification of items that have satisfactorily passed required inspections and tests where necessary to preclude inadvertent bypassing of the inspections and tests.

(b) Establish measures to identify the operating status of structures, systems, and components of the facility, such as tagging valves and switches, to prevent inadvertent operation.

(12) Nonconforming materials, parts and components by establishing measures to control materials, parts, or components that do not conform to their requirements in order to prevent their inadvertent use or installation. These measures must include, as appropriate, procedures for identification, documentation, segregation, disposition, and notification to affected organizations. Nonconforming items must be reviewed and accepted, rejected, repaired, or reworked in accordance with documented procedures.

(13) Corrective action by establishing measures to ensure that conditions adverse to quality, such as failures, malfunctions, deficiencies, deviations, defective material and equipment, and nonconformances, are promptly identified and corrected. In the case of a significant condition identified as adverse to quality, the measures must ensure that the cause of the condition is determined and corrective action is taken to preclude repetition. The identification of the significant condition adverse to quality, the cause of the condition, and the corrective action taken must be documented and reported to appropriate levels of management.

(14) Record keeping requirements, the licensee, or applicant for a license, shall maintain sufficient records to furnish evidence of activities affecting quality. The records must include the following: design records, records of use, and the results of reviews, inspections, tests, audits, monitoring of work performance, and materials analyses. The records must include closely related data such as qualifications of personnel, procedures, and equipment. Inspection and test records must, at a minimum, identify the inspector or data recorder, the type of observation, the results, the acceptability, and the action taken in connection with any noted deficiencies. Records must be identifiable and retrievable. Records pertaining to the design, fabrication, erection, facility as built diagrams, testing, maintenance, and use of structures, systems, and components important to safety must be maintained by or under the control of the licensee until the director terminates the license.

(15) Auditing requirements by conducting a comprehensive system of planned and periodic audits to verify compliance with all aspects of the quality assurance program and to determine the effectiveness of the program. The audits must be performed in accordance with written procedures or checklists by appropriately trained personnel not having direct responsibilities in the areas being audited. Audited results must be documented and reviewed by management having responsibility in the area audited. Follow-up action, including reaudit of deficient areas, must be taken where indicated.

(16) Measures for the identification and control of design interfaces and for coordination among participating design organizations. These measures must include the establishment of written procedures among participating design organizations for the review, approval, release, distribution, and revision of documents involving design interfaces. The design control measures must provide for verifying or checking the adequacy of the design.

(a) For verifying or checking processes, the licensee shall designate individuals or groups other than those who were responsible for the original design, but who may be from the same organization.

(b) Where a test program is used to verify the adequacy of a specific design feature in lieu of other verifying or checking the processes, the licensee shall include suitable qualification testing of a prototype or sample unit under the most adverse testing condition.

(c) The licensee, or applicant for a license, shall subject design changes, including field changes, to design control measures commensurate with those applied to the original design. Changes in the conditions specified in the license requires prior approval by the director.

Last updated August 1, 2023 at 2:47 PM

History

• Effective: April 15, 2013
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-40-17

(A) Prior to the director issuing a radioactive materials license:

(1) Each applicant for a specific license or license renewal authorizing the possession and use of unsealed radioactive material of half-life greater than one hundred twenty days and in quantities exceeding ten thousand times the applicable quantities set forth in appendix A to this rule shall submit a decommissioning funding plan as described in paragraph (D) of this rule. The decommissioning funding plan must also be submitted when a combination of radionuclides is involved if R divided by ten thousand is greater than one, where R is defined here as the sum of the ratios of the quantity of each radionuclide to the applicable value in appendix A to this rule.

(2) Each applicant for a specific license or license renewal authorizing the possession and use of sealed sources or plated foils of half-life greater than one hundred twenty days and in quantities exceeding one trillion times the applicable quantities of appendix A to this rule, shall submit a decommissioning funding plan as described in paragraph (D) of this rule. The decommissioning funding plan must also be submitted when a combination of radionuclides is involved if R divided by one trillion is greater than one, where R is defined here as the sum of the ratios of the quantity of each radionuclide to the applicable value in appendix A to this rule.

(B) Prior to the director issuing a radioactive materials license, each applicant for a specific license or license renewal authorizing possession and use of radioactive material of half-life greater than one hundred twenty days and in quantities specified in paragraph (C) of this rule shall either:

(1) Submit a decommissioning funding plan as described in paragraph (D) of this rule; or

(2) Submit a certification that financial assurance for decommissioning has been provided in the amount prescribed by paragraph (C) of this rule using one of the methods described in paragraph (E) of this rule. The applicant shall submit to the director, as part of the certification, a signed original of the financial instrument obtained to satisfy the requirements of paragraph (E) of this rule.

(C) Prior to the director issuing a radioactive materials license, an applicant providing certification of financial assurance for decommissioning as specified in paragraph (B)(2) of this rule shall provide the certification in a monetary amount based upon the quantity of licensed material specified as follows:

(1) Greater than one thousand but less than or equal to ten thousand times the applicable quantities of appendix A to this rule in unsealed form. For a combination of radionuclides, if R, as defined in paragraph (A) of this rule, divided by one thousand is greater than one but R divided by ten thousand is less than or equal to one, the sum of three hundred thousand dollars.

(2) Greater than ten billion but less than one trillion times the applicable quantities of appendix A to this rule in sealed sources or plated foils. For a combination of radionuclides, if R, as defined in paragraph (A) of this rule, divided by ten billion is greater than one but R divided by one trillion is less than or equal to one, the sum of one hundred fifty thousand dollars.

(D) .

(1) Each decommissioning funding plan must be submitted for review and approval and must contain:

(a) A detailed cost estimate for decommissioning, in an amount reflecting:

(i) The cost of an independent contractor to perform all decommissioning activities;

(ii) The cost of meeting the criteria specified in paragraph (B) of rule 3701:1-38-22 of the Administrative Code for unrestricted use, provided that, if the applicant or licensee can demonstrate its ability to meet the provisions of paragraph (D) of rule 3701:1-38-22 of the Administrative Code, the cost estimate may be based on meeting this criteria;

(iii) The volume of onsite subsurface material containing residual radioactivity that will require remediation to meet the criteria for license termination; and

(iv) An adequate contingency factor.

(b) Identification of and justification for using the key assumptions contained in the decommissioning cost estimate;

(c) A description of the method of assuring funds for decommissioning from paragraph (E) of this rule, including means for adjusting cost estimates and associated funding levels periodically over the life of the facility;

(d) A certification by the licensee that financial assurance for decommissioning has been provided in the amount of the cost estimate for decommissioning; and

(e) A signed original of the financial instrument obtained to satisfy the requirements of paragraph (E) of this rule (unless a previously submitted and accepted financial instrument continues to cover the cost estimate for decommissioning).

(2) At the time of license renewal and at intervals not to exceed three years, the decommissioning funding plan must be resubmitted with adjustments as necessary to account for the changes in costs and the extent of contamination. If the amount of financial assurance will be adjusted downward, this cannot be done until the updated decommissioning funding plan is approved. The decommissioning funding plan must update the information submitted with the original or prior approved plan, and must specifically consider the effect of the following events on decommissioning costs:

(a) Spills of radioactive material producing additional residual radioactivity in onsite subsurface material;

(b) Waste inventory increasing above the amount previously estimated;

(c) Waste disposal costs increasing above the amount previously estimated;

(d) Facility modifications;

(e) Changes in authorized possession limits;

(f) Actual remediation costs that exceed the previous cost estimate;

(g) Onsite disposal; and

(h) Use of a settling pond.

(E) Financial assurance for decommissioning, either by a decommissioning funding plan or certification of financial assurance, shall be provided by the licensee and approved by the director prior to the issuance of the license and shall be provided by one or more of the following methods:

(1) Prepayment by depositing into an account segregated from licensee assets and outside the licensee's administrative control, cash or liquid assets such that the amount of funds will be sufficient to pay decommissioning costs. Prepayment may be in the form of a trust, escrow account, government fund, certificate of deposit, or deposit of government securities.

(2) Surety, insurance, or other method in accordance with paragraph (F) of this rule, that guarantees that decommissioning costs will be paid. A surety method may be in the form of a surety bond, letter of credit, or line of credit. A guarantee by the applicant or licensee may not be used in combination with any other financial methods used to satisfy the requirements of this paragraph or in any situation where the applicant or licensee has a parent company holding majority control of the voting stock of the company.

(3) A parent company guarantee of funds for decommissioning costs based on a financial test may be used provided that the parent company meets the requirements specified in appendix B of this rule. A parent company guarantee may not be used in combination with other financial methods to satisfy the requirements of this rule.

(4) For commercial corporations that issue bonds, a guarantee of funds by the applicant or licensee for decommissioning costs based on a financial test may be used provided that the guarantee meets the requirements of appendix C to this rule.

(5) For commercial companies that do not issue bonds, a guarantee of funds for decommissioning costs may be used provided that the guarantee meets the requirements of appendix D to this rule.

(6) For nonprofit colleges, universities, hospitals, or research and development entities, a guarantee of funds for decommissioning costs may be used provided that the guarantee meets the requirements of appendix E to this rule. The director may require proof of nonprofit status.

(7) An external sinking fund in which deposits are made at least annually, coupled with a surety method or insurance, the value of which may decrease by the amount being accumulated in the sinking fund. An external sinking fund is a fund established and maintained by setting aside funds periodically in an account segregated from licensee assets and outside the licensee's administrative control in which the total amount of funds would be sufficient to pay decommissioning costs at the time termination of operation is expected. An external sinking fund may be in the form of a trust, escrow account, government fund, certificate of deposit, or deposit of government securities. The surety or insurance provisions must be as stated in paragraph (F) of this rule.

(8) In the case of state or local government licensee, a statement of intent containing a cost estimate for decommissioning or an amount specified in paragraphs (C)(1) to (C)(2) of this rule, and indicating that funds for decommissioning will be obtained when necessary. As used in this rule, "state or local government licensee" does not include government owned or assisted colleges, universities or hospitals.

(F) Any surety method or insurance used to provide financial assurance for decommissioning shall be in the form of instruments that contain language as provided in appendix F to this rule, and shall contain the following conditions:

(1) The surety method or insurance must be open-ended or, if written for a specified term, such as five years, must be renewed automatically unless ninety days or more prior to the renewal date, the issuer notifies the director, the beneficiary, and the licensee of its intention not to renew. The surety method or insurance must also provide that the full face amount be paid to the beneficiary automatically prior to the expiration without proof of forfeiture if the licensee fails to provide a replacement acceptable to the director within thirty days after receipt of notification of cancellation.

(2) The surety method or insurance must be payable to a trust established for decommissioning costs. The trustee and trust must be acceptable to the director. An acceptable trustee includes an appropriate state or federal government agency or an entity which has the authority to act as a trustee and whose trust operations are regulated and examined by a federal or state agency.

(3) The surety method or insurance must remain in effect until the director has terminated the license.

(4) The surety company issuing the bond must, at a minimum, be among those listed as acceptable in the "Circular 570" of the United States department of the treasury (as in effect on the effective date of this rule).

(G) A licensee must notify the director by certified mail within ten business days of the commencement of a voluntary or involuntary bankruptcy proceeding under Title 11 of the United States Code (as amended April 20, 2005). A licensee who fulfills the financial assurance requirements by obtaining a trust fund, surety bond, or other acceptable financial assurance will be deemed to be without the required financial assurance or liability coverage in the event of bankruptcy of the trustee or issuing institution, or a suspension or revocation of the authority of the trustee institution issuing the instrument. The licensee shall establish other financial assurance within sixty days after such an event.

(H) Financial assurance for decommissioning, either by a decommissioning funding plan or certification of financial assurance, that is provided by a contract of insurance shall not include any arrangement that constitutes self-insurance. As used in this rule:

(1) "Insurance" means a contract issued or underwritten by an insurance company, insurance service, or insurance organization which is licensed to engage in the business of insurance in Ohio, that binds the insurer to indemnify another against a specified loss in return for premiums paid.

(2) "Self insurance" means a contract of insurance issued either by the licensee or by an insurer affiliated with or an affiliate of the licensee.

(3) "Affiliate of" or "affiliated with" means that the licensee, either directly or indirectly, through one or more intermediaries or subsidiaries, controls, is controlled by, or is under common control with the insurer.

(4) "Control", including "controlled by", and "under common control with" means the possession, direct or indirect, of the power to direct or cause the direction of the management and policies of a person, whether through the ownership of voting securities, by contract, proxy, membership on the board, or otherwise.

(I) Each person licensed under this chapter, and rule 3701:1-38-02 of the Administrative Code as well as chapters containing rules regarding manufacturing and distribution (Chapter 3701:1-46 of the Administrative Code), industrial radiography (Chapter 3701:1-48 of the Administrative Code), well logging Chapter 3701:1-49 of the Administrative Code), irradiators (Chapter 3701:1-52 of the Administrative Code), and medical use (Chapter 3701:1-58 of the Administrative Code) promulgated pursuant to Chapter 3748. of the Revised Code shall keep records of information important to the decommissioning of a facility in an identified location until the site is released for unrestricted use. Before licensed activities are transferred or assigned in accordance with paragraph (B) of rule 3701:1-40-20 of the Administrative Code, a licensee shall transfer all records described in this paragraph to the new licensee, which will be responsible for maintaining these records until the license is terminated. If records important to the decommissioning of a facility are kept for other purposes, reference to these records and their locations may be used. As used in this rule, "information important to the decommissioning of a facility" includes the following:

(1) Records of spills or other unusual occurrences involving the spread of contamination in and around the facility, equipment, or site. These records may be limited to instances when contamination remains after any cleanup procedures or when there is reasonable likelihood that contaminants may have spread to inaccessible areas as in the case of possible seepage into porous materials such as concrete. These records must include any known information on identification of involved radionuclides, quantities, forms, and concentrations.

(2) As-built drawings and modifications of structures and equipment in restricted areas where radioactive materials are used or stored, and of locations of possible inaccessible contamination such as buried pipes which may be subject to contamination. If required drawings are referenced, each relevant document need not be indexed individually. If drawings are not available, the licensee shall substitute appropriate records of available information concerning these areas and locations.

(3) Except in the case of an area that contains only a sealed source, provided the source has not leaked or no contamination remains after any leak, or in the case of a byproduct or accelerator produced material having only a half-life of less than sixty-five days, a list contained in a single document and updated every two years, of the following:

(a) All areas designated and formerly designated restricted areas as defined in rule 3701:1-38-01 of the Administrative Code.

(b) All areas outside of restricted areas that require documentation under paragraph (I)(1) of this rule.

(c) All areas outside of restricted areas where current and previous wastes have been buried as documented under rule 3701:1-38-20 of the Administrative Code; and

(d) All areas outside of restricted areas that contain material such that, if the license expired, the licensee would be required to either decontaminate the area to meet the criteria for decommissioning in rule 3701:1-38-22 of the Administrative Code, or apply for approval for disposal under rule 3701:1-38-19 of the Administrative Code.

(4) Records of the cost estimate performed for the decommissioning funding plan or of the amount certified for decommissioning, and records of the funding method used for assuring funds if either a funding plan or certification is used.

View AppendixView AppendixView AppendixView AppendixView AppendixView Appendix

Last updated April 19, 2022 at 8:35 AM

History

• Effective: April 17, 2022
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-54-05 Radioactive waste processing.

(A) This rule covers the licensing of radioactive waste processors. The requirements of this rule are in addition to those in Chapters 3701:1-40, 3701:1-44 and 3701:1-56 of the Administrative Code, and other rules pursuant to Chapter 3748. of the Revised Code.

(B) The performance objectives for a radioactive waste processing facility are to:

(1) Protect the environment, the general public, and workers from unnecessary exposures to ionizing radiation and radionuclide releases exceeding the limits and constraints delineated in Chapter 3701:1-38 of the Administrative Code;

(2) Keep radioactive material secure from unauthorized access or removal; and

(3) Use sound engineering designs and prudent procedural practices to maintain doses to workers and the general public and radionuclide releases to the environment as low as reasonably achievable (ALARA).

(C) A facility is exempt from the licensing requirements of this rule to process radioactive waste if:

(1) The facility, in accordance with a specific license, processes only its own radioactive waste;

(2) Site decommissioning activities are conducted on-site in accordance with a specific license; or

(3) The facility is not required to have a decommissioning funding plan pursuant to rule 3701:1-40-17 of the Administrative Code.

(D) The application for a radioactive waste processing facility shall provide sufficient information on the facility and its operators, and the types of waste processed, to provide reasonable assurance that the performance objectives in paragraph (B) of this rule will be met. As a minimum, the applicant shall do the following:

(1) Submit a license application pursuant to Chapter 3701:1-40 of the Administrative Code;

(2) Provide a description of the site suitability for processing radioactive waste for each of the following categories:

(a) The location of the facility in terms of land use. Include in the description the nearby structures present, local land usage, local populations, public facilities, local roads and traffic;

(b) The characteristics of the site in accordance with criteria contained in paragraph (E)(1) of this rule; and

(c) The site radiological environmental monitoring program to meet the criteria in paragraph (I) of this rule. Include baseline information for the data to be collected.

(3) Provide a complete description of the facility, including but not limited to drawings, to meet the criteria of paragraphs (E) and (F) of this rule.

(4) Submit details on the operation of the facility covering the topics listed in paragraph (G) of this rule.

(5) Submit the quality assurance program used in accordance with rule 3701:1-54-04 of the Administrative Code to ensure that the construction, maintenance and operation of the facility meets the performance objectives, is consistent with the contents of the license application, and satisfies the requirements for the receipt, handling, processing and shipping of waste in this rule.

(6) In addition to the requirements of rule 3701:1-40-38 of the Administrative Code, provide a description of the community awareness and communication program to be used. Identify the means of communication, types of information to be provided, and when the information will be provided to notify the community of the proposed operation and licensing, and identify how the effectiveness of the communication will be monitored and ensured.

(7) Describe the program for training personnel in procedures for packaging, handling, placement, inspection, surveying and emergency response for radioactive waste processing, storage and transportation.

(E) The facility design, location, and site geology shall provide reasonable assurance that radioactive materials will remain isolated from the environment as intended.

(1) The overall hydrogeologic environment of the site, in combination with engineering design, shall act to minimize and control potential radioactive material migration into surface water and ground water in the event of an accidental release. Identification and consideration of the hydrogeologic environment shall include, but is not limited to:

(a) Upstream drainage features including the potential for frequent ponding and slope stability;

(b) Characteristics of nearby rivers, streams, wetlands, or other bodies of water;

(c) Distance to the water table and aquifer;

(d) Analysis of earthquake potential or other land movement and its consequences; and

(e) Soil types under the facility with respect to compatibility with the foundation and structural design.

(2) Ensure that the licensee's structures shall meet the standards prescribed in ASCE/SEI 7-10 "Minimum Design Loads for Buildings and Other Structures" for a Category II facility as defined in the standard. This publication may be purchased from the "American Society of Civil Engineers, 1801 Alexander Bell Drive, Reston, Virginia 20191-4400, telephone (800) 548-2723," or this publication can be viewed at "the Bureau of Environmental Health and Radiation Protection library, 246 N. High Street Columbus, Ohio 43215." Facilities that will have containers exceeding type A quantities of radioactive material in normal form, as defined in Chapter 3701:1-50 of the Administrative Code, must meet the criteria for a category III facility as defined in the standard.

(3) No facility shall be:

(a) Located in a one hundred year flood plain;

(b) Located in a wetland; or

(c) Operated where an emergency response plan would be required as identified in paragraph (G) of rule 3701:1-40-14 of the Administrative Code.

(4) The facility shall be constructed to:

(a) Safely handle and process the waste commensurate with the characteristics of the waste;

(b) Aid in fire suppression, provide filtered air ventilation, maintain environmental controls, and to the extent possible, be constructed of nonflammable building materials; and

(c) Use materials considered to ease future decontamination and decommissioning efforts.

(5) The facility shall incorporate the following design features to aid in keeping the radioactive waste isolated.

(a) Buildings and areas used for processing radioactive waste shall have appropriate ventilation and fire protection systems to minimize the release of radioactive materials into the soil, water, or atmosphere.

(b) Provide facilities and equipment for repackaging leaking or damaged containers.

(c) The facility shall be designed to confine spills. Independent and diverse engineering barriers shall be provided as necessary to minimize potential releases from the facility.

(d) Any person's radioactive waste may not be held on site for more than one year from the time of receipt.

(F) Using both general descriptions and detailed drawings of the facility, identify the following features, and any design features used in support of the performance objectives.

(1) Describe the ventilation system and how it will assure adequate environmental controls of the processing and holding areas. Describe any applicable exhaust air filtration used.

(2) Describe the fire protection and suppression system to minimize the likelihood and extent of fire.

(3) Describe the physical security of the radioactive waste areas and the facility.

(4) Identify radioactive waste processing areas and where radioactive waste will be held. Identify how the processing areas and radioactive waste containers will be accessible for routine inspections.

(5) Describe the locations of radioactive waste handling areas, air sampling stations, effluent filters and any sources of flammable or explosive material.

(6) Provide a description and accurate drawing of any required special handling equipment to be employed.

(7) Describe the equipment installed to maintain control over the maximum concentrations of radioactive materials in gaseous and liquid effluents produced during normal operation and the means employed to keep levels of radioactive material in effluents to unrestricted areas ALARA.

(8) Identify the building codes and standards applied to the design and construction of the facility, and verify that the facility has been certified as complying with these codes.

(G) Pursuant to the requirements of paragraph (B) of this rule, describe the following.

(1) Procedures to secure radioactive materials from unauthorized access and removal, including control of access to the facility;

(2) Procedures used to ensure that all radioactive waste subject to transportation will meet transportation requirements;

(3) Radiation safety program for control and monitoring of radioactive effluents to ensure compliance with the occupational radiation exposure limits, and to control contamination of personnel, vehicles, equipment, buildings, and the facility. Both routine operations and accidents must be addressed. The program description must include procedures, instrumentation, facilities, and equipment;

(4) Procedures for receipt and acceptance of waste packages. The procedures shall include examination of shipping documents, visual check of waste package, survey for removable contamination and external radiation level, identification of packages requiring remediation, corrective actions, and disposition of unacceptable packages;

(5) A program for safe placement and inspection of waste and maintaining occupational exposures ALARA when it is not being processed. The program shall include periodic radiation and contamination surveys of individual packages;

(6) A program for periodic inspections of radioactive waste packages to ensure that they retain their integrity and containment of radioactive waste;

(7) The procedures and equipment used for remote handling and/or repackaging damaged or leaking waste containers;

(8) General flow diagram and detailed procedures of radioactive waste receipt, handling, processing, and storage operations;

(9) Spill detection equipment and cleanup plans for the site and associated transportation of radioactive material; and

(10) A system for maintaining inventory of receipt, processing, storage, and transfer of radioactive waste.

(H) The radiation safety requirements shall include the following documents and content:

(1) The radiation safety manual shall include a description of personnel monitoring methods, training and procedures to be followed to limit employees' exposure to radioactive materials, and methods to keep radiation exposures ALARA;

(2) The operating manual shall include procedures to protect the integrity of the equipment and radioactive material containment during normal handling, processing, and storage conditions, and when shipping radioactive materials; and

(3) An emergency response manual shall include procedures to address likely accident conditions.

(I) The facility shall maintain a radiological environmental monitoring program, to measure and monitor radionuclides in all pathways to individuals, the environment, and the general public from radiological operations. In establishing such a program, the facility must do the following:

(1) Identify all the possible onsite and offsite environmental radiological exposure pathways. The exposure pathways shall include but are not limited to applicable air, soil, groundwater, surface water, and vegetation. The offsite pathway exposure locations shall take into consideration meteorological, terrestrial, and emission source parameters;

(2) Describe the environmental monitoring program to provide data to evaluate radionuclide releases and accumulations in the environment;

(3) Describe the action levels of radionuclides in the environment that will initiate an investigation or corrective action; and

(4) Describe the plan for taking corrective measures if an unintentional release of radionuclides material is indicated.

(J) The licensee shall:

(1) Keep records showing the receipt, inventory, processing, transfer, and disposal of all radioactive waste; and

(2) Prepare and send an annual summary report to the director and publish a local notice of the report's availability to the public. The report shall include, at a minimum, a summary of radioactive waste received, processed, disposed, transferred, incidents, and environmental monitoring results. The annual summary report shall be completed and submitted within ninety days after the end of the licensee's fiscal year.

(K) The processor shall contractually agree with the generator to the return of radioactive waste to the generator. The waste processor may dispose of the radioactive waste on behalf of the generator at a licensed disposal facility in a timely manner.

Last updated November 15, 2022 at 8:58 AM

History

• Effective: November 14, 2022
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-40-38

(A) The scope of this process applies to the initial licensing, decommissioning, and any major amendment for the following types of facilities: waste disposal, assured isolation storage, waste processing, and facilities required to have an emergency response plan pursuant to paragraph (G) of rule 3701:1-40-14 of the Administrative Code. A major amendment consists of proposed changes to a facility or operations within a facility that would impact radiological operations to the extent that an enhancement of radiation dose to the general public may potentially exist.

(B) Notice of complete license application will be given to the public. A public notice of the pending action will be issued in the local newspaper of general circulation in the county where the applicant is located. The contiguous local governments in proximity to the facility in question will be likewise notified. A copy of the public notice will be placed in the depository library closest to the proposed facility. A notice that the department has received a complete license application for any facility referenced in paragraph (A) of this rule will be provided to everyone on the mailing list of interested parties and the listserv of the bureau of environmental health and radiation protection at the conclusion of the completeness review of an application for such a facility. The notice will also be posted on the department's web page for a period of forty-five days. The public may submit comments on the application to the department for consideration during the forty-five day comment period.

(C) A public participation program will be part of this process. The applicant for a facility listed in paragraph (A) of this rule shall be required to include, in any application for a license or major amendment to a license, the information provided to the public and the mechanism for such provision. This information shall be adequate to portray the types of radiological operations on site, the potential dose to the general population in proximity to the site, precautions to be taken to maintain such exposure ALARA, and how any member of the public can obtain additional information.

(D) The director may establish a public meeting process for the types of actions identified in paragraph (A) of this rule, if the director believes that such is needed in order to adequately address issues associated with the application.

(1) The scope of the meeting shall be limited to whether the application complies with applicable provisions of Chapter 3748. of the Revised Code and all applicable rules adopted thereunder.

(a) The department may hold one or more public meetings on the application at the discretion of the director.

(b) The department shall provide public notice of the meeting to one newspaper having general circulation in the county of the facility and to the individuals specified in paragraph (B) of this rule, including the availability of guidance.

(c) The department shall develop and provide guidance on the process for participation. Individuals may contact the department to obtain a copy of the guidance in advance of the meeting.

(2) The department is responsible for maintaining all records, exhibits, and correspondence submitted or issued in any public meeting. The department will maintain these documents on file for the duration of the license.

(3) The director shall designate a facilitator for any public meeting that is held.

(4) In any public meeting the applicant shall be a participant. Any other person may present information, orally or in writing, at the public meeting.

(5) After publication of a notice of public meeting, participants are afforded the opportunity to submit written presentations. If a participant provides a written presentation, the presentation shall describe in detail any deficiency resulting in a regulatory noncompliance in the license application, why such is deficient, and the relief sought.

(6) The facilitator shall allow oral presentations. Oral presentations shall focus on the content requirements specified in paragraph (D)(5) of this rule. Time limits may also be imposed by the facilitator.

(7) The processing of information received by the department shall be as follows:

(a) All information received concerning the application shall be considered by the department in deliberations for approval or denial of the license application under consideration.

(b) No later than forty-five days after the meeting, the department shall issue a written summary of the information presented pursuant to this rule. The report will be available on the department's web page.

(c) Written comments may be submitted to the department within two weeks following issuance of a summary report by the department on the public meeting.

(8) The applicant for a facility license shall pay all costs associated with the conduct of any public meeting(s) conducted pursuant to this rule. The costs associated with the meeting shall be invoiced at full cost in accordance with paragraph (M) of rule 3701:1-38-02 of the Administrative Code.

Last updated April 19, 2022 at 8:37 AM

History

• Effective: April 17, 2022
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-40-14

(A) An applicant for a license to receive and possess radioactive material shall apply in accordance with rule 3701:1-38-02 of the Administrative Code and this chapter on a form prescribed by the director. The original application shall be filed with the director. Information contained in previous applications, statements or reports filed with the director may be incorporated by reference, provided that the reference is clear, specific, and has been on file with the department for not more than two licensing periods, and provided that the item being referenced in the document is being referenced without change.

(B) The director may at any time after the filing of the original application require additional information from the applicant in order to determine whether a license should be issued or whether a current license should be modified or revoked.

(C) Each application shall be signed by the applicant or a person duly authorized to act for the applicant.

(D) An application for a license to receive and possess radioactive material for the conduct of any activity which the director has determined pursuant to rule 3701:1-40-36 of the Administrative Code could potentially affect the quality of the environment shall be filed at least nine months prior to commencement of construction of the plant or facility in which the activity will be conducted and shall be accompanied by any environmental report required pursuant to rule 3701:1-40-36 of the Administrative Code. The applicant is prohibited from the commencement of construction activities in areas covered by the environmental reporting requirements identified in rules 3701:1-40-30 to 3701:1-40-38 of the Administrative Code before the conclusion of these reviews. The terms "construction" and "commencement of construction" shall have the same meaning as identified in rule 3701:1-38-01 of the Administrative Code.

(E)

(1) Except as provided in paragraphs (E)(2), (E)(3), and (E)(4) of this rule, an application for a specific license to use radioactive material in the form of a sealed source or in a device that contains the sealed sources must either:

(a) Identify the source or device by manufacturer and model number as registered in the sealed source and device registry of the United States nuclear regulatory commission in accordance with sealed source and device registry requirements contained in rule 3701:1-46-49 of the Administrative Code, or with equivalent requirements from an agreement state or the United States nuclear regulatory commission; or

(b) Contain the information specified in sealed source and device registry requirements contained in paragraph (C) of rule 3701:1-46-49 of the Administrative Code so that the director is able to perform the review.

(2) For sources or devices manufactured before October 23, 2012 that are not registered with the director in accordance with rule 3701:1-46-49 of the Administrative Code or equivalent requirements from an agreement state or the United States nuclear regulatory commission, and for which the applicant is unable to provide all categories of information specified in rule 3701:1-46-49 of the Administrative Code, the applicant must provide:

(a) All available information identified in rule 3701:1-46-49 of the Administrative Code concerning the source, and, if applicable, the device; and

(b) Sufficient additional information to demonstrate that there is reasonable assurance that the radiation safety properties of the source or device are adequate to protect health and minimize danger to life and property. Such information must include a description of the source or device, a description of radiation safety features, the intended use and associated operating experience, and the results of a recent leak test.

(3) For sealed sources and devices allowed to be distributed without registration of safety information in accordance with rule 3701:1-46-49 of the Administrative Code, the applicant may supply only the manufacturer, model number, and radionuclide and quantity.

(4) If it is not feasible to identify each sealed source and device individually, the applicant may propose constraints on the number and type of sealed sources and devices to be used and the conditions under which they will be used, in lieu of identifying each sealed sources and device.

(F) In the case of an application for a license specified in rule 3701:1-40-16 of the Administrative Code, or an application for a specific license specified in Chapter 3701:1-46, 3701:1-48, or 3701:1-58 of the Administrative Code, the applicant shall provide a proposed decommissioning funding plan or a certification of financial assurance for decommissioning.

(G) Requirement for an emergency response plan:

(1) Each application to possess radioactive materials in excess of the quantities specified in the appendix to this rule, whether in unsealed form, on foils or plated sources, or sealed in glass, shall contain either:

(a) An evaluation showing that the maximum dose to a person offsite due to a release of radioactive materials would not exceed 0.01 sievert (one rem) TEDE or 0.05 sievert (five rem) to the thyroid; or

(b) An emergency plan for responding to a release of radioactive material.

(2) One or more of the following factors may be used to support an evaluation of the need to submit an emergency plan under this paragraph:

(a) The radioactive material is physically separated so that only a portion of the material could be involved in an accident;

(b) All or part of the radioactive material is not subject to release during an accident because of the way it is stored or packaged;

(c) The release fraction in the respirable size range would be lower than the release fraction specified in the appendix to this rule due to the chemical or physical form of the material;

(d) The solubility of the radioactive material would reduce the dose received;

(e) Facility design or engineered safety features in the facility would cause the release fraction to be lower than the limit specified in the appendix to this rule;

(f) Operating restrictions or procedures would prevent a release fraction as large as that shown in the appendix to this rule; or

(g) Other factors appropriate for the specific facility as determined by the director.

(3) An emergency plan for responding to a release of radioactive material submitted under paragraph (G)(1)(b) of this rule shall include the following information:

(a) A brief description of the licensee's facility and the area near the site.

(b) An identification of each type of possible radioactive material accident which may require protective action.

(c) A classification system for classifying an accident as either an alert or a site area emergency.

(d) Identification of the means of detecting each type of accident in a timely manner.

(e) A brief description of the means and equipment for mitigating the consequences of each type of accident, including those provided to protect workers onsite, and a description of the program for maintaining the equipment.

(f) A brief description of the methods and equipment to assess releases of byproduct and accelerator produced materials.

(g) A brief description of the responsibilities of the licensee's personnel should an accident occur, including identification of personnel responsible for promptly notifying offsite response organizations and the department, and identification of personnel responsible for developing, maintaining, and updating the plan.

(h) A commitment to, and a brief description of, the means to promptly notify offsite response organizations and request offsite assistance, including medical assistance for the treatment of contaminated injured onsite workers when appropriate. A control point shall be established. The notification and coordination shall be planned so that in the event that some personnel, parts of the facility, or some equipment is not available, that unavailability will not prevent such notification and coordination. The licensee shall also commit to notifying the department immediately after notification of the appropriate offsite response organizations and not later than one hour after the licensee declares an emergency. These reporting requirements do not supersede or release licensees from complying with the requirements of the "Emergency Planning and Community Right-to-Know Act of 1986, "Title III of Pub. L. 99-499, 100 Stat. 1728, 42 U.S.C. 11001 et seg. or other state or federal reporting requirements.

(i) A brief description of the types of information on facility status, radioactive releases, and recommended protective actions, if necessary, to be given to offsite response organizations and to the department.

(j) A brief description of the frequency, performance objectives and plans for the training that the licensee will provide workers on how to respond to an emergency including any special instructions and orientation tours the licensee would offer to fire, police, medical and other emergency personnel. The training shall familiarize personnel with site-specific emergency procedures. The training also shall thoroughly prepare site personnel for their responsibilities in the event of an accident, including training on the emergency scenarios postulated as most probable for the specific site, and the use of team training for such scenarios.

(k) A brief description of the means of restoring the facility to a safe condition after an accident.

(l) Provisions for conducting quarterly communication checks with offsite response organizations and biennial onsite exercises to test response to simulated emergencies. Quarterly communication checks with offsite response organizations must include the check and update of all necessary telephone numbers. The licensee shall invite offsite response organizations to participate in the biennial exercises. Participation of offsite response organizations in biennial exercises, although recommended, is not required. Exercises must use accident scenarios postulated as most probable for the specific site and the scenarios shall not be known to most exercise participants. The licensee shall critique each exercise using individuals not having direct implementation responsibility for the plan. Critiques of exercises must evaluate the appropriateness of the plan, emergency procedures, facilities, equipment, training of personnel, and overall effectiveness of the response. Deficiencies found by the critiques must be corrected.

(m) A certification that the applicant has met all responsibilities under the "Emergency Planning and Community Right-to-Know Act of 1986, "Title III of Pub. L. 99-499, 100 Stat. 1728, 42 U.S.C. 11001 et seq, if applicable to the applicant's activities at the proposed place of use of the byproduct or accelerator produced material.

(n) The licensee must have and maintain liability coverage for incidents which would activate the plan to cover bodily injury and property damage to third parties caused by incidents which would activate the plan in the amount of at least one million dollars per occurrence with an annual aggregate of at least two million dollars, exclusive of legal defense costs.

(4) The licensee shall allow the offsite response organizations expected to respond in case of an accident sixty days to comment on the licensee's emergency plan before submitting it to the department. The licensee shall provide any comments received within the sixty days to the department with the emergency plan.

(H) Information provided by a licensee or applicant for a license or license renewal that constitutes a "trade secret" as defined in section 1333.61 of the Revised Code is not subject to public disclosure in accordance with sections 1333.61 to 1333.69 of the Revised Code.

(I) An application from a medical facility, or educational institution to produce positron emission tomography (PET) radioactive drugs for noncommercial transfer to licensees in its consortium authorized for medical use in accordance with rules in Chapter 3701:1-58 of the Administrative Code shall include:

(1) A request for authorization for the production of PET radionuclides or evidence of an existing license issued in accordance with rule 3701:1-38-02 of the Administrative Code for a PET radionuclide production facility within its consortium from which it receives PET radionuclides.

(2) Evidence that the applicant is qualified to produce radioactive drugs for medical use by meeting one of the criteria in paragraph (A)(2) of rule 3701:1-46-43 of the Administrative Code.

(3) Identification of individual(s) authorized to prepare the PET radioactive drugs if the applicant is a pharmacy, and documentation that each individual meets the requirements of an authorized nuclear pharmacist as specified in paragraph (B)(2) of rule 3701:1-46-43 of the Administrative Code.

(4) Information identified in paragraph (A)(3) of rule 3701:1-46-43 of the Administrative Code, on the PET drugs to be non-commercially transferred to members of its consortium.

View Appendix

Last updated July 10, 2025 at 12:13 PM

History

• Effective: April 17, 2022
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-38-01

(A) As used in this chapter and all other rules promulgated pursuant to Chapter 3748. of the Revised Code:

(1) "A₁" means the maximum activity of special form radioactive material permitted in a type A package. These values are listed in rule 3701:1-50-25 of the Administrative Code, or may be derived in accordance with the procedure prescribed in rule 3701:1-50-25 of the Administrative Code.

(2) "A₂" means the maximum activity of radioactive material, other than special form, low specific activity and surface contaminated object material, permitted in a type A package. These values are listed in rule 3701:1-50-25 of the Administrative Code, or may be derived in accordance with the procedure prescribed in rule 3701:1-50-25 of the Administrative Code.

(3) "Absorbed dose" means the energy imparted by ionizing radiation per unit mass of irradiated material. The units of absorbed dose are the gray, or Gy, and the rad.

(4) "Accelerator or charged particle accelerator" means any of a class of radiation generating equipment designed to electronically accelerate atomic or sub-atomic particles for subsequent bombardment of targets.

(5) "Accelerator-produced radioactive material" means any material made radioactive by a particle accelerator.

(6) "Activity" means the rate of disintegration or transformation or decay of radioactive material. The units of activity are the becquerel, or Bq, and the curie, or Ci.

(7) "Address of use" means the building or buildings that are identified on the license or registration and where the source of radiation may be received, used, prepared, or stored, except for temporary job sites.

(8) "Administrative controls" means mechanisms used to protect health and minimize damage to life and property through the use of written policies, procedures, instructions, training, observation of work practices, and related compliance audits.

(9) "Administrative monetary penalty" means a monetary penalty assessed by the director under section 3748.05 of the Revised Code and in compliance with rules adopted thereunder, to emphasize the need for lasting remedial action and to deter future violations.

(10) "Adult" means an individual eighteen or more years of age.

(11) "Agreement state" means any state with which the United States nuclear regulatory commission or the atomic energy commission has entered into an effective agreement under subsection 274B of the Atomic Energy Act of 1954, 68 Stat. 919, 42 U.S.C. 2021, as amended (1978). Non-agreement state means any other state.

(12) "Airborne radioactive material" means radioactive material dispersed in the air in the form of dusts, fumes, particulates, mists, vapors, or gases.

(13) "Airborne radioactivity area" means a room, enclosure, or area in which airborne radioactive materials, composed wholly or partly of licensed material, exist in concentrations:

(a) In excess of the derived air concentrations (DACs) specified in appendix C to rule 3701:1-38-12 of the Administrative Code, or

(b) To such a degree that an individual present in the area without respiratory protective equipment could exceed, during the hours an individual is present in a week, an intake of 0.6 per cent of the annual limit on intake or twelve DAC-hours.

(14) "Air-purifying respirator" means a respirator with an air-purifying filter, cartridge, or canister that removes specific air contaminants by passing ambient air through the air-purifying element.

(15) "ALARA" or "as low as is reasonably achievable" means every reasonable effort to maintain exposures to radiation as far below the dose limits as is practical consistent with the purpose for which the licensed or registered activity is undertaken, taking into account the state of technology, the economics of improvements in relation to benefits to the public health and safety, and other societal and socioeconomic considerations, and in relation to utilization of nuclear energy and licensed materials and registered activities in the public interest.

(16) "Alert" means events may occur, are in progress, or have occurred that could lead to a release of radioactive material but that the release is not expected to require a response by off-site response organizations to protect persons off-site.

(17) "Annual limit on intake" or "ALI" means the derived limit for the amount of radioactive material taken into the body of an adult worker by inhalation or ingestion in a year. ALI is the smaller value of intake of a given radionuclide in a year by the reference man that would result in a committed effective dose equivalent of 0.05 sievert (five rem) or a committed dose equivalent of 0.5 sievert (fifty rem) to any individual organ or tissue. ALI values for intake by ingestion and by inhalation of selected radionuclides are given in appendix C to rule 3701:1-38-12 of the Administrative Code.

(18) "Annually" means either

(a) At intervals not to exceed one year; or

(b) Once per year, at about the same time each year, plus or minus one month.

(19) "Area of use" means a portion of an address of use that has been set aside for the purpose of receiving, preparing, using, or storing sources of radiation.

(20) "Assigned protection factor" or "APF" means the expected workplace level of respiratory protection that would be provided by a properly functioning respirator or a class of respirators to properly fitted and trained users. Operationally, the inhaled concentration can be estimated by dividing the ambient airborne concentration by the APF.

(21) "Atmosphere-supplying respirator" means a respirator that supplies the respirator user with breathing air from a source independent of the ambient atmosphere, and includes supplied air respirators, or SARs, and self-contained breathing apparatus, or SCBA, units.

(22) "Atomic energy commission" or "AEC" means the federal agency created by the Atomic Energy Act of 1954, 68 Stat. 919, 42 U.S.C. 2011, as amended (1964), and was the predecessor agency to the current United States nuclear regulatory commission.

(23) "Background radiation" means radiation from cosmic sources; naturally occurring radioactive materials, including radon, except as a decay product of source or special nuclear material, and global fallout as it exists in the environment from the testing of nuclear explosive devices or from past nuclear accidents such as Chernobyl that contribute to background radiation and are not under the control of the licensee. "Background radiation" does not include radiation from radioactive materials regulated by the department.

(24) "Becquerel" or "Bq" means the SI unit of activity. One becquerel is equal to one disintegration per second.

(25) "Bioassay" or "radiobioassay" means the determination of kinds, quantities or concentrations, and, in some cases, the locations of radioactive material in the human body, whether by direct measurement, in vivo counting, or by analysis and evaluation of materials excreted or removed from the human body.

(26) "Byproduct material" means

(a) Any radioactive material, except special nuclear material, yielded in or made radioactive by exposure to the radiation incident to the process of producing or utilizing special nuclear materials; or

(b) The tailings or wastes produced by the extraction or concentration of uranium or thorium from any ore processed primarily for its source material content, including discrete surface wastes resulting from solution extraction processes. Underground ore bodies depleted by such solution extraction do not constitute byproduct material within the definition.

(27) "Chelating agent" means a chemical compound or mixture that enhances the removal of radioactive material from the body, water or similar applications. Typical chelating agents include amine polycarboxylic acids such as EDTA or DTPA; hydroxy-carboxylic acids; and polycarboxylic acids such as citric acid, carbolic acid, and gluconic acid.

(28) "Chiropractor" means an individual licensed by the state of Ohio to practice chiropractic medicine pursuant to Chapter 4734. of the Revised Code.

(29) "Class" or "lung class" or "inhalation class" means a classification scheme for inhaled material according to its rate of clearance from the pulmonary region of the lung. Materials are classified as D, W, or Y, which applies to a range of clearance half-times: for class D, days, of less than ten days, for class W, weeks, from ten to one hundred days, and for class Y, years, of greater than one hundred days.

(30) "Collective dose" means the sum of the individual doses received in a given period of time by a specified population from exposure to a specified source of radiation.

(31) "Commencement of construction" means taking any action defined as "construction" or any other activity at the site of a facility subject to the rules promulgated pursuant to Chapter 3748. of the Revised Code that has a reasonable nexus to radiological health and safety.

(32) "Committed dose equivalent" or "H_T,50" means the dose equivalent to organs or tissues of reference, T, that will be received from an intake of radioactive material by an individual during the fifty year period following the intake.

(33) "Committed effective dose equivalent" or "H_E,50" means the sum of the products of the weighting factors applicable to each of the body organs or tissues, W_T, that are irradiated and the committed dose equivalent to each of these organs or tissues (H_{E, 50} = W_TH_T,50).

(34) "Consortium" means an association of medical use licensees and a PET radionuclide production facility in the same geographical area that jointly own or share in the operation and maintenance cost of the PET radionuclide production facility that produces PET radionuclides for use in producing radioactive drugs within the consortium for noncommercial distributions among its associated members for medical use. The PET radionuclide production facility within the consortium must be located at an educational institution or a medical facility.

(35) "Constraint" or "dose constraint" means a value above which specified licensee actions are required.

(36) "Construction" means the installation of foundations, or in-place assembly, erection, fabrication, or testing for any structure, system, or component of a facility or activity subject to the rules promulgated pursuant to Chapter 3748. of the Revised Code that are related to radiological safety or security. The term "construction" does not include:

(a) Changes for temporary use of the land for public recreational purposes;

(b) Site exploration, including necessary borings to determine foundation conditions or other preconstruction monitoring to establish background information related to the suitability of the site, the environmental impacts of construction or operation, or the protection of environmental values;

(c) Preparation of the site for construction of the facility, including clearing of the site, grading, installation of drainage, erosion and other environmental mitigation measures, and construction of temporary roads and borrow areas;

(d) Erection of fences and other access control measures that are not related to the safe use of, or security of, radiological materials subject to the rules promulgated pursuant to Chapter 3748. of the Revised Code;

(e) Excavation;

(f) Erection of support buildings (e.g. construction equipment storage sheds, warehouse and shop facilities, utilities, concrete mixing plants, docking and unloading facilities, and office buildings) for use in connection with the construction of the facility;

(g) Building of service facilities (e.g. paved roads, parking lots, railroad spurs, exterior utility and lighting systems, potable water systems, sanitary sewerage treatment facilities, and transmission lines);

(h) Procurement or fabrication of components or portions of the proposed facility occurring at other than the final, in-place location at the facility; or

(i) Taking any other action that has no reasonable nexus to radiological health and safety.

(37) "Controlled area" means an area, outside of a restricted area but inside the site boundary, access to which can be limited by the licensee or registrant for any reason.

(38) "Critical group" means the group of individuals reasonably expected to receive the greatest exposure to residual radioactivity for any applicable set of circumstances.

(39) "Curie" or "Ci" means a unit of activity. One curie equals 3.7 x 10¹⁰ disintegrations per second equals 3.7 x 10¹⁰ becquerels equals 2.22 x 10¹² disintegrations per minute.

(40) "Cyclotron" means a particle accelerator in which the charged particles travel in an outward spiral or circular path. A cyclotron accelerates charged particles at energies usually in excess of ten megaelectron volts and is commonly used for production of short half-life radionuclides for medical use.

(41) "Declared pregnant woman" means a woman who has voluntarily informed the licensee or registrant, in writing, of her pregnancy and the estimated date of conception. The declaration remains in effect until the declared pregnant woman withdraws the declaration in writing or is no longer pregnant.

(42) "Decommission" means to safely remove any licensed operation from service and reduce residual radioactivity to a level that permits release of the licensee's property for unrestricted use and termination of the license.

(43) "Dedicated check source" means a radioactive source that is used to assure the consistent performance of a radiation detection or measurement device over several months or years.

(44) "Deep dose equivalent" or "H_d" applies to external whole body exposure, and means the dose equivalent at a tissue depth of one centimeter, one thousand milligram per square centimeter.

(45) "Demand respirator" means an atmosphere-supplying respirator that admits breathing air to the facepiece only when a negative pressure is created inside the facepiece by inhalation.

(46) "Dentist" means an individual licensed by the state of Ohio to practice dentistry under Chapter 4715. of the Revised Code.

(47) "Department" means the Ohio department of health.

(48) "Depleted uranium" means uranium containing less uranium-235 than the naturally occurring distribution of uranium isotopes.

(49) "Derived air concentration" or "DAC" means the concentration of a given radionuclide in air which, if breathed by the reference man for a working year of two thousand hours under conditions of light work, results in an intake of one ALI. The condition of light work is inhaling 1.2 cubic meters of air per hour for two thousand hours in a year. DAC values are given in appendix C to rule 3701:1-38-12 of the Administrative Code.

(50) "Derived air concentration-hour or DAC-hour" means the product of the concentration of radioactive material in air, which is expressed as a fraction or multiple of the derived air concentration for each radionuclide, and the time of exposure to that radionuclide, in hours. A licensee or registrant may take two thousand DAC-hours to represent one ALI, equivalent to a committed effective dose equivalent of 0.05 Sv (five rem).

(51) "Direct reading dosimeter" means a device that measures radiation dose that does not require another device to read the measured radiation dose. Examples of direct reading dosimeters include pocket dosimeters and electronic dosimeters.

(52) "Director" means the director of health or a designee or authorized representative of the director.

(53) "Discipline" means a branch of knowledge or of teaching.

(54) "Discrete source" means a radionuclide that has been processed so that its concentration within a material has been purposely increased for use for commercial, medical, or research activities.

(55) "Disposable respirator" means a respirator for which maintenance is not intended and that is designed to be discarded after excessive breathing resistance, sorbent exhaustion, physical damage, or end-of service-life renders it unsuitable for use. Examples of this type of respirator are a disposable half-mask respirator or a disposable escape-only self-contained breathing apparatus.

(56) "Dose" or "radiation dose" is a generic term that means absorbed dose, dose equivalent, effective dose equivalent, committed effective dose equivalent, or total effective dose equivalent as defined in other paragraphs of this rule.

(57) "Dose equivalent" or "H_T" means the product of the absorbed dose in tissue, quality factor, and all other necessary modifying factors at the location of interest. The units of dose equivalent are the sievert and rem.

(58) "Dose limits" or "limits" means the permissible upper bounds of radiation doses established in accordance with these regulations but excludes background radiation and medical exposure.

(59) "Dosimetry processor" means a person that processes and evaluates individual monitoring devices in order to determine the radiation dose delivered to the monitoring devices.

(60) "Effective dose equivalent" or "H_E" means the sum of the products of the dose equivalent to each organ or tissue, H_T, and the weighting factor, W_T, applicable to each of the body organs or tissues that are irradiated: (H_E = ∑W_TH_T).

(61) "Embryo" or "fetus" means the developing human organism from conception until time of birth.

(62) "Engineering controls" means mechanisms used to protect health and minimize damage to life and property through engineering specifications, design, and construction of the product or facility including all of the security and safety features. This includes, but is not limited to, auxiliary security and safety features such as additional external shielding, barriers, and operational interlocks with associated processes.

(63) "Entrance" or "access point" means any opening through which an individual or extremity of an individual could gain access to radiation areas or to licensed radioactive materials or registered radiation generating equipment. This includes entry or exit portals of sufficient size to permit human entry, irrespective of their intended use.

(64) "Explosive material" means any chemical compound, mixture or device which produces a substantial instantaneous release of gas and heat spontaneously or by contact with sparks or flame.

(65) "Exposure" means being exposed to sources of ionizing radiation.

(66) "External dose" means that portion of the dose equivalent received from radiation sources outside the body.

(67) "Extremity" means hand, elbow, arm below the elbow, foot, knee, or leg below the knee.

(68) "Eye dose equivalent" means the same as lens dose equivalent.

(69) "Facility" means all buildings, equipment, structures and other stationary items that, in addition to the meaning defined in division (H) of section 3748.01 of the Revised Code, are:

(a) Located on a single site or on contiguous or adjacent sites and are operated by the same person and have common corporate or business interests; or

(b) Portions of a building or structure which are operated by the same person and have common corporate or business interests.

(70) "Filtering facepiece" or "dust mask" means a negative pressure particulate respirator with a filter as an integral part of the facepiece or with the entire facepiece composed of the filtering medium, not equipped with elastomeric sealing surfaces and adjustable straps.

(71) "Fissile material" means the radionuclides uranium-233, uranium-235, plutonium-239, and plutonium-241, or any combination of these radionuclides. Fissile material means the fissile nuclides themselves, not material containing fissile nuclides. Unirradiated natural uranium and depleted uranium and natural uranium or depleted uranium that has been irradiated in thermal reactors only, are not included in this definition. Certain exclusions from fissile material controls are provided in rule 3701:1-50-13 of the Administrative Code.

(72) "Fit factor" means quantitative estimate of the fit of a particular respirator to a specific individual, and typically estimates the ratio of the concentration of a substance in ambient air to its concentration inside the respirator when worn.

(73) "Fit test" means the use of a protocol to qualitatively or quantitatively evaluate the fit of a respirator on an individual.

(74) "Generally applicable environmental radiation standards" means standards issued by the United States environmental protection agency under the authority of the Atomic Energy Act of 1954, 68 Stat. 919, 42 U.S.C. 2011, as amended (2005), that impose limits on radiation exposures or levels, or concentrations or quantities of radioactive material, in the general environment outside the boundaries of locations under the control of persons possessing or using radioactive material.

(75) "Gray" or "Gy" means the SI unit of absorbed dose. One gray is equal to an absorbed dose of one joule per kilogram (one hundred rads).

(76) "Handle" means receive, possess, use, store, transfer, install, service, or dispose of sources of radiation unless possession is solely for the purpose of transportation.

(77) "Handler" means a facility that handles sources of radiation unless possession is solely for the purpose of transportation.

(78) "Hazardous waste" means those wastes designated as hazardous by rule 3745-51-03 of the Administrative Code.

(79) "Helmet" means a rigid respiratory inlet covering that also provides head protection against impact and penetration.

(80) "High radiation area" means an area, accessible to individuals, in which radiation levels from radiation sources external to the body could result in an individual receiving a dose equivalent in excess of one millisievert (0.1 rem) in one hour at thirty centimeters from the radiation source or thirty centimeters from any surface that the radiation penetrates.

(81) "Hood" means a respiratory inlet covering that completely covers the head and neck and may also cover portions of the shoulders and torso.

(82) "Individual" means any human being.

(83) "Individual monitoring" means

(a) The assessment of dose equivalent by the use of devices designed to be worn by an individual;

(b) The assessment of committed effective dose equivalent by bioassay or by determination of the time-weighted air concentrations to which an individual has been exposed, i.e. DAC-hours; or

(c) The assessment of dose equivalent by the use of survey data.

(84) "Individual monitoring devices" means devices designed to be worn by a single individual for the assessment of dose equivalent such as film badges; thermoluminescent dosimeters; optically stimulated luminescent dosimeters; pocket ionization chambers; and personal air sampling devices.

(85) "Industrial radiography" means the examination of the structure of materials by nondestructive methods, utilizing sealed sources of radioactive material or radiation-generating equipment.

(86) "Internal dose" means that portion of the dose equivalent received from radioactive material taken into the body.

(87) "Irradiator" means a facility that uses radioactive sealed sources for the irradiation of objects or materials and in which radiation dose rates exceeding five grays (five hundred rads) per hour exist at one meter from the sealed radioactive source in air or water, as applicable for the irradiator type, but does not include irradiators in which both the sealed source and the area subject to irradiation are contained within a device and are not accessible to personnel.

(88) "Lens dose equivalent" or "eye dose equivalent" means the external exposure of the lens of the eye and is taken as the dose equivalent at a tissue depth of 0.3 centimeters; i.e. three hundred milligrams per square centimeter.

(89) "License" means a license issued by the nuclear regulatory commission, the director, or another agreement state in accordance with rules adopted by those organizations.

(90) "Licensee" means a person to whom a license is issued.

(91) "Licensed activity" means an activity authorized by a radioactive material license which is essential to achieving the purpose for which the license was issued or amended.

(92) "Licensed material" means radioactive material received, possessed, used, transferred or disposed of under a general or specific license.

(93) "Loose-fitting facepiece" means a respiratory inlet covering that is designed to form a partial seal with the face.

(94) "Lost or missing licensed source of radiation" means a licensed source of radiation whose location is unknown. It includes material that has been shipped but has not reached its destination and whose location cannot be readily traced in the transportation system.

(95) "Low-level radioactive waste" or "LLRW," also "low-level waste," or "LLW" means radioactive waste which is not high-level radioactive waste, spent nuclear fuel, NARM, or byproduct material as defined in section 11 E. (2) of the Atomic Energy Act of 1954 68 Stat. 919, 42 U.S.C. 2011, as amended (2005), but is radioactive material that the United States nuclear regulatory commission classifies as low-level radioactive waste.

(96) "Low specific activity material" or "LSA" means radioactive material with limited specific activity which is nonfissile or is excepted under rule 3701:1-50-13 of the Administrative Code, and which satisfies the descriptions and limits set forth below. Shielding materials surrounding the LSA material may not be considered in determining the estimated average specific activity of the package contents. LSA must be in one of three groups:

(a) LSA - I.

(i) Uranium and thorium ores, concentrates of uranium and thorium ores, and other ores containing naturally occurring radioactive radionuclides that are intended to be processed for the use of these radionuclides;

(ii) Natural uranium, depleted uranium, natural thorium or their compounds or mixtures, provided they are unirradiated and in solid or liquid form;

(iii) Radioactive material other than fissile material, for which the A₂ value is unlimited; or

(iv) Other radioactive material in which the activity is distributed throughout and the estimated average specific activity does not exceed thirty times the value for exempt material activity concentration determined in accordance with rule 3701:1-50-25 of the Administrative Code.

(b) LSA-II.

(i) Water with tritium concentration up to 0.8 terabecquerels per liter (twenty curies per liter); or

(ii) Other material in which the activity is distributed throughout and the estimated average specific activity does not exceed ( 10^-4 A₂) per gram for solids and gases, and (10^-5 A₂) per gram for liquids.

(c) LSA-III. Solids (e.g., consolidated wastes, activated materials), excluding powders, that satisfy the requirements of 10 C.F.R. 71.77 (as in effect on the effective date of this rule), in which:

(i) The radioactive material is distributed throughout a solid or a collection of solid objects, or is essentially uniformly distributed in a solid compact binding agent (such as concrete, bitumen, ceramic, etc.);

(ii) The radioactive material is relatively insoluble, or it is intrinsically contained in a relatively insoluble material, so that even under loss of packaging, the loss of radioactive material per package by leaching, when placed in water for seven days, would not exceed (0.1 x A₂); and

(iii) The estimated average specific activity of the solid, excluding any shielding material, does not exceed (0.002 x A₂) per gram.

(97) "Management" means the chief executive officer or other individual having the authority to manage, direct, or administer the licensee's activities, or those persons' delegate or delegates.

(98) "Medical institution" means an organization in which more than one medical discipline is practiced.

(99) "Medical use" means the intentional internal or external administration of radioactive material or the radiation therefrom to patients or human research subjects under the supervision of an authorized user.

(100) "Member of the public" means any individual except when that individual is receiving an occupational dose.

(101) "Minor" means an individual less than eighteen years of age.

(102) "Monitoring" or "radiation monitoring" or "radiation protection monitoring" means the measurement of radiation levels, concentrations, surface area concentrations or quantities of radioactive material and the use of the results of these measurements to evaluate potential exposures and doses.

(103) "NARM" or "naturally occurring or accelerator-produced radioactive material" means naturally occurring or accelerator-produced radioactive material, including naturally occurring material that is technologically enhanced, and those nuclides that are generated in a charged particle accelerator, but does not include source material, byproduct material, or special nuclear material.

(104) "NARM licensing state" means any state with regulations equivalent to the suggested state regulations for control of radiation relating to, and an effective program for, the regulatory control of NARM and which has been granted final designation by the conference of radiation control program directors, inc.

(105) "Nationally tracked source" means a sealed source containing a quantity equal to or greater than "Category 1" or "Category 2" levels of any radioactive material listed in the appendix to rule 3701:1-38-25 of the Administrative Code. In this context a sealed source is defined as radioactive material that is sealed in a capsule or closely bonded, in a solid form and which is not exempt from regulatory control. It does not mean material encapsulated solely for disposal, or nuclear material contained in any fuel assembly, subassembly, fuel rod, or fuel pellet. "Category 1" nationally tracked sources are those containing radioactive material at a quantity equal to or greater than the "Category 1" threshold. "Category 2" nationally tracked sources are those containing radioactive material at a quantity equal to or greater than the "Category 2" threshold but less than the "Category 1" threshold.

(106) "Negative pressure respirator" or "tight fitting respirator" means a respirator in which the air pressure inside the facepiece is negative during inhalation with respect to the ambient air pressure outside the respirator.

(107) "Nonstochastic effect" or "deterministic effect" means health effects, the severity of which varies with the dose and for which a threshold is believed to exist. Radiation-induced cataract formation is an example of a nonstochastic effect.

(108) "NORM" or "naturally occurring radioactive material" means any nuclide that is radioactive in its natural physical state, but does not include source material, byproduct material, or special nuclear material.

(109) "Normal form radioactive material" means radioactive material that has not been demonstrated to qualify as special form radioactive material.

(110) "Nuclear regulatory commission" means the federal agency established by Title II of the Energy Reorganization Act of 1974, 88 Stat. 1233, 42 U.S.C.A. 5801, as amended (2005), comprising the members of the commission and all offices, employees, and representatives authorized to act in any case or matter related to licensing and related regulatory function previously assigned to the AEC.

(111) "Occupational dose" means the dose received by an individual in the course of employment in which the individual's assigned duties involve exposure to radiation or radioactive material from licensed and unlicensed sources of radiation, whether in the possession of the licensee or other person. Occupational dose does not include doses received from background radiation, from any medical administration the individual has received, from exposures to individuals administered radioactive materials and released in accordance with rule 3701:1-58-30 of the Administrative Code or equivalent United States nuclear regulatory commission or agreement state regulations, from voluntary participation in medical research programs, or as a member of the public.

(112) "Package" means the packaging together with its radioactive contents as presented for transport.

(a) Fissile material package or type AF package, type BF package, type B(U)F package, or type B(M)F package means a fissile material packaging together with its fissile material contents.

(b) Type A package means a type A packaging together with its radioactive contents. A type A package is defined and must comply with the United States department of transportation regulations in 49 C.F.R. 173 (as in effect on the effective date of this rule).

(c) Type B package means a type B packaging together with its radioactive contents. On approval, a type B package design is designated by the United States nuclear regulatory commission as B(U) unless the package has a maximum normal operating pressure of more than seven hundred kilopascals (one hundred pounds per square inch) gauge or a pressure relief device that would allow the release of radioactive material to the environment under the tests specified in 10 C.F.R. 71.73 (hypothetical accident conditions) (as in effect on the effective date of this rule), in which case it will receive a designation B(M). B(U) refers to the need for unilateral approval of international shipments; B(M) refers to the need for multilateral approval of international shipments. There is no distinction made in how packages with these designations may be used in domestic transportation. To determine their distinction for international transportation, see United States department of transportation regulations in 49 C.F.R. 173 (as in effect on the effective date of this rule). A type B package approved before September 6, 1983, was designated only as type B. Limitations on its use are specified in 10 C.F.R. 71.19 (as in effect on the effective date of this rule).

(113) "Packaging" means the assembly of components necessary to ensure compliance with the packaging requirements of rule 49 C.F.R. 173 Subpart I (as in effect on the effective date of this rule). It may consist of one or more receptacles, absorbent materials, spacing structures, thermal insulation, radiation shielding, and devices for cooling or absorbing mechanical shocks. The vehicle, tie-down system and auxiliary equipment may be designated as part of the packaging.

(114) "Particle accelerator" means any machine capable of accelerating electrons, protons, deuterons, or other charged particles in a vacuum and of discharging the resultant particulate or other radiation into a medium at energies usually in excess of one megaelectron volt. For purposes of this definition, "accelerator" is an equivalent term.

(115) "Person" means any individual, corporation, association, business enterprise, or other legal entity either public or private and any legal successor, representative, agent, or agency of that individual, corporation, association, business enterprise, or other legal entity. Person also includes the United States, states, political subdivisions of states, and any department, agency, or instrumentality of the United States or a state, except the U.S. department of energy or the U.S. nuclear regulatory commission where the state regulation of radioactive material by either of those agencies is prohibited by federal law.

(116) "Personnel dosimeter", means a device that measures radiation dose that is processed and evaluated by an accredited "National Voluntary Laboratory Accreditation Program" (NVLAP) processor. Examples of personnel dosimeters include film badges, thermo-luminescent dosimeters (TLD), and optically stimulated luminescence (OSL) dosimeters.

(117) "Pharmacist" means a person who is licensed by the state of Ohio to practice pharmacy pursuant to Chapter 4731. of the Revised Code.

(118) "Physician" means a person who is licensed pursuant to Chapter 4731. of the Revised Code to practice medicine or surgery or osteopathic medicine or surgery.

(119) "Planned special exposure" means an infrequent exposure to radiation, separate from and in addition to the annual dose limits.

(120) "Podiatrist" means an individual licensed by the state of Ohio to practice podiatry pursuant to Chapter 4731. of the Revised Code.

(121) "Positive pressure respirator" means a respirator in which the pressure inside the respiratory inlet covering exceeds the ambient air pressure outside the respirator.

(122) "Positron Emission Tomography (PET) radionuclide production facility" means a facility operating a cyclotron or accelerator for the purpose of producing PET radionuclides.

(123) "Powered air-purifying respirator" or "PAPR" means an air-purifying respirator that uses a blower to force the ambient air through air purifying elements to the inlet covering.

(124) "Pressure demand respirator" means a positive pressure atmosphere supplying respirator that admits breathing air to the facepiece when the positive pressure is reduced inside the facepiece by inhalation.

(125) "Public dose" means the dose received by a member of the public from exposure to radiation and/or radioactive material released by the licensee, or to any other source of radiation under the control of a licensee or registrant. Public dose does not include occupational dose or doses received from background radiation, from any medical administration the individual has received, from exposures to individuals administered radioactive materials and released in accordance with rule 3701:1-58-30 of the Administrative Code or equivalent United States nuclear regulatory commission or agreement state regulations, or from voluntary participation in medical research programs.

(126) "Pyrophoric material" means any liquid that ignites spontaneously in dry or moist air at or below 54.4 degrees celsius (one hundred thirty degrees fahrenheit). A pyrophoric solid is any solid material, other than one classed as an explosive, which under normal conditions is liable to cause fires through friction, retained heat from manufacturing or processing, or which can be ignited readily and when ignited burns so vigorously and persistently as to create a serious transportation, handling, or disposal hazard. Included are spontaneously combustible and water-reactive materials.

(127) "Qualitative fit test" or "QLFT" means a pass/fail fit test to assess the adequacy of respirator fit that relies on the individual's response to the test agent.

(128) "Quality factor" or "Q" means the modifying factor, as listed in paragraphs (A) and (B) of rule 3701:1-38-11 of the Administrative Code, that is used to derive dose equivalent from absorbed dose.

(129) "Quantitative fit test" or "QNFT" means an assessment of the adequacy of respirator fit by numerically measuring the amount of leakage into the respirator.

(130) "Quarter" or "quarterly" means a period of time equal to one-fourth of the year observed by the licensee or registrant, approximately thirteen consecutive weeks, providing that the beginning of the first quarter in a year coincides with the starting date of the year and that no day is omitted or duplicated in consecutive quarters.

(131) "Rad" means the special unit of radiation absorbed dose. One rad is equal to an absorbed dose of one hundred ergs per gram, or 0.01 joule per kilogram, or 0.01 gray.

(132) "Radiation" or "ionizing radiation" means alpha particles, beta particles, gamma rays, x-rays, neutrons, high speed electrons, high speed protons, and other particles capable of producing ions. Radiation does not include nonionizing radiation, such as radio or microwaves, or visible, infrared or ultraviolet light.

(133) "Radiation area" means an area, accessible to individuals, in which radiation levels could result in an individual receiving a dose equivalent in excess of 0.05 millisievert (0.005 rem) in one hour at thirty centimeters from the source of radiation or from any surface that the radiation penetrates.

(134) "Radiation-generating equipment" or "RGE" means any manufactured product or device, or component of such a product or device, or any machine or system that during operation can generate or emit radiation, except those that emit radiation only from radioactive material. "Radiation-generating equipment" does not include either of the following:

(a) Diathermy machines;

(b) Microwave ovens, including food service microwave ovens used for commercial and industrial uses, television receivers, electric lamps, and other household appliances and products that generate very low levels of radiation.

(135) "Radiation Safety Officer" or "RSO" means an individual designated by the licensee who has the knowledge and responsibility for the overall radiation safety program at the facility, to include the implementation of the daily radiation safety operations and compliance with the rules.

(136) "Radioactive material" means any solid, liquid or gaseous material that emits ionizing radiation spontaneously. "Radioactive material" includes accelerator-produced and naturally occurring radioactive materials and byproduct, source, and special nuclear material.

(137) "Radioactive waste" means waste containing regulated radioactive material.

(138) "Radioactivity" means the transformation of unstable atoms by the emission of radiation.

(139) "Radiography" means the same as industrial radiography.

(140) "Reference man" means a hypothetical aggregation of human physical and physiological characteristics arrived at by international consensus. These characteristics may be used by researchers and public health workers to standardize results of experiments and to relate biological insult to a common base.

(141) "Registrant" means a person required by Chapter 3748. of the Revised Code to register radiation-generating equipment with the director.

(142) "Rem" means the special unit of any of the quantities expressed as dose equivalent. The dose equivalent in rem is equal to the absorbed dose in rads multiplied by the quality factor (one rem = 0.01 Sv).

(143) "Research and development" means

(a) Theoretical analysis, exploration, or experimentation; or

(b) The extension of investigative findings and theories of a scientific or technical nature into practical application for experimental and demonstration purposes, including the experimental production and testing of models, devices, equipment, materials and processes. "Research and development" does not include the internal or external administration of sources of radiation to human beings.

(144) "Residual radioactivity" means radioactivity in structures, materials, soils, groundwater, and other media at a site resulting from activities under the licensee's control. This includes radioactivity from all licensed and unlicensed sources used by the licensee, but excludes background radiation. It also includes radioactive materials remaining at the site as a result of routine or accidental releases of radioactive material at the site and previous burials at the site, even if those burials were made in accordance with the provisions of 10 C.F.R. 20 (as in effect on the effective date of this rule).

(145) "Respiratory protective equipment or device" means an apparatus, such as a respirator, used to reduce the individual's intake of airborne radioactive materials.

(146) "Restricted area" means an area access to which is limited by the licensee or registrant for the purpose of protecting individuals against undue risks from exposure to sources of radiation. Restricted area does not include areas used as residential quarters, but separate rooms in a residential building may be set apart as a restricted area.

(147) "Roentgen" means the amount of gamma or x-rays required to produce ions resulting in a charge of 0.000258 coulombs per kilogram of air under standard conditions.

(148) "Sanitary sewerage" means a system of public sewers for carrying off wastewater and refuse, but excluding sewage treatment facilities, septic tanks, and leach fields owned or operated by the licensee.

(149) "Sealed source" means radioactive material that is encased in a manner designed to prevent leakage or escape of the radioactive material.

(150) "Sealed source and device registry" means the national registry that contains all the registration certificates, generated by both the United States nuclear regulatory commission and the agreement states, that summarize the radiation safety information for the sealed sources and devices and describe the licensing and use conditions approved for the product.

(151) "Seismic area" means any area where the probability of a horizontal acceleration in rock of more than 0.3 times the acceleration of gravity in two hundred fifty years is greater than ten per cent, as designated by the United States geological survey.

(152) "Self-contained breathing apparatus" or "SCBA" means an atmosphere-supplying respirator for which the breathing air source is designed to be carried by the user.

(153) "Shallow dose equivalent" or "H_S" means the external exposure of the skin of the whole body or the skin of an extremity, is taken as the dose equivalent at a tissue depth of 0.007 centimeter, or seven milligrams per square centimeter.

(154) "Sievert" or "Sv" means the SI unit of any of the quantities expressed as dose equivalent. The dose equivalent in sieverts is equal to the absorbed dose in grays multiplied by the quality factor. One sievert equals one hundred rem.

(155) "Site area emergency" means events may occur, are in progress, or have occurred that could lead to a significant release of radioactive material and that could require a response by off-site response organizations to protect persons off-site.

(156) "Site boundary" means that line beyond which the land or property is not owned, leased, or otherwise controlled by the licensee or registrant.

(157) "Site closure and stabilization" means those actions that are taken upon completion of operations that prepare a disposal site for custodial care and that assure that the disposal site will remain stable and will not need ongoing active maintenance.

(158) "Source material" means uranium, thorium, or any combination thereof in any physical or chemical form, or any ores that contain by weight at least one-twentieth of one per cent (0.05 per cent) of uranium, thorium, or any combination thereof. Source material does not include special nuclear material.

(159) "Sources of radiation" means radioactive material or radiation generating equipment.

(160) "Special form radioactive material" means radioactive material that satisfies the following conditions:

(a) It is either a single solid piece or is contained in a sealed capsule that can be opened only by destroying the capsule;

(b) The piece or capsule has at least one dimension not less than five millimeters (0.2 inch); and

(c) It satisfies the test requirements specified by the United States nuclear regulatory commission in 10 C.F.R. 71.75 (as in effect on the effective date of this rule). A special form encapsulation designed in accordance with the United States nuclear regulatory commission requirements identified in 10 C.F.R. 71.4, in effect on June 30, 1983, and constructed prior to July 1, 1985; a special form encapsulation designed in accordance with the requirements of 10 C.F.R. 71.4 in effect on March 31, 1996, and constructed before April 1, 1998; and special form material that was successfully tested before September 10, 2015 in accordance with the requirements of 10 C.F.R. 71.75(d) of this section in effect before September 10, 2015 may continue to be used. Any other special form encapsulation must meet the specifications of this definition.

(161) "Special nuclear material" means either of the following:

(a) Plutonium, uranium-233, uranium enriched in the isotope 233, or in the isotope 235, and any other material that the United States nuclear regulatory commission determines to be special nuclear material, but does not include source material pursuant to section 51 of the Atomic Energy Act of 1954, 68 Stat 919, 42 USCA 2071, as amended (2005).

(b) Any material artificially enriched by any of the foregoing but does not include source material.

(162) "Special nuclear material in quantities not sufficient to form a critical mass" means uranium enriched in the isotope uranium-235 in quantities not exceeding three hundred fifty grams of contained uranium-235; uranium-233 in quantities not exceeding two hundred grams; plutonium in quantities not exceeding two hundred grams; or any combination of them in accordance with the following formula: for each kind of special nuclear material, determine the ratio between the quantity of that special nuclear material and the quantity specified in this paragraph for the same kind of special nuclear material. The sum of such ratios for all of the kinds of special nuclear material in combination shall not exceed unity.

(163) "Stochastic effect" means health effects that occur randomly and for which the probability of the effect occurring, rather than its severity, is assumed to be a linear function of dose without threshold. Hereditary effects and cancer incidence are examples of stochastic effects.

(164) "Supplied-air respirator" or "SAR" or "airline respirator" means an atmosphere-supplying respirator for which the source of breathing air is not designed to be carried by the user.

(165) "Surface contaminated object" or "SCO" means a solid object that is not itself classed as radioactive material, but which has radioactive material distributed on any of its surfaces. SCO must be in one of two groups with surface activity not exceeding the following limits:

(a) SCO-I: a solid object on which:

(i) The non-fixed contamination on the accessible surface averaged over three hundred square centimeters, or the area of the surface if less than three hundred square centimeters, does not exceed four becquerels per square centimeter (10^-4 microcurie per square centimeter) for beta and gamma and low toxicity alpha emitters, or 0.4 becquerels per square centimeter 10^-5 microcurie per square centimeter) for all other alpha emitters;

(ii) The fixed contamination on the accessible surface averaged over three hundred square centimeters, or the area of the surface if less than three hundred square centimeters, does not exceed forty thousand becquerels per square centimeter (one microcurie per square centimeter) for beta and gamma and low toxicity alpha emitters, or four thousand becquerels per square centimeter (0.1 microcurie per square centimeter) for all other alpha emitters; and

(iii) The non-fixed contamination plus the fixed contamination on the inaccessible surface averaged over three hundred square centimeters, or the area of the surface if less than three hundred square centimeters, does not exceed forty thousand becquerels per square centimeter (one microcurie per square centimeter) for beta and gamma and low toxicity alpha emitters, or four thousand becquerels per square centimeter (0.1 microcurie per square centimeter) for all other alpha emitters.

(b) SCO-II: a solid object on which the limits for SCO-I are exceeded and on which:

(i) The non-fixed contamination on the accessible surface averaged over three hundred square centimeters, or the area of the surface if less than three hundred square centimeter, does not exceed four hundred becquerels per square centimeter (10^-2 microcurie per square centimeter) for beta and gamma and low toxicity alpha emitters, or forty becquerels per square centimeter (10^-3 microcurie per square centimeter) for all other alpha emitters;

(ii) The fixed contamination on the accessible surface averaged over three hundred square centimeters, or the area of the surface if less than three hundred square centimeters, does not exceed eight hundred thousand becquerels per square centimeter (twenty microcuries per square centimeter) for beta and gamma and low toxicity alpha emitters, or eighty thousand becquerels per square centimeter (two microcuries per square centimeter) for all other alpha emitters; and

(iii) The non-fixed contamination plus the fixed contamination on the inaccessible surface averaged over three hundred square centimeters, or the area of the surface if less than three hundred square centimeters, does not exceed eight hundred thousand becquerels per square centimeter (twenty microcuries per square centimeter) for beta and gamma and low toxicity alpha emitters, or eighty thousand becquerels per square centimeter (two microcuries per square centimeter) for all other alpha emitters.

(166) "Survey" means an evaluation of the radiological conditions and potential hazards incident to the production, use, transfer, release, disposal or presence of radioactive material or other sources of radiation. When appropriate, such an evaluation includes a physical survey of the location of radioactive material, or the sources of radiation and measurements or calculations of levels of radiation, or concentrations or quantities of radioactive material present.

(167) "Tight-fitting facepiece" means a respiratory inlet covering that forms a complete seal with the face.

(168) "Total effective dose equivalent" or "TEDE" means the sum of the effective dose equivalent (for external exposures) and the committed effective dose equivalent (for internal exposures).

(169) "Transport index" means the dimensionless number, rounded up to the next tenth, placed on the label of a package, to designate the degree of control to be exercised by the carrier during transportation. The transport index is the number determined by multiplying the maximum radiation level in millisievert per hour at one meter (3.3 feet) from the external surface of the package by one hundred, which is equivalent to the maximum radiation level in millirem per hour at one meter (3.3 feet).

(170) "Type A quantity" means a quantity of radioactive material, the aggregate radioactivity of which does not exceed A₁ for special form radioactive material, or A₂ for normal form radioactive material, where A₁ and A₂ are given in rule 3701:1-50-25 of the Administrative Code.

(171) "Type B quantity" means a quantity of radioactive material greater than a type A quantity.

(172) "Type B package" is defined under "Package."

(173) "United States department of energy" means the department of energy established by the Department of Energy Organization Act, PL 95-91, 91 Stat. 565 (1977), 42 U.S.C. 7101 et seq., as amended (2006), to the extent that the department of energy or its duly authorized representatives, exercises functions formerly vested in the United States atomic energy commission, its chairman, members, officers and components and transferred to the United States energy research and development administration and to the administrator thereof pursuant to Sections 104(b) to (d) of the Energy Reorganization Act of 1974, PL 93-438, 88 Stat. 1233 at 1237 (1974), 42 U.S.C. 5814 and retransferred to the secretary of energy pursuant to Section 301(a) of the Department of Energy Organization Act, PL 95-91, 91 Stat. 565 at 577-578 (1977), 42 U.S.C. 7151.

(174) "Unrestricted area" or "uncontrolled area" means any area, access to which is neither restricted nor controlled by the licensee or registrant.

(175) "User seal check" or "fit check" means an action conducted by the respirator user to determine if the respirator is properly seated to the face. Examples include negative pressure check, positive pressure check, irritant smoke check, or isoamyl acetate check.

(176) "Very high radiation area" means an area, accessible to individuals, in which radiation levels from radiation sources external to the body could result in an individual receiving an absorbed dose in excess of five gray (five hundred rad) in one hour at one meter from a source of radiation or from any surface that the radiation penetrates. At very high doses received at high dose rates, units of absorbed dose, gray and rad, are appropriate, rather than units of dose equivalent, sievert and rem.

(177) "Veterinarian" means an individual licensed by the state of Ohio to practice veterinary medicine pursuant to Chapter 4741. of the Revised Code.

(178) "Waste" means those low-level radioactive wastes containing source, special nuclear, or byproduct material that are acceptable for disposal in a land disposal facility. For the purposes of this definition, low-level radioactive waste means radioactive waste not classified as high-level radioactive waste, transuranic waste, spent nuclear fuel, or byproduct material as defined in paragraph (A)(26)(b) of this rule, or byproduct material as defined in section 11 E. (3) and (4) of the Atomic Energy Act of 1954, 68 Stat. 919, 42 USC 2014, as amended (2005).

(179) "Week" means seven consecutive days starting on Sunday.

(180) "Weighting factor

• W_T" for an organ or tissue, (T), is the proportion of the risk of stochastic effects resulting from irradiation of that organ or tissue to the total risk of stochastic effects when the whole body is irradiated uniformly. For calculating the effective dose equivalent, the values of W_T are:

| Organ doseweighting factors | | | --- | --- | | Organ ortissue | W_T | | Gonads | 0.25 | | Breast | 0.15 | | Red bone marrow | 0.12 | | Lung | 0.12 | | Thyroid | 0.03 | | Bonesurfaces | 0.03 | | Remainder | 0.30^a | | Whole body | 1.00^b |

^\a 0.30 results from 0.06 for each of five "remainder" organs, excluding the skin and the lens of the eye, that receive the highest doses.

^\b for the purpose of weighting the external whole body dose (for adding it to the internal dose) a single weighting factor, W_T = 1.0, has been specified. The use of other weighting factors for external exposure will be approved on a case-by-case basis until such time as specific guidance is issued.

(181) "Whole body" means for purposes of external exposure, head; trunk, including male gonads; arms above the elbow; legs above the knee.

(182) "Worker" means an individual engaged in activities licensed or registered by the department and controlled by a licensee or registrant, but does not include the licensee or registrant.

(183) "Working level" or "WL" means any combination of short-lived radon decay products (for radon-222: polonium-218, lead-214, bismuth-214, and polonium-214; and for radon-220: polonium-216, lead-212, bismuth-212, and polonium-212) in one liter of air that will result in the ultimate emission of 1.3 x 10⁵ million electron volts alpha particle energy.

(184) "Working level month" or "WLM" means a cumulative exposure to one working level for one hundred seventy hours. (Two thousand working hours per year/twelve months per year equals approximately one hundred seventy hours per month.)

(185) "Year" means the period of time beginning in January used to determine compliance with the provisions of this rule. The licensee or registrant may change the starting date of the year used to determine compliance by the licensee or registrant provided that the change is made at the beginning of the year and that no day is omitted or duplicated in consecutive years.

(B) The terms set out in paragraph (A) of this rule may be redefined in other chapters as promulgated pursuant to Chapter 3748. of the Revised Code as used in that chapter only.

Last updated May 13, 2026 at 11:20 AM

History

• Effective: January 20, 2022
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-54-07 Land disposal - license.

(A) No person shall receive, possess or dispose of radioactive waste received from another licensee at a land disposal facility unless authorized by a license issued by the department pursuant to this rule. Each person shall file an application with the department in accordance with the procedural requirements of Chapter 3701:1-40 of the Administrative Code as if those rules also included source, and special nuclear material, and obtain a license as provided in this rule before commencement of construction of a land disposal facility. Failure to comply with this requirement may be grounds for denial of a license.

(B) In addition to the requirements set forth in paragraph (A) of this rule, an application to receive, possess, and dispose of wastes received from other licensees at a land disposal facility shall consist of the following general information, specific technical information, institutional information, and financial information.

(1) The general information shall include:

(a) Identity of the applicant;

(b) Qualifications of the applicant:

(i) The organizational structure of the applicant, both offsite and onsite, including a description of the lines of authority and assignments of responsibilities, whether in the form of administrative directives, contract provisions, or otherwise;

(ii) Technical qualifications, including minimum training and experience for the applicant and each member of the applicant's organization engaging in the proposed activities;

(iii) A description of the applicant's personnel training program; and

(iv) The plan to maintain an adequate complement of trained personnel to conduct waste receipt, handling, and disposal operations in a safe manner;

(c) A description of:

(i) The location of the proposed disposal site;

(ii) The general scope of the proposed activities;

(iii) The type and quantities of waste to be received, possessed and disposed;

(iv) Plans for the use of the land disposal facility for purposes other than disposal of wastes; and

(v) The proposed facility and equipment; and

(d) Proposed schedules of construction, receipt of the waste, and first emplacement of waste at the proposed disposal facility.

(2) Specific technical information shall include, but is not limited to, the following information needed to demonstrate that the performance objectives and the applicable technical requirements of rules 3701:1-54-06 to 3701:1-54-12 of the Administrative Code will be met:

(a) Include a description of the natural and demographic disposal site characteristics as determined by disposal site selection and characterization activities. The description shall include geologic, geochemical, geotechnical, hydrologic, ecologic, archaelogic, meteorologic, climatologic, and biotic features, as well as projected population growth, population distribution, political subdivision, and land use of the disposal site and vicinity.

(b) Include a description of the design features of the land disposal facility and the disposal units. The description shall include those design features related to infiltration of water; integrity of covers for disposal units; structural stability of backfill, wastes, and covers; contact of wastes with standing water; disposal site drainage; disposal site closure and stabilization; elimination to the extent practicable of long-term disposal site maintenance; inadvertent intrusion; occupational exposures; disposal site monitoring; and adequacy of the size of the buffer zone for monitoring and potential mitigative measures.

(c) Include a description of the principal design criteria and their relationship to the performance objectives.

(d) Include a description of the design basis natural events or phenomena and their relationship to the principal design criteria.

(e) Include a description of codes and standards that the applicant has applied to the design, and will apply to construction of the land disposal facilities.

(f) Include a description of the construction and operation of the land disposal facility. The description shall include as a minimum the methods of construction of disposal units; waste emplacement; the procedures for and areas of waste segregation; types of intruder barriers; onsite traffic and drainage systems; survey control program; methods and areas of waste storage; and methods to control surface water and groundwater access to the wastes. The description shall also include a description of the methods to be employed in the handling and disposal of wastes containing chelating agents or other nonradiological substances that might affect meeting the performance objectives of rule 3701:1-54-08 of the Administrative Code.

(g) Include a description of the disposal site closure plan, including those design features which are intended to facilitate disposal site closure and to eliminate the need for ongoing active maintenance.

(h) Include an identification of the known natural resources at the disposal site, the exploitation of which could result in inadvertent intrusion into the wastes after removal of active institutional control.

(i) Include a description of the kind, amount, classification and specifications of the radioactive material proposed to be received, possessed, and disposed of at the land disposal facility.

(j) Submit a quality assurance program meeting the requirements in rule 3701:1-54-04 of the Administrative Code. Include a description of the quality assurance program for the determination of natural disposal site characteristics and for quality assurance during the design, construction, operation, and closure of the land disposal facility and the receipt, handling, and emplacement of waste. Audits and managerial controls must be included.

(k) Include a description of the radiation safety program for control and monitoring of (i) radioactive effluents to ensure compliance with the performance objectives in paragraph (B)(1) of rule 3701:1-54-08 of the Administrative Code, (ii) occupational radiation exposures to ensure compliance with the requirements of Chapter 3701:1-38 of the Administrative Code, and (iii) contamination of personnel, vehicles, equipment, buildings, and the disposal site. Both routine operations and accidents shall be addressed. The program description must include procedures, instrumentation, facilities, and equipment.

(l) Include a description of the environmental monitoring program to provide data to evaluate potential health and environmental impacts and the plan for taking corrective measures if migration is indicated.

(m) Include a description of the administrative procedures that the applicant will apply to control activities at the land disposal facility.

(n) Include a description of the facility's record keeping system as required in rule 3701:1-54-12 of the Administrative Code.

(o) Include a description of the security and safeguards for radioactive material as required in paragraph (B)(5) of rule 3701:1-54-08 of the Administrative Code.

(3) The specific technical information shall also include the following analyses needed to demonstrate that the performance objectives of rule 3701:1-54-08 of the Administrative Code will be met.

(a) Pathways analyzed in demonstrating protection of the general population from releases of radioactivity shall include air, soil, groundwater, surface water, plant uptake, and exhumation by burrowing animals. The analyses shall clearly identify and differentiate between the roles performed by the natural disposal site characteristics and design features in isolating and segregating the wastes. The analyses shall clearly demonstrate that there is reasonable assurance that the exposures to humans from the release of radioactivity will not exceed the limits set forth in paragraph (B)(1) of rule 3701:1-54-08 of the Administrative Code.

(b) Analyses of the protection of individuals from inadvertent intrusion shall include demonstration that there is reasonable assurance the waste classification and segregation requirements will be met and that adequate barriers to inadvertent intrusion will be provided.

(c) Analyses of the protection of individuals during operations shall include assessments of expected exposures due to routine operations and likely accidents during handling, storage, and disposal of waste. The analyses shall provide reasonable assurance that exposures will be controlled to meet the requirements of Chapter 3701:1-38 of the Administrative Code.

(d) Analyses of the long-term stability of the disposal site and the need for ongoing active maintenance after closure shall be based upon analyses of active natural processes such as erosion, mass wasting, slope failure, settlement of wastes and backfill, infiltration through covers over disposal areas and adjacent soils, and surface drainage of the disposal site. The analyses shall provide reasonable assurance that there will not be a need for ongoing active maintenance of the disposal site following closure.

(4) The financial information shall be sufficient to demonstrate that the financial qualifications of the applicant are adequate to carry out the activities for which the license is sought and meet other financial assurance requirements of rule 3701:1-54-11 of the Administrative Code.

(C) A license for the receipt, possession, and disposal of waste containing or contaminated with radioactive material will be issued by the department upon finding that:

(1) The issuance of a license will not constitute an unreasonable risk to the health and safety of the public;

(2) The applicant is qualified by reason of training and experience to carry out the disposal operations requested in a manner that protects health and minimizes danger to life or property;

(3) The applicant's proposed disposal site, disposal design, land disposal facility operations, including equipment, facilities and procedures, disposal site closure, and post-closure institutional control are adequate to protect the public health and safety in that they provide reasonable assurance that the general population will be protected from releases of radioactivity as specified in the performance objectives in paragraph (B)(1) of rule 3701:1-54-08 of the Administrative Code;

(4) The applicant's proposed disposal site, disposal site design, land disposal facility operations, including equipment, facilities, and procedures, disposal site closure, and post-closure institutional control are adequate to protect the public health and safety in that they will provide reasonable assurance that individual inadvertent intruders are protected in accordance with the performance objectives in paragraph (B)(2) of rule 3701:1-54-08 of the Administrative Code;

(5) The applicant's proposed land disposal facility operations, including equipment, facilities, and procedures, are adequate to protect the public health and safety in that they will provide reasonable assurance that the standards for radiation protection set out in Chapter 3701:1-38 of the Administrative Code will be met;

(6) The applicant's proposed disposal site, disposal site design, land disposal facility operations, disposal site closure, post-closure institutional control are adequate to protect the public health and safety in that they will provide reasonable assurance that the long-term stability of the disposed waste and the disposal site will be achieved and will eliminate to the extent practicable the need for ongoing maintenance of the disposal site post-closure;

(7) The applicant's demonstration provides reasonable assurance that the applicable technical requirements of rules 3701:1-54-06 to 3701:1-54-12 of the Administrative Code have been met;

(8) The applicant's proposal for institutional control provides reasonable assurance that such control will be provided for the length of time found necessary to ensure the findings in paragraphs (C)(3) to (C)(6) of this rule and that the institutional control meets the requirements in paragraph (A) of rule 3701:1-54-08 of the Administrative Code;

(9) The financial or surety arrangements meet the requirements of rule 3701:1-54-11 of the Administrative Code; and

(10) Adequate security and safeguards exist to provide a reasonable assurance precluding theft or sabotage of the radioactive materials.

(D) A license issued under this rule is subject to the requirements in Chapters 3701:1-40, 3701:1-44, and 3701:1-56 of the Administrative Code in addition to individual license conditions.

(E) An application for renewal or for closure under paragraph (F) of this rule must be filed at least one hundred-eighty days prior to license expiration.

(1) Applications for renewal of a license must be filed in accordance with paragraph (B) of this rule. Applications for closure must be filed in accordance with paragraph (F) of this rule. Information contained in previous applications, statements, or reports filed with the department under the license may be incorporated by reference if the references are clear and specific.

(2) If a licensee has properly filed an application for renewal of a license, the license will not expire until the department has taken final action on the application for renewal.

(3) The department will apply the criteria set forth in paragraph (C) of this rule to descriptions and changes not previously approved on a license amendment in order to determine if a license will be renewed.

(F) Prior to final closure of the disposal site, or as otherwise directed by the department, the licensee shall submit an application to amend the license for closure.

(1) The closure application shall include a final revision and specific details of the disposal site closure plan included as part of the license application submitted under paragraph (B)(2)(g) of this rule that includes each of the following:

(a) Additional geologic, hydrologic, or other data pertinent to the long-term containment of emplaced wastes obtained during the operational period.

(b) The results of tests, experiments, or any other analyses relating to backfill of excavated areas, closure and sealing, waste migration and interaction with emplacement media, or any other tests, experiments, or analyses pertinent to the long-term containment of emplaced waste within the disposal site.

(c) Any proposed revision of plans for:

(i) Decontamination and/or dismantlement of surface facilities;

(ii) Backfilling of excavated areas; or

(iii) Stabilization of the disposal site for post-closure care.

(d) Any significant new information regarding the environmental impact of closure activities and long-term performance of the disposal site.

(2) Upon review and consideration of an application to amend the license for closure submitted in accordance with paragraph (F)(1) of this rule, the department shall issue an amendment authorizing closure if there is reasonable assurance that the long-term performance objectives will be met.

(G) The licensee shall observe, monitor, and carry out necessary maintenance and repairs at the disposal site until the site closure is complete and the license is transferred by the department in accordance with paragraph (H) of this rule. Responsibility for the disposal site must be maintained by the licensee for five years. A shorter or longer time period for post-closure observation and maintenance may be established and approved as part of the site closure plan, based on site-specific conditions.

(H) Following closure and the period of post-closure observation and maintenance, the licensee may apply for an amendment to transfer the license to the disposal site owner. The license shall be transferred when the department finds:

(1) That the closure of the disposal site has been made in conformance with the licensee's disposal site closure plan, as amended and approved as part of the license;

(2) That reasonable assurance has been provided by the licensee that the performance objectives of rule 3701:1-54-08 of the Administrative Code are met;

(3) That any funds and necessary records for care will be transferred to the disposal site owner;

(4) That the post-closure monitoring program is operational for implementation by the disposal site owner.

(I) Following any period of institutional control needed to meet the requirements found necessary under paragraph (C) of this rule, the licensee may apply for an amendment to terminate the license.

(1) The application shall be filed in accordance with the provisions of Chapter 3701:1-40 of the Administrative Code.

(2) A license shall be terminated only when the department finds:

(a) That the institutional control requirements found necessary under paragraph (C)(8) of this rule have been met;

(b) That any additional requirements resulting from new information developed during the institutional control period have been met;

(c) Permanent monuments or markers warning against intrusion have been installed; and

(d) All records are transferred to the department.

Last updated August 1, 2023 at 2:47 PM

History

• Effective: November 28, 2010
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-54-08

(A) The land owner or custodial agency shall conduct an institutional control program to physically control access to the disposal site following transfer of control of the disposal site from the disposal site operator. The institutional control program shall also include, but not be limited to, conducting an environmental monitoring program at the disposal site, periodic surveillance, minor custodial care, and other requirements as determined by the department; and administration of funds to cover the costs for these activities. The period of institutional controls will be determined by the department, but institutional controls may not be relied upon for more than one hundred years following transfer of control of the disposal site to the owner.

(B) The performance objectives for the general requirements of a land disposal facility are to ensure public health and safety. Land disposal facilities shall be sited, designed, operated, closed, and controlled after closure to provide reasonable assurance that the following performance objectives will be met.

(1) Concentrations of radioactive material which may be released to the general environment in ground water, surface water, air, soil, plants, or animals must not result in an annual dose exceeding the equivalent of 0.25 millisievert (twenty-five millirem) to the whole body, 0.75 millisievert (seventy-five millirem) to the thyroid, or 0.25 millisievert (twenty-five millirem) to any other organ to any member of the public. Reasonable effort should be made to maintain releases of radioactivity in effluents to the general environment as low as is reasonably achievable.

(2) The design, operation and closure of the land disposal facility shall ensure protection of any individual inadvertently intruding into the disposal site and occupying the site or contacting the waste at any time after institutional controls over the disposal site are removed.

(3) Operations at the land disposal facility shall be conducted in compliance with the standards for radiation protection as set out in Chapter 3701:1-38 of the Administrative Code, except for those releases of radioactivity in effluents from the land disposal facility, which shall be governed by paragraph (B)(1) of this rule. Every reasonable effort should be made to maintain radiation exposures as low as is reasonably achievable.

(4) The disposal facility shall be sited, designed, used, operated, and closed to achieve long-term stability of the disposal site and to eliminate, to the extent practical, the need for ongoing active maintenance of the disposal site after closure so that only surveillance, monitoring, or minor custodial care are required.

(5) The licensee shall develop and implement security measures to protect against and to detect unauthorized access to radioactive material or safety and security systems from external as well as internal threats. The licensee shall perform periodic inspections to ensure that all radioactive material is accounted for and that safety and security systems are operating as designed. The licensee shall report any deficiency involving the radioactive material inventory or a safety and security system to the department.

(6) The radioactive waste and its containers shall be protected from adverse environmental conditions including, but not limited to, temperature changes that could compromise the isolation of the waste from the biosphere.

(7) The licensee shall use standard engineering designs and procedural practices to maintain doses to people, and radionuclide releases to the environment, as low as reasonably achievable.

(C) The operation of the disposal facility shall incorporate the following items.

(1) Wastes designated as class A pursuant to paragraph (A) of rule 3701:1-54-10 of the Administrative Code shall be segregated from other wastes by placing in disposal units which are sufficiently separated from disposal units for the other waste classes so that any interaction between class A wastes and other wastes will not result in the failure to meet the performance objectives of this rule. This segregation is not necessary for class A wastes if they meet the stability requirements of in paragraph (B) of rule 3701:1-54-10 of the Administrative Code.

(2) Wastes designated as class C pursuant to paragraph (A) of rule 3701:1-54-10 of the Administrative Code, shall be disposed of with intruder barriers that are designed to protect against an inadvertent intrusion for at least five hundred years.

(3) Only waste classified as class A, B, or C pursuant to rule 3701:1-54-10 of the Administrative Code, shall be acceptable for land disposal. All waste shall be disposed of in accordance with requirements of paragraphs (C)(4) to (C)(11) of this rule.

(4) Waste shall be packaged in appropriate containers for disposal when applicable. Wastes shall be emplaced in a manner that maintains the package integrity during emplacement, minimizes void spaces between packages, and permits the void spaces to be filled.

(5) Void spaces between packages shall be filled as needed to reduce future subsidence within the fill.

(6) Waste shall be placed and covered in a manner that limits the radiation dose rate at the surface of the cover to levels that at a minimum will permit the licensee to comply with all provisions of rule 3701:1-38-13 of the Administrative Code at the time the license is transferred pursuant to paragraph (H) of rule 3701:1-54-07 of the Administrative Code.

(7) The boundaries and locations of each disposal unit shall be accurately located and mapped by means of a land survey. Disposal units shall be marked in such a way that the boundaries of each unit can be easily defined. Three permanent survey marker control points shall be established on the site to facilitate surveys.

(8) A buffer zone of land shall be maintained between any disposed waste and the disposal site boundary and beneath the disposed waste. The buffer zone shall be of adequate dimensions to carry out environmental monitoring activities specified in paragraph (E) of rule 3701:1-54-09 of the Administrative Code and to take mitigative measures if needed.

(9) Closure and stabilization measures as set forth in the approved site closure plan shall be carried out as each disposal unit is filled and covered.

(10) Active waste disposal operations shall not have an adverse effect on completed closure and stabilization measures.

(11) Only wastes containing or contaminated with radioactive material shall be disposed of at the disposal site.

(12) Proposals for disposal of waste that is not acceptable for land disposal because the waste form and disposal methods must be different and, in general, more stringent than those specified for class C waste, may be submitted to the department for approval.

(D) Each licensee shall perform, or permit the department to perform, any tests the department deems appropriate or necessary for the administration of the regulations in rules 3701:1-54-06 to 3701:1-54-12 of the Administrative Code, including, but not limited to, tests of:

(1) Wastes, including physical form;

(2) Facilities used for the receipt, storage, treatment, handling or disposal of wastes;

(3) Radiation detection and monitoring instruments;

(4) Other equipment and devices used in connection with the receipt, possession, handling, treatment, storage, or disposal of waste; or

(5) Environmental sampling or testing.

(E) The licensee shall comply with the quality assurance requirements identified in rule 3701:1-54-04 of the Administrative Code.

(F) The licensee shall make land disposal facilities available for inspections as follows:

(1) Each licensee shall afford to the department at all reasonable times opportunity to inspect waste not yet disposed of, and the premises, equipment, operations, and facilities in which wastes are received, possessed, handled, treated, stored, or disposed.

(2) Each licensee shall make available to the department for inspection, upon reasonable notice, records kept by it pursuant to these regulations. Authorized representatives of the department may copy and take away copies of, for the department's use, any record required to be kept pursuant to this chapter.

Last updated August 1, 2023 at 2:47 PM

History

• Effective: February 6, 2006
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-54-11

(A) Each applicant shall show that it either possesses the necessary funds or has reasonable assurance of obtaining the necessary funds, or by a combination of the two, to cover the estimated costs of conducting all licensed activities over the planned operating life of the project, including costs of construction and operation.

(B) The licensee shall satisfy the disposal site closure and stabilization funding requirements identified below.

(1) The applicant shall provide assurances prior to the commencement of operations that sufficient funds will be available to carry out disposal site closure and stabilization, including:

(a) Decontamination or dismantlement of land disposal facility structures; and

(b) Closure and stabilization of the disposal site so that following transfer of the disposal site to the site owner, the need for ongoing active maintenance is eliminated to the extent practicable and only minor custodial care, surveillance, and monitoring are required.

(2) These assurances shall be based on department-approved cost estimates reflecting the department-approved plan for disposal site closure and stabilization. The applicant's cost estimates must take into account total costs that would be incurred if an independent contractor were hired to perform the closure and stabilization work.

(3) The licensee's surety mechanism will be annually reviewed by the department to assure that sufficient funds are available for completion of the closure plan, assuming that the work has to be performed by an independent contractor.

(4) The amount of the licensee's financial or surety arrangement shall change in accordance with changes in the predicted costs of closure and stabilization. Factors affecting closure and stabilization cost estimates include inflation, increases in the amount of disturbed land, changes in engineering plans, closure and stabilization that has already been accomplished, and any other conditions affecting costs. The financial or surety arrangement shall be sufficient at all times to cover the costs of closure and stabilization of the disposal units that are expected to be used before the next license renewal.

(5) The financial or surety arrangement shall be either open-ended or be written for a specified period of time and shall be automatically renewed unless the person who issues the surety notifies the department, the beneficiary (the site owner), and the principal (the licensee) not less than ninety days prior to the renewal date of its intention not to renew. In such a situation, the licensee must submit a replacement surety within thirty days after notification of cancellation. If the licensee fails to provide a replacement surety acceptable to the department, the beneficiary may collect on the original surety.

(6) Proof of forfeiture shall not be necessary to collect the surety so that, in the event that the licensee could not provide an acceptable replacement surety within the required time, the surety shall be automatically collected prior to its expiration. The conditions described above shall be clearly stated on any surety instrument.

(7) Financial or surety arrangements shall satisfy the requirements identified in rule 3701:1-40-17 of the Administrative Code.

(8) The licensee's financial or surety arrangement shall remain in effect until the closure and stabilization program has been completed and approved by the department, and the license has been transferred to the site owner.

(C) The licensee shall provide financial assurances for institutional controls as recorded below.

(1) Prior to the issuance of the license, the applicant shall provide for department approval a decommissioning funding plan that ensures that sufficient funds will be available to cover the costs of monitoring and any required maintenance during the institutional control period. The decommissioning funding plan shall be reviewed every five years by the department to ensure that changes in inflation, technology, and disposal facility operations are reflected in the arrangements.

(2) Subsequent changes to the decommissioning funding plan specified in paragraph (C)(1) of this rule relevant to institutional control shall be submitted to the department for prior approval.

(3) For the purposes of the decommissioning funding plan required in paragraph (C)(1) of this rule the types of acceptable financial guaranties shall include bonds issued by fidelity or surety companies authorized to do business in the state, certificates of deposit, deposits of government securities, irrevocable letters or lines of credit, trust funds, escrow accounts, or similar types of arrangements, but shall not include any arrangements that constitute self-insurance.

(4) Financial or surety arrangements shall satisfy the requirements identified in rule 3701:1-40-17 of the Administrative Code.

Last updated August 1, 2023 at 2:48 PM

History

• Effective: February 6, 2006
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-38-13

(A) Each licensee or registrant shall conduct operations so that:

(1) The total effective dose equivalent to individual members of the public from the licensed or registered operation does not exceed one millisievert (0.1 rem) in a year, exclusive of the dose contribution from the following:

(a) Background radiation;

(b) Radiation attributable to any medical administration the individual has received;

(c) Exposure to an individual that was administered radioactive materials and has been released in accordance with rule 3701:1-58-30 of the Administrative Code or equivalent United States nuclear regulatory agency or agreement state regulations;

(d) Voluntary participation in medical research programs;

(e) The licensee's disposal of radioactive material into sanitary sewerage in accordance with paragraph (D) of rule 3701:1-38-19 of the Administrative Code; and

(2) The dose in any unrestricted area from external sources, exclusive of the dose contribution from patients administered radioactive material and released in accordance with rule 3701:1-58-30 of the Administrative Code or equivalent United States nuclear regulatory agency or agreement state regulations, does not exceed 0.02 millisievert (0.002 rem) in any one hour.

(B) If the licensee or registrant permits members of the public to have access to controlled or restricted areas, the limits for members of the public continue to apply to those individuals.

(C) A licensee, registrant, or an applicant for a license or registration may apply for prior department authorization to operate up to an annual dose limit for an individual member of the public of five millisievert (0.5 rem). This application shall include the following information:

(1) Demonstration of the need for and the expected duration of operation in excess of the limit set forth in paragraph (A) of this rule;

(2) The licensee's or registrant's program to assess and control dose within the five millisievert (0.5 rem) annual limit; and

(3) The procedures that the registrant or licensee will follow to maintain the dose ALARA.

(4) Notwithstanding paragraph (A)(1) of this rule, a licensee may permit visitors to an individual who cannot be released, under rule 3701:1-58-30 of the Administrative Code, to receive a radiation dose greater than one millisievert (0.1 rem) if:

(a) The radiation dose received does not exceed five millisievert (0.5 rem); and

(b) The authorized user, as defined in Chapter 3701:1-58 of the Administrative Code, has determined before the visit that it is appropriate.

(D) In addition to the requirements of paragraphs (A) and (B) of this rule:

(1) A licensee subject to the provisions of the United States environmental protection agency's generally applicable environmental radiation standards in 40 C.F.R. 190 (as in effect on the effective date of this rule), shall also comply with those standards.

(2) The department may impose additional restrictions on radiation levels in unrestricted areas and on the total quantity of radionuclides that a licensee may release in effluents in order to restrict the collective dose.

(E) The licensee or registrant shall demonstrate compliance with dose limits for individual members of the public.

(1) The licensee or registrant shall make or cause to be made surveys of radiation levels in unrestricted and controlled areas and radioactive materials in effluents released to unrestricted and controlled areas to demonstrate compliance with the dose limits for individual members of the public in paragraph (A) of this rule.

(2) A licensee or registrant shall show compliance with the annual dose limit in paragraph (A) of this rule by:

(a) Demonstrating by measurement or calculation that the total effective dose equivalent to the individual likely to receive the highest dose from the licensed or registered operation does not exceed the annual dose limit; or

(b) Demonstrating that:

(i) The annual average concentrations of radioactive material released in gaseous and liquid effluents at the boundary of the unrestricted area do not exceed the values specified in appendix C to rule 3701:1-38-12 of the Administrative Code; and

(ii) If an individual were continuously present in an unrestricted area, the dose from external sources would not exceed 0.02 millisievert (0.002 rem) in an hour and 0.5 millisievert (0.05 rem) in a year.

(3) Upon approval from the department, the licensee may adjust the effluent concentration values in appendix C to rule 3701:1-38-12 of the Administrative Code for members of the public, to take into account the actual physical and chemical characteristics of the effluents, such as aerosol size distribution, solubility, density, radioactive decay equilibrium, or chemical form.

Last updated January 20, 2022 at 8:47 AM

History

• Effective: January 20, 2022
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-54-09

(A) The primary emphasis in disposal site suitability is given to isolation of wastes, a matter having long-term impacts, and to disposal site features that ensure that the long-term performance objectives are met, as opposed to short-term convenience or benefits.

(1) Suitable disposal site features shall include the following items.

(a) The disposal site shall be capable of being characterized, modeled, analyzed and monitored.

(b) Within the region where the facility will be located, a disposal site should be selected so that projected population growth and future developments are not likely to affect the ability of the disposal facility to meet the performance objectives of this rule.

(c) Areas shall be avoided having known natural resources that, if exploited, could result in failure to meet the performance objectives of this rule.

(d) The disposal site shall be generally well drained and free of areas of flooding or frequent ponding. The disposal site shall not be located in a one hundred year flood plain, coastal high-hazard area, or wetland, as defined in Federal Executive Order 11988, "Floodplain Management Guidelines." The disposal units shall be designed and constructed to be outside the five hundred year floodplain.

(e) Upstream drainage areas shall be minimized to decrease the amount of runoff that could erode or inundate waste disposal units.

(f) The disposal site shall provide sufficient depth to the water table that ground water intrusion, perennial or otherwise, into the waste will not occur.

(g) The hydrogeologic unit used for disposal shall not discharge groundwater to the surface within the disposal site. The soil or rock layers immediately beneath the facility, but above the water table shall have good vertical drainage or be engineered to have good drainage to prevent water from ponding around the base of the facility. The shallowest hydrogeologic unit beneath the facility shall not discharge perennially to the site.

(h) Areas shall be avoided where tectonic processes such as faulting, folding, seismic activity, or vulcanization may occur with such frequency and extent that it may significantly affect the ability of the disposal site to meet the performance objectives of this rule or may preclude defensible modeling and prediction of long-term impacts.

(i) Areas should be avoided where surface geologic processes such as mass wasting, erosion, slumping, landsliding, or weathering occur with such frequency and extent that it may significantly affect the ability of the disposal site to meet the performance objectives of this rule, or may preclude defensible modeling and prediction of long-term impacts.

(j) The disposal site must not be located where nearby facilities or activities could affect the ability of the site to meet the performance objectives of this rule or mask the environmental monitoring program.

(2) Additional exclusionary criteria include prohibiting a site from having any of the following features listed in this paragraph.

(a) The disposal units shall not be located within one kilometer (0.62 miles) of any of the following:

(i) Any area designated by the United States department of the interior as a national park or recreation area or national monument;

(ii) Any area designated by the United States department of the interior as a national wildlife refuge or a national wild and scenic river;

(iii) Any area designated by the forest service in the United States department of agriculture as a special interest area or a research natural area in the Wayne national forest;

(iv) Any area designated by the department of natural resources as a state park or state park purchase area under Chapter 1541. of the Revised Code;

(v) The Shawnee wilderness area as designated under section 1503.43 of the Revised Code, any area dedicated by the department of natural resources as a state nature preserve under Chapter 1517. of the Revised Code, any area established as a wildlife area under Chapter 1531. of the Revised Code and rules adopted under it, or a wild, scenic, or recreational river area established by the department under section 1517.14 of the Revised Code;

(vi) An area designated as an archeological or historic site in the national register of historic places under the "National Historic Preservation Act" 80 Stat. 915 to 919 (1966), 16 U.S.C. 470.

(vii) This chapter applies to land dedicated for any use specified in it on or before the effective date of section 3747.12 of the Revised Code (September 8, 1995).

(b) The disposal site shall not be located within the Lake Erie coastal area, as "coastal area" is defined in section 1506.01 of the Revised Code.

(c) The disposal site shall not be located where activities related to the development, construction, operation, closure, institutional control, or long-term care of the facility would result in the elimination at the site of endangered or threatened plant or animal species identified under federal law or in rules adopted under section 1518.01 or section 1531.25 of the Revised Code.

(d) The disposal site shall not contain any wetlands, as defined in 40 C.F.R. 230.3 (as in effect on the effective date of this rule), or lakes unless they can be declassified.

(e) The disposal site shall not be located in any of the following:

(i) An area likely to experience ground motions with a horizontal acceleration greater than twenty per cent of gravity in rock with a ninety per cent probability of not being exceeded in two hundred fifty years, as defined by currently available seismic risk evaluation procedures; or

(ii) An area with frequent earthquake activity.

(f) The disposal site shall not be located in an area of known or probable subsidence caused by an operating underground mine in existence at the time the disposal site is being characterized or by an abandoned underground mine.

(g) The disposal site shall not contain areas of steeply sloping topography or areas underlain by unconsolidated or bedrock geological units known to be susceptible to mass movement or land failure, such as landsliding or liquefaction, and where "steeply sloping topography" means a slope greater than twenty degrees.

(h) The disposal site shall not be located in areas of known or probable karst.

(i) The disposal site shall not be located over a sole source aquifer or within an endorsed wellhead protection area as defined by the state wellhead protection program established pursuant to Chapter 6109. and Chapter 6111. of the Revised Code.

(j) The disposal site shall not be located above an aquifer capable of sustaining a yield of one hundred gallons per minute of potable water for a twenty-four hour period to a water supply well located within one thousand feet of the disposal site.

(k) The use of shallow land burial, caverns, mines, or wells shall not be used as disposal techniques at the facility.

(B) Provide an environmental assessment report required by Chapter 3701:1-40 of the Administrative Code as if that chapter also included source, and special nuclear material.

(C) Provide a description of the public participation process as required by rule 3701:1-40-38 of the Administrative Code.

(D) The licensee shall perform environmental monitoring as recorded below.

(1) At the time a license application is submitted, the applicant shall have conducted a preoperational monitoring program to provide basic environmental data on the disposal site characteristics. The applicant shall obtain information about the ecology, meteorology, climate, hydrology, hydrogeology, geology including geophysics and geotechnical engineering, geochemistry, and seismology of the disposal site. For those characteristics that are subject to seasonal variation, data must cover at least a twelve month period.

(2) During the land disposal facility site construction and operation, the licensee shall maintain an environmental monitoring program. Measurements and observations must be made and recorded to provide data to evaluate the potential health and environmental impacts during both the construction and the operation of the facility and to enable the evaluation of long-term effects and the need for mitigative measures. The monitoring system must be capable of providing early warning of releases of radionuclides from the disposal site before they leave the site boundary.

(3) After the disposal site is closed, the licensee responsible for post-operational surveillance of the disposal site shall maintain a monitoring system based on the operating history and the closure and stabilization of the disposal site. The monitoring system must be capable of providing early warning of releases of radionuclides from the disposal site before they leave the site boundary.

(4) The licensee will provide continuous monitoring to be able to detect a breech of the disposal unit boundary.

(5) The licensee shall have a plan for taking corrective measures if the environmental monitoring program detects migration of radionuclides which would indicate that the performance objectives may not be met.

(E) The director may, upon request or on his or her own initiative, authorize provisions other than those set forth in paragraphs (D) and (E) of this rule and paragraph (C) of rule 3701:1-54-08 of the Administrative Code for the segregation and disposal of waste and for the design and operation of a land disposal facility on a specific basis, if he or she finds reasonable assurance of compliance with the performance objectives of this chapter.

Last updated November 15, 2022 at 8:58 AM

History

• Effective: November 14, 2022
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-50-17

Before each shipment of licensed material, the licensee shall ensure that the package with its contents satisfies the applicable requirements of this chapter and of the license. The licensee shall determine that:

(A) The package is proper for the contents to be shipped;

(B) The package is in unimpaired physical condition except for superficial defects such as marks or dents;

(C) Each closure device of the packaging, including any required gasket, is properly installed and secured and free of defects;

(D) Any system for containing liquid is adequately sealed and has adequate space or other specified provision for expansion of the liquid;

(E) Any pressure relief device is operable and set in accordance with written procedures;

(F) The package has been loaded and closed in accordance with written procedures;

(G) For fissile material, any moderator or neutron absorber, if required, is present and in proper condition;

(H) Any structural part of the package that could be used to lift or tie down the package during transport is rendered inoperable for that purpose, unless it satisfies the design requirements of 10 C.F.R. 71.45 (as in effect on the effective date of this rule).

(I) The level of non-fixed or removable radioactive contamination on the external surfaces of each package offered for shipment is as low as reasonably achievable and within the limits as specified in DOT regulations in 49 C.F.R. 173.443 (as in effect on the effective date of this rule).

(J) External radiation levels around the package, and around the vehicle if applicable, will not exceed the limits specified in this paragraph at any time during transportation:

(1) Except as provided in paragraph (J)(2) of this rule, each package of radioactive materials offered for transportation must be designed and prepared for shipment so that under conditions normally incident to transportation the radiation level does not exceed two millisievert per hour (two hundred millirem per hour) at any point on the external surface of the package, and the transport index does not exceed ten;

(2) A package that exceeds the radiation level limits specified in paragraph (J)(1) of this rule must be transported by exclusive use shipment only, and the radiation levels for such shipment must not exceed the following during transportation:

(a) Two millisievert per hour (two hundred millirem per hour) on the external surface of the package, unless the following conditions are met, in which case the limit is ten millisievert per hour (one thousand millirem per hour):

(i) The shipment is made in a closed transport vehicle;

(ii) The package is secured within the vehicle so that its position remains fixed during transportation; and

(iii) There are no loading or unloading operations between the beginning and end of the transportation;

(b) Two millisievert per hour (two hundred millirem per hour) at any point on the outer surface of the vehicle, including the top and underside of the vehicle; or in the case of a flat-bed style vehicle, at any point on the vertical planes projected from the outer edges of the vehicle, on the upper surface of the load or enclosure, if used, and on the lower external surface of the vehicle; and

(c) 0.1 millisievert per hour (ten millirem per hour) at any point two meters (6.6 feet) from the outer lateral surfaces of the vehicle (excluding the top and underside of the vehicle); or in the case of a flat-bed style vehicle, at any point two meters (6.6 feet) from the vertical planes projected by the outer edges of the vehicle (excluding the top and underside of the vehicle); and

(d) 0.02 millisievert per hour (two millirem per hour) in any normally occupied space, except that this provision does not apply to private carriers, if exposed personnel under their control wear radiation dosimetry devices in conformance with rule 3701:1-38-14 of the Administrative Code.

(3) For shipments made under the provisions of paragraph (J)(2) of this rule, the shipper shall provide specific written instructions to the carrier for maintenance of the exclusive use shipment controls. The instructions must be included with the shipping paper information.

(4) The written instructions required for exclusive use shipments must be sufficient so that, when followed, they will cause the carrier to avoid actions that will unnecessarily delay delivery or unnecessarily result in increased radiation levels or radiation exposures to transport workers or members of the general public; and

(K) Accessible package surface temperatures will not exceed the limits specified in 10 C.F.R. 71.43(g) (as in effect on the effective date of this rule) at any time during transportation.

History

• Effective: February 15, 2021
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-40-19

(A) No licensee shall transfer radioactive material except as authorized by this rule.

(B) Except as otherwise provided in the license and subject to the provisions of paragraph (C) of this rule, any licensee may transfer radioactive material:

(1) To the United States department of energy;

(2) To the agency in any agreement state which regulates radioactive material pursuant to an agreement under section 274 of the "Atomic Energy Act", as amended;

(3) To any person exempt from the licensing requirements of the act and regulations in this chapter, to the extent permitted under such exemption;

(4) To any person in an agreement state, subject to the jurisdiction of that state, who has been exempted from the licensing requirements and regulations of that state, to the extent permitted under such exemption;

(5) To any person authorized to receive such radioactive material under terms of a specific license or a general license or their equivalents issued by the United States atomic energy commission, the United States nuclear regulatory commission, or an agreement state; or

(6) As otherwise authorized by the director in writing.

(C) Before transferring radioactive material to an entity specified in paragraph (B) of this rule, the licensee transferring the material shall verify that the transferee's license authorizes the receipt of the type, form, and quantity of radioactive material to be transferred. The licensee may verify the transferee's authorization to accept the material by possessing one of the following:

(1) A current copy of the transferee's specific license or registration certificate specifying the type, form, and quantity of radioactive material to be transferred;

(2) A written certification by the receiving licensee certifying that the licensee is authorized by license or registration certificate to receive the type, form, and quantity of radioactive material to be transferred, and further specifying the license or registration certificate number, issuing agency, and expiration date;

(3) In the case of an emergency shipment, the transferring licensee may accept oral certification by the receiving licensee that the licensee is authorized by license or registration certificate to receive the type, form, and quantity of radioactive material to be transferred, and further, specifying the license or registration certificate number, issuing agency and expiration date. The transferring licensee shall obtain written confirmation detailing the oral certification within ten days of the emergency transfer; or

(4) The transferor may obtain other sources of information compiled by a reporting service from official records of the department, United States nuclear regulatory commission, or the licensing agency of an agreement state as to the identity of the receiving licensee, whether the licensee is authorized by license or registration certificate to receive the type, form, and quantity of radioactive material to be transferred, and the expiration date of the receiving licensee's license or registration.

Last updated November 2, 2022 at 2:12 PM

History

• Effective: October 4, 2010
• Promulgated Under: 119.03

Chapter 3701:1-56 License for Special Nuclear Material

Ohio Adm.Code 3701:1-56-01 Purpose and scope.

(A) This chapter establishes procedures and criteria for the issuance of licenses to receive title to, own, acquire, deliver, receive, possess, use, and transfer special nuclear material in quantities less than critical mass, and establishes and provides for the terms and conditions upon which the director will issue such licenses.

(B) Except as provided in rules 3701:1-56-14 and 3701:1-56-15 of the Administrative Code, the rules in this chapter apply to all persons in the State of Ohio.

Last updated August 1, 2023 at 2:49 PM

History

• Effective: October 8, 2007
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-56-14

(A) Except to the extent that United States department of energy facilities or activities of the types subject to licensing pursuant to section 202 of the "Energy Reorganization Act of 1974" (Pub.L. 93-438, 88 Stat. 1233, 42 U.S.C. 5842) are involved, any prime contractor of the United States department of energy is exempt from the requirements for a license set forth in section 53 of the act and from the rules in this chapter to the extent that such contractor, under his prime contract with the United States department of energy, receives title to, owns, acquires, delivers, receives, possesses, uses, or transfers special nuclear material for:

(1) The performance of work for the United States department of energy at a United States government-owned or controlled site, including the transportation of special nuclear material to or from such site and the performance of contract services during temporary interruptions of such transportation;

(2) Research in, or development, manufacture, storage, testing or transportation of, atomic weapons or components thereof; or

(3) The use or operation of nuclear reactors or other nuclear devices in a United States government-owned vehicle or vessel.

(B) In addition to the foregoing exemptions, and subject to the requirement for licensing of United States department of energy facilities and activities pursuant to section 202 of the "Energy Reorganization Act of 1974" (Pub.L. 93-438, 88 Stat. 1233, 42 U.S.C. 5842) any prime contractor or subcontractor of the United States department of energy or the United States nuclear regulatory commission is exempt from the requirements for a license set forth in section 53 of the "Energy Reorganization Act of 1974" (Pub.L. 93-438, 88 Stat. 1233, 42 U.S.C. 5842) and from the rules in Chapter 3701:1-56 of the Administrative Code to the extent that such prime contractor or subcontractor receives title to, owns, acquires, delivers, receives, possesses, uses, or transfers special nuclear material under his prime contract or subcontract when the director determines that the exemption of the prime contractor or subcontractor is authorized by law; and that, under the terms of the contract or subcontract, there is adequate assurance that the work thereunder can be accomplished without undue risk to the public health and safety.

Last updated May 23, 2022 at 8:00 AM

History

• Effective: May 23, 2022
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-56-15

Common and contract carriers, freight forwarders, warehousemen, and the U.S. postal service are exempt from the regulations in this chapter to the extent that they transport special nuclear material in the regular course of carriage for another or storage incident thereto.

Last updated August 1, 2023 at 2:51 PM

History

• Effective: October 8, 2007
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-56-02 General license for calibration or reference sources.

(A) A general license is hereby issued to any person in Ohio, who holds a specific license issued by the director which authorizes him or her to receive, possess, use and transfer special nuclear material, to receive title to, own, acquire, deliver, receive, possess, use and transfer in accordance with the provisions of paragraphs (B) and (C) of this rule, plutonium in the form of calibration or reference sources.

(B) The general license in paragraph (A) of this rule applies only to calibration or reference sources which have been manufactured or initially transferred in accordance with the specifications contained in a specific license issued pursuant to rule 3701:1-56-06 of the Administrative Code, or in accordance with the specifications contained in a specific license issued by the United States nuclear regulatory commission or an agreement state, which authorizes manufacture of the sources for distribution to persons generally licensed by the United States nuclear regulatory commission or an agreement state.

(C) The general license in paragraph (A) of this rule is subject to the provisions of rules 3701:1-56-04, 3701:1-56-09, 3701:1-56-10, and Chapters 3701:1-40 and 3701:1-38 of the Administrative Code. In addition, persons who receive title to, own, acquire, deliver, receive, possess, use or transfer one or more calibration or reference sources pursuant to this general license:

(1) Shall not possess at any one time, at any one location of storage or use, more than one hundred eighty-five kilobecquerels (five microcuries) of plutonium in such sources;

(2) Shall not receive, possess, use or transfer such source unless the source, or the storage container, bears a label which includes the following statement or a substantially similar statement which contains the information called for in the following statement:

(a) The receipt, possession, use and transfer of this source, model ____, serial no. ____, are subject to a general license and the regulations of the United States nuclear regulatory commission or of a state with which the commission has entered into an agreement for the exercise of regulatory authority. Do not remove this label.

Caution - radioactive material - this source contains plutonium. Do not touch radioactive portion of this source.

(Name of manufacturer or initial transferor)

(b) Sources generally licensed prior to January 19, 1975 may bear labels authorized by the regulations in effect on January 1, 1975 if they are different from the label in paragraph (C)(2)(a) of this rule.

(3) Shall not transfer, abandon, or dispose of such source except by transfer to a person authorized by a license from the director, the United States nuclear regulatory commission, or an agreement state to receive the source.

(4) Shall store such source, except when the source is being used, in a closed container adequately designed and constructed to contain plutonium which might otherwise escape during storage.

(5) Shall not use such source for any purpose other than the calibration of radiation detectors or the standardization of other sources.

(D) The general license in paragraph (A) of this rule does not authorize the manufacture, import, or export of calibration or reference sources containing plutonium.

Last updated August 1, 2023 at 2:49 PM

History

• Effective: September 1, 2012
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-56-06

(A) An application for a specific license to manufacture or initially transfer calibration or reference sources containing plutonium, for distribution to persons generally licensed under rule 3701:1-56-02 of the Administrative Code, will be approved if:

(1) The applicant satisfies the general requirements of the license application requirements of Chapters 3701:1-40 and 3701:1-46 of the Administrative Code, and rule 3701:1-38-02 of the Administrative Code.

(2) The applicant submits sufficient information regarding each type of calibration or reference source pertinent to evaluation of the potential radiation exposure, including:

(a) Chemical and physical form and maximum quantity of plutonium in the source;

(b) Details of construction and design;

(c) Details of the method of incorporation and binding of the plutonium in the source;

(d) Procedures for and results of prototype testing of sources, which are designed to contain more than one hundred eighty-five becquerels (0.005 microcurie) of plutonium, to demonstrate that the plutonium contained in each source will not be released or be removed from the source under normal conditions of use;

(e) Details of quality control procedures to be followed in manufacture of the source;

(f) Description of labeling to be affixed to the source or the storage container for the source; and

(g) Any additional information, including experimental studies and tests, required by the director to facilitate a determination of the safety of the source.

(3) Each source will contain no more than one hundred eighty-five kilobecquerels (five microcuries) of plutonium.

(4) The director determines, with respect to any type of source containing more than one hundred eighty-five becquerels (0.005 microcurie) of plutonium, that:

(a) The method of incorporation and binding of the plutonium in the source is such that the plutonium will not be released or be removed from the source under normal conditions of use and handling of the source; and

(b) The source has been subjected to and has satisfactorily passed the prototype tests prescribed by paragraph (A)(5) of this rule.

(5) For any type of source which is designed to contain more than one hundred eighty-five becquerels (0.005 microcurie) of plutonium, the applicant has conducted prototype tests, in the order listed, on each of five prototypes of such source, which contains more than one hundred eighty-five becquerels (0.005 microcurie) of plutonium, as follows:

(a) The quantity of radioactive material deposited on the source shall be measured by direct counting of the source.

(b) The entire radioactive surface of the source shall be wiped with filter paper with the application of moderate finger pressure. Removal of radioactive material from the source shall be determined by measuring the radioactivity on the filter paper or by direct measurement of the radioactivity on the source following the dry wipe.

(c) The entire radioactive surface of the source shall be wiped with filter paper, moistened with water, with the application of moderate finger pressure. Removal of radioactive material from the source shall be determined by measuring the radioactivity on the filter paper after it has dried or by direct measurement of the radioactivity on the source following the wet wipe.

(d) The source shall be immersed in water at room temperature for a period of twenty four consecutive hours. The source shall then be removed from the water. Removal of radioactive material from the source shall be determined by direct measurement of the radioactivity on the source after it has dried or by measuring the radioactivity in the residue obtained by evaporation of the water in which the source was immersed.

(e) On completion of the preceding tests in paragraphs (A)(5)(a) to (A)(5)(d) of this rule, the dry wipe test described in paragraph (A)(5)(b) of this rule shall be repeated.

(f) Removal of more than one hundred eighty-five becquerels (0.005 microcurie) of radioactivity in any test prescribed by this paragraph shall be cause for rejection of the source design. Results of prototype tests submitted to the director shall be given in terms of radioactivity in microcuries and percent of removal from the total amount of radioactive material deposited on the source.

(B) Each person licensed under this rule shall affix to each source, or storage container for the source, a label which shall contain sufficient information relative to safe use and storage of the source and shall include the following statement or a substantially similar statement which contains the information called for in the following statement:

(1) The receipt, possession, use and transfer of this source, model ____, serial no. ____, are subject to a general license and the regulations of the United States nuclear regulatory commission or of a state with which the commission has entered into an agreement for the exercise of regulatory authority. Do not remove this label.

Caution - radioactive material - this source contains plutonium. Do not touch radioactive portion of this source.

(Name of manufacturer or initial transferor)

(2) Sources generally licensed under this rule prior to January 19, 1975 may bear labels authorized by the United States nuclear regulatory commission regulations in effect on January 1, 1975.

(C) Each person licensed under this rule shall perform a dry wipe test upon each source containing more than 3.7 kilobecquerels (0.1 microcurie) of plutonium prior to transferring the source to a general licensee under rule 3701:1-56-02 of the Administrative Code. This test shall be performed by wiping the entire radioactive surface of the source with a filter paper with the application of moderate finger pressure. The radioactivity on the paper shall be measured by using radiation detection instrumentation capable of detecting one hundred eighty-five becquerels (0.005 microcurie) of plutonium. If any such test discloses more than one hundred eighty-five becquerels (0.005 microcurie) of radioactive material, the source shall be deemed to be leaking or losing plutonium and shall not be transferred to a general licensee.

Last updated August 1, 2023 at 2:49 PM

History

• Effective: September 1, 2012
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-56-04

(A) Each license shall contain and be subject to the following conditions:

(1) No right to the special nuclear material shall be conferred by the license except as defined by the license;

(2) Neither the license nor any right under the license shall be assigned or otherwise transferred in violation of the provisions of Chapter 3748. of the Revised Code and the rules adopted thereunder; and

(3) The license shall be subject to and the licensee shall observe, all applicable rules, regulations and orders of the department.

(B) Each licensee shall notify the director, in writing, within ten days following the filing of a voluntary or involuntary petition for bankruptcy under any chapter of Title 11 (bankruptcy) of the United States Code by or against:

(1) The licensee;

(2) An entity, defined in this rule as person, estate, trust, governmental unit, and United States trustee, controlling the licensee or listing the license or licensee as property of the estate; or

(3) An affiliate of the license, defined in this rule as an entity that directly or indirectly owns, controls, or holds with power to vote, twenty per cent or more of the outstanding voting securities of the debtor, other than an entity that holds such securities:

(a) In a fiduciary or agency capacity without sole discretionary power to vote such securities; or

(b) Solely to secure a debt, if such entity has not in fact exercised such power to vote.

(C) The director may incorporate in any license such additional conditions and requirements with respect to the licensee's ownership, receipt, possession, use, and transfer of special nuclear material as it deems appropriate or necessary in order to:

(1) Protect health or to minimize danger to life or property; and

(2) Require such reports and the keeping of such records, and to provide for such inspections, of activities under the license as may be necessary or appropriate to effectuate the purposes of the act and regulations thereunder.

Last updated May 23, 2022 at 7:59 AM

History

• Effective: May 23, 2022
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-56-03 General license to own special nuclear material.

A general license is hereby issued to receive title to and own special nuclear material without regard to quantity. Notwithstanding any other provision of this chapter, a general licensee under this rule is not authorized to physically acquire, deliver, receive, possess, use, transfer, import, or export from the country special nuclear material, except as authorized in a specific license.

Last updated August 1, 2023 at 2:49 PM

History

• Effective: April 14, 2003
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-56-05 Inalienability of licenses.

(A) No license granted under this chapter, and no right to possess or utilize special nuclear material granted by any license issued pursuant to this chapter, shall be transferred, assigned or in any manner disposed of, either voluntarily or involuntarily, directly or indirectly, through transfer of control of any license to any person, unless the director shall, after securing full information, find that the transfer is in accordance with the provisions of rule 3701:1-56-04 of the Administrative Code, and shall give his consent in writing.

(B) An application for transfer of a license must include:

(1) The identity, technical and financial qualifications of the proposed transferee; and

(2) Financial assurance for decommissioning information required by rule 3701:1-56-19 of the Administrative Code.

Last updated August 1, 2023 at 2:49 PM

History

• Effective: November 22, 2013
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-56-19

(A) Each applicant for a specific license authorizing possession and use of unsealed special nuclear material in quantities specified in paragraph (B) of this rule shall either:

(1) Submit a decommissioning funding plan as described in paragraph (C) of this rule; or

(2) Submit a certification that financial assurance for decommissioning has been provided in the amount prescribed by paragraph (B) of this rule using one of the methods described in rule 3701:1-40-17 of the Administrative Code. For an applicant, this certification may state that the appropriate assurance will be obtained after the application has been approved and the license issued but before the receipt of licensed material. If the applicant defers execution of the financial instrument until after the license has been issued, a signed original of the financial instrument obtained to satisfy the requirements of rule 3701:1-40-17 of the Administrative Code must be submitted to the director prior to receipt of licensed material. If the applicant does not defer execution of the financial instrument, the applicant shall submit to the director, as part of the certification, a signed original of the financial instrument obtained to satisfy the requirements of rule 3701:1-40-17 of the Administrative Code.

(B) Prior to the director issuing a radioactive materials license, an applicant providing certification of financial assurance for decommissioning as specified in paragraph (A)(1) of this rule shall provide the certification in a monetary amount based upon the quantity of licensed material specified as follows:

(1) Greater than ten thousand but less than or equal to one hundred thousand times the applicable quantities in appendix A to rule 3701:1-40-17 of the Administrative Code. For a combination of radionuclides if R, where R is defined as the sum of the ratios of the quantity of each radionuclide to the applicable value in appendix A to rule 3701:1-40-17 of the Administrative Code, divided by ten thousand is greater than one but R divided by one hundred thousand is less than or equal to one, the sum of one million one hundred twenty-five thousand dollars.

(2) Greater than one thousand but less than or equal to ten thousand times the applicable quantities of appendix A to rule 3701:1-40-17 of the Administrative Code. For a combination of radionuclides, if R, where R is defined as the sum of the ratios of the quantity of each radionuclide to the applicable value in appendix A to rule 3701:1-40-17 of the Administrative Code, divided by one thousand is greater than one but R divided by ten thousand is less than or equal to one, the sum of two hundred twenty-five thousand dollars.

(C)

Each decommissioning funding plan must be submitted for review and approval and must contain:

(1) A detailed cost estimate for decommissioning, in an amount reflecting:

(a) The cost of an independent contractor to perform all decommissioning activities;

(b) The cost of meeting the criteria specified in paragraph (B) of rule 3701:1-38-22 of the Administrative Code for unrestricted use, provided that, if the applicant or licensee can demonstrate its ability to meet the provisions of paragraph (D) of rule 3701:1-38-22 of the Administrative Code, the cost estimate may be based on meeting this criteria;

(c) The volume of onsite subsurface material containing residual radioactivity that will require remediation; and

(d) An adequate contingency factor.

(2) Identification of and justification for using the key assumptions contained in the decommissioning cost estimate;

(3) A description of the method of assuring funds for decommissioning in accordance with rule 3701:1-40-17 of the Administrative Code, including means for adjusting cost estimates and associated funding levels periodically over the life of the facility;

(4) A certification by the licensee that financial assurance for decommissioning has been provided in the amount of the cost estimate for decommissioning; and

(5) A signed original of the financial instrument obtained to satisfy the requirements of rule 3701:1-40-17 of the Administrative Code (unless a previously submitted and accepted financial instrument continues to cover the cost estimate for decommissioning).

(D) At the time of license renewal and at intervals not to exceed three years, the decommissioning funding plan must be resubmitted with adjustments as necessary to account for the changes in costs and the extent of contamination. If the amount of financial assurance will be adjusted downward, this cannot be done until the updated decommissioning funding plan is approved. The decommissioning funding plan must update the information submitted with the original or prior approved plan, and must specifically consider the effect of the following events on decommissioning costs:

(1) Spills of radioactive material producing additional residual radioactivity in onsite subsurface material;

(2) Waste inventory increasing above the amount previously estimated;

(3) Waste disposal costs increasing above the amount previously estimated;

(4) Facility modifications;

(5) Changes in authorized possession limits;

(6) Actual remediation costs that exceed the previous estimate;

(7) Onsite disposal; and

(8) Use of a settling pond.

(E) Each person licensed under Chapter 3701:1-56 of the Administrative Code shall keep records of information important to the decommissioning of a facility in an identified location until the site is released for unrestricted use. If records important to the decommissioning of a facility are kept for other purposes, reference to these records and their locations may be used. Information the director considers important to decommissioning consists of:

(1) Records of spills or other unusual occurrences involving the spread of contamination in and around the facility, equipment, or site. These records may be limited to instances when contamination remains after any cleanup procedures or when there is reasonable likelihood that contaminants may have spread to inaccessible areas as in the case of possible seepage into porous materials such as concrete. These records must include any known information on identification of involved nuclides, quantities, forms, and concentrations.

(2) As-built drawings and modifications of structures and equipment in restricted areas where radioactive materials are used and/or stored, and of locations of possible inaccessible contamination such as buried pipes which may be subject to contamination. If required drawings are referenced, each relevant document need not be indexed individually. If drawings are not available, the licensee shall substitute appropriate records of available information concerning these areas and locations.

(3) Except for areas containing only sealed sources (provided the sources have not leaked or no contamination remains after cleanup of any leak), a list contained in a single document and updated every two years, of the following:

(a) All areas designated and formerly designated as restricted areas as defined in rule 3701:1-38-01 of the Administrative Code;

(b) All areas outside of restricted areas that require documentation under paragraph (D)(1) of this rule;

(c) All areas outside of restricted areas where current and previous wastes have been buried as documented under paragraph (K) of rule 3701:1-38-20 of the Administrative Code; and

(d) All areas outside of restricted areas that contain material such that, if the license expired, the licensee would be required to either decontaminate the area to meet the criteria for decommissioning in rule 3701:1-38-22 of the Administrative Code, or apply for approval for disposal under paragraph (C) of rule 3701:1-38-19 of the Administrative Code.

(4) Records of the cost estimate performed for the decommissioning funding plan or of the amount certified for decommissioning, and records of the funding method used for assuring funds if either a funding plan or certification is used.

Last updated July 10, 2025 at 10:48 AM

History

• Effective: November 22, 2013
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-38-02

(A) As used in this rule, "facility" has the meaning defined in division (H) of section 3748.01 of the Revised Code and the following:

(1) All buildings, equipment, structures, and other stationary items that are located on a single site or on contiguous or adjacent sites and that are operated by the same person and have common corporate or business interests; and

(2) Portions of a building or structure which are operated by the same person and have common corporate or business interests.

(B) Notwithstanding the definition of "facility," the director may consider sites that are not contiguous or adjacent as one facility provided that:

(1) The sites are operated by the same person;

(2) The sites are in the same license category or categories;

(3) The applicant for a license provides for one radiation safety officer, and if applicable, one radiation safety committee, as responsible for all sites; and

(4) The director is reasonably satisfied from the information provided in the application that the applicant will adequately control radioactive material at all sites listed in the application.

(a) Unless the director has information of violations of Chapter 3748. of the Revised Code or the rules adopted thereunder at one or more sites, the director shall presume the applicant will adequately control radioactive material at all sites if the sites are located not more than twenty miles driving distance apart as documented by the licensee, and if all sites are within a twenty mile radius from the main site as designated on the license.

(b) The director shall continue to renew a license issued under this paragraph that contains all the sites listed thereon provided the licensee demonstrates continued compliance with this paragraph, Chapter 3748. of the Revised Code, and the rules adopted thereunder.

(C) Every facility that handles radioactive material in any license category as specified in appendix A to this rule for which licensure is required shall apply for a license, license amendment, or license renewal in accordance with this rule. Application for a license, license amendment, or license renewal shall be made on any format prescribed and provided by the director. Licenses shall be issued in accordance with the requirements of Chapter 3748. of the Revised Code, and the rules adopted thereunder. Except as otherwise provided in this rule, a license shall expire five years from the date of issuance.

(1) As used in this paragraph, site means an address of use listed on the license. Temporary job sites are exempted.

(a) Any individual applying for a new license with one or more additional sites or a current licensee amending a license to add one or more additional sites that are located more than twenty miles from the main site shall pay an additional site fee for each such site as follows:

(i) The additional site fee(s) shall be seventy-five percent of the applicable annual fee, as those fees are set forth in paragraphs (D), (F), and (J) of this rule.

(ii) Additional site fees will be invoiced annually with the annual fee.

(b) Broad scope licensees are exempt from paragraph (C)(1)(a) of this rule.

(2) As used in this paragraph, "service" means activities performed by a person, other than a worker as defined in rule 3701:1-38-01 of the Administrative Code, pursuant to an agreement with the facility to perform activities that deal with sources of radiation for the facility.

(a) These activities include, but are not limited to the following:

(i) Conduct leak tests;

(ii) Calibrate survey instruments;

(iii) Provide quality control tests;

(iv) Conduct surveys, characterization, and/or remediation activities;

(v) Manage the disposal of radioactive waste for other persons; or

(vi) Install sources or devices or change sources within a device.

(b) License categories affected are:

(i) 3219 - decontamination services;

(ii) 3220 - leak test service;

(iii) 3221 - instrument calibration service only - source less than 3.7 terabecquerels (one hundred curies);

(iv) 3222 - instrument calibration service only - source equal to or greater than 3.7 terabecquerels (one hundred curies);

(v) 3223 - leak test and instrument calibration - source less than 3.7 terabecquerels (one hundred curies);

(vi) 3224 - leak test and instrument calibration - source equal to or greater than 3.7 terabecquerels (one hundred curies);

(vii) 3225 - other services - including teletherapy, irradiator, and gauge service;

(viii) 3232 - waste disposal service prepackaged only;

(ix) 3233 - waste disposal service - incineration; and

(x) 3234 - waste disposal service processing and/or repackaging.

(D) A radioactive materials license issued by the department may, at the discretion of the director, have more than one license category on any one specific license. A licensee may have more than one radioactive materials license. Except as otherwise provided in paragraph (J) of this rule, the annual fee for a radioactive material license shall be in an amount in accordance with appendix A to this rule.

(1) Upon receipt of an application for a new radioactive material license, the department will issue an invoice for the appropriate fee specified in appendix A to this rule or paragraph (J) of this rule. Annual fees will be invoiced based on the month of the license expiration date and the invoice will state that the fee is due thirty days after the date of the invoice. License fees are not refundable.

(2) An applicant for a new or a renewal or amendment of a radioactive material license must submit a complete application before the director will finalize the review of the application. A complete application is one in which the applicant has provided all the information requested by the director, including any additional information requested after receipt of the application package.

(3) Upon receipt of an application for a license amendment, the department will issue an invoice for the appropriate fee for the proposed amendment as specified in appendix A to this rule. If the amendment is to change the license from operational phase to storage of sealed sources only incident to disposal of the sources, after the amendment the annual fee for the license shall be reduced to fifty per cent of the fee for the operational phase of the license, provided that the sources continue to be in safe storage and leak tested as provided by license condition for the specific sources in storage. The inspection frequency will remain the same as that for the operational phase of the license until after source disposal.

(4) The applicant for a new, or renewal or amendment of a radioactive materials license shall provide to the director all additional information requested within sixty days from the date of the information request. If the director does not receive the requested information within the stated time period, the director may consider the application abandoned. Any further consideration of a new license, or a renewal or amendment of a license shall be pursuant to another application.

(5) The director shall grant a new license, license amendment, or license renewal to any applicant who has submitted a complete application and is in compliance with Chapter 3748. of the Revised Code and the rules adopted thereunder.

(6) When an amendment to a license results in a change to a license category with a higher fee, the licensee will be charged the higher of the two amendment fees for that category. The annual fee for the licensee will escalate to the new category fee on the date of the next annual invoice.

(7) The director shall charge a fee for minor license amendments that do not require review by members of the technical staff at a rate of one hundred dollars per amendment provided that no licensee shall be required to pay more than one thousand dollars for minor amendments in any calendar year. Minor amendments include, but are not limited to, adding a new gauge of the same type already licensed unless that additional gauge increases the license or inspection fee, a corporate name change if the corporate ownership does not change, adding a user name that does not require review of education and experience, and corporate address change if the location of the use of the radioactive material does not change. Amendments to change the radiation safety officer or the chair or members of the radiation safety committee that require review of education or experience are not minor amendments.

(8) License terminations shall be handled as follows:

(a) Except as provided in paragraph (D)(8)(c) of this rule, a termination fee of five hundred dollars or fifty per cent of the annual fee, whichever is less, will be invoiced upon written request from the licensee for termination of the license. This fee is not refundable.

(b) Except as provided in paragraph (D)(8)(c) of this rule, if the termination cost, as determined by paragraph (M) of this rule, exceeds the termination fee in paragraph (D)(8)(a) of this rule, the remainder of the termination expense will be assessed at full cost.

(c) If the license termination would be covered under paragraph (D)(9) of this rule, that paragraph will be used for the termination process.

(d) The license termination process will not be completed until the licensee is in compliance with all rules, including payment of fees.

(9) Licenses, and other approvals related to the licensed activity requiring decommissioning, decontamination, reclamation, site restoration, or long-term care due to the continued presence of radioactive materials shall be charged an annual fee based on the approved decommissioning funding plan as specified in appendix B to this rule.

(a) A decommissioning plan must be approved by the department. Prior to approval of the decommissioning plan the licensee must submit an amendment requesting decommissioning. Until the amendment is approved the licensee's annualized license fee will be reduced by fifty per cent. After approval of the amendment containing the decommissioning plan, the licensee will be invoiced at the annual fee specified in appendix B to this rule.

(b) The annual fee specified in appendix B to this rule is based on the cost of decommissioning. The fee is payable within thirty days of mailing of an invoice by the department.

(c) Routine decommissioning oversight by the department will be charged against the annual amount received and additional invoices will not be issued unless the cost of activities exceeds the annual amount in any given year.

(d) The facility shall receive a monthly statement of items and amounts charged against the annual fee.

(e) If the cost of additional activities arise that require use of additional staff, including any consulting service that exceeds the amount of the annual fee paid by the licensee, these additional costs will be included in any invoice as separate items invoiced for the full cost of the oversight by additional staff or consultants. Oversight activities will be performed at a frequency which adequately monitors health, safety, and the environment.

(f) When the approved decommissioning plan is less than one hundred thousand dollars, the licensee will remain in the current license category and continue to pay the required annual fee specified in appendix A to this rule during decommissioning. Inspections of these licensees will be done as non-routine inspections. Non-routine inspection fees will not be applied until the number of decommissioning inspections performed exceed the inspections that would have been performed if the licensee had not chosen the decommissioning option.

(g) When the licensee has completed the decommissioning, and the director has determined that the licensee cannot terminate the license as provided by the Administrative Code, Chapter 3748. of the Revised Code or the rules adopted thereunder, but the licensee has successfully completed the decommissioning of the operation as required by the approved decommissioning plan, the director will amend the license to a decommissioning/possession only license. The annual fee for a decommissioning/possession only license is provided in appendix B to this rule.

(E) Licenses shall be renewed in accordance with the standard renewal procedure established in Chapter 4745. of the Revised Code, except that a licensee, other than a broad scope licensee, shall apply for renewal of the license ninety days prior to the expiration date of the current license and broad scope licensees shall apply for renewal of their license one hundred eighty days prior to expiration.

(F) The annual fee is listed in appendix A to this rule "column 5" for a new license or "column 6" for a renewal license. To recover the costs of oversight activities where radioactive material is found in the public domain and there is no evident individual that is determined to be responsible, a surcharge of 5.25 per cent has been included in the annual fee listed in "column 5" and "column 6" of appendix A to this rule.

(G) The department shall charge an inspection fee for all non-routine inspections. A non-routine inspection is defined as any inspection that the department conducts in addition to the scheduled routine inspections and one follow-up inspection if necessary. Non-routine inspections include, without limitation:

(1) An inspection performed as a result of an incident;

(2) Any pre-license inspections for a new license applicant when the director determines that an inspection is necessary to assess the adequacy of the information provided in the application;

(3) Inspections prior to license amendment, category change, or termination;

(4) An inspection performed at a facility that results in the issuance of an adjudication order by the director; or

(5) Other enforcement or regulatory inspections, not specified above, that the director determines is necessary to assess compliance with Chapter 3748. of the Revised Code.

(H) The fee for a non-routine inspection shall be based on the actual cost for conducting the inspection which shall include:

(1) An hourly charge of seventy dollars per staff person assigned to the inspection, except staff participating as training will not be included in the charges;

(2) An administrative fee of three hundred thirty dollars;

(3) All necessary laboratory analysis costs for samples collected by department personnel; and

(4) Any staff travel costs which shall be calculated in accordance with rule 126-01-02 of the Administrative Code.

(I) All fees invoiced as provided within this rule, including full cost, routine, and non-routine inspection fees, shall be paid within thirty days of the invoice date specified on the invoice. In accordance with sections 3748.07 and 3748.13 of the Revised Code, any fee that remains unpaid on the ninety-first day after the original invoice date shall be assessed an additional amount equal to ten per cent of the original fee.

(1) The department shall mail invoices by ordinary U.S. mail to the most recent address provided by the licensee.

(2) The department shall maintain a list of the invoices issued and date mailed.

(J) Notwithstanding paragraph (D) of this rule, the department shall charge the following types of licensees reduced license fees in the following specified amounts:

(1) A private entity that provides services, does not engage in manufacturing, and that has three hundred fifty thousand to two million dollars in gross annual receipts, shall pay a total license fee of seventy-five per cent of the amount specified for that use of radioactive materials in appendix A to this rule.

(2) A private entity that provides services, does not engage in manufacturing, and that has less than three hundred fifty thousand dollars in gross annual receipts shall pay a total license fee of fifty per cent of the amount specified for that use of radioactive material in appendix A to this rule.

(3) A private entity that engages in manufacturing and that has thirty-five to two hundred employees, irrespective of gross annual receipts, shall pay a total license fee of seventy-five per cent of the amount specified for that use of radioactive material in appendix A to this rule.

(4) A private entity that engages in manufacturing and that has less than thirty-five employees, irrespective of gross annual receipts, shall pay a total license fee of fifty per cent of the amount specified for that use of radioactive material in appendix A to this rule.

(5) A nonprofit entity that has gross annual receipts of three hundred fifty thousand dollars to two million dollars shall pay a total license fee of seventy-five per cent of the amount specified for that use of radioactive material in appendix A to this rule.

(6) A nonprofit entity that has gross annual receipts of less than three hundred fifty thousand dollars shall pay a total license fee of fifty per cent of the amount specified for that use of radioactive material in appendix A to this rule.

(7) A government jurisdiction or district with a population of twenty thousand to fifty thousand shall pay a total license fee of seventy-five per cent of the amount specified for that use of radioactive material as specified in appendix A to this rule.

(8) A government jurisdiction or district with a population of less than twenty thousand shall pay a total license fee of fifty per cent of the amount specified for that use of radioactive materials as specified in appendix A to this rule.

(9) A health district as defined in section 3709.01 of the Revised Code shall pay a total license fee of twenty-five per cent of the amount specified in appendix A to this rule.

(10) An accredited private or public college or university possessing or using radioactive material in a sealed or unsealed source solely as a part of a college or university course supported by tuition and leading to an accredited degree, but excluding clinical training, shall pay a total license fee as set forth for category "1129" as that amount is specified in appendix A to this rule.

The reduced annual fees specified in this paragraph do not apply to any other fees that a licensee may be required to pay under Chapter 3748. of the Revised Code or rules adopted thereunder. Licensees shall provide certification of their compliance with the provisions of paragraphs (J)(1) to (J)(6) of this rule upon initial application and renewal.

(K) The director may modify the inspection frequency of licensed facilities based upon the performance of the facility.

(L) In accordance with section 3748.22 of the Revised Code, the department shall charge fees sufficient to cover all costs of regulatory, administrative, and enforcement activities conducted pursuant to Chapter 3748. of the Revised Code. The director shall recommend to the radiation advisory council and the public health council changes in the radioactive materials fees if the director finds that fees do not meet the requirements of section 3748.22 of the Revised Code.

(M) Fees for those categories listed as "full cost" such as decommissioning activities, for either partial, building or selected area of a licensed site, or full decommissioning leading to license amendment, category change, or termination and for review of sources and/or devices shall be specified as "full cost" and shall be calculated as the sum of the seventy dollar hourly charge per staff member for the number of hours spent on document review and preparation, licensing, inspection, meetings, teleconferences, in travel, administrative time, the cost of any special contractors as determined necessary by the director, any environmental monitoring for radioactive materials and laboratory analysis, any other associated activities. The administrative fee from paragraph (H)(2) of this rule shall be used for administrative time. Travel expenses shall also be invoiced and shall be calculated at the rate determined by rule 126-1-02 of the Administrative Code. These fees will be invoiced monthly.

(N)

(1) Reciprocity to engage in activities in the state of Ohio which involve radioactive materials may be authorized provided:

(a) The person requesting reciprocity possesses a valid radioactive materials license issued by another agreement state or the United States nuclear regulatory commission which authorizes the same activities proposed to be conducted in Ohio;

(b) The request for reciprocity is made by submission of a completed reciprocity application provided by the director, a copy of the person's radioactive materials license, and payment of the reciprocity fee specified in appendix A to this rule;

(c) The duration of activities to be performed in Ohio under reciprocity does not exceed one hundred eighty days in any one calendar year.

(2) A person who has been granted reciprocity in Ohio shall notify the director at least three business days in advance of each time the person proposes to begin a new use of radioactive materials in the state of Ohio, with the notification made on a form provided by the director.

(3) Activities conducted in Ohio under reciprocity are subject to inspection by the department at any time and the department shall invoice a reciprocity inspection fee of one thousand dollars for each inspection of a person's authorized reciprocity activities.

(4) Reciprocity is authorized for one calendar year, beginning on January first or later date when reciprocity is initially applied for, and ending on December thirty-first.

(5) A person who is authorized reciprocity shall apply for an Ohio radioactive materials license at least thirty days prior to exceeding one hundred eighty days of activities in Ohio.

(O) Requests for safety evaluation of devices, products, or sealed sources used for radioactive materials either for commercial distribution or manufactured in accordance with the unique specifications of, and for use by, a single applicant shall be submitted to the director on a form provided by the director for that review prior to manufacture or commercial distribution.

(1) The application shall specify a license amendment for one of the areas listed below:

(a) Safety evaluation of sealed sources or devices or products containing NARM, byproduct material, source material, or special nuclear material (less than critical mass) for commercial distribution.

(b) Safety evaluation of sealed sources or devices or products containing NARM, byproduct material, source material, or special nuclear material (less than critical mass) manufactured in accordance with the unique specifications of, and for use by, a single applicant.

(2) The amendment fee for a source or device review shall be "full cost" as outlined in paragraph ((M) of this rule.

(3) The amendment fee in appendix A to this rule for categories under manufacturing and distribution shall be for amendments other than source or device reviews.

(4) Licensees for categories 3211, 3212, 3213, 3214, and 22162 shall pay an annual surcharge of six hundred fifty dollars to cover administrative costs of overall maintenance activities associated with source or device data submitted to the United States nuclear regulatory commission. This surcharge is included in the annual fee for the above listed categories in "column 5" and "column 6" of appendix A to this rule.

(P) When considered necessary by the director, the director may conduct a review of shielding plans or the adequacy of shielding. The director may also conduct such a review upon the request of the licensee or the applicant for a license. The applicant or licensee shall pay a fee for review of shielding plans or adequacy of shielding as specified in paragraph (M) of this rule.

(Q) Individuals with implanted pacemakers that have a radioactive source will not be charged an annual fee as an individual because of the necessity of possessing the device. Unless the director determines other provisions are required, the medical institution that implanted the device shall hold the license for the individual.

(R) If, because of the complexity of a review, such as that for a sealed source or device, decommissioning, license, or incident, it is necessary to obtain the services of a consultant to assist in a final determination, the licensee or applicant will be invoiced for the consulting services.

(S) Licensees with general licenses requiring an annual report to the director shall submit the report with a fee of four hundred twenty dollars within thirty days of mailing an invoice by the department and are subject to late penalties in paragraph (I) of this rule. If a facility has a specific license which is in a category that would include the generally licensed material, the facility may add the generally licensed material to the specific license and will not be charged the additional fee for that generally licensed material. Annual reports are required for devices under a general license containing radionuclides at or above activities listed in paragraph (C)(13) of rule 3701:1-46-05 of the Administrative Code.

View AppendixView Appendix

Last updated November 2, 2022 at 2:09 PM

History

• Effective: April 15, 2013
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-56-07 Authorized use of special nuclear material.

(A) Each licensee shall confine possession and use of special nuclear material to the locations and purposes authorized in the license. Except as otherwise provided in the license, each license issued pursuant to the rules in this chapter, Chapter 3701:1-40, and rule 3701:1-38-02 of the Administrative Code shall carry with it the right to receive title to, own, acquire, receive, possess and use special nuclear material. Preparation for shipment and transport of special nuclear material shall be in accordance with the provisions of Chapter 3701:1-50 of the Administrative Code.

(B) The possession, use and transfer of any special nuclear material produced by a licensee, in connection with or as a result of use of special nuclear material received under the license, shall be subject to the provisions of the license and the regulations in this chapter.

Last updated August 1, 2023 at 2:50 PM

History

• Effective: August 26, 2016
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-56-08 Transfer of special nuclear material.

(A) No licensee shall transfer special nuclear material except as authorized pursuant to this rule.

(B) Except as otherwise provided in the license and subject to the provisions of paragraphs (C) and (D) of this rule, any licensee may transfer special nuclear material:

(1) To the agency in any agreement state which regulates radioactive materials pursuant to an agreement with the United States nuclear regulatory commission, if the quantity transferred is not sufficient to form a critical mass;

(2) To any person exempt from the licensing requirements of the Chapter 3701:1-40 of the Administrative Code and rules in this chapter, to the extent permitted under such exemption;

(3) To any person in an agreement state, subject to the jurisdiction of that state, who has been exempted from the licensing requirements and regulations of that state, to the extent permitted under such exemption;

(4) To any person authorized to receive such special nuclear material under terms of a specific license or a general license or their equivalents issued by the United States nuclear regulatory commission or an agreement state; or

(5) As otherwise authorized by the director in writing.

(C) When transferring special nuclear material:

(1) The licensee transferring the material shall verify that the transferee's license authorizes receipt of the type, form, and quantity of special nuclear material to be transferred, before transferring special nuclear material to a specific licensee of the director, the United States nuclear regulatory commission or an agreement state; or

(2) The licensee transferring the material shall verify that the transferee's license authorizes receipt of the type, form, and quantity of special nuclear material to be transferred, prior to receipt of the special nuclear material by a general licensee who is required to register with the director, the United States nuclear regulatory commission or with an agreement state.

(D) The following methods for the verification required by paragraph (C) of this rule are acceptable:

(1) The transferor may have in his or her possession, and read, a current copy of the transferee's specific license or registration certificate. The transferor shall retain a copy of each license or certificate for three years from the date that it was obtained;

(2) The transferor may have in its possession a written certification by the transferee that the transferee is authorized by license or registration certificate to receive the type, form, and quantity of special nuclear material to be transferred, specifying the license or registration certificate number, issuing agency, and expiration date. The transferor shall retain the written certification as a record for three years from the date of receipt of the certification;

(3) For emergency shipments the transferor may accept oral certification by the transferee that he or she is authorized by license or registration certificate to receive the type, form, and quantity of special nuclear material to be transferred, specifying the license or registration certificate number, issuing agency, and expiration date, provided that the oral certification is confirmed in writing within ten days. The transferor shall retain the written confirmation of the oral certification for three years from the date of receipt of the confirmation;

(4) The transferor may obtain other sources of information compiled by a reporting service from official records of the department, the United States nuclear regulatory commission or the licensing agency of an agreement state as to the identity of licensees and the scope and expiration dates of licenses and registrations. The transferor shall retain the compilation of information as a record for three years from the date that it was obtained; or

(5) When none of the methods of verification described in paragraphs (D)(1) to (D)(4) of this rule are readily available or when a transferor desires to verify that information received by one of these methods is correct or up-to-date, the transferor may obtain and record confirmation from the department, the United States nuclear regulatory commission or the licensing agency of an agreement state that the transferee is licensed to receive the special nuclear material. The transferor shall retain the record of confirmation for three years from the date the record is made.

Last updated August 1, 2023 at 2:50 PM

History

• Effective: September 1, 2012
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-56-09 Reporting requirements.

(A) Each licensee shall notify the director as soon as possible but not later than four hours after the discovery of an event that prevents immediate protective actions necessary to avoid exposures to radiation or radioactive materials that could exceed regulatory limits or releases of licensed material that could exceed regulatory limits (events may include fires, explosions, toxic gas releases, etc.).

(B) Each licensee shall notify the director within twenty-four hours after the discovery of any of the following events involving licensed material:

(1) An unplanned contamination event that:

(a) Requires access to the contaminated area, by workers or the public, to be restricted for more than twenty-four hours by imposing additional radiological controls or by prohibiting entry into the area;

(b) Involves a quantity of material greater than five times the lowest annual limit on intake specified in appendix C to rule 3701:1-38-12 of the Administrative Code for the material; and

(c) Has access to the area restricted for a reason other than to allow radionuclides with a half-life of less than twenty-four hours to decay prior to decontamination.

(2) An event in which equipment is disabled or fails to function as designed when:

(a) The equipment is required by regulation or license condition to prevent releases exceeding regulatory limits, to prevent exposures to radiation and radioactive materials exceeding regulatory limits, or to mitigate the consequences of an accident;

(b) The equipment is required to be available and operable when it is disabled or fails to function; and

(c) No redundant equipment is available and operable to perform the required safety function.

(3) An event that requires unplanned medical treatment at a medical facility of an individual with spreadable radioactive contamination on the individual's clothing or body.

(4) An unplanned fire or explosion damaging any licensed material or any device, container, or equipment containing licensed material when:

(a) The quantity of material involved is greater than five times the lowest annual limit on intake specified in appendix C to rule 3701:1-38-12 of the Administrative Code for the material; and

(b) The damage affects the integrity of the licensed material or its container.

(C) Reports made by licensees in response to the requirements of this rule must be made as follows:

(1) Licensees shall make reports required by paragraphs (A) and (B) of this rule by telephone to the department's twenty-four hour number, 614-644-2727. To the extent that the information is available at the time of notification, the information provided in these reports must include:

(a) Caller's name, position title, and call back telephone number;

(b) Date, time, and exact location of the event;

(c) Description of the event, including:

(i) Radiological or chemical hazards involved, including isotopes, quantities, and chemical and physical form of any material released;

(ii) Actual or potential health and safety consequences to the workers, the public, and the environment, including relevant chemical and radiation data for actual personnel exposures to radiation or radioactive materials or hazardous chemicals produced from licensed materials (e.g., level of radiation exposure, concentration of chemicals, and duration of exposure);

(iii) The sequence of occurrences leading to the event, including degradation or failure of structures, systems, equipment, components, and activities of personnel relied on to prevent potential accidents or mitigate their consequences; and

(iv) Whether the remaining structures, systems, equipment, components, and activities of personnel relied on to prevent potential accidents or mitigate their consequences are available and reliable to perform their function;

(d) External conditions affecting the event;

(e) Additional actions taken by the licensee in response to the event;

(f) Status of the event (e.g., whether the event is on-going or was terminated);

(g) Current and planned site status, including any declared emergency class;

(h) Notifications, related to the event, that were made or are planned to any local, state, or federal agencies; and

(i) Status of any press releases, related to the event, that were made or are planned.

(2) Each licensee who makes a report required by paragraph (A) or (B) of this rule shall submit a written follow-up report within thirty days of the initial report. Written reports prepared pursuant to other regulations may be submitted to fulfill this requirement if the reports contain all of the necessary information and the appropriate distribution is made. These written reports must be sent to the director in accordance with rule 3701:1-56-12 of the Administrative Code. The reports must include the following:

(a) Complete applicable information required by paragraph (C)(1) of this rule;

(b) The probable cause of the event, including all factors that contributed to the event and the manufacturer and model number (if applicable) of any equipment that failed or malfunctioned; and

(c) Corrective actions taken or planned to prevent occurrence of similar or identical events in the future and the results of any evaluations or assessments.

Last updated August 1, 2023 at 2:50 PM

History

• Effective: August 26, 2016
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-38-12

(A) Except in the case of a planned special exposure pursuant to paragraph (F) of this rule, a licensee or registrant shall limit the occupational dose received by an individual adult, as follows:

(1) An annual limit, which is the more limiting of:

(a) The total effective dose equivalent being equal to 0.05 sievert (five rem); or

(b) The sum of the deep dose equivalent and the committed dose equivalent to any individual organ or tissue other than the lens of the eye being equal to 0.5 sievert (fifty rem).

(2) The annual limits to the lens of the eye, to the skin of the whole body, and to the skin of the extremities, which are:

(a) A lens dose equivalent of 0.15 sievert (fifteen rem), and

(b) A shallow-dose equivalent of 0.5 sievert (fifty rem) to the skin of the whole body or to the skin of any extremity.

(3) Doses received in excess of the annual limits, including doses received during accidents, emergencies, and planned special exposures, shall be subtracted from the limits for planned special exposures that the individual may receive during the current calendar year and during the individual's lifetime in accordance with paragraph (F)(5) of this rule.

(4) When the external exposure is determined by measurement with an external personal monitoring device, the deep-dose equivalent must be used in place of the effective dose equivalent, unless the effective dose equivalent is determined by a dosimetry method approved by the director. The assigned deep-dose equivalent must be for the part of the body receiving the highest exposure.

(a) The assigned shallow-dose equivalent must be the dose averaged over the contiguous ten square centimeters of skin receiving the highest exposure. The deep-dose equivalent, lens-dose equivalent, and shallow-dose equivalent may be assessed from surveys or other radiation measurements for the purpose of demonstrating compliance with the occupational dose limits, if the individual monitoring device was not in the region of highest potential exposure, or the results of individual monitoring are unavailable; or

(b) When a protective apron is worn while working with radiation-generating equipment and monitoring is conducted as specified in paragraph (C)(1) of rule 3701:1-38-14 of the Administrative Code, the effective dose equivalent for external radiation shall be determined as follows:

(i) When only one individual monitoring device is used and it is located at the neck outside the protective apron, the reported deep dose equivalent value multiplied by 0.3 shall be the effective dose equivalent for external radiation; or

(ii) When two individual monitoring devices are worn, one under the protective apron at the waist and the other outside the protective apron at the neck, the effective dose equivalent for external radiation shall be assigned the value of the sum of the deep dose equivalent reported for the individual monitoring device located at the waist under the protective apron multiplied by 1.5 and the deep dose equivalent reported for the individual monitoring device located at the neck outside the protective apron multiplied by 0.04; or

(iii) Through the use of computational methods endorsed by the "American National Standards Institute", recommended by the "National Council on Radiation Protection and Measurements", or approved by the director.

(5) Derived air concentration (DAC) and annual limit on intake (ALI) values are specified in appendix C to this rule and may be used by the licensee to determine the individual's dose and to demonstrate compliance with the occupational dose limits. Appendices A and B are explanatory supplements to appendix C to this rule. Notwithstanding the annual dose limits, the licensee shall limit the soluble uranium intake by an individual to ten milligrams in a week in consideration of chemical toxicity.

(6) In accordance with paragraph (E) of this rule, the licensee or registrant shall reduce the dose that an individual may be allowed to receive in the current year by the amount of occupational dose received while employed by any other person.

(B) Compliance with requirements for summation of external and internal doses shall be in accordance with the following:

(1) If the licensee is required to monitor under both paragraphs (B)(1) and (B)(2) of rule 3701:1-38-14 of the Administrative Code, the licensee shall demonstrate compliance with the dose limits by summing external and internal doses. If the licensee is required to monitor only under paragraph (B)(1) or only under paragraph (B)(2) of rule 3701:1-38-14 of the Administrative Code, then summation is not required to demonstrate compliance with the dose limits. The licensee may demonstrate compliance with the requirements for summation of external and internal doses by meeting one of the conditions specified in paragraph (B)(2) of this rule and the conditions in paragraphs (B)(3) and (B)(4) of this rule. The dose equivalents for the lens of the eye, the skin, and the extremities are not included in the summation, but are subject to separate limits.

(2) If the only intake of radionuclides is by inhalation, the total effective dose equivalent limit is not exceeded if the sum of the deep dose equivalent divided by the total effective dose equivalent limit, plus one of the following does not exceed unity:

(a) The sum of the fractions of the inhalation ALI for each radionuclide; or

(b) The total number of derived air concentration-hours, or DAC-hours, for all radionuclides divided by two thousand; or

(c) The sum of the calculated committed effective dose equivalents to all significantly irradiated organs or tissues (T) calculated from bioassay data using appropriate biological models and expressed as a fraction of the annual limit. For purposes of this requirement, an organ or tissue is deemed to be significantly irradiated if, for that organ or tissue, the product of the weighting factors, W_T, and the committed dose equivalent, H_T,50, per unit intake is greater than ten per cent of the maximum weighted value of H_T,50, that is, W_TH_T,50, per unit intake for any organ or tissue.

(3) If the occupationally exposed individual also receives an intake of radionuclides by oral ingestion greater than ten percent of the applicable oral ALI, the licensee shall account for this intake and include it in demonstrating compliance with the limits set forth in paragraph (A) of this rule.

(4) The licensee shall evaluate and, to the extent practical, account for intakes through wounds or skin absorption. The intake through intact skin has been included in the calculation of DAC for hydrogen-3 and does not need to be further evaluated or accounted for pursuant to this paragraph.

(C) Determination of external dose from airborne radioactive material shall be in accordance with the following:

(1) When determining the dose from airborne radioactive material, the licensee shall include the contribution to the deep dose equivalent, lens dose equivalent, and shallow dose equivalent from external exposure to the radioactive cloud as specified in appendix C to this rule, footnotes ^A and ^B.

(2) The licensee should not use airborne radioactivity measurements or DAC values as the primary means to assess the deep dose equivalent when the airborne radioactive material includes radionuclides other than noble gases, or if the cloud of airborne radioactive material is not relatively uniform. The determination of the deep dose equivalent to an individual should be based upon measurements using instruments or individual monitoring devices.

(D) Determination of internal exposure shall be in accordance with the following:

(1) For purposes of assessing dose used to determine compliance with occupational dose equivalent limits, the licensee shall, when required under paragraph (B) of rule 3701:1-38-14 of the Administrative Code, take suitable and timely measurements of:

(a) Concentrations of radioactive materials in air in work areas; or

(b) Quantities of radionuclides in the body; or

(c) Quantities of radionuclides excreted from the body; or

(d) Combinations of these measurements.

(2) Unless respiratory protective equipment is used, as provided in paragraph (C) of rule 3701:1-38-16 of the Administrative Code or the assessment of intake is based on bioassays, the licensee shall assume that an individual inhales radioactive material at the airborne concentration in which the individual is present.

(3) When specific information on the physical and biochemical properties of the radionuclides taken into the body or the behavior of the material in an individual is known, the licensee may:

(a) Use that information to calculate the committed effective dose equivalent, and, if used, the licensee shall document that information in the individual's record; and

(b) Upon prior approval of the department, adjust the DAC or ALI values to reflect the actual physical and chemical characteristics of airborne radioactive material, for example, aerosol size distribution or density; and

(c) Separately assess the contribution of fractional intakes of Class D, W, or Y compounds of a given radionuclide to the committed effective dose equivalent as specified in appendix A to this rule.

(4) If the licensee chooses to assess intakes of Class Y material using the measurements given in paragraph (D)(1)(b) or (D)(1)(c) of this rule in order to make additional measurements basic to the assessments, the licensee may delay the recording and reporting of the assessments for periods up to seven months, unless otherwise required by paragraph (B)(2) or (C) of rule 3701:1-38-21 of the Administrative Code.

(5) If the identity and concentration of each radionuclide in a mixture are known, the fraction of the DAC applicable to the mixture for use in calculating DAC-hours shall be either:

(a) The sum of the ratios of the concentration to the appropriate DAC value, that is, D, W, or Y, from appendix C to this rule for each radionuclide in the mixture; or

(b) The ratio of the total concentration for all radionuclides in the mixture to the most restrictive DAC value for any radionuclide in the mixture.

(6) If the identity of each radionuclide in a mixture is known, but the concentration of one or more of the radionuclides in the mixture is not known, the DAC for the mixture shall by the most restrictive DAC of any radionuclide in the mixture.

(7) When a mixture of radionuclides in air exists, a licensee may disregard certain radionuclides in the mixture if all of the following occur:

(a) The licensee uses the total activity of the mixture in demonstrating compliance with the dose limits in paragraph (A) of this rule and in complying with the monitoring requirements in paragraph (B) of rule 3701:1-38-14 of the Administrative Code;

(b) The concentration of any radionuclide disregarded is less than ten percent of its DAC; and

(c) The sum of these percentages for all of the radionuclides disregarded in the mixture does not exceed thirty percent.

(8) When determining the committed effective dose equivalent, the licensee may consider the following:

(a) In order to calculate the committed effective dose equivalent, the licensee may assume that the inhalation of one ALI, or an exposure of two thousand DAC-hours, results in a committed effective dose equivalent of 0.05 sievert (five rem), for radionuclides that have their ALIs or DACs based on the committed effective dose equivalent; or

(b) For an ALI and the associated DAC determined by the nonstochastic organ dose limit of 0.5 sievert (fifty rem), the intake of radionuclides that would result in a committed effective dose equivalent of 0.05 sievert (five rem), that is, the stochastic ALI, is listed in parentheses in table I of appendix C to this rule. The licensee may, as a simplifying assumption, use the stochastic ALI to determine committed effective dose equivalent. However, if the licensee uses the stochastic ALI, the licensee shall also demonstrate that the limit in paragraph (A)(1)(b) of this rule is met.

(E) Determination of prior occupational dose shall be made in accordance with the following:

(1) For each individual who is likely to receive an annual occupational dose requiring monitoring pursuant to paragraph (B) of rule 3701:1-38-14 of the Administrative Code, the licensee or registrant shall determine the occupational radiation dose received during the current year.

(2) Prior to permitting an individual to participate in a planned special exposure, the licensee shall determine:

(a) The internal and external doses from all previous planned special exposures; and

(b) All doses in excess of the limits, including doses received during accidents and emergencies, received during the lifetime of the individual.

(3) In complying with the requirements of paragraph (E)(1) or (E)(2) of this rule, a licensee or registrant may:

(a) Accept, as a record of the occupational dose that the individual received during the current year, a written signed statements from the individual, or from the individual's most recent employer for work involving radiation exposure, that discloses the nature and the amount of any occupational dose that the individual may have received during the current year;

(b) Accept, as the record of lifetime cumulative radiation dose, a current department form entitled "lifetime occupational exposure history" or equivalent, signed by the individual and countersigned by an appropriate official of the most recent employer for work involving radiation exposure, or the individual's current employer, if the individual is not employed by the licensee or registrant; and

(c) Obtain reports of the individual's dose equivalent from the most recent employer for work involving radiation exposure, or the individual's current employer, if the individual is not employed by the licensee or registrant, by telephone, telegram, facsimile, e-mail or letter. The licensee or registrant shall request a written verification of the dose data if the authenticity of the transmitted report cannot be established.

(4) The licensee or registrant shall record the exposure history, as required by paragraph (A) of this rule, on a form provided by the department or other clear and legible record, of all the information required on that form. The form or record shall show each period in which the individual received occupational exposure to radiation or radioactive material and shall be signed by the individual who received the exposure. For each period for which the licensee or registrant obtains reports, the licensee or registrant shall use the dose shown in the report in preparing the exposure history form. For any period in which the licensee or registrant does not obtain a report, the licensee or registrant shall place a notation on the exposure history form indicating the periods of time for which data are not available.

(5) If the licensee or registrant is unable to obtain a complete record of an individual's current and previously accumulated occupational dose, the licensee or registrant shall assume:

(a) In establishing administrative controls pursuant to paragraph (A)(6) of this rule for the current year, that the allowable dose limit for the individual is reduced by 12.5 millisievert (1.25 rem), for each quarter for which records were unavailable and the individual was engaged in activities that could have resulted in occupational radiation exposure; and

(b) That the individual is not available for planned special exposures.

(6) The licensee or registrant shall retain the records on the exposure history form until the department terminates each pertinent license or registration requiring this record. The licensee or registrant shall retain records used in preparing the exposure history form for three years after the record is made.

(F) A planned special exposure may be authorized by a licensee in accordance with this paragraph. A licensee may authorize an adult worker to receive doses in addition to and accounted for separately from the doses received under the limits specified in paragraph (A) of this rule provided that each of the following is satisfied:

(1) The licensee authorizes a planned special exposure only in an exceptional situation when alternatives that might avoid the higher exposure are unavailable or impractical;

(2) The licensee and employer, if the employer is not the licensee, specifically authorizes the planned special exposure, in writing, before the exposure occurs;

(3) Before a planned special exposure, the licensee ensures that each individual involved is:

(a) Informed of the purpose of the planned operation; and

(b) Informed of the estimated doses and associated potential risks and specific radiation levels or other conditions that might be involved in performing the task; and

(c) Instructed in the measures to be taken to keep the dose ALARA considering other risks that may be present;

(4) Prior to permitting an individual to participate in a planned special exposure, the licensee ascertains prior doses as required by paragraph (E)(2) of this rule during the lifetime of the individual for each individual involved;

(5) The licensee shall not authorize a planned special exposure that would cause an individual to receive a dose from all planned special exposures and all doses in excess of the limits to exceed:

(a) The numerical values of any of the dose limits in paragraph (A) of this rule in any calendar year; and

(b) Five times the annual dose limits specified in paragraph (A) of this rule during the individual's lifetime;

(6) The licensee maintains records of the conduct of a planned special exposure in accordance with paragraph (E) of rule 3701:1-38-20 of the Administrative Code and submits a written report in accordance with paragraph (D) of rule 3701:1-38-21 of the Administrative Code;

(7) The licensee records the best estimate of the dose resulting from the planned special exposure in the individual's record and informs the individual, in writing, of the dose within thirty days from the date of the planned special exposure. The dose from planned special exposures shall not be considered in controlling future occupational dose of the individual pursuant to paragraph (A)(1) of this rule, but shall be included in evaluations required by paragraphs (F)(4) and (F)(5) of this rule.

(G) Occupational dose limits for minors shall be ten per cent of the annual occupational dose limits specified for adult workers in paragraph (A) of this rule.

(H) Dose equivalent to an embryo or fetus shall be in accordance with the following:

(1) The licensee or registrant shall ensure that the dose equivalent to an embryo or fetus during the entire pregnancy, due to occupational exposure of a declared pregnant woman, does not exceed five millisievert (0.5 rem). Records shall be maintained in accordance with paragraph (I) of rule 3701:1-38-20 of the Administrative Code.

(2) The licensee or registrant shall make efforts to avoid substantial variation above a uniform monthly exposure rate to a declared pregnant woman so as to satisfy the limit in paragraph (H)(1) of this rule.

(3) The dose equivalent to the embryo or fetus is the sum of:

(a) The deep-dose equivalent to the declared pregnant woman; and

(b) The dose equivalent to the embryo or fetus resulting from radionuclides in the embryo or fetus and from radionuclides in the declared pregnant woman.

(4) If the declared pregnant woman's exposure includes exposure from radiation generating equipment and a protective apron is worn, the dose equivalent to an embryo or fetus shall be taken as the sum of:

(a) The dose equivalent to the embryo or fetus from radionuclides in the embryo or fetus and radionuclides in the declared pregnant woman; and

(b) The dose equivalent that is most representative of the dose to the embryo or fetus from external radiation, that is, in the mother's lower torso region.

(i) If multiple measurements have not been made, assignment of the highest deep dose equivalent for the declared pregnant woman shall be the dose to the embryo or fetus, in accordance with paragraph (A)(4) of this rule; or

(ii) If multiple measurements have been made, assignment of the deep dose equivalent for the declared pregnant woman from the individual monitoring device which is most representative of the dose to the embryo or fetus shall be the dose to the embryo or fetus. Assignment of the highest deep dose equivalent for the declared pregnant woman to the embryo or fetus is not required unless that dose is also the most representative deep dose equivalent for the region of the embryo or fetus.

(5) If by the time the woman declares pregnancy to the licensee or registrant, the dose equivalent to the embryo or fetus has exceeded five millisievert, or 0.5 rem, the licensee or registrant shall be deemed to be in compliance with paragraph (A) of this rule, provided that the additional dose equivalent to the embryo or fetus does not exceed 0.5 millisievert (0.05 rem), during the remainder of the pregnancy.

View AppendixView AppendixView Appendix

Last updated November 2, 2022 at 2:10 PM

History

• Effective: October 4, 2010
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-56-12

Except as otherwise provided, any communication or report required by Chapter 3701:1-56 of the Administrative Code shall be filed in accordance with Chapter 3748. of the Revised Code and rules promulgated thereunder. Documents pertaining to a license application or any license matter, unless otherwise directed in writing, shall be submitted to the director at the following address:

"Ohio Department of Health

Bureau of Environmental Health and Radiation Protection

246 North High Street

Columbus, Ohio 43215"

Last updated August 1, 2023 at 2:51 PM

History

• Effective: August 26, 2016
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-56-10 Material balance, inventory, and records requirements.

(A) As used in this rule, "physical inventory" means determination on a measured basis of the quantity of special nuclear material on hand at a given time. The methods of physical inventory and associated measurements will vary depending on the material to be inventoried and the process involved.

(B)

(1) Each licensee shall keep records showing the receipt, inventory (including location), disposal, acquisition, and transfer of all special nuclear material in their possession regardless of its origin or method of acquisition. Licensees who possess one gram or more of uranium-235, uranium-233, or plutonium must comply with United States nuclear regulatory commission annual reporting requirements listed in 10 CFR 74.13 (as in effect on the effective date of this rule).

(2) Each record that is required by the rules in this chapter or by license condition must be maintained and retained for the period specified by the appropriate rule or license condition. If a retention period is not otherwise specified by regulation or license condition, the licensee shall retain the record until the director terminates each license that authorizes the activity that is subject to the recordkeeping requirement.

(3) Each record of receipt, acquisition, or physical inventory of special nuclear material that must be maintained pursuant to paragraph (B)(1) of this rule must be retained as long as the licensee retains possession of the material and for three years following transfer of such material.

(4) Each record of transfer of special nuclear material to other persons must be retained by the licensee who transferred the material until the director terminates the license authorizing the licensee's possession of the material.

(5) Before license termination, licensees shall forward the following records to the director:

(a) Records of disposal of licensed material made under paragraphs (C), (D), and (F) of rule 3701:1-38-19 of the Administrative Code, including burials authorized before January 28, 1981;

(b) Records required by paragraph (D)(4) of rule 3701:1-38-20 of the Administrative Code; and

(c) Records required by rule 3701:1-56-21 of the Administrative Code.

(6) If licensed activities are transferred or assigned in accordance with paragraph (A)(2) of rule 3701:1-56-04 of the Administrative Code, the licensee shall transfer the following records to the new licensee and the new licensee will be responsible for maintaining these records until the license is terminated:

(a) Records of disposal of licensed material made under paragraphs (C), (D), and (F) of rule 3701:1-38-19 of the Administrative Code, including burials authorized before January 28, 1981;

(b) Records required by paragraph (D)(4) of rule 3701:1-38-20 of the Administrative Code; and

(c) Records required by rule 3701:1-56-21 of the Administrative Code.

Last updated May 23, 2022 at 7:59 AM

History

• Effective: May 23, 2022
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-38-19

(A) A licensee shall dispose of licensed radioactive material in accordance with this rule. Licensed material shall be disposed of in one of the following manners:

(1) By transfer to an authorized recipient as provided in this chapter, Chapter 3701:1-40 of the Administrative Code, or to the United States department of energy;

(2) By decay in storage provided that the radionuclide has a half-life of one hundred twenty days or less, or as otherwise permitted by the license;

(3) By release in effluents within the limits set forth in rule 3701:1-38-13 of the Administrative Code; or

(4) As authorized pursuant to paragraphs (B) to (F) of this rule.

(B) A person shall be specifically licensed to receive waste containing licensed material from another person for:

(1) Treatment prior to disposal;

(2) Treatment or disposal by incineration;

(3) Decay in storage;

(4) Disposal at a land disposal facility licensed pursuant to rules 3701:1-54-06 to 3701:1-54-12 of the Administrative Code or equivalent United States nuclear regulatory commission or agreement state regulations; or

(5) Storage until transfer to a storage or disposal facility authorized to receive the waste.

(C) A licensee or applicant for a license may apply to the director for approval of proposed disposal procedures that are not otherwise authorized in these rules for the disposal of licensed material generated in the licensee's operations. Each application shall include:

(1) A description of the waste containing licensed material to be disposed of, including the physical and chemical properties that have an impact on risk evaluation, and the proposed manner and conditions of waste disposal;

(2) An analysis and evaluation of pertinent information on the nature of the environment;

(3) The nature and location of other potentially affected facilities; and

(4) An analysis and procedures to ensure that doses are maintained ALARA and within the dose limits in rules 3701:1-38-12 and 3701:1-38-13 of the Administrative Code.

(D) A licensee may discharge licensed material into sanitary sewerage as follows:

(1) The material is readily soluble in water or is a biological material that is readily dispersible in water;

(2) The quantity of licensed or other radioactive material that the licensee releases into the sewer in one month divided by the average monthly volume of water released into the sewer by the licensee does not exceed the concentration listed in table III of appendix C to rule 3701:1-38-12 of the Administrative Code; and

(3) If more than one radionuclide is to be released, the following conditions must also be satisfied:

(a) The licensee shall determine the fraction of the limit in table III of appendix C to rule 3701:1-38-12 of the Administrative Code represented by discharges into sanitary sewerage by dividing the actual monthly average concentration of each radionuclide released by the licensee into the sewer by the concentration of that radionuclide listed in table III of appendix C to rule 3701:1-38-12 of the Administrative Code; and

(b) The sum of the fractions for each radionuclide required by paragraph (D)(3)(a) of this rule does not exceed unity.

(4) The total quantity of licensed and other radioactive material that the licensee releases into the sanitary sewerage in a year does not exceed one hundred eighty-five gigabecquerels (five curies) of hydrogen-3, thirty-seven gigabecquerels (one curie) of carbon-14, and thirty-seven gigabecquerels (one curie) of all other radioactive materials combined.

(5) Excreta from an individual undergoing medical diagnosis or therapy with radioactive material is not subject to the limitations contained in paragraph (D) of this rule.

(E) A licensee may dispose of licensed material by decay in storage. A licensee may hold radioactive material with a physical half-life of one hundred twenty days or less for decay-in-storage before disposal as non-radioactive material provided the licensee does the following:

(1) Monitors the material at the container surface prior to disposal and determines that the radioactivity cannot be distinguished from the background radiation level with an appropriate radiation detection survey meter set on its most sensitive scale and with no interposing shielding;

(2) Removes or obliterates all radiation caution labels and symbols, unless otherwise specified in the license; and

(3) Retains a record of the disposal for three years.

(F) A licensee may treat or dispose of licensed material by incineration only in the form and concentration specified in paragraph (G) of this rule or as specifically approved by the director pursuant to paragraph (C) of this rule.

(G) A licensee may dispose of the following licensed material as if it were not radioactive. The licensee shall maintain records in accordance with paragraph (K) of rule 3701:1-38-20 of the Administrative Code.

(1) 1.85 kilobecquerels (0.05 microcurie) or less, of hydrogen-3 or carbon-14 per gram of medium used for liquid scintillation counting; or

(2) 1.85 kilobecquerels (0.05 microcurie) or less, of hydrogen-3 or carbon-14 per gram of animal tissue, averaged over the weight of the entire animal. A licensee shall not dispose of tissue pursuant to this paragraph in a manner that would permit its use either as food for humans or as animal feed.

(H) A licensee shall transfer and dispose of licensed material in accordance with the following:

(1) For transfer of radioactive waste intended for disposal at a licensed radioactive waste disposal facility, establish a manifest tracking system, and supplement existing requirements concerning transfers and recordkeeping for those wastes. Each shipment of radioactive waste designated for disposal at a licensed radioactive waste disposal facility shall be accompanied by a shipment manifest as specified in the appendix to this rule.

(2) Each shipment manifest shall include a certification by the waste generator in accordance with the appendix to this rule.

(3) Each person involved in the transfer of waste for disposal or in the disposal of waste, including the waste generator, waste collector, waste processor, and disposal facility operator, shall comply with the requirements specified in the appendix to this rule.

(I) Nothing in this rule relieves a licensee from complying with other applicable federal, state and local regulations governing any other toxic or hazardous properties of materials that may be disposed of under this rule.

View Appendix

Last updated January 20, 2022 at 8:48 AM

History

• Effective: January 20, 2022
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-38-20

(A) Each licensee or registrant shall use the SI units becquerel, gray, sievert and coulomb per kilogram, or the special units curie, rad, rem and roentgen, including multiples and subdivisions, and shall clearly indicate the units of all quantities on records required by this chapter. The licensee or registrant shall make a clear distinction among the quantities entered on the records such as, total effective dose equivalent, total organ dose equivalent, shallow dose equivalent, lens dose equivalent, deep dose equivalent, or committed effective dose equivalent.

(B) Each licensee or registrant shall maintain records of the radiation protection program, including the provisions of the program and audits and other reviews of program content and implementation. The licensee or registrant shall retain the records of the provisions of the program until the department terminates each license or registration pertinent to the record. The licensee or registrant shall retain all the other records required by this paragraph for three years after the record is made.

(C) Records of surveys showing the results of surveys and calibrations required by paragraph (A) of rule 3701:1-38-14 and paragraph (F) of rule 3701:1-38-18 of the Administrative Code shall be maintained and retained by the licensee or registrant for three years after the record is made.

(D) The licensee or registrant shall retain each of the following records until the department terminates each license or registration pertinent to the record:

(1) Records of the results of surveys to determine the dose from external sources of radiation used, in the absence of or in combination with individual monitoring data, in the assessment of individual dose equivalents;

(2) Records of the results of measurements and calculations used to determine individual intakes of radioactive material and used in the assessment of internal dose;

(3) Records showing the results of air sampling, surveys, and bioassays required pursuant to paragraphs (C)(2)(a) and (C)(2)(b) of rule 3701:1-38-16 of the Administrative Code; and

(4) Records of the results of measurements and calculations used to evaluate the release of radioactive effluents to the environment.

(E) Records of tests for leakage or contamination of sealed sources shall be kept in units of becquerel or microcurie, or multiples thereof, and maintained for inspection by the department for at least three years after the records are made.

(F) Records of prior occupational dose and exposure history as required in paragraph (E) of rule 3701:1-38-12 of the Administrative Code shall be recorded by the licensee or registrant on a form provided by the department entitled "lifetime occupational exposure history" in accordance with the instructions for completing this form, or in clear and legible records containing all the information required by the same form. The licensee or registrant shall maintain these records until the department terminates each license or registration pertinent to this record. The licensee or registrant shall retain records used in preparing the form for three years after the record is made.

(G) Records of planned special exposures as required in paragraph (F) of rule 3701:1-38-12 of the Administrative Code shall be maintained by the licensee:

(1) The licensee shall maintain records that describe the following:

(a) The exceptional circumstances requiring the use of a planned special exposure;

(b) The name of the management official who authorized the planned special exposure and a copy of the signed authorization;

(c) What actions were necessary;

(d) Why the actions were necessary;

(e) What precautions were taken to assure that doses were maintained ALARA;

(f) What individual and collective doses were expected to result; and

(g) The doses actually received in the planned special exposure.

(2) The licensee shall retain the records until the department terminates each license pertinent to these records.

(H) Records of individual dose monitoring results shall be maintained by each licensee or registrant for each individual for whom monitoring is required pursuant to paragraph (B) of rule 3701:1-38-14 of the Administrative Code, and records of doses received during planned special exposures, accidents, and emergency conditions. Assessments of dose equivalent and records made using units in effect before the effective date of these rules need not be changed.

(1) These records shall include, when applicable:

(a) The deep dose equivalent to the whole body, lens dose equivalent, shallow dose equivalent to the skin, and shallow dose equivalent to the extremities;

(b) The estimated intake or radionuclides as provided in paragraph (B) of rule 3701:1-38-12 of the Administrative Code;

(c) The committed effective dose equivalent assigned to the intake of radionuclides; and

(d) The specific information used to calculate the committed effective dose equivalent pursuant to paragraph (D)(8) of rule 3701:1-38-12 of the Administrative Code; and

(e) The total effective dose equivalent when required by paragraph (B) of rule 3701:1-38-12 of the Administrative Code; and

(f) The total of the deep dose equivalent and the committed dose to the organ receiving the highest total dose.

(2) The licensee or registrant shall make entries of the records specified in paragraph (H) of this rule at least annually.

(I) Each licensee or registrant shall maintain the records specified in paragraph (H) of this rule on department form entitled "occupational exposure record for a monitoring period" in accordance with the instructions for completing this form, or in clear and legible records containing all the information required by the same form. The licensee or registrant shall maintain the records of dose to an embryo or fetus with the records of dose to the declared pregnant woman. The declaration of pregnancy shall also be kept on file, but may be maintained separately from the dose records. The licensee or registrant shall retain each required form or record until the department terminates each license or registration pertinent to the record.

(J) Each licensee or registrant shall maintain records sufficient to demonstrate compliance with the dose limits for individual members of the public specified in paragraph (A) of rule 3701:1-38-13 of the Administrative Code. Each licensee or registrant shall retain the records required by paragraph (H) of this rule until the department terminates each license or registration pertinent to the record.

(K) Records of the disposal of licensed material shall be maintained by each licensee in accordance with paragraphs (C), (D), (F), and (G) of rule 3701:1-38-19, and Chapter 3701:1-54 of the Administrative Code. The licensee shall retain the records required by this paragraph until the department terminates each pertinent license that requires the record.

(L) Records of tests performed on entry control devices located in a very high radiation area shall be maintained by each licensee in accordance with Chapter 3701:1-52 of the Administrative Code or registrant in accordance with Chapters 3701:1-66, 3701:1-67, and 3701:1-68 of the Administrative Code. These records must include the date, time, and results of each such test of function. The licensee or registrant shall retain the records required by this paragraph for at least three years after the record is made.

(M) Each record required by this chapter shall be legible throughout the specified retention period. The record shall be the original or a reproduced copy or a microform, provided that the copy or microform is authenticated by authorized personnel and that the microform is capable of producing a clear copy throughout the required retention period. The record may also be stored in electronic media with the capability for producing legible, accurate, and complete records during the required retention period. Records, such as letters, drawings, and specifications, shall include all pertinent information, such as stamps, initials, and signatures. The licensee or registrant shall maintain adequate safeguards against tampering with and loss of records.

Last updated January 20, 2022 at 8:48 AM

History

• Effective: January 20, 2022
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-56-21

(A) Each specific license expires at the end of the day on the expiration date stated in the license unless the licensee has filed an application for renewal under rule 3701:1-38-02 of the Administrative Code not less than ninety days before the expiration date stated in the existing license. If an application for renewal has been filed at least ninety days before the expiration date stated in the existing license, the existing license expires at the end of the day on which the director makes a final determination to deny the renewal application or, if the determination states an expiration date, the expiration date stated in the determination.

(B) Each specific license revoked by the director expires at the end of the day on the date of the director's final determination to revoke the license, or on the expiration date stated in the determination, or as otherwise provided by a director's order.

(C) Each specific license continues in effect, beyond the expiration date if necessary, with respect to possession of special nuclear material until the director notifies the licensee in writing that the license is terminated. During this time, the licensee shall:

(1) Limit actions involving special nuclear material to those related to decommissioning; and

(2) Continue to control entry to restricted areas until they are suitable for release in accordance with department requirements.

(D) Within sixty days of the occurrence of any of the following, consistent with the administrative directions in rule 3701:1-56-12 of the Administrative Code, each licensee shall provide notification to the director in writing and either begin decommissioning its site, or any separate building or outdoor area that contains residual radioactivity, so that the building or outdoor area is suitable for release in accordance with department requirements, or submit within twelve months of notification a decommissioning plan, if required by paragraph (G)(1) of this rule, and begin decommissioning upon approval of that plan if:

(1) The license has expired pursuant to paragraph (A) or (B) of this rule;

(2) The licensee has decided to permanently cease principal activities at the entire site or in any separate building or outdoor area;

(3) No principal activities under the license have been conducted for a period of twenty-four months; or

(4) No principal activities have been conducted for a period of twenty-four months in any separate building or outdoor area that contains residual radioactivity such that the building or outdoor area is unsuitable for release in accordance with department requirements.

(E) Coincident with the notification required by paragraph (D) of this rule, the licensee shall maintain in effect all decommissioning financial assurances established by the licensee pursuant to rule 3701:1-56-20 of the Administrative Code in conjunction with a license issuance or renewal or as required by this rule. The amount of the financial assurance must be increased, or may be decreased, as appropriate, to cover the detailed cost estimate for decommissioning established pursuant to paragraph (G)(4)(e) of this rule. Following approval of the decommissioning plan, a licensee may reduce the amount of the financial assurance as decommissioning proceeds and radiological contamination is reduced at the site with the approval of the director.

(F) The director may grant a request to delay or postpone initiation of the decommissioning process if the director determines that such relief is not detrimental to the public health and safety and is otherwise in the public interest. The request must be submitted no later than thirty days before notification pursuant to paragraph (D) of this rule. The schedule for decommissioning set forth in paragraph (D) of this rule may not commence until the director has made a determination on the request.

(G)

(1) A decommissioning plan must be submitted if required by license condition or if the procedures and activities necessary to carry out decommissioning of the site or separate building or outdoor area have not been previously approved by the director and these procedures could increase potential health and safety impacts to workers or to the public, such as in any of the following cases:

(a) Procedures would involve techniques not applied routinely during cleanup or maintenance operations;

(b) Workers would be entering areas not normally occupied where surface contamination and radiation levels are significantly higher than routinely encountered during operation;

(c) Procedures could result in significantly greater airborne concentrations of radioactive materials than are present during operation; or

(d) Procedures could result in significantly greater releases of radioactive material to the environment than those associated with operation.

(2) The director may approve an alternate schedule for submittal of a decommissioning plan required pursuant to paragraph (D) of this rule if the director determines that the alternative schedule is necessary to the effective conduct of decommissioning operations and presents no undue risk from radiation to the public health and safety and is otherwise in the public interest.

(3) The procedures listed in paragraph (G)(1) of this rule may not be carried out prior to approval of the decommissioning plan.

(4) The proposed decommissioning plan for the site or separate building or outdoor area must include:

(a) A description of the conditions of the site or separate building or outdoor area sufficient to evaluate the acceptability of the plan;

(b) A description of planned decommissioning activities;

(c) A description of methods used to ensure protection of workers and the environment against radiation hazards during decommissioning;

(d) A description of the planned final radiation survey;

(e) An updated detailed cost estimate for decommissioning, comparison of that estimate with present funds set aside for decommissioning, and a plan for assuring the availability of adequate funds for completion of decommissioning; and

(f) For decommissioning plans calling for completion of decommissioning later than twenty-four months after plan approval, a justification for the delay based on the criteria in paragraph (I) of this rule.

(5) The proposed decommissioning plan will be approved by the director if the information therein demonstrates that the decommissioning will be completed as soon as practicable and that the health and safety of workers and the public will be adequately protected.

(H)

(1) Except as provided in paragraph (I) of this rule, licensees shall complete decommissioning of the site or separate building or outdoor area as soon as practicable but no later than twenty-four months following the initiation of decommissioning.

(2) Except as provided in paragraph (I) of this rule, when decommissioning involves the entire site, the licensee shall request license termination as soon as practicable but no later than twenty-four months following the initiation of decommissioning.

(I) The director may approve a request for an alternate schedule for completion of decommissioning of the site or separate building or outdoor area, and license termination if appropriate, if the director determines that the alternative is warranted by consideration of the following:

(1) Whether it is technically feasible to complete decommissioning within the allotted twenty-four month period;

(2) Whether sufficient waste disposal capacity is available to allow completion of decommissioning within the allotted twenty-four month period;

(3) Whether a significant volume reduction in wastes requiring disposal will be achieved by allowing short-lived radionuclides to decay;

(4) Whether a significant reduction in radiation exposure to workers can be achieved by allowing short-lived radionuclides to decay; and

(5) Other site-specific factors which the director may consider appropriate on a case-by-case basis, such as the regulatory requirements of other government agencies, lawsuits, ground-water treatment activities, monitored natural ground-water restoration, actions that could result in more environmental harm than deferred cleanup, and other factors beyond the control of the licensee.

(J) As the final step in decommissioning, the licensee shall:

(1) Certify the disposition of all licensed material, including accumulated wastes, by submitting a completed form HEA 5119 or equivalent information; and

(2) Conduct a radiation survey of the premises where the licensed activities were carried out and submit a report of the results of this survey, unless the licensee demonstrates in some other manner that the premises are suitable for release in accordance with the criteria for decommissioning in rule 3701:1-38-22 of the Administrative Code. The licensee shall, as appropriate:

(a) Report levels of gamma radiation in units of millisieverts (microroentgen) per hour at one meter from surfaces, and report levels of radioactivity, including alpha and beta, in units of megabecquerels (disintegrations per minute or microcuries) per one hundred square centimeters removable and fixed for surfaces, megabecquerels (microcuries) per milliliter for water, and becquerels (picocuries) per gram for solids such as soils or concrete; and

(b) Specify the survey instrument(s) used and certify that each instrument is properly calibrated and tested.

(K) Specific licenses, including expired licenses, will be terminated by written notice to the licensee when the director determines that:

(1) Special nuclear material has been properly disposed;

(2) Reasonable effort has been made to eliminate residual radioactive contamination, if present; and

(3)

(a) A radiation survey has been performed which demonstrates that the premises are suitable for release in accordance with the criteria for decommissioning in rule 3701:1-38-22 of the Administrative Code; or

(b) Other information submitted by the licensee is sufficient to demonstrate that the premises are suitable for release in accordance with the criteria for decommissioning in rule 3701:1-38-22 of the Administrative Code.

(4) Records required by paragraph (B)(5) of rule 3701:1-56-10 of the Administrative Code have been received.

(L) As used in this rule, "principal activities" means activities authorized by the license which are essential to achieving the purpose(s) for which the license was issued or amended. Storage during which no licensed material is accessed for use or disposal and activities incidental to decontamination or decommissioning are not principal activities.

Last updated May 23, 2022 at 8:00 AM

History

• Effective: May 23, 2022
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-56-11 License requirements.

A person subject to the rules in Chapter 3701:1-56 of the Administrative Code may not receive title to, own, acquire, deliver, receive, possess, use, or transfer special nuclear material unless authorized in a specific or general license issued by the director under the rules in Chapter 3701:1-56 of the Administrative Code.

Last updated August 1, 2023 at 2:51 PM

History

• Effective: September 1, 2012
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-56-13 Completeness and accuracy of information.

(A) Information provided to the director by an applicant for a license or by a licensee or information required by statute or by the department's rules, orders, or license conditions to be maintained by the applicant or the licensee shall be complete and accurate in all material respects.

(B) Each applicant or licensee shall notify the director of information identified by the applicant or licensee as having for the regulated activity a significant implication for public health and safety or common defense and security. An applicant or licensee violates this paragraph only if the applicant or licensee fails to notify the director of information that the applicant or licensee has identified as having a significant implication for public health and safety or common defense and security. Notification shall be provided to the director within two working days of identifying the information. This requirement is not applicable to information which is already required to be provided to the director by other reporting or updating requirements.

Last updated August 1, 2023 at 2:51 PM

History

• Effective: September 1, 2012
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-56-16 Specific exemptions.

(A) The director may, upon application of any interested person or upon its own initiative, grant such exemptions from the requirements of the rules in Chapter 3701:1-56 of the Administrative Code as the director determines are authorized by law and will not endanger life or property or the common defense and security and are otherwise in the public interest.

(B) The United States department of energy is exempt from the requirements of Chapter 3701:1-56 of the Administrative Code.

(C) Except as specifically provided in Chapter 3701:1-54 of the Administrative Code, any licensee is exempt from the requirements of Chapter 3701:1-56 of the Administrative Code to the extent that its activities are subject to the requirements of Chapter 3701:1-54 of the Administrative Code.

Last updated August 1, 2023 at 2:51 PM

History

• Effective: September 1, 2012
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-56-17 Types of licenses.

Licenses for special nuclear material are of two types: general and specific. The general licenses provided in rules 3701:1-56-02 and 3701:1-56-03 of the Administrative Code are effective without the filing of applications with the director or the issuance of licensing documents to particular persons. Specific licenses are issued to named persons upon applications filed pursuant to rule 3701:1-38-02 of the Administrative Code.

Last updated May 23, 2022 at 8:00 AM

History

• Effective: May 23, 2022
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-56-18 Requirements for the approval of applications.

An application for a specific license will be approved if:

(A) The application is for a purpose authorized by Chapter 3748. of the Revised Code and the rules promulgated thereunder;

(B) The applicant is qualified by reason of training and experience to use the material for the purpose requested in accordance with the rules in this chapter;

(C) The applicant's proposed equipment and facilities are adequate to protect health and minimize danger to life or property;

(D) The applicant's proposed procedures to protect health and to minimize danger to life or property are adequate; and

(E) Where the nature of the proposed activities is such as to require consideration by the director, the applicant is financially qualified to engage in the proposed activities in accordance with the rules in this chapter.

Last updated August 1, 2023 at 2:51 PM

History

• Effective: September 1, 2012
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-40-17

(A) Prior to the director issuing a radioactive materials license:

(1) Each applicant for a specific license or license renewal authorizing the possession and use of unsealed radioactive material of half-life greater than one hundred twenty days and in quantities exceeding ten thousand times the applicable quantities set forth in appendix A to this rule shall submit a decommissioning funding plan as described in paragraph (D) of this rule. The decommissioning funding plan must also be submitted when a combination of radionuclides is involved if R divided by ten thousand is greater than one, where R is defined here as the sum of the ratios of the quantity of each radionuclide to the applicable value in appendix A to this rule.

(2) Each applicant for a specific license or license renewal authorizing the possession and use of sealed sources or plated foils of half-life greater than one hundred twenty days and in quantities exceeding one trillion times the applicable quantities of appendix A to this rule, shall submit a decommissioning funding plan as described in paragraph (D) of this rule. The decommissioning funding plan must also be submitted when a combination of radionuclides is involved if R divided by one trillion is greater than one, where R is defined here as the sum of the ratios of the quantity of each radionuclide to the applicable value in appendix A to this rule.

(B) Prior to the director issuing a radioactive materials license, each applicant for a specific license or license renewal authorizing possession and use of radioactive material of half-life greater than one hundred twenty days and in quantities specified in paragraph (C) of this rule shall either:

(1) Submit a decommissioning funding plan as described in paragraph (D) of this rule; or

(2) Submit a certification that financial assurance for decommissioning has been provided in the amount prescribed by paragraph (C) of this rule using one of the methods described in paragraph (E) of this rule. The applicant shall submit to the director, as part of the certification, a signed original of the financial instrument obtained to satisfy the requirements of paragraph (E) of this rule.

(C) Prior to the director issuing a radioactive materials license, an applicant providing certification of financial assurance for decommissioning as specified in paragraph (B)(2) of this rule shall provide the certification in a monetary amount based upon the quantity of licensed material specified as follows:

(1) Greater than one thousand but less than or equal to ten thousand times the applicable quantities of appendix A to this rule in unsealed form. For a combination of radionuclides, if R, as defined in paragraph (A) of this rule, divided by one thousand is greater than one but R divided by ten thousand is less than or equal to one, the sum of three hundred thousand dollars.

(2) Greater than ten billion but less than one trillion times the applicable quantities of appendix A to this rule in sealed sources or plated foils. For a combination of radionuclides, if R, as defined in paragraph (A) of this rule, divided by ten billion is greater than one but R divided by one trillion is less than or equal to one, the sum of one hundred fifty thousand dollars.

(D) .

(1) Each decommissioning funding plan must be submitted for review and approval and must contain:

(a) A detailed cost estimate for decommissioning, in an amount reflecting:

(i) The cost of an independent contractor to perform all decommissioning activities;

(ii) The cost of meeting the criteria specified in paragraph (B) of rule 3701:1-38-22 of the Administrative Code for unrestricted use, provided that, if the applicant or licensee can demonstrate its ability to meet the provisions of paragraph (D) of rule 3701:1-38-22 of the Administrative Code, the cost estimate may be based on meeting this criteria;

(iii) The volume of onsite subsurface material containing residual radioactivity that will require remediation to meet the criteria for license termination; and

(iv) An adequate contingency factor.

(b) Identification of and justification for using the key assumptions contained in the decommissioning cost estimate;

(c) A description of the method of assuring funds for decommissioning from paragraph (E) of this rule, including means for adjusting cost estimates and associated funding levels periodically over the life of the facility;

(d) A certification by the licensee that financial assurance for decommissioning has been provided in the amount of the cost estimate for decommissioning; and

(e) A signed original of the financial instrument obtained to satisfy the requirements of paragraph (E) of this rule (unless a previously submitted and accepted financial instrument continues to cover the cost estimate for decommissioning).

(2) At the time of license renewal and at intervals not to exceed three years, the decommissioning funding plan must be resubmitted with adjustments as necessary to account for the changes in costs and the extent of contamination. If the amount of financial assurance will be adjusted downward, this cannot be done until the updated decommissioning funding plan is approved. The decommissioning funding plan must update the information submitted with the original or prior approved plan, and must specifically consider the effect of the following events on decommissioning costs:

(a) Spills of radioactive material producing additional residual radioactivity in onsite subsurface material;

(b) Waste inventory increasing above the amount previously estimated;

(c) Waste disposal costs increasing above the amount previously estimated;

(d) Facility modifications;

(e) Changes in authorized possession limits;

(f) Actual remediation costs that exceed the previous cost estimate;

(g) Onsite disposal; and

(h) Use of a settling pond.

(E) Financial assurance for decommissioning, either by a decommissioning funding plan or certification of financial assurance, shall be provided by the licensee and approved by the director prior to the issuance of the license and shall be provided by one or more of the following methods:

(1) Prepayment by depositing into an account segregated from licensee assets and outside the licensee's administrative control, cash or liquid assets such that the amount of funds will be sufficient to pay decommissioning costs. Prepayment may be in the form of a trust, escrow account, government fund, certificate of deposit, or deposit of government securities.

(2) Surety, insurance, or other method in accordance with paragraph (F) of this rule, that guarantees that decommissioning costs will be paid. A surety method may be in the form of a surety bond, letter of credit, or line of credit. A guarantee by the applicant or licensee may not be used in combination with any other financial methods used to satisfy the requirements of this paragraph or in any situation where the applicant or licensee has a parent company holding majority control of the voting stock of the company.

(3) A parent company guarantee of funds for decommissioning costs based on a financial test may be used provided that the parent company meets the requirements specified in appendix B of this rule. A parent company guarantee may not be used in combination with other financial methods to satisfy the requirements of this rule.

(4) For commercial corporations that issue bonds, a guarantee of funds by the applicant or licensee for decommissioning costs based on a financial test may be used provided that the guarantee meets the requirements of appendix C to this rule.

(5) For commercial companies that do not issue bonds, a guarantee of funds for decommissioning costs may be used provided that the guarantee meets the requirements of appendix D to this rule.

(6) For nonprofit colleges, universities, hospitals, or research and development entities, a guarantee of funds for decommissioning costs may be used provided that the guarantee meets the requirements of appendix E to this rule. The director may require proof of nonprofit status.

(7) An external sinking fund in which deposits are made at least annually, coupled with a surety method or insurance, the value of which may decrease by the amount being accumulated in the sinking fund. An external sinking fund is a fund established and maintained by setting aside funds periodically in an account segregated from licensee assets and outside the licensee's administrative control in which the total amount of funds would be sufficient to pay decommissioning costs at the time termination of operation is expected. An external sinking fund may be in the form of a trust, escrow account, government fund, certificate of deposit, or deposit of government securities. The surety or insurance provisions must be as stated in paragraph (F) of this rule.

(8) In the case of state or local government licensee, a statement of intent containing a cost estimate for decommissioning or an amount specified in paragraphs (C)(1) to (C)(2) of this rule, and indicating that funds for decommissioning will be obtained when necessary. As used in this rule, "state or local government licensee" does not include government owned or assisted colleges, universities or hospitals.

(F) Any surety method or insurance used to provide financial assurance for decommissioning shall be in the form of instruments that contain language as provided in appendix F to this rule, and shall contain the following conditions:

(1) The surety method or insurance must be open-ended or, if written for a specified term, such as five years, must be renewed automatically unless ninety days or more prior to the renewal date, the issuer notifies the director, the beneficiary, and the licensee of its intention not to renew. The surety method or insurance must also provide that the full face amount be paid to the beneficiary automatically prior to the expiration without proof of forfeiture if the licensee fails to provide a replacement acceptable to the director within thirty days after receipt of notification of cancellation.

(2) The surety method or insurance must be payable to a trust established for decommissioning costs. The trustee and trust must be acceptable to the director. An acceptable trustee includes an appropriate state or federal government agency or an entity which has the authority to act as a trustee and whose trust operations are regulated and examined by a federal or state agency.

(3) The surety method or insurance must remain in effect until the director has terminated the license.

(4) The surety company issuing the bond must, at a minimum, be among those listed as acceptable in the "Circular 570" of the United States department of the treasury (as in effect on the effective date of this rule).

(G) A licensee must notify the director by certified mail within ten business days of the commencement of a voluntary or involuntary bankruptcy proceeding under Title 11 of the United States Code (as amended April 20, 2005). A licensee who fulfills the financial assurance requirements by obtaining a trust fund, surety bond, or other acceptable financial assurance will be deemed to be without the required financial assurance or liability coverage in the event of bankruptcy of the trustee or issuing institution, or a suspension or revocation of the authority of the trustee institution issuing the instrument. The licensee shall establish other financial assurance within sixty days after such an event.

(H) Financial assurance for decommissioning, either by a decommissioning funding plan or certification of financial assurance, that is provided by a contract of insurance shall not include any arrangement that constitutes self-insurance. As used in this rule:

(1) "Insurance" means a contract issued or underwritten by an insurance company, insurance service, or insurance organization which is licensed to engage in the business of insurance in Ohio, that binds the insurer to indemnify another against a specified loss in return for premiums paid.

(2) "Self insurance" means a contract of insurance issued either by the licensee or by an insurer affiliated with or an affiliate of the licensee.

(3) "Affiliate of" or "affiliated with" means that the licensee, either directly or indirectly, through one or more intermediaries or subsidiaries, controls, is controlled by, or is under common control with the insurer.

(4) "Control", including "controlled by", and "under common control with" means the possession, direct or indirect, of the power to direct or cause the direction of the management and policies of a person, whether through the ownership of voting securities, by contract, proxy, membership on the board, or otherwise.

(I) Each person licensed under this chapter, and rule 3701:1-38-02 of the Administrative Code as well as chapters containing rules regarding manufacturing and distribution (Chapter 3701:1-46 of the Administrative Code), industrial radiography (Chapter 3701:1-48 of the Administrative Code), well logging Chapter 3701:1-49 of the Administrative Code), irradiators (Chapter 3701:1-52 of the Administrative Code), and medical use (Chapter 3701:1-58 of the Administrative Code) promulgated pursuant to Chapter 3748. of the Revised Code shall keep records of information important to the decommissioning of a facility in an identified location until the site is released for unrestricted use. Before licensed activities are transferred or assigned in accordance with paragraph (B) of rule 3701:1-40-20 of the Administrative Code, a licensee shall transfer all records described in this paragraph to the new licensee, which will be responsible for maintaining these records until the license is terminated. If records important to the decommissioning of a facility are kept for other purposes, reference to these records and their locations may be used. As used in this rule, "information important to the decommissioning of a facility" includes the following:

(1) Records of spills or other unusual occurrences involving the spread of contamination in and around the facility, equipment, or site. These records may be limited to instances when contamination remains after any cleanup procedures or when there is reasonable likelihood that contaminants may have spread to inaccessible areas as in the case of possible seepage into porous materials such as concrete. These records must include any known information on identification of involved radionuclides, quantities, forms, and concentrations.

(2) As-built drawings and modifications of structures and equipment in restricted areas where radioactive materials are used or stored, and of locations of possible inaccessible contamination such as buried pipes which may be subject to contamination. If required drawings are referenced, each relevant document need not be indexed individually. If drawings are not available, the licensee shall substitute appropriate records of available information concerning these areas and locations.

(3) Except in the case of an area that contains only a sealed source, provided the source has not leaked or no contamination remains after any leak, or in the case of a byproduct or accelerator produced material having only a half-life of less than sixty-five days, a list contained in a single document and updated every two years, of the following:

(a) All areas designated and formerly designated restricted areas as defined in rule 3701:1-38-01 of the Administrative Code.

(b) All areas outside of restricted areas that require documentation under paragraph (I)(1) of this rule.

(c) All areas outside of restricted areas where current and previous wastes have been buried as documented under rule 3701:1-38-20 of the Administrative Code; and

(d) All areas outside of restricted areas that contain material such that, if the license expired, the licensee would be required to either decontaminate the area to meet the criteria for decommissioning in rule 3701:1-38-22 of the Administrative Code, or apply for approval for disposal under rule 3701:1-38-19 of the Administrative Code.

(4) Records of the cost estimate performed for the decommissioning funding plan or of the amount certified for decommissioning, and records of the funding method used for assuring funds if either a funding plan or certification is used.

View AppendixView AppendixView AppendixView AppendixView AppendixView Appendix

Last updated April 19, 2022 at 8:35 AM

History

• Effective: April 17, 2022
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-38-22

(A) This rule applies to the decommissioning of facilities licensed under Chapter 3748. of the Revised Code. For low-level waste disposal facilities, this rule applies only to ancillary surface facilities that support radioactive waste disposal activities. This rule does not apply to uranium and thorium recovery facilities already subject to source material licensing requirements in Chapter 3701:1-44 of the Administrative Code or to uranium solution extraction facilities.

(B) Decommissioning with license termination shall be limited to sites considered acceptable for unrestricted release where the residual radioactivity that is distinguishable from background radiation results in a total effective dose equivalent (TEDE) to an average member of the critical group that does not exceed 0.25 millisievert (twenty-five millirem) per year, including that from groundwater sources of drinking water, and the residual radioactivity has been reduced to levels that are as low as reasonably achievable (ALARA). Determination of the levels which are ALARA must take into account consideration of detriments, such as deaths from transportation accidents, expected to potentially result from decontamination and waste disposal.

(C) After a facility has been decommissioned and the license terminated in accordance with the criteria in this rule, the director will require additional cleanup only if, based on new information, it is determined that the criteria of this rule were not met and residual radioactivity remaining at the site could result in a significant threat to public health and safety. When calculating TEDE to the average member of the critical group the licensee shall determine the peak annual TEDE dose expected within the first one thousand years after decommissioning.

(D) A licensee may decommission a facility and maintain a decommissioning possession only license using alternate criteria greater than the dose criterion specified in paragraph (B) of this rule, provided that the licensee:

(1) Provides assurance that public health and safety would continue to be protected, and that it is unlikely that the dose from all man-made sources combined, other than medical, would be more than the one millisievert (one hundred millirem) per year limit set forth in this chapter, by submitting an analysis of possible sources of exposure;

(2) Has employed, to the extent practicable, restrictions on site use in minimizing exposures at the site;

(3) Reduces doses to ALARA levels, taking into consideration any detriments, such as traffic accidents expected to potentially result from decontamination and waste disposal; and

(4) Has submitted a decommissioning plan or license termination plan (LTP) to the director indicating the licensee's intent to decommission in accordance with rule 3701:1-40-18 of the Administrative Code, and specifying that the licensee proposes to decommission by restricting use of the site. The licensee shall document in the decommissioning plan or LTP how the advice of individuals and institutions in the community who may be affected by the decommissioning has been sought and incorporated, as appropriate, following analysis of that advice. In seeking such advice, the licensee shall provide for:

(a) Participation by representatives of a broad cross section of community interests who may be affected by the decommissioning;

(b) An opportunity for a comprehensive, collective discussion on the issues by the participants represented; and

(c) A publicly available summary of the results of all such discussions, including a description of the individual viewpoints of the participants on the issues and the extent of agreement and disagreement among the participants on the issues.

(5) Has provided sufficient financial assurance in the form of a trust fund to enable an independent third party, including a governmental custodian of a site, to assume and carry out responsibilities for any necessary control and maintenance of the site.

(E) When a decommissioning with restrictions is proposed by a licensee, a decommissioning possession only license is required to assure that the provisions of the decommissioning plan as approved by the director remain effective. The license will contain a condition that the director will not require further cleanup unless he or she determines that the criteria of this rule or terms of the license were not met or that residual radioactivity at the site could result in a significant threat to public health and safety.

(F) Any facility that has been decommissioned and has had the United States nuclear regulatory commission license terminated in accordance with a plan approved by the commission on or before August 31, 1999, will not be required to obtain a license or conduct further cleanup unless the director determines that residual radioactivity at the site could result in a significant threat to the public health and safety.

(G) Applicants for licenses, other than renewals, shall describe in the application how facility design and procedures for operation will minimize, to the extent practical, contamination of the facility and the environment, facilitate eventual decommissioning, and minimize, to the extent practical, the generation of radioactive waste.

(H) Licensees shall, to the extent practical, conduct operations to minimize the introduction of residual radioactivity into the site, including the subsurface, in accordance with the existing radiation protection requirements in rule 3701:1-38-11 of the Administrative Code and radiological criteria for license termination in accordance with this rule.

Last updated November 2, 2022 at 2:10 PM

History

• Effective: August 30, 2015
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-38-01

(A) As used in this chapter and all other rules promulgated pursuant to Chapter 3748. of the Revised Code:

(1) "A₁" means the maximum activity of special form radioactive material permitted in a type A package. These values are listed in rule 3701:1-50-25 of the Administrative Code, or may be derived in accordance with the procedure prescribed in rule 3701:1-50-25 of the Administrative Code.

(2) "A₂" means the maximum activity of radioactive material, other than special form, low specific activity and surface contaminated object material, permitted in a type A package. These values are listed in rule 3701:1-50-25 of the Administrative Code, or may be derived in accordance with the procedure prescribed in rule 3701:1-50-25 of the Administrative Code.

(3) "Absorbed dose" means the energy imparted by ionizing radiation per unit mass of irradiated material. The units of absorbed dose are the gray, or Gy, and the rad.

(4) "Accelerator or charged particle accelerator" means any of a class of radiation generating equipment designed to electronically accelerate atomic or sub-atomic particles for subsequent bombardment of targets.

(5) "Accelerator-produced radioactive material" means any material made radioactive by a particle accelerator.

(6) "Activity" means the rate of disintegration or transformation or decay of radioactive material. The units of activity are the becquerel, or Bq, and the curie, or Ci.

(7) "Address of use" means the building or buildings that are identified on the license or registration and where the source of radiation may be received, used, prepared, or stored, except for temporary job sites.

(8) "Administrative controls" means mechanisms used to protect health and minimize damage to life and property through the use of written policies, procedures, instructions, training, observation of work practices, and related compliance audits.

(9) "Administrative monetary penalty" means a monetary penalty assessed by the director under section 3748.05 of the Revised Code and in compliance with rules adopted thereunder, to emphasize the need for lasting remedial action and to deter future violations.

(10) "Adult" means an individual eighteen or more years of age.

(11) "Agreement state" means any state with which the United States nuclear regulatory commission or the atomic energy commission has entered into an effective agreement under subsection 274B of the Atomic Energy Act of 1954, 68 Stat. 919, 42 U.S.C. 2021, as amended (1978). Non-agreement state means any other state.

(12) "Airborne radioactive material" means radioactive material dispersed in the air in the form of dusts, fumes, particulates, mists, vapors, or gases.

(13) "Airborne radioactivity area" means a room, enclosure, or area in which airborne radioactive materials, composed wholly or partly of licensed material, exist in concentrations:

(a) In excess of the derived air concentrations (DACs) specified in appendix C to rule 3701:1-38-12 of the Administrative Code, or

(b) To such a degree that an individual present in the area without respiratory protective equipment could exceed, during the hours an individual is present in a week, an intake of 0.6 per cent of the annual limit on intake or twelve DAC-hours.

(14) "Air-purifying respirator" means a respirator with an air-purifying filter, cartridge, or canister that removes specific air contaminants by passing ambient air through the air-purifying element.

(15) "ALARA" or "as low as is reasonably achievable" means every reasonable effort to maintain exposures to radiation as far below the dose limits as is practical consistent with the purpose for which the licensed or registered activity is undertaken, taking into account the state of technology, the economics of improvements in relation to benefits to the public health and safety, and other societal and socioeconomic considerations, and in relation to utilization of nuclear energy and licensed materials and registered activities in the public interest.

(16) "Alert" means events may occur, are in progress, or have occurred that could lead to a release of radioactive material but that the release is not expected to require a response by off-site response organizations to protect persons off-site.

(17) "Annual limit on intake" or "ALI" means the derived limit for the amount of radioactive material taken into the body of an adult worker by inhalation or ingestion in a year. ALI is the smaller value of intake of a given radionuclide in a year by the reference man that would result in a committed effective dose equivalent of 0.05 sievert (five rem) or a committed dose equivalent of 0.5 sievert (fifty rem) to any individual organ or tissue. ALI values for intake by ingestion and by inhalation of selected radionuclides are given in appendix C to rule 3701:1-38-12 of the Administrative Code.

(18) "Annually" means either

(a) At intervals not to exceed one year; or

(b) Once per year, at about the same time each year, plus or minus one month.

(19) "Area of use" means a portion of an address of use that has been set aside for the purpose of receiving, preparing, using, or storing sources of radiation.

(20) "Assigned protection factor" or "APF" means the expected workplace level of respiratory protection that would be provided by a properly functioning respirator or a class of respirators to properly fitted and trained users. Operationally, the inhaled concentration can be estimated by dividing the ambient airborne concentration by the APF.

(21) "Atmosphere-supplying respirator" means a respirator that supplies the respirator user with breathing air from a source independent of the ambient atmosphere, and includes supplied air respirators, or SARs, and self-contained breathing apparatus, or SCBA, units.

(22) "Atomic energy commission" or "AEC" means the federal agency created by the Atomic Energy Act of 1954, 68 Stat. 919, 42 U.S.C. 2011, as amended (1964), and was the predecessor agency to the current United States nuclear regulatory commission.

(23) "Background radiation" means radiation from cosmic sources; naturally occurring radioactive materials, including radon, except as a decay product of source or special nuclear material, and global fallout as it exists in the environment from the testing of nuclear explosive devices or from past nuclear accidents such as Chernobyl that contribute to background radiation and are not under the control of the licensee. "Background radiation" does not include radiation from radioactive materials regulated by the department.

(24) "Becquerel" or "Bq" means the SI unit of activity. One becquerel is equal to one disintegration per second.

(25) "Bioassay" or "radiobioassay" means the determination of kinds, quantities or concentrations, and, in some cases, the locations of radioactive material in the human body, whether by direct measurement, in vivo counting, or by analysis and evaluation of materials excreted or removed from the human body.

(26) "Byproduct material" means

(a) Any radioactive material, except special nuclear material, yielded in or made radioactive by exposure to the radiation incident to the process of producing or utilizing special nuclear materials; or

(b) The tailings or wastes produced by the extraction or concentration of uranium or thorium from any ore processed primarily for its source material content, including discrete surface wastes resulting from solution extraction processes. Underground ore bodies depleted by such solution extraction do not constitute byproduct material within the definition.

(27) "Chelating agent" means a chemical compound or mixture that enhances the removal of radioactive material from the body, water or similar applications. Typical chelating agents include amine polycarboxylic acids such as EDTA or DTPA; hydroxy-carboxylic acids; and polycarboxylic acids such as citric acid, carbolic acid, and gluconic acid.

(28) "Chiropractor" means an individual licensed by the state of Ohio to practice chiropractic medicine pursuant to Chapter 4734. of the Revised Code.

(29) "Class" or "lung class" or "inhalation class" means a classification scheme for inhaled material according to its rate of clearance from the pulmonary region of the lung. Materials are classified as D, W, or Y, which applies to a range of clearance half-times: for class D, days, of less than ten days, for class W, weeks, from ten to one hundred days, and for class Y, years, of greater than one hundred days.

(30) "Collective dose" means the sum of the individual doses received in a given period of time by a specified population from exposure to a specified source of radiation.

(31) "Commencement of construction" means taking any action defined as "construction" or any other activity at the site of a facility subject to the rules promulgated pursuant to Chapter 3748. of the Revised Code that has a reasonable nexus to radiological health and safety.

(32) "Committed dose equivalent" or "H_T,50" means the dose equivalent to organs or tissues of reference, T, that will be received from an intake of radioactive material by an individual during the fifty year period following the intake.

(33) "Committed effective dose equivalent" or "H_E,50" means the sum of the products of the weighting factors applicable to each of the body organs or tissues, W_T, that are irradiated and the committed dose equivalent to each of these organs or tissues (H_{E, 50} = W_TH_T,50).

(34) "Consortium" means an association of medical use licensees and a PET radionuclide production facility in the same geographical area that jointly own or share in the operation and maintenance cost of the PET radionuclide production facility that produces PET radionuclides for use in producing radioactive drugs within the consortium for noncommercial distributions among its associated members for medical use. The PET radionuclide production facility within the consortium must be located at an educational institution or a medical facility.

(35) "Constraint" or "dose constraint" means a value above which specified licensee actions are required.

(36) "Construction" means the installation of foundations, or in-place assembly, erection, fabrication, or testing for any structure, system, or component of a facility or activity subject to the rules promulgated pursuant to Chapter 3748. of the Revised Code that are related to radiological safety or security. The term "construction" does not include:

(a) Changes for temporary use of the land for public recreational purposes;

(b) Site exploration, including necessary borings to determine foundation conditions or other preconstruction monitoring to establish background information related to the suitability of the site, the environmental impacts of construction or operation, or the protection of environmental values;

(c) Preparation of the site for construction of the facility, including clearing of the site, grading, installation of drainage, erosion and other environmental mitigation measures, and construction of temporary roads and borrow areas;

(d) Erection of fences and other access control measures that are not related to the safe use of, or security of, radiological materials subject to the rules promulgated pursuant to Chapter 3748. of the Revised Code;

(e) Excavation;

(f) Erection of support buildings (e.g. construction equipment storage sheds, warehouse and shop facilities, utilities, concrete mixing plants, docking and unloading facilities, and office buildings) for use in connection with the construction of the facility;

(g) Building of service facilities (e.g. paved roads, parking lots, railroad spurs, exterior utility and lighting systems, potable water systems, sanitary sewerage treatment facilities, and transmission lines);

(h) Procurement or fabrication of components or portions of the proposed facility occurring at other than the final, in-place location at the facility; or

(i) Taking any other action that has no reasonable nexus to radiological health and safety.

(37) "Controlled area" means an area, outside of a restricted area but inside the site boundary, access to which can be limited by the licensee or registrant for any reason.

(38) "Critical group" means the group of individuals reasonably expected to receive the greatest exposure to residual radioactivity for any applicable set of circumstances.

(39) "Curie" or "Ci" means a unit of activity. One curie equals 3.7 x 10¹⁰ disintegrations per second equals 3.7 x 10¹⁰ becquerels equals 2.22 x 10¹² disintegrations per minute.

(40) "Cyclotron" means a particle accelerator in which the charged particles travel in an outward spiral or circular path. A cyclotron accelerates charged particles at energies usually in excess of ten megaelectron volts and is commonly used for production of short half-life radionuclides for medical use.

(41) "Declared pregnant woman" means a woman who has voluntarily informed the licensee or registrant, in writing, of her pregnancy and the estimated date of conception. The declaration remains in effect until the declared pregnant woman withdraws the declaration in writing or is no longer pregnant.

(42) "Decommission" means to safely remove any licensed operation from service and reduce residual radioactivity to a level that permits release of the licensee's property for unrestricted use and termination of the license.

(43) "Dedicated check source" means a radioactive source that is used to assure the consistent performance of a radiation detection or measurement device over several months or years.

(44) "Deep dose equivalent" or "H_d" applies to external whole body exposure, and means the dose equivalent at a tissue depth of one centimeter, one thousand milligram per square centimeter.

(45) "Demand respirator" means an atmosphere-supplying respirator that admits breathing air to the facepiece only when a negative pressure is created inside the facepiece by inhalation.

(46) "Dentist" means an individual licensed by the state of Ohio to practice dentistry under Chapter 4715. of the Revised Code.

(47) "Department" means the Ohio department of health.

(48) "Depleted uranium" means uranium containing less uranium-235 than the naturally occurring distribution of uranium isotopes.

(49) "Derived air concentration" or "DAC" means the concentration of a given radionuclide in air which, if breathed by the reference man for a working year of two thousand hours under conditions of light work, results in an intake of one ALI. The condition of light work is inhaling 1.2 cubic meters of air per hour for two thousand hours in a year. DAC values are given in appendix C to rule 3701:1-38-12 of the Administrative Code.

(50) "Derived air concentration-hour or DAC-hour" means the product of the concentration of radioactive material in air, which is expressed as a fraction or multiple of the derived air concentration for each radionuclide, and the time of exposure to that radionuclide, in hours. A licensee or registrant may take two thousand DAC-hours to represent one ALI, equivalent to a committed effective dose equivalent of 0.05 Sv (five rem).

(51) "Direct reading dosimeter" means a device that measures radiation dose that does not require another device to read the measured radiation dose. Examples of direct reading dosimeters include pocket dosimeters and electronic dosimeters.

(52) "Director" means the director of health or a designee or authorized representative of the director.

(53) "Discipline" means a branch of knowledge or of teaching.

(54) "Discrete source" means a radionuclide that has been processed so that its concentration within a material has been purposely increased for use for commercial, medical, or research activities.

(55) "Disposable respirator" means a respirator for which maintenance is not intended and that is designed to be discarded after excessive breathing resistance, sorbent exhaustion, physical damage, or end-of service-life renders it unsuitable for use. Examples of this type of respirator are a disposable half-mask respirator or a disposable escape-only self-contained breathing apparatus.

(56) "Dose" or "radiation dose" is a generic term that means absorbed dose, dose equivalent, effective dose equivalent, committed effective dose equivalent, or total effective dose equivalent as defined in other paragraphs of this rule.

(57) "Dose equivalent" or "H_T" means the product of the absorbed dose in tissue, quality factor, and all other necessary modifying factors at the location of interest. The units of dose equivalent are the sievert and rem.

(58) "Dose limits" or "limits" means the permissible upper bounds of radiation doses established in accordance with these regulations but excludes background radiation and medical exposure.

(59) "Dosimetry processor" means a person that processes and evaluates individual monitoring devices in order to determine the radiation dose delivered to the monitoring devices.

(60) "Effective dose equivalent" or "H_E" means the sum of the products of the dose equivalent to each organ or tissue, H_T, and the weighting factor, W_T, applicable to each of the body organs or tissues that are irradiated: (H_E = ∑W_TH_T).

(61) "Embryo" or "fetus" means the developing human organism from conception until time of birth.

(62) "Engineering controls" means mechanisms used to protect health and minimize damage to life and property through engineering specifications, design, and construction of the product or facility including all of the security and safety features. This includes, but is not limited to, auxiliary security and safety features such as additional external shielding, barriers, and operational interlocks with associated processes.

(63) "Entrance" or "access point" means any opening through which an individual or extremity of an individual could gain access to radiation areas or to licensed radioactive materials or registered radiation generating equipment. This includes entry or exit portals of sufficient size to permit human entry, irrespective of their intended use.

(64) "Explosive material" means any chemical compound, mixture or device which produces a substantial instantaneous release of gas and heat spontaneously or by contact with sparks or flame.

(65) "Exposure" means being exposed to sources of ionizing radiation.

(66) "External dose" means that portion of the dose equivalent received from radiation sources outside the body.

(67) "Extremity" means hand, elbow, arm below the elbow, foot, knee, or leg below the knee.

(68) "Eye dose equivalent" means the same as lens dose equivalent.

(69) "Facility" means all buildings, equipment, structures and other stationary items that, in addition to the meaning defined in division (H) of section 3748.01 of the Revised Code, are:

(a) Located on a single site or on contiguous or adjacent sites and are operated by the same person and have common corporate or business interests; or

(b) Portions of a building or structure which are operated by the same person and have common corporate or business interests.

(70) "Filtering facepiece" or "dust mask" means a negative pressure particulate respirator with a filter as an integral part of the facepiece or with the entire facepiece composed of the filtering medium, not equipped with elastomeric sealing surfaces and adjustable straps.

(71) "Fissile material" means the radionuclides uranium-233, uranium-235, plutonium-239, and plutonium-241, or any combination of these radionuclides. Fissile material means the fissile nuclides themselves, not material containing fissile nuclides. Unirradiated natural uranium and depleted uranium and natural uranium or depleted uranium that has been irradiated in thermal reactors only, are not included in this definition. Certain exclusions from fissile material controls are provided in rule 3701:1-50-13 of the Administrative Code.

(72) "Fit factor" means quantitative estimate of the fit of a particular respirator to a specific individual, and typically estimates the ratio of the concentration of a substance in ambient air to its concentration inside the respirator when worn.

(73) "Fit test" means the use of a protocol to qualitatively or quantitatively evaluate the fit of a respirator on an individual.

(74) "Generally applicable environmental radiation standards" means standards issued by the United States environmental protection agency under the authority of the Atomic Energy Act of 1954, 68 Stat. 919, 42 U.S.C. 2011, as amended (2005), that impose limits on radiation exposures or levels, or concentrations or quantities of radioactive material, in the general environment outside the boundaries of locations under the control of persons possessing or using radioactive material.

(75) "Gray" or "Gy" means the SI unit of absorbed dose. One gray is equal to an absorbed dose of one joule per kilogram (one hundred rads).

(76) "Handle" means receive, possess, use, store, transfer, install, service, or dispose of sources of radiation unless possession is solely for the purpose of transportation.

(77) "Handler" means a facility that handles sources of radiation unless possession is solely for the purpose of transportation.

(78) "Hazardous waste" means those wastes designated as hazardous by rule 3745-51-03 of the Administrative Code.

(79) "Helmet" means a rigid respiratory inlet covering that also provides head protection against impact and penetration.

(80) "High radiation area" means an area, accessible to individuals, in which radiation levels from radiation sources external to the body could result in an individual receiving a dose equivalent in excess of one millisievert (0.1 rem) in one hour at thirty centimeters from the radiation source or thirty centimeters from any surface that the radiation penetrates.

(81) "Hood" means a respiratory inlet covering that completely covers the head and neck and may also cover portions of the shoulders and torso.

(82) "Individual" means any human being.

(83) "Individual monitoring" means

(a) The assessment of dose equivalent by the use of devices designed to be worn by an individual;

(b) The assessment of committed effective dose equivalent by bioassay or by determination of the time-weighted air concentrations to which an individual has been exposed, i.e. DAC-hours; or

(c) The assessment of dose equivalent by the use of survey data.

(84) "Individual monitoring devices" means devices designed to be worn by a single individual for the assessment of dose equivalent such as film badges; thermoluminescent dosimeters; optically stimulated luminescent dosimeters; pocket ionization chambers; and personal air sampling devices.

(85) "Industrial radiography" means the examination of the structure of materials by nondestructive methods, utilizing sealed sources of radioactive material or radiation-generating equipment.

(86) "Internal dose" means that portion of the dose equivalent received from radioactive material taken into the body.

(87) "Irradiator" means a facility that uses radioactive sealed sources for the irradiation of objects or materials and in which radiation dose rates exceeding five grays (five hundred rads) per hour exist at one meter from the sealed radioactive source in air or water, as applicable for the irradiator type, but does not include irradiators in which both the sealed source and the area subject to irradiation are contained within a device and are not accessible to personnel.

(88) "Lens dose equivalent" or "eye dose equivalent" means the external exposure of the lens of the eye and is taken as the dose equivalent at a tissue depth of 0.3 centimeters; i.e. three hundred milligrams per square centimeter.

(89) "License" means a license issued by the nuclear regulatory commission, the director, or another agreement state in accordance with rules adopted by those organizations.

(90) "Licensee" means a person to whom a license is issued.

(91) "Licensed activity" means an activity authorized by a radioactive material license which is essential to achieving the purpose for which the license was issued or amended.

(92) "Licensed material" means radioactive material received, possessed, used, transferred or disposed of under a general or specific license.

(93) "Loose-fitting facepiece" means a respiratory inlet covering that is designed to form a partial seal with the face.

(94) "Lost or missing licensed source of radiation" means a licensed source of radiation whose location is unknown. It includes material that has been shipped but has not reached its destination and whose location cannot be readily traced in the transportation system.

(95) "Low-level radioactive waste" or "LLRW," also "low-level waste," or "LLW" means radioactive waste which is not high-level radioactive waste, spent nuclear fuel, NARM, or byproduct material as defined in section 11 E. (2) of the Atomic Energy Act of 1954 68 Stat. 919, 42 U.S.C. 2011, as amended (2005), but is radioactive material that the United States nuclear regulatory commission classifies as low-level radioactive waste.

(96) "Low specific activity material" or "LSA" means radioactive material with limited specific activity which is nonfissile or is excepted under rule 3701:1-50-13 of the Administrative Code, and which satisfies the descriptions and limits set forth below. Shielding materials surrounding the LSA material may not be considered in determining the estimated average specific activity of the package contents. LSA must be in one of three groups:

(a) LSA - I.

(i) Uranium and thorium ores, concentrates of uranium and thorium ores, and other ores containing naturally occurring radioactive radionuclides that are intended to be processed for the use of these radionuclides;

(ii) Natural uranium, depleted uranium, natural thorium or their compounds or mixtures, provided they are unirradiated and in solid or liquid form;

(iii) Radioactive material other than fissile material, for which the A₂ value is unlimited; or

(iv) Other radioactive material in which the activity is distributed throughout and the estimated average specific activity does not exceed thirty times the value for exempt material activity concentration determined in accordance with rule 3701:1-50-25 of the Administrative Code.

(b) LSA-II.

(i) Water with tritium concentration up to 0.8 terabecquerels per liter (twenty curies per liter); or

(ii) Other material in which the activity is distributed throughout and the estimated average specific activity does not exceed ( 10^-4 A₂) per gram for solids and gases, and (10^-5 A₂) per gram for liquids.

(c) LSA-III. Solids (e.g., consolidated wastes, activated materials), excluding powders, that satisfy the requirements of 10 C.F.R. 71.77 (as in effect on the effective date of this rule), in which:

(i) The radioactive material is distributed throughout a solid or a collection of solid objects, or is essentially uniformly distributed in a solid compact binding agent (such as concrete, bitumen, ceramic, etc.);

(ii) The radioactive material is relatively insoluble, or it is intrinsically contained in a relatively insoluble material, so that even under loss of packaging, the loss of radioactive material per package by leaching, when placed in water for seven days, would not exceed (0.1 x A₂); and

(iii) The estimated average specific activity of the solid, excluding any shielding material, does not exceed (0.002 x A₂) per gram.

(97) "Management" means the chief executive officer or other individual having the authority to manage, direct, or administer the licensee's activities, or those persons' delegate or delegates.

(98) "Medical institution" means an organization in which more than one medical discipline is practiced.

(99) "Medical use" means the intentional internal or external administration of radioactive material or the radiation therefrom to patients or human research subjects under the supervision of an authorized user.

(100) "Member of the public" means any individual except when that individual is receiving an occupational dose.

(101) "Minor" means an individual less than eighteen years of age.

(102) "Monitoring" or "radiation monitoring" or "radiation protection monitoring" means the measurement of radiation levels, concentrations, surface area concentrations or quantities of radioactive material and the use of the results of these measurements to evaluate potential exposures and doses.

(103) "NARM" or "naturally occurring or accelerator-produced radioactive material" means naturally occurring or accelerator-produced radioactive material, including naturally occurring material that is technologically enhanced, and those nuclides that are generated in a charged particle accelerator, but does not include source material, byproduct material, or special nuclear material.

(104) "NARM licensing state" means any state with regulations equivalent to the suggested state regulations for control of radiation relating to, and an effective program for, the regulatory control of NARM and which has been granted final designation by the conference of radiation control program directors, inc.

(105) "Nationally tracked source" means a sealed source containing a quantity equal to or greater than "Category 1" or "Category 2" levels of any radioactive material listed in the appendix to rule 3701:1-38-25 of the Administrative Code. In this context a sealed source is defined as radioactive material that is sealed in a capsule or closely bonded, in a solid form and which is not exempt from regulatory control. It does not mean material encapsulated solely for disposal, or nuclear material contained in any fuel assembly, subassembly, fuel rod, or fuel pellet. "Category 1" nationally tracked sources are those containing radioactive material at a quantity equal to or greater than the "Category 1" threshold. "Category 2" nationally tracked sources are those containing radioactive material at a quantity equal to or greater than the "Category 2" threshold but less than the "Category 1" threshold.

(106) "Negative pressure respirator" or "tight fitting respirator" means a respirator in which the air pressure inside the facepiece is negative during inhalation with respect to the ambient air pressure outside the respirator.

(107) "Nonstochastic effect" or "deterministic effect" means health effects, the severity of which varies with the dose and for which a threshold is believed to exist. Radiation-induced cataract formation is an example of a nonstochastic effect.

(108) "NORM" or "naturally occurring radioactive material" means any nuclide that is radioactive in its natural physical state, but does not include source material, byproduct material, or special nuclear material.

(109) "Normal form radioactive material" means radioactive material that has not been demonstrated to qualify as special form radioactive material.

(110) "Nuclear regulatory commission" means the federal agency established by Title II of the Energy Reorganization Act of 1974, 88 Stat. 1233, 42 U.S.C.A. 5801, as amended (2005), comprising the members of the commission and all offices, employees, and representatives authorized to act in any case or matter related to licensing and related regulatory function previously assigned to the AEC.

(111) "Occupational dose" means the dose received by an individual in the course of employment in which the individual's assigned duties involve exposure to radiation or radioactive material from licensed and unlicensed sources of radiation, whether in the possession of the licensee or other person. Occupational dose does not include doses received from background radiation, from any medical administration the individual has received, from exposures to individuals administered radioactive materials and released in accordance with rule 3701:1-58-30 of the Administrative Code or equivalent United States nuclear regulatory commission or agreement state regulations, from voluntary participation in medical research programs, or as a member of the public.

(112) "Package" means the packaging together with its radioactive contents as presented for transport.

(a) Fissile material package or type AF package, type BF package, type B(U)F package, or type B(M)F package means a fissile material packaging together with its fissile material contents.

(b) Type A package means a type A packaging together with its radioactive contents. A type A package is defined and must comply with the United States department of transportation regulations in 49 C.F.R. 173 (as in effect on the effective date of this rule).

(c) Type B package means a type B packaging together with its radioactive contents. On approval, a type B package design is designated by the United States nuclear regulatory commission as B(U) unless the package has a maximum normal operating pressure of more than seven hundred kilopascals (one hundred pounds per square inch) gauge or a pressure relief device that would allow the release of radioactive material to the environment under the tests specified in 10 C.F.R. 71.73 (hypothetical accident conditions) (as in effect on the effective date of this rule), in which case it will receive a designation B(M). B(U) refers to the need for unilateral approval of international shipments; B(M) refers to the need for multilateral approval of international shipments. There is no distinction made in how packages with these designations may be used in domestic transportation. To determine their distinction for international transportation, see United States department of transportation regulations in 49 C.F.R. 173 (as in effect on the effective date of this rule). A type B package approved before September 6, 1983, was designated only as type B. Limitations on its use are specified in 10 C.F.R. 71.19 (as in effect on the effective date of this rule).

(113) "Packaging" means the assembly of components necessary to ensure compliance with the packaging requirements of rule 49 C.F.R. 173 Subpart I (as in effect on the effective date of this rule). It may consist of one or more receptacles, absorbent materials, spacing structures, thermal insulation, radiation shielding, and devices for cooling or absorbing mechanical shocks. The vehicle, tie-down system and auxiliary equipment may be designated as part of the packaging.

(114) "Particle accelerator" means any machine capable of accelerating electrons, protons, deuterons, or other charged particles in a vacuum and of discharging the resultant particulate or other radiation into a medium at energies usually in excess of one megaelectron volt. For purposes of this definition, "accelerator" is an equivalent term.

(115) "Person" means any individual, corporation, association, business enterprise, or other legal entity either public or private and any legal successor, representative, agent, or agency of that individual, corporation, association, business enterprise, or other legal entity. Person also includes the United States, states, political subdivisions of states, and any department, agency, or instrumentality of the United States or a state, except the U.S. department of energy or the U.S. nuclear regulatory commission where the state regulation of radioactive material by either of those agencies is prohibited by federal law.

(116) "Personnel dosimeter", means a device that measures radiation dose that is processed and evaluated by an accredited "National Voluntary Laboratory Accreditation Program" (NVLAP) processor. Examples of personnel dosimeters include film badges, thermo-luminescent dosimeters (TLD), and optically stimulated luminescence (OSL) dosimeters.

(117) "Pharmacist" means a person who is licensed by the state of Ohio to practice pharmacy pursuant to Chapter 4731. of the Revised Code.

(118) "Physician" means a person who is licensed pursuant to Chapter 4731. of the Revised Code to practice medicine or surgery or osteopathic medicine or surgery.

(119) "Planned special exposure" means an infrequent exposure to radiation, separate from and in addition to the annual dose limits.

(120) "Podiatrist" means an individual licensed by the state of Ohio to practice podiatry pursuant to Chapter 4731. of the Revised Code.

(121) "Positive pressure respirator" means a respirator in which the pressure inside the respiratory inlet covering exceeds the ambient air pressure outside the respirator.

(122) "Positron Emission Tomography (PET) radionuclide production facility" means a facility operating a cyclotron or accelerator for the purpose of producing PET radionuclides.

(123) "Powered air-purifying respirator" or "PAPR" means an air-purifying respirator that uses a blower to force the ambient air through air purifying elements to the inlet covering.

(124) "Pressure demand respirator" means a positive pressure atmosphere supplying respirator that admits breathing air to the facepiece when the positive pressure is reduced inside the facepiece by inhalation.

(125) "Public dose" means the dose received by a member of the public from exposure to radiation and/or radioactive material released by the licensee, or to any other source of radiation under the control of a licensee or registrant. Public dose does not include occupational dose or doses received from background radiation, from any medical administration the individual has received, from exposures to individuals administered radioactive materials and released in accordance with rule 3701:1-58-30 of the Administrative Code or equivalent United States nuclear regulatory commission or agreement state regulations, or from voluntary participation in medical research programs.

(126) "Pyrophoric material" means any liquid that ignites spontaneously in dry or moist air at or below 54.4 degrees celsius (one hundred thirty degrees fahrenheit). A pyrophoric solid is any solid material, other than one classed as an explosive, which under normal conditions is liable to cause fires through friction, retained heat from manufacturing or processing, or which can be ignited readily and when ignited burns so vigorously and persistently as to create a serious transportation, handling, or disposal hazard. Included are spontaneously combustible and water-reactive materials.

(127) "Qualitative fit test" or "QLFT" means a pass/fail fit test to assess the adequacy of respirator fit that relies on the individual's response to the test agent.

(128) "Quality factor" or "Q" means the modifying factor, as listed in paragraphs (A) and (B) of rule 3701:1-38-11 of the Administrative Code, that is used to derive dose equivalent from absorbed dose.

(129) "Quantitative fit test" or "QNFT" means an assessment of the adequacy of respirator fit by numerically measuring the amount of leakage into the respirator.

(130) "Quarter" or "quarterly" means a period of time equal to one-fourth of the year observed by the licensee or registrant, approximately thirteen consecutive weeks, providing that the beginning of the first quarter in a year coincides with the starting date of the year and that no day is omitted or duplicated in consecutive quarters.

(131) "Rad" means the special unit of radiation absorbed dose. One rad is equal to an absorbed dose of one hundred ergs per gram, or 0.01 joule per kilogram, or 0.01 gray.

(132) "Radiation" or "ionizing radiation" means alpha particles, beta particles, gamma rays, x-rays, neutrons, high speed electrons, high speed protons, and other particles capable of producing ions. Radiation does not include nonionizing radiation, such as radio or microwaves, or visible, infrared or ultraviolet light.

(133) "Radiation area" means an area, accessible to individuals, in which radiation levels could result in an individual receiving a dose equivalent in excess of 0.05 millisievert (0.005 rem) in one hour at thirty centimeters from the source of radiation or from any surface that the radiation penetrates.

(134) "Radiation-generating equipment" or "RGE" means any manufactured product or device, or component of such a product or device, or any machine or system that during operation can generate or emit radiation, except those that emit radiation only from radioactive material. "Radiation-generating equipment" does not include either of the following:

(a) Diathermy machines;

(b) Microwave ovens, including food service microwave ovens used for commercial and industrial uses, television receivers, electric lamps, and other household appliances and products that generate very low levels of radiation.

(135) "Radiation Safety Officer" or "RSO" means an individual designated by the licensee who has the knowledge and responsibility for the overall radiation safety program at the facility, to include the implementation of the daily radiation safety operations and compliance with the rules.

(136) "Radioactive material" means any solid, liquid or gaseous material that emits ionizing radiation spontaneously. "Radioactive material" includes accelerator-produced and naturally occurring radioactive materials and byproduct, source, and special nuclear material.

(137) "Radioactive waste" means waste containing regulated radioactive material.

(138) "Radioactivity" means the transformation of unstable atoms by the emission of radiation.

(139) "Radiography" means the same as industrial radiography.

(140) "Reference man" means a hypothetical aggregation of human physical and physiological characteristics arrived at by international consensus. These characteristics may be used by researchers and public health workers to standardize results of experiments and to relate biological insult to a common base.

(141) "Registrant" means a person required by Chapter 3748. of the Revised Code to register radiation-generating equipment with the director.

(142) "Rem" means the special unit of any of the quantities expressed as dose equivalent. The dose equivalent in rem is equal to the absorbed dose in rads multiplied by the quality factor (one rem = 0.01 Sv).

(143) "Research and development" means

(a) Theoretical analysis, exploration, or experimentation; or

(b) The extension of investigative findings and theories of a scientific or technical nature into practical application for experimental and demonstration purposes, including the experimental production and testing of models, devices, equipment, materials and processes. "Research and development" does not include the internal or external administration of sources of radiation to human beings.

(144) "Residual radioactivity" means radioactivity in structures, materials, soils, groundwater, and other media at a site resulting from activities under the licensee's control. This includes radioactivity from all licensed and unlicensed sources used by the licensee, but excludes background radiation. It also includes radioactive materials remaining at the site as a result of routine or accidental releases of radioactive material at the site and previous burials at the site, even if those burials were made in accordance with the provisions of 10 C.F.R. 20 (as in effect on the effective date of this rule).

(145) "Respiratory protective equipment or device" means an apparatus, such as a respirator, used to reduce the individual's intake of airborne radioactive materials.

(146) "Restricted area" means an area access to which is limited by the licensee or registrant for the purpose of protecting individuals against undue risks from exposure to sources of radiation. Restricted area does not include areas used as residential quarters, but separate rooms in a residential building may be set apart as a restricted area.

(147) "Roentgen" means the amount of gamma or x-rays required to produce ions resulting in a charge of 0.000258 coulombs per kilogram of air under standard conditions.

(148) "Sanitary sewerage" means a system of public sewers for carrying off wastewater and refuse, but excluding sewage treatment facilities, septic tanks, and leach fields owned or operated by the licensee.

(149) "Sealed source" means radioactive material that is encased in a manner designed to prevent leakage or escape of the radioactive material.

(150) "Sealed source and device registry" means the national registry that contains all the registration certificates, generated by both the United States nuclear regulatory commission and the agreement states, that summarize the radiation safety information for the sealed sources and devices and describe the licensing and use conditions approved for the product.

(151) "Seismic area" means any area where the probability of a horizontal acceleration in rock of more than 0.3 times the acceleration of gravity in two hundred fifty years is greater than ten per cent, as designated by the United States geological survey.

(152) "Self-contained breathing apparatus" or "SCBA" means an atmosphere-supplying respirator for which the breathing air source is designed to be carried by the user.

(153) "Shallow dose equivalent" or "H_S" means the external exposure of the skin of the whole body or the skin of an extremity, is taken as the dose equivalent at a tissue depth of 0.007 centimeter, or seven milligrams per square centimeter.

(154) "Sievert" or "Sv" means the SI unit of any of the quantities expressed as dose equivalent. The dose equivalent in sieverts is equal to the absorbed dose in grays multiplied by the quality factor. One sievert equals one hundred rem.

(155) "Site area emergency" means events may occur, are in progress, or have occurred that could lead to a significant release of radioactive material and that could require a response by off-site response organizations to protect persons off-site.

(156) "Site boundary" means that line beyond which the land or property is not owned, leased, or otherwise controlled by the licensee or registrant.

(157) "Site closure and stabilization" means those actions that are taken upon completion of operations that prepare a disposal site for custodial care and that assure that the disposal site will remain stable and will not need ongoing active maintenance.

(158) "Source material" means uranium, thorium, or any combination thereof in any physical or chemical form, or any ores that contain by weight at least one-twentieth of one per cent (0.05 per cent) of uranium, thorium, or any combination thereof. Source material does not include special nuclear material.

(159) "Sources of radiation" means radioactive material or radiation generating equipment.

(160) "Special form radioactive material" means radioactive material that satisfies the following conditions:

(a) It is either a single solid piece or is contained in a sealed capsule that can be opened only by destroying the capsule;

(b) The piece or capsule has at least one dimension not less than five millimeters (0.2 inch); and

(c) It satisfies the test requirements specified by the United States nuclear regulatory commission in 10 C.F.R. 71.75 (as in effect on the effective date of this rule). A special form encapsulation designed in accordance with the United States nuclear regulatory commission requirements identified in 10 C.F.R. 71.4, in effect on June 30, 1983, and constructed prior to July 1, 1985; a special form encapsulation designed in accordance with the requirements of 10 C.F.R. 71.4 in effect on March 31, 1996, and constructed before April 1, 1998; and special form material that was successfully tested before September 10, 2015 in accordance with the requirements of 10 C.F.R. 71.75(d) of this section in effect before September 10, 2015 may continue to be used. Any other special form encapsulation must meet the specifications of this definition.

(161) "Special nuclear material" means either of the following:

(a) Plutonium, uranium-233, uranium enriched in the isotope 233, or in the isotope 235, and any other material that the United States nuclear regulatory commission determines to be special nuclear material, but does not include source material pursuant to section 51 of the Atomic Energy Act of 1954, 68 Stat 919, 42 USCA 2071, as amended (2005).

(b) Any material artificially enriched by any of the foregoing but does not include source material.

(162) "Special nuclear material in quantities not sufficient to form a critical mass" means uranium enriched in the isotope uranium-235 in quantities not exceeding three hundred fifty grams of contained uranium-235; uranium-233 in quantities not exceeding two hundred grams; plutonium in quantities not exceeding two hundred grams; or any combination of them in accordance with the following formula: for each kind of special nuclear material, determine the ratio between the quantity of that special nuclear material and the quantity specified in this paragraph for the same kind of special nuclear material. The sum of such ratios for all of the kinds of special nuclear material in combination shall not exceed unity.

(163) "Stochastic effect" means health effects that occur randomly and for which the probability of the effect occurring, rather than its severity, is assumed to be a linear function of dose without threshold. Hereditary effects and cancer incidence are examples of stochastic effects.

(164) "Supplied-air respirator" or "SAR" or "airline respirator" means an atmosphere-supplying respirator for which the source of breathing air is not designed to be carried by the user.

(165) "Surface contaminated object" or "SCO" means a solid object that is not itself classed as radioactive material, but which has radioactive material distributed on any of its surfaces. SCO must be in one of two groups with surface activity not exceeding the following limits:

(a) SCO-I: a solid object on which:

(i) The non-fixed contamination on the accessible surface averaged over three hundred square centimeters, or the area of the surface if less than three hundred square centimeters, does not exceed four becquerels per square centimeter (10^-4 microcurie per square centimeter) for beta and gamma and low toxicity alpha emitters, or 0.4 becquerels per square centimeter 10^-5 microcurie per square centimeter) for all other alpha emitters;

(ii) The fixed contamination on the accessible surface averaged over three hundred square centimeters, or the area of the surface if less than three hundred square centimeters, does not exceed forty thousand becquerels per square centimeter (one microcurie per square centimeter) for beta and gamma and low toxicity alpha emitters, or four thousand becquerels per square centimeter (0.1 microcurie per square centimeter) for all other alpha emitters; and

(iii) The non-fixed contamination plus the fixed contamination on the inaccessible surface averaged over three hundred square centimeters, or the area of the surface if less than three hundred square centimeters, does not exceed forty thousand becquerels per square centimeter (one microcurie per square centimeter) for beta and gamma and low toxicity alpha emitters, or four thousand becquerels per square centimeter (0.1 microcurie per square centimeter) for all other alpha emitters.

(b) SCO-II: a solid object on which the limits for SCO-I are exceeded and on which:

(i) The non-fixed contamination on the accessible surface averaged over three hundred square centimeters, or the area of the surface if less than three hundred square centimeter, does not exceed four hundred becquerels per square centimeter (10^-2 microcurie per square centimeter) for beta and gamma and low toxicity alpha emitters, or forty becquerels per square centimeter (10^-3 microcurie per square centimeter) for all other alpha emitters;

(ii) The fixed contamination on the accessible surface averaged over three hundred square centimeters, or the area of the surface if less than three hundred square centimeters, does not exceed eight hundred thousand becquerels per square centimeter (twenty microcuries per square centimeter) for beta and gamma and low toxicity alpha emitters, or eighty thousand becquerels per square centimeter (two microcuries per square centimeter) for all other alpha emitters; and

(iii) The non-fixed contamination plus the fixed contamination on the inaccessible surface averaged over three hundred square centimeters, or the area of the surface if less than three hundred square centimeters, does not exceed eight hundred thousand becquerels per square centimeter (twenty microcuries per square centimeter) for beta and gamma and low toxicity alpha emitters, or eighty thousand becquerels per square centimeter (two microcuries per square centimeter) for all other alpha emitters.

(166) "Survey" means an evaluation of the radiological conditions and potential hazards incident to the production, use, transfer, release, disposal or presence of radioactive material or other sources of radiation. When appropriate, such an evaluation includes a physical survey of the location of radioactive material, or the sources of radiation and measurements or calculations of levels of radiation, or concentrations or quantities of radioactive material present.

(167) "Tight-fitting facepiece" means a respiratory inlet covering that forms a complete seal with the face.

(168) "Total effective dose equivalent" or "TEDE" means the sum of the effective dose equivalent (for external exposures) and the committed effective dose equivalent (for internal exposures).

(169) "Transport index" means the dimensionless number, rounded up to the next tenth, placed on the label of a package, to designate the degree of control to be exercised by the carrier during transportation. The transport index is the number determined by multiplying the maximum radiation level in millisievert per hour at one meter (3.3 feet) from the external surface of the package by one hundred, which is equivalent to the maximum radiation level in millirem per hour at one meter (3.3 feet).

(170) "Type A quantity" means a quantity of radioactive material, the aggregate radioactivity of which does not exceed A₁ for special form radioactive material, or A₂ for normal form radioactive material, where A₁ and A₂ are given in rule 3701:1-50-25 of the Administrative Code.

(171) "Type B quantity" means a quantity of radioactive material greater than a type A quantity.

(172) "Type B package" is defined under "Package."

(173) "United States department of energy" means the department of energy established by the Department of Energy Organization Act, PL 95-91, 91 Stat. 565 (1977), 42 U.S.C. 7101 et seq., as amended (2006), to the extent that the department of energy or its duly authorized representatives, exercises functions formerly vested in the United States atomic energy commission, its chairman, members, officers and components and transferred to the United States energy research and development administration and to the administrator thereof pursuant to Sections 104(b) to (d) of the Energy Reorganization Act of 1974, PL 93-438, 88 Stat. 1233 at 1237 (1974), 42 U.S.C. 5814 and retransferred to the secretary of energy pursuant to Section 301(a) of the Department of Energy Organization Act, PL 95-91, 91 Stat. 565 at 577-578 (1977), 42 U.S.C. 7151.

(174) "Unrestricted area" or "uncontrolled area" means any area, access to which is neither restricted nor controlled by the licensee or registrant.

(175) "User seal check" or "fit check" means an action conducted by the respirator user to determine if the respirator is properly seated to the face. Examples include negative pressure check, positive pressure check, irritant smoke check, or isoamyl acetate check.

(176) "Very high radiation area" means an area, accessible to individuals, in which radiation levels from radiation sources external to the body could result in an individual receiving an absorbed dose in excess of five gray (five hundred rad) in one hour at one meter from a source of radiation or from any surface that the radiation penetrates. At very high doses received at high dose rates, units of absorbed dose, gray and rad, are appropriate, rather than units of dose equivalent, sievert and rem.

(177) "Veterinarian" means an individual licensed by the state of Ohio to practice veterinary medicine pursuant to Chapter 4741. of the Revised Code.

(178) "Waste" means those low-level radioactive wastes containing source, special nuclear, or byproduct material that are acceptable for disposal in a land disposal facility. For the purposes of this definition, low-level radioactive waste means radioactive waste not classified as high-level radioactive waste, transuranic waste, spent nuclear fuel, or byproduct material as defined in paragraph (A)(26)(b) of this rule, or byproduct material as defined in section 11 E. (3) and (4) of the Atomic Energy Act of 1954, 68 Stat. 919, 42 USC 2014, as amended (2005).

(179) "Week" means seven consecutive days starting on Sunday.

(180) "Weighting factor

• W_T" for an organ or tissue, (T), is the proportion of the risk of stochastic effects resulting from irradiation of that organ or tissue to the total risk of stochastic effects when the whole body is irradiated uniformly. For calculating the effective dose equivalent, the values of W_T are:

| Organ doseweighting factors | | | --- | --- | | Organ ortissue | W_T | | Gonads | 0.25 | | Breast | 0.15 | | Red bone marrow | 0.12 | | Lung | 0.12 | | Thyroid | 0.03 | | Bonesurfaces | 0.03 | | Remainder | 0.30^a | | Whole body | 1.00^b |

^\a 0.30 results from 0.06 for each of five "remainder" organs, excluding the skin and the lens of the eye, that receive the highest doses.

^\b for the purpose of weighting the external whole body dose (for adding it to the internal dose) a single weighting factor, W_T = 1.0, has been specified. The use of other weighting factors for external exposure will be approved on a case-by-case basis until such time as specific guidance is issued.

(181) "Whole body" means for purposes of external exposure, head; trunk, including male gonads; arms above the elbow; legs above the knee.

(182) "Worker" means an individual engaged in activities licensed or registered by the department and controlled by a licensee or registrant, but does not include the licensee or registrant.

(183) "Working level" or "WL" means any combination of short-lived radon decay products (for radon-222: polonium-218, lead-214, bismuth-214, and polonium-214; and for radon-220: polonium-216, lead-212, bismuth-212, and polonium-212) in one liter of air that will result in the ultimate emission of 1.3 x 10⁵ million electron volts alpha particle energy.

(184) "Working level month" or "WLM" means a cumulative exposure to one working level for one hundred seventy hours. (Two thousand working hours per year/twelve months per year equals approximately one hundred seventy hours per month.)

(185) "Year" means the period of time beginning in January used to determine compliance with the provisions of this rule. The licensee or registrant may change the starting date of the year used to determine compliance by the licensee or registrant provided that the change is made at the beginning of the year and that no day is omitted or duplicated in consecutive years.

(B) The terms set out in paragraph (A) of this rule may be redefined in other chapters as promulgated pursuant to Chapter 3748. of the Revised Code as used in that chapter only.

Last updated May 13, 2026 at 11:20 AM

History

• Effective: January 20, 2022
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-56-20 Issuance of licenses.

A specific license will be issued if:

(A) The application is for a purpose authorized by Chapter 3748. of the Revised Code and the rules promulgated thereunder;

(B) The applicant is qualified by reason of training and experience to use the special nuclear material for the purpose requested in such manner as to protect health and minimize danger to life or property; and

(C) The applicant's proposed equipment, facilities and procedures are adequate to protect health and minimize danger to life or property.

Last updated August 1, 2023 at 2:52 PM

History

• Effective: September 1, 2012
• Promulgated Under: 119.03

Chapter 3701:1-58 Medical Use of Radioactive Materials

Ohio Adm.Code 3701:1-58-01 Definitions.

The terms used in this chapter have the same meaning as found in rule 3701:1-38-01 of the Administrative Code, unless an alternative definition is provided in this rule or in another rules of this chapter:

(A) "Associate radiation safety officer" means an individual who:

(1) Meets the requirements in rules 3701:1-58-18 and 3701:1-58-22 of the Administrative Code; and

(2) Is currently identified as an associate radiation safety officer for the types of use of radioactive material for which the individual has been assigned duties and tasks by the radiation safety officer on:

(a) A specific medical use license issued by the director, the United States nuclear regulatory commission, or an agreement state; or

(b) A medical use permit issued by a United States nuclear regulatory commission master material licensee.

(B) "Authorized medical physicist" means an individual who:

(1) Meets the requirements in paragraph (A) of rule 3701:1-58-19 and in rule 3701:1-58-22 of the Administrative Code; or

(2) Is identified as an authorized medical physicist or teletherapy physicist on:

(a) A specific medical use license issued by the director, the United States nuclear regulatory commission, or an agreement state;

(b) A medical use permit issued by a United States nuclear regulatory commission master material licensee;

(c) A permit issued by a United States nuclear regulatory commission or agreement state broad scope medical use licensee; or

(d) A permit issued by a United States nuclear regulatory commission master material license broad scope medical use permittee.

(C) "Authorized nuclear pharmacist" means a pharmacist who:

(1) Meets the requirements in paragraph (A) of rule 3701:1-58-20 and in rule 3701:1-58-22 of the Administrative Code; or

(2) Is identified as an authorized nuclear pharmacist on:

(a) A specific license issued by the director, the United States nuclear regulatory commission, or an agreement state that authorizes medical use or the practice of nuclear pharmacy;

(b) A permit issued by a United States nuclear regulatory commission master material licensee that authorizes medical use or the practice of nuclear pharmacy;

(c) A permit issued by a United States nuclear regulatory commission or agreement state broad scope medical use licensee that authorizes medical use or the practice of nuclear pharmacy; or

(d) A permit issued by a United States nuclear regulatory commission master material license broad scope medical use permittee that authorizes medical use or the practice of nuclear pharmacy; or

(3) Is identified as an authorized nuclear pharmacist by a commercial nuclear pharmacy that has been authorized to identify authorized nuclear pharmacists; or

(4) Is designated as an authorized nuclear pharmacist in accordance with rule 3701:1-46-43 of the Administrative Code.

(D) "Authorized user" means a physician, dentist, or podiatrist who:

(1) Meets the requirements in rule 3701:1-58-22 of the Administrative Code and paragraph (A) of rule 3701:1-58-33, paragraph (A) of rule 3701:1-58-36, paragraph (A) of rule 3701:1-58-40, paragraph (A) of rule 3701:1-58-41, paragraph (A) of rule 3701:1-58-42, paragraph (A) of rule 3701:1-58-51, paragraph (A) of rule 3701:1-58-54, or paragraph (A) of rule 3701:1-58-71 of the Administrative Code; or

(2) Is identified as an authorized user on:

(a) A license issued by the director, the United States nuclear regulatory commission, or an agreement state that authorizes the medical use of radioactive material;

(b) A permit issued by a United States nuclear regulatory commission master material licensee that is authorized to permit the medical use of radioactive material;

(c) A permit issued by a United States nuclear regulatory commission or agreement state specific licensee of broad scope that is authorized to permit the medical use of radioactive material; or

(d) A permit issued by a United States nuclear regulatory commission master material license broad scope permittee that is authorized to permit the medical use of radioactive material.

(E) "Brachytherapy" means a method of radiation therapy in which sources are used to deliver a radiation dose at a distance of up to a few centimeters by surface, intracavitary, intraluminal, or interstitial application.

(F) "Brachytherapy source" means a radioactive source or a manufacturer-assembled source train or a combination of these sources that is designed to deliver a therapeutic dose within a distance of a few centimeters.

(G) "Client's address" means the area of use or a temporary job site, as defined in this rule, for the purpose of providing mobile medical service in accordance with rule 3701:1-58-31 of the Administrative Code.

(H) "High dose-rate remote afterloader," as used in this chapter, means a brachytherapy device that remotely delivers a dose rate in excess of twelve gray (one thousand two hundred rads) per hour at the point or surface where the dose is prescribed.

(I) "Low dose-rate remote afterloader," as used in this chapter, means a brachytherapy device that remotely delivers a dose rate of less than or equal to two gray (two hundred rads) per hour at the point or surface where the dose is prescribed.

(J) "Manual brachytherapy," as used in this chapter, means a type of brachytherapy in which the brachytherapy sources, such as seeds or ribbons are manually placed topically on or inserted either into the body cavities that are in close proximity to a treatment site or directly into the tissue volume.

(K) "Medical event" means an event that meets the criteria in paragraph (A) or (B) of rule 3701:1-58-101 of the Administrative Code.

(L) "Medium dose-rate remote afterloader," as used in this chapter, means a brachytherapy device that remotely delivers a dose rate of greater than two gray (two hundred rads) per hour, but less than or equal to twelve gray (one thousand two hundred rads) per hour at the point or surface where the dose is prescribed.

(M) "Mobile medical service" means the transportation of radioactive material to and its medical use at the client's address.

(N) "Ophthalmic physicist" means an individual who:

(1) Meets the requirements in paragraph (A)(2) of rule 3701:1-58-49 and in rule 3701:1-58-22 of the Administrative Code; and

(2) Is identified as an ophthalmic physicist on a:

(a) Specific medical use license issued by the director, the United States nuclear regulatory commission, or an agreement state;

(b) Permit issued by a United States nuclear regulatory commission or agreement state broad scope medical use licensee;

(c) Medical use permit issued by a United States nuclear regulatory commission master material licensee; or

(d) Permit issued by a United States nuclear regulatory commission master material licensee broad scope medical use permittee.

(O) "Output" means the exposure rate, dose rate, or a quantity related in a known manner to these rates from a brachytherapy source or a teletherapy, remote afterloader, or gamma stereotactic radiosurgery unit for a specified set of exposure conditions.

(P) "Patient intervention" means actions by the patient or human research subject, whether intentional or unintentional, such as dislodging or removing treatment devices or prematurely terminating the administration.

(Q) "Personal Representative" means:

(1) A person who has authority to act on behalf of an individual who is an adult or an emancipated minor in making decisions related to health care, or

(2) A parent, guardian, or other person acting in loco parentis who has authority to act on behalf of an individual who is an unemancipated minor in making decisions related to health care.

(R) "Preceptor" means an individual who provides, directs, or verifies the training and experience required for an individual to become an authorized user, an authorized medical physicist, an authorized nuclear pharmacist, a radiation safety officer, or an associate radiation safety officer.

(S) "Prescribed dosage" means the specified activity or range of activity of unsealed radioactive material as documented:

(1) In a written directive; or

(2) In accordance with the directions of the authorized user for procedures performed pursuant to rules 3701:1-58-32 and 3701:1-58-34 of the Administrative Code.

(T) "Prescribed dose" means:

(1) For gamma stereotactic radiosurgery, the total dose as documented in the written directive;

(2) For teletherapy, the total dose and dose per fraction as documented in the written directive;

(3) For manual brachytherapy, either the total source strength and exposure time or the total dose, as documented in the written directive; or

(4) For remote brachytherapy afterloaders, the total dose and dose per fraction as documented in the written directive.

(U) "Pulsed dose-rate remote afterloader," as used in this chapter, means a special type of remote afterloading brachytherapy device that uses a single source capable of delivering dose rates in the "high dose-rate'' range, but:

(1) Is approximately one-tenth of the activity of typical high dose-rate remote afterloader sources; and

(2) Is used to simulate the radiobiology of a low dose-rate treatment by inserting the source for a given fraction of each hour.

(V) "Radiation safety officer," as used in this chapter, means an individual who:

(1) Meets the requirements in paragraph (A) or (C)(1) of rule 3701:1-58-18 and in rule 3701:1-58-22 of the Administrative Code, or

(2) Is identified as a radiation safety officer on:

(a) A specific medical use license issued by the director, the United States nuclear regulatory commission, or an agreement state that authorizes the medical use of radioactive material; or

(b) A medical use permit issued by a United States nuclear regulatory commission master material licensee.

(W) "Stereotactic radiosurgery" means the use of external radiation in conjunction with a stereotactic guidance device to very precisely deliver a therapeutic dose to a tissue volume.

(X) "Structured educational program" means an educational program designed to impart particular knowledge and practical education through interrelated studies and supervised training.

(Y) "Teletherapy," as used in this chapter, means a method of radiation therapy in which collimated gamma rays are delivered at a distance from the patient or human research subject.

(Z) "Teletherapy Physicist" means the individual identified as the teletherapy physicist on a radioactive material license issued by the state of Ohio.

(AA) "Temporary job site," as used in this chapter, means a location where mobile medical services are conducted other than those location(s) of use authorized on the license.

(BB) "Therapeutic dosage" means a dosage of unsealed radioactive material that is intended to deliver a radiation dose to a patient or human research subject for palliative or curative treatment.

(CC) "Therapeutic dose" means a radiation dose delivered from a source containing radioactive material to a patient or human research subject for palliative or curative treatment.

(DD) "Treatment site" means the anatomical description of the tissue intended to receive a radiation dose, as described in a written directive.

(EE) "Type of use" means use of radioactive material under rule 3701:1-58-32, 3701:1-58-34, 3701:1-58-37, 3701:1-58-43, 3701:1-58-53, 3701:1-58-55 or 3701:1-58-72 of the Administrative Code.

(FF) "Unit dosage" means a dosage prepared for medical use for administration as a single dosage to a patient or human research subject without any further manipulation of the dosage after it is initially prepared.

(GG) "Written directive," as specified in rule 3701:1-58-15 of the Administrative Code, means an authorized user's written order for the administration of radioactive material or radiation from radioactive material to a specific patient or human research subject.

Last updated November 18, 2022 at 8:27 AM

History

• Effective: August 15, 2021
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-38-01

(A) As used in this chapter and all other rules promulgated pursuant to Chapter 3748. of the Revised Code:

(1) "A₁" means the maximum activity of special form radioactive material permitted in a type A package. These values are listed in rule 3701:1-50-25 of the Administrative Code, or may be derived in accordance with the procedure prescribed in rule 3701:1-50-25 of the Administrative Code.

(2) "A₂" means the maximum activity of radioactive material, other than special form, low specific activity and surface contaminated object material, permitted in a type A package. These values are listed in rule 3701:1-50-25 of the Administrative Code, or may be derived in accordance with the procedure prescribed in rule 3701:1-50-25 of the Administrative Code.

(3) "Absorbed dose" means the energy imparted by ionizing radiation per unit mass of irradiated material. The units of absorbed dose are the gray, or Gy, and the rad.

(4) "Accelerator or charged particle accelerator" means any of a class of radiation generating equipment designed to electronically accelerate atomic or sub-atomic particles for subsequent bombardment of targets.

(5) "Accelerator-produced radioactive material" means any material made radioactive by a particle accelerator.

(6) "Activity" means the rate of disintegration or transformation or decay of radioactive material. The units of activity are the becquerel, or Bq, and the curie, or Ci.

(7) "Address of use" means the building or buildings that are identified on the license or registration and where the source of radiation may be received, used, prepared, or stored, except for temporary job sites.

(8) "Administrative controls" means mechanisms used to protect health and minimize damage to life and property through the use of written policies, procedures, instructions, training, observation of work practices, and related compliance audits.

(9) "Administrative monetary penalty" means a monetary penalty assessed by the director under section 3748.05 of the Revised Code and in compliance with rules adopted thereunder, to emphasize the need for lasting remedial action and to deter future violations.

(10) "Adult" means an individual eighteen or more years of age.

(11) "Agreement state" means any state with which the United States nuclear regulatory commission or the atomic energy commission has entered into an effective agreement under subsection 274B of the Atomic Energy Act of 1954, 68 Stat. 919, 42 U.S.C. 2021, as amended (1978). Non-agreement state means any other state.

(12) "Airborne radioactive material" means radioactive material dispersed in the air in the form of dusts, fumes, particulates, mists, vapors, or gases.

(13) "Airborne radioactivity area" means a room, enclosure, or area in which airborne radioactive materials, composed wholly or partly of licensed material, exist in concentrations:

(a) In excess of the derived air concentrations (DACs) specified in appendix C to rule 3701:1-38-12 of the Administrative Code, or

(b) To such a degree that an individual present in the area without respiratory protective equipment could exceed, during the hours an individual is present in a week, an intake of 0.6 per cent of the annual limit on intake or twelve DAC-hours.

(14) "Air-purifying respirator" means a respirator with an air-purifying filter, cartridge, or canister that removes specific air contaminants by passing ambient air through the air-purifying element.

(15) "ALARA" or "as low as is reasonably achievable" means every reasonable effort to maintain exposures to radiation as far below the dose limits as is practical consistent with the purpose for which the licensed or registered activity is undertaken, taking into account the state of technology, the economics of improvements in relation to benefits to the public health and safety, and other societal and socioeconomic considerations, and in relation to utilization of nuclear energy and licensed materials and registered activities in the public interest.

(16) "Alert" means events may occur, are in progress, or have occurred that could lead to a release of radioactive material but that the release is not expected to require a response by off-site response organizations to protect persons off-site.

(17) "Annual limit on intake" or "ALI" means the derived limit for the amount of radioactive material taken into the body of an adult worker by inhalation or ingestion in a year. ALI is the smaller value of intake of a given radionuclide in a year by the reference man that would result in a committed effective dose equivalent of 0.05 sievert (five rem) or a committed dose equivalent of 0.5 sievert (fifty rem) to any individual organ or tissue. ALI values for intake by ingestion and by inhalation of selected radionuclides are given in appendix C to rule 3701:1-38-12 of the Administrative Code.

(18) "Annually" means either

(a) At intervals not to exceed one year; or

(b) Once per year, at about the same time each year, plus or minus one month.

(19) "Area of use" means a portion of an address of use that has been set aside for the purpose of receiving, preparing, using, or storing sources of radiation.

(20) "Assigned protection factor" or "APF" means the expected workplace level of respiratory protection that would be provided by a properly functioning respirator or a class of respirators to properly fitted and trained users. Operationally, the inhaled concentration can be estimated by dividing the ambient airborne concentration by the APF.

(21) "Atmosphere-supplying respirator" means a respirator that supplies the respirator user with breathing air from a source independent of the ambient atmosphere, and includes supplied air respirators, or SARs, and self-contained breathing apparatus, or SCBA, units.

(22) "Atomic energy commission" or "AEC" means the federal agency created by the Atomic Energy Act of 1954, 68 Stat. 919, 42 U.S.C. 2011, as amended (1964), and was the predecessor agency to the current United States nuclear regulatory commission.

(23) "Background radiation" means radiation from cosmic sources; naturally occurring radioactive materials, including radon, except as a decay product of source or special nuclear material, and global fallout as it exists in the environment from the testing of nuclear explosive devices or from past nuclear accidents such as Chernobyl that contribute to background radiation and are not under the control of the licensee. "Background radiation" does not include radiation from radioactive materials regulated by the department.

(24) "Becquerel" or "Bq" means the SI unit of activity. One becquerel is equal to one disintegration per second.

(25) "Bioassay" or "radiobioassay" means the determination of kinds, quantities or concentrations, and, in some cases, the locations of radioactive material in the human body, whether by direct measurement, in vivo counting, or by analysis and evaluation of materials excreted or removed from the human body.

(26) "Byproduct material" means

(a) Any radioactive material, except special nuclear material, yielded in or made radioactive by exposure to the radiation incident to the process of producing or utilizing special nuclear materials; or

(b) The tailings or wastes produced by the extraction or concentration of uranium or thorium from any ore processed primarily for its source material content, including discrete surface wastes resulting from solution extraction processes. Underground ore bodies depleted by such solution extraction do not constitute byproduct material within the definition.

(27) "Chelating agent" means a chemical compound or mixture that enhances the removal of radioactive material from the body, water or similar applications. Typical chelating agents include amine polycarboxylic acids such as EDTA or DTPA; hydroxy-carboxylic acids; and polycarboxylic acids such as citric acid, carbolic acid, and gluconic acid.

(28) "Chiropractor" means an individual licensed by the state of Ohio to practice chiropractic medicine pursuant to Chapter 4734. of the Revised Code.

(29) "Class" or "lung class" or "inhalation class" means a classification scheme for inhaled material according to its rate of clearance from the pulmonary region of the lung. Materials are classified as D, W, or Y, which applies to a range of clearance half-times: for class D, days, of less than ten days, for class W, weeks, from ten to one hundred days, and for class Y, years, of greater than one hundred days.

(30) "Collective dose" means the sum of the individual doses received in a given period of time by a specified population from exposure to a specified source of radiation.

(31) "Commencement of construction" means taking any action defined as "construction" or any other activity at the site of a facility subject to the rules promulgated pursuant to Chapter 3748. of the Revised Code that has a reasonable nexus to radiological health and safety.

(32) "Committed dose equivalent" or "H_T,50" means the dose equivalent to organs or tissues of reference, T, that will be received from an intake of radioactive material by an individual during the fifty year period following the intake.

(33) "Committed effective dose equivalent" or "H_E,50" means the sum of the products of the weighting factors applicable to each of the body organs or tissues, W_T, that are irradiated and the committed dose equivalent to each of these organs or tissues (H_{E, 50} = W_TH_T,50).

(34) "Consortium" means an association of medical use licensees and a PET radionuclide production facility in the same geographical area that jointly own or share in the operation and maintenance cost of the PET radionuclide production facility that produces PET radionuclides for use in producing radioactive drugs within the consortium for noncommercial distributions among its associated members for medical use. The PET radionuclide production facility within the consortium must be located at an educational institution or a medical facility.

(35) "Constraint" or "dose constraint" means a value above which specified licensee actions are required.

(36) "Construction" means the installation of foundations, or in-place assembly, erection, fabrication, or testing for any structure, system, or component of a facility or activity subject to the rules promulgated pursuant to Chapter 3748. of the Revised Code that are related to radiological safety or security. The term "construction" does not include:

(a) Changes for temporary use of the land for public recreational purposes;

(b) Site exploration, including necessary borings to determine foundation conditions or other preconstruction monitoring to establish background information related to the suitability of the site, the environmental impacts of construction or operation, or the protection of environmental values;

(c) Preparation of the site for construction of the facility, including clearing of the site, grading, installation of drainage, erosion and other environmental mitigation measures, and construction of temporary roads and borrow areas;

(d) Erection of fences and other access control measures that are not related to the safe use of, or security of, radiological materials subject to the rules promulgated pursuant to Chapter 3748. of the Revised Code;

(e) Excavation;

(f) Erection of support buildings (e.g. construction equipment storage sheds, warehouse and shop facilities, utilities, concrete mixing plants, docking and unloading facilities, and office buildings) for use in connection with the construction of the facility;

(g) Building of service facilities (e.g. paved roads, parking lots, railroad spurs, exterior utility and lighting systems, potable water systems, sanitary sewerage treatment facilities, and transmission lines);

(h) Procurement or fabrication of components or portions of the proposed facility occurring at other than the final, in-place location at the facility; or

(i) Taking any other action that has no reasonable nexus to radiological health and safety.

(37) "Controlled area" means an area, outside of a restricted area but inside the site boundary, access to which can be limited by the licensee or registrant for any reason.

(38) "Critical group" means the group of individuals reasonably expected to receive the greatest exposure to residual radioactivity for any applicable set of circumstances.

(39) "Curie" or "Ci" means a unit of activity. One curie equals 3.7 x 10¹⁰ disintegrations per second equals 3.7 x 10¹⁰ becquerels equals 2.22 x 10¹² disintegrations per minute.

(40) "Cyclotron" means a particle accelerator in which the charged particles travel in an outward spiral or circular path. A cyclotron accelerates charged particles at energies usually in excess of ten megaelectron volts and is commonly used for production of short half-life radionuclides for medical use.

(41) "Declared pregnant woman" means a woman who has voluntarily informed the licensee or registrant, in writing, of her pregnancy and the estimated date of conception. The declaration remains in effect until the declared pregnant woman withdraws the declaration in writing or is no longer pregnant.

(42) "Decommission" means to safely remove any licensed operation from service and reduce residual radioactivity to a level that permits release of the licensee's property for unrestricted use and termination of the license.

(43) "Dedicated check source" means a radioactive source that is used to assure the consistent performance of a radiation detection or measurement device over several months or years.

(44) "Deep dose equivalent" or "H_d" applies to external whole body exposure, and means the dose equivalent at a tissue depth of one centimeter, one thousand milligram per square centimeter.

(45) "Demand respirator" means an atmosphere-supplying respirator that admits breathing air to the facepiece only when a negative pressure is created inside the facepiece by inhalation.

(46) "Dentist" means an individual licensed by the state of Ohio to practice dentistry under Chapter 4715. of the Revised Code.

(47) "Department" means the Ohio department of health.

(48) "Depleted uranium" means uranium containing less uranium-235 than the naturally occurring distribution of uranium isotopes.

(49) "Derived air concentration" or "DAC" means the concentration of a given radionuclide in air which, if breathed by the reference man for a working year of two thousand hours under conditions of light work, results in an intake of one ALI. The condition of light work is inhaling 1.2 cubic meters of air per hour for two thousand hours in a year. DAC values are given in appendix C to rule 3701:1-38-12 of the Administrative Code.

(50) "Derived air concentration-hour or DAC-hour" means the product of the concentration of radioactive material in air, which is expressed as a fraction or multiple of the derived air concentration for each radionuclide, and the time of exposure to that radionuclide, in hours. A licensee or registrant may take two thousand DAC-hours to represent one ALI, equivalent to a committed effective dose equivalent of 0.05 Sv (five rem).

(51) "Direct reading dosimeter" means a device that measures radiation dose that does not require another device to read the measured radiation dose. Examples of direct reading dosimeters include pocket dosimeters and electronic dosimeters.

(52) "Director" means the director of health or a designee or authorized representative of the director.

(53) "Discipline" means a branch of knowledge or of teaching.

(54) "Discrete source" means a radionuclide that has been processed so that its concentration within a material has been purposely increased for use for commercial, medical, or research activities.

(55) "Disposable respirator" means a respirator for which maintenance is not intended and that is designed to be discarded after excessive breathing resistance, sorbent exhaustion, physical damage, or end-of service-life renders it unsuitable for use. Examples of this type of respirator are a disposable half-mask respirator or a disposable escape-only self-contained breathing apparatus.

(56) "Dose" or "radiation dose" is a generic term that means absorbed dose, dose equivalent, effective dose equivalent, committed effective dose equivalent, or total effective dose equivalent as defined in other paragraphs of this rule.

(57) "Dose equivalent" or "H_T" means the product of the absorbed dose in tissue, quality factor, and all other necessary modifying factors at the location of interest. The units of dose equivalent are the sievert and rem.

(58) "Dose limits" or "limits" means the permissible upper bounds of radiation doses established in accordance with these regulations but excludes background radiation and medical exposure.

(59) "Dosimetry processor" means a person that processes and evaluates individual monitoring devices in order to determine the radiation dose delivered to the monitoring devices.

(60) "Effective dose equivalent" or "H_E" means the sum of the products of the dose equivalent to each organ or tissue, H_T, and the weighting factor, W_T, applicable to each of the body organs or tissues that are irradiated: (H_E = ∑W_TH_T).

(61) "Embryo" or "fetus" means the developing human organism from conception until time of birth.

(62) "Engineering controls" means mechanisms used to protect health and minimize damage to life and property through engineering specifications, design, and construction of the product or facility including all of the security and safety features. This includes, but is not limited to, auxiliary security and safety features such as additional external shielding, barriers, and operational interlocks with associated processes.

(63) "Entrance" or "access point" means any opening through which an individual or extremity of an individual could gain access to radiation areas or to licensed radioactive materials or registered radiation generating equipment. This includes entry or exit portals of sufficient size to permit human entry, irrespective of their intended use.

(64) "Explosive material" means any chemical compound, mixture or device which produces a substantial instantaneous release of gas and heat spontaneously or by contact with sparks or flame.

(65) "Exposure" means being exposed to sources of ionizing radiation.

(66) "External dose" means that portion of the dose equivalent received from radiation sources outside the body.

(67) "Extremity" means hand, elbow, arm below the elbow, foot, knee, or leg below the knee.

(68) "Eye dose equivalent" means the same as lens dose equivalent.

(69) "Facility" means all buildings, equipment, structures and other stationary items that, in addition to the meaning defined in division (H) of section 3748.01 of the Revised Code, are:

(a) Located on a single site or on contiguous or adjacent sites and are operated by the same person and have common corporate or business interests; or

(b) Portions of a building or structure which are operated by the same person and have common corporate or business interests.

(70) "Filtering facepiece" or "dust mask" means a negative pressure particulate respirator with a filter as an integral part of the facepiece or with the entire facepiece composed of the filtering medium, not equipped with elastomeric sealing surfaces and adjustable straps.

(71) "Fissile material" means the radionuclides uranium-233, uranium-235, plutonium-239, and plutonium-241, or any combination of these radionuclides. Fissile material means the fissile nuclides themselves, not material containing fissile nuclides. Unirradiated natural uranium and depleted uranium and natural uranium or depleted uranium that has been irradiated in thermal reactors only, are not included in this definition. Certain exclusions from fissile material controls are provided in rule 3701:1-50-13 of the Administrative Code.

(72) "Fit factor" means quantitative estimate of the fit of a particular respirator to a specific individual, and typically estimates the ratio of the concentration of a substance in ambient air to its concentration inside the respirator when worn.

(73) "Fit test" means the use of a protocol to qualitatively or quantitatively evaluate the fit of a respirator on an individual.

(74) "Generally applicable environmental radiation standards" means standards issued by the United States environmental protection agency under the authority of the Atomic Energy Act of 1954, 68 Stat. 919, 42 U.S.C. 2011, as amended (2005), that impose limits on radiation exposures or levels, or concentrations or quantities of radioactive material, in the general environment outside the boundaries of locations under the control of persons possessing or using radioactive material.

(75) "Gray" or "Gy" means the SI unit of absorbed dose. One gray is equal to an absorbed dose of one joule per kilogram (one hundred rads).

(76) "Handle" means receive, possess, use, store, transfer, install, service, or dispose of sources of radiation unless possession is solely for the purpose of transportation.

(77) "Handler" means a facility that handles sources of radiation unless possession is solely for the purpose of transportation.

(78) "Hazardous waste" means those wastes designated as hazardous by rule 3745-51-03 of the Administrative Code.

(79) "Helmet" means a rigid respiratory inlet covering that also provides head protection against impact and penetration.

(80) "High radiation area" means an area, accessible to individuals, in which radiation levels from radiation sources external to the body could result in an individual receiving a dose equivalent in excess of one millisievert (0.1 rem) in one hour at thirty centimeters from the radiation source or thirty centimeters from any surface that the radiation penetrates.

(81) "Hood" means a respiratory inlet covering that completely covers the head and neck and may also cover portions of the shoulders and torso.

(82) "Individual" means any human being.

(83) "Individual monitoring" means

(a) The assessment of dose equivalent by the use of devices designed to be worn by an individual;

(b) The assessment of committed effective dose equivalent by bioassay or by determination of the time-weighted air concentrations to which an individual has been exposed, i.e. DAC-hours; or

(c) The assessment of dose equivalent by the use of survey data.

(84) "Individual monitoring devices" means devices designed to be worn by a single individual for the assessment of dose equivalent such as film badges; thermoluminescent dosimeters; optically stimulated luminescent dosimeters; pocket ionization chambers; and personal air sampling devices.

(85) "Industrial radiography" means the examination of the structure of materials by nondestructive methods, utilizing sealed sources of radioactive material or radiation-generating equipment.

(86) "Internal dose" means that portion of the dose equivalent received from radioactive material taken into the body.

(87) "Irradiator" means a facility that uses radioactive sealed sources for the irradiation of objects or materials and in which radiation dose rates exceeding five grays (five hundred rads) per hour exist at one meter from the sealed radioactive source in air or water, as applicable for the irradiator type, but does not include irradiators in which both the sealed source and the area subject to irradiation are contained within a device and are not accessible to personnel.

(88) "Lens dose equivalent" or "eye dose equivalent" means the external exposure of the lens of the eye and is taken as the dose equivalent at a tissue depth of 0.3 centimeters; i.e. three hundred milligrams per square centimeter.

(89) "License" means a license issued by the nuclear regulatory commission, the director, or another agreement state in accordance with rules adopted by those organizations.

(90) "Licensee" means a person to whom a license is issued.

(91) "Licensed activity" means an activity authorized by a radioactive material license which is essential to achieving the purpose for which the license was issued or amended.

(92) "Licensed material" means radioactive material received, possessed, used, transferred or disposed of under a general or specific license.

(93) "Loose-fitting facepiece" means a respiratory inlet covering that is designed to form a partial seal with the face.

(94) "Lost or missing licensed source of radiation" means a licensed source of radiation whose location is unknown. It includes material that has been shipped but has not reached its destination and whose location cannot be readily traced in the transportation system.

(95) "Low-level radioactive waste" or "LLRW," also "low-level waste," or "LLW" means radioactive waste which is not high-level radioactive waste, spent nuclear fuel, NARM, or byproduct material as defined in section 11 E. (2) of the Atomic Energy Act of 1954 68 Stat. 919, 42 U.S.C. 2011, as amended (2005), but is radioactive material that the United States nuclear regulatory commission classifies as low-level radioactive waste.

(96) "Low specific activity material" or "LSA" means radioactive material with limited specific activity which is nonfissile or is excepted under rule 3701:1-50-13 of the Administrative Code, and which satisfies the descriptions and limits set forth below. Shielding materials surrounding the LSA material may not be considered in determining the estimated average specific activity of the package contents. LSA must be in one of three groups:

(a) LSA - I.

(i) Uranium and thorium ores, concentrates of uranium and thorium ores, and other ores containing naturally occurring radioactive radionuclides that are intended to be processed for the use of these radionuclides;

(ii) Natural uranium, depleted uranium, natural thorium or their compounds or mixtures, provided they are unirradiated and in solid or liquid form;

(iii) Radioactive material other than fissile material, for which the A₂ value is unlimited; or

(iv) Other radioactive material in which the activity is distributed throughout and the estimated average specific activity does not exceed thirty times the value for exempt material activity concentration determined in accordance with rule 3701:1-50-25 of the Administrative Code.

(b) LSA-II.

(i) Water with tritium concentration up to 0.8 terabecquerels per liter (twenty curies per liter); or

(ii) Other material in which the activity is distributed throughout and the estimated average specific activity does not exceed ( 10^-4 A₂) per gram for solids and gases, and (10^-5 A₂) per gram for liquids.

(c) LSA-III. Solids (e.g., consolidated wastes, activated materials), excluding powders, that satisfy the requirements of 10 C.F.R. 71.77 (as in effect on the effective date of this rule), in which:

(i) The radioactive material is distributed throughout a solid or a collection of solid objects, or is essentially uniformly distributed in a solid compact binding agent (such as concrete, bitumen, ceramic, etc.);

(ii) The radioactive material is relatively insoluble, or it is intrinsically contained in a relatively insoluble material, so that even under loss of packaging, the loss of radioactive material per package by leaching, when placed in water for seven days, would not exceed (0.1 x A₂); and

(iii) The estimated average specific activity of the solid, excluding any shielding material, does not exceed (0.002 x A₂) per gram.

(97) "Management" means the chief executive officer or other individual having the authority to manage, direct, or administer the licensee's activities, or those persons' delegate or delegates.

(98) "Medical institution" means an organization in which more than one medical discipline is practiced.

(99) "Medical use" means the intentional internal or external administration of radioactive material or the radiation therefrom to patients or human research subjects under the supervision of an authorized user.

(100) "Member of the public" means any individual except when that individual is receiving an occupational dose.

(101) "Minor" means an individual less than eighteen years of age.

(102) "Monitoring" or "radiation monitoring" or "radiation protection monitoring" means the measurement of radiation levels, concentrations, surface area concentrations or quantities of radioactive material and the use of the results of these measurements to evaluate potential exposures and doses.

(103) "NARM" or "naturally occurring or accelerator-produced radioactive material" means naturally occurring or accelerator-produced radioactive material, including naturally occurring material that is technologically enhanced, and those nuclides that are generated in a charged particle accelerator, but does not include source material, byproduct material, or special nuclear material.

(104) "NARM licensing state" means any state with regulations equivalent to the suggested state regulations for control of radiation relating to, and an effective program for, the regulatory control of NARM and which has been granted final designation by the conference of radiation control program directors, inc.

(105) "Nationally tracked source" means a sealed source containing a quantity equal to or greater than "Category 1" or "Category 2" levels of any radioactive material listed in the appendix to rule 3701:1-38-25 of the Administrative Code. In this context a sealed source is defined as radioactive material that is sealed in a capsule or closely bonded, in a solid form and which is not exempt from regulatory control. It does not mean material encapsulated solely for disposal, or nuclear material contained in any fuel assembly, subassembly, fuel rod, or fuel pellet. "Category 1" nationally tracked sources are those containing radioactive material at a quantity equal to or greater than the "Category 1" threshold. "Category 2" nationally tracked sources are those containing radioactive material at a quantity equal to or greater than the "Category 2" threshold but less than the "Category 1" threshold.

(106) "Negative pressure respirator" or "tight fitting respirator" means a respirator in which the air pressure inside the facepiece is negative during inhalation with respect to the ambient air pressure outside the respirator.

(107) "Nonstochastic effect" or "deterministic effect" means health effects, the severity of which varies with the dose and for which a threshold is believed to exist. Radiation-induced cataract formation is an example of a nonstochastic effect.

(108) "NORM" or "naturally occurring radioactive material" means any nuclide that is radioactive in its natural physical state, but does not include source material, byproduct material, or special nuclear material.

(109) "Normal form radioactive material" means radioactive material that has not been demonstrated to qualify as special form radioactive material.

(110) "Nuclear regulatory commission" means the federal agency established by Title II of the Energy Reorganization Act of 1974, 88 Stat. 1233, 42 U.S.C.A. 5801, as amended (2005), comprising the members of the commission and all offices, employees, and representatives authorized to act in any case or matter related to licensing and related regulatory function previously assigned to the AEC.

(111) "Occupational dose" means the dose received by an individual in the course of employment in which the individual's assigned duties involve exposure to radiation or radioactive material from licensed and unlicensed sources of radiation, whether in the possession of the licensee or other person. Occupational dose does not include doses received from background radiation, from any medical administration the individual has received, from exposures to individuals administered radioactive materials and released in accordance with rule 3701:1-58-30 of the Administrative Code or equivalent United States nuclear regulatory commission or agreement state regulations, from voluntary participation in medical research programs, or as a member of the public.

(112) "Package" means the packaging together with its radioactive contents as presented for transport.

(a) Fissile material package or type AF package, type BF package, type B(U)F package, or type B(M)F package means a fissile material packaging together with its fissile material contents.

(b) Type A package means a type A packaging together with its radioactive contents. A type A package is defined and must comply with the United States department of transportation regulations in 49 C.F.R. 173 (as in effect on the effective date of this rule).

(c) Type B package means a type B packaging together with its radioactive contents. On approval, a type B package design is designated by the United States nuclear regulatory commission as B(U) unless the package has a maximum normal operating pressure of more than seven hundred kilopascals (one hundred pounds per square inch) gauge or a pressure relief device that would allow the release of radioactive material to the environment under the tests specified in 10 C.F.R. 71.73 (hypothetical accident conditions) (as in effect on the effective date of this rule), in which case it will receive a designation B(M). B(U) refers to the need for unilateral approval of international shipments; B(M) refers to the need for multilateral approval of international shipments. There is no distinction made in how packages with these designations may be used in domestic transportation. To determine their distinction for international transportation, see United States department of transportation regulations in 49 C.F.R. 173 (as in effect on the effective date of this rule). A type B package approved before September 6, 1983, was designated only as type B. Limitations on its use are specified in 10 C.F.R. 71.19 (as in effect on the effective date of this rule).

(113) "Packaging" means the assembly of components necessary to ensure compliance with the packaging requirements of rule 49 C.F.R. 173 Subpart I (as in effect on the effective date of this rule). It may consist of one or more receptacles, absorbent materials, spacing structures, thermal insulation, radiation shielding, and devices for cooling or absorbing mechanical shocks. The vehicle, tie-down system and auxiliary equipment may be designated as part of the packaging.

(114) "Particle accelerator" means any machine capable of accelerating electrons, protons, deuterons, or other charged particles in a vacuum and of discharging the resultant particulate or other radiation into a medium at energies usually in excess of one megaelectron volt. For purposes of this definition, "accelerator" is an equivalent term.

(115) "Person" means any individual, corporation, association, business enterprise, or other legal entity either public or private and any legal successor, representative, agent, or agency of that individual, corporation, association, business enterprise, or other legal entity. Person also includes the United States, states, political subdivisions of states, and any department, agency, or instrumentality of the United States or a state, except the U.S. department of energy or the U.S. nuclear regulatory commission where the state regulation of radioactive material by either of those agencies is prohibited by federal law.

(116) "Personnel dosimeter", means a device that measures radiation dose that is processed and evaluated by an accredited "National Voluntary Laboratory Accreditation Program" (NVLAP) processor. Examples of personnel dosimeters include film badges, thermo-luminescent dosimeters (TLD), and optically stimulated luminescence (OSL) dosimeters.

(117) "Pharmacist" means a person who is licensed by the state of Ohio to practice pharmacy pursuant to Chapter 4731. of the Revised Code.

(118) "Physician" means a person who is licensed pursuant to Chapter 4731. of the Revised Code to practice medicine or surgery or osteopathic medicine or surgery.

(119) "Planned special exposure" means an infrequent exposure to radiation, separate from and in addition to the annual dose limits.

(120) "Podiatrist" means an individual licensed by the state of Ohio to practice podiatry pursuant to Chapter 4731. of the Revised Code.

(121) "Positive pressure respirator" means a respirator in which the pressure inside the respiratory inlet covering exceeds the ambient air pressure outside the respirator.

(122) "Positron Emission Tomography (PET) radionuclide production facility" means a facility operating a cyclotron or accelerator for the purpose of producing PET radionuclides.

(123) "Powered air-purifying respirator" or "PAPR" means an air-purifying respirator that uses a blower to force the ambient air through air purifying elements to the inlet covering.

(124) "Pressure demand respirator" means a positive pressure atmosphere supplying respirator that admits breathing air to the facepiece when the positive pressure is reduced inside the facepiece by inhalation.

(125) "Public dose" means the dose received by a member of the public from exposure to radiation and/or radioactive material released by the licensee, or to any other source of radiation under the control of a licensee or registrant. Public dose does not include occupational dose or doses received from background radiation, from any medical administration the individual has received, from exposures to individuals administered radioactive materials and released in accordance with rule 3701:1-58-30 of the Administrative Code or equivalent United States nuclear regulatory commission or agreement state regulations, or from voluntary participation in medical research programs.

(126) "Pyrophoric material" means any liquid that ignites spontaneously in dry or moist air at or below 54.4 degrees celsius (one hundred thirty degrees fahrenheit). A pyrophoric solid is any solid material, other than one classed as an explosive, which under normal conditions is liable to cause fires through friction, retained heat from manufacturing or processing, or which can be ignited readily and when ignited burns so vigorously and persistently as to create a serious transportation, handling, or disposal hazard. Included are spontaneously combustible and water-reactive materials.

(127) "Qualitative fit test" or "QLFT" means a pass/fail fit test to assess the adequacy of respirator fit that relies on the individual's response to the test agent.

(128) "Quality factor" or "Q" means the modifying factor, as listed in paragraphs (A) and (B) of rule 3701:1-38-11 of the Administrative Code, that is used to derive dose equivalent from absorbed dose.

(129) "Quantitative fit test" or "QNFT" means an assessment of the adequacy of respirator fit by numerically measuring the amount of leakage into the respirator.

(130) "Quarter" or "quarterly" means a period of time equal to one-fourth of the year observed by the licensee or registrant, approximately thirteen consecutive weeks, providing that the beginning of the first quarter in a year coincides with the starting date of the year and that no day is omitted or duplicated in consecutive quarters.

(131) "Rad" means the special unit of radiation absorbed dose. One rad is equal to an absorbed dose of one hundred ergs per gram, or 0.01 joule per kilogram, or 0.01 gray.

(132) "Radiation" or "ionizing radiation" means alpha particles, beta particles, gamma rays, x-rays, neutrons, high speed electrons, high speed protons, and other particles capable of producing ions. Radiation does not include nonionizing radiation, such as radio or microwaves, or visible, infrared or ultraviolet light.

(133) "Radiation area" means an area, accessible to individuals, in which radiation levels could result in an individual receiving a dose equivalent in excess of 0.05 millisievert (0.005 rem) in one hour at thirty centimeters from the source of radiation or from any surface that the radiation penetrates.

(134) "Radiation-generating equipment" or "RGE" means any manufactured product or device, or component of such a product or device, or any machine or system that during operation can generate or emit radiation, except those that emit radiation only from radioactive material. "Radiation-generating equipment" does not include either of the following:

(a) Diathermy machines;

(b) Microwave ovens, including food service microwave ovens used for commercial and industrial uses, television receivers, electric lamps, and other household appliances and products that generate very low levels of radiation.

(135) "Radiation Safety Officer" or "RSO" means an individual designated by the licensee who has the knowledge and responsibility for the overall radiation safety program at the facility, to include the implementation of the daily radiation safety operations and compliance with the rules.

(136) "Radioactive material" means any solid, liquid or gaseous material that emits ionizing radiation spontaneously. "Radioactive material" includes accelerator-produced and naturally occurring radioactive materials and byproduct, source, and special nuclear material.

(137) "Radioactive waste" means waste containing regulated radioactive material.

(138) "Radioactivity" means the transformation of unstable atoms by the emission of radiation.

(139) "Radiography" means the same as industrial radiography.

(140) "Reference man" means a hypothetical aggregation of human physical and physiological characteristics arrived at by international consensus. These characteristics may be used by researchers and public health workers to standardize results of experiments and to relate biological insult to a common base.

(141) "Registrant" means a person required by Chapter 3748. of the Revised Code to register radiation-generating equipment with the director.

(142) "Rem" means the special unit of any of the quantities expressed as dose equivalent. The dose equivalent in rem is equal to the absorbed dose in rads multiplied by the quality factor (one rem = 0.01 Sv).

(143) "Research and development" means

(a) Theoretical analysis, exploration, or experimentation; or

(b) The extension of investigative findings and theories of a scientific or technical nature into practical application for experimental and demonstration purposes, including the experimental production and testing of models, devices, equipment, materials and processes. "Research and development" does not include the internal or external administration of sources of radiation to human beings.

(144) "Residual radioactivity" means radioactivity in structures, materials, soils, groundwater, and other media at a site resulting from activities under the licensee's control. This includes radioactivity from all licensed and unlicensed sources used by the licensee, but excludes background radiation. It also includes radioactive materials remaining at the site as a result of routine or accidental releases of radioactive material at the site and previous burials at the site, even if those burials were made in accordance with the provisions of 10 C.F.R. 20 (as in effect on the effective date of this rule).

(145) "Respiratory protective equipment or device" means an apparatus, such as a respirator, used to reduce the individual's intake of airborne radioactive materials.

(146) "Restricted area" means an area access to which is limited by the licensee or registrant for the purpose of protecting individuals against undue risks from exposure to sources of radiation. Restricted area does not include areas used as residential quarters, but separate rooms in a residential building may be set apart as a restricted area.

(147) "Roentgen" means the amount of gamma or x-rays required to produce ions resulting in a charge of 0.000258 coulombs per kilogram of air under standard conditions.

(148) "Sanitary sewerage" means a system of public sewers for carrying off wastewater and refuse, but excluding sewage treatment facilities, septic tanks, and leach fields owned or operated by the licensee.

(149) "Sealed source" means radioactive material that is encased in a manner designed to prevent leakage or escape of the radioactive material.

(150) "Sealed source and device registry" means the national registry that contains all the registration certificates, generated by both the United States nuclear regulatory commission and the agreement states, that summarize the radiation safety information for the sealed sources and devices and describe the licensing and use conditions approved for the product.

(151) "Seismic area" means any area where the probability of a horizontal acceleration in rock of more than 0.3 times the acceleration of gravity in two hundred fifty years is greater than ten per cent, as designated by the United States geological survey.

(152) "Self-contained breathing apparatus" or "SCBA" means an atmosphere-supplying respirator for which the breathing air source is designed to be carried by the user.

(153) "Shallow dose equivalent" or "H_S" means the external exposure of the skin of the whole body or the skin of an extremity, is taken as the dose equivalent at a tissue depth of 0.007 centimeter, or seven milligrams per square centimeter.

(154) "Sievert" or "Sv" means the SI unit of any of the quantities expressed as dose equivalent. The dose equivalent in sieverts is equal to the absorbed dose in grays multiplied by the quality factor. One sievert equals one hundred rem.

(155) "Site area emergency" means events may occur, are in progress, or have occurred that could lead to a significant release of radioactive material and that could require a response by off-site response organizations to protect persons off-site.

(156) "Site boundary" means that line beyond which the land or property is not owned, leased, or otherwise controlled by the licensee or registrant.

(157) "Site closure and stabilization" means those actions that are taken upon completion of operations that prepare a disposal site for custodial care and that assure that the disposal site will remain stable and will not need ongoing active maintenance.

(158) "Source material" means uranium, thorium, or any combination thereof in any physical or chemical form, or any ores that contain by weight at least one-twentieth of one per cent (0.05 per cent) of uranium, thorium, or any combination thereof. Source material does not include special nuclear material.

(159) "Sources of radiation" means radioactive material or radiation generating equipment.

(160) "Special form radioactive material" means radioactive material that satisfies the following conditions:

(a) It is either a single solid piece or is contained in a sealed capsule that can be opened only by destroying the capsule;

(b) The piece or capsule has at least one dimension not less than five millimeters (0.2 inch); and

(c) It satisfies the test requirements specified by the United States nuclear regulatory commission in 10 C.F.R. 71.75 (as in effect on the effective date of this rule). A special form encapsulation designed in accordance with the United States nuclear regulatory commission requirements identified in 10 C.F.R. 71.4, in effect on June 30, 1983, and constructed prior to July 1, 1985; a special form encapsulation designed in accordance with the requirements of 10 C.F.R. 71.4 in effect on March 31, 1996, and constructed before April 1, 1998; and special form material that was successfully tested before September 10, 2015 in accordance with the requirements of 10 C.F.R. 71.75(d) of this section in effect before September 10, 2015 may continue to be used. Any other special form encapsulation must meet the specifications of this definition.

(161) "Special nuclear material" means either of the following:

(a) Plutonium, uranium-233, uranium enriched in the isotope 233, or in the isotope 235, and any other material that the United States nuclear regulatory commission determines to be special nuclear material, but does not include source material pursuant to section 51 of the Atomic Energy Act of 1954, 68 Stat 919, 42 USCA 2071, as amended (2005).

(b) Any material artificially enriched by any of the foregoing but does not include source material.

(162) "Special nuclear material in quantities not sufficient to form a critical mass" means uranium enriched in the isotope uranium-235 in quantities not exceeding three hundred fifty grams of contained uranium-235; uranium-233 in quantities not exceeding two hundred grams; plutonium in quantities not exceeding two hundred grams; or any combination of them in accordance with the following formula: for each kind of special nuclear material, determine the ratio between the quantity of that special nuclear material and the quantity specified in this paragraph for the same kind of special nuclear material. The sum of such ratios for all of the kinds of special nuclear material in combination shall not exceed unity.

(163) "Stochastic effect" means health effects that occur randomly and for which the probability of the effect occurring, rather than its severity, is assumed to be a linear function of dose without threshold. Hereditary effects and cancer incidence are examples of stochastic effects.

(164) "Supplied-air respirator" or "SAR" or "airline respirator" means an atmosphere-supplying respirator for which the source of breathing air is not designed to be carried by the user.

(165) "Surface contaminated object" or "SCO" means a solid object that is not itself classed as radioactive material, but which has radioactive material distributed on any of its surfaces. SCO must be in one of two groups with surface activity not exceeding the following limits:

(a) SCO-I: a solid object on which:

(i) The non-fixed contamination on the accessible surface averaged over three hundred square centimeters, or the area of the surface if less than three hundred square centimeters, does not exceed four becquerels per square centimeter (10^-4 microcurie per square centimeter) for beta and gamma and low toxicity alpha emitters, or 0.4 becquerels per square centimeter 10^-5 microcurie per square centimeter) for all other alpha emitters;

(ii) The fixed contamination on the accessible surface averaged over three hundred square centimeters, or the area of the surface if less than three hundred square centimeters, does not exceed forty thousand becquerels per square centimeter (one microcurie per square centimeter) for beta and gamma and low toxicity alpha emitters, or four thousand becquerels per square centimeter (0.1 microcurie per square centimeter) for all other alpha emitters; and

(iii) The non-fixed contamination plus the fixed contamination on the inaccessible surface averaged over three hundred square centimeters, or the area of the surface if less than three hundred square centimeters, does not exceed forty thousand becquerels per square centimeter (one microcurie per square centimeter) for beta and gamma and low toxicity alpha emitters, or four thousand becquerels per square centimeter (0.1 microcurie per square centimeter) for all other alpha emitters.

(b) SCO-II: a solid object on which the limits for SCO-I are exceeded and on which:

(i) The non-fixed contamination on the accessible surface averaged over three hundred square centimeters, or the area of the surface if less than three hundred square centimeter, does not exceed four hundred becquerels per square centimeter (10^-2 microcurie per square centimeter) for beta and gamma and low toxicity alpha emitters, or forty becquerels per square centimeter (10^-3 microcurie per square centimeter) for all other alpha emitters;

(ii) The fixed contamination on the accessible surface averaged over three hundred square centimeters, or the area of the surface if less than three hundred square centimeters, does not exceed eight hundred thousand becquerels per square centimeter (twenty microcuries per square centimeter) for beta and gamma and low toxicity alpha emitters, or eighty thousand becquerels per square centimeter (two microcuries per square centimeter) for all other alpha emitters; and

(iii) The non-fixed contamination plus the fixed contamination on the inaccessible surface averaged over three hundred square centimeters, or the area of the surface if less than three hundred square centimeters, does not exceed eight hundred thousand becquerels per square centimeter (twenty microcuries per square centimeter) for beta and gamma and low toxicity alpha emitters, or eighty thousand becquerels per square centimeter (two microcuries per square centimeter) for all other alpha emitters.

(166) "Survey" means an evaluation of the radiological conditions and potential hazards incident to the production, use, transfer, release, disposal or presence of radioactive material or other sources of radiation. When appropriate, such an evaluation includes a physical survey of the location of radioactive material, or the sources of radiation and measurements or calculations of levels of radiation, or concentrations or quantities of radioactive material present.

(167) "Tight-fitting facepiece" means a respiratory inlet covering that forms a complete seal with the face.

(168) "Total effective dose equivalent" or "TEDE" means the sum of the effective dose equivalent (for external exposures) and the committed effective dose equivalent (for internal exposures).

(169) "Transport index" means the dimensionless number, rounded up to the next tenth, placed on the label of a package, to designate the degree of control to be exercised by the carrier during transportation. The transport index is the number determined by multiplying the maximum radiation level in millisievert per hour at one meter (3.3 feet) from the external surface of the package by one hundred, which is equivalent to the maximum radiation level in millirem per hour at one meter (3.3 feet).

(170) "Type A quantity" means a quantity of radioactive material, the aggregate radioactivity of which does not exceed A₁ for special form radioactive material, or A₂ for normal form radioactive material, where A₁ and A₂ are given in rule 3701:1-50-25 of the Administrative Code.

(171) "Type B quantity" means a quantity of radioactive material greater than a type A quantity.

(172) "Type B package" is defined under "Package."

(173) "United States department of energy" means the department of energy established by the Department of Energy Organization Act, PL 95-91, 91 Stat. 565 (1977), 42 U.S.C. 7101 et seq., as amended (2006), to the extent that the department of energy or its duly authorized representatives, exercises functions formerly vested in the United States atomic energy commission, its chairman, members, officers and components and transferred to the United States energy research and development administration and to the administrator thereof pursuant to Sections 104(b) to (d) of the Energy Reorganization Act of 1974, PL 93-438, 88 Stat. 1233 at 1237 (1974), 42 U.S.C. 5814 and retransferred to the secretary of energy pursuant to Section 301(a) of the Department of Energy Organization Act, PL 95-91, 91 Stat. 565 at 577-578 (1977), 42 U.S.C. 7151.

(174) "Unrestricted area" or "uncontrolled area" means any area, access to which is neither restricted nor controlled by the licensee or registrant.

(175) "User seal check" or "fit check" means an action conducted by the respirator user to determine if the respirator is properly seated to the face. Examples include negative pressure check, positive pressure check, irritant smoke check, or isoamyl acetate check.

(176) "Very high radiation area" means an area, accessible to individuals, in which radiation levels from radiation sources external to the body could result in an individual receiving an absorbed dose in excess of five gray (five hundred rad) in one hour at one meter from a source of radiation or from any surface that the radiation penetrates. At very high doses received at high dose rates, units of absorbed dose, gray and rad, are appropriate, rather than units of dose equivalent, sievert and rem.

(177) "Veterinarian" means an individual licensed by the state of Ohio to practice veterinary medicine pursuant to Chapter 4741. of the Revised Code.

(178) "Waste" means those low-level radioactive wastes containing source, special nuclear, or byproduct material that are acceptable for disposal in a land disposal facility. For the purposes of this definition, low-level radioactive waste means radioactive waste not classified as high-level radioactive waste, transuranic waste, spent nuclear fuel, or byproduct material as defined in paragraph (A)(26)(b) of this rule, or byproduct material as defined in section 11 E. (3) and (4) of the Atomic Energy Act of 1954, 68 Stat. 919, 42 USC 2014, as amended (2005).

(179) "Week" means seven consecutive days starting on Sunday.

(180) "Weighting factor

• W_T" for an organ or tissue, (T), is the proportion of the risk of stochastic effects resulting from irradiation of that organ or tissue to the total risk of stochastic effects when the whole body is irradiated uniformly. For calculating the effective dose equivalent, the values of W_T are:

| Organ doseweighting factors | | | --- | --- | | Organ ortissue | W_T | | Gonads | 0.25 | | Breast | 0.15 | | Red bone marrow | 0.12 | | Lung | 0.12 | | Thyroid | 0.03 | | Bonesurfaces | 0.03 | | Remainder | 0.30^a | | Whole body | 1.00^b |

^\a 0.30 results from 0.06 for each of five "remainder" organs, excluding the skin and the lens of the eye, that receive the highest doses.

^\b for the purpose of weighting the external whole body dose (for adding it to the internal dose) a single weighting factor, W_T = 1.0, has been specified. The use of other weighting factors for external exposure will be approved on a case-by-case basis until such time as specific guidance is issued.

(181) "Whole body" means for purposes of external exposure, head; trunk, including male gonads; arms above the elbow; legs above the knee.

(182) "Worker" means an individual engaged in activities licensed or registered by the department and controlled by a licensee or registrant, but does not include the licensee or registrant.

(183) "Working level" or "WL" means any combination of short-lived radon decay products (for radon-222: polonium-218, lead-214, bismuth-214, and polonium-214; and for radon-220: polonium-216, lead-212, bismuth-212, and polonium-212) in one liter of air that will result in the ultimate emission of 1.3 x 10⁵ million electron volts alpha particle energy.

(184) "Working level month" or "WLM" means a cumulative exposure to one working level for one hundred seventy hours. (Two thousand working hours per year/twelve months per year equals approximately one hundred seventy hours per month.)

(185) "Year" means the period of time beginning in January used to determine compliance with the provisions of this rule. The licensee or registrant may change the starting date of the year used to determine compliance by the licensee or registrant provided that the change is made at the beginning of the year and that no day is omitted or duplicated in consecutive years.

(B) The terms set out in paragraph (A) of this rule may be redefined in other chapters as promulgated pursuant to Chapter 3748. of the Revised Code as used in that chapter only.

Last updated May 13, 2026 at 11:20 AM

History

• Effective: January 20, 2022
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-58-18

Except as provided in rule 3701:1-58-21 of the Administrative Code, the licensee shall require an individual fulfilling the responsibilities of the radiation safety officer or an individual assigned duties and tasks as an associate radiation safety officer as provided in rule 3701:1-58-12 of the Administrative Code to be an individual who:

(A) Is certified by a specialty board whose certification process has been recognized by the director, the United States nuclear regulatory commission, or an agreement state and who meets the requirements in paragraph (D) of this rule. The names of board certifications which have been recognized by the director, the United States nuclear regulatory commission, or an agreement state will be posted on the United States nuclear regulatory commission's "Medical Uses Licensee Toolkit" web page at www.nrc.gov. To have its certification process recognized, a specialty board shall require all candidates for certification to:

(1)

(a) Hold a bachelor's or graduate degree from an accredited college or university in physical science or engineering or biological science with a minimum of twenty college credits in physical science;

(b) Have five or more years of professional experience in health physics, for which graduate training may be substituted for no more than two years of the required experience, with at least three years in applied health physics; and

(c) Pass an examination administered by diplomates of the specialty board, which evaluates knowledge and competence in radiation physics and instrumentation, radiation protection, mathematics pertaining to the use and measurement of radioactivity, radiation biology, and radiation dosimetry; or

(2)

(a) Hold a master's or doctor's degree in physics, medical physics, other physical science, engineering, or applied mathematics from an accredited college or university;

(b) Have two years of full-time practical training and/or supervised experience in medical physics:

(i) Under the supervision of a medical physicist who is certified in medical physics by a specialty board recognized by the director, United States nuclear regulatory commission, or an agreement state; or

(ii) In clinical nuclear medicine facilities providing diagnostic and/or therapeutic services under the direction of physicians who meet the requirements for authorized users in rule 3701:1-58-21, 3701:1-58-36 or rule 3701:1-58-40 of the Administrative Code; and

(c) Pass an examination, administered by diplomates of the specialty board, that assesses knowledge and competence in clinical diagnostic radiological or nuclear medicine physics and in radiation safety; or

(B) Has achieved the following requirements:

(1) Has completed a structured educational program consisting of both:

(a) Two hundred hours of classroom and laboratory training in the following areas:

(i) Radiation physics and instrumentation;

(ii) Radiation protection;

(iii) Mathematics pertaining to the use and measurement of radioactivity;

(iv) Radiation biology; and

(v) Radiation dosimetry; and

(b) One year of full-time radiation safety experience under the supervision of the individual identified as the radiation safety officer on a United States nuclear regulatory commission or agreement state license, or permit issued by a United States nuclear regulatory commission master material licensee, that authorizes similar type(s) of use(s) of radioactive material. An associate radiation safety officer may provide supervision for those areas for which the associate radiation safety officer is authorized on a United States nuclear regulatory commission or agreement state license, or permit issued by a United States nuclear regulatory commission master material licensee. The full-time radiation safety experience must involve the following:

(i) Shipping, receiving, and performing related radiation surveys;

(ii) Using and performing checks for proper operation of instruments used to determine the activity of dosages, survey meters, and instruments used to measure radionuclides;

(iii) Securing and controlling radioactive material;

(iv) Using administrative controls to avoid mistakes in the administration of radioactive material;

(v) Using procedures to prevent or minimize radioactive contamination and using proper decontamination procedures;

(vi) Using emergency procedures to control radioactive material; and

(vii) Disposing of radioactive material; and

(2) This individual must obtain a written attestation, signed by a preceptor radiation safety officer or associate radiation safety officer who has experience with the radiation safety aspects of similar types of use of radioactive material for which the individual is seeking approval as a radiation safety officer or an associate radiation safety officer. The written attestation must state that the individual has satisfactorily completed the requirements in paragraphs (B)(1) and (D) of this rule, and is able to independently fulfill the radiation safety-related duties as a radiation safety officer or as an associate radiation safety officer for a medical use license; or

(C)

(1) Is a medical physicist who has been certified by a specialty board whose certification process has been recognized by the director, United States nuclear regulatory commission, or an agreement state under paragraph (A) of rule 3701:1-58-19 of the Administrative Code and has experience in radiation safety for similar types of use of radioactive material for which the licensee is seeking the approval of the individual as radiation safety officer or an associate radiation safety officer and who meets the requirements in paragraph (D) of this rule; or

(2) Is an authorized user, authorized medical physicist, or authorized nuclear pharmacist identified on a United States nuclear regulatory commission or an agreement state license, a permit issued by a United States nuclear regulatory commission master material licensee, a permit issued by a United States nuclear regulatory commission or an agreement state licensee of broad scope, or a permit issued by a United States nuclear regulatory commission master material license broad scope permittee, has experience with the radiation safety aspects of similar types of use of radioactive material for which the licensee seeks the approval of the individual as the radiation safety officer or associate radiation safety officer, and meets the requirements in paragraph (D) of this rule; or

(3) Has experience with the radiation safety aspects of the types of use of radioactive material for which the individual is seeking simultaneous approval both as the radiation safety officer and the authorized user on the same new medical use license or new medical use permit issued by a United States nuclear regulatory commission master material licensee. The individual must also meet the requirements in paragraph (D) of this rule.

(D) Has training in the radiation safety, regulatory issues, and emergency procedures for the types of use for which a licensee seeks approval. This training requirement may be satisfied by completing training that is supervised by a radiation safety officer, an associate radiation safety officer, authorized medical physicist, authorized nuclear pharmacist, or authorized user, as appropriate, who is authorized for the type(s) of use for which the licensee is seeking approval.

Last updated January 9, 2026 at 7:48 AM

History

• Effective: May 15, 2023
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-58-22

The training and experience specified in rules 3701:1-58-12 to 3701:1-58-21, 3701:1-58-32 to 3701:1-58-71, and 3701:1-58-104 of the Administrative Code must have been obtained within the seven years preceding the date of application or the individual must have had related continuing education and experience since the required training and experience was completed.

Last updated November 18, 2022 at 8:31 AM

History

• Effective: December 22, 2008
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-58-19

Except as provided in rule 3701:1-58-21 of the Administrative Code, the licensee shall require the authorized medical physicist to be an individual who:

(A) Is certified by a specialty board whose certification process has been recognized by the director, the United States nuclear regulatory commission, or an agreement state and who meets the requirements in paragraph (C) of this rule. The names of board certifications which have been recognized by the director, the United States nuclear regulatory commission, or an agreement state will be posted on the United States nuclear regulatory commission's "Medical Uses Licensee Toolkit" web page at www.nrc.gov. To have its certification process recognized, a specialty board shall require all candidates for certification to:

(1) Hold a master's or doctor's degree in physics, medical physics, other physical science, engineering, or applied mathematics from an accredited college or university;

(2) Have two years of full-time practical training and/or supervised experience in medical physics:

(a) Under the supervision of a medical physicist who is certified in medical physics by a specialty board whose certification process has been recognized under this rule by the director, the United States nuclear regulatory commission, or an agreement state; or

(b) In clinical radiation facilities providing high-energy, external beam therapy with photons and electrons with energies greater than or equal to one million electron volts and brachytherapy services under the direction of physicians who meet the requirements for authorized users in rule 3701:1-58-21, 3701:1-58-51, or 3701:1-58-71 of the Administrative Code; and

(3) Pass an examination, administered by diplomates of the specialty board, that assesses knowledge and competence in clinical radiation therapy, radiation safety, calibration, quality assurance, and treatment planning for external beam therapy, brachytherapy, and stereotactic radiosurgery; or

(B)

(1) Holds a master's or doctor's degree in physics, medical physics, other physical science, engineering, or applied mathematics from an accredited college or university; and has completed one year of full-time training in medical physics and an additional year of full-time work experience under the supervision of an individual who meets the requirements for an authorized medical physicist for the type(s) of use for which the individual is seeking authorization. This training and work experience must be conducted in clinical radiation facilities that provide high-energy, external beam therapy with photons and electrons with energies greater than or equal to one million electron volts and brachytherapy services and must include:

(a) Performing sealed source leak tests and inventories;

(b) Performing decay corrections;

(c) Performing full calibration and periodic spot checks of external beam treatment units, stereotactic radiosurgery units, and remote afterloading units as applicable; and

(d) Conducting radiation surveys around external beam treatment units, stereotactic radiosurgery units, and remote afterloading units as applicable; and

(2) Has obtained written attestation that the individual has satisfactorily completed the requirements in paragraphs (B)(1) and (C) of this rule, and is able to independently fulfill the radiation safety-related duties as an authorized medical physicist for each type of therapeutic medical unit for which the individual is requesting authorized medical physicist status. The written attestation must be signed by a preceptor authorized medical physicist who meets the requirements in rule 3701:1-58-19 or 3701:1-58-21 of the Administrative Code or equivalent United States nuclear regulatory commission or agreement state requirements for an authorized medical physicist for each type of therapeutic medical unit for which the individual is requesting authorized medical physicist status.

(C) Has training for the type(s) of use for which authorization is sought that includes hands-on device operation, safety procedures, clinical use, and the operation of a treatment planning system. This training requirement may be satisfied by satisfactorily completing either a training program provided by the vendor or by training supervised by an authorized medical physicist authorized for the type(s) of use for which the individual is seeking authorization.

Last updated November 18, 2022 at 8:31 AM

History

• Effective: August 15, 2021
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-58-20

Except as provided in rule 3701:1-58-21 of the Administrative Code, the licensee shall require the authorized nuclear pharmacist to be a pharmacist who:

(A) Is certified by a specialty board whose certification process has been recognized by the director, United States nuclear regulatory commission, or an agreement state. The names of board certifications which have been recognized by the director, United States nuclear regulatory commission, or an agreement state will be posted on the United States nuclear regulatory commission's "Medical Uses Licensee Toolkit" web page at www.nrc.gov. To have its certification process recognized, a specialty board shall require all candidates for certification to:

(1) Have graduated from a pharmacy program accredited by the "Accreditation Council on Pharmaceutical Education" (ACPE) (previously named the "American Council on Pharmaceutical Education") or have passed the "Foreign Pharmacy Graduate Examination Committee" (FPGEC) examination;

(2) Hold a current, active license to practice pharmacy;

(3) Provide evidence of having acquired at least four thousand hours of training/experience in nuclear pharmacy practice. Academic training may be substituted for no more than two thousand hours of the required training and experience; and

(4) Pass an examination in nuclear pharmacy administered by diplomates of the specialty board, that assesses knowledge and competency in procurement, compounding, quality assurance, dispensing, distribution, health and safety, radiation safety, provision of information and consultation, monitoring patient outcomes, research and development; or

(B) Has achieved the following requirements:

(1) Has completed seven hundred hours in a structured educational program consisting of both:

(a) Two hundred hours of classroom and laboratory training in the following areas:

(i) Radiation physics and instrumentation;

(ii) Radiation protection;

(iii) Mathematics pertaining to the use and measurement of radioactivity;

(iv) Chemistry of radioactive material for medical use; and

(v) Radiation biology; and

(b) Supervised practical experience in a nuclear pharmacy involving:

(i) Shipping, receiving, and performing related radiation surveys;

(ii) Using and performing checks for proper operation of instruments used to determine the activity of dosages, survey meters, and, if appropriate, instruments used to measure alpha- or beta-emitting radionuclides;

(iii) Calculating, assaying, and safely preparing dosages for patients or human research subjects;

(iv) Using administrative controls to avoid medical events in the administration of radioactive material; and

(v) Using procedures to prevent or minimize radioactive contamination and using proper decontamination procedures; and

(2) Has obtained written attestation, signed by a preceptor authorized nuclear pharmacist, that the individual has satisfactorily completed the requirements in paragraph (B)(1) of this rule and is able to independently fulfill the radiation safety-related duties as an authorized nuclear pharmacist.

Last updated January 9, 2026 at 8:01 AM

History

• Effective: May 15, 2023
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-46-43

(A) An application for a specific license to manufacture, prepare, or transfer for commercial distribution radioactive drugs containing radioactive material for use by persons authorized pursuant to Chapter 3701:1-58 of the Administrative Code or equivalent regulations of an agreement state will be approved if:

(1) The applicant satisfies the general requirements specified in rule 3701:1-40-15 of the Administrative Code;

(2) The applicant submits evidence that the applicant is at least one of the following:

(a) Registered with the United States food and drug administration as the owner or operator of a drug establishment that engages in the manufacture, preparation, propagation, compounding, or processing of a drug under 21 C.F.R. 207.20(a) (as in effect on the effective date of this rule);

(b) Registered or licensed with a state agency as a drug manufacturer;

(c) Licensed as a pharmacy by a state board of pharmacy;

(d) Operating as a nuclear pharmacy within a federal medical institution; or

(e) A positron emission tomography (PET) drug production facility registered with a state agency.

(3) The applicant submits information on the radionuclide; the chemical and physical form; the maximum activity per vial, syringe, generator, or other container of the radioactive drug; and the shielding provided by the packaging to show it is appropriate for the safe handling and storage of the radioactive drugs by medical use licensees; and

(4) The applicant commits to the following labeling requirements:

(a) A label is affixed to each transport radiation shield, whether it is constructed of lead, glass, plastic, or other material, of a radioactive drug to be transferred for commercial distribution. The label must include the radiation symbol and the words "CAUTION, RADIOACTIVE MATERIAL" or "DANGER, RADIOACTIVE MATERIAL"; the name of the radioactive drug or its abbreviation; and the quantity of radioactivity at a specified date and time. For radioactive drugs with a half-life greater than one hundred days, the time may be omitted.

(b) A label is affixed to each syringe, vial, or other container used to hold a radioactive drug to be transferred for commercial distribution. The label must include the radiation symbol and the words "CAUTION, RADIOACTIVE MATERIAL" or "DANGER, RADIOACTIVE MATERIAL" and an identifier that ensures that the syringe, vial, or other container can be correlated with the information on the transport radiation shield label.

(B) A licensee described by paragraph (A)(2)(c) or (A)(2)(d) of this rule:

(1) May prepare radioactive drugs for medical use, as defined in rule 3701:1-38-01 of the Administrative Code, provided that the radioactive drug is prepared by either an authorized nuclear pharmacist, as specified in paragraphs (B)(2) and (B)(3) of this rule, or an individual under the supervision of an authorized nuclear pharmacist as specified in rule 3701:1-58-14 of the Administrative Code.

(2) May allow a pharmacist to work as an authorized nuclear pharmacist if:

(a) This individual qualifies as an authorized nuclear pharmacist as defined in rule 3701:1-58-01 of the Administrative Code,

(b) This individual meets the requirements specified in paragraph (B) of rule 3701:1-58-20 of the Administrative Code and rule 3701:1-58-22 of the Administrative Code and the licensee has received an approved license amendment identifying this individual as an authorized nuclear pharmacist, or

(c) This individual is designated as an authorized nuclear pharmacist in accordance with paragraph (B)(4) of this rule.

(3) The actions authorized in paragraphs (B)(1) and (B)(2) of this rule are permitted in spite of more restrictive language in license conditions.

(4) May designate a pharmacist as an authorized nuclear pharmacist if:

(a) The individual was a nuclear pharmacist preparing only radioactive drugs containing accelerator-produced radioactive material, and

(b) The individual practiced at a pharmacy at a government agency or federally recognized indian tribe before November 30, 2007 or at all other pharmacies before August 8, 2009, or an earlier date as noticed by the United States nuclear regulatory commission.

(5) Shall provide to the director a copy of:

(a) A copy of each individual's certification by a specialty board whose certification process has been recognized by the United States nuclear regulatory commission or an agreement state as specified in paragraph (A) of rule 3701:1-58-20 of the Administrative Code; or

(b) The United States nuclear regulatory commission or agreement state license; or

(c) The permit issued by a United States nuclear regulatory commission master materials licensee; or

(d) The permit issued by a licensee or United States nuclear regulatory commission master materials permittee of broad scope; or

(e) The authorization from a commercial nuclear pharmacy authorized to list its own authorized nuclear pharmacist; or

(f) Documentation that only accelerator-produced radioactive materials were used in the practice of nuclear pharmacy at a government agency or federally recognized indian tribe before November 30, 2007, or at all other locations of use before August 8, 2009, or an earlier date as noticed by the United States nuclear regulatory commission; and

(g) State pharmacy licensure or registration, no later than thirty days after the date that the licensee allows, under paragraphs (B)(2)(a) and (B)(2)(c) of this rule, the individual to work as an authorized nuclear pharmacist.

(C) A licensee shall possess and use instrumentation to measure the radioactivity of radioactive drugs. The licensee shall have procedures for use of the instrumentation. The licensee shall measure, by direct measurement or by combination of measurements and calculations, the amount of radioactivity in dosages of alpha-, beta-, or photon-emitting radioactive drugs prior to transfer for commercial distribution. In addition, the licensee shall:

(1) Perform tests before initial use, periodically, and following repair, on each instrument for accuracy, linearity, and geometry dependence, as appropriate for the use of the instrument; and make adjustments when necessary; and

(2) Check each instrument for constancy and proper operation at the beginning of each day of use.

(D) A licensee shall satisfy the labeling requirements in paragraph (A)(4) of this rule.

(E) Nothing in this rule relieves the licensee from complying with applicable United States food and drug administration, other federal, and state requirements governing radioactive drugs.

Last updated August 1, 2023 at 2:36 PM

History

• Effective: August 15, 2021
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-58-33

Except as provided in rule 3701:1-58-21 of the Administrative Code, the licensee shall require an authorized user of unsealed radioactive material for the uses authorized under rule 3701:1-58-32 of the Administrative Code to be a physician who:

(A) Is certified by a medical specialty board whose certification process has been recognized by the director, United States nuclear regulatory commission, or an agreement state. The names of board certifications which have been recognized by the director, United States nuclear regulatory commission, or an agreement state will be posted on the United States nuclear regulatory commission's "Medical Uses Licensee Toolkit" web page at www.nrc.gov. To have its certification process recognized, a specialty board shall require all candidates for certification to:

(1) Complete sixty hours of training and experience in basic radionuclide handling techniques and radiation safety applicable to the medical use of unsealed radioactive material for uptake, dilution, and excretion studies that includes the topics listed in paragraphs (C)(1)(a) and (C)(1)(b) of this rule; and

(2) Pass an examination, administered by diplomates of the specialty board, that assesses knowledge and competence in radiation safety, radionuclide handling, and quality control; or

(B) Is an authorized user under this rule and rule 3701:1-58-36 or 3701:1-58-40 of the Administrative Code or equivalent United States nuclear regulatory commission or agreement state requirements; or

(C) Has achieved the following requirements:

(1) Has completed sixty hours of training and experience, including a minimum of eight hours of classroom and laboratory training, in basic radionuclide handling techniques applicable to the medical use of unsealed radioactive material for uptake, dilution, and excretion studies. The training and experience must include:

(a) Classroom and laboratory training in the following areas:

(i) Radiation physics and instrumentation;

(ii) Radiation protection;

(iii) Mathematics pertaining to the use and measurement of radioactivity;

(iv) Chemistry of radioactive material for medical use; and

(v) Radiation biology; and

(b) Work experience, under the supervision of an authorized user who meets the requirements in this rule, rule 3701:1-58-21, 3701:1-58-36, or 3701:1-58-40 of the Administrative Code or equivalent United States nuclear regulatory commission or agreement state requirements, involving:

(i) Ordering, receiving, and unpacking radioactive materials safely and performing the related radiation surveys;

(ii) Performing quality control procedures on instruments used to determine the activity of dosages and performing checks for proper operation of survey meters;

(iii) Calculating, measuring, and safely preparing patient or human research subject dosages;

(iv) Using administrative controls to prevent a medical event involving the use of unsealed radioactive material;

(v) Using procedures to contain spilled radioactive material safely and using proper decontamination procedures; and

(vi) Administering dosages of radioactive drugs to patients or human research subjects; and

(2) Has obtained written attestation that the individual has satisfactorily completed the requirements in paragraph (C)(1) of this rule and is able to independently fulfill the radiation safety-related duties as an authorized user for the medical uses authorized under rule 3701:1-58-32 of the Administrative Code. The attestation must be obtained from either:

(a) A preceptor authorized user who meets the requirements in rule 3701:1-58-21, 3701:1-58-33, 3701:1-58-36, or 3701:1-58-40 of the Administrative Code or equivalent United States nuclear regulatory commission or agreement state requirements; or

(b) A residency program director who affirms in writing that the attestation represents the consensus of the residency program faculty where at least one faculty member is an authorized user who meets the requirements in rule 3701:1-58-21, 3701:1-58-33, 3701:1-58-36, or 3701:1-58-40 of the Administrative Code or equivalent United States nuclear regulatory commission or agreement state requirements, and concurs with the attestation provided by the residency program director. The residency training program must be approved by the residency review committee of the "Accreditation Council for Graduate Medical Education," the "Royal College of Physicians and Surgeons of Canada," or the "Council on Postdoctoral Training of the American Osteopathic Association," and must include training and experience specified in paragraph (C)(1) of this rule.

Last updated November 18, 2022 at 8:33 AM

History

• Effective: August 15, 2021
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-58-36

Except as provided in rule 3701:1-58-21 of the Administrative Code, the licensee shall require an authorized user of unsealed radioactive material for the uses authorized in rule 3701:1-58-34 of the Administrative Code to be a physician who:

(A) Is certified by a medical specialty board whose certification process has been recognized by the director, United States nuclear regulatory commission, or an agreement state. The names of board certifications which have been recognized by the director, the United States nuclear regulatory commission, or an agreement state will be posted on the United States nuclear regulatory commission's "Medical Uses Licensee Toolkit" web page at www.nrc.gov. To have its certification process recognized, a specialty board shall require all candidates for certification to:

(1) Complete seven hundred hours of training and experience in basic radionuclide handling techniques and radiation safety applicable to the medical use of unsealed radioactive material for imaging and localization studies that includes the topics listed in paragraphs (C)(1)(a) and (C)(1)(b) of this rule; and

(2) Pass an examination, administered by diplomates of the specialty board, which assesses knowledge and competence in radiation safety, radionuclide handling, and quality control; or

(B) Is an authorized user under rule 3701:1-58-40 of the Administrative Code and meets the requirements in paragraph (C)(1)(b)(vii) of rule 3701:1-58-36 of the Administrative Code, or equivalent United States nuclear regulatory commission or agreement state requirements; or

(C)

(1) Has completed seven hundred hours of training and experience, including a minimum of eighty hours of classroom and laboratory training, in basic radionuclide handling techniques applicable to the medical use of unsealed radioactive material for imaging and localization studies. The training and experience must include, at a minimum:

(a) Classroom and laboratory training in the following areas:

(i) Radiation physics and instrumentation;

(ii) Radiation protection;

(iii) Mathematics pertaining to the use and measurement of radioactivity;

(iv) Chemistry of radioactive material for medical use; and

(v) Radiation biology; and

(b) Work experience, under the supervision of an authorized user, who meets the requirements in this rule, rule 3701:1-58-21, or 3701:1-58-40 of the Administrative Code and paragraph (C)(1)(b)(vii) of this rule, or equivalent United States nuclear regulatory commission or agreement state requirements. An authorized nuclear pharmacist who meets the requirements in rule 3701:1-58-20 or 3701:1-58-21 of the Administrative Code may provide the supervised work experience for paragraph (C)(1)(b)(vii) of this rule. Work experience must involve:

(i) Ordering, receiving, and unpacking radioactive materials safely and performing the related radiation surveys;

(ii) Performing quality control procedures on instruments used to determine the activity of dosages and performing checks for proper operation of survey meters;

(iii) Calculating, measuring, and safely preparing patient or human research subject dosages;

(iv) Using administrative controls to prevent a medical event involving the use of unsealed radioactive material;

(v) Using procedures to safely contain spilled radioactive material and using proper decontamination procedures;

(vi) Administering dosages of radioactive drugs to patients or human research subjects; and

(vii) Eluting generator systems appropriate for preparation of radioactive drugs for imaging and localization studies, measuring and testing the eluate for radionuclidic purity, and processing the eluate with reagent kits to prepare labeled radioactive drugs; and

(2) Has obtained written attestation that the individual has satisfactorily completed the requirements in paragraph (C)(1) of this rule and is able to independently fulfill the radiation safety-related duties as an authorized user for the medical uses authorized under rules 3701:1-58-32 and 3701:1-58-34 of the Administrative Code. The attestation must be obtained from either:

(a) A preceptor authorized user who meets the requirements in this rule, rule 3701:1-58-21, or 3701:1-58-40 of the Administrative Code and paragraph (C)(1)(b)(vii) of this rule, or United States nuclear regulatory commission or agreement state requirements; or

(b) A residency program director who affirms in writing that the attestation represents the consensus of the residency program faculty where at least one faculty member is an authorized user who meets the requirements in this rule, rule 3701:1-58-21, or 3701:1-58-40 of the Administrative Code and paragraph (C)(1)(b)(vii) of this rule, or United States nuclear regulatory commission or agreement state requirements, and concurs with the attestation provided by the residency program director. The residency training program must be approved by the residency review committee of the "Accreditation Council for Graduate Medical Education," the "Royal College of Physicians and Surgeons of Canada," or the "Council on Postdoctoral Training of the American Osteopathic Association," and must include training and experience specified in paragraph (C)(1) of this rule.

Last updated November 18, 2022 at 8:33 AM

History

• Effective: August 15, 2021
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-58-40

Except as provided in rule 3701:1-58-21 of the Administrative Code, the licensee shall require an authorized user of unsealed radioactive material for the uses authorized under rule 3701:1-58-37 of the Administrative Code to be a physician who:

(A) Is certified by a medical specialty board whose certification process has been recognized by the director, United States nuclear regulatory commission, or an agreement state and who meets the requirements in paragraph (B)(1)(b)(vi) of this rule. Specialty boards whose certification processes have been recognized by the director, the United States nuclear regulatory commission, or an agreement state will be posted on the United States nuclear regulatory commission's "Medical Uses Licensee Toolkit" web page at www.nrc.gov. To be recognized, a specialty board shall require all candidates for certification to:

(1) Successfully complete residency training in a radiation therapy or nuclear medicine training program or a program in a related medical specialty. These residency training programs must include seven hundred hours of training and experience as described in paragraphs (B)(1)(a) to (B)(1)(b)(v) of this rule. Eligible training programs must be approved by the "Residency Review Committee of the Accreditation Council for Graduate Medical Education," the "Royal College of Physicians and Surgeons of Canada," or the "Council on Postdoctoral Training of the American Osteopathic Association;" and

(2) Pass an examination, administered by diplomates of the specialty board, which tests knowledge and competence in radiation safety, radionuclide handling, quality assurance, and clinical use of unsealed radioactive material for which a written directive is required; or

(B)

(1) Has completed seven hundred hours of training and experience, including a minimum of two hundred hours of classroom and laboratory training, in basic radionuclide handling techniques applicable to the medical use of unsealed radioactive material requiring a written directive. The training and experience must include:

(a) Classroom and laboratory training in the following areas:

(i) Radiation physics and instrumentation;

(ii) Radiation protection;

(iii) Mathematics pertaining to the use and measurement of radioactivity;

(iv) Chemistry of radioactive material for medical use; and

(v) Radiation biology; and

(b) Work experience, under the supervision of an authorized user who meets the requirements in this rule or rule 3701:1-58-21 of the Administrative Code, or equivalent United States nuclear regulatory commission or agreement state requirements. A supervising authorized user, who meets the requirements in paragraph (B) of this rule, must also have experience in administering dosages in the same dosage category or categories, such as paragraph (B)(1)(b)(vi) of this rule, as the individual requesting authorized user status. The work experience must involve:

(i) Ordering, receiving, and unpacking radioactive materials safely and performing the related radiation surveys;

(ii) Performing quality control procedures on instruments used to determine the activity of dosages, and performing checks for proper operation of survey meters;

(iii) Calculating, measuring, and safely preparing patient or human research subject dosages;

(iv) Using administrative controls to prevent a medical event involving the use of unsealed radioactive material;

(v) Using procedures to contain spilled radioactive material safely and using proper decontamination procedures; and

(vi) Administering dosages of radioactive drugs to patients or human research subjects from the three categories in this paragraph. Radioactive drugs containing radionuclides in categories not included in this paragraph are regulated under rule 3701:1-58-72 of the Administrative Code. This work experience must involve a minimum of three cases in each of the following categories for which the individual is requesting authorized user status:

(a) Oral administration of less than or equal to 1.22 gigabecquerels (thirty-three millicuries) of sodium iodide I-131, for which a written directive is required;

(b) Oral administration of greater than 1.22 gigabecquerels, (thirty-three millicuries) of sodium iodide I-131. Experience with at least three cases in this paragraph also satisfies the requirement in paragraph (B)(1)(b)(vi)(a) of this rule;

(c) Parenteral administration of any radioactive drug that contains a radionuclide that is primarily used for its electron emission, beta radiation characteristics, alpha radiation characteristics, or photon energy of less than one hundred fifty keV, for which a written directive is required; and

(2) Has obtained written attestation that the individual has satisfactorily completed the requirements in paragraph (B)(1) of this rule and is able to independently fulfill the radiation safety-related duties as an authorized user for the medical uses authorized under rule 3701:1-58-37 of the Administrative Code for which the individual is requesting authorized user status. The attestation must be obtained from either:

(a) A preceptor authorized user who meets the requirements in rule 3701:1-58-21 of the Administrative Code, rule 3701:1-58-40 of the Administrative Code, or equivalent United States nuclear regulatory commission or agreement state requirements and has experience in administering dosages in the same dosage category or categories as the individual requesting authorized user status; or

(b) A residency program director who affirms in writing that the attestation represents the consensus of the residency program faculty where at least one faculty member is an authorized user who meets the requirements in rule 3701:1-58-21 of the Administrative Code, rule 3701:1-58-40 of the Administrative Code, or equivalent United States nuclear regulatory commission or agreement state requirements, has experience in administering dosages in the same dosage category or categories as the individual requesting authorized user status, and concurs with the attestation provided by the residency program director. The residency training program must be approved by the residency review committee of the "Accreditation Council for Graduate Medical Education," the "Royal College of Physicians and Surgeons of Canada," or the "Council on Postdoctoral Training of the American Osteopathic Association," and must include training and experience specified in paragraph (B)(1) of this rule.

Last updated October 6, 2022 at 8:25 AM

History

• Effective: October 6, 2022
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-58-41

Except as provided in rule 3701:1-58-21 of the Administrative Code, the licensee shall require an authorized user for the oral administration of sodium iodide iodine-131 requiring a written directive in quantities less than or equal to 1.22 gigabecquerels (thirty-three millicuries) to be a physician who:

(A) Is certified by a medical specialty board whose certification process includes all of the requirements in paragraphs (C)(1) and (C)(2) of this rule and whose certification process has been recognized by the director, the United States nuclear regulatory commission, or an agreement state. The names of board certifications which have been recognized by the director, the United States nuclear regulatory commission, or an agreement state will be posted on the United States nuclear regulatory commission's "Medical Uses Licensee Toolkit" web page at www.nrc.gov; or

(B) Is an authorized user under rule 3701:1-58-40 of the Administrative Code for uses listed in paragraph (B)(1)(b)(vi)(a) or (B)(1)(b)(vi)(b) of rule 3701:1-58-40 of the Administrative Code, rule 3701:1-58-42 of the Administrative Code, or equivalent United States nuclear regulatory commission or agreement state requirements; or

(C) Has achieved the following requirements:

(1) Has successfully completed eighty hours of classroom and laboratory training, applicable to the medical use of sodium iodide iodine-131 for procedures requiring a written directive. The training must include:

(a) Radiation physics and instrumentation;

(b) Radiation protection;

(c) Mathematics pertaining to the use and measurement of radioactivity;

(d) Chemistry of radioactive material for medical use; and

(e) Radiation biology;

(2) Has work experience, under the supervision of an authorized user who meets the requirements in rule 3701:1-58-21, 3701:1-58-40, this rule, or rule 3701:1-58-42 of the Administrative Code, or equivalent United States nuclear regulatory commission or agreement state requirements. A supervising authorized user who meets the requirements in paragraph (B) of rule 3701:1-58-40 of the Administrative Code must have experience in administering dosages as specified in paragraph (B)(1)(b)(vi)(a) or (B)(1)(b)(vi)(a) of rule 3701:1-58-40 of the Administrative Code. The work experience must involve:

(a) Ordering, receiving, and unpacking radioactive materials safely and performing the related radiation surveys;

(b) Performing quality control procedures on instruments used to determine the activity of dosages and performing checks for proper operation of survey meters;

(c) Calculating, measuring, and safely preparing patient or human research subject dosages;

(d) Using administrative controls to prevent a medical event involving the use of radioactive material;

(e) Using procedures to contain spilled radioactive material safely and using proper decontamination procedures; and

(f) Administering dosages to patients or human research subjects, that includes at least three cases involving the oral administration of less than or equal to 1.22 gigabecquerels (thirty-three millicuries) of sodium iodide iodine-131; and

(3) Has obtained written attestation that the individual has satisfactorily completed the requirements in paragraphs (C)(1) and (C)(2) of this rule and is able to independently fulfill the radiation safety-related duties for oral administration of less than or equal to 1.22 gigabecquerels (thirty-three millicuries) of sodium iodide iodine-131 for medical uses authorized under rule 3701:1-58-37 of the Administrative Code. The attestation must be obtained from either:

(a) A preceptor authorized user who meets the requirements in rule 3701:1-58-21, 3701:1-58-40, this rule, or rule 3701:1-58-42 of the Administrative Code, or equivalent United States nuclear regulatory commission or agreement state requirements and has experience in administering dosages as specified in paragraph (B)(1)(b)(vi)(a) or (B)(1)(b)(vi)(b) of the Administrative Code; or

(b) A residency program director who affirms in writing that the attestation represents the consensus of the residency program faculty where at least one faculty member is an authorized user who meets the requirements in rule 3701:1-58-21, 3701:1-58-40, this rule, or rule 3701:1-58-42 of the Administrative Code, or equivalent United States nuclear regulatory commission or agreement state requirements, has experience in administering dosages as specified in paragraph (B)(1)(b)(vi)(a) or (B)(1)(b)(vi)(b) of the Administrative Code, and concurs with the attestation provided by the residency program director. The residency training program must be approved by the residency review committee of the "Accreditation Council for Graduate Medical Education," the "Royal College of Physicians and Surgeons of Canada," or the "Council on Postdoctoral Training of the American Osteopathic Association," and must include training and experience specified in paragraphs (C)(1) and (C)(2) of this rule.

Last updated November 18, 2022 at 8:34 AM

History

• Effective: August 15, 2021
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-58-42

Except as provided in rule 3701:1-58-21 of the Administrative Code, the licensee shall require an authorized user for the oral administration of sodium iodide iodine-131 requiring a written directive in quantities greater than 1.22 gigabecquerels (thirty-three millicuries) to be a physician who:

(A) Is certified by a medical specialty board whose certification process includes all of the requirements in paragraphs (C)(1) and (C)(2) of this rule, and whose certification has been recognized by the director, the United States nuclear regulatory commission, or an agreement state. The names of board certifications which have been recognized by the director, the United States nuclear regulatory commission, or an agreement state will be posted on the United States nuclear regulatory commission's "Medical Uses Licensee Toolkit" web page at www.nrc.gov.; or

(B) Is an authorized user under rule 3701:1-58-40 of the Administrative Code, for uses listed in paragraph (B)(1)(b)(vi)(b) of rule 3701:1-58-40 of the Administrative Code, or equivalent United States nuclear regulatory commission or agreement state requirements; or

(C) Has achieved the following requirements:

(1) Has successfully completed eighty hours of classroom and laboratory training, applicable to the medical use of sodium iodide iodine-131 for procedures requiring a written directive. The training must include:

(a) Radiation physics and instrumentation;

(b) Radiation protection;

(c) Mathematics pertaining to the use and measurement of radioactivity;

(d) Chemistry of radioactive material for medical use; and

(e) Radiation biology;

(2) Has work experience, under the supervision of an authorized user who meets the requirements in rule 3701:1-58-21, 3701:1-58-40, or this rule of the Administrative Code, or equivalent United States nuclear regulatory commission or agreement state requirements. A supervising authorized user who meets the requirements in paragraph (B) of rule 3701:1-58-40 of the Administrative Code, must have experience in administering dosages as specified in paragraph (B)(1)(b)(vi)(b) of rule 3701:1-58-40 of the Administrative Code. The work experience must involve:

(a) Ordering, receiving, and unpacking radioactive materials safely and performing the related radiation surveys;

(b) Performing quality control procedures on instruments used to determine the activity of dosages and performing checks for proper operation of survey meters;

(c) Calculating, measuring, and safely preparing patient or human research subject dosages;

(d) Using administrative controls to prevent a medical event involving the use of radioactive material;

(e) Using procedures to contain spilled radioactive material safely and using proper decontamination procedures; and

(f) Administering dosages to patients or human research subjects, that includes at least three cases involving the oral administration of greater than 1.22 gigabecquerels (thirty-three millicuries) of sodium iodide iodine-131; and

(3) Has obtained written attestation that the individual has satisfactorily completed the requirements in paragraphs (C)(1) and (C)(2) of this rule, and is able to independently fulfill the radiation safety-related duties as an authorized user for oral administration of greater than 1.22 gigabecquerels (thirty-three millicuries) of sodium iodide I-131 for medical uses authorized under rule 3701:1-58-37 of the Administrative Code. The attestation must be obtained from either:

(a) A preceptor authorized user who meets the requirements in rule 3701:1-58-21, 3701:1-58-40, or this rule of the Administrative Code, or equivalent United States nuclear regulatory commission or agreement state requirements, and has experience in administering dosages as specified in paragraph (B)(1)(b)(vii)(b) of rule 3701:1-58-40 of the Administrative Code; or

(b) A residency program director who affirms in writing that the attestation represents the consensus of the residency program faculty where at least one faculty member is an authorized user who meets the requirements in rule 3701:1-58-21, 3701:1-58-40, or this rule of the Administrative Code, or equivalent United States nuclear regulatory commission or agreement state requirements, has experience in administering dosages as specified in paragraph (B)(1)(b)(vii)(b) of rule 3701:1-58-40 of the Administrative Code, and concurs with the attestation provided by the residency program director. The residency training program must be approved by the residency review committee of the "Accreditation Council for Graduate Medical Education," the "Royal College of Physicians and Surgeons of Canada," or the "Council on Postdoctoral Training of the American Osteopathic Association," and must include training and experience specified in paragraphs (C)(1) and (C)(2) of this rule.

Last updated November 18, 2022 at 8:34 AM

History

• Effective: August 15, 2021
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-58-51

Except as provided in rule 3701:1-58-21 of the Administrative Code, the licensee shall require an authorized user of a manual brachytherapy source for the uses authorized under rule 3701:1-58-43 of the Administrative Code to be a physician who:

(A) Is certified by a medical specialty board whose certification process has been recognized by the director, the United States nuclear regulatory commission, or an agreement state. The names of board certifications which have been recognized by the director, the United States nuclear regulatory commission, or an agreement state will be posted on the United States nuclear regulatory commission's "Medical Uses Licensee Toolkit" web page at www.nrc.gov. To have its certification process recognized, a specialty board shall require all candidates for certification to:

(1) Successfully complete a minimum of three years of residency training in a radiation oncology program approved by the "Residency Review Committee of the Accreditation Council for Graduate Medical Education" or the "Royal College of Physicians and Surgeons of Canada" or the "Council on Postdoctoral Training of the American Osteopathic Association"; and

(2) Pass an examination, administered by diplomates of the specialty board, that tests knowledge and competence in radiation safety, radionuclide handling, treatment planning, quality assurance, and clinical use of manual brachytherapy; or

(B) Has achieved the following requirements:

(1) Has completed a structured educational program in basic radionuclide handling techniques applicable to the use of manual brachytherapy sources that includes:

(a) Two hundred hours of classroom and laboratory training in the following areas:

(i) Radiation physics and instrumentation;

(ii) Radiation protection;

(iii) Mathematics pertaining to the use and measurement of radioactivity; and

(iv) Radiation biology; and

(b) Five hundred hours of work experience, under the supervision of an authorized user who meets the requirements in this rule or rule 3701:1-58-21 of the Administrative Code, or equivalent United States nuclear regulatory commission or agreement state requirements at a medical facility authorized to use radioactive materials under rule 3701:1-58-43 of the Administrative Code, involving:

(i) Ordering, receiving, and unpacking radioactive materials safely and performing the related radiation surveys;

(ii) Checking survey meters for proper operation;

(iii) Preparing, implanting, and removing brachytherapy sources;

(iv) Maintaining running inventories of material on hand;

(v) Using administrative controls to prevent a medical event involving the use of radioactive material; and

(vi) Using emergency procedures to control radioactive material;

(2) Has completed three years of supervised clinical experience in radiation oncology, under an authorized user who meets the requirements in this rule or rule 3701:1-58-21 of the Administrative Code, or equivalent United States nuclear regulatory commission or agreement state requirements, as part of a formal training program approved by the "Residency Review Committee for Radiation Oncology of the Accreditation Council for Graduate Medical Education" or the "Royal College of Physicians and Surgeons of Canada" or the "Council on Postdoctoral Training of the American Osteopathic Association." This experience may be obtained concurrently with the supervised work experience required by paragraph (B)(1)(b) of this rule; and

(3) Has obtained written attestation that the individual has satisfactorily completed the requirements in paragraphs (B)(1) and (B)(2) of this rule and is able to independently fulfill the radiation safety-related duties as an authorized user of manual brachytherapy sources for the medical uses authorized under rule 3701:1-58-43 of the Administrative Code. The attestation must be obtained from either:

(a) A preceptor authorized user who meets the requirements in this rule or rule 3701:1-58-21 of the Administrative Code, or equivalent United States nuclear regulatory commission or agreement state requirements; or

(b) A residency program director who affirms in writing that the attestation represents the consensus of the residency program faculty where at least one faculty member is an authorized user who meets the requirements in his rule or rule 3701:1-58-21 of the Administrative Code, or equivalent United States nuclear regulatory commission or agreement state requirements, and concurs with the attestation provided by the residency program director. The residency training program must be approved by the residency review committee of the "Accreditation Council for Graduate Medical Education," the "Royal College of Physicians and Surgeons of Canada," or the "Council on Postdoctoral Training of the American Osteopathic Association," and must include training and experience specified in paragraphs (B)(1) and (B)(2) of this rule.

Last updated October 6, 2022 at 8:25 AM

History

• Effective: October 6, 2022
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-58-54

Except as provided in rule 3701:1-58-21 of the Administrative Code, the licensee shall require the authorized user of a diagnostic sealed source or a device authorized under rule 3701:1-58-53 of the Administrative Code to be a physician, dentist, or podiatrist who:

(A) Is certified by a specialty board whose certification process includes all of the requirements in paragraphs (C) and (D) of this rule and whose certification has been recognized by the director, United States nuclear regulatory commission, or an agreement state. The names of board certifications which have been recognized by the director, the United States nuclear regulatory commission, or an agreement state will be posted on the United States nuclear regulatory commission's "Medical Uses Licensee Toolkit" web page at www.nrc.gov; or

(B) Is an authorized user for uses listed in rule 3701:1-58-34 of the Administrative Code, or equivalent United States nuclear regulatory commission or agreement state requirements; or

(C) Has completed eight hours of classroom and laboratory training in basic radionuclide handling techniques specifically applicable to the use of the device. The training must include:

(1) Radiation physics and instrumentation;

(2) Radiation protection;

(3) Mathematics pertaining to the use and measurement of radioactivity; and

(4) Radiation biology; and

(D) Has completed training in the use of the device for the uses requested.

Last updated November 18, 2022 at 8:36 AM

History

• Effective: August 15, 2021
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-58-71

Except as provided in rule 3701:1-58-21 of the Administrative Code, the licensee shall require an authorized user of a sealed source for a use authorized under rule 3701:1-58-55 of the Administrative Code to be a physician who:

(A) Is certified by a medical specialty board whose certification process has been recognized by the director, the United States nuclear regulatory commission, or an agreement state and who meets the requirements in paragraph (C) of this rule. The names of board certifications which have been recognized by the director, the United States nuclear regulatory commission, or an agreement state will be posted on the United States nuclear regulatory commission's "Medical Uses Licensee Toolkit" web page at www.nrc.gov. To have its certification process recognized, a specialty board shall require all candidates for certification to:

(1) Successfully complete a minimum of three years of residency training in a radiation therapy program approved by the "Residency Review Committee of the Accreditation Council for Graduate Medical Education" or the "Royal College of Physicians and Surgeons of Canada" or the "Council on Postdoctoral Training of the American Osteopathic Association"; and

(2) Pass an examination, administered by diplomates of the specialty board, which tests knowledge and competence in radiation safety, radionuclide handling, treatment planning, quality assurance, and clinical use of stereotactic radiosurgery, remote afterloaders and external beam therapy; or

(B) Has achieved the following requirements:

(1) Has completed a structured educational program in basic radionuclide techniques applicable to the use of a sealed source in a therapeutic medical unit that includes:

(a) Two hundred hours of classroom and laboratory training in the following areas:

(i) Radiation physics and instrumentation;

(ii) Radiation protection;

(iii) Mathematics pertaining to the use and measurement of radioactivity; and

(iv) Radiation biology; and

(b) Five hundred hours of work experience, under the supervision of an authorized user who meets the requirements in this rule or rule 3701:1-58-21 of the Administrative Code, or equivalent United States nuclear regulatory commission or agreement state requirements, at a medical facility that is authorized to use radioactive materials in rule 3701:1-58-55 of the Administrative Code, involving:

(i) Reviewing full calibration measurements and periodic spot-checks;

(ii) Preparing treatment plans and calculating treatment doses and times;

(iii) Using administrative controls to prevent a medical event involving the use of radioactive material;

(iv) Implementing emergency procedures to be followed in the event of the abnormal operation of the medical unit or console;

(v) Checking and using survey meters; and

(vi) Selecting the proper dose and how it is to be administered;

(2) Has completed three years of supervised clinical experience in radiation therapy, under an authorized user who meets the requirements in this rule or rule 3701:1-58-21 of the Administrative Code, or equivalent United States nuclear regulatory commission or agreement state requirements, as part of a formal training program approved by the "Residency Review Committee for Radiation Oncology of the Accreditation Council for Graduate Medical Education" or the "Royal College of Physicians and Surgeons of Canada" or the "Council on Postdoctoral Training of the American Osteopathic Association." This experience may be obtained concurrently with the supervised work experience required by paragraph (B)(1)(b) of this rule; and

(3) Has obtained written attestation that the individual has satisfactorily completed the requirements in paragraphs (B)(1), (B)(2), and (C) of this rule, and is able to independently fulfill the radiation safety-related duties as an authorized user of each type of therapeutic medical unit for which the individual is requesting authorized user status. The attestation must be obtained from either:

(a) A preceptor authorized user who meets the requirements in this rule, rule 3701:1-58-21 of the Administrative Code, or equivalent United States nuclear regulatory commission or agreement state requirements for the type(s) of therapeutic medical unit for which the individual is requesting authorized user status; or

(b) A residency program director who affirms in writing that the attestation represents the consensus of the residency program faculty where at least one faculty member is an authorized user who meets the requirements in this rule, rule 3701:1-58-21 of the Administrative Code, or equivalent United States nuclear regulatory commission or agreement state requirements, for the type(s) of therapeutic medical unit for which the individual is requesting authorized user status, and concurs with the attestation provided by the residency program director. The residency training program must be approved by the residency review committee of the "Accreditation Council for Graduate Medical Education," the "Royal College of Physicians and Surgeons of Canada," or the "Council on Postdoctoral Training of the American Osteopathic Association," and must include training and experience specified in paragraphs (B)(1) and (B)(2) of this rule.

(C) Has received training in device operation, safety procedures, and clinical use for the type(s) of use for which authorization is sought. This training requirement may be satisfied by satisfactory completion of a training program provided by the vendor for new users or by receiving training supervised by an authorized user or authorized medical physicist, as appropriate, who is authorized for the type(s) of use for which the individual is seeking authorization.

Last updated October 6, 2022 at 8:25 AM

History

• Effective: October 6, 2022
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-58-31

(A) A licensee providing mobile medical service shall:

(1) Obtain a letter signed by the management of each client for which services are rendered that permits the use of radioactive material at the client's address and clearly delineates the authority and responsibility of the licensee and the client;

(2) Check instruments used to measure the activity of unsealed radioactive material for proper function before medical use at each client's address or on each day of use, whichever is more frequent. At a minimum, the check for proper function required by this paragraph must include a constancy check;

(3) Check survey instruments for proper operation with a dedicated check source before use at each client's address; and

(4) Before leaving a client's address, survey all areas of use to ensure compliance with the requirements in Chapter 3701:1-38 of the Administrative Code.

(B) A mobile medical service may not have radioactive material delivered from the manufacturer or the distributor to the client unless the client has a license allowing possession of the radioactive material. Radioactive material delivered to the client must be received and handled in conformance with the client's license.

(C) A licensee providing mobile medical services shall retain the letter required in paragraph (A)(1) of this rule and the record of each survey required in paragraph (A)(4) of this rule in accordance with paragraphs (A) and (B) of rule 3701:1-58-83 of the Administrative Code, respectively.

Last updated November 18, 2022 at 8:33 AM

History

• Effective: August 15, 2005
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-58-101

(A) A licensee shall report any event as a medical event, except for an event that results from patient intervention, in which:

(1) The administration of radioactive material or radiation from radioactive material, except permanent implant brachytherapy, results in:

(a) A dose that differs from the prescribed dose or dose that would have resulted from the prescribed dosage by more than 0.05 sievert (five rem) effective dose equivalent, 0.5 sievert (fifty rem) to an organ or tissue, or 0.5 sievert (fifty rem) shallow dose equivalent to the skin; and

(i) The total dose delivered differs from the prescribed dose by twenty per cent or more;

(ii) The total dosage delivered differs from the prescribed dosage by twenty per cent or more or falls outside the prescribed dosage range; or

(iii) The fractionated dose delivered differs from the prescribed dose for a single fraction, by fifty per cent or more.

(b) A dose that exceeds 0.05 sievert (five rem) effective dose equivalent, 0.5 sievert (fifty rem) to an organ or tissue, or 0.5 sievert (fifty rem) shallow dose equivalent to the skin from any of the following:

(i) An administration of a wrong radioactive drug containing radioactive material or the wrong radionuclide for a brachytherapy procedure;

(ii) An administration of a radioactive drug containing radioactive material by the wrong route of administration;

(iii) An administration of a dose or dosage to the wrong individual or human research subject;

(iv) An administration of a dose or dosage delivered by the wrong mode of treatment; or

(v) A leaking sealed source.

(c) A dose to the skin or an organ or tissue other than the treatment site that exceeds by:

(i) 0.5 sievert (fifty rem) or more the expected dose to that site from the procedure if the administration had been given in accordance with the written directive prepared or revised before administration; and

(ii) Fifty per cent or more the expected dose to that site from the procedure if the administration had been given in accordance with the written directive prepared or revised before administration.

(2) For permanent implant brachytherapy, the administration of radioactive material or radiation from radioactive material (excluding sources that were implanted in the correct site but migrated outside the treatment site) that results in:

(a) The total source strength administered differing by twenty per cent or more from the total source strength documented in the post-implantation portion of the written directive;

(b) The total source strength administered outside of the treatment site exceeding twenty per cent of the total source strength documented in the post-implantation portion of the written directive; or

(c) An administration that includes any of the following:

(i) The wrong radionuclide;

(ii) The wrong individual or human research subject;

(iii) Sealed source(s) implanted directly into a location discontiguous from the treatment site, as documented in the post-implantation portion of the written directive; or

(iv) A leaking sealed source resulting in a dose that exceeds 0.5 sievert (fifty rem) to an organ or tissue.

(B) A licensee shall report any event resulting from intervention of a patient or human research subject in which the administration of radioactive material or radiation from radioactive material results or will result in unintended permanent functional damage to an organ or a physiological system, as determined by a physician.

(C) The licensee shall notify by telephone the Ohio department of health, bureau of environmental health and radiation protection no later than the next calendar day after discovery of the medical event.

(D) The licensee shall submit a written report to the Ohio department of health, bureau of environmental health and radiation protection to the address listed in listed in rule 3701:1-40-04 of the Administrative Code within fifteen days after discovery of the medical event.

(1) The written report must include:

(a) The licensee's name;

(b) The name of the prescribing physician;

(c) A brief description of the event;

(d) Why the event occurred;

(e) The effect, if any, on the individual(s) who received the administration;

(f) What actions, if any, have been taken or are planned to prevent recurrence; and

(g) Certification that the licensee notified the individual (or the individual's personal representative), and if not, why not.

(2) The report may not contain the individual's name or any other information that could lead to identification of the individual.

(E) The licensee shall provide notification of the event to the referring physician and also notify the individual who is the subject of the medical event no later than twenty- four hours after its discovery, unless the referring physician personally informs the licensee either that he or she will inform the individual or that, based on medical judgment, telling the individual would be harmful to the individual. The licensee is not required to notify the individual without first consulting the referring physician. If the referring physician or the affected individual cannot be reached within twenty-four hours, the licensee shall notify the individual as soon as possible thereafter. The licensee may not delay any appropriate medical care for the individual, including any necessary remedial care as a result of the medical event, because of any delay in notification. To meet the requirements of this paragraph, the notification of the individual who is the subject of the medical event may be made instead to that individual's personal representative. If a verbal notification is made, the licensee shall inform the individual, or appropriate personal representative, that a written description of the event can be obtained from the licensee upon request. The licensee shall provide such a written description if requested.

(F) Aside from the notification requirement, nothing in this section affects any rights or duties of licensees and physicians in relation to each other, to individuals affected by the medical event, or to that individual's personal representative.

(G) A licensee shall:

(1) Annotate a copy of the report provided to the Ohio department of health, bureau of environmental health and radiation protection with the:

(a) Name of the individual who is the subject of the event; and

(b) Identification number or if no other identification number is available, the social security number of the individual who is the subject of the event; and

(2) Provide a copy of the annotated report to the referring physician, if other than the licensee, no later than fifteen days after the discovery of the event.

Last updated January 9, 2026 at 8:02 AM

History

• Effective: May 15, 2023
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-58-49

(A) Licensees who use strontium-90 for ophthalmic treatments must ensure that certain activities as specified in paragraph (B) of this rule are performed by either:

(1) An authorized medical physicist; or

(2) An individual who:

(a) Is identified as an ophthalmic physicist on a specific medical use license issued by the director, United States nuclear regulatory commission or an agreement state; permit issued by a United States nuclear regulatory commission or an agreement state broad scope medical use licensee; medical use permit issued by a United States nuclear regulatory commission master material licensee; or permit issued by a United States nuclear regulatory commission master material licensee broad scope medical use permittee; and

(b) Holds a master's or doctor's degree in physics, medical physics, other physical sciences, engineering, or applied mathematics from an accredited college or university; and

(c) Has successfully completed one year of full-time training in medical physics and an additional year of full-time work experience under the supervision of a medical physicist; and

(d) Has documented training in:

(i) The creation, modification, and completion of written directives;

(ii) Procedures for administrations requiring a written directive; and

(iii) Performing the calibration measurements of brachytherapy sources as detailed in rule 3701:1-58-48 of the Administrative Code.

(B) The individuals who are identified in paragraph (A) of this rule must:

(1) Calculate the activity of each strontium-90 source that is used to determine the treatment times for ophthalmic treatments. The decay must be based on the activity determined under rule 3701:1-58-48 of the Administrative Code; and

(2) Assist the licensee in developing, implementing, and maintaining written procedures to provide high confidence that the administration is in accordance with the written directive. These procedures must include the frequencies that the individual meeting the requirements in paragraph (A) of this rule will observe treatments, review the treatment methodology, calculate treatment time for the prescribed dose, and review records to verify that the administrations were in accordance with the written directives.

(C) Licensees must retain a record of the activity of each strontium-90 source in accordance with rule 3701:1-58-90 of the Administrative Code.

Last updated November 18, 2022 at 8:35 AM

History

• Effective: August 15, 2021
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-58-32

Except for quantities that require a written directive under paragraph (B) of rule 3701:1-58-15 of the Administrative Code, a licensee may use any unsealed radioactive material prepared for medical use for uptake, dilution, or excretion studies that is:

(A) Obtained from:

(1) A manufacturer or preparer licensed under rule 3701:1-46-43 of the Administrative Code or equivalent United States nuclear regulatory commission or agreement state requirements; or

(2) A PET radioactive drug producer licensed in accordance with paragraph (I) of rule 3701:1-40-14 of the Administrative Code or equivalent United States nuclear regulatory commission or agreement state requirement; or

(B) Excluding production of PET radionuclides, prepared by:

(1) An authorized nuclear pharmacist; or

(2) A physician who is an authorized user and who meets the requirements specified in rule 3701:1-58-36, or rule 3701:1-58-40 and paragraph (C)(1)(b)(vii) of rule 3701:1-58-36 of the Administrative Code; or

(3) An individual under the supervision, as specified in rule 3701:1-58-14 of the Administrative Code, of the authorized nuclear pharmacist in paragraph (B)(1) of this rule or the physician who is an authorized user in paragraph (B)(2) of this rule; or

(C) Obtained from and prepared by an United States nuclear regulatory commission or agreement state licensee for use in research in accordance with a radioactive drug research committee-approved protocol or an investigational new drug protocol accepted by United States food and drug administration; or

(D) Prepared by the licensee for use in research in accordance with a radioactive drug research committee-approved application or an investigational new drug protocol accepted by United States food and drug administration.

Last updated November 18, 2022 at 8:33 AM

History

• Effective: October 4, 2010
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-58-34

Except for quantities that require a written directive under paragraph (B) of rule 3701:1-58-15 of the Administrative Code, a licensee may use any unsealed radioactive material prepared for medical use for imaging and localization studies that is:

(A) Obtained from:

(1) A manufacturer or preparer licensed under rule 3701:1-46-43 of the Administrative Code or equivalent United States nuclear regulatory commission or agreement state requirements; or

(2) A PET radioactive drug producer licensed in accordance with paragraph (I) of rule 3701:1-40-14 of the Administrative Code or equivalent United States nuclear regulatory commission or agreement state requirement; or

(B) Excluding production of PET radionuclides, prepared by:

(1) An authorized nuclear pharmacist;

(2) A physician who is an authorized user and who meets the requirements specified in rule 3701:1-58-36 or 3701:1-58-40 and paragraph (C)(1)(b)(vii) of rule 3701:1-58-36 of the Administrative Code; or

(3) An individual under the supervision, as specified in rule 3701:1-58-14 of the Administrative Code, of the authorized nuclear pharmacist in paragraph (B)(1) of this rule or the physician who is an authorized user in paragraph (B)(2) of this rule;

(C) Obtained from and prepared by an United States nuclear regulatory commission or agreement state licensee for use in research in accordance with a radioactive drug research committee-approved protocol or an investigational new drug protocol accepted by United States food and drug administration; or

(D) Prepared by the licensee for use in research in accordance with a radioactive drug research committee-approved application or an investigational new drug protocol accepted by United States food and drug administration.

Last updated November 18, 2022 at 8:33 AM

History

• Effective: October 4, 2010
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-58-15

(A) A written directive must be dated and signed by an authorized user before the administration of iodine-131 sodium iodide greater than 1.11 megabecquerels (thirty microcuries), any therapeutic dosage of unsealed radioactive material or any therapeutic dose of radiation from radioactive material. If, because of the emergent nature of the patient's condition, a delay in order to provide a written directive would jeopardize the patient's health, an oral directive is acceptable. The information contained in the oral directive must be documented as soon as possible in writing in the patient's record. A written directive must be prepared within forty-eight hours of the oral directive.

(B) The written directive must contain the patient or human research subject's name and the following information:

(1) For any administration of quantities greater than 1.11 megabecquerels (thirty microcuries) of sodium iodide iodine-131: the dosage;

(2) For an administration of a therapeutic dosage of unsealed radioactive material other than sodium iodide iodine-131: the radioactive drug, dosage, and route of administration;

(3) For gamma stereotactic radiosurgery: the total dose, treatment site, and values for the target coordinate settings per treatment for each anatomically distinct treatment site;

(4) For teletherapy: the total dose, dose per fraction, number of fractions, and treatment site;

(5) For high dose-rate remote afterloading brachytherapy: the radionuclide, treatment site, dose per fraction, number of fractions, and total dose;

(6) For permanent implant brachytherapy:

(a) Before implantation: treatment site, the radionuclide, and the total source strength; and

(b) After implantation but before the patient leaves the post-treatment recovery area: the treatment site, the number of sources implanted, the total source strength implanted, and the date when the licensee assessed the patient's implantation; or

(7) For all other brachytherapy, including low, medium, and pulsed dose rate remote afterloaders:

(a) Before implantation: The treatment site, radionuclide, and dose; and

(b) After implantation but before completion of the procedure: The radionuclide; treatment site; number of sources; total source strength and exposure time (or the total dose); and the date when the licensee assessed the patient's implantation.

(C) A written revision to an existing written directive may be made if the revision is dated and signed by an authorized user before the administration of the dosage of unsealed radioactive material, the brachytherapy dose, the gamma stereotactic radiosurgery dose, the teletherapy dose, or the next fractional dose. If, because of the patient's condition, a delay in order to provide a written revision to an existing written directive would jeopardize the patient's health, an oral revision to an existing written directive is acceptable. The oral revision must be documented as soon as possible in the patient's record. A revised written directive must be signed by the authorized user within forty-eight hours of the oral revision.

(D) The licensee shall retain a copy of the written directive in accordance with rule 3701:1-58-75 of the Administrative Code.

Last updated November 18, 2022 at 8:31 AM

History

• Effective: August 15, 2021
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-58-02 Purpose and scope.

This chapter contains the requirements and provisions for the medical use of radioactive material and for issuance of specific licenses authorizing the medical use of this material. These requirements and provisions provide for the radiation safety of workers, the general public, patients, and human research subjects. The requirements and provisions of this chapter are in addition to, and not in substitution for, other rules of the Administrative Code. The requirements and provisions of Chapters 3701:1-38, 3701:1-40, and 3701:1-50 of the Administrative Code also apply to applicants and licensees subject to this chapter unless specifically exempted.

Last updated November 18, 2022 at 8:28 AM

History

• Effective: August 15, 2005
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-58-03 Maintenance of records.

Each record required by this chapter must be legible throughout the specified retention period. The record may be the original, a reproduced copy, or a microform if the copy or microform is authenticated by authorized personnel and the microform is capable of producing a clear copy throughout the required retention period. The record may also be stored in electronic media with the capability for producing legible, accurate, and complete records during the required retention period. Records such as letters, drawings, and specifications must include all pertinent information such as stamps, initials, and signatures. The licensee shall maintain adequate safeguards against tampering with and loss of records.

Last updated November 18, 2022 at 8:28 AM

History

• Effective: August 15, 2005
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-58-04 Provisions for the protection of human research subjects.

(A) A licensee may conduct research involving human research subjects only if it uses the radioactive materials specified on its license for the uses authorized on its license.

(B) If the research is conducted, funded, supported, or regulated by a federal agency that has implemented the federal policy for the protection of human subjects as specified in 45 C.F.R. Part 46 (as in effect on the effective date of this rule), the licensee shall, before conducting research:

(1) Obtain review and approval of the research from an "institutional review board," as defined and described in the federal policy; and

(2) Obtain "informed consent," as defined and described in the federal policy, from the human research subject.

(C) If the research will not be conducted, funded, supported, or regulated by a federal agency that has implemented the federal policy, the licensee shall, before conducting research, apply for and receive a specific amendment to its medical use license. The amendment request must include a written commitment that the licensee will, before conducting research:

(1) Obtain review and approval of the research from an "institutional review board," as defined and described in the federal policy, and approved by the office of human research protection; and

(2) Obtain "informed consent," as defined and described in the federal policy, from the human research subject.

(D) Nothing in this rule relieves licensees from complying with the other requirements in this chapter.

Last updated April 19, 2022 at 8:38 AM

History

• Effective: April 17, 2022
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-58-05 United States food and drug administration, other federal, and state requirements.

Nothing in this chapter relieves the licensee from complying with applicable United States food and drug administration, other federal, and state requirements governing radioactive drugs or devices.

Last updated November 18, 2022 at 8:28 AM

History

• Effective: August 15, 2005
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-58-06 License required.

(A) A person may manufacture, produce, acquire, receive, possess, prepare, use, or transfer radioactive material for medical use only in accordance with a specific license issued by the director, United States nuclear regulatory commission, an agreement state, or as allowed in paragraph (B)(1) or (B)(2) of this rule.

(B) A specific license is not needed for an individual who:

(1) Receives, possesses, uses, or transfers radioactive material in accordance with the regulations in this chapter under the supervision of an authorized user as provided in rule 3701:1-58-14 of the Administrative Code, unless prohibited by license condition; or

(2) Prepares unsealed radioactive material for medical use in accordance with the regulations in this chapter under the supervision of an authorized nuclear pharmacist or authorized user as provided in rule 3701:1-58-14 of the Administrative Code, unless prohibited by license condition.

Last updated November 18, 2022 at 8:28 AM

History

• Effective: October 4, 2010
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-58-14

(A) A licensee that permits the receipt, possession, use, or transfer of radioactive material by an individual under the supervision of an authorized user, as allowed by paragraph (B)(1) of rule 3701:1-58-06 of the Administrative Code, shall:

(1) In addition to the requirements in rule 3701:1-38-10 of the Administrative Code, instruct the supervised individual in the licensee's written radiation protection procedures, written directive procedures, regulations of this chapter, and license conditions with respect to the use of radioactive material; and

(2) Require the supervised individual to follow the instructions of the supervising authorized user for medical uses of radioactive material, written radiation protection procedures established by the licensee, written directive procedures, regulations of this chapter, and license conditions with respect to the medical use of radioactive material.

(B) A licensee that permits the preparation of radioactive material for medical use by an individual under the supervision of an authorized nuclear pharmacist or physician who is an authorized user, as allowed by paragraph (B)(2) of rule 3701:1-58-06 of the Administrative Code shall:

(1) In addition to the requirements in rule 3701:1-38-10 of the Administrative Code, instruct the supervised individual in the preparation of radioactive material for medical use, as appropriate to that individual's involvement with radioactive material; and

(2) Require the supervised individual to follow the instructions of the supervising authorized user or authorized nuclear pharmacist regarding the preparation of radioactive material for medical use, written radiation protection procedures established by the licensee, the rules of this chapter, and license conditions.

(C) A licensee that permits supervised activities under paragraphs (A) and (B) of this rule is responsible for the acts and omissions of the supervised individual.

Last updated November 18, 2022 at 8:30 AM

History

• Effective: August 15, 2005
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-58-07 Application for license, amendment or renewal.

(A) An application must be signed by the applicant's or licensee's "management," as defined in rule 3701:1-38-01 of the Administrative Code.

(B) An application for a license for medical use of radioactive material, as described in rules 3701:1-58-32, 3701:1-58-34, 3701:1-58-37, 3701:1-58-43, 3701:1-58-53, 3701:1-58-55, and 3701:1-58-72 of the Administrative Code, must be made by:

(1) Submitting documentation in accordance with rule 3701:1-40-14 of the Administrative Code, and including the facility diagram; equipment; and training and experience qualifications of the radiation safety officer, associate radiation safety officer(s), authorized user(s), authorized medical physicist(s), ophthalmic physicist(s), and authorized nuclear pharmacist(s);

(2) Submitting the appropriate license fees listed in rule 3701:1-38-02 of the Administrative Code after receiving an invoice from the department; and

(3) Submitting procedures required by rules 3701:1-58-58 and 3701:1-58-64 to 3701:1-58-66 of the Administrative Code, as applicable.

(C) A request for a license amendment or renewal must be made by:

(1) Submitting documentation in accordance with rule 3701:1-40-14 of the Administrative Code;

(2) Submitting the appropriate license or amendment fees listed in rule 3701:1-38-02 of the Administrative Code after receiving an invoice from the department; and

(3) Submitting procedures required by rules 3701:1-58-58 and 3701:1-58-64 to 3701:1-58-66 of the Administrative Code, as applicable.

(D) In addition to the requirements in paragraphs (B) and (C) of this rule, an application for a license or amendment for medical use of radioactive material as described in rule 3701:1-58-72 of the Administrative Code must also include:

(1) Any additional aspects of the medical use of the material that are applicable to radiation safety that are not addressed in, or differ from, rules 3701:1-58-01 to 3701:1-58-31, 3701:1-58-73 to 3701:1-58-103, and 3701:1-58-105 of the Administrative Code;

(2) Identification of and commitment to follow the applicable radiation safety program requirements in rules 3701:1-58-32 to 3701:1-58-71 and 3701:1-58-104 of the Administrative Code that are appropriate for the specific rule 3701:1-58-72 of the Administrative Code medical use;

(3) Any additional specific information on:

(a) Radiation safety precautions and instructions;

(b) Methodology for measurement of dosages or doses to be administered to patients or human research subjects; and

(c) Calibration, maintenance, and repair of instruments and equipment necessary for radiation safety; and

(4) Any other information requested by the director in review of the application.

(E) An applicant that satisfies the requirements specified in rule 3701:1-40-23 of the Administrative Code may apply for a type A specific license of broad scope.

Last updated November 18, 2022 at 8:28 AM

History

• Effective: August 15, 2021
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-40-14

(A) An applicant for a license to receive and possess radioactive material shall apply in accordance with rule 3701:1-38-02 of the Administrative Code and this chapter on a form prescribed by the director. The original application shall be filed with the director. Information contained in previous applications, statements or reports filed with the director may be incorporated by reference, provided that the reference is clear, specific, and has been on file with the department for not more than two licensing periods, and provided that the item being referenced in the document is being referenced without change.

(B) The director may at any time after the filing of the original application require additional information from the applicant in order to determine whether a license should be issued or whether a current license should be modified or revoked.

(C) Each application shall be signed by the applicant or a person duly authorized to act for the applicant.

(D) An application for a license to receive and possess radioactive material for the conduct of any activity which the director has determined pursuant to rule 3701:1-40-36 of the Administrative Code could potentially affect the quality of the environment shall be filed at least nine months prior to commencement of construction of the plant or facility in which the activity will be conducted and shall be accompanied by any environmental report required pursuant to rule 3701:1-40-36 of the Administrative Code. The applicant is prohibited from the commencement of construction activities in areas covered by the environmental reporting requirements identified in rules 3701:1-40-30 to 3701:1-40-38 of the Administrative Code before the conclusion of these reviews. The terms "construction" and "commencement of construction" shall have the same meaning as identified in rule 3701:1-38-01 of the Administrative Code.

(E)

(1) Except as provided in paragraphs (E)(2), (E)(3), and (E)(4) of this rule, an application for a specific license to use radioactive material in the form of a sealed source or in a device that contains the sealed sources must either:

(a) Identify the source or device by manufacturer and model number as registered in the sealed source and device registry of the United States nuclear regulatory commission in accordance with sealed source and device registry requirements contained in rule 3701:1-46-49 of the Administrative Code, or with equivalent requirements from an agreement state or the United States nuclear regulatory commission; or

(b) Contain the information specified in sealed source and device registry requirements contained in paragraph (C) of rule 3701:1-46-49 of the Administrative Code so that the director is able to perform the review.

(2) For sources or devices manufactured before October 23, 2012 that are not registered with the director in accordance with rule 3701:1-46-49 of the Administrative Code or equivalent requirements from an agreement state or the United States nuclear regulatory commission, and for which the applicant is unable to provide all categories of information specified in rule 3701:1-46-49 of the Administrative Code, the applicant must provide:

(a) All available information identified in rule 3701:1-46-49 of the Administrative Code concerning the source, and, if applicable, the device; and

(b) Sufficient additional information to demonstrate that there is reasonable assurance that the radiation safety properties of the source or device are adequate to protect health and minimize danger to life and property. Such information must include a description of the source or device, a description of radiation safety features, the intended use and associated operating experience, and the results of a recent leak test.

(3) For sealed sources and devices allowed to be distributed without registration of safety information in accordance with rule 3701:1-46-49 of the Administrative Code, the applicant may supply only the manufacturer, model number, and radionuclide and quantity.

(4) If it is not feasible to identify each sealed source and device individually, the applicant may propose constraints on the number and type of sealed sources and devices to be used and the conditions under which they will be used, in lieu of identifying each sealed sources and device.

(F) In the case of an application for a license specified in rule 3701:1-40-16 of the Administrative Code, or an application for a specific license specified in Chapter 3701:1-46, 3701:1-48, or 3701:1-58 of the Administrative Code, the applicant shall provide a proposed decommissioning funding plan or a certification of financial assurance for decommissioning.

(G) Requirement for an emergency response plan:

(1) Each application to possess radioactive materials in excess of the quantities specified in the appendix to this rule, whether in unsealed form, on foils or plated sources, or sealed in glass, shall contain either:

(a) An evaluation showing that the maximum dose to a person offsite due to a release of radioactive materials would not exceed 0.01 sievert (one rem) TEDE or 0.05 sievert (five rem) to the thyroid; or

(b) An emergency plan for responding to a release of radioactive material.

(2) One or more of the following factors may be used to support an evaluation of the need to submit an emergency plan under this paragraph:

(a) The radioactive material is physically separated so that only a portion of the material could be involved in an accident;

(b) All or part of the radioactive material is not subject to release during an accident because of the way it is stored or packaged;

(c) The release fraction in the respirable size range would be lower than the release fraction specified in the appendix to this rule due to the chemical or physical form of the material;

(d) The solubility of the radioactive material would reduce the dose received;

(e) Facility design or engineered safety features in the facility would cause the release fraction to be lower than the limit specified in the appendix to this rule;

(f) Operating restrictions or procedures would prevent a release fraction as large as that shown in the appendix to this rule; or

(g) Other factors appropriate for the specific facility as determined by the director.

(3) An emergency plan for responding to a release of radioactive material submitted under paragraph (G)(1)(b) of this rule shall include the following information:

(a) A brief description of the licensee's facility and the area near the site.

(b) An identification of each type of possible radioactive material accident which may require protective action.

(c) A classification system for classifying an accident as either an alert or a site area emergency.

(d) Identification of the means of detecting each type of accident in a timely manner.

(e) A brief description of the means and equipment for mitigating the consequences of each type of accident, including those provided to protect workers onsite, and a description of the program for maintaining the equipment.

(f) A brief description of the methods and equipment to assess releases of byproduct and accelerator produced materials.

(g) A brief description of the responsibilities of the licensee's personnel should an accident occur, including identification of personnel responsible for promptly notifying offsite response organizations and the department, and identification of personnel responsible for developing, maintaining, and updating the plan.

(h) A commitment to, and a brief description of, the means to promptly notify offsite response organizations and request offsite assistance, including medical assistance for the treatment of contaminated injured onsite workers when appropriate. A control point shall be established. The notification and coordination shall be planned so that in the event that some personnel, parts of the facility, or some equipment is not available, that unavailability will not prevent such notification and coordination. The licensee shall also commit to notifying the department immediately after notification of the appropriate offsite response organizations and not later than one hour after the licensee declares an emergency. These reporting requirements do not supersede or release licensees from complying with the requirements of the "Emergency Planning and Community Right-to-Know Act of 1986, "Title III of Pub. L. 99-499, 100 Stat. 1728, 42 U.S.C. 11001 et seg. or other state or federal reporting requirements.

(i) A brief description of the types of information on facility status, radioactive releases, and recommended protective actions, if necessary, to be given to offsite response organizations and to the department.

(j) A brief description of the frequency, performance objectives and plans for the training that the licensee will provide workers on how to respond to an emergency including any special instructions and orientation tours the licensee would offer to fire, police, medical and other emergency personnel. The training shall familiarize personnel with site-specific emergency procedures. The training also shall thoroughly prepare site personnel for their responsibilities in the event of an accident, including training on the emergency scenarios postulated as most probable for the specific site, and the use of team training for such scenarios.

(k) A brief description of the means of restoring the facility to a safe condition after an accident.

(l) Provisions for conducting quarterly communication checks with offsite response organizations and biennial onsite exercises to test response to simulated emergencies. Quarterly communication checks with offsite response organizations must include the check and update of all necessary telephone numbers. The licensee shall invite offsite response organizations to participate in the biennial exercises. Participation of offsite response organizations in biennial exercises, although recommended, is not required. Exercises must use accident scenarios postulated as most probable for the specific site and the scenarios shall not be known to most exercise participants. The licensee shall critique each exercise using individuals not having direct implementation responsibility for the plan. Critiques of exercises must evaluate the appropriateness of the plan, emergency procedures, facilities, equipment, training of personnel, and overall effectiveness of the response. Deficiencies found by the critiques must be corrected.

(m) A certification that the applicant has met all responsibilities under the "Emergency Planning and Community Right-to-Know Act of 1986, "Title III of Pub. L. 99-499, 100 Stat. 1728, 42 U.S.C. 11001 et seq, if applicable to the applicant's activities at the proposed place of use of the byproduct or accelerator produced material.

(n) The licensee must have and maintain liability coverage for incidents which would activate the plan to cover bodily injury and property damage to third parties caused by incidents which would activate the plan in the amount of at least one million dollars per occurrence with an annual aggregate of at least two million dollars, exclusive of legal defense costs.

(4) The licensee shall allow the offsite response organizations expected to respond in case of an accident sixty days to comment on the licensee's emergency plan before submitting it to the department. The licensee shall provide any comments received within the sixty days to the department with the emergency plan.

(H) Information provided by a licensee or applicant for a license or license renewal that constitutes a "trade secret" as defined in section 1333.61 of the Revised Code is not subject to public disclosure in accordance with sections 1333.61 to 1333.69 of the Revised Code.

(I) An application from a medical facility, or educational institution to produce positron emission tomography (PET) radioactive drugs for noncommercial transfer to licensees in its consortium authorized for medical use in accordance with rules in Chapter 3701:1-58 of the Administrative Code shall include:

(1) A request for authorization for the production of PET radionuclides or evidence of an existing license issued in accordance with rule 3701:1-38-02 of the Administrative Code for a PET radionuclide production facility within its consortium from which it receives PET radionuclides.

(2) Evidence that the applicant is qualified to produce radioactive drugs for medical use by meeting one of the criteria in paragraph (A)(2) of rule 3701:1-46-43 of the Administrative Code.

(3) Identification of individual(s) authorized to prepare the PET radioactive drugs if the applicant is a pharmacy, and documentation that each individual meets the requirements of an authorized nuclear pharmacist as specified in paragraph (B)(2) of rule 3701:1-46-43 of the Administrative Code.

(4) Information identified in paragraph (A)(3) of rule 3701:1-46-43 of the Administrative Code, on the PET drugs to be non-commercially transferred to members of its consortium.

View Appendix

Last updated July 10, 2025 at 12:13 PM

History

• Effective: April 17, 2022
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-38-02

(A) As used in this rule, "facility" has the meaning defined in division (H) of section 3748.01 of the Revised Code and the following:

(1) All buildings, equipment, structures, and other stationary items that are located on a single site or on contiguous or adjacent sites and that are operated by the same person and have common corporate or business interests; and

(2) Portions of a building or structure which are operated by the same person and have common corporate or business interests.

(B) Notwithstanding the definition of "facility," the director may consider sites that are not contiguous or adjacent as one facility provided that:

(1) The sites are operated by the same person;

(2) The sites are in the same license category or categories;

(3) The applicant for a license provides for one radiation safety officer, and if applicable, one radiation safety committee, as responsible for all sites; and

(4) The director is reasonably satisfied from the information provided in the application that the applicant will adequately control radioactive material at all sites listed in the application.

(a) Unless the director has information of violations of Chapter 3748. of the Revised Code or the rules adopted thereunder at one or more sites, the director shall presume the applicant will adequately control radioactive material at all sites if the sites are located not more than twenty miles driving distance apart as documented by the licensee, and if all sites are within a twenty mile radius from the main site as designated on the license.

(b) The director shall continue to renew a license issued under this paragraph that contains all the sites listed thereon provided the licensee demonstrates continued compliance with this paragraph, Chapter 3748. of the Revised Code, and the rules adopted thereunder.

(C) Every facility that handles radioactive material in any license category as specified in appendix A to this rule for which licensure is required shall apply for a license, license amendment, or license renewal in accordance with this rule. Application for a license, license amendment, or license renewal shall be made on any format prescribed and provided by the director. Licenses shall be issued in accordance with the requirements of Chapter 3748. of the Revised Code, and the rules adopted thereunder. Except as otherwise provided in this rule, a license shall expire five years from the date of issuance.

(1) As used in this paragraph, site means an address of use listed on the license. Temporary job sites are exempted.

(a) Any individual applying for a new license with one or more additional sites or a current licensee amending a license to add one or more additional sites that are located more than twenty miles from the main site shall pay an additional site fee for each such site as follows:

(i) The additional site fee(s) shall be seventy-five percent of the applicable annual fee, as those fees are set forth in paragraphs (D), (F), and (J) of this rule.

(ii) Additional site fees will be invoiced annually with the annual fee.

(b) Broad scope licensees are exempt from paragraph (C)(1)(a) of this rule.

(2) As used in this paragraph, "service" means activities performed by a person, other than a worker as defined in rule 3701:1-38-01 of the Administrative Code, pursuant to an agreement with the facility to perform activities that deal with sources of radiation for the facility.

(a) These activities include, but are not limited to the following:

(i) Conduct leak tests;

(ii) Calibrate survey instruments;

(iii) Provide quality control tests;

(iv) Conduct surveys, characterization, and/or remediation activities;

(v) Manage the disposal of radioactive waste for other persons; or

(vi) Install sources or devices or change sources within a device.

(b) License categories affected are:

(i) 3219 - decontamination services;

(ii) 3220 - leak test service;

(iii) 3221 - instrument calibration service only - source less than 3.7 terabecquerels (one hundred curies);

(iv) 3222 - instrument calibration service only - source equal to or greater than 3.7 terabecquerels (one hundred curies);

(v) 3223 - leak test and instrument calibration - source less than 3.7 terabecquerels (one hundred curies);

(vi) 3224 - leak test and instrument calibration - source equal to or greater than 3.7 terabecquerels (one hundred curies);

(vii) 3225 - other services - including teletherapy, irradiator, and gauge service;

(viii) 3232 - waste disposal service prepackaged only;

(ix) 3233 - waste disposal service - incineration; and

(x) 3234 - waste disposal service processing and/or repackaging.

(D) A radioactive materials license issued by the department may, at the discretion of the director, have more than one license category on any one specific license. A licensee may have more than one radioactive materials license. Except as otherwise provided in paragraph (J) of this rule, the annual fee for a radioactive material license shall be in an amount in accordance with appendix A to this rule.

(1) Upon receipt of an application for a new radioactive material license, the department will issue an invoice for the appropriate fee specified in appendix A to this rule or paragraph (J) of this rule. Annual fees will be invoiced based on the month of the license expiration date and the invoice will state that the fee is due thirty days after the date of the invoice. License fees are not refundable.

(2) An applicant for a new or a renewal or amendment of a radioactive material license must submit a complete application before the director will finalize the review of the application. A complete application is one in which the applicant has provided all the information requested by the director, including any additional information requested after receipt of the application package.

(3) Upon receipt of an application for a license amendment, the department will issue an invoice for the appropriate fee for the proposed amendment as specified in appendix A to this rule. If the amendment is to change the license from operational phase to storage of sealed sources only incident to disposal of the sources, after the amendment the annual fee for the license shall be reduced to fifty per cent of the fee for the operational phase of the license, provided that the sources continue to be in safe storage and leak tested as provided by license condition for the specific sources in storage. The inspection frequency will remain the same as that for the operational phase of the license until after source disposal.

(4) The applicant for a new, or renewal or amendment of a radioactive materials license shall provide to the director all additional information requested within sixty days from the date of the information request. If the director does not receive the requested information within the stated time period, the director may consider the application abandoned. Any further consideration of a new license, or a renewal or amendment of a license shall be pursuant to another application.

(5) The director shall grant a new license, license amendment, or license renewal to any applicant who has submitted a complete application and is in compliance with Chapter 3748. of the Revised Code and the rules adopted thereunder.

(6) When an amendment to a license results in a change to a license category with a higher fee, the licensee will be charged the higher of the two amendment fees for that category. The annual fee for the licensee will escalate to the new category fee on the date of the next annual invoice.

(7) The director shall charge a fee for minor license amendments that do not require review by members of the technical staff at a rate of one hundred dollars per amendment provided that no licensee shall be required to pay more than one thousand dollars for minor amendments in any calendar year. Minor amendments include, but are not limited to, adding a new gauge of the same type already licensed unless that additional gauge increases the license or inspection fee, a corporate name change if the corporate ownership does not change, adding a user name that does not require review of education and experience, and corporate address change if the location of the use of the radioactive material does not change. Amendments to change the radiation safety officer or the chair or members of the radiation safety committee that require review of education or experience are not minor amendments.

(8) License terminations shall be handled as follows:

(a) Except as provided in paragraph (D)(8)(c) of this rule, a termination fee of five hundred dollars or fifty per cent of the annual fee, whichever is less, will be invoiced upon written request from the licensee for termination of the license. This fee is not refundable.

(b) Except as provided in paragraph (D)(8)(c) of this rule, if the termination cost, as determined by paragraph (M) of this rule, exceeds the termination fee in paragraph (D)(8)(a) of this rule, the remainder of the termination expense will be assessed at full cost.

(c) If the license termination would be covered under paragraph (D)(9) of this rule, that paragraph will be used for the termination process.

(d) The license termination process will not be completed until the licensee is in compliance with all rules, including payment of fees.

(9) Licenses, and other approvals related to the licensed activity requiring decommissioning, decontamination, reclamation, site restoration, or long-term care due to the continued presence of radioactive materials shall be charged an annual fee based on the approved decommissioning funding plan as specified in appendix B to this rule.

(a) A decommissioning plan must be approved by the department. Prior to approval of the decommissioning plan the licensee must submit an amendment requesting decommissioning. Until the amendment is approved the licensee's annualized license fee will be reduced by fifty per cent. After approval of the amendment containing the decommissioning plan, the licensee will be invoiced at the annual fee specified in appendix B to this rule.

(b) The annual fee specified in appendix B to this rule is based on the cost of decommissioning. The fee is payable within thirty days of mailing of an invoice by the department.

(c) Routine decommissioning oversight by the department will be charged against the annual amount received and additional invoices will not be issued unless the cost of activities exceeds the annual amount in any given year.

(d) The facility shall receive a monthly statement of items and amounts charged against the annual fee.

(e) If the cost of additional activities arise that require use of additional staff, including any consulting service that exceeds the amount of the annual fee paid by the licensee, these additional costs will be included in any invoice as separate items invoiced for the full cost of the oversight by additional staff or consultants. Oversight activities will be performed at a frequency which adequately monitors health, safety, and the environment.

(f) When the approved decommissioning plan is less than one hundred thousand dollars, the licensee will remain in the current license category and continue to pay the required annual fee specified in appendix A to this rule during decommissioning. Inspections of these licensees will be done as non-routine inspections. Non-routine inspection fees will not be applied until the number of decommissioning inspections performed exceed the inspections that would have been performed if the licensee had not chosen the decommissioning option.

(g) When the licensee has completed the decommissioning, and the director has determined that the licensee cannot terminate the license as provided by the Administrative Code, Chapter 3748. of the Revised Code or the rules adopted thereunder, but the licensee has successfully completed the decommissioning of the operation as required by the approved decommissioning plan, the director will amend the license to a decommissioning/possession only license. The annual fee for a decommissioning/possession only license is provided in appendix B to this rule.

(E) Licenses shall be renewed in accordance with the standard renewal procedure established in Chapter 4745. of the Revised Code, except that a licensee, other than a broad scope licensee, shall apply for renewal of the license ninety days prior to the expiration date of the current license and broad scope licensees shall apply for renewal of their license one hundred eighty days prior to expiration.

(F) The annual fee is listed in appendix A to this rule "column 5" for a new license or "column 6" for a renewal license. To recover the costs of oversight activities where radioactive material is found in the public domain and there is no evident individual that is determined to be responsible, a surcharge of 5.25 per cent has been included in the annual fee listed in "column 5" and "column 6" of appendix A to this rule.

(G) The department shall charge an inspection fee for all non-routine inspections. A non-routine inspection is defined as any inspection that the department conducts in addition to the scheduled routine inspections and one follow-up inspection if necessary. Non-routine inspections include, without limitation:

(1) An inspection performed as a result of an incident;

(2) Any pre-license inspections for a new license applicant when the director determines that an inspection is necessary to assess the adequacy of the information provided in the application;

(3) Inspections prior to license amendment, category change, or termination;

(4) An inspection performed at a facility that results in the issuance of an adjudication order by the director; or

(5) Other enforcement or regulatory inspections, not specified above, that the director determines is necessary to assess compliance with Chapter 3748. of the Revised Code.

(H) The fee for a non-routine inspection shall be based on the actual cost for conducting the inspection which shall include:

(1) An hourly charge of seventy dollars per staff person assigned to the inspection, except staff participating as training will not be included in the charges;

(2) An administrative fee of three hundred thirty dollars;

(3) All necessary laboratory analysis costs for samples collected by department personnel; and

(4) Any staff travel costs which shall be calculated in accordance with rule 126-01-02 of the Administrative Code.

(I) All fees invoiced as provided within this rule, including full cost, routine, and non-routine inspection fees, shall be paid within thirty days of the invoice date specified on the invoice. In accordance with sections 3748.07 and 3748.13 of the Revised Code, any fee that remains unpaid on the ninety-first day after the original invoice date shall be assessed an additional amount equal to ten per cent of the original fee.

(1) The department shall mail invoices by ordinary U.S. mail to the most recent address provided by the licensee.

(2) The department shall maintain a list of the invoices issued and date mailed.

(J) Notwithstanding paragraph (D) of this rule, the department shall charge the following types of licensees reduced license fees in the following specified amounts:

(1) A private entity that provides services, does not engage in manufacturing, and that has three hundred fifty thousand to two million dollars in gross annual receipts, shall pay a total license fee of seventy-five per cent of the amount specified for that use of radioactive materials in appendix A to this rule.

(2) A private entity that provides services, does not engage in manufacturing, and that has less than three hundred fifty thousand dollars in gross annual receipts shall pay a total license fee of fifty per cent of the amount specified for that use of radioactive material in appendix A to this rule.

(3) A private entity that engages in manufacturing and that has thirty-five to two hundred employees, irrespective of gross annual receipts, shall pay a total license fee of seventy-five per cent of the amount specified for that use of radioactive material in appendix A to this rule.

(4) A private entity that engages in manufacturing and that has less than thirty-five employees, irrespective of gross annual receipts, shall pay a total license fee of fifty per cent of the amount specified for that use of radioactive material in appendix A to this rule.

(5) A nonprofit entity that has gross annual receipts of three hundred fifty thousand dollars to two million dollars shall pay a total license fee of seventy-five per cent of the amount specified for that use of radioactive material in appendix A to this rule.

(6) A nonprofit entity that has gross annual receipts of less than three hundred fifty thousand dollars shall pay a total license fee of fifty per cent of the amount specified for that use of radioactive material in appendix A to this rule.

(7) A government jurisdiction or district with a population of twenty thousand to fifty thousand shall pay a total license fee of seventy-five per cent of the amount specified for that use of radioactive material as specified in appendix A to this rule.

(8) A government jurisdiction or district with a population of less than twenty thousand shall pay a total license fee of fifty per cent of the amount specified for that use of radioactive materials as specified in appendix A to this rule.

(9) A health district as defined in section 3709.01 of the Revised Code shall pay a total license fee of twenty-five per cent of the amount specified in appendix A to this rule.

(10) An accredited private or public college or university possessing or using radioactive material in a sealed or unsealed source solely as a part of a college or university course supported by tuition and leading to an accredited degree, but excluding clinical training, shall pay a total license fee as set forth for category "1129" as that amount is specified in appendix A to this rule.

The reduced annual fees specified in this paragraph do not apply to any other fees that a licensee may be required to pay under Chapter 3748. of the Revised Code or rules adopted thereunder. Licensees shall provide certification of their compliance with the provisions of paragraphs (J)(1) to (J)(6) of this rule upon initial application and renewal.

(K) The director may modify the inspection frequency of licensed facilities based upon the performance of the facility.

(L) In accordance with section 3748.22 of the Revised Code, the department shall charge fees sufficient to cover all costs of regulatory, administrative, and enforcement activities conducted pursuant to Chapter 3748. of the Revised Code. The director shall recommend to the radiation advisory council and the public health council changes in the radioactive materials fees if the director finds that fees do not meet the requirements of section 3748.22 of the Revised Code.

(M) Fees for those categories listed as "full cost" such as decommissioning activities, for either partial, building or selected area of a licensed site, or full decommissioning leading to license amendment, category change, or termination and for review of sources and/or devices shall be specified as "full cost" and shall be calculated as the sum of the seventy dollar hourly charge per staff member for the number of hours spent on document review and preparation, licensing, inspection, meetings, teleconferences, in travel, administrative time, the cost of any special contractors as determined necessary by the director, any environmental monitoring for radioactive materials and laboratory analysis, any other associated activities. The administrative fee from paragraph (H)(2) of this rule shall be used for administrative time. Travel expenses shall also be invoiced and shall be calculated at the rate determined by rule 126-1-02 of the Administrative Code. These fees will be invoiced monthly.

(N)

(1) Reciprocity to engage in activities in the state of Ohio which involve radioactive materials may be authorized provided:

(a) The person requesting reciprocity possesses a valid radioactive materials license issued by another agreement state or the United States nuclear regulatory commission which authorizes the same activities proposed to be conducted in Ohio;

(b) The request for reciprocity is made by submission of a completed reciprocity application provided by the director, a copy of the person's radioactive materials license, and payment of the reciprocity fee specified in appendix A to this rule;

(c) The duration of activities to be performed in Ohio under reciprocity does not exceed one hundred eighty days in any one calendar year.

(2) A person who has been granted reciprocity in Ohio shall notify the director at least three business days in advance of each time the person proposes to begin a new use of radioactive materials in the state of Ohio, with the notification made on a form provided by the director.

(3) Activities conducted in Ohio under reciprocity are subject to inspection by the department at any time and the department shall invoice a reciprocity inspection fee of one thousand dollars for each inspection of a person's authorized reciprocity activities.

(4) Reciprocity is authorized for one calendar year, beginning on January first or later date when reciprocity is initially applied for, and ending on December thirty-first.

(5) A person who is authorized reciprocity shall apply for an Ohio radioactive materials license at least thirty days prior to exceeding one hundred eighty days of activities in Ohio.

(O) Requests for safety evaluation of devices, products, or sealed sources used for radioactive materials either for commercial distribution or manufactured in accordance with the unique specifications of, and for use by, a single applicant shall be submitted to the director on a form provided by the director for that review prior to manufacture or commercial distribution.

(1) The application shall specify a license amendment for one of the areas listed below:

(a) Safety evaluation of sealed sources or devices or products containing NARM, byproduct material, source material, or special nuclear material (less than critical mass) for commercial distribution.

(b) Safety evaluation of sealed sources or devices or products containing NARM, byproduct material, source material, or special nuclear material (less than critical mass) manufactured in accordance with the unique specifications of, and for use by, a single applicant.

(2) The amendment fee for a source or device review shall be "full cost" as outlined in paragraph ((M) of this rule.

(3) The amendment fee in appendix A to this rule for categories under manufacturing and distribution shall be for amendments other than source or device reviews.

(4) Licensees for categories 3211, 3212, 3213, 3214, and 22162 shall pay an annual surcharge of six hundred fifty dollars to cover administrative costs of overall maintenance activities associated with source or device data submitted to the United States nuclear regulatory commission. This surcharge is included in the annual fee for the above listed categories in "column 5" and "column 6" of appendix A to this rule.

(P) When considered necessary by the director, the director may conduct a review of shielding plans or the adequacy of shielding. The director may also conduct such a review upon the request of the licensee or the applicant for a license. The applicant or licensee shall pay a fee for review of shielding plans or adequacy of shielding as specified in paragraph (M) of this rule.

(Q) Individuals with implanted pacemakers that have a radioactive source will not be charged an annual fee as an individual because of the necessity of possessing the device. Unless the director determines other provisions are required, the medical institution that implanted the device shall hold the license for the individual.

(R) If, because of the complexity of a review, such as that for a sealed source or device, decommissioning, license, or incident, it is necessary to obtain the services of a consultant to assist in a final determination, the licensee or applicant will be invoiced for the consulting services.

(S) Licensees with general licenses requiring an annual report to the director shall submit the report with a fee of four hundred twenty dollars within thirty days of mailing an invoice by the department and are subject to late penalties in paragraph (I) of this rule. If a facility has a specific license which is in a category that would include the generally licensed material, the facility may add the generally licensed material to the specific license and will not be charged the additional fee for that generally licensed material. Annual reports are required for devices under a general license containing radionuclides at or above activities listed in paragraph (C)(13) of rule 3701:1-46-05 of the Administrative Code.

View AppendixView Appendix

Last updated November 2, 2022 at 2:09 PM

History

• Effective: April 15, 2013
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-58-58

(A) A licensee shall:

(1) Secure the unit, the console, the console keys, and the treatment room when not in use or unattended;

(2) Permit only individuals approved by the authorized user, radiation safety officer, or authorized medical physicist to be present in the treatment room during treatment with the source(s);

(3) Prevent dual operation of more than one radiation producing device in a treatment room if applicable; and

(4) Develop, implement, and maintain written procedures for responding to an abnormal situation when the operator is unable to place the source(s) in the shielded position, or remove the patient or human research subject from the radiation field with controls from outside the treatment room. These procedures must include:

(a) Instructions for responding to equipment failures and the names of the individuals responsible for implementing corrective actions;

(b) The process for restricting access to and posting of the treatment area to minimize the risk of inadvertent exposure; and

(c) The names and telephone numbers of the authorized users, the authorized medical physicist, and the radiation safety officer to be contacted if the unit or console operates abnormally.

(B) A copy of the procedures required by paragraph (A)(4) of this rule must be physically located at the unit console.

(C) A licensee shall post instructions at the unit console to inform the operator of:

(1) The location of the procedures required by paragraph (A)(4) of this rule; and

(2) The names and telephone numbers of the authorized users, the authorized medical physicist, and the radiation safety officer to be contacted if the unit or console operates abnormally.

(D) A licensee shall:

(1) Prior to the first use for patient treatment of a new unit or an existing unit with a manufacturer upgrade that affects the operation and safety of the unit, ensure that vendor operational and safety training is provided to all individuals who will operate the unit. The vendor operational and safety training must be provided by the device manufacturer or by an individual certified by the device manufacturer to provide the operational and safety training.

(2) Provide operational and safety instructions initially and at least annually to all individuals who operate the unit at the facility, as appropriate to the individual's assigned duties. The instructions shall include instruction in:

(a) The procedures identified in paragraph (A)(4) of this rule; and

(b) The operating procedures for the unit.

(E) A licensee shall ensure that operators, authorized medical physicists, and authorized users participate in drills of the emergency procedures, initially and at least annually.

(F) A licensee shall retain a record of individuals receiving instruction required by paragraph (D) of this rule, in accordance with rule 3701:1-58-86 of the Administrative Code.

(G) A licensee shall retain a copy of the procedures required by paragraphs (A)(4) and (D)(2)(b) of this rule in accordance with rule 3701:1-58-92 of the Administrative Code.

Last updated November 18, 2022 at 8:37 AM

History

• Effective: August 15, 2021
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-58-72

A licensee may use radioactive material or a radiation source approved for medical use which is not specifically addressed in rules 3701:1-58-32, 3701:1-58-34, 3701:1-58-37, 3701:1-58-43, 3701:1-58-53 and 3701:1-58-55 of the Administrative Code if:

(A) The applicant or licensee has submitted the information required by paragraphs (B) to (D) of rule 3701:1-58-07 of the Administrative Code; and

(B) The applicant or licensee has received written approval from the director in a license or license amendment and uses the material in accordance with the regulations and specific conditions the director considers necessary for the medical use of the material.

Last updated November 18, 2022 at 8:39 AM

History

• Effective: August 15, 2005
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-58-73

(A) A licensee shall retain a record of actions taken by the licensee's management in accordance with paragraph (A) of rule 3701:1-58-12 of the Administrative Code for five years. The record must include a summary of the actions taken and a signature of licensee management.

(B) The licensee shall retain a record of the authority, duties, and responsibilities of the radiation safety officer as required by paragraph (E) of rule 3701:1-58-12 of the Administrative Code, and a signed copy of each radiation safety officer's agreement to be responsible for implementing the radiation safety program, as required by paragraph (B) of rule 3701:1-58-12 of the Administrative Code, for the duration of the license. The records must include the signature of the radiation safety officer and licensee management.

(C) For each associate radiation safety officer appointed under paragraph (B) of rule 3701:1-58-12 of the Administrative Code, the licensee shall retain, for five years after the associate radiation safety officer is removed from the license, a copy of the written document appointing the associate radiation safety officer signed by the licensee's management.

Last updated November 18, 2022 at 8:39 AM

History

• Effective: August 15, 2021
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-58-103

A licensee shall file a report within five days if a leak test required by rule 3701:1-58-27 of the Administrative Code reveals the presence of one hundred eighty-five becquerels (0.005 microcurie) or more of removable contamination. The report must be filed with the address listed in rule 3701:1-40-04 of the Administrative Code. The written report must include the model number and serial number if assigned, of the leaking source; the radionuclide and its estimated activity; the results of the test; the date of the test; and the action taken.

Last updated November 18, 2022 at 8:43 AM

History

• Effective: October 4, 2010
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-40-23

The director shall approve an application for a type A specific license of broad scope provided that the applicant:

(A) Satisfies the general requirements specified in rules 3701:1-38-02 and 3701:1-40-15 of the Administrative Code;

(B) Has engaged in a reasonable number of activities involving the use of radioactive material; and

(C) Has established administrative controls and provisions relating to organization and management, procedures, record keeping, material control, and accounting and management review that are necessary to assure safe operations, including:

(1) The establishment of a radiation safety committee composed of such persons as a radiation safety officer, a representative of management, and persons trained and experienced in the safe use of radioactive materials;

(2) The appointment of a radiation safety officer who is qualified by training and experience in radiation protection, and who is available for advice and assistance on radiological safety matters; and

(3) The establishment of appropriate administrative procedures to assure:

(a) Control of procurement and use of radioactive material;

(b) Completion of safety evaluations of proposed uses of radioactive material which take into consideration such matters as the adequacy of facilities and equipment, training and experience of the user, and the operating or handling procedures; and

(c) Review, approval, and recording by the radiation safety committee of safety evaluations of proposed uses prepared in accordance with paragraph (C)(3)(b) of this rule prior to use of the radioactive material.

Last updated November 2, 2022 at 2:13 PM

History

• Effective: October 4, 2010
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-58-08 License amendments.

A licensee shall apply for and must receive a license amendment and pay the invoiced amendment fee specified in rule 3701:1-38-02 of the Administrative Code:

(A) Before it receives, prepares, or uses radioactive material for a type of use that is permitted under this chapter, but that is not authorized on the licensee's current license issued under this chapter, and Chapter 3701:1-40 of the Administrative Code;

(B) Before it permits anyone to work as an authorized user, authorized nuclear pharmacist, ophthalmic physicist, or authorized medical physicist under the license, except:

(1) For an authorized user, an individual who meets the requirements in rule 3701:1-58-22, and paragraph (A) of rule 3701:1-58-33, paragraph (A) of rule 3701:1-58-36, paragraph (A) of rule 3701:1-58-40, paragraph (A) of rule 3701:1-58-41, paragraph (A) of rule 3701:1-58-42, paragraph (A) of rule 3701:1-58-51, paragraph (A) of rule 3701:1-58-54, and paragraph (A) of rule 3701:1-58-71 of the Administrative Code.

(2) For an authorized nuclear pharmacist, an individual who meets the requirements in paragraph (A) of rule 3701:1-58-20 and rule 3701:1-58-22 of the Administrative Code.

(3) For an authorized medical physicist, an individual who meets the requirements in paragraph (A) of rule 3701:1-58-19 and rule 3701:1-58-22 of the Administrative Code.

(4) An individual who is identified as an authorized user, an authorized nuclear pharmacist, ophthalmic physicist, or authorized medical physicist:

(a) On a United States nuclear regulatory commission or agreement state license or other equivalent permit or license recognized by the director that authorizes the use of radioactive material in medical use or in the practice of nuclear pharmacy;

(b) On a permit issued by a United States nuclear regulatory commission or agreement state specific license of broad scope that is authorized to permit the use of radioactive material in medical use or in the practice of nuclear pharmacy;

(c) On a permit issued by a United States nuclear regulatory commission master material licensee that is authorized to permit the use of radioactive material in medical use or in the practice of nuclear pharmacy; or

(d) By a commercial nuclear pharmacy that has been authorized to identify authorized nuclear pharmacists;

(C) Before a radiation safety officer is changed, except as provided in rule 3701:1-58-12 of the Administrative Code;

(D) Before it permits anyone to work as an associate radiation safety officer, or before the radiation safety officer assigns duties and tasks to an associate radiation safety officer that differ from those for which this individual is authorized on the license;

(E) Before it receives radioactive material in excess of the amount or in a different form, or receives a different radionuclide than is authorized on the license;

(F) Before it adds to or changes the areas of use identified in the application or on the license, except for areas of use where radioactive material is used only in accordance with either rule 3701:1-58-32 or 3701:1-58-34 of the Administrative Code;

(G) Before it changes the address(es) of use identified in the application or on the license;

(H) Before it revises procedures required by rules 3701:1-58-58 and 3701:1-58-64 to 3701:1-58-66 of the Administrative Code, as applicable, where such revision reduces radiation safety; and

(I) Before it receives a sealed source from a different manufacturer or of a different model number than authorized by its license unless the sealed source is used for manual brachytherapy, is listed in the sealed source and device registry, and is in a quantity and for an isotope authorized by the license.

Last updated November 18, 2022 at 8:28 AM

History

• Effective: August 15, 2021
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-58-12

(A) In addition to the radiation protection program requirements of rule 3701:1-38-11 of the Administrative Code, a licensee's management shall approve in writing:

(1) Requests for a license application, renewal, or amendment before submittal to the director;

(2) Any individual before allowing that individual to work as an authorized user, authorized nuclear pharmacist, or authorized medical physicist; and

(3) Radiation protection program changes that do not require a license amendment and are permitted under rule 3701:1-58-13 of the Administrative Code.

(B) A licensee's management shall appoint a radiation safety officer, who agrees, in writing, to be responsible for implementing the radiation protection program. The licensee, through the radiation safety officer, shall ensure that radiation safety activities are being performed in accordance with licensee-approved procedures and regulatory requirements. A licensee's management may appoint, in writing, one or more associate radiation safety officers to support the radiation safety officer. The radiation safety officer, with written agreement of the licensee's management, must assign the specific duties and tasks to each associate radiation safety officer. These duties and tasks are restricted to the types of use for which the associate radiation safety officer is listed on a license. The radiation safety officer may delegate duties and tasks to the associate radiation safety officer but shall not delegate the authority or responsibilities for implementing the radiation protection program.

(C) For up to sixty days each year, a licensee may permit an individual qualified to be a radiation safety officer, under rules 3701:1-58-18 and 3701:1-58-22 of the Administrative Code, to function as a temporary radiation safety officer and to perform the functions of a radiation safety officer, as provided in paragraph (G) of this rule, if the licensee takes the actions required in paragraphs (B), (E), (G), and (H) of this rule and notifies the director in accordance with paragraph (B) of rule 3701:1-58-09 of the Administrative Code.

(D) A licensee may simultaneously appoint more than one temporary radiation safety officer in accordance with paragraph (C) of this rule, if needed to ensure that the licensee has a temporary radiation safety officer that satisfies the requirements to be a radiation safety officer for each of the different types of uses of radioactive material permitted by the license.

(E) A licensee shall establish the authority, duties, and responsibilities of the radiation safety officer in writing.

(F) Licensees that are authorized for two or more different types of uses of radioactive material under rules 3701:1-58-37 to 3701:1-58-52 of the Administrative Code and rules 3701:1-58-55 to 3701:1-58-71 of the Administrative Code, or two or more types of units under rules 3701:1-58-55 to 3701:1-58-71 of the Administrative Code, shall establish a radiation safety committee to oversee all uses of radioactive material permitted by the license. The committee must include an authorized user of each type of use permitted by the license, the radiation safety officer, a representative of the nursing service, and a representative of management who is neither an authorized user nor a radiation safety officer. The committee may include other members the licensee considers appropriate.

(G) A licensee shall provide the radiation safety officer sufficient authority, organizational freedom, time, resources, and management prerogative, to:

(1) Identify radiation safety problems;

(2) Initiate, recommend, or provide corrective actions;

(3) Stop unsafe operations; and,

(4) Verify implementation of corrective actions.

(H) A licensee shall retain a record of actions taken under paragraphs (A), (B), and (E) of this rule in accordance with rule 3701:1-58-73 of the Administrative Code.

Last updated November 18, 2022 at 8:29 AM

History

• Effective: August 15, 2021
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-58-64

(A) A licensee authorized to use teletherapy units for medical use shall perform output spot-checks on each teletherapy unit once in each calendar month that include determination of:

(1) Timer accuracy, and timer linearity over the range of use;

(2) On-off error;

(3) The coincidence of the radiation field and the field indicated by the light beam localizing device;

(4) The accuracy of all distance measuring and localization devices used for medical use;

(5) The output for one typical set of operating conditions measured with the dosimetry system described in paragraph (B) of rule 3701:1-58-60 of the Administrative Code; and

(6) The difference between the measurement made in paragraph (A)(5) of this rule and the anticipated output, expressed as a percentage of the anticipated output (i.e., the value obtained at last full calibration corrected mathematically for radioactive decay).

(B) A licensee shall perform measurements required by paragraph (A) of this rule in accordance with written procedures established by the authorized medical physicist. That individual need not actually perform the spot-check measurements.

(C) A licensee shall have the authorized medical physicist review the results of each spot-check within fifteen days. The authorized medical physicist shall notify the licensee as soon as possible in writing of the results of each spot-check.

(D) A licensee authorized to use a teletherapy unit for medical use shall perform safety spot-checks of each teletherapy facility once in each calendar month and after each source installation to assure proper operation of:

(1) Electrical interlocks at each teletherapy room entrance;

(2) Electrical or mechanical stops installed for the purpose of limiting use of the primary beam of radiation (restriction of source housing angulation or elevation, carriage or stand travel and operation of the beam on-off mechanism);

(3) Source exposure indicator lights on the teletherapy unit, on the control console, and in the facility;

(4) Viewing and intercom systems;

(5) Treatment room doors from inside and outside the treatment room; and

(6) Electrically assisted treatment room doors with the teletherapy unit electrical power turned off.

(E) If the results of the checks required in paragraph (D) of this rule indicate the malfunction of any system, a licensee shall lock the control console in the off position and not use the unit except as may be necessary to repair, replace, or check the malfunctioning system.

(F) A licensee shall retain a record of each spot-check required by paragraphs (A) and (D) of this rule, and a copy of the procedures required by paragraph (B) of this rule, in accordance with rule 3701:1-58-95 of the Administrative Code.

Last updated November 18, 2022 at 8:38 AM

History

• Effective: August 15, 2005
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-58-66

(A) A licensee authorized to use a gamma stereotactic radiosurgery unit for medical use shall perform spot-checks of each gamma stereotactic radiosurgery facility and on each unit:

(1) Monthly;

(2) Before the first use of the unit on a given day; and

(3) After each source installation.

(B) A licensee shall:

(1) Perform the measurements required by paragraph (A) of this rule in accordance with written procedures established by the authorized medical physicist. That individual need not actually perform the spot-check measurements.

(2) Have the authorized medical physicist review the results of each spot-check within fifteen days. The authorized medical physicist shall notify the licensee as soon as possible in writing of the results of each spot-check.

(C) To satisfy the requirements of paragraph (A)(1) of this rule, spot-checks must, at a minimum:

(1) Assure proper operation of:

(a) Treatment table retraction mechanism, using backup battery power or hydraulic backups with the unit off;

(b) Helmet microswitches;

(c) Emergency timing circuits; and

(d) Stereotactic frames and localizing devices (trunnions).

(2) Determine:

(a) The output for one typical set of operating conditions measured with the dosimetry system described in paragraph (B) of rule 3701:1-58-60 of the Administrative Code;

(b) The difference between the measurement made in paragraph (C)(2)(a) of this rule and the anticipated output, expressed as a percentage of the anticipated output (i.e., the value obtained at last full calibration corrected mathematically for radioactive decay);

(c) Source output against computer calculation;

(d) Timer accuracy and linearity over the range of use;

(e) On-off error; and

(f) Trunnion centricity.

(D) To satisfy the requirements of paragraphs (A)(2) and (A)(3) of this rule, spot-checks must assure proper operation of:

(1) Electrical interlocks at each gamma stereotactic radiosurgery room entrance;

(2) Source exposure indicator lights on the gamma stereotactic radiosurgery unit, on the control console, and in the facility;

(3) Viewing and intercom systems;

(4) Timer termination;

(5) Radiation monitors used to indicate room exposures; and

(6) Emergency off buttons.

(E) A licensee shall arrange for the repair of any system identified in paragraph (C) of this rule that is not operating properly as soon as possible.

(F) If the results of the checks required in paragraph (D) of this rule indicate the malfunction of any system, a licensee shall lock the control console in the off position and not use the unit except as may be necessary to repair, replace, or check the malfunctioning system.

(G) A licensee shall retain a record of each check required by paragraphs (C) and (D) of this rule and a copy of the procedures required by paragraph (B) of this rule in accordance with rule 3701:1-58-97 of the Administrative Code.

Last updated November 18, 2022 at 8:38 AM

History

• Effective: August 15, 2005
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-58-09 Notifications.

(A) A licensee shall provide the director a copy of the board certification and the written attestation(s), signed by a preceptor, the United States nuclear regulatory commission or agreement state license, the permit issued by a United States nuclear regulatory commission master material licensee, the permit issued by a United States nuclear regulatory commission or agreement state licensee of broad scope, or the permit issued by a United States nuclear regulatory commission master material license broad scope permittee for each individual no later than thirty days after the date that the licensee permits the individual to work as an authorized user, an authorized nuclear pharmacist, ophthalmic physicist, or an authorized medical physicist, under paragraph (B) of rule 3701:1-58-08 of the Administrative Code. For individuals permitted to work under paragraph (B)(4) of rule 3701:1-58-08 of the Administrative Code, within the same thirty day time frame, the licensee shall also provide, as appropriate, verification of completion of;

(1) Any additional case experience required in paragraph (B)(1)(b)(vi) of rule 3701:1-58-40 of the Administrative Code for an authorized user under rule 3701:1-58-37 of the Administrative Code;

(2) Any additional training required in paragraph (C) of rule 3701:1-58-71 of the Administrative Code for an authorized user under rule 3701:1-58-55 of the Administrative Code; and

(3) Any additional training required in paragraph (C) of rule 3701:1-58-19 of the Administrative Code for an authorized medical physicist.

(B) A licensee shall notify the director by letter no later than thirty days after:

(1) An authorized user, an authorized nuclear pharmacist, a radiation safety officer, an associate radiation safety officer, ophthalmic physicist, or an authorized medical physicist permanently discontinues performance of duties under the license or has a name change;

(2) The licensee permits an authorized user or an individual qualified to be a radiation safety officer under rules 3701:1-58-18 and 3701:1-58-22 of the Administrative Code, to function as a temporary radiation safety officer and to perform the functions of a radiation safety officer in accordance with paragraph (C) of rule 3701:1-58-12 of the Administrative Code.

(3) The licensee's mailing address changes;

(4) The licensee's name changes, but the name change does not constitute a transfer of control of the license as described in paragraph (A) of rule 3701:1-40-16 of the Administrative Code;

(5) The licensee has added to or changed the areas of use identified in the application or on the license where radioactive material is used in accordance with either rule 3701:1-58-32 or 3701:1-58-34 of the Administrative Code; or

(6) The licensee obtains a sealed source for use in manual brachytherapy from a different manufacturer or with a different model number than authorized by its license for which it did not require a license amendment as provided in paragraph (I) of rule 3701:1-58-08 of the Administrative Code. The notification must include the manufacturer and model number of the sealed source, the isotope, and the quantity per sealed source.

(C) The licensee shall provide the documents required in this rule to the director either electronically or at the appropriate address identified in rule 3701:1-40-04 of the Administrative Code.

Last updated November 18, 2022 at 8:29 AM

History

• Effective: August 15, 2021
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-58-37

A licensee may use any unsealed radioactive material identified in paragraph (B)(1)(b)(vi) of rule 3701:1-58-40 the Administrative Code prepared for medical use and for which a written directive is required that is:

(A) Obtained from:

(1) A manufacturer or preparer licensed under rule 3701:1-46-43 of the Administrative Code or equivalent United States nuclear regulatory commission or agreement state requirements; or

(2) A PET radioactive drug producer licensed in accordance with paragraph (I) of rule 3701:1-40-14 of the Administrative Code or equivalent United States nuclear regulatory commission or agreement state requirement; or

(B) Prepared by, excluding production of PET radionuclides:

(1) An authorized nuclear pharmacist;

(2) A physician who is an authorized user and who meets the requirements specified in rule 3701:1-58-36 or 3701:1-58-40 of the Administrative Code; or

(3) An individual under the supervision, as specified in rule 3701:1-58-14 of the Administrative Code, of the authorized nuclear pharmacist in paragraph (B)(1) of this rule or the physician who is an authorized user in paragraph (B)(2) of this rule; or

(C) Obtained from and prepared by an United States nuclear regulatory commission or agreement state licensee for use in research in accordance with an investigational new drug protocol accepted by United States food and drug administration; or

(D) Prepared by the licensee for use in research in accordance with an investigational new drug protocol accepted by United States food and drug administration.

Last updated November 18, 2022 at 8:34 AM

History

• Effective: August 15, 2021
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-58-55

(A) A licensee must only use sealed sources:

(1) Approved and as provided for in the sealed source and device registry in photon emitting remote afterloader units, teletherapy units, or gamma stereotactic radiosurgery units to deliver therapeutic doses for medical uses; or

(2) In research involving photon-emitting remote afterloader units, teletherapy units, or gamma stereotactic radiosurgery units in accordance with an active investigational device exemption (IDE) application accepted by the United States food and drug administration provided the requirements of paragraph (A) of rule 3701:1-58-17 of the Administrative Code are met.

(B) A licensee must use photon-emitting remote afterloader units, teletherapy units, or gamma stereotactic radiosurgery units:

(1) Approved in the sealed source and device registry to deliver a therapeutic dose for medical use. These devices may be used for therapeutic medical treatments that are not explicitly provided for in the sealed source and device registry, but must be used in accordance with radiation safety conditions and limitations described in the sealed source and device registry; or

(2) In research in accordance with an active investigational device exemption (IDE) application accepted by the United States food and drug administration provided the requirements of paragraph (A) of rule 3701:1-58-17 of the Administrative Code are met.

Last updated November 18, 2022 at 8:36 AM

History

• Effective: August 15, 2021
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-40-16

(A)

(1) A license, or any right under a license, shall not be transferred, assigned or in any manner disposed of, either voluntarily or involuntarily, directly or indirectly, through transfer of control of any license to any person, unless the director finds that the transfer is in accordance with this rule and Chapters 3701:1-46, 3701:1-48, 3701:1-49, 3701:1-52, and 3701:1-58 of the Administrative Code. A license or any right contained therein may not be transferred or conveyed without the written authorization of the director. If the director approves the transfer and receives payment of the appropriate licensing fee, a new license will be issued to the transferee.

(2) An application for transfer of license must include:

(a) The identity, technical and financial qualifications of the proposed transferee; and

(b) Financial assurance for decommissioning information required by rule 3701:1-40-17 of the Administrative Code.

(B) Each licensee shall confine possession and use of radioactive material to the locations and purposes authorized in the license. Preparation for shipment and transport of radioactive material shall be in accordance with Chapter 3701:1-50 of the Administrative Code.

(C) The director may incorporate at the time of issuance, or thereafter by appropriate rule, regulation, or order, such additional requirements or conditions with respect to the licensee's receipt, possession, use and transfer of radioactive material as the director deems appropriate or necessary in order to protect the environment, protect health, or minimize danger to life or property. The director may require such reports and the keeping of such records, and provide for such inspections of activities under the license as may be necessary to effectuate the purposes of Chapter 3748. of the Revised Code or rules adopted thereunder.

(D) A licensee that is required to submit an emergency plan pursuant to rule 3701:1-40-14 of the Administrative Code shall follow the emergency plan approved by the director. The licensee may amend the approved plan without approval of the director provided that the amendment does not decrease the effectiveness of the plan. Within six months after amending the emergency plan, the licensee shall furnish the amended plan to both the director and to affected offsite response organizations. Any proposed amendment to the emergency plan that decreases, or potentially decreases, the effectiveness of the approved emergency plan may not be implemented without prior approval by the director.

(E) Each licensee preparing technetium-99m radiopharmaceuticals from molybdenum-99/technetium-99m generators or rubidium-82 from strontium-82/rubidium-82 generators shall test the generator eluates for molybdenum-99 breakthrough or strontium-82 and strontium-85 contamination, respectively, in accordance with rule 3701:1-58-35 of the Administrative Code. The licensee shall record the results of each test and retain each record for three years after the record is made. The licensee shall report the results of any test that exceeds the permissible concentration listed in paragraph (A) of rule 3701:1-58-35 of the Administrative Code at the time of generator elution, in accordance with rule 3701:1-58-105 of the Administrative Code.

(F) Each licensee must notify the director by certified mail within ten business days of the commencement of a voluntary or involuntary bankruptcy petition that has been filed by or against:

(1) The licensee;

(2) An entity, defined in this rule as person, estate, trust, governmental unit, and United States trustee, controlling the licensee or listing the license or licensee as property of the estate; or

(3) An affiliate of the licensee defined in this rule as an entity that directly or indirectly owns, controls, or holds with power to vote, twenty per cent or more of the outstanding voting securities of the debtor, other than an entity that holds such securities:

(a) In a fiduciary or agency capacity without sole discretionary power to vote such securities; or

(b) Solely to secure a debt, if such entity has not in fact exercised such power to vote.

The notification shall specify the bankruptcy court in which the petition for bankruptcy was filed and the date of the filing petition.

(G) The director may, upon application including adequate documentation by a person or by his own initiative, grant such exemptions from the requirements of this chapter or other chapters of the Administrative Code involving radioactive materials promulgated under Chapter 3748. of the Revised Code that are authorized by law and will not result in undue hazard to life or property and are otherwise in the public interest.

(H) Each portable gauge licensee shall use a minimum of two independent physical controls that form tangible barriers to secure portable gauges from unauthorized removal, whenever portable gauges are not under the control and constant surveillance of the licensee.

(I)

(1) Authorization under paragraph (I) of rule 3701:1-40-14 of the Administrative Code to produce positron emission tomography (PET) radioactive drugs for noncommercial transfer to medical use licensees in its consortium does not relieve the licensee from complying with applicable United States federal drug administration, other federal, and state requirements governing radioactive drugs.

(2) Each licensee authorized under paragraph (I) of rule 3701:1-40-14 of the Administrative Code to produce PET radioactive drugs for noncommercial transfer to medical use licensees in its consortium shall:

(a) Satisfy the labeling requirements in paragraph (A)(4) of rule 3701:1-46-43 of the Administrative Code for each PET radioactive drug transport radiation shield and each syringe, vial, or other container used to hold a PET radioactive drug intended for noncommercial distribution to members of its consortium.

(b) Possess and use instrumentation to measure the radioactivity of the PET radioactive drugs intended for noncommercial distribution to members of its consortium and meet the procedural, radioactivity measurement, instrument test, instrument check, and instrument adjustment requirements in paragraph (C) of rule 3701:1-46-43 of the Administrative Code.

(3) A licensee that is a pharmacy authorized under paragraph (I) of rule 3701:1-40-14 of the Administrative Code to produce PET radioactive drugs for noncommercial transfer to medical use licensees in its consortium shall require that any individual that prepares PET radioactive drugs shall be:

(a) An authorized nuclear pharmacist that meets the requirements in paragraph (B)(2) of rule 3701:1-46-43 of the Administrative Code, or

(b) An individual under the supervision of an authorized nuclear pharmacist as specified in rule 3701:1-58-14 of the Administrative Code.

(4) A pharmacy, authorized under paragraph (I) of rule 3701:1-40-14 of the Administrative Code to produce PET radioactive drugs for noncommercial transfer to medical use licensees in its consortium that allows an individual to work as an authorized nuclear pharmacist, shall meet the requirements of paragraph (B)(5) of rule 3701:1-46-43 of the Administrative Code.

Last updated August 17, 2021 at 11:43 PM

History

• Effective: August 15, 2021
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-40-04

(A) Except as otherwise provided, any communication or report required by this chapter shall be filed in accordance with Chapter 3748. of the Revised Code and rules promulgated thereunder. Documents pertaining to license application or any license matter, unless otherwise directed in writing, shall be submitted to the following address or by electronic submission in a manner approved by the director:

"Ohio Department of Health

Bureau of Environmental Health and Radiation Protection

246 North High Street

Columbus, Ohio 43215."

(B) If pemitted to submit via electronic mail, communications may be sent to the Ohio department of health at:

"BRadiation@odh.ohio.gov"

Last updated April 19, 2022 at 8:33 AM

History

• Effective: April 17, 2022
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-58-10 Exemptions regarding type A specific licenses of broad scope.

A licensee possessing a type A specific license of broad scope for medical use, issued under rules 3701:1-40-22 and 3701:1-40-23 of the Administrative Code, is exempt from:

(A) The provisions of paragraph (D) of rule 3701:1-58-07 of the Administrative Code regarding the need to file an amendment to the license for medical use of radioactive material, as described in rule 3701:1-58-72 of the Administrative Code;

(B) The provisions of paragraph (B) of rule 3701:1-58-08 of the Administrative Code;

(C) The provisions of paragraph (F) of rule 3701:1-58-08 of the Administrative Code regarding additions to or changes in the areas of use at the addresses identified in the application or on the license;

(D) The provisions of paragraph (A) of rule 3701:1-58-09 of the Administrative Code;

(E) The provisions of paragraph (B)(1) of rule 3701:1-58-09 of the Administrative Code for an authorized user, an authorized nuclear pharmacist, ophthalmic physicist, or an authorized medical physicist;

(F) The provisions of paragraph (B)(5) of rule 3701:1-58-09 of the Administrative Code regarding additions to or changes in the areas of use identified in the application or on the license where radioactive material is used in accordance with either rule 3701:1-58-32 or 3701:1-58-34 of the Administrative Code; and

(G) The provisions of paragraph (A) of rule 3701:1-58-17 of the Administrative Code.

Last updated November 18, 2022 at 8:29 AM

History

• Effective: August 15, 2021
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-40-22

(A) An application for specific license of broad scope shall be made in accordance with rules 3701:1-38-02 and 3701:1-40-14 of the Administrative Code.

(1) If a current licensee wants to obtain a broad scope license, the application will be considered by the director if the application addresses and meets requirements of this chapter and rule 3701:1-38-02 of the Administrative Code.

(2) Broad scope licensees are not exempt from the notification requirements in paragraph (C) of rule 3701:1-40-18 of the Administrative Code.

(B) A "type A specific license of broad scope", or "type A broad license" is a specific license authorizing receipt, acquisition, ownership, possession, use, and transfer of any chemical or physical form of the radioactive material specified in the license, but not exceeding quantities specified in the license, for authorized purposes, with quantities usually greater than one curie.

(C) A "type B specific license of broad scope" or "type B broad license" is a specific license authorizing receipt, acquisition, ownership, possession, use, and transfer of any chemical or physical form of radioactive material specified in column I of the appendix to this rule for authorized purposes. The possession limit for a type B broad license, if only one radionuclide is possessed thereunder, is the quantity specified for that radionuclide in column I of the appendix to this rule. If two or more radionuclides are possessed under a type B broad license, the possession limit for each is calculated as follows:

(1) For each radionuclide, determine the ratio of the quantity possessed to the applicable quantity specified for that radionuclide in column I of the appendix to this rule.

(2) Add the ratios for all radionuclides possessed under the license. The possession limit is reached when the sum of all ratios exceeds unity.

(D) A "type C specific license of broad scope" or "type C broad license" is a specific license authorizing receipt, acquisition, ownership, possession, use, and transfer of any chemical or physical form of radioactive material specified in column II of the appendix to this rule, for authorized purposes. The possession limit for a type C broad license, if only one radionuclide is possessed thereunder, is the quantity specified for that radionuclide in column II of the appendix to this rule. If two or more radionuclides are possessed under a type C broad license, the possession limit for each is calculated as follows:

(1) For each radionuclide, determine the ratio of the quantity possessed to the applicable quantity specified for that radionuclide in column II of the appendix to this rule.

(2) Add the ratios for all radionuclides possessed under the license. The possession limit is reached when the sum of all ratios exceeds unity.

View Appendix

Last updated April 19, 2022 at 8:35 AM

History

• Effective: April 17, 2022
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-58-17

For medical use, a licensee may only use:

(A) Sealed sources or devices manufactured, labeled, packaged, and distributed in accordance with a license issued under Chapter 3701:1-40 and rules 3701:1-38-02 and 3701:1-46-44 of the Administrative Code or equivalent requirements of the United States nuclear regulatory commission or an agreement state;

(B) Sealed sources or devices noncommercially transferred from an individual licensed in accordance with rule 3701:1-58-06 of the Administrative Code or a United States nuclear regulatory commission or agreement state medical use licensee; or

(C) Teletherapy sources manufactured and distributed in accordance with a license issued under Chapter 3701:1-40 of the Administrative Code or the equivalent requirements of the United States nuclear regulatory commission or an agreement state.

Last updated November 18, 2022 at 8:31 AM

History

• Effective: December 22, 2008
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-58-11 License issuance.

(A) The director shall issue a license for the medical use of radioactive material if:

(1) The applicant has filed documentation in accordance with rule 3701:1-58-07 of the Administrative Code;

(2) The applicant has paid any applicable fee as provided in rule 3701:1-38-02 of the Administrative Code;

(3) The director finds the applicant equipped and committed to observe the safety standards established by the director for the protection of the public health and safety; and

(4) The applicant meets the requirements of Chapter 3701:1-40 and rule 3701:1-38-02 of the Administrative Code.

(B) The director shall issue a license for mobile medical service if the applicant:

(1) Meets the requirements in paragraph (A) of this rule; and

(2) Assures that individuals or human research subjects to whom unsealed radioactive material or radiation from implants containing radioactive material will be administered may be released following treatment in accordance with rule 3701:1-58-30 of the Administrative Code.

Last updated November 18, 2022 at 8:29 AM

History

• Effective: October 4, 2010
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-58-30

(A) A licensee may authorize the release from its control of any individual who has been administered unsealed radioactive material or implants containing radioactive material if the total effective dose equivalent to any other individual from exposure to the released individual is not likely to exceed five millisieverts (0.5 rem).

(B) A licensee shall provide the released individual, or the individual's parent or guardian, with instructions, including written instructions, on actions recommended to maintain doses to other individuals as low as is reasonably achievable if the total effective dose equivalent to any other individual is likely to exceed one millisievert (0.1 rem). If the total effective dose equivalent to a nursing infant or child could exceed one millisievert (0.1 rem) assuming there were no interruption of breast-feeding, the instructions must also include:

(1) Guidance on the interruption or discontinuation of breast-feeding; and

(2) Information on the potential consequences, if any, of failure to follow the guidance.

(C) A licensee shall maintain a record of the basis for authorizing the release of an individual in accordance with paragraph (A) of rule 3701:1-58-82 of the Administrative Code.

(D) The licensee shall maintain a record of instructions provided to a breast-feeding female in accordance with rule 3701:1-58-82 of the Administrative Code.

(E) Any patient administered gamma emitting radiopharmaceuticals or permanent brachytherapy sources and is required to be furnished written instructions in accordance with paragraph (B) of this rule shall be provided a patient release card to include:

(1) The patient's name;

(2) The radionuclide administered and its activity;

(3) The facility name which administered the radionuclide;

(4) The date of the administration of the radionuclide; and

(5) The expiration date of the card.

The card is not applicable to those patients who are institutionalized in facilities such as hospitals, nursing homes, correctional institutions, etc. or to those patients whose radiation levels do not exceed one microsievert per hour (0.1 mrem/hr) at one meter.

Last updated October 6, 2022 at 8:25 AM

History

• Effective: October 6, 2022
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-38-11

(A) Quality factors for converting absorbed dose to dose equivalent are as follows:

| Type of radiation | Quality factor (Q) | Absorbed dose equal to a unit dose equivalent^A/ | | --- | --- | --- | | X-, gamma, or beta radiation and high-speed electrons ..... | 1 | 1 | | Alpha particles, multiple-charged particles, fission fragments and heavy particles of unknown charge ..... | 20 | 0.05 | | Neutrons of unknown energy .... | 10 | 0.1 | | High-energy protons ..... | 10 | 0.1 |

^A/ Absorbed dose in gray equal to one sievert or the absorbed dose in rad equal to one rem.

(B) If it is more convenient to measure the neutron fluence rate than to determine the neutron dose equivalent rate in sievert per hour or rem per hour, as provided in paragraph (A) of this rule, 0.01 sievert (one rem) of neutron radiation of unknown energies may, for purposes of these regulations, be assumed to result from a total fluence of twenty-five million neutrons per square centimeter incident upon the body. If sufficient information exists to estimate the approximate energy distribution of the neutrons, the licensee may use the fluence rate per unit dose equivalent or the appropriate Q value as provided in this paragraph to convert a measured tissue dose in gray or rad to dose equivalent in sievert or rem as follows:

| | Neutron energy (MeV) | Quality factor^A/ (Q) | Fluence per unit dose equivalent^B/ (neutrons cm^-2 rem^-1) | Fluence per unit dose equivalent^B/ (neutrons cm^-2 Sv^-1) | | --- | --- | --- | --- | --- | | (Thermal)........ | 2.5x10^-8 | 2 | 980x10⁶ | 980x10⁸ | | | 1x10^-7 | 2 | 980x10⁶ | 980x10⁸ | | | 1x10^-6 | 2 | 810x10⁶ | 810x10⁸ | | | 1x10^-5 | 2 | 810x10⁶ | 810x10⁸ | | | 1x10^-4 | 2 | 840x10⁶ | 840x10⁸ | | | 1x10^-3 | 2 | 980x10⁶ | 980x10⁸ | | | 1x10^-2 | 2.5 | 1010x10⁶ | 1010x10⁸ | | | 1x10^-1 | 7.5 | 170x10⁶ | 170x10⁸ | | | 5x10^-1 | 11 | 39x10⁶ | 39x10⁸ | | | 1 | 11 | 27x10⁶ | 27x10⁸ | | | 2.5 | 9 | 29x10⁶ | 29x10⁸ | | | 5 | 8 | 23x10⁶ | 23x10⁸ | | | 7 | 7 | 24x10⁶ | 24x10⁸ | | | 10 | 6.5 | 24x10⁶ | 24x10⁸ | | | 14 | 7.5 | 17x10⁶ | 17x10⁸ | | | 20 | 8 | 16x10⁶ | 16x10⁸ | | | 40 | 7 | 14x10⁶ | 14x10⁸ | | | 60 | 5.5 | 16x10⁶ | 16x10⁸ | | | 1x10² | 4 | 20x10⁶ | 20x10⁸ | | | 2x10² | 3.5 | 19x10⁶ | 19x10⁸ | | | 3x10² | 3.5 | 16x10⁶ | 16x10⁸ | | | 4x10² | 3.5 | 14x10⁶ | 14x10⁸ |

^A/Value of quality factor (Q) at the point where the dose equivalent is maximum in a 30-centimeter diameter cylinder tissue-equivalent phantom.

^B/Monoenergetic neutrons incident normally on a 30-centimeter diameter cylinder tissue-equivalent phantom.

(C) For the purpose of Chapter 3701:1-38 of the Administrative Code, activity is expressed in the SI unit of becquerel, Bq, or in the special unit of curie, Ci, or their multiples, or disintegrations or transformations per unit of time.

(D) Radiation protection programs.

(1) Each licensee or registrant shall develop, document, and implement a radiation protection program commensurate with the scope and extent of licensed or registered activities to ensure compliance with the provisions of this chapter. Record keeping requirements are provided in paragraph (B) of rule 3701:1-38-20 of the Administrative Code.

(2) The licensee or registrant shall use, to the extent practicable, procedures and engineering controls based upon sound radiation protection principles to achieve occupational doses and public doses that are as low as is reasonably achievable.

(3) The licensee or registrant shall, at intervals not to exceed twelve months, review the radiation protection program content and implementation.

(4) To implement the ALARA requirements of paragraph (D)(2) of this rule, and notwithstanding the requirements in rule 3701:1-38-13 of the Administrative Code, a constraint on air emissions of radioactive material to the environment, excluding radon-222 and its daughters, shall be established by licensees, such that the individual member of the public likely to receive the highest dose will not be expected to receive a total effective dose equivalent in excess of 0.1 millisievert (ten millirem) per year from these emissions. If a licensee subject to this requirement exceeds this dose constraint, the licensee shall report the amount exceeding the dose constraint as provided in paragraph (C) of rule 3701:1-38-21 of the Administrative Code and promptly take appropriate corrective action to ensure against recurrence.

Last updated November 2, 2022 at 2:10 PM

History

• Effective: September 1, 2011
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-58-13

(A) A licensee may revise its radiation protection program without the director's approval if:

(1) The revision does not require a license amendment under rule 3701:1-58-08 of the Administrative Code;

(2) The revision is in compliance with the regulations and the license;

(3) The revision has been reviewed and approved by the radiation safety officer and licensee management; and

(4) The affected individuals are instructed on the revised program before the changes are implemented.

(B) A licensee shall retain a record of each change in accordance with rule 3701:1-58-74 of the Administrative Code.

Last updated November 18, 2022 at 8:30 AM

History

• Effective: August 15, 2005
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-58-52

Except as provided in rule 3701:1-58-21 of the Administrative Code, the licensee shall require the authorized user of strontium-90 for ophthalmic radiotherapy to be a physician who:

(A) Is an authorized user under rule 3701:1-58-51 of the Administrative Code, or equivalent United States nuclear regulatory commission or agreement state requirements; or

(B) Has achieved the following requirements:

(1) Has completed twenty-four hours of classroom and laboratory training applicable to the medical use of strontium-90 for ophthalmic radiotherapy. The training must include:

(a) Radiation physics and instrumentation;

(b) Radiation protection;

(c) Mathematics pertaining to the use and measurement of radioactivity; and

(d) Radiation biology;

(2) Supervised clinical training in ophthalmic radiotherapy under the supervision of an authorized user at a medical institution, clinic, or private practice that includes the use of strontium-90 for the ophthalmic treatment of five individuals. This supervised clinical training must involve:

(a) Examination of each individual to be treated;

(b) Calculation of the dose to be administered;

(c) Administration of the dose; and

(d) Follow up and review of each individual's case history; and

(3) Has obtained written attestation, signed by a preceptor authorized user who meets the requirements in this rule, rule 3701:1-58-21, or 3701:1-58-51 of the Administrative Code, or equivalent United States nuclear regulatory commission or agreement state requirements, that the individual has satisfactorily completed the requirements in paragraphs (B)(1) and (B)(2) of this rule and is able to independently fulfill the radiation safety-related duties as an authorized user of strontium-90 for ophthalmic use.

Last updated November 18, 2022 at 8:36 AM

History

• Effective: August 15, 2021
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-58-74

A licensee shall retain a record of each radiation protection program change made in accordance with paragraph (A) of rule 3701:1-58-13 of the Administrative Code for five years. The record must include a copy of the old and new procedures, the effective date of the change, and the signature of the licensee management that reviewed and approved the change.

Last updated November 18, 2022 at 8:39 AM

History

• Effective: October 4, 2010
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-38-10

(A) Posting of notices to workers.

(1) Each licensee or registrant shall post current copies of the following documents:

(a) All applicable rules promulgated pursuant to Chapters 3748. and 4773. of the Revised Code;

(b) The license or certificate of registration, including, any conditions or documents incorporated by reference into a license and amendments thereto;

(c) The safe operating procedures applicable to activities under the license or registration; and

(d) Any notice of violation involving radiological working conditions, proposed imposition of civil or administrative monetary penalty, or order issued pursuant to rule 3701:1-38-06 of the Administrative Code and any response from the licensee or registrant. Such document shall be posted within five working days after receipt of the document. The licensee's or registrant's response, if any, shall be posted within five working days after dispatch of the document to the director. Such documents shall remain posted for a minimum of five working days or until action correcting the violation has been completed, whichever is later.

(e) The Ohio department of health, bureau of environmental health and radiation protection issued form titled "Notice to Employees."

(2) If posting of a document specified in paragraphs (A)(1)(a) to (A)(1)(c) of this rule is not practical, the licensee or registrant may post a notice which describes the document and states where it may be readily examined.

(3) Documents, notices, or forms posted pursuant to paragraph (A) of this rule shall appear in a sufficient number of places to permit individuals engaged in licensed or registered activity under the license or registration to observe them on the way to or from any particular work location to which the document applies, shall be conspicuous, and shall be replaced if defaced or altered.

(B) Instruction to workers.

(1) The licensee or registrant shall, with respect to all individuals likely to receive an annual TEDE occupational dose in excess of one millisievert (one hundred millirem):

(a) Keep such individuals informed of the storage, transfer, or use of sources of radiation in the licensee's or registrant's workplace;

(b) Instruct such individuals in the health effects associated with exposure to radiation or radioactive material to the individual and potential offspring, in precautions or procedures to minimize exposure, and in the purposes and functions of protective devices employed;

(c) Instruct such individuals in, and instruct such individuals to observe, to the extent within the individual's control, the applicable provisions of rules promulgated under Chapter 3748. of the Revised Code and any license conditions for the protection of personnel from exposures to radiation or radioactive material;

(d) Instruct each such individual of his or her responsibility to report promptly to the licensee or registrant any condition which may constitute, lead to, or cause a violation of Chapter 3748. of the Revised Code, the rules promulgated thereunder, any license condition, or order, and any unnecessary exposure to radiation or radioactive material;

(e) Instruct such individuals in the appropriate response to warnings made in the event of any unusual occurrence or malfunction that may involve exposure to radiation or radioactive material; and

(f) Advise such individuals of any radiation exposure reports furnished pursuant to paragraph (C) of this rule.

(2) In determining those individuals subject to the requirements of paragraph (B)(1) of this rule, licensees and registrants shall take into consideration assigned activities during normal and abnormal situations involving exposure to radiation and radioactive materials which can reasonably be expected to occur during the life of the facility. The extent of these instructions shall be commensurate with potential radiological health protection problems present in the workplace.

(C) Notifications and reports to individuals.

(1) Radiation exposure data for an individual and the results of any measurements, analyses, and calculations of radioactive material deposited or retained in the body of an individual shall be reported to the individual as specified in this rule. The information reported shall include data and results obtained pursuant to Chapter 3748. of the Revised Code or rules adopted thereunder, an order, or license condition as shown in records maintained by the licensee or registrant pursuant to paragraph (H) of rule 3701:1-38-20 of the Administrative Code. Each notification and report shall:

(a) Be in writing;

(b) Include appropriate identifying data such as the name of the licensee or registrant, the name of the individual, and the individual's identification number, preferably social security number;

(c) Include the individual's exposure information; and

(d) Contain the statement: "This report is furnished to you under the provisions of rule 3701:1-38-10 of the Administrative Code. You should preserve this report for further reference."

(2) Each licensee or registrant shall make dose information available to workers as shown in records maintained by the licensee under the provisions of paragraph (H) of rule 3701:1-38-20 of the Administrative Code. The licensee or registrant shall provide an annual report to each individual monitored under rule 3701:1-38-14 of the Administrative Code, of the dose received in that monitoring year if:

(a) The individual's occupational dose exceeds one millisievert (one hundred millirem) TEDE or one millisievert (one hundred millirem) to any individual organ or tissue; or

(b) The individual requests his or her annual dose report.

(3) Each licensee or registrant shall furnish reports to workers.

(a) At the request of a worker formerly engaged in activities controlled by the licensee or registrant, each licensee or registrant shall furnish to the worker a report of the worker's exposure to sources of radiation:

(i) As shown in records maintained by the licensee or registrant pursuant to rule 3701:1-38-20 of the Administrative Code for each year the worker was required to be monitored under the provisions of rule 3701:1-38-14 of the Administrative Code; and

(ii) For each year the worker was required to be monitored under the monitoring requirements in effect prior to August 31, 1999.

(b) This report must be furnished within thirty days from the time the request is made or within thirty days after the exposure of the individual has been determined by the licensee or registrant, whichever is later. This report must cover the period of time that the worker's activities involved exposure to sources of radiation licensed or registered by the director and must include the dates and locations of licensed or registered activities in which the worker participated during this period.

(4) When a licensee or registrant is required pursuant to paragraphs (A) to (C) of rule 3701:1-38-21 of the Administrative Code to report to the director any exposure of an individual to sources of radiation, the licensee or the registrant shall also provide the individual a written report on the exposure data included in the report to the director. This report must be transmitted no later than the transmittal to the director.

(5) At the request of a worker who is terminating employment with the licensee or registrant that involved exposure to sources of radiation during the current calendar quarter or the current year, each licensee or registrant shall provide at termination to each worker, or to the worker's designee, a written report regarding the radiation dose received by that worker from operations of the licensee or registrant during the current calendar year or fraction thereof. If the most recent individual monitoring results are not available at that time, a written estimate of the dose must be provided together with a clear indication that this is an estimate.

Last updated November 2, 2022 at 2:09 PM

History

• Effective: May 17, 2018
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-58-75

For purposes of this chapter, a licensee shall retain a copy of each written directive as required by rule 3701:1-58-15 of the Administrative Code for three years.

Last updated November 18, 2022 at 8:39 AM

History

• Effective: August 15, 2005
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-58-16 Procedures for administrations requiring a written directive.

(A) For any administration requiring a written directive, the licensee shall develop, implement, and maintain written procedures to provide high confidence that:

(1) The patient's or human research subject's identity is verified before each administration; and

(2) Each administration is in accordance with the written directive.

(B) At a minimum, the procedures required by paragraph (A) of this rule must address the following items that are applicable to the licensee's use of radioactive material:

(1) Verifying the identity of the patient or human research subject;

(2) Verifying that the administration is in accordance with the treatment plan, if applicable, and the written directive;

(3) Checking both manual and computer-generated dose calculations;

(4) Verifying that any computer-generated dose calculations are correctly transferred into the consoles of therapeutic medical units authorized by rule 3701:1-58-55 or 3701:1-58-72 of the Administrative Code;

(5) Determining if a medical event, as defined in rule 3701:1-58-101 of the Administrative Code, has occurred; and

(6) Determining, for permanent implant brachytherapy, within sixty calendar days from the date the implant was performed, the total source strength administered outside of the treatment site compared to the total source strength documented in the post-implantation portion of the written directive, unless a written justification of patient unavailability is documented.

(C) A licensee shall retain a copy of the procedures required under paragraph (A) of this rule in accordance with rule 3701:1-58-76 of the Administrative Code.

Last updated November 18, 2022 at 8:31 AM

History

• Effective: August 15, 2021
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-58-76

For purposes of this chapter, a licensee shall retain a copy of the procedures required by paragraph (A) of rule 3701:1-58-16 of the Administrative Code for the duration of the license.

Last updated November 18, 2022 at 8:39 AM

History

• Effective: August 15, 2005
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-46-44

(A) An application for a specific license to manufacture and distribute sources and devices containing radioactive material to persons licensed pursuant to Chapter 3701:1-58 of the Administrative Code or equivalent regulations of the United States nuclear regulatory commission or agreement state for use as a calibration, transmission, or reference source or for the uses listed in rules 3701:1-58-43, 3701:1-58-53, 3701:1-58-55, and 3701:1-58-72 of the Administrative Code or equivalent regulations of the United States nuclear regulatory commission or agreement state will be approved if:

(1) The applicant satisfies the general requirements in rule 3701:1-40-15 of the Administrative Code;

(2) The applicant submits sufficient information regarding each type of source or device pertinent to an evaluation of its radiation safety, including:

(a) The radioactive material contained, its chemical and physical form, and amount;

(b) Details of design and construction of the source or device;

(c) Procedures for, and results of, prototype tests to demonstrate that the source or device will maintain its integrity under stresses likely to be encountered in normal use and accidents;

(d) For devices containing radioactive material, the radiation profile of a prototype device;

(e) Details of quality control procedures to assure that production sources and devices meet the standards of the design and prototype tests;

(f) Procedures and standards for calibrating sources and devices;

(g) Legend and methods for labeling sources and devices as to their radioactive content;

(h) Instructions for handling and storing the source or device from the radiation safety standpoint; these instructions are to be included on a durable label attached to the source or device or attached to a permanent storage container for the source or device: provided, that instructions which are too lengthy for such label may be summarized on the label and printed in detail on a brochure which is referenced on the label;

(3) The label affixed to the source or device, or to the permanent storage container for the source or device, contains information on the radionuclide, quantity and date of assay, and a statement that the director has approved distribution of the (name of source or device) to persons licensed to use radioactive material identified in rules 3701:1-58-26, 3701:1-58-43, 3701:1-58-53, and 3701:1-58-55 of the Administrative Code, as appropriate, and to persons who hold an equivalent license issued by the United States nuclear regulatory commission or an agreement state; and

(4) The source or device has been registered in the sealed source and device registry.

(B) The following is applicable:

(1) In the event the applicant desires that the source or device be required to be tested for leakage of radioactive material at intervals longer than six months, he/she shall include in his/her application sufficient information to demonstrate that such longer interval is justified by performance characteristics of the source or device or similar sources or devices and by design features that have a significant bearing on the probability or consequences of leakage of radioactive material from the source.

(2) In determining the acceptable interval for test of leakage of radioactive material, the director will consider information that includes, but is not limited to:

(a) Primary containment (source capsule);

(b) Protection of primary containment;

(c) Method of sealing containment;

(d) Containment construction materials;

(e) Form of contained radioactive material;

(f) Maximum temperature withstood during prototype tests;

(g) Maximum pressure withstood during prototype tests;

(h) Maximum quantity of contained radioactive material;

(i) Radiotoxicity of contained radioactive material;

(j) Operating experience with identical sources or devices or similarly designed and constructed sources or devices.

Last updated November 2, 2022 at 2:36 PM

History

• Effective: November 8, 2015
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-58-21

(A)

(1) An individual identified as a radiation safety officer, a teletherapy or medical physicist, an authorized medical physicist, a nuclear pharmacist or an authorized nuclear pharmacist on a United States nuclear regulatory commission or agreement state license or a permit issued by a United States nuclear regulatory commission or agreement state broad scope licensee or master material license permit or by a master material license permittee of broad scope on or before January 14, 2019 need not comply with the training requirements of rule 3701:1-58-18, 3701:1-58-19, or 3701:1-58-20 of the Administrative Code, respectively, except the radiation safety officers and authorized medical physicists identified in this paragraph must meet the training requirements in paragraph (D) of rule 3701:1-58-18 of the Administrative Code or paragraph (C) of rule 3701:1-58-19 of the Administrative Code, as appropriate, for any material or uses for which they were not authorized prior to this date.

(2) Any individual certified by the "American Board of Health Physics" in comprehensive health physics; "American Board of Radiology"; "American Board of Nuclear Medicine"; "American Board of Science" in nuclear medicine; "Board of Pharmaceutical Specialties" in nuclear pharmacy; "American Board of Medical Physics" in radiation oncology physics; "Royal College of Physicians and Surgeons of Canada" in nuclear medicine; "American Osteopathic Board of Radiology"; or "American Osteopathic Board of Nuclear Medicine" on or before October 24, 2005, need not comply with the training requirements of rule 3701:1-58-18 of the Administrative Code to be identified as a radiation safety officer or as an associate radiation safety officer on a United States nuclear regulatory commission or an agreement state license or United States nuclear regulatory commission master material license permit for those materials and uses that these individuals performed on or before October 24, 2005.

(3) Any individual certified by the "American Board of Radiology" in therapeutic radiological physics, Roentgen ray and gamma ray physics, xray and radium physics, or radiological physics, or certified by the "American Board of Medical Physics" in radiation oncology physics, on or before October 24, 2005, need not comply with the training requirements for an authorized medical physicist described in rule 3701:1-58-19 of the Administrative Code, for those materials and uses that these individuals performed on or before October 24, 2005.

(4) A radiation safety officer, a medical physicist, or a nuclear pharmacist, who used only accelerator-produced radioactive materials, discrete sources of radium-226, or both, for medical uses or in the practice of nuclear pharmacy at a government agency or federally recognized indian tribe before November 30, 2007, or at all other locations of use before August 8, 2009, or an earlier date as noticed by the United States nuclear regulatory commission, need not comply with the training requirements of rule 3701:1-58-18, 3701:1-58-19, or 3701:1-58-20 of the Administrative Code, respectively, when performing the same uses. A nuclear pharmacist, who prepared only radioactive drugs containing accelerator-produced radioactive materials, or a medical physicist, who used only accelerator-produced radioactive materials, at the locations and time period identified in this paragraph, qualifies as an authorized nuclear pharmacist or an authorized medical physicist, respectively, for those materials and uses performed before these dates, for purposes of this chapter.

(B)

(1) Physicians, dentists, or podiatrists identified as authorized users for the medical use of byproduct material on a license issued by the United States nuclear regulatory commission or agreement state, a permit issued by a United States nuclear regulatory commission master material licensee, a permit issued by a United States nuclear regulatory commission or agreement state broad scope licensee, or a permit issued by a United States nuclear regulatory commission master material license broad scope permittee on or before January 14, 2019, who perform only those medical uses for which they were authorized on or before that date need not comply with the training requirements of rules 3701:1-58-32 to 3701:1-58-71 of the Administrative Code.

(2) Physicians, dentists, or podiatrists not identified as authorized users for the medical use of byproduct material on a license issued by the United States nuclear regulatory commission or agreement state, a permit issued by a United States nuclear regulatory commission master material licensee, a permit issued by a United States nuclear regulatory commission or agreement state broad scope licensee, or a permit issued in accordance with a United States nuclear regulatory commission master material broad scope license on or before October 24, 2005, need not comply with the training requirements of rules 3701:1-58-32 to 3701:1-58-71 of the Administrative Code for those materials and uses that these individuals performed on or before October 24, 2005, as follows:

(a) For uses authorized under rule 3701:1-58-32 of the Administrative Code or rule 3701:1-58-34 of the Administrative Code, or oral administration of sodium iodide I131 requiring a written directive for imaging and localization purposes, a physician who was certified on or before October 24, 2005, in nuclear medicine by the "American Board of Nuclear Medicine"; diagnostic radiology by the "American Board of Radiology"; diagnostic radiology or radiology by the "American Osteopathic Board of Radiology"; nuclear medicine by the "Royal College of Physicians and Surgeons of Canada"; or "American Osteopathic Board of Nuclear Medicine" in nuclear medicine;

(b) For uses authorized under rule 3701:1-58-37 of the Administrative Code, a physician who was certified on or before October 24, 2005, by the "American Board of Nuclear Medicine"; the "American Board of Radiology" in radiology, therapeutic radiology, or radiation oncology; nuclear medicine by the "Royal College of Physicians and Surgeons of Canada"; or the "American Osteopathic Board of Radiology" after 1984;

(c) For uses authorized under rule 3701:1-58-43 of the Administrative Code or rule 3701:1-58-55 of the Administrative Code, a physician who was certified on or before October 24, 2005, in radiology, therapeutic radiology or radiation oncology by the "American Board of Radiology"; radiation oncology by the "American Osteopathic Board of Radiology"; radiology, with specialization in radiotherapy, as a British "Fellow of the Faculty of Radiology" or "Fellow of the Royal College of Radiology"; or therapeutic radiology by the "Canadian Royal College of Physicians and Surgeons"; and

(d) For uses authorized under rule 3701:1-58-53 of the Administrative Code, a physician who was certified on or before October 24, 2005, in radiology, diagnostic radiology, therapeutic radiology, or radiation oncology by the "American Board of Radiology"; nuclear medicine by the "American Board of Nuclear Medicine"; diagnostic radiology or radiology by the "American Osteopathic Board of Radiology"; or nuclear medicine by the "Royal College of Physicians and Surgeons of Canada."

(3) Physicians, dentists, or podiatrists who used only accelerator-produced radioactive materials, discrete sources of radium-226, or both, for medical uses performed at a government agency or federally recognized indian tribe before November 30, 2007, or at all other locations of use before August 8, 2009, or an earlier date as noticed by the United States nuclear regulatory commission, need not comply with the training requirements of rules 3701:1-58-32 to 3701:1-58-71 of the Administrative Code, when performing the same medical uses. A physician, dentist, or podiatrist, who used only accelerator-produced radioactive materials, discrete sources of radium-226, or both, for medical uses at the locations and time period identified in this paragraph, qualifies as an authorized user for those materials and uses performed before these dates, for purposes of this chapter.

(C) Individuals who need not comply with training requirements as described in this rule may serve as preceptors for, and supervisors of, applicants seeking authorization on Ohio radioactive material licenses for the same uses for which these individuals are authorized.

Last updated January 9, 2026 at 8:02 AM

History

• Effective: May 15, 2023
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-58-43

A licensee shall use only brachytherapy sources:

(A) As approved in the sealed source and device registry for manual brachytherapy medical use. The manual brachytherapy sources may be used for manual brachytherapy uses that are not explicitly listed in the sealed source and device registry, but must be used in accordance with the radiation safety conditions and limitations described in the sealed source and device registry; or

(B) In research to deliver therapeutic doses for medical use in accordance with an active investigational device exemption application accepted by the United States food and drug administration provided the requirements of paragraph (A) of rule 3701:1-58-17 of the Administrative Code are met.

Last updated November 18, 2022 at 8:34 AM

History

• Effective: August 15, 2021
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-58-53

(A) A licensee must use only sealed sources that are not in medical devices for diagnostic medical uses if the sealed sources are approved in the sealed source and device registry for diagnostic medicine. The sealed sources may be used for diagnostic medical uses that are not explicitly listed in the sealed source and device registry but must be used in accordance with the radiation safety conditions and limitations described in the sealed source and device registry.

(B) A licensee must only use medical devices containing sealed sources for diagnostic medical uses if both the sealed sources and medical devices are approved in the sealed source and device registry for diagnostic medical uses. The diagnostic medical devices may be used for diagnostic medical uses that are not explicitly listed in the sealed source and device registry but must be used in accordance with the radiation safety conditions and limitations described in the sealed source and device registry.

(C) Sealed sources and devices for diagnostic medical uses may be used in research in accordance with an active investigational device exemption (IDE) application accepted by the United States food and drug administration provided the requirements of paragraph (A) of rule 3701:1-58-17 of the Administrative Code are met.

Last updated November 18, 2022 at 8:36 AM

History

• Effective: August 15, 2021
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-58-104

(A) Except as provided in rule 3701:1-58-21 of the Administrative Code, the licensee shall require an authorized user for the parenteral administration of unsealed radioactive material requiring a written directive, to be a physician who:

(1) Is an authorized user under rule 3701:1-58-40 of the Administrative Code for uses listed in paragraph (B)(1)(b)(vi)(c) of rule 3701:1-58-40 of the Administrative Code or equivalent United States nuclear regulatory commission or agreement state requirements; or

(2) Is an authorized user under rule 3701:1-58-51 or 3701:1-58-71 of the Administrative code, or equivalent United States nuclear regulatory commission or agreement state requirements and who meets the requirements in paragraph (B) of this rule; or

(3) Is certified by a medical specialty board whose certification process has been recognized by the director, the United States nuclear regulatory commission, or an agreement state under rule 3701:1-58-51 or 3701:1-58-71 of the Administrative Code, and who meets the requirements in paragraph (B) of this rule.

(B) The physician:

(1) Has successfully completed eighty hours of classroom and laboratory training, applicable to parenteral administrations listed in paragraph (B)(1)(b)(vi)(c) of rule 3701:1-58-40 of the Administrative Code or equivalent United States nuclear regulatory commission or agreement state requirements. The training must include:

(a) Radiation physics and instrumentation;

(b) Radiation protection;

(c) Mathematics pertaining to the use and measurement of radioactivity;

(d) Chemistry of radioactive material for medical use; and

(e) Radiation biology; and

(2) Has work experience, under the supervision of an authorized user who meets the requirements in this rule, rule 3701:1-58-21, or 3701:1-58-40 of the Administrative Code, or equivalent United States nuclear regulatory commission or agreement state requirements, in the parenteral administrations listed in paragraph (B)(1)(b)(vi)(c) of rule 3701:1-58-40 of the Administrative Code or equivalent United States nuclear regulatory commission or agreement state requirements. A supervising authorized user who meets the requirements in rule 3701:1-58-40 of the Administrative Code, this rule, or equivalent United States nuclear regulatory commission or agreement state requirements, must have experience in administering dosages in the same category or categories as the individual requesting authorized user status. The work experience must involve:

(a) Ordering, receiving, and unpacking radioactive materials safely, and performing the related radiation surveys;

(b) Performing quality control procedures on instruments used to determine the activity of dosages, and performing checks for proper operation of survey meters;

(c) Calculating, measuring, and safely preparing patient or human research subject dosages;

(d) Using administrative controls to prevent a medical event involving the use of unsealed radioactive material;

(e) Using procedures to contain spilled radioactive material safely, and using proper decontamination procedures; and

(f) Administering dosages to patients or human research subjects, that include at least three cases involving the parenteral administration, as specified in paragraphs (B)(1)(b)(vi)(c) of rule 3701:1-58-40 of the Administrative Code; and

(3) Has obtained written attestation that the individual has satisfactorily completed the requirements in paragraphs (B)(1) and (B)(2) of this rule, and is able to independently fulfill the radiation safety-related duties as an authorized user for the parenteral administration of unsealed radioactive material requiring a written directive. The attestation must be obtained from either:

(a) A preceptor authorized user who meets the requirements in this rule, rule 3701:1-58-21, or 3701:1-58-40 of the Administrative Code, or equivalent United States nuclear regulatory commission or agreement state requirements, or equivalent agreement state requirements. A preceptor authorized user who meets the requirements in this rule, or 3701:1-58-40 of the Administrative Code, or equivalent United States nuclear regulatory commission or agreement state requirements, must have experience in administering dosages in the same category or categories as the individual requesting authorized user status; or

(b) A residency program director who affirms in writing that the attestation represents the consensus of the residency program faculty where at least one faculty member is an authorized user who meets the requirements in this rule, rule 3701:1-58-21, or 3701:1-58-40 of the Administrative Code, or equivalent United States nuclear regulatory commission or agreement state requirements, has experience in administering dosages in the same dosage category or categories as the individual requesting authorized user status, and concurs with the attestation provided by the residency program director. The residency training program must be approved by the residency review committee of the "Accreditation Council for Graduate Medical Education," the "Royal College of Physicians and Surgeons of Canada," or the "Council on Postdoctoral Training of the American Osteopathic Association," and must include training and experience specified in paragraphs (B)(1) and (B)(2) of this rule.

Last updated November 18, 2022 at 8:43 AM

History

• Effective: August 15, 2021
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-58-23 Possession, use, and calibration of instruments used to measure the activity of unsealed radioactive material.

(A) For direct measurements performed in accordance with rule 3701:1-58-25 of the Administrative Code, a licensee shall possess and use instrumentation to measure the activity of unsealed radioactive material before it is administered to each patient or human research subject.

(B) A licensee shall calibrate the instrumentation required in paragraph (A) of this rule in accordance with nationally recognized standards or the manufacturer's instructions.

(C) A licensee shall retain a record of each instrument calibration required by this rule in accordance with rule 3701:1-58-77 of the Administrative Code.

Last updated November 18, 2022 at 8:32 AM

History

• Effective: August 15, 2005
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-58-25

(A) A licensee shall determine and record the activity of each dosage before medical use.

(B) For a unit dosage, this determination must be made by:

(1) Direct measurement of radioactivity; or

(2) A decay correction, based on the activity or activity concentration determined by:

(a) A manufacturer or preparer licensed under rule 3701:1-46-43 of the Administrative Code or equivalent United States nuclear regulatory commission, or agreement state requirements;

(b) An United States nuclear regulatory commission, or agreement state licensee for use in research in accordance with a radioactive drug research committee-approved protocol or an investigational new drug protocol accepted by United States food and drug administration; or

(c) A PET radioactive drug producer licensed under paragraph (I) of rule 3701:1-40-14 of the Administrative Code, or equivalent United States nuclear regulatory commission or agreement state requirements.

(C) For other than unit dosages, this determination must be made by:

(1) Direct measurement of radioactivity;

(2) Combination of measurement of radioactivity and mathematical calculations; or

(3) Combination of volumetric measurements and mathematical calculations, based on the measurement made by:

(a) A manufacturer or preparer licensed under rule 3701:1-46-43 of the Administrative Code or equivalent United States nuclear regulatory commission or agreement state requirements; or

(b) A PET radioactive drug producer licensed under paragraph (I) of rule 3701:1-40-14 of the Administrative Code, or equivalent United States nuclear regulatory commission or agreement state requirements.

(D) Unless otherwise directed by the authorized user, a licensee may not use a dosage if the dosage does not fall within the prescribed dosage range or if the dosage differs from the prescribed dosage by more than twenty per cent.

(E) A licensee shall retain a record of the dosage determination required by this rule in accordance with rule 3701:1-58-79 of the Administrative Code.

Last updated November 18, 2022 at 8:32 AM

History

• Effective: October 4, 2010
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-58-77

A licensee shall maintain a record of instrument calibrations required by rule 3701:1-58-23 of the Administrative Code for three years. The records must include the model and serial number of the instrument, the date of the calibration, the results of the calibration, and the name of the individual who performed the calibration.

Last updated November 18, 2022 at 8:40 AM

History

• Effective: August 15, 2005
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-58-24 Calibration of survey instruments.

(A) A licensee shall calibrate the survey instruments used to show compliance with this chapter and Chapter 3701:1-38 of the Administrative Code before first use, annually, and following a repair that affects the calibration. A licensee shall:

(1) Calibrate all scales with readings up to ten millisievert (one thousand millirem) per hour with a radiation source;

(2) Calibrate two separate readings on each scale or decade that will be used to show compliance; and

(3) Conspicuously note on the instrument the date of calibration.

(B) A licensee may not use survey instruments if the difference between the indicated exposure rate and the calculated exposure rate is more than twenty per cent.

(C) A licensee shall retain a record of each survey instrument calibration in accordance with rule 3701:1-58-78 of the Administrative Code.

Last updated November 18, 2022 at 8:32 AM

History

• Effective: October 4, 2010
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-58-78

A licensee shall maintain a record of radiation survey instrument calibrations required by rule 3701:1-58-24 of the Administrative Code for three years. The record must include the model and serial number of the instrument, the date of the calibration, the results of the calibration, and the name of the individual who performed the calibration.

Last updated November 18, 2022 at 8:40 AM

History

• Effective: August 15, 2005
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-58-79

(A) For purposes of this chapter, a licensee shall maintain a record of dosage determinations required by rule 3701:1-58-25 of the Administrative Code for three years.

(B) The record must contain:

(1) The radiopharmaceutical;

(2) The patient's or human research subject's name, or identification number if one has been assigned;

(3) The prescribed dosage, the determined dosage, or a notation that the total activity is less than 1.1 megabecquerels (thirty microcuries);

(4) The date and time of the dosage determination; and

(5) The name of the individual who determined the dosage.

Last updated November 18, 2022 at 8:40 AM

History

• Effective: October 4, 2010
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-58-26 Authorization for calibration, transmission, and reference sources.

(A) Any person authorized by rule 3701:1-58-06 of the Administrative Code for medical use of radioactive material may receive, possess, and use any of the following radioactive material for check, calibration, transmission, and reference use:

(1) Sealed sources, not exceeding 1.11 gigabecquerels (thirty millicuries) each, manufactured and distributed by a person licensed under rule 3701:1-46-44 of the Administrative Code or equivalent United States nuclear regulatory commission, or agreement state regulations.

(2) Sealed sources, not exceeding 1.11 gigabecquerels (thirty millicuries) each, redistributed by a licensee authorized to redistribute the sealed sources manufactured and distributed by a person licensed under rule 3701:1-46-44 of the Administrative Code or equivalent United States nuclear regulatory commission or agreement state regulations, providing the redistributed sealed sources are in the original packaging and shielding and are accompanied by the manufacturer's approved instructions.

(3) Any radioactive material with a half-life not longer than one hundred twenty days in individual amounts not to exceed 0.56 gigabecquerels (fifteen millicuries).

(4) Any radioactive material with a half-life longer than one hundred twenty days in individual amounts not to exceed the smaller of 7.4 megabecquerels (two hundred microcuries) or one thousand times the quantities in appendix A to rule 3701:1-40-17 of the Administrative Code.

(5) Technetium-99m in amounts as needed.

(B) Radioactive material in sealed sources authorized by this provision shall not be:

(1) Used for medical use as defined in rule 3701:1-38-01 of the Adminstrative Code except in accordance with the requirements in rule 3701:1-58-53 of the Adminstrative Code; or

(2) Combined (i.e., bundled or aggregated) to create an activity greater than the maximum activity of any single sealed source authorized under this chapter.

(C) A licensee using calibration, transmission, and reference sources in accordance with the requirements in paragraph (A) or (B) of this rule need not list these sources on a specific medical use license.

Last updated October 6, 2022 at 8:25 AM

History

• Effective: October 6, 2022
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-40-17

(A) Prior to the director issuing a radioactive materials license:

(1) Each applicant for a specific license or license renewal authorizing the possession and use of unsealed radioactive material of half-life greater than one hundred twenty days and in quantities exceeding ten thousand times the applicable quantities set forth in appendix A to this rule shall submit a decommissioning funding plan as described in paragraph (D) of this rule. The decommissioning funding plan must also be submitted when a combination of radionuclides is involved if R divided by ten thousand is greater than one, where R is defined here as the sum of the ratios of the quantity of each radionuclide to the applicable value in appendix A to this rule.

(2) Each applicant for a specific license or license renewal authorizing the possession and use of sealed sources or plated foils of half-life greater than one hundred twenty days and in quantities exceeding one trillion times the applicable quantities of appendix A to this rule, shall submit a decommissioning funding plan as described in paragraph (D) of this rule. The decommissioning funding plan must also be submitted when a combination of radionuclides is involved if R divided by one trillion is greater than one, where R is defined here as the sum of the ratios of the quantity of each radionuclide to the applicable value in appendix A to this rule.

(B) Prior to the director issuing a radioactive materials license, each applicant for a specific license or license renewal authorizing possession and use of radioactive material of half-life greater than one hundred twenty days and in quantities specified in paragraph (C) of this rule shall either:

(1) Submit a decommissioning funding plan as described in paragraph (D) of this rule; or

(2) Submit a certification that financial assurance for decommissioning has been provided in the amount prescribed by paragraph (C) of this rule using one of the methods described in paragraph (E) of this rule. The applicant shall submit to the director, as part of the certification, a signed original of the financial instrument obtained to satisfy the requirements of paragraph (E) of this rule.

(C) Prior to the director issuing a radioactive materials license, an applicant providing certification of financial assurance for decommissioning as specified in paragraph (B)(2) of this rule shall provide the certification in a monetary amount based upon the quantity of licensed material specified as follows:

(1) Greater than one thousand but less than or equal to ten thousand times the applicable quantities of appendix A to this rule in unsealed form. For a combination of radionuclides, if R, as defined in paragraph (A) of this rule, divided by one thousand is greater than one but R divided by ten thousand is less than or equal to one, the sum of three hundred thousand dollars.

(2) Greater than ten billion but less than one trillion times the applicable quantities of appendix A to this rule in sealed sources or plated foils. For a combination of radionuclides, if R, as defined in paragraph (A) of this rule, divided by ten billion is greater than one but R divided by one trillion is less than or equal to one, the sum of one hundred fifty thousand dollars.

(D) .

(1) Each decommissioning funding plan must be submitted for review and approval and must contain:

(a) A detailed cost estimate for decommissioning, in an amount reflecting:

(i) The cost of an independent contractor to perform all decommissioning activities;

(ii) The cost of meeting the criteria specified in paragraph (B) of rule 3701:1-38-22 of the Administrative Code for unrestricted use, provided that, if the applicant or licensee can demonstrate its ability to meet the provisions of paragraph (D) of rule 3701:1-38-22 of the Administrative Code, the cost estimate may be based on meeting this criteria;

(iii) The volume of onsite subsurface material containing residual radioactivity that will require remediation to meet the criteria for license termination; and

(iv) An adequate contingency factor.

(b) Identification of and justification for using the key assumptions contained in the decommissioning cost estimate;

(c) A description of the method of assuring funds for decommissioning from paragraph (E) of this rule, including means for adjusting cost estimates and associated funding levels periodically over the life of the facility;

(d) A certification by the licensee that financial assurance for decommissioning has been provided in the amount of the cost estimate for decommissioning; and

(e) A signed original of the financial instrument obtained to satisfy the requirements of paragraph (E) of this rule (unless a previously submitted and accepted financial instrument continues to cover the cost estimate for decommissioning).

(2) At the time of license renewal and at intervals not to exceed three years, the decommissioning funding plan must be resubmitted with adjustments as necessary to account for the changes in costs and the extent of contamination. If the amount of financial assurance will be adjusted downward, this cannot be done until the updated decommissioning funding plan is approved. The decommissioning funding plan must update the information submitted with the original or prior approved plan, and must specifically consider the effect of the following events on decommissioning costs:

(a) Spills of radioactive material producing additional residual radioactivity in onsite subsurface material;

(b) Waste inventory increasing above the amount previously estimated;

(c) Waste disposal costs increasing above the amount previously estimated;

(d) Facility modifications;

(e) Changes in authorized possession limits;

(f) Actual remediation costs that exceed the previous cost estimate;

(g) Onsite disposal; and

(h) Use of a settling pond.

(E) Financial assurance for decommissioning, either by a decommissioning funding plan or certification of financial assurance, shall be provided by the licensee and approved by the director prior to the issuance of the license and shall be provided by one or more of the following methods:

(1) Prepayment by depositing into an account segregated from licensee assets and outside the licensee's administrative control, cash or liquid assets such that the amount of funds will be sufficient to pay decommissioning costs. Prepayment may be in the form of a trust, escrow account, government fund, certificate of deposit, or deposit of government securities.

(2) Surety, insurance, or other method in accordance with paragraph (F) of this rule, that guarantees that decommissioning costs will be paid. A surety method may be in the form of a surety bond, letter of credit, or line of credit. A guarantee by the applicant or licensee may not be used in combination with any other financial methods used to satisfy the requirements of this paragraph or in any situation where the applicant or licensee has a parent company holding majority control of the voting stock of the company.

(3) A parent company guarantee of funds for decommissioning costs based on a financial test may be used provided that the parent company meets the requirements specified in appendix B of this rule. A parent company guarantee may not be used in combination with other financial methods to satisfy the requirements of this rule.

(4) For commercial corporations that issue bonds, a guarantee of funds by the applicant or licensee for decommissioning costs based on a financial test may be used provided that the guarantee meets the requirements of appendix C to this rule.

(5) For commercial companies that do not issue bonds, a guarantee of funds for decommissioning costs may be used provided that the guarantee meets the requirements of appendix D to this rule.

(6) For nonprofit colleges, universities, hospitals, or research and development entities, a guarantee of funds for decommissioning costs may be used provided that the guarantee meets the requirements of appendix E to this rule. The director may require proof of nonprofit status.

(7) An external sinking fund in which deposits are made at least annually, coupled with a surety method or insurance, the value of which may decrease by the amount being accumulated in the sinking fund. An external sinking fund is a fund established and maintained by setting aside funds periodically in an account segregated from licensee assets and outside the licensee's administrative control in which the total amount of funds would be sufficient to pay decommissioning costs at the time termination of operation is expected. An external sinking fund may be in the form of a trust, escrow account, government fund, certificate of deposit, or deposit of government securities. The surety or insurance provisions must be as stated in paragraph (F) of this rule.

(8) In the case of state or local government licensee, a statement of intent containing a cost estimate for decommissioning or an amount specified in paragraphs (C)(1) to (C)(2) of this rule, and indicating that funds for decommissioning will be obtained when necessary. As used in this rule, "state or local government licensee" does not include government owned or assisted colleges, universities or hospitals.

(F) Any surety method or insurance used to provide financial assurance for decommissioning shall be in the form of instruments that contain language as provided in appendix F to this rule, and shall contain the following conditions:

(1) The surety method or insurance must be open-ended or, if written for a specified term, such as five years, must be renewed automatically unless ninety days or more prior to the renewal date, the issuer notifies the director, the beneficiary, and the licensee of its intention not to renew. The surety method or insurance must also provide that the full face amount be paid to the beneficiary automatically prior to the expiration without proof of forfeiture if the licensee fails to provide a replacement acceptable to the director within thirty days after receipt of notification of cancellation.

(2) The surety method or insurance must be payable to a trust established for decommissioning costs. The trustee and trust must be acceptable to the director. An acceptable trustee includes an appropriate state or federal government agency or an entity which has the authority to act as a trustee and whose trust operations are regulated and examined by a federal or state agency.

(3) The surety method or insurance must remain in effect until the director has terminated the license.

(4) The surety company issuing the bond must, at a minimum, be among those listed as acceptable in the "Circular 570" of the United States department of the treasury (as in effect on the effective date of this rule).

(G) A licensee must notify the director by certified mail within ten business days of the commencement of a voluntary or involuntary bankruptcy proceeding under Title 11 of the United States Code (as amended April 20, 2005). A licensee who fulfills the financial assurance requirements by obtaining a trust fund, surety bond, or other acceptable financial assurance will be deemed to be without the required financial assurance or liability coverage in the event of bankruptcy of the trustee or issuing institution, or a suspension or revocation of the authority of the trustee institution issuing the instrument. The licensee shall establish other financial assurance within sixty days after such an event.

(H) Financial assurance for decommissioning, either by a decommissioning funding plan or certification of financial assurance, that is provided by a contract of insurance shall not include any arrangement that constitutes self-insurance. As used in this rule:

(1) "Insurance" means a contract issued or underwritten by an insurance company, insurance service, or insurance organization which is licensed to engage in the business of insurance in Ohio, that binds the insurer to indemnify another against a specified loss in return for premiums paid.

(2) "Self insurance" means a contract of insurance issued either by the licensee or by an insurer affiliated with or an affiliate of the licensee.

(3) "Affiliate of" or "affiliated with" means that the licensee, either directly or indirectly, through one or more intermediaries or subsidiaries, controls, is controlled by, or is under common control with the insurer.

(4) "Control", including "controlled by", and "under common control with" means the possession, direct or indirect, of the power to direct or cause the direction of the management and policies of a person, whether through the ownership of voting securities, by contract, proxy, membership on the board, or otherwise.

(I) Each person licensed under this chapter, and rule 3701:1-38-02 of the Administrative Code as well as chapters containing rules regarding manufacturing and distribution (Chapter 3701:1-46 of the Administrative Code), industrial radiography (Chapter 3701:1-48 of the Administrative Code), well logging Chapter 3701:1-49 of the Administrative Code), irradiators (Chapter 3701:1-52 of the Administrative Code), and medical use (Chapter 3701:1-58 of the Administrative Code) promulgated pursuant to Chapter 3748. of the Revised Code shall keep records of information important to the decommissioning of a facility in an identified location until the site is released for unrestricted use. Before licensed activities are transferred or assigned in accordance with paragraph (B) of rule 3701:1-40-20 of the Administrative Code, a licensee shall transfer all records described in this paragraph to the new licensee, which will be responsible for maintaining these records until the license is terminated. If records important to the decommissioning of a facility are kept for other purposes, reference to these records and their locations may be used. As used in this rule, "information important to the decommissioning of a facility" includes the following:

(1) Records of spills or other unusual occurrences involving the spread of contamination in and around the facility, equipment, or site. These records may be limited to instances when contamination remains after any cleanup procedures or when there is reasonable likelihood that contaminants may have spread to inaccessible areas as in the case of possible seepage into porous materials such as concrete. These records must include any known information on identification of involved radionuclides, quantities, forms, and concentrations.

(2) As-built drawings and modifications of structures and equipment in restricted areas where radioactive materials are used or stored, and of locations of possible inaccessible contamination such as buried pipes which may be subject to contamination. If required drawings are referenced, each relevant document need not be indexed individually. If drawings are not available, the licensee shall substitute appropriate records of available information concerning these areas and locations.

(3) Except in the case of an area that contains only a sealed source, provided the source has not leaked or no contamination remains after any leak, or in the case of a byproduct or accelerator produced material having only a half-life of less than sixty-five days, a list contained in a single document and updated every two years, of the following:

(a) All areas designated and formerly designated restricted areas as defined in rule 3701:1-38-01 of the Administrative Code.

(b) All areas outside of restricted areas that require documentation under paragraph (I)(1) of this rule.

(c) All areas outside of restricted areas where current and previous wastes have been buried as documented under rule 3701:1-38-20 of the Administrative Code; and

(d) All areas outside of restricted areas that contain material such that, if the license expired, the licensee would be required to either decontaminate the area to meet the criteria for decommissioning in rule 3701:1-38-22 of the Administrative Code, or apply for approval for disposal under rule 3701:1-38-19 of the Administrative Code.

(4) Records of the cost estimate performed for the decommissioning funding plan or of the amount certified for decommissioning, and records of the funding method used for assuring funds if either a funding plan or certification is used.

View AppendixView AppendixView AppendixView AppendixView AppendixView Appendix

Last updated April 19, 2022 at 8:35 AM

History

• Effective: April 17, 2022
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-58-27 Requirements for possession of sealed sources and brachytherapy sources.

(A) A licensee in possession of any sealed source or brachytherapy source shall follow the radiation safety and handling instructions supplied by the manufacturer.

(B) A licensee in possession of a sealed source shall:

(1) Test the source for leakage before its first use unless the licensee has a certificate from the supplier indicating that the source was tested within six months before transfer to the licensee; and

(2) Test the source for leakage at intervals not to exceed six months or at other intervals approved by the director, United States nuclear regulatory commission, or an agreement state.

(C) To satisfy the leak test requirements of this rule, the licensee shall measure the sample so that the leak test can detect the presence of one hundred eighty-five becquerels (0.005 microcurie) of radioactive material in the sample.

(D) A licensee shall retain leak test records in accordance with paragraph (A) of rule 3701:1-58-80 of the Administrative Code.

(E) If the leak test reveals the presence of one hundred eighty-five becquerels (0.005 microcurie) or more of removable contamination, the licensee shall:

(1) Immediately withdraw the sealed source from use and store, dispose, or cause it to be repaired in accordance with the requirements in Chapter 3701:1-38 of the Administrative Code, and

(2) File a report within five days of the leak test in accordance with rule 3701:1-58-103 of the Administrative Code.

(F) A licensee need not perform a leak test on the following sources:

(1) Sources containing only radioactive material with a half-life of less than thirty days;

(2) Sources containing only radioactive material as a gas;

(3) Sources containing 3.7 megabecquerels (one hundred microcuries) or less of beta or gamma-emitting material or 0.37 megabecquerel (ten microcuries) or less of alpha-emitting material;

(4) Seeds of iridium-192 encased in nylon ribbon; and

(5) Sources stored and not being used. However, the licensee shall test each such source for leakage before any use or transfer unless it has been leak tested within six months before the date of use or transfer.

(G) A licensee in possession of sealed sources or brachytherapy sources, except for gamma stereotactic radiosurgery sources, shall conduct a semi-annual physical inventory of all such sources in its possession. The licensee shall retain each inventory record in accordance with paragraph (B) of rule 3701:1-58-80 of the Administrative Code.

Last updated November 18, 2022 at 8:32 AM

History

• Effective: October 4, 2010
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-58-80

(A) A licensee shall retain records of leak tests required by paragraph (B) of rule 3701:1-58-27 of the Administrative Code for three years. The records must include the model number, and serial number if one has been assigned, of each source tested; the identity of each source by radionuclide and its estimated activity; the results of the test; the date of the test; and the name of the individual who performed the test.

(B) A licensee shall retain records of the semi-annual physical inventory of sealed sources and brachytherapy sources required by paragraph (G) of rule 3701:1-58-27 of the Administrative Code for three years. The inventory records must contain the model number of each source, and serial number if one has been assigned, the identity of each source by radionuclide and its nominal activity, the location of each source, and the name of the individual who performed the inventory.

Last updated November 18, 2022 at 8:40 AM

History

• Effective: August 15, 2005
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-58-28 Labeling of vials and syringes.

Each syringe and vial that contains unsealed radioactive material must be labeled to identify the radioactive drug. Each syringe shield and vial shield must also be labeled unless the label on the syringe or vial is visible when shielded.

Last updated November 18, 2022 at 8:32 AM

History

• Effective: August 15, 2005
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-58-29 Surveys of ambient radiation exposure rate.

(A) In addition to the surveys required by Chapter 3701:1-38 of the Administrative Code, a licensee shall survey, with a radiation detection survey instrument at the end of each day of use, the following:

(1) All areas where unsealed radioactive material requiring a written directive was prepared for use or administered. This includes all unsealed radiopharmaceuticals prepared for use or administered under rule 3701:1-58-37 of the Administrative Code.

(2) All areas where unsealed radioactive material not requiring a written directive was routinely prepared for use or routinely administered. This includes all unsealed radiopharmaceuticals prepared for use or administered under rule 3701:1-58-32 or 3701:1-58-34 of the Administrative Code.

(B) A licensee does not need to perform the surveys required by paragraph (A) of this rule in an area(s) where patients or human research subjects are confined when they cannot be released under rule 3701:1-58-30 of the Administrative Code.

(C) A licensee shall retain a record of each survey in accordance with rule 3701:1-58-81 of the Administrative Code.

Last updated November 18, 2022 at 8:32 AM

History

• Effective: August 15, 2005
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-58-81

A licensee shall retain a record of each survey required by rule 3701:1-58-29 of the Administrative Code for three years. The record must include the date of the survey, the results of the survey, the instrument used to make the survey, and the name of the individual who performed the survey.

Last updated November 18, 2022 at 8:40 AM

History

• Effective: August 15, 2005
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-58-82

(A) A licensee shall retain a record of the basis for authorizing the release of an individual in accordance with rule 3701:1-58-30 of the Administrative Code, if the total effective dose equivalent is calculated by:

(1) Using the retained activity rather than the activity administered;

(2) Using an occupancy factor less than 0.25 at one meter;

(3) Using the biological or effective half-life; or

(4) Considering the shielding by tissue.

(B) A licensee shall retain a record that the instructions required by paragraph (B) of rule 3701:1-58-30 of the Administrative Code were provided to a breast-feeding female if the radiation dose to the infant or child from continued breast feeding could result in a total effective dose equivalent exceeding five millisieverts (0.5 rem).

(C) For purposes of this chapter, the records required by paragraphs (A) and (B) of this rule must be retained for three years after the date of release of the individual.

Last updated November 18, 2022 at 8:40 AM

History

• Effective: October 4, 2010
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-58-83

(A) A licensee shall retain a copy of each letter that permits the use of radioactive material at a client's address, as required by paragraph (A)(1) of rule 3701:1-58-31 of the Administrative Code. Each letter must clearly delineate the authority and responsibility of the licensee and the client and must be retained for three years after the last provision of service.

(B) A licensee shall retain the record of each survey required by paragraph (A)(4) of rule 3701:1-58-31 of the Administrative Code for three years. The record must include the date of the survey, the results of the survey, the instrument used to make the survey, and the name of the individual who performed the survey.

Last updated November 18, 2022 at 8:40 AM

History

• Effective: August 15, 2005
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-58-35 Permissible molybdenum-99, strontium-82, and strontium-85 concentrations.

(A) A licensee may not administer to humans a radiopharmaceutical that contains:

(1) More than 0.15 kilobecquerel of molybdenum-99 per megabecquerel of technetium-99m (0.15 microcurie of molybdenum-99 per millicurie of technetium-99m); or

(2) More than 0.02 kilobecquerel of strontium-82 per megabecquerel of rubidium-82 chloride injection (0.02 microcurie of strontium-82 per millicurie of rubidium-82 chloride); or more than 0.2 kilobecquerel of strontium-85 per megabecquerel of rubidium-82 chloride injection (0.2 microcurie of strontium-85 per millicurie of rubidium-82).

(B) A licensee that uses molybdenum-99/technetium-99m generators for preparing a technetium-99m radiopharmaceutical shall measure the molybdenum-99 concentration of the first eluate from a generator to demonstrate compliance with paragraph (A) of this rule.

(C) A licensee that uses a strontium-82/rubidium-82 generator for preparing a rubidium-82 radiopharmaceutical shall, before the first patient use of the day, measure the concentration of radionuclides strontium-82 and strontium-85 to demonstrate compliance with paragraph (A) of this rule.

(D) If a licensee is required to measure the molybdenum-99 concentration or strontium-82 and strontium-85 concentrations, the licensee shall retain a record of each measurement in accordance with rule 3701:1-58-85 of the Administrative Code.

(E) The licensee shall report any measurement that exceeds the limits in paragraph (A) of this rule at the time of generator elution, in accordance with rule 3701:1-58-105 of the Administrative Code.

Last updated November 18, 2022 at 8:33 AM

History

• Effective: August 15, 2021
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-58-85

A licensee shall maintain a record of the molybdenum-99 concentration or strontium-82 and strontium-85 concentration tests required by paragraph (B) of rule 3701:1-58-35 of the Administrative Code for three years. The record must include:

(A) For each measured elution of technetium-99m, the ratio of the measures expressed as kilobecquerel (microcuries) of molybdenum-99 per megabecquerel (millicurie) of technetium-99m, the time and date of the measurement, and the name of the individual who made the measurement; or

(B) For each measured elution of rubidium-82, the ratio of the measures expressed as kilobecquerel (microcuries) of strontium-82 per megabecquerel (millicurie) of rubidium-82, kilobecquerel (microcuries) of strontium-85 per megabecquerel (millicurie) of rubidium-82, the time and date of the measurement, and the name of the individual who made the measurement.

Last updated November 18, 2022 at 8:41 AM

History

• Effective: October 4, 2010
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-58-105

(A) The licensee shall notify by telephone the department at 614-644-2727 and the distributor of the generator within seven calendar days after discovery that an eluate exceeded the permissible concentration listed in paragraph (A) of rule 3701:1-58-35 of the Administrative Code at the time of generator elution. The telephone report to the department must include the manufacturer, model number, and serial number (or lot number) of the generator; the results of the measurement; the date of the measurement; whether dosages were administered to patients or human research subjects, when the distributor was notified, and the action taken.

(B) By an appropriate method listed in rule 3701:1-40-04 of the Administrative Code, the licensee shall submit a written report to the department within thirty calendar days after discovery of an eluate exceeding the permissible concentration at the time of generator elution. The written report must include the action taken by the licensee; the patient dose assessment; the methodology used to make this dose assessment if the eluate was administered to patients or human research subjects; and the probable cause and an assessment of failure in the licensee's equipment, procedures or training that contributed to the excessive readings if an error occurred in the licensee's breakthrough determination; and the information in the telephone report as required by paragraph (A) of this rule.

Last updated November 18, 2022 at 8:43 AM

History

• Effective: August 15, 2021
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-58-38 Safety instruction for unsealed radioactive material.

In addition to the requirements of rule 3701:1-38-10 of the Administrative Code,

(A) A licensee shall provide radiation safety instruction, initially and at least annually, to personnel caring for patients or human research subjects who cannot be released under rule 3701:1-58-30 of the Administrative Code. To satisfy this requirement, the instruction must be commensurate with the duties of the personnel and include:

(1) Patient or human research subject control;

(2) Visitor control, including:

(a) Routine visitation to hospitalized individuals in accordance with paragraph (A)(1) of rule 3701:1-38-13 of the Administrative Code, and

(b) Visitation authorized in accordance with paragraph (C) of rule 3701:1-38-13 of the Administrative Code;

(3) Contamination control;

(4) Waste control; and

(5) Notification of the radiation safety officer, or his or her designee, and an authorized user if the patient or the human research subject has a medical emergency or dies.

(B) A licensee shall retain a record of individuals receiving instruction in accordance with rule 3701:1-58-86 of the Administrative Code.

Last updated November 18, 2022 at 8:34 AM

History

• Effective: August 10, 2015
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-38-13

(A) Each licensee or registrant shall conduct operations so that:

(1) The total effective dose equivalent to individual members of the public from the licensed or registered operation does not exceed one millisievert (0.1 rem) in a year, exclusive of the dose contribution from the following:

(a) Background radiation;

(b) Radiation attributable to any medical administration the individual has received;

(c) Exposure to an individual that was administered radioactive materials and has been released in accordance with rule 3701:1-58-30 of the Administrative Code or equivalent United States nuclear regulatory agency or agreement state regulations;

(d) Voluntary participation in medical research programs;

(e) The licensee's disposal of radioactive material into sanitary sewerage in accordance with paragraph (D) of rule 3701:1-38-19 of the Administrative Code; and

(2) The dose in any unrestricted area from external sources, exclusive of the dose contribution from patients administered radioactive material and released in accordance with rule 3701:1-58-30 of the Administrative Code or equivalent United States nuclear regulatory agency or agreement state regulations, does not exceed 0.02 millisievert (0.002 rem) in any one hour.

(B) If the licensee or registrant permits members of the public to have access to controlled or restricted areas, the limits for members of the public continue to apply to those individuals.

(C) A licensee, registrant, or an applicant for a license or registration may apply for prior department authorization to operate up to an annual dose limit for an individual member of the public of five millisievert (0.5 rem). This application shall include the following information:

(1) Demonstration of the need for and the expected duration of operation in excess of the limit set forth in paragraph (A) of this rule;

(2) The licensee's or registrant's program to assess and control dose within the five millisievert (0.5 rem) annual limit; and

(3) The procedures that the registrant or licensee will follow to maintain the dose ALARA.

(4) Notwithstanding paragraph (A)(1) of this rule, a licensee may permit visitors to an individual who cannot be released, under rule 3701:1-58-30 of the Administrative Code, to receive a radiation dose greater than one millisievert (0.1 rem) if:

(a) The radiation dose received does not exceed five millisievert (0.5 rem); and

(b) The authorized user, as defined in Chapter 3701:1-58 of the Administrative Code, has determined before the visit that it is appropriate.

(D) In addition to the requirements of paragraphs (A) and (B) of this rule:

(1) A licensee subject to the provisions of the United States environmental protection agency's generally applicable environmental radiation standards in 40 C.F.R. 190 (as in effect on the effective date of this rule), shall also comply with those standards.

(2) The department may impose additional restrictions on radiation levels in unrestricted areas and on the total quantity of radionuclides that a licensee may release in effluents in order to restrict the collective dose.

(E) The licensee or registrant shall demonstrate compliance with dose limits for individual members of the public.

(1) The licensee or registrant shall make or cause to be made surveys of radiation levels in unrestricted and controlled areas and radioactive materials in effluents released to unrestricted and controlled areas to demonstrate compliance with the dose limits for individual members of the public in paragraph (A) of this rule.

(2) A licensee or registrant shall show compliance with the annual dose limit in paragraph (A) of this rule by:

(a) Demonstrating by measurement or calculation that the total effective dose equivalent to the individual likely to receive the highest dose from the licensed or registered operation does not exceed the annual dose limit; or

(b) Demonstrating that:

(i) The annual average concentrations of radioactive material released in gaseous and liquid effluents at the boundary of the unrestricted area do not exceed the values specified in appendix C to rule 3701:1-38-12 of the Administrative Code; and

(ii) If an individual were continuously present in an unrestricted area, the dose from external sources would not exceed 0.02 millisievert (0.002 rem) in an hour and 0.5 millisievert (0.05 rem) in a year.

(3) Upon approval from the department, the licensee may adjust the effluent concentration values in appendix C to rule 3701:1-38-12 of the Administrative Code for members of the public, to take into account the actual physical and chemical characteristics of the effluents, such as aerosol size distribution, solubility, density, radioactive decay equilibrium, or chemical form.

Last updated January 20, 2022 at 8:47 AM

History

• Effective: January 20, 2022
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-58-86

A licensee shall maintain a record of safety instructions required by rules 3701:1-58-38, 3701:1-58-46 of the Administrative Code, and the operational and safety instructions required by rule 3701:1-58-58 of the Administrative Code, for three years. The record must include a list of the topics covered, the date of the instruction, the name(s) of the attendee(s), and the name(s) of the individual(s) who provided the instruction.

Last updated November 18, 2022 at 8:41 AM

History

• Effective: August 15, 2021
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-58-39 Safety precautions for unsealed radioactive material.

(A) For each patient or human research subject who cannot be released under rule 3701:1-58-30 of the Administrative Code, a licensee shall:

(1) Quarter the patient or the human research subject either in:

(a) A private room with a private sanitary facility; or

(b) A room, with a private sanitary facility, with another individual who also has received therapy with unsealed radioactive material and who also cannot be released under rule 3701:1-58-30 of the Administrative Code;

(2) Visibly post the patient's or the human research subject's room with a "radioactive materials" sign.

(3) Note on the door or in the patient's or human research subject's chart where and how long visitors may stay in the patient's or the human research subject's room; and

(4) Either monitor material and items removed from the patient's or the human research subject's room to determine that their radioactivity cannot be distinguished from the natural background radiation level with a radiation detection survey instrument set on its most sensitive scale and with no interposed shielding, or handle the material and items as radioactive waste.

(B) A licensee shall notify the radiation safety officer, or his or her designee, and an authorized user as soon as possible if the patient or human research subject has a medical emergency or dies.

Last updated November 18, 2022 at 8:34 AM

History

• Effective: August 10, 2015
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-58-44 Surveys after source implant and removal.

(A) The licensee shall make a survey to locate and account for all sources that have not been implanted immediately after implanting sources in a patient or a human research subject.

(B) The licensee shall make a survey of the patient or the human research subject with a radiation detection survey instrument to confirm that all sources have been removed immediately after removing the last temporary implant source from a patient or a human research subject.

(C) A licensee shall retain a record of the surveys required by paragraphs (A) and (B) of this rule in accordance with rule 3701:1-58-87 of the Administrative Code.

Last updated November 18, 2022 at 8:35 AM

History

• Effective: August 15, 2005
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-58-87

For purposes of this chapter, a licensee shall maintain a record of the surveys required by rules 3701:1-58-44 and 3701:1-58-56 of the Administrative Code for three years. Each record must include the date and results of the survey, the survey instrument used, and the name of the individual who made the survey.

Last updated November 18, 2022 at 8:41 AM

History

• Effective: August 15, 2005
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-58-45 Brachytherapy sources accountability.

(A) A licensee shall maintain accountability at all times for all brachytherapy sources in storage or use.

(B) As soon as possible after removing sources from a patient or a human research subject, a licensee shall return brachytherapy sources to a secure storage area.

(C) A licensee shall maintain a record of the brachytherapy source accountability in accordance with rule 3701:1-58-88 of the Administrative Code.

Last updated November 18, 2022 at 8:35 AM

History

• Effective: August 15, 2005
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-58-88

(A) A licensee shall maintain a record of brachytherapy source accountability required by rule 3701:1-58-45 of the Administrative Code for three years.

(B) For temporary implants, the record must include:

(1) The number and activity of sources removed from storage, the time and date they were removed from storage, the name of the individual who removed them from storage, and the location of use; and

(2) The number and activity of sources returned to storage, the time and date they were returned to storage, and the name of the individual who returned them to storage.

(C) For permanent implants, the record must include:

(1) The number and activity of sources removed from storage, the date they were removed from storage, and the name of the individual who removed them from storage;

(2) The number and activity of sources not implanted, the date they were returned to storage, and the name of the individual who returned them to storage; and

(3) The number and activity of sources permanently implanted in the patient or human research subject.

Last updated November 18, 2022 at 8:41 AM

History

• Effective: August 15, 2005
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-58-46 Safety instruction for manual brachytherapy.

In addition to the requirements of rule 3701:1-38-10 of the Administrative Code:

(A) The licensee shall provide radiation safety instruction, initially and at least annually, to personnel caring for patients or human research subjects who are receiving brachytherapy and cannot be released under rule 3701:1-58-30 of the Administrative Code. To satisfy this requirement, the instruction must be commensurate with the duties of the personnel and include the:

(1) Size and appearance of the brachytherapy sources;

(2) Safe handling and shielding instructions;

(3) Patient or human research subject control;

(4) Visitor control, including both:

(a) Routine visitation of hospitalized individuals in accordance with paragraph (A)(1) of rule 3701:1-38-13 of the Administrative Code; and

(b) Visitation authorized in accordance with paragraph (C) of rule 3701:1-38-13 of the Administrative Code; and

(5) Notification of the radiation safety officer, or his or her designee, and an authorized user if the patient or the human research subject has a medical emergency or dies.

(B) A licensee shall retain a record of individuals receiving instruction in accordance with rule 3701:1-58-86 of the Administrative Code.

Last updated November 18, 2022 at 8:35 AM

History

• Effective: August 10, 2015
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-58-47 Safety precautions for manual brachytherapy.

(A) For each patient or human research subject who is receiving brachytherapy and cannot be released under rule 3701:1-58-30 of the Administrative Code, a licensee shall:

(1) Not quarter the patient or the human research subject in the same room as an individual who is not receiving brachytherapy;

(2) Visibly post the patient's or human research subject's room with a "radioactive materials" sign; and

(3) Note on the door or in the patient's or human research subject's chart where and how long visitors may stay in the patient's or human research subject's room.

(B) A licensee shall have applicable emergency response equipment available near each treatment room to respond to a source:

(1) Dislodged from the patient; or

(2) Lodged within the patient following removal of the source applicators.

(C) A licensee shall notify the radiation safety officer, or his or her designee, and an authorized user as soon as possible if the patient or human research subject has a medical emergency or dies.

Last updated November 18, 2022 at 8:35 AM

History

• Effective: August 10, 2015
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-58-48 Calibration measurements of brachytherapy sources.

(A) Before the first medical use of a brachytherapy source, a licensee shall have:

(1) Determined the source output or activity using a dosimetry system that meets the requirements of paragraph (A) of rule 3701:1-58-60 of the Administrative Code;

(2) Determined source positioning accuracy within applicators; and

(3) Used published protocols currently accepted by nationally recognized bodies to meet the requirements of paragraphs (A)(1) and (A)(2) of this rule.

(B) Instead of a licensee making its own measurements as required in paragraph (A) of this rule, the licensee may use measurements provided by the source manufacturer or by a calibration laboratory accredited by the "American Association of Physicists in Medicine" (AAPM) that are made in accordance with paragraph (A) of this rule.

(C) A licensee shall mathematically correct the outputs or activities determined in paragraph (A) of this rule for radioactive decay at intervals consistent with one percent radioactive decay.

(D) A licensee shall retain a record of each calibration in accordance with rule 3701:1-58-89 of the Administrative Code.

Last updated November 18, 2022 at 8:35 AM

History

• Effective: October 4, 2010
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-58-60

(A) Except for low dose-rate remote afterloader sources where the source output or activity is determined by the manufacturer, a licensee shall have a calibrated dosimetry system available for use. To satisfy this requirement, one of the following two conditions must be met:

(1) The system must have been calibrated using a system or source traceable to the "National Institute of Standards and Technology" (NIST) and published protocols accepted by nationally recognized bodies; or by a calibration laboratory accredited by the "American Association of Physicists in Medicine" (AAPM). The calibration must have been performed within the previous two years and after any servicing that may have affected system calibration; or

(2) The system must have been calibrated within the previous four years. Eighteen to thirty months after that calibration, the system must have been intercompared with another dosimetry system that was calibrated within the past twenty-four months by NIST or by a calibration laboratory accredited by the AAPM. The results of the intercomparison must indicate that the calibration factor of the licensee's system had not changed by more than two per cent. The licensee may not use the intercomparison result to change the calibration factor. When intercomparing dosimetry systems to be used for calibrating sealed sources for therapeutic units, the licensee shall use a comparable unit with beam attenuators or collimators, as applicable, and sources of the same radionuclide as the source used at the licensee's facility.

(B) The licensee shall have a dosimetry system available for use for spot-check output measurements, if applicable. To satisfy this requirement, the system may be compared with a system that has been calibrated in accordance with paragraph (A) of this rule. This comparison must have been performed within the previous year and after each servicing that may have affected system calibration. The spot-check system may be the same system used to meet the requirement in paragraph (A) of this rule.

(C) The licensee shall retain a record of each calibration, intercomparison, and comparison in accordance with rule 3701:1-58-93 of the Administrative Code.

Last updated November 18, 2022 at 8:37 AM

History

• Effective: October 4, 2010
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-58-89

(A) A licensee shall maintain a record of the calibrations of brachytherapy sources required by rule 3701:1-58-48 of the Administrative Code for three years after the last use of the source.

(B) The record must include:

(1) The date of the calibration;

(2) The manufacturer's name, model number, and serial number for the source and the instruments used to calibrate the source;

(3) The source output or activity;

(4) The source positioning accuracy within the applicators; and

(5) The name of the individual, the source manufacturer, or the calibration laboratory that performed the calibration.

Last updated November 18, 2022 at 8:41 AM

History

• Effective: August 15, 2005
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-58-90

(A) A licensee shall maintain a record of the activity of a strontium-90 source required by rule 3701:1-58-49 of the Administrative Code for the life of the source.

(B) The record must include:

(1) The date and initial activity of the source as determined under rule 3701:1-58-48 of the Administrative Code; and

(2) For each decay calculation, the date and the source activity as determined under rule 3701:1-58-49 of the Administrative Code.

Last updated November 18, 2022 at 8:41 AM

History

• Effective: August 15, 2005
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-58-50 Therapy-related computer systems for manual brachytherapy.

The licensee shall perform acceptance testing on the treatment planning system of therapy-related computer systems in accordance with published protocols accepted by nationally recognized bodies. At a minimum, the acceptance testing must include, as applicable, verification of:

(A) The source-specific input parameters required by the dose calculation algorithm;

(B) The accuracy of dose, dwell time, and treatment time calculations at representative points;

(C) The accuracy of isodose plots and graphic displays; and

(D) The accuracy of the software used to determine sealed source positions from radiographic images.

Last updated November 18, 2022 at 8:36 AM

History

• Effective: August 15, 2005
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-58-56 Surveys of patients and human research subjects treated with a remote afterloader unit.

(A) Before releasing a patient or a human research subject from licensee control, a licensee shall survey the patient or the human research subject and the remote afterloader unit with a portable radiation detection survey instrument to confirm that the source(s) has been removed from the patient or human research subject and returned to the safe shielded position.

(B) A licensee shall retain a record of these surveys in accordance with rule 3701:1-58-87 of the Administrative Code.

Last updated November 18, 2022 at 8:37 AM

History

• Effective: August 15, 2005
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-58-57 Installation, maintenance, adjustment, and repair of remote afterloader units, teletherapy units, and gamma stereotactic radiosurgery units.

(A) Only a person specifically licensed by the director, the United States nuclear regulatory commission, or an agreement state shall install, maintain, adjust, or repair a remote afterloader unit, teletherapy unit, or gamma stereotactic radiosurgery unit that involves work on the source(s) shielding, the source(s) driving unit, or other electronic or mechanical component that could expose the source(s), reduce the shielding around the source(s), or compromise the radiation safety of the unit or the source(s).

(B) Except for low dose-rate remote afterloader units, only a person specifically licensed by the director, United States nuclear regulatory commission, or an agreement state shall install, replace, relocate, or remove a sealed source or source contained in other remote afterloader units, teletherapy units, or gamma stereotactic radiosurgery units.

(C) For a low dose-rate remote afterloader unit, only a person specifically licensed by the director, United States nuclear regulatory commission, or an agreement state, or an authorized medical physicist shall install, replace, relocate, or remove a sealed source(s) contained in the unit.

(D) A licensee shall retain a record of the installation, maintenance, adjustment, and repair of remote afterloader units, teletherapy units, and gamma stereotactic radiosurgery units in accordance with rule 3701:1-58-91 of the Administrative Code.

Last updated November 18, 2022 at 8:37 AM

History

• Effective: August 10, 2015
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-58-91

A licensee shall retain a record of the installation, maintenance, adjustment, and repair of remote afterloader units, teletherapy units, and gamma stereotactic radiosurgery units as required by rule 3701:1-58-57 of the Administrative Code for three years. For each installation, maintenance, adjustment and repair, the record must include the date, description of the service, and name(s) of the individual(s) who performed the work.

Last updated November 18, 2022 at 8:41 AM

History

• Effective: August 15, 2005
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-58-92

A licensee shall retain a copy of the procedures required by paragraphs (A)(4) and (D)(2) of rule 3701:1-58-58 of the Administrative Code until the licensee no longer possesses the remote afterloader, teletherapy unit, or gamma stereotactic radiosurgery unit.

Last updated November 18, 2022 at 8:42 AM

History

• Effective: October 4, 2010
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-58-59 Safety precautions for remote afterloader units, teletherapy units, and gamma stereotactic radiosurgery units.

(A) A licensee shall control access to the treatment room by a door at each entrance.

(B) A licensee shall equip each entrance to the treatment room with an electrical interlock system that will:

(1) Prevent the operator from initiating the treatment cycle unless each treatment room entrance door is closed;

(2) Cause the source(s) to be shielded when an entrance door is opened; and

(3) Prevent the source(s) from being exposed following an interlock interruption until all treatment room entrance doors are closed and the source(s) on-off control is reset at the console.

(C) A licensee shall require any individual entering the treatment room to assure, through the use of appropriate radiation monitors, that radiation levels have returned to ambient levels.

(D) Except for low-dose remote afterloader units, a licensee shall construct or equip each treatment room with viewing and intercom systems to permit continuous observation of the patient or the human research subject from the treatment console during irradiation.

(E) For licensed activities where sources are placed within the patient's or human research subject's body, a licensee shall only conduct treatments which allow for expeditious removal of a decoupled or jammed source.

(F) In addition to the requirements specified in paragraphs (A) to (E) of this rule, a licensee shall:

(1) For medium dose-rate and pulsed dose-rate remote afterloader units, require:

(a) An authorized medical physicist and either an authorized user or a physician, under the supervision of an authorized user, who has been trained in the operation and emergency response for the unit to be physically present during the initiation of all patient treatments involving the unit; and

(b) An authorized medical physicist and either an authorized user or an individual, under the supervision of an authorized user, who has been trained to remove the source applicator(s) in the event of an emergency involving the unit, to be immediately available during continuation of all patient treatments involving the unit.

(2) For high dose-rate remote afterloader units, require:

(a) An authorized user and an authorized medical physicist to be physically present during the initiation of all patient treatments involving the unit; and

(b) An authorized medical physicist and either an authorized user or a physician, under the supervision of an authorized user, who has been trained in the operation and emergency response for the unit, to be physically present during continuation of all patient treatments involving the unit.

(3) For gamma stereotactic radiosurgery units, require an authorized user and an authorized medical physicist to be physically present throughout all patient treatments involving the unit.

(4) Notify the radiation safety officer, or his/her designee, and an authorized user as soon as possible if the patient or human research subject has a medical emergency or dies.

(G) A licensee shall have applicable emergency response equipment available near each treatment room to respond to a source:

(1) Remaining in the unshielded position; or

(2) Lodged within the patient following completion of the treatment.

Last updated November 18, 2022 at 8:37 AM

History

• Effective: August 15, 2005
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-58-93

(A) A licensee shall retain a record of the calibration, intercomparison, and comparisons of its dosimetry equipment done in accordance with rule 3701:1-58-60 of the Administrative Code for the duration of the license.

(B) For each calibration, intercomparison, or comparison, the record must include:

(1) The date;

(2) The manufacturer's name, model numbers and serial numbers of the instruments that were calibrated, intercompared, or compared as required by paragraphs (A) and (B) of rule 3701:1-58-60 of the Administrative Code;

(3) The correction factor that was determined from the calibration or comparison or the apparent correction factor that was determined from an intercomparison; and

(4) The names of the individuals who performed the calibration, intercomparison, or comparison.

Last updated November 18, 2022 at 8:42 AM

History

• Effective: August 15, 2005
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-58-61 Full calibration measurements on teletherapy units.

(A) A licensee authorized to use a teletherapy unit for medical use shall perform full calibration measurements on each teletherapy unit:

(1) Before the first medical use of the unit;

(2) Before medical use under the following conditions:

(a) Whenever spot-check measurements, as described in rule 3701:1-58-64 of the Administrative Code, indicate that the output differs by more than five per cent from the output obtained at the last full calibration corrected mathematically for radioactive decay;

(b) Following replacement of the source or following reinstallation of the teletherapy unit in a new location;

(c) Following any repair of the teletherapy unit that includes removal of the source or major repair of the components associated with the source exposure assembly; and

(3) At intervals not exceeding one year.

(B) To satisfy the requirement of paragraph (A) of this rule, full calibration measurements must include determination of:

(1) The output within plus or minus three per cent for the range of field sizes and for the distance or range of distances used for medical use;

(2) The coincidence of the radiation field and the field indicated by the light beam localizing device;

(3) The uniformity of the radiation field and its dependence on the orientation of the useful beam;

(4) Timer accuracy and linearity over the range of use;

(5) On-off error; and

(6) The accuracy of all distance measuring and localization devices in medical use.

(C) A licensee shall use the dosimetry system described in paragraph (A) of rule 3701:1-58-60 of the Administrative Code to measure the output for one set of exposure conditions. The remaining radiation measurements required in paragraph (B)(1) of this rule may be made using a dosimetry system that indicates relative dose rates.

(D) A licensee shall make full calibration measurements required by paragraph (A) of this rule in accordance with published protocols accepted by nationally recognized bodies.

(E) A licensee shall mathematically correct the outputs determined in paragraph (B)(1) of this rule for radioactive decay for intervals not exceeding one month for cobalt-60, six months for cesium-137, or at intervals consistent with one per cent decay for all other nuclides.

(F) Full calibration measurements required by paragraph (A) of this rule and radioactive decay corrections required by paragraph (E) of this rule must be performed by the authorized medical physicist.

(G) A licensee shall retain a record of each calibration in accordance with rule 3701:1-58-94 of the Administrative Code.

Last updated November 18, 2022 at 8:38 AM

History

• Effective: October 4, 2010
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-58-94

(A) A licensee shall maintain a record of the teletherapy unit, remote afterloader unit, and gamma stereotactic radiosurgery unit full calibrations required by rules 3701:1-58-61 to 3701:1-58-63 of the Administrative Code for three years.

(B) The record must include:

(1) The date of the calibration;

(2) The manufacturer's name, model number, and serial number of the teletherapy, remote afterloader, and gamma stereotactic radiosurgery unit(s), the source(s), and the instruments used to calibrate the unit(s);

(3) The results and an assessment of the full calibrations;

(4) The results of the autoradiograph required for low dose-rate remote afterloader units; and

(5) The signature of the authorized medical physicist who performed the full calibration.

Last updated November 18, 2022 at 8:42 AM

History

• Effective: October 4, 2010
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-58-62 Full calibration measurements on remote afterloader units.

(A) A licensee authorized to use a remote afterloader unit for medical use shall perform full calibration measurements on each unit:

(1) Before the first medical use of the unit;

(2) Before medical use under the following conditions:

(a) Following replacement of the source or following reinstallation of the unit in a new location outside the facility; and

(b) Following any repair of the unit that includes removal of the source or major repair of the components associated with the source exposure assembly;

(3) At intervals not exceeding one quarter for high dose-rate, medium dose-rate, and pulsed dose-rate remote afterloader units with sources whose half-life exceeds seventy-five days; and

(4) At intervals not exceeding one year for low dose-rate remote afterloader units.

(B) To satisfy the requirement of paragraph (A) of this rule, full calibration measurements must include, as applicable, determination of:

(1) The output within five per cent;

(2) Source positioning accuracy to within one millimeter;

(3) Source retraction with backup battery upon power failure;

(4) Length of the source transfer tubes;

(5) Timer accuracy and linearity over the typical range of use;

(6) Length of the applicators; and

(7) Function of the source transfer tubes, applicators, and transfer tube-applicator interfaces.

(C) A licensee shall use the dosimetry system described in paragraph (A) of rule 3701:1-58-60 of the Administrative Code to measure the output.

(D) A licensee shall make full calibration measurements required by paragraph (A) of this rule in accordance with published protocols accepted by nationally recognized bodies.

(E) In addition to the requirements for full calibrations for low dose-rate remote afterloader units in paragraph (B) of this rule, a licensee shall perform an autoradiograph of the source(s) to verify inventory and source(s) arrangement at intervals not exceeding one quarter.

(F) For low dose-rate remote afterloader units, a licensee may use measurements provided by the source manufacturer that are made in accordance with paragraphs (A) to (E) of this rule.

(G) A licensee shall mathematically correct the outputs determined in paragraph (B)(1) of this rule for radioactive decay at intervals consistent with one per cent radioactive decay.

(H) Full calibration measurements required by paragraph (A) of this rule and radioactive decay corrections required by paragraph (G) of this rule must be performed by the authorized medical physicist.

(I) A licensee shall retain a record of each calibration in accordance with rule 3701:1-58-94 of the Administrative Code.

Last updated November 18, 2022 at 8:38 AM

History

• Effective: October 4, 2010
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-58-63 Full calibration measurements on gamma stereotactic radiosurgery units.

(A) A licensee authorized to use a gamma stereotactic radiosurgery unit for medical use shall perform full calibration measurements on each unit:

(1) Before the first medical use of the unit;

(2) Before medical use under the following conditions:

(a) Whenever spot-check measurements, as described in rule 3701:1-58-66 of the Administrative Code, indicate that the output differs by more than five per cent from the output obtained at the last full calibration corrected mathematically for radioactive decay;

(b) Following replacement of the sources or following reinstallation of the gamma stereotactic radiosurgery unit in a new location; and

(c) Following any repair of the gamma stereotactic radiosurgery unit that includes removal of the sources or major repair of the components associated with the source assembly; and

(3) At intervals not exceeding one year, with the exception that relative helmet factors need only be determined before the first medical use of a helmet and following any damage to a helmet.

(B) To satisfy the requirement of paragraph (A) of this rule, full calibration measurements must include determination of:

(1) The output within three per cent;

(2) Relative helmet factors;

(3) Isocenter coincidence;

(4) Timer accuracy and linearity over the range of use;

(5) On-off error;

(6) Trunnion centricity;

(7) Treatment table retraction mechanism, using backup battery power or hydraulic backups with the unit off;

(8) Helmet microswitches;

(9) Emergency timing circuits; and

(10) Stereotactic frames and localizing devices (trunnions).

(C) A licensee shall use the dosimetry system described in paragraph (A) of rule 3701:1-58-60 of the Administrative Code to measure the output for one set of exposure conditions. The remaining radiation measurements required in paragraph (B)(1) of this rule may be made using a dosimetry system that indicates relative dose rates.

(D) A licensee shall make full calibration measurements required by paragraph (A) of this rule in accordance with published protocols accepted by nationally recognized bodies.

(E) A licensee shall mathematically correct the outputs determined in paragraph (B)(1) of this rule at intervals not exceeding one month for cobalt-60 and at intervals consistent with one per cent radioactive decay for all other radionuclides.

(F) Full calibration measurements required by paragraph (A) of this rule and radioactive decay corrections required by paragraph (E) of this rule must be performed by the authorized medical physicist.

(G) A licensee shall retain a record of each calibration in accordance with rule 3701:1-58-94 of the Administrative Code.

Last updated November 18, 2022 at 8:38 AM

History

• Effective: October 4, 2010
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-58-95

(A) A licensee shall retain a record of each periodic spot-check for teletherapy units required by rule 3701:1-58-64 of the Administrative Code for three years.

(B) The record must include:

(1) The date of the spot-check;

(2) The manufacturer's name, model number, and serial number of the teletherapy unit, source and instrument used to measure the output of the teletherapy unit;

(3) An assessment of timer linearity and constancy;

(4) The calculated on-off error;

(5) A determination of the coincidence of the radiation field and the field indicated by the light beam localizing device;

(6) The determined accuracy of each distance measuring and localization device;

(7) The difference between the anticipated output and the measured output;

(8) Notations indicating the operability of each entrance door electrical interlock, each electrical or mechanical stop, each source exposure indicator light, and the viewing and intercom system and doors; and

(9) The name of the individual who performed the periodic spot-check and the signature of the authorized medical physicist who reviewed the record of the spot-check.

(C) A licensee shall retain a copy of the procedures required by paragraph (B) of rule 3701:1-58-64 of the Administrative Code until the licensee no longer possesses the teletherapy unit.

Last updated November 18, 2022 at 8:42 AM

History

• Effective: August 15, 2005
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-58-65 Periodic spot-checks for remote afterloader units.

(A) A licensee authorized to use a remote afterloader unit for medical use shall perform spot-checks of each remote afterloader facility and on each unit:

(1) Before the first use on any given day that a high dose-rate, medium dose-rate, or pulsed dose-rate remote afterloader is in operation;

(2) Before each patient treatment with a low dose-rate remote afterloader unit; and

(3) After each source installation.

(B) A licensee shall perform the measurements required by paragraph (A) of this rule in accordance with written procedures established by the authorized medical physicist. That individual need not actually perform the spot-check measurements.

(C) A licensee shall have the authorized medical physicist review the results of each spot-check within fifteen days. The authorized medical physicist shall notify the licensee as soon as possible in writing of the results of each spot-check.

(D) To satisfy the requirements of paragraph (A) of this rule, spot-checks must, at a minimum, assure proper operation of:

(1) Electrical interlocks at each remote afterloader unit room entrance;

(2) Source exposure indicator lights on the remote afterloader unit, on the control console, and in the facility;

(3) Viewing and intercom systems in each high dose-rate, medium dose-rate, and pulsed dose-rate remote afterloader facility;

(4) Emergency response equipment;

(5) Radiation monitors used to indicate the source position;

(6) Timer accuracy;

(7) Clock (date and time) in the unit's computer; and

(8) Decayed source(s) activity in the unit's computer.

(E) If the results of the checks required in paragraph (D) of this rule indicate the malfunction of any system, a licensee shall lock the control console in the off position and not use the unit except as may be necessary to repair, replace, or check the malfunctioning system.

(F) A licensee shall retain a record of each check required by paragraph (D) of this rule and a copy of the procedures required by paragraph (B) of this rule in accordance with rule 3701:1-58-96 of the Administrative Code.

Last updated November 18, 2022 at 8:38 AM

History

• Effective: August 15, 2005
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-58-96

(A) A licensee shall retain a record of each spot-check for remote afterloader units required by rule 3701:1-58-65 of the Administrative Code for three years.

(B) The record must include, as applicable:

(1) The date of the spot-check;

(2) The manufacturer's name, model number, and serial number for the remote afterloader unit and source;

(3) An assessment of timer accuracy;

(4) Notations indicating the operability of each entrance door electrical interlock, radiation monitors, source exposure indicator lights, viewing and intercom systems, and clock and decayed source activity in the unit's computer; and

(5) The name of the individual who performed the periodic spot-check and the signature of the authorized medical physicist who reviewed the record of the spot-check.

(C) A licensee shall retain a copy of the procedures required by paragraph (B) of rule 3701:1-58-65 of the Administrative Code until the licensee no longer possesses the remote afterloader unit.

Last updated November 18, 2022 at 8:42 AM

History

• Effective: August 15, 2005
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-58-97

(A) A licensee shall retain a record of each spot-check for gamma stereotactic radiosurgery units required by rule 3701:1-58-66 of the Administrative Code for three years.

(B) The record must include:

(1) The date of the spot-check;

(2) The manufacturer's name, model number, and serial number for the gamma stereotactic radiosurgery unit and the instrument used to measure the output of the unit;

(3) An assessment of timer linearity and accuracy;

(4) The calculated on-off error;

(5) A determination of trunnion centricity;

(6) The difference between the anticipated output and the measured output;

(7) An assessment of source output against computer calculations;

(8) Notations indicating the operability of radiation monitors, helmet microswitches, emergency timing circuits, emergency off buttons, electrical interlocks, source exposure indicator lights, viewing and intercom systems, timer termination, treatment table retraction mechanism, and stereotactic frames and localizing devices (trunnions); and

(9) The name of the individual who performed the periodic spot-check and the signature of the authorized medical physicist who reviewed the record of the spot-check.

(C) A licensee shall retain a copy of the procedures required by paragraph (B) of rule 3701:1-58-66 of the Administrative Code until the licensee no longer possesses the gamma stereotactic radiosurgery unit.

Last updated November 18, 2022 at 8:42 AM

History

• Effective: August 15, 2005
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-58-67 Additional technical requirements for mobile remote afterloader units.

(A) A licensee providing mobile remote afterloader service shall:

(1) Check survey instruments before medical use at each address of use or on each day of use, whichever is more frequent; and

(2) Account for all sources before departure from a client's address of use.

(B) In addition to the periodic spot-checks required by rule 3701:1-58-65 of the Administrative Code, a licensee authorized to use mobile afterloaders for medical use shall perform checks on each remote afterloader unit before use at each address of use. At a minimum, checks must be made to verify the operation of:

(1) Electrical interlocks on treatment area access points;

(2) Source exposure indicator lights on the remote afterloader unit, on the control console, and in the facility;

(3) Viewing and intercom systems;

(4) Applicators, source transfer tubes, and transfer tube-applicator interfaces;

(5) Radiation monitors used to indicate room exposures;

(6) Source positioning (accuracy); and

(7) Radiation monitors used to indicate whether the source has returned to a safe shielded position.

(C) In addition to the requirements for checks in paragraph (B) of this rule, a licensee shall ensure overall proper operation of the remote afterloader unit by conducting a simulated cycle of treatment before use at each address of use.

(D) If the results of the checks required in paragraph (B) of this rule indicate the malfunction of any system, a licensee shall lock the control console in the off position and not use the unit except as may be necessary to repair, replace, or check the malfunctioning system.

(E) A licensee shall retain a record of each check required by paragraph (B) of this rule in accordance with rule 3701:1-58-98 of the Administrative Code.

Last updated November 18, 2022 at 8:38 AM

History

• Effective: August 15, 2005
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-58-98

(A) A licensee shall retain a record of each check for mobile remote afterloader units required by rule 3701:1-58-67 of the Administrative Code for three years.

(B) The record must include:

(1) The date of the check;

(2) The manufacturer's name, model number, and serial number of the remote afterloader unit;

(3) Notations accounting for all sources before the licensee departs from a facility;

(4) Notations indicating the operability of each entrance door electrical interlock, radiation monitors, source exposure indicator lights, viewing and intercom system, applicators, source transfer tubes, and transfer tube applicator interfaces, and source positioning accuracy; and

(5) The signature of the individual who performed the check.

Last updated November 18, 2022 at 8:42 AM

History

• Effective: August 15, 2005
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-58-68 Radiation surveys for remote afterloader units, teletherapy units, and gamma stereotactic radiosurgery units.

(A) In addition to the survey requirement in rule 3701:1-38-14 of the Administrative Code, a person subject to rules 3701:1-58-55 to 3701:1-58-71 of the Administrative Code shall make surveys to ensure that the maximum radiation levels and average radiation levels from the surface of the main source safe with the source(s) in the shielded position do not exceed the levels stated in the sealed source and device registry.

(B) The licensee shall make the survey required by paragraph (A) of this rule at installation of a new source and following repairs to the source(s) shielding, the source(s) driving unit, or other electronic or mechanical component that could expose the source, reduce the shielding around the source(s), or compromise the radiation safety of the unit or the source(s).

(C) A licensee shall retain a record of the radiation surveys required by paragraph (A) of this rule in accordance with rule 3701:1-58-99 of the Administrative Code.

Last updated November 18, 2022 at 8:38 AM

History

• Effective: October 4, 2010
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-38-14

(A) Each licensee or registrant shall:

(1) Make, or cause to be made, surveys of areas, including the subsurface, that are:

(a) Necessary to comply with this chapter: and

(b) Reasonable under the circumstances to evaluate:

(i) Radiation levels;

(ii) Concentrations or quantities of residual radioactivity; and

(iii) The potential radiological hazards of the radiation levels and residual radioactivity detected.

(2) Notwithstanding paragraph (C) of rule 3701:1-38-20 of the Administrative Code, records from surveys describing the location and amount of subsurface residual radioactivity identified at the site must be kept with records important for decommissioning, and such records must be retained in accordance with paragraph (I) of rule 3701:1-40-17, paragraph (F) of rule 3701:1-44-18, and paragraph (D) of rule 3701:1-56-19 of the Administrative Code, as applicable.

(3) Ensure that instruments and equipment used for quantitative radiation measurements, such as dose rate and effluent monitoring, are calibrated annually for the radiation measured, except as otherwise specified in Chapter 3748. of the Revised Code, rules adopted thereunder, or a license condition.

(4) Ensure that all personnel dosimeters, except for direct and indirect reading dosimeters used to measure the dose to any extremity, that require processing to determine the radiation dose and that are used to comply with paragraph (A) of rule 3701:1-38-12 of the Administrative Code, with other applicable provisions of these regulations, or with conditions specified in a license or registration shall be processed and evaluated by a dosimetry processor that:

(a) Holds a current personnel dosimetry accreditation from the national voluntary laboratory accreditation program of the national institute of standards and technology; and

(b) Is approved in this accreditation process for the type of radiation or radiations included in the national voluntary laboratory accreditation program that most closely approximates the type of radiation or radiations for which the individual wearing the dosimeter is monitored; and

(5) Have procedures in place to minimize the likelihood of a deceptive exposure of an individual monitoring device, and in the event of a suspected deceptive exposure, an investigation should be conducted by the radiation safety officer for licensees or individual responsible for radiation protection for registrants which will lead to corrective action as necessary.

(B) Conditions requiring individual monitoring of external and internal occupational dose are as follows:

(1) Each licensee or registrant shall monitor exposures from sources of radiation at levels sufficient to demonstrate compliance with the occupational dose limits of rule 3701:1-38-12 of the Administrative Code. Each licensee or registrant shall monitor occupational exposure to radiation from sources of radiation under the control of the licensee or registrant and shall supply and require the use of individual monitoring devices by:

(a) Adults likely to receive, in one year from sources of radiation external to the body, a dose in excess of ten per cent of the limits in paragraph (A) of rule 3701:1-38-12 of the Administrative Code;

(b) Minors likely to receive, in one year, from radiation sources external to the body, a deep dose equivalent in excess of one millisievert (0.1 rem), a lens dose equivalent in excess of 1.5 millisievert (0.15 rem), or a shallow dose equivalent to the skin or to the extremities in excess of five millisievert (0.5 rem);

(c) Declared pregnant women likely to receive during the entire pregnancy, from radiation sources external to the body, a deep dose equivalent in excess of one millisievert (0.1 rem); and

(d) Individuals entering a high or very high radiation area.

(2) To determine compliance with paragraph (D) of rule 3701:1-38-12 of the Administrative Code, each licensee shall monitor the occupational intake of radioactive material by and assess the committed effective dose equivalent to:

(a) Adults likely to receive, in one year, an intake in excess of ten per cent of the applicable ALI in appendix C to rule 3701:1-38-12 of the Administrative Code;

(b) Minors likely to receive, in one year, a committed effective dose equivalent in excess of one millisievert (0.1 rem); and

(c) Declared pregnant women likely to receive, during the entire pregnancy, a committed effective dose equivalent in excess of one millisievert (0.1 rem).

(C) Each licensee or registrant shall ensure that any individual who is required to monitor occupational doses in accordance with paragraph (B)(1) of this rule wears an individual monitoring device as follows:

(1) An individual monitoring device, used for monitoring the dose to the whole body, shall be worn at the unshielded location of the whole body likely to receive the highest exposure. When a protective apron is worn, the location of the individual monitoring device is typically at the neck.

(2) An individual monitoring device, used for monitoring the dose to an embryo or fetus of a declared pregnant woman pursuant to paragraph (H) of rule 3701:1-38-12 of the Administrative Code, shall be located at the waist under any protective apron being worn by the woman.

(3) An individual monitoring device, used for monitoring the lens dose equivalent, to demonstrate compliance with paragraph (A) of rule 3701:1-38-12 of the Administrative Code, shall be located at the neck outside any protective apron being worn by the monitored individual, or at an unshielded location close to the eye.

(4) An individual monitoring device, used for monitoring the dose to the extremities, to demonstrate compliance with paragraph (A)(2) of rule 3701:1-38-12 of the Administrative Code, shall be worn on the extremity likely to receive the highest exposure. Each individual monitoring device shall be oriented to measure the highest dose to the extremity being monitored.

(5) When only one individual monitoring device is used to determine the effective dose equivalent for external radiation pursuant to paragraph (A)(4)(b) of rule 3701:1-38-12 of the Administrative Code, it shall be located at the neck outside the protective apron. When a second individual monitoring device is used for the same purpose, it shall be located under the protective apron at the waist. The second individual monitoring device is required for a declared pregnant woman.

Last updated November 2, 2022 at 2:10 PM

History

• Effective: August 30, 2015
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-58-99

(A) A licensee shall maintain a record of radiation surveys of treatment units made in accordance with rule 3701:1-58-68 of the Administrative Code for the duration of use of the unit.

(B) The record must include:

(1) The date of the measurements;

(2) The manufacturer's name, model number and serial number of the treatment unit, source, and instrument used to measure radiation levels;

(3) Each dose rate measured around the source while the unit is in the off position and the average of all measurements; and

(4) The signature of the individual who performed the test.

Last updated November 18, 2022 at 8:42 AM

History

• Effective: August 15, 2005
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-58-69 Five-year inspection for teletherapy and gamma stereotactic radiosurgery units.

(A) A licensee shall have each teletherapy unit and gamma stereotactic radiosurgery unit fully inspected and serviced during source replacement, to assure proper functioning of the source exposure mechanism and other safety components. The interval between each full-inspection servicing shall not exceed five years for each teletherapy unit and shall not exceed seven years for each gamma stereotactic radiosurgery unit.

(B) This inspection and servicing may only be performed by persons specifically licensed to do so by the director, the United States nuclear regulatory commission, or an agreement state.

(C) A licensee shall keep a record of the inspection and servicing in accordance with rule 3701:1-58-100 of the Administrative Code.

Last updated November 18, 2022 at 8:39 AM

History

• Effective: August 15, 2021
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-58-100

(A) A licensee shall maintain a record of the full-inspection servicing for teletherapy and gamma stereotactic radiosurgery units required by rule 3701:1-58-69 of the Administrative Code for the duration of use of the unit.

(B) The record must contain:

(1) The inspector's radioactive materials license number;

(2) The date of inspection;

(3) The manufacturer's name and model number and the serial number of both the treatment unit and source;

(4) A list of components inspected and serviced, and the type of service; and

(5) The signature of the inspector.

Last updated November 18, 2022 at 8:43 AM

History

• Effective: August 15, 2021
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-58-70 Therapy-related computer systems for remote afterloader units, teletherapy units, and gamma stereotactic radiosurgery units.

The licensee shall perform acceptance testing on the treatment planning system of therapy-related computer systems in accordance with published protocols accepted by nationally recognized bodies. At a minimum, the acceptance testing must include, as applicable, verification of:

(A) The source-specific input parameters required by the dose calculation algorithm;

(B) The accuracy of dose, dwell time, and treatment time calculations at representative points;

(C) The accuracy of isodose plots and graphic displays;

(D) The accuracy of the software used to determine sealed source positions from radiographic images; and

(E) The accuracy of electronic transfer of the treatment delivery parameters to the treatment delivery unit from the treatment planning system.

Last updated November 18, 2022 at 8:39 AM

History

• Effective: August 15, 2005
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-58-84 Records of decay-in-storage.

A licensee shall maintain records of the disposal of licensed materials, as required by rule 3701:1-38-19 of the Administrative Code, for three years. The record must include the date of the disposal, the survey instrument used, the background radiation level, the radiation level measured at the surface of each waste container, and the name of the individual who performed the survey.

Last updated November 18, 2022 at 8:41 AM

History

• Effective: August 15, 2005
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-38-19

(A) A licensee shall dispose of licensed radioactive material in accordance with this rule. Licensed material shall be disposed of in one of the following manners:

(1) By transfer to an authorized recipient as provided in this chapter, Chapter 3701:1-40 of the Administrative Code, or to the United States department of energy;

(2) By decay in storage provided that the radionuclide has a half-life of one hundred twenty days or less, or as otherwise permitted by the license;

(3) By release in effluents within the limits set forth in rule 3701:1-38-13 of the Administrative Code; or

(4) As authorized pursuant to paragraphs (B) to (F) of this rule.

(B) A person shall be specifically licensed to receive waste containing licensed material from another person for:

(1) Treatment prior to disposal;

(2) Treatment or disposal by incineration;

(3) Decay in storage;

(4) Disposal at a land disposal facility licensed pursuant to rules 3701:1-54-06 to 3701:1-54-12 of the Administrative Code or equivalent United States nuclear regulatory commission or agreement state regulations; or

(5) Storage until transfer to a storage or disposal facility authorized to receive the waste.

(C) A licensee or applicant for a license may apply to the director for approval of proposed disposal procedures that are not otherwise authorized in these rules for the disposal of licensed material generated in the licensee's operations. Each application shall include:

(1) A description of the waste containing licensed material to be disposed of, including the physical and chemical properties that have an impact on risk evaluation, and the proposed manner and conditions of waste disposal;

(2) An analysis and evaluation of pertinent information on the nature of the environment;

(3) The nature and location of other potentially affected facilities; and

(4) An analysis and procedures to ensure that doses are maintained ALARA and within the dose limits in rules 3701:1-38-12 and 3701:1-38-13 of the Administrative Code.

(D) A licensee may discharge licensed material into sanitary sewerage as follows:

(1) The material is readily soluble in water or is a biological material that is readily dispersible in water;

(2) The quantity of licensed or other radioactive material that the licensee releases into the sewer in one month divided by the average monthly volume of water released into the sewer by the licensee does not exceed the concentration listed in table III of appendix C to rule 3701:1-38-12 of the Administrative Code; and

(3) If more than one radionuclide is to be released, the following conditions must also be satisfied:

(a) The licensee shall determine the fraction of the limit in table III of appendix C to rule 3701:1-38-12 of the Administrative Code represented by discharges into sanitary sewerage by dividing the actual monthly average concentration of each radionuclide released by the licensee into the sewer by the concentration of that radionuclide listed in table III of appendix C to rule 3701:1-38-12 of the Administrative Code; and

(b) The sum of the fractions for each radionuclide required by paragraph (D)(3)(a) of this rule does not exceed unity.

(4) The total quantity of licensed and other radioactive material that the licensee releases into the sanitary sewerage in a year does not exceed one hundred eighty-five gigabecquerels (five curies) of hydrogen-3, thirty-seven gigabecquerels (one curie) of carbon-14, and thirty-seven gigabecquerels (one curie) of all other radioactive materials combined.

(5) Excreta from an individual undergoing medical diagnosis or therapy with radioactive material is not subject to the limitations contained in paragraph (D) of this rule.

(E) A licensee may dispose of licensed material by decay in storage. A licensee may hold radioactive material with a physical half-life of one hundred twenty days or less for decay-in-storage before disposal as non-radioactive material provided the licensee does the following:

(1) Monitors the material at the container surface prior to disposal and determines that the radioactivity cannot be distinguished from the background radiation level with an appropriate radiation detection survey meter set on its most sensitive scale and with no interposing shielding;

(2) Removes or obliterates all radiation caution labels and symbols, unless otherwise specified in the license; and

(3) Retains a record of the disposal for three years.

(F) A licensee may treat or dispose of licensed material by incineration only in the form and concentration specified in paragraph (G) of this rule or as specifically approved by the director pursuant to paragraph (C) of this rule.

(G) A licensee may dispose of the following licensed material as if it were not radioactive. The licensee shall maintain records in accordance with paragraph (K) of rule 3701:1-38-20 of the Administrative Code.

(1) 1.85 kilobecquerels (0.05 microcurie) or less, of hydrogen-3 or carbon-14 per gram of medium used for liquid scintillation counting; or

(2) 1.85 kilobecquerels (0.05 microcurie) or less, of hydrogen-3 or carbon-14 per gram of animal tissue, averaged over the weight of the entire animal. A licensee shall not dispose of tissue pursuant to this paragraph in a manner that would permit its use either as food for humans or as animal feed.

(H) A licensee shall transfer and dispose of licensed material in accordance with the following:

(1) For transfer of radioactive waste intended for disposal at a licensed radioactive waste disposal facility, establish a manifest tracking system, and supplement existing requirements concerning transfers and recordkeeping for those wastes. Each shipment of radioactive waste designated for disposal at a licensed radioactive waste disposal facility shall be accompanied by a shipment manifest as specified in the appendix to this rule.

(2) Each shipment manifest shall include a certification by the waste generator in accordance with the appendix to this rule.

(3) Each person involved in the transfer of waste for disposal or in the disposal of waste, including the waste generator, waste collector, waste processor, and disposal facility operator, shall comply with the requirements specified in the appendix to this rule.

(I) Nothing in this rule relieves a licensee from complying with other applicable federal, state and local regulations governing any other toxic or hazardous properties of materials that may be disposed of under this rule.

View Appendix

Last updated January 20, 2022 at 8:48 AM

History

• Effective: January 20, 2022
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-58-102 Report and notification of a dose to an embryo/fetus or a nursing child.

(A) A licensee shall report any dose to an embryo/fetus that is greater than fifty millisievert (five rem) dose equivalent that is a result of an administration of radioactive material or radiation from radioactive material to a pregnant individual unless the dose to the embryo/fetus was specifically approved, in advance, by the authorized user.

(B) A licensee shall report any dose to a nursing child that is a result of an administration of radioactive material to a breast-feeding individual that:

(1) Is greater than fifty millisievert (five rem) total effective dose equivalent; or

(2) Has resulted in unintended permanent functional damage to an organ or a physiological system of the child, as determined by a physician.

(C) The licensee shall notify by telephone the Ohio department of health, bureau of radiation protection no later than the next calendar day after discovery of a dose to the embryo/fetus or nursing child that requires a report in paragraph (A) or (B) in this rule.

(D) The licensee shall submit a written report to the appropriate address listed in rule 3701:1-40-04 of the Administrative Code within fifteen days after discovery of a dose to the embryo/fetus or nursing child that requires a report in paragraph (A) or (B) in this rule.

(1) The written report must include:

(a) The licensee's name;

(b) The name of the prescribing physician;

(c) A brief description of the event;

(d) Why the event occurred;

(e) The effect, if any, on the embryo/fetus or the nursing child;

(f) What actions, if any, have been taken or are planned to prevent recurrence; and

(g) Certification that the licensee notified the pregnant individual or mother (or the mother's or child's personal representative), and if not, why not.

(2) The report must not contain the individual's or child's name or any other information that could lead to identification of the individual or child.

(E) The licensee shall provide notification of the event to the referring physician and also notify the pregnant individual or mother, both hereafter referred to as the mother, no later than twenty-four hours after discovery of an event that would require reporting under paragraph (A) or (B) of this rule, unless the referring physician personally informs the licensee either that he or she will inform the mother or that, based on medical judgment, telling the mother would be harmful to the mother. The licensee is not required to notify the mother without first consulting with the referring physician. If the referring physician or mother cannot be reached within twenty-four hours, the licensee shall make the appropriate notifications as soon as possible thereafter. The licensee may not delay any appropriate medical care for the embryo/fetus or for the nursing child, including any necessary remedial care as a result of the event, because of any delay in notification. To meet the requirements of this paragraph, the notification may be made to the mother's or child's personal representative instead of the mother. If a verbal notification is made, the licensee shall inform the mother, or the mother's or child's personal representative, that a written description of the event can be obtained from the licensee upon request. The licensee shall provide such a written description if requested.

(F) A licensee shall:

(1) Annotate a copy of the report provided to the director with the:

(a) Name of the pregnant individual or the nursing child who is the subject of the event; and

(b) Identification number or if no other identification number is available, the social security number of the individual who is the subject of the event; and

(2) Provide a copy of the annotated report to the referring physician, if other than the licensee, no later than fifteen days after the discovery of the event.

Last updated January 9, 2026 at 8:03 AM

History

• Effective: May 15, 2023
• Promulgated Under: 119.03

Chapter 3701:1-66 Radiation Generating Equipment

Ohio Adm.Code 3701:1-66-01 Definitions.

(A) As used in this chapter:

(1) "Air kerma" means the sum of the initial kinetic energy of all charged ionizing particles liberated by uncharged ionizing radiation in a given mass of air. The unit for air kerma is joules per kilogram which is given the special name of gray (Gy). To determine air kerma in Gy from exposure in units of roentgens (R) multiply exposure by the conversion factor 0.00876 Gy/R.

(2) "Air kerma rate" or "(AKR)" means the air kerma per unit time.

(3) "Aluminum equivalent" means the thickness of type 1100 aluminum alloy affording the same attenuation, under specified conditions, as the material in question.

(4) "Automatic exposure control" or "(AEC)" means a device which automatically controls one or more technique factors in order to obtain a specific quantity of radiation at a preselected location.

(5) "Beam-limiting device" means a collimator which provides a means to restrict the dimensions of the x-ray field.

(6) "Bone densitometry equipment" means radiation-generating equipment used for the medical purpose of quantifying bone density and mineral content by x-ray measurements through the bone and adjacent tissues.

(7) "C-arm fluoroscope" means a fluoroscopic x-ray system in which the image receptor and the x-ray tube housing assembly are connected or coordinated to maintain a spatial relationship. Such a system allows a change in the direction of the beam axis with respect to the patient without moving the patient.

(8) "Calibration" means the determination of the response or reading of an instrument relative to a series of known radiation values over the range of the instrument, or the radiation output of a source of radiation relative to a standard.

(9) "Coefficient of variation" means the ratio of the standard deviation to the mean value of the observations.

(10) "Collimator" means a device or mechanism by which the x-ray beam is restricted in size.

(11) "Computed radiography" means a system that utilizes a photostimulable phosphor (PSP) plate for capturing radiographic images. The components of the system include, at a minimum, the PSP plate and a computed radiography reader which laser scans the exposed plate, collects the stimulated light and ultimately creates the digital image.

(12) "Computed tomography" or "(CT)" means an imaging procedure that uses multiple x-ray transmission measurements and computer programs to generate tomographic images.

(13) "Control panel" means that part of the radiation-generating equipment used for setting the technique factors.

(14) "CT conditions of operation" means all selectable parameters governing the operation of CT radiation-generating equipment including, but not limited to, nominal image thickness, filtration, milliampere (mA), kilovoltage peak (kVp), and scan time.

(15) "CT noise" means the per cent standard deviation of the fluctuations in CTN expressed as a percentage of the attenuation coefficient of water.

(16) "CT number" or "(CTN)" means the number used to represent the x-ray attenuation associated with each elemental area of the CT image.

(17) "Cumulative air kerma" means the total air kerma accrued from the beginning of an examination or procedure and includes all contributions from fluoroscopic and radiographic irradiation.

(18) "Dead-man switch" means a switch so constructed that a circuit closing contact can be maintained only by continuous pressure on the switch by the operator.

(19) "Dental equipment" means radiation-generating equipment used for dental radiography.

(20) "Digital radiography" or "(DR)" means a general radiography system that utilizes an imaging plate to capture and produce a digital image for immediate viewing without the use of a laser scanning cassette reader.

(21) "Direct scattered radiation" means scattered radiation which has been deviated once in direction only by materials irradiated by the useful beam.

(22) "Executive administration" means individuals employed in the hospital's administration and having the authority to expend capital funds, approve personnel actions, and implement changes to hospital policy and procedure.

(23) "Filter" means material placed in the useful beam to preferentially attenuate selected radiations.

(24) "Fluoroscopic irradiation time" means the cumulative duration of x-ray tube activation in any fluoroscopic mode of operation.

(25) Fluoroscopic equipment" means radiation-generating equipment used for real time imaging of internal structures for medical purposes.

(26) "Fluoroscopically-guided interventional (FGI) procedures" means an interventional diagnostic or therapeutic procedure performed via percutaneous or other access routes, usually with local anesthesia or intravenous sedation, which uses external ionizing radiation in the form of fluoroscopy to localize or characterize a lesion, diagnostic site, or treatment site, to monitor the procedure, and to control and document therapy. This statement is focused on the FGI subset of potentially high-dose procedures.

(27) "Fluoroscopy" means a technique for generating x-ray images and presenting them simultaneously and continuously as visible images.

(28) "Full time training in medical physics" means having been engaged in the practice of clinical medical physics for a minimum of eighteen hundred hours within twelve consecutive months, under the supervision of a board-certified medical physicist.

(29) "Full time work experience" means a minimum of eighteen hundred hours of work experience earned within twelve consecutive months.

(30) "General purpose radiographic equipment" means stationary, mobile, and portable radiation-generating equipment used for medical purpose, but does not include dental intraoral, panoral, mammography, bone densitometry, computed tomography, fluoroscopy or spot film imaging and equipment used in radiation therapy.

(31) "Half-value layer (HVL)" means the thickness of specified material which attenuates the beam of radiation to an extent such that the AKR is reduced by one-half of its original value.

(32) "Hand-held radiation-generating equipment" means x-ray equipment that is specifically designed to be held in the hand during operation.

(33) "Handle" means receive, possess, use, store, transfer, install, service, or dispose of radiation-generating equipment unless possession is solely for the purpose of transportation.

(34) "Hybrid imaging system" means a combination of systems that separately produce anatomic and functional images in very close temporal proximity without the need for patient repositioning and allow images to be co-registered and fused. These systems may be used for purposes including, but not limited to, attenuation correction, localization, registration, or fusion, but not used independently for diagnosis.

(35) "Image intensifier" means a device, installed in its housing, which instantaneously converts an x-ray pattern into a corresponding light image of higher intensity.

(36) "Image receptor" means any device that transforms incident x-ray photons into either a visible image or another form that can be made into a visible image by further transformation. In those cases, where means are provided to preselect a portion of the image receptor, the term "image receptor" means the preselected portion of the device.

(37) "Individual responsible for radiation protection (IRRP)" means an individual designated by the registrant who has the knowledge and responsibility for overall radiation safety and the quality assurance program at the facility, to include daily radiation safety operations and compliance with the rules.

(38) "Interventional procedure" means an invasive procedure that utilizes radiation-generating equipment for diagnostic or therapeutic purposes.

(39) "Kilovoltage peak (kVp)" means the maximum value of the electrical potential difference between the cathode and the anode of the x-ray tube during an exposure.

(40) "Last image hold" means an image obtained either by retaining one or more fluoroscopic images, which may be temporarily integrated, at the end of a fluoroscopic exposure or by initiating a separate and distinct radiographic exposure automatically and immediately in conjunction with termination of the fluoroscopic exposure.

(41) "Lateral fluoroscope" means the portion of a biplane system consisting of an x-ray tube housing assembly and an image receptor that are fixed in position to produce a horizontal x-ray beam.

(42) "Lead equivalent" means the thickness of lead affording the same attenuation, under specified conditions, as the material in question.

(43) "Leakage radiation" means all radiation coming from within the x-ray tube housing except the useful beam.

(44) "Licensed practitioner" means an individual licensed by the state of Ohio pursuant to:

(a) Chapter 4715. of the Revised Code to practice dentistry;

(b) Chapter 4731. of the Revised Code to practice medicine or surgery or osteopathic medicine or surgery;

(c) Chapter 4731. of the Revised Code to practice podiatry;

(d) Chapter 4741. of the Revised Code to practice veterinary medicine;

(e) Chapter 4734. of the Revised Code to practice chiropractic medicine; and

(f) Chapter 4723. of the Revised Code to practice as an advanced practice registered nurse within the scope of practice of his or her collaborating physician and in accordance with the standard care arrangement and under the appropriate level of supervision.

(g) Chapter 4730. of the Revised Code to practice as a physician assistant within the scope of practice of his or her supervising physician and in accordance with the utilization plan approved by the state medical board.

(45) "Light field" means that area of the intersection of the light beam from the beam-limiting device and one of the set of planes parallel to and including the plane of the image receptor, whose perimeter is the locus of points at which the illumination is one-fourth of the maximum in the intersection.

(46) "Medical event" means one or more of the following criteria have occurred to a human patient:

(a) Unintended skin dose to the same area in a single procedure greater than 2 sievert (200 rem);

(b) Unintended dose other than skin dose in a single procedure greater than:

(i) 0.5 sievert (50 rem) to any organ; or

(ii) 0.05 sievert (5 rem) effective dose equivalent;

(c) Wrong patient or wrong site for entire procedure when the resultant dose is:

(i) Greater than 0.5 sievert (50 rem) to any organ; or

(ii) Effective dose equivalent greater than or equal to 0.05 sievert (5 rem).

(47) "Medical, Medical use" or "Medical purpose" means using radiation-generating equipment to irradiate human beings or animals for dental, diagnostic, localization, or other healing arts purposes.

(48) "Milliampere (mA)" means the measurement of tube current which reflects the number of electrons flowing from the cathode to the anode of an x-ray tube during x-ray production.

(49) "Mobile radiation-generating equipment" means x-ray equipment permanently mounted on a base with wheels or castors for moving while completely assembled and is not used in a fixed location.

(50) "Patient" means an individual or animal subjected to radiation for the purposes of examination or therapy.

(51) "Portable radiation-generating equipment" means radiation-generating equipment designed to be hand-carried.

(52) "Primary protective barrier" means a barrier sufficient to attenuate the useful beam to the specified radiation level.

(53) "Protective apron" means an apron made of radiation-attenuating materials used to reduce radiation exposure.

(54) "Protective barrier" means a barrier of radiation-attenuating materials used to reduce radiation exposure.

(55) "Protective glove" means a glove made of radiation-attenuating materials used to reduce radiation exposure.

(56) "Radiation expert" means an individual who meets the qualifications of:

(a) Applicable paragraphs of rule 3701:1-66-03 of the Administrative Code;

(b) Paragraph (D) of rule 3701-83-45 of the Administrative Code, for any facility providing radiation therapy services;

(c) Paragraph (C)(3) of rule 3701-83-52 of the Administrative Code for CT equipment, or paragraph (F)(3) of rule 3701-83-52 of the Administrative Code for fluoroscopy, at any facility providing CT or fluoroscopy services; or

(d) 21 C.F.R. 900.12(a)(3) (as effective on the effective date of this rule) for any facility providing mammography services.

(57) "Radiation worker" means an individual engaged in activities registered by the department and controlled by the registrant.

(58) "Reference plane" means a plane which is displaced from and parallel to the computed tomographic plane.

(59) "Scan" means the complete process of collecting x-ray transmission data for the production of a tomogram. Data can be collected simultaneously during a single scan for the production of one or more tomograms.

(60) "Scan sequence" means a pre-selected set of two or more scans performed consecutively under pre-selected CT conditions of operation.

(61) "Scattered radiation" means radiation that, during passage through matter, has been deviated in direction.

(62) "Secondary protective barrier" means a barrier sufficient to attenuate stray ionizing radiation to a specified level.

(63) "Source" means the point of origin of the useful radiation beam.

(64) "Source-to-image receptor distance" or "(SID)" means the distance from the source to the center of the input surface of the image receptor.

(65) "Source-to-skin distance" or "(SSD)" means the distance between the source and the skin of the patient.

(66) "Spot film" means a radiograph which is made during a fluoroscopic examination to permanently record conditions which exist during the fluoroscopic procedure.

(67) "Stationary radiation-generating equipment" means equipment which is installed in a fixed location.

(68) "Stray radiation" means leakage radiation or scattered radiation.

(69) "Table increment" means the amount of relative displacement of the patient with respect to the CT x-ray system between successive scans measured along the direction of such displacement.

(70) "Technique factors" means any combination of the following which determines the exposure rate: kVp, mA, time, x-ray pulses, or the product of tube current and exposure time in mAs.

(71) "Tomogram" means the depiction of the radiation attenuation properties of a section through a body.

(72) "Tomographic plane" means that geometric plane which is identified as corresponding to the output tomogram.

(73) "Tube housing assembly" means the tube housing with tube installed. It includes high voltage or filament transformers and other appropriate elements when they are contained within the tube housing.

(74) "Unintended Dose" or "Unintended Skin Dose" means a patient radiation dose resulting from an error or equipment malfunction during a procedure.

(75) "Useful beam" means that part of the radiation which passes through the window, aperture, cone, or other collimating device of the source housing.

(76) "Veterinary radiation-generating equipment" means radiation-generating equipment used for veterinary radiography.

(77) "Visible area" means that portion of the input surface of the image receptor over which incident x-ray photons are producing a visible image.

(78) "X-ray field" means that area of the intersection of the useful beam and any one of the set of planes parallel to and including the plane of the image receptor, whose perimeter is the locus of points at which the air kerma rate is one-fourth of the maximum in the intersection.

(B) Terms appearing in this chapter, which are not defined in this rule, may be defined in rule 3701:1-38-01 of the Administrative Code.

Last updated February 17, 2026 at 7:59 AM

History

• Effective: February 16, 2026
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-66-03

(A) An individual may seek certification from the Ohio department of health as a radiation expert in one or more of the following categories of radiation-generating equipment:

(1) Therapeutic;

(2) Diagnostic other than mammography; or

(3) Mammography.

(B) An individual seeking certification or renewal of certification as a radiation expert will apply to the department on a form prescribed and provided by the director. The application will contain at least the following:

(1) Name and address of the applicant;

(2) Category or categories for which application is being made;

(3) A non-refundable check, electronic payment, or money order payable to "treasurer, state of Ohio" for the appropriate certification fee in the amount of one hundred dollars for each category specified in paragraph (A) of this rule;

(4) Evidence that the applicant has appropriate training and qualifications to perform oversight and maintenance of quality assurance programs obligated by division (A) of section 3748.13 of the Revised Code for the category for which the applicant is applying as set forth in paragraphs (C) to (E) of this rule; and

(5) As applicable, a certified copy of any felony conviction.

(6) Individuals that submit with their applications, proof that they are a service member or veteran, or the spouse or surviving spouse of a service member or veteran will receive priority expedited certification processing. Their applications will be reviewed within five business days of receipt and before all other applications for certification.

(a) The acceptable proof of service member/veteran status documents are:

(i) Department of defense identification card (active, retired, temporary disability retirement list (TDRL));

(ii) DD214 military discharge certificate indicating disposition of discharge;

(iii) Report of separation from the national archives national personnel records center in St. Louis, Missouri; or

(iv) Veterans identification card from the department of veterans affairs.

(b) All acceptable proof documents, except veterans identification card, will show the veteran status as honorable, general, general under honorable conditions, or discharged or released under conditions other than dishonorable.

(C) An applicant for radiation expert certification for the category of therapeutic radiation-generating equipment will have at least one of the following:

(1) Certification by the "American Board of Radiology" in one of the following:

(a) Therapeutic radiologic physics;

(b) Therapeutic medical physics;

(c) Radiologic physics; or

(2) Certification by the "American Board of Medical Physics in Radiation Oncology Physics"; or

(3) Certification by the "Canadian College of Physicists in Medicine in Radiation Oncology Physics"; or

(4) A master's or doctorate degree in physics, medical physics, other physical science, engineering, or applied mathematics from an accredited college or university; or equivalent international degree as evaluated and determined by an international credential evaluation service approved by the Ohio department of education or the United States department of education; and

(a) Have completed a clinical residency applicable to this category from an accredited program, or one year of full time training in medical physics and an additional year of full time work experience under the supervision of a board certified medical physicist who meets the qualifications of paragraph (C)(1), (C)(2) or (C)(3) of this rule at a medical institution. This training and work experience will be conducted in clinical radiation facilities that provide high-energy external beam radiation therapy with photons and electrons with energies greater than or equal to one MV or one MeV;

(b) The individual will have performed the applicable tasks listed in rules 3701:1-67-08 and 3701:1-67-09 of the Administrative Code under the supervision of a qualified medical physicist during the year of work experience; and

(c) Obtain certification pursuant to paragraph (C)(1), (C)(2), or (C)(3) of this rule within six years of qualifying as an Ohio therapeutic radiation expert under paragraphs (C)(4), (C)(4)(a) and (C)(4)(b) of this rule.

(D) An applicant for radiation expert certification for the category of diagnostic radiation-generating equipment will have at least one of the following:

(1) Certification by the "American Board of Radiology" in radiologic physics, diagnostic radiologic physics or diagnostic medical physics;

(2) Certification by the "American Board of Medical Physics" in medical physics with a specialty in diagnostic imaging physics;

(3) A master's or doctorate degree in physics, biophysics, medical physics, radiological physics or health physics, engineering, or applied mathematics with a minor in physics from an accredited college or university; or equivalent international degree as evaluated and determined by an international credential evaluation service approved by the Ohio department of education or the United States department of education; and completed a clinical residency applicable to this category from an accredited program, or completed one year of full time training in medical physics and an additional year of full time work experience under the direct supervision of a certified individual as provided in paragraph (D)(1) or (D)(2) of this rule or a radiation expert certified in diagnostic radiation-generating equipment in developing and performing oversight of quality assurance for diagnostic radiation-generating equipment.

(E) An applicant for radiation expert certification for the category of mammography radiation-generating equipment will have at least one of the following:

(1) Certification by the "American Board of Radiology" in radiologic physics, diagnostic radiologic physics or diagnostic medical physics;

(2) Certification by the "American Board of Medical Physics" with a specialty in diagnostic imaging physics;

(3) A master's degree or higher in a physical science from an accredited college or university; or equivalent international degree as evaluated and determined by an international credential evaluation service approved by the Ohio department of education or the United States department of education; and at least the following:

(a) Twenty semester hours or thirty quarter hours of graduate or undergraduate level physics;

(b) Twenty contact hours of documented specialized training in conducting surveys of mammography facilities; and

(c) Have the experience of conducting surveys of at least ten mammography x-ray units under the direct supervision of a certified individual as provided in paragraph (E)(1) or (E)(2) of this rule or a radiation expert certified in mammography.

(F) The department may return an incomplete application for certification or certification renewal. The applicant will respond to the director's request for additional information within twenty days of receiving the request.

(G) A certificate issued under this rule will expire two years after the date of its issuance and may be renewed in accordance with the standard renewal procedures established in Chapter 4745. of the Revised Code. On or before thirty days prior to the expiration of a certificate, the department will mail or email a notice and application for renewal to the certificate holder. The certificate holder will complete the application and return it to the treasurer of state with the certification renewal fee in the form of a check, electronic payment, or money order payable to "treasurer, state of Ohio," in the amount of one hundred dollars for each category specified in paragraph (A) of this rule.

(H) Within sixty days of receiving a complete application for certification or certification renewal, the director will, pursuant to Chapter 119. of the Revised Code, either issue a certification or certification renewal or, deny the application, or the director may at any time suspend or revoke a certification if the applicant or certificate holder:

(1) Does not meet the applicable obligations specified in this rule for attaining and maintaining certification as a radiation expert;

(2) Previously had a radiation expert certificate revoked or currently has a certificate suspended pursuant to this paragraph;

(3) Has provided services for a category of radiation-generating equipment that is not identified on his or her radiation expert certificate;

(4) Misrepresents the types of quality assurance programs for which he or she is certified to provide services or otherwise has provided services for which he or she was not certified to provide;

(5) Misrepresents information on the application or has misrepresented an audit report filed with the director pursuant to rule 3701:1-66-04 of the Administrative Code;

(6) Has submitted an audit report to the director that the radiation expert did not personally perform or supervise the individual assisting in the performance of quality assurance tests;

(7) Does not respond to the request for additional information within twenty days of receiving the request as provided in paragraph (F) of this rule;

(8) Does not comply with paragraphs (C) to (E) of this rule, as applicable, in which case the director will deny the application only for that certification for the affected category of radiation-generating equipment;

(9) Fails to pay any fee assessed in accordance with this rule;

(10) Fails to comply with Chapter 3748. of the Revised Code or the rules adopted thereunder; or

(11) Has any felony conviction that indicates that the individual may pose a risk to public health and safety.

(I) An individual certified as a radiation expert will immediately notify the director in writing of the following:

(1) If the radiation expert is no longer practicing as a CRE;

(2) A change in the name, address, or phone number of the radiation expert;

(3) A change to the listing of hospitals in which the radiation expert is designated as CRE; and

(4) Any other change that would render an application or certificate no longer accurate.

(J) The individual certified as a radiation expert will provide the director upon request with any other information regarding the obligations set forth in this rule.

(K) Each certified radiation expert will obtain continuing education for each certification period in accordance with the following:

(1) Certified radiation experts having certification in one category specified in paragraph (A) of this rule will obtain fifteen hours of continuing education pertaining to the category of certification;

(2) Certified radiation experts having certification in two categories specified in paragraph (A) of this rule will obtain twenty hours of continuing education pertaining to one or both categories of certification; and

(3) Certified radiation experts having certification in three categories specified in paragraph (A) of this rule will obtain twenty-five hours of continuing education pertaining to one or more categories of certification.

(4) Individuals in active military service during the certification renewal period may have the continuing education period extended in accordance with section 5903.12 of the Revised Code.

(L) Continuing education programs are subject to approval by the director.

(M) A certified radiation expert who provides instruction in a continuing education program related to radiation safety is eligible to claim up to five hours of instruction time as continuing education for his or her certification period.

(N) In accordance with section 3748.12 of the Revised Code, a certification renewal fee that remains unpaid on the ninety-first day after the original invoice date will be assessed an additional amount equal to ten per cent of the original fee.

(O) Application for the same certification category may be denied after the expiration date of the previous certification for individuals who do not renew their certification according to this rule, and who do not provide written notification that they no longer need or want certification in that category.

(P) If an individual allows his or her certification to expire and the individual applies for the same certification within one year following the expiration of that certification, the individual will submit evidence of completing the continuing education obligations provided in this rule.

Last updated December 13, 2024 at 7:31 AM

History

• Effective: December 13, 2024
• Promulgated Under: 119.03

Ohio Adm.Code 3701-83-45

(A) Each freestanding radiation therapy center shall have an administrator.

(B) Each freestanding radiation therapy center shall have a medical director who is a radiation oncologist, nuclear medicine physician, radiologist, or other authorized user, as defined in paragraph (I), (J), or (K) of rule 3701-83-43 of the Administrative Code or rule 3701:1-58-40, 3701:1-58-51 or 3701:1-58-54 of the Administrative Code. The medical director shall:

(1) Approve specific duties that may be performed by each member of the physics staff as specified by the medical physicist under paragraph (E) of this rule; and

(2) Ensure appropriate coverage of the radiation therapy center by radiation oncologists or other authorized users and staff.

(C) The medical director, radiation oncologists, radiologists, nuclear medicine physicians, and authorized users shall be qualified by training, experience, and certification to perform the scope of radiation therapy services provided by the facility. A radiation oncologist, nuclear medicine physician, radiologist, or other authorized user shall be available for direct care and quality review on a daily basis. If the radiation oncologist, nuclear medicine physician, radiologist, or other authorized user is not on-site, the radiation oncologist, nuclear medicine physician, radiologist, or other authorized user shall be accessible by phone, beeper, or other designated mechanism.

(D) Each freestanding radiation therapy center shall have a medical physicist or teletherapy physicist:

(1) For radioactive materials, meets the requirements of rules 3701:1-58-19 and 3701:1-58-21 of the Administrative Code; and

(2) For radiation therapy equipment, meets the requirements of paragraph (C)(1), (C)(2), (C)(3), or (C)(4) of rule 3701:1-66-03 of the Administrative Code; or who is certified by the Ohio department of health as a certified radiation expert in accordance with paragraph (C) of rule 3701:1-66-03 of the Administrative Code.

(E) The medical physicist or teletherapy physicist shall be available for consultation with the radiation oncologist, nuclear medicine physician, radiologist, or other authorized user to provide advice or direction to staff when patient treatments are being planned or patients are being treated. Radiation therapy centers shall have regular on-site physics support during hours of clinical activity. The on-site support shall, at a minimum, be provided on a weekly basis. When a medical physicist or teletherapy physicist is not available on-site, other physics duties shall be established and documented in writing by the medical physicist or teletherapy physicist. The medical physicist shall specify the specific physics duties to be performed by each member of the physics staff in accordance with their qualification and competence.

(F) Each freestanding radiation therapy center shall have available a sufficient number of qualified staff for the radiation therapy services provided including individuals licensed as radiation therapy technologists or nuclear medicine technologists under Chapter 4773. of the Revised Code, who are able to supervise and conduct the radiation therapy services as appropriate for the services being offered. The nuclear medicine physician, radiologist, radiation oncologist, or other authorized user and support staff shall be available on a twenty-four hour basis to initiate urgent treatment within a medically appropriate response time.

(G) Each freestanding radiation therapy center shall establish personnel files for all individuals who provide radiation therapy services and shall:

(1) Maintain files for each individual which specify the types of procedures or services the individual is permitted to perform; and

(2) Update all files at least every twelve months.

Last updated July 15, 2022 at 9:49 AM

History

• Effective: July 15, 2022
• Promulgated Under: 119.03

Ohio Adm.Code 3701-83-52

(A) Each freestanding or mobile diagnostic imaging center shall have a radiologist, nuclear medicine physician, authorized user, physician acting within their scope of practice, or chiropractic radiologist, as appropriate to the diagnostic imaging services being offered, that has overall responsibility for the diagnostic imaging services being provided by the freestanding or mobile diagnostic imaging center.

(B) Each freestanding or mobile diagnostic imaging center shall have;

(1) A physician on site when anesthesia, other than local anesthesia, is being administered; and

(2) One of the following on site when local anesthesia or diagnostic imaging contrast are being administered:

(a) A physician;

(b) A certified nurse practitioner;

(c) A certified nurse-midwife;

(d) A certified nurse specialist; or

(e) A physician assistant.

(3) If the administration of local anesthesia or diagnostic imaging contrast agents are being supervised by a certified nurse practitioner, clinical nurse specialist, certified nurse-midwife, or physician assistant, the approval for the supervision of the administration of the local anesthesia or diagnostic imaging contrast shall be documented in the standard care arrangement or supervision agreement.

(C) CT freestanding and mobile diagnostic imaging centers shall have available sufficient and qualified personnel as appropriate for the services being offered as follows:

(1) CT services shall be provided only upon the written order of a physician, chiropractor, dentist or podiatrist;

(2) CT image interpretation shall be conducted by:

(a) A radiologist; or

(b) A physician or chiropractic radiologist acting within their scope of practice who does not meet the requirements of paragraph (N) of rule 3701-83-51 of the Administrative Code who has at least two years cross-sectional imaging and interpretation experience;

(3) A medical physicist who meets the requirements of paragraph (D)(1), (D)(2), or (D)(3) of rule 3701:1-66-03 of the Administrative Code, or who is certified by the Ohio department of health as a certified radiation expert in accordance with rule 3701:1-66-03 of the Administrative Code; and

(4) An individual licensed as a radiographer under Chapter 4773. of the Revised Code.

(D) MRI freestanding and mobile diagnostic imaging centers shall have available sufficient and qualified personnel as appropriate for the services being offered as follows:

(1) MRI services shall be provided only upon the written order of a physician, chiropractor, dentist or podiatrist;

(2) MRI image interpretation shall be conducted by:

(a) A radiologist; or

(b) A physician or chiropractic radiologist acting within their scope of practice who does not meet the requirements of paragraph (S) of rule 3701-83-51 of the Administrative Code who has at least six months experience or training in cross-sectional body imaging and image evaluation and interpretation.

(3) A service engineer, or medical physicist certified by:

(a) The American board of radiology in diagnostic medical or diagnostic radiologic physics; or

(b) The American board of medical physics in diagnostic medical physics or MRI physics; or

(c) The Canadian college of physicists in medicine in MRI physics.

(4) A technologist for preparing and positioning the patient and for obtaining the MRI data in a manner suitable for interpretation. As used in this paragraph, "technologist" means an individual:

(a) Registered with the American registry of radiologic technologists in the categories of "radiography," "nuclear medicine technology," "radiation therapy technology" or "magnetic resonance imaging;"

(b) Certified by the American registry of magnetic resonance imaging technologists; or

(c) Registered as a nuclear medicine technologist with the nuclear medicine technology certification board.

(E) PET and nuclear medicine freestanding and mobile diagnostic imaging centers shall have available sufficient and qualified personnel as appropriate for the services being offered as follows:

(1) PET and nuclear medicine services shall be provided only upon the written order of an authorized user pursuant to rule 3701:1-58 of the Administrative Code;

(2) PET and nuclear medicine image interpretation shall be conducted by one of the following:

(a) A nuclear medicine physician;

(b) A radiologist;

(c) A physician acting within their scope of practice who meets the requirements of rule 3701:1-58-36 of the Administrative Code;

(d) A physician acting within their scope of practice who does not meet the requirements of paragraph (R) or (S) of rule 3701-83-51 of the Administrative Code that is supervised by a physician who is qualified pursuant to paragraph (E)(2)(a), (E)(2)(b), or (E)(2)(c) of this rule while the physician is completing a training program that will result in certification as a physician listed in paragraph (E)(2)(a), (E)(2)(b), or (E)(2)(c) of this rule.

(3) An individual licensed as a nuclear medicine technologist under Chapter 4773. of the Revised Code; and

(4) A radiation safety officer who meets the requirements of rule 3701:1-58-18 of the Administrative Code and is listed on the Ohio radioactive materials license.

(F) Fluoroscopy freestanding and mobile diagnostic imaging centers shall have available sufficient and qualified personnel as appropriate for the services being offered as follows:

(1) Fluoroscopy services shall only be provided upon the written order of a physician, dentist, or chiropractor;

(2) Fluoroscopy image interpretation shall be conducted by one of the following:

(a) A radiologist;

(b) A physician or chiropractic radiologist acting within their scope of practice who does not meet the requirements of paragraph (S) of rule 3701-83-51 of the Administrative Code who has at least six months experience or training in the performance and interpretation of fluoroscopy;

(3) A medical physicist who meets the requirements of paragraph (D)(1), (D)(2), or (D)(3) of rule 3701:1-66-03 of the Administrative Code, or who is certified by the Ohio department of health as a certified radiation expert in accordance with rule 3701:1-66-03 of the Administrative Code; and

(4) An individual licensed as a radiographer under Chapter 4773. of the Revised Code.

(G) Each freestanding or mobile diagnostic imaging center shall establish personnel files for all individuals who provide diagnostic imaging services and shall:

(1) Maintain files for each individual which specify the types of procedures the individual is permitted to perform; and

(2) Update all files at least every twelve months.

(H) For CT and fluoroscopy services, the medical physicist shall be available for consultation with the radiologist or authorized user responsible for diagnostic imaging services to provide advice and direction. The freestanding or mobile diagnostic imaging center shall document the availability of the medical physicist in a written record that also includes:

(1) Documentation that the medical physicist performed an annual on-site survey of the imaging equipment in accordance with the manufacturer's specifications to evaluate compliance with:

(a) Applicable rules adopted pursuant to Chapter 3748. of the Revised Code;

(b) The equipment management program required by rule 3701-83-53 of the Administrative Code; and

(c) The quality assessment and improvement program required by rules 3701-83-12 and 3701-83-55 of the Administrative Code.

(2) The medical physicist's written procedures to specify the physics duties to be performed by each member of the physics staff in accordance with their qualifications and competence, and with the approval of the radiologist or authorized user responsible for diagnostic imaging services, as applicable to the services provided.

(I) For MRI services, the service engineer or the medical physicist shall be available for consultation with the physcian or radiologist. The availability of the service engineer or the medical physicist shall be documented in a written record that also includes:

(1) The service engineer's or medical physicist's annual on-site survey to evaluate the equipment management program, as required by rule 3701-83-53 of the Administrative Code; and

(2) The service engineer's or medical physicist's written procedures to specify the service and preventive maintenance duties to be performed by each member of the staff in accordance with their qualifications and competence that are approved by the individual specified in paragraph (A) of this rule.

(J) For PET and nuclear medicine services, radiation safety officer qualified under the requirements of paragraph (E)(4) of this rule shall implement and conduct the activities specified in rules 3701:1-58-38, 3701:1:58-40, 3701:1-58-50 and 3701:1-58-58 of the Administrative Code.

Last updated July 15, 2022 at 9:51 AM

History

• Effective: July 15, 2022
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-38-01

(A) As used in this chapter and all other rules promulgated pursuant to Chapter 3748. of the Revised Code:

(1) "A₁" means the maximum activity of special form radioactive material permitted in a type A package. These values are listed in rule 3701:1-50-25 of the Administrative Code, or may be derived in accordance with the procedure prescribed in rule 3701:1-50-25 of the Administrative Code.

(2) "A₂" means the maximum activity of radioactive material, other than special form, low specific activity and surface contaminated object material, permitted in a type A package. These values are listed in rule 3701:1-50-25 of the Administrative Code, or may be derived in accordance with the procedure prescribed in rule 3701:1-50-25 of the Administrative Code.

(3) "Absorbed dose" means the energy imparted by ionizing radiation per unit mass of irradiated material. The units of absorbed dose are the gray, or Gy, and the rad.

(4) "Accelerator or charged particle accelerator" means any of a class of radiation generating equipment designed to electronically accelerate atomic or sub-atomic particles for subsequent bombardment of targets.

(5) "Accelerator-produced radioactive material" means any material made radioactive by a particle accelerator.

(6) "Activity" means the rate of disintegration or transformation or decay of radioactive material. The units of activity are the becquerel, or Bq, and the curie, or Ci.

(7) "Address of use" means the building or buildings that are identified on the license or registration and where the source of radiation may be received, used, prepared, or stored, except for temporary job sites.

(8) "Administrative controls" means mechanisms used to protect health and minimize damage to life and property through the use of written policies, procedures, instructions, training, observation of work practices, and related compliance audits.

(9) "Administrative monetary penalty" means a monetary penalty assessed by the director under section 3748.05 of the Revised Code and in compliance with rules adopted thereunder, to emphasize the need for lasting remedial action and to deter future violations.

(10) "Adult" means an individual eighteen or more years of age.

(11) "Agreement state" means any state with which the United States nuclear regulatory commission or the atomic energy commission has entered into an effective agreement under subsection 274B of the Atomic Energy Act of 1954, 68 Stat. 919, 42 U.S.C. 2021, as amended (1978). Non-agreement state means any other state.

(12) "Airborne radioactive material" means radioactive material dispersed in the air in the form of dusts, fumes, particulates, mists, vapors, or gases.

(13) "Airborne radioactivity area" means a room, enclosure, or area in which airborne radioactive materials, composed wholly or partly of licensed material, exist in concentrations:

(a) In excess of the derived air concentrations (DACs) specified in appendix C to rule 3701:1-38-12 of the Administrative Code, or

(b) To such a degree that an individual present in the area without respiratory protective equipment could exceed, during the hours an individual is present in a week, an intake of 0.6 per cent of the annual limit on intake or twelve DAC-hours.

(14) "Air-purifying respirator" means a respirator with an air-purifying filter, cartridge, or canister that removes specific air contaminants by passing ambient air through the air-purifying element.

(15) "ALARA" or "as low as is reasonably achievable" means every reasonable effort to maintain exposures to radiation as far below the dose limits as is practical consistent with the purpose for which the licensed or registered activity is undertaken, taking into account the state of technology, the economics of improvements in relation to benefits to the public health and safety, and other societal and socioeconomic considerations, and in relation to utilization of nuclear energy and licensed materials and registered activities in the public interest.

(16) "Alert" means events may occur, are in progress, or have occurred that could lead to a release of radioactive material but that the release is not expected to require a response by off-site response organizations to protect persons off-site.

(17) "Annual limit on intake" or "ALI" means the derived limit for the amount of radioactive material taken into the body of an adult worker by inhalation or ingestion in a year. ALI is the smaller value of intake of a given radionuclide in a year by the reference man that would result in a committed effective dose equivalent of 0.05 sievert (five rem) or a committed dose equivalent of 0.5 sievert (fifty rem) to any individual organ or tissue. ALI values for intake by ingestion and by inhalation of selected radionuclides are given in appendix C to rule 3701:1-38-12 of the Administrative Code.

(18) "Annually" means either

(a) At intervals not to exceed one year; or

(b) Once per year, at about the same time each year, plus or minus one month.

(19) "Area of use" means a portion of an address of use that has been set aside for the purpose of receiving, preparing, using, or storing sources of radiation.

(20) "Assigned protection factor" or "APF" means the expected workplace level of respiratory protection that would be provided by a properly functioning respirator or a class of respirators to properly fitted and trained users. Operationally, the inhaled concentration can be estimated by dividing the ambient airborne concentration by the APF.

(21) "Atmosphere-supplying respirator" means a respirator that supplies the respirator user with breathing air from a source independent of the ambient atmosphere, and includes supplied air respirators, or SARs, and self-contained breathing apparatus, or SCBA, units.

(22) "Atomic energy commission" or "AEC" means the federal agency created by the Atomic Energy Act of 1954, 68 Stat. 919, 42 U.S.C. 2011, as amended (1964), and was the predecessor agency to the current United States nuclear regulatory commission.

(23) "Background radiation" means radiation from cosmic sources; naturally occurring radioactive materials, including radon, except as a decay product of source or special nuclear material, and global fallout as it exists in the environment from the testing of nuclear explosive devices or from past nuclear accidents such as Chernobyl that contribute to background radiation and are not under the control of the licensee. "Background radiation" does not include radiation from radioactive materials regulated by the department.

(24) "Becquerel" or "Bq" means the SI unit of activity. One becquerel is equal to one disintegration per second.

(25) "Bioassay" or "radiobioassay" means the determination of kinds, quantities or concentrations, and, in some cases, the locations of radioactive material in the human body, whether by direct measurement, in vivo counting, or by analysis and evaluation of materials excreted or removed from the human body.

(26) "Byproduct material" means

(a) Any radioactive material, except special nuclear material, yielded in or made radioactive by exposure to the radiation incident to the process of producing or utilizing special nuclear materials; or

(b) The tailings or wastes produced by the extraction or concentration of uranium or thorium from any ore processed primarily for its source material content, including discrete surface wastes resulting from solution extraction processes. Underground ore bodies depleted by such solution extraction do not constitute byproduct material within the definition.

(27) "Chelating agent" means a chemical compound or mixture that enhances the removal of radioactive material from the body, water or similar applications. Typical chelating agents include amine polycarboxylic acids such as EDTA or DTPA; hydroxy-carboxylic acids; and polycarboxylic acids such as citric acid, carbolic acid, and gluconic acid.

(28) "Chiropractor" means an individual licensed by the state of Ohio to practice chiropractic medicine pursuant to Chapter 4734. of the Revised Code.

(29) "Class" or "lung class" or "inhalation class" means a classification scheme for inhaled material according to its rate of clearance from the pulmonary region of the lung. Materials are classified as D, W, or Y, which applies to a range of clearance half-times: for class D, days, of less than ten days, for class W, weeks, from ten to one hundred days, and for class Y, years, of greater than one hundred days.

(30) "Collective dose" means the sum of the individual doses received in a given period of time by a specified population from exposure to a specified source of radiation.

(31) "Commencement of construction" means taking any action defined as "construction" or any other activity at the site of a facility subject to the rules promulgated pursuant to Chapter 3748. of the Revised Code that has a reasonable nexus to radiological health and safety.

(32) "Committed dose equivalent" or "H_T,50" means the dose equivalent to organs or tissues of reference, T, that will be received from an intake of radioactive material by an individual during the fifty year period following the intake.

(33) "Committed effective dose equivalent" or "H_E,50" means the sum of the products of the weighting factors applicable to each of the body organs or tissues, W_T, that are irradiated and the committed dose equivalent to each of these organs or tissues (H_{E, 50} = W_TH_T,50).

(34) "Consortium" means an association of medical use licensees and a PET radionuclide production facility in the same geographical area that jointly own or share in the operation and maintenance cost of the PET radionuclide production facility that produces PET radionuclides for use in producing radioactive drugs within the consortium for noncommercial distributions among its associated members for medical use. The PET radionuclide production facility within the consortium must be located at an educational institution or a medical facility.

(35) "Constraint" or "dose constraint" means a value above which specified licensee actions are required.

(36) "Construction" means the installation of foundations, or in-place assembly, erection, fabrication, or testing for any structure, system, or component of a facility or activity subject to the rules promulgated pursuant to Chapter 3748. of the Revised Code that are related to radiological safety or security. The term "construction" does not include:

(a) Changes for temporary use of the land for public recreational purposes;

(b) Site exploration, including necessary borings to determine foundation conditions or other preconstruction monitoring to establish background information related to the suitability of the site, the environmental impacts of construction or operation, or the protection of environmental values;

(c) Preparation of the site for construction of the facility, including clearing of the site, grading, installation of drainage, erosion and other environmental mitigation measures, and construction of temporary roads and borrow areas;

(d) Erection of fences and other access control measures that are not related to the safe use of, or security of, radiological materials subject to the rules promulgated pursuant to Chapter 3748. of the Revised Code;

(e) Excavation;

(f) Erection of support buildings (e.g. construction equipment storage sheds, warehouse and shop facilities, utilities, concrete mixing plants, docking and unloading facilities, and office buildings) for use in connection with the construction of the facility;

(g) Building of service facilities (e.g. paved roads, parking lots, railroad spurs, exterior utility and lighting systems, potable water systems, sanitary sewerage treatment facilities, and transmission lines);

(h) Procurement or fabrication of components or portions of the proposed facility occurring at other than the final, in-place location at the facility; or

(i) Taking any other action that has no reasonable nexus to radiological health and safety.

(37) "Controlled area" means an area, outside of a restricted area but inside the site boundary, access to which can be limited by the licensee or registrant for any reason.

(38) "Critical group" means the group of individuals reasonably expected to receive the greatest exposure to residual radioactivity for any applicable set of circumstances.

(39) "Curie" or "Ci" means a unit of activity. One curie equals 3.7 x 10¹⁰ disintegrations per second equals 3.7 x 10¹⁰ becquerels equals 2.22 x 10¹² disintegrations per minute.

(40) "Cyclotron" means a particle accelerator in which the charged particles travel in an outward spiral or circular path. A cyclotron accelerates charged particles at energies usually in excess of ten megaelectron volts and is commonly used for production of short half-life radionuclides for medical use.

(41) "Declared pregnant woman" means a woman who has voluntarily informed the licensee or registrant, in writing, of her pregnancy and the estimated date of conception. The declaration remains in effect until the declared pregnant woman withdraws the declaration in writing or is no longer pregnant.

(42) "Decommission" means to safely remove any licensed operation from service and reduce residual radioactivity to a level that permits release of the licensee's property for unrestricted use and termination of the license.

(43) "Dedicated check source" means a radioactive source that is used to assure the consistent performance of a radiation detection or measurement device over several months or years.

(44) "Deep dose equivalent" or "H_d" applies to external whole body exposure, and means the dose equivalent at a tissue depth of one centimeter, one thousand milligram per square centimeter.

(45) "Demand respirator" means an atmosphere-supplying respirator that admits breathing air to the facepiece only when a negative pressure is created inside the facepiece by inhalation.

(46) "Dentist" means an individual licensed by the state of Ohio to practice dentistry under Chapter 4715. of the Revised Code.

(47) "Department" means the Ohio department of health.

(48) "Depleted uranium" means uranium containing less uranium-235 than the naturally occurring distribution of uranium isotopes.

(49) "Derived air concentration" or "DAC" means the concentration of a given radionuclide in air which, if breathed by the reference man for a working year of two thousand hours under conditions of light work, results in an intake of one ALI. The condition of light work is inhaling 1.2 cubic meters of air per hour for two thousand hours in a year. DAC values are given in appendix C to rule 3701:1-38-12 of the Administrative Code.

(50) "Derived air concentration-hour or DAC-hour" means the product of the concentration of radioactive material in air, which is expressed as a fraction or multiple of the derived air concentration for each radionuclide, and the time of exposure to that radionuclide, in hours. A licensee or registrant may take two thousand DAC-hours to represent one ALI, equivalent to a committed effective dose equivalent of 0.05 Sv (five rem).

(51) "Direct reading dosimeter" means a device that measures radiation dose that does not require another device to read the measured radiation dose. Examples of direct reading dosimeters include pocket dosimeters and electronic dosimeters.

(52) "Director" means the director of health or a designee or authorized representative of the director.

(53) "Discipline" means a branch of knowledge or of teaching.

(54) "Discrete source" means a radionuclide that has been processed so that its concentration within a material has been purposely increased for use for commercial, medical, or research activities.

(55) "Disposable respirator" means a respirator for which maintenance is not intended and that is designed to be discarded after excessive breathing resistance, sorbent exhaustion, physical damage, or end-of service-life renders it unsuitable for use. Examples of this type of respirator are a disposable half-mask respirator or a disposable escape-only self-contained breathing apparatus.

(56) "Dose" or "radiation dose" is a generic term that means absorbed dose, dose equivalent, effective dose equivalent, committed effective dose equivalent, or total effective dose equivalent as defined in other paragraphs of this rule.

(57) "Dose equivalent" or "H_T" means the product of the absorbed dose in tissue, quality factor, and all other necessary modifying factors at the location of interest. The units of dose equivalent are the sievert and rem.

(58) "Dose limits" or "limits" means the permissible upper bounds of radiation doses established in accordance with these regulations but excludes background radiation and medical exposure.

(59) "Dosimetry processor" means a person that processes and evaluates individual monitoring devices in order to determine the radiation dose delivered to the monitoring devices.

(60) "Effective dose equivalent" or "H_E" means the sum of the products of the dose equivalent to each organ or tissue, H_T, and the weighting factor, W_T, applicable to each of the body organs or tissues that are irradiated: (H_E = ∑W_TH_T).

(61) "Embryo" or "fetus" means the developing human organism from conception until time of birth.

(62) "Engineering controls" means mechanisms used to protect health and minimize damage to life and property through engineering specifications, design, and construction of the product or facility including all of the security and safety features. This includes, but is not limited to, auxiliary security and safety features such as additional external shielding, barriers, and operational interlocks with associated processes.

(63) "Entrance" or "access point" means any opening through which an individual or extremity of an individual could gain access to radiation areas or to licensed radioactive materials or registered radiation generating equipment. This includes entry or exit portals of sufficient size to permit human entry, irrespective of their intended use.

(64) "Explosive material" means any chemical compound, mixture or device which produces a substantial instantaneous release of gas and heat spontaneously or by contact with sparks or flame.

(65) "Exposure" means being exposed to sources of ionizing radiation.

(66) "External dose" means that portion of the dose equivalent received from radiation sources outside the body.

(67) "Extremity" means hand, elbow, arm below the elbow, foot, knee, or leg below the knee.

(68) "Eye dose equivalent" means the same as lens dose equivalent.

(69) "Facility" means all buildings, equipment, structures and other stationary items that, in addition to the meaning defined in division (H) of section 3748.01 of the Revised Code, are:

(a) Located on a single site or on contiguous or adjacent sites and are operated by the same person and have common corporate or business interests; or

(b) Portions of a building or structure which are operated by the same person and have common corporate or business interests.

(70) "Filtering facepiece" or "dust mask" means a negative pressure particulate respirator with a filter as an integral part of the facepiece or with the entire facepiece composed of the filtering medium, not equipped with elastomeric sealing surfaces and adjustable straps.

(71) "Fissile material" means the radionuclides uranium-233, uranium-235, plutonium-239, and plutonium-241, or any combination of these radionuclides. Fissile material means the fissile nuclides themselves, not material containing fissile nuclides. Unirradiated natural uranium and depleted uranium and natural uranium or depleted uranium that has been irradiated in thermal reactors only, are not included in this definition. Certain exclusions from fissile material controls are provided in rule 3701:1-50-13 of the Administrative Code.

(72) "Fit factor" means quantitative estimate of the fit of a particular respirator to a specific individual, and typically estimates the ratio of the concentration of a substance in ambient air to its concentration inside the respirator when worn.

(73) "Fit test" means the use of a protocol to qualitatively or quantitatively evaluate the fit of a respirator on an individual.

(74) "Generally applicable environmental radiation standards" means standards issued by the United States environmental protection agency under the authority of the Atomic Energy Act of 1954, 68 Stat. 919, 42 U.S.C. 2011, as amended (2005), that impose limits on radiation exposures or levels, or concentrations or quantities of radioactive material, in the general environment outside the boundaries of locations under the control of persons possessing or using radioactive material.

(75) "Gray" or "Gy" means the SI unit of absorbed dose. One gray is equal to an absorbed dose of one joule per kilogram (one hundred rads).

(76) "Handle" means receive, possess, use, store, transfer, install, service, or dispose of sources of radiation unless possession is solely for the purpose of transportation.

(77) "Handler" means a facility that handles sources of radiation unless possession is solely for the purpose of transportation.

(78) "Hazardous waste" means those wastes designated as hazardous by rule 3745-51-03 of the Administrative Code.

(79) "Helmet" means a rigid respiratory inlet covering that also provides head protection against impact and penetration.

(80) "High radiation area" means an area, accessible to individuals, in which radiation levels from radiation sources external to the body could result in an individual receiving a dose equivalent in excess of one millisievert (0.1 rem) in one hour at thirty centimeters from the radiation source or thirty centimeters from any surface that the radiation penetrates.

(81) "Hood" means a respiratory inlet covering that completely covers the head and neck and may also cover portions of the shoulders and torso.

(82) "Individual" means any human being.

(83) "Individual monitoring" means

(a) The assessment of dose equivalent by the use of devices designed to be worn by an individual;

(b) The assessment of committed effective dose equivalent by bioassay or by determination of the time-weighted air concentrations to which an individual has been exposed, i.e. DAC-hours; or

(c) The assessment of dose equivalent by the use of survey data.

(84) "Individual monitoring devices" means devices designed to be worn by a single individual for the assessment of dose equivalent such as film badges; thermoluminescent dosimeters; optically stimulated luminescent dosimeters; pocket ionization chambers; and personal air sampling devices.

(85) "Industrial radiography" means the examination of the structure of materials by nondestructive methods, utilizing sealed sources of radioactive material or radiation-generating equipment.

(86) "Internal dose" means that portion of the dose equivalent received from radioactive material taken into the body.

(87) "Irradiator" means a facility that uses radioactive sealed sources for the irradiation of objects or materials and in which radiation dose rates exceeding five grays (five hundred rads) per hour exist at one meter from the sealed radioactive source in air or water, as applicable for the irradiator type, but does not include irradiators in which both the sealed source and the area subject to irradiation are contained within a device and are not accessible to personnel.

(88) "Lens dose equivalent" or "eye dose equivalent" means the external exposure of the lens of the eye and is taken as the dose equivalent at a tissue depth of 0.3 centimeters; i.e. three hundred milligrams per square centimeter.

(89) "License" means a license issued by the nuclear regulatory commission, the director, or another agreement state in accordance with rules adopted by those organizations.

(90) "Licensee" means a person to whom a license is issued.

(91) "Licensed activity" means an activity authorized by a radioactive material license which is essential to achieving the purpose for which the license was issued or amended.

(92) "Licensed material" means radioactive material received, possessed, used, transferred or disposed of under a general or specific license.

(93) "Loose-fitting facepiece" means a respiratory inlet covering that is designed to form a partial seal with the face.

(94) "Lost or missing licensed source of radiation" means a licensed source of radiation whose location is unknown. It includes material that has been shipped but has not reached its destination and whose location cannot be readily traced in the transportation system.

(95) "Low-level radioactive waste" or "LLRW," also "low-level waste," or "LLW" means radioactive waste which is not high-level radioactive waste, spent nuclear fuel, NARM, or byproduct material as defined in section 11 E. (2) of the Atomic Energy Act of 1954 68 Stat. 919, 42 U.S.C. 2011, as amended (2005), but is radioactive material that the United States nuclear regulatory commission classifies as low-level radioactive waste.

(96) "Low specific activity material" or "LSA" means radioactive material with limited specific activity which is nonfissile or is excepted under rule 3701:1-50-13 of the Administrative Code, and which satisfies the descriptions and limits set forth below. Shielding materials surrounding the LSA material may not be considered in determining the estimated average specific activity of the package contents. LSA must be in one of three groups:

(a) LSA - I.

(i) Uranium and thorium ores, concentrates of uranium and thorium ores, and other ores containing naturally occurring radioactive radionuclides that are intended to be processed for the use of these radionuclides;

(ii) Natural uranium, depleted uranium, natural thorium or their compounds or mixtures, provided they are unirradiated and in solid or liquid form;

(iii) Radioactive material other than fissile material, for which the A₂ value is unlimited; or

(iv) Other radioactive material in which the activity is distributed throughout and the estimated average specific activity does not exceed thirty times the value for exempt material activity concentration determined in accordance with rule 3701:1-50-25 of the Administrative Code.

(b) LSA-II.

(i) Water with tritium concentration up to 0.8 terabecquerels per liter (twenty curies per liter); or

(ii) Other material in which the activity is distributed throughout and the estimated average specific activity does not exceed ( 10^-4 A₂) per gram for solids and gases, and (10^-5 A₂) per gram for liquids.

(c) LSA-III. Solids (e.g., consolidated wastes, activated materials), excluding powders, that satisfy the requirements of 10 C.F.R. 71.77 (as in effect on the effective date of this rule), in which:

(i) The radioactive material is distributed throughout a solid or a collection of solid objects, or is essentially uniformly distributed in a solid compact binding agent (such as concrete, bitumen, ceramic, etc.);

(ii) The radioactive material is relatively insoluble, or it is intrinsically contained in a relatively insoluble material, so that even under loss of packaging, the loss of radioactive material per package by leaching, when placed in water for seven days, would not exceed (0.1 x A₂); and

(iii) The estimated average specific activity of the solid, excluding any shielding material, does not exceed (0.002 x A₂) per gram.

(97) "Management" means the chief executive officer or other individual having the authority to manage, direct, or administer the licensee's activities, or those persons' delegate or delegates.

(98) "Medical institution" means an organization in which more than one medical discipline is practiced.

(99) "Medical use" means the intentional internal or external administration of radioactive material or the radiation therefrom to patients or human research subjects under the supervision of an authorized user.

(100) "Member of the public" means any individual except when that individual is receiving an occupational dose.

(101) "Minor" means an individual less than eighteen years of age.

(102) "Monitoring" or "radiation monitoring" or "radiation protection monitoring" means the measurement of radiation levels, concentrations, surface area concentrations or quantities of radioactive material and the use of the results of these measurements to evaluate potential exposures and doses.

(103) "NARM" or "naturally occurring or accelerator-produced radioactive material" means naturally occurring or accelerator-produced radioactive material, including naturally occurring material that is technologically enhanced, and those nuclides that are generated in a charged particle accelerator, but does not include source material, byproduct material, or special nuclear material.

(104) "NARM licensing state" means any state with regulations equivalent to the suggested state regulations for control of radiation relating to, and an effective program for, the regulatory control of NARM and which has been granted final designation by the conference of radiation control program directors, inc.

(105) "Nationally tracked source" means a sealed source containing a quantity equal to or greater than "Category 1" or "Category 2" levels of any radioactive material listed in the appendix to rule 3701:1-38-25 of the Administrative Code. In this context a sealed source is defined as radioactive material that is sealed in a capsule or closely bonded, in a solid form and which is not exempt from regulatory control. It does not mean material encapsulated solely for disposal, or nuclear material contained in any fuel assembly, subassembly, fuel rod, or fuel pellet. "Category 1" nationally tracked sources are those containing radioactive material at a quantity equal to or greater than the "Category 1" threshold. "Category 2" nationally tracked sources are those containing radioactive material at a quantity equal to or greater than the "Category 2" threshold but less than the "Category 1" threshold.

(106) "Negative pressure respirator" or "tight fitting respirator" means a respirator in which the air pressure inside the facepiece is negative during inhalation with respect to the ambient air pressure outside the respirator.

(107) "Nonstochastic effect" or "deterministic effect" means health effects, the severity of which varies with the dose and for which a threshold is believed to exist. Radiation-induced cataract formation is an example of a nonstochastic effect.

(108) "NORM" or "naturally occurring radioactive material" means any nuclide that is radioactive in its natural physical state, but does not include source material, byproduct material, or special nuclear material.

(109) "Normal form radioactive material" means radioactive material that has not been demonstrated to qualify as special form radioactive material.

(110) "Nuclear regulatory commission" means the federal agency established by Title II of the Energy Reorganization Act of 1974, 88 Stat. 1233, 42 U.S.C.A. 5801, as amended (2005), comprising the members of the commission and all offices, employees, and representatives authorized to act in any case or matter related to licensing and related regulatory function previously assigned to the AEC.

(111) "Occupational dose" means the dose received by an individual in the course of employment in which the individual's assigned duties involve exposure to radiation or radioactive material from licensed and unlicensed sources of radiation, whether in the possession of the licensee or other person. Occupational dose does not include doses received from background radiation, from any medical administration the individual has received, from exposures to individuals administered radioactive materials and released in accordance with rule 3701:1-58-30 of the Administrative Code or equivalent United States nuclear regulatory commission or agreement state regulations, from voluntary participation in medical research programs, or as a member of the public.

(112) "Package" means the packaging together with its radioactive contents as presented for transport.

(a) Fissile material package or type AF package, type BF package, type B(U)F package, or type B(M)F package means a fissile material packaging together with its fissile material contents.

(b) Type A package means a type A packaging together with its radioactive contents. A type A package is defined and must comply with the United States department of transportation regulations in 49 C.F.R. 173 (as in effect on the effective date of this rule).

(c) Type B package means a type B packaging together with its radioactive contents. On approval, a type B package design is designated by the United States nuclear regulatory commission as B(U) unless the package has a maximum normal operating pressure of more than seven hundred kilopascals (one hundred pounds per square inch) gauge or a pressure relief device that would allow the release of radioactive material to the environment under the tests specified in 10 C.F.R. 71.73 (hypothetical accident conditions) (as in effect on the effective date of this rule), in which case it will receive a designation B(M). B(U) refers to the need for unilateral approval of international shipments; B(M) refers to the need for multilateral approval of international shipments. There is no distinction made in how packages with these designations may be used in domestic transportation. To determine their distinction for international transportation, see United States department of transportation regulations in 49 C.F.R. 173 (as in effect on the effective date of this rule). A type B package approved before September 6, 1983, was designated only as type B. Limitations on its use are specified in 10 C.F.R. 71.19 (as in effect on the effective date of this rule).

(113) "Packaging" means the assembly of components necessary to ensure compliance with the packaging requirements of rule 49 C.F.R. 173 Subpart I (as in effect on the effective date of this rule). It may consist of one or more receptacles, absorbent materials, spacing structures, thermal insulation, radiation shielding, and devices for cooling or absorbing mechanical shocks. The vehicle, tie-down system and auxiliary equipment may be designated as part of the packaging.

(114) "Particle accelerator" means any machine capable of accelerating electrons, protons, deuterons, or other charged particles in a vacuum and of discharging the resultant particulate or other radiation into a medium at energies usually in excess of one megaelectron volt. For purposes of this definition, "accelerator" is an equivalent term.

(115) "Person" means any individual, corporation, association, business enterprise, or other legal entity either public or private and any legal successor, representative, agent, or agency of that individual, corporation, association, business enterprise, or other legal entity. Person also includes the United States, states, political subdivisions of states, and any department, agency, or instrumentality of the United States or a state, except the U.S. department of energy or the U.S. nuclear regulatory commission where the state regulation of radioactive material by either of those agencies is prohibited by federal law.

(116) "Personnel dosimeter", means a device that measures radiation dose that is processed and evaluated by an accredited "National Voluntary Laboratory Accreditation Program" (NVLAP) processor. Examples of personnel dosimeters include film badges, thermo-luminescent dosimeters (TLD), and optically stimulated luminescence (OSL) dosimeters.

(117) "Pharmacist" means a person who is licensed by the state of Ohio to practice pharmacy pursuant to Chapter 4731. of the Revised Code.

(118) "Physician" means a person who is licensed pursuant to Chapter 4731. of the Revised Code to practice medicine or surgery or osteopathic medicine or surgery.

(119) "Planned special exposure" means an infrequent exposure to radiation, separate from and in addition to the annual dose limits.

(120) "Podiatrist" means an individual licensed by the state of Ohio to practice podiatry pursuant to Chapter 4731. of the Revised Code.

(121) "Positive pressure respirator" means a respirator in which the pressure inside the respiratory inlet covering exceeds the ambient air pressure outside the respirator.

(122) "Positron Emission Tomography (PET) radionuclide production facility" means a facility operating a cyclotron or accelerator for the purpose of producing PET radionuclides.

(123) "Powered air-purifying respirator" or "PAPR" means an air-purifying respirator that uses a blower to force the ambient air through air purifying elements to the inlet covering.

(124) "Pressure demand respirator" means a positive pressure atmosphere supplying respirator that admits breathing air to the facepiece when the positive pressure is reduced inside the facepiece by inhalation.

(125) "Public dose" means the dose received by a member of the public from exposure to radiation and/or radioactive material released by the licensee, or to any other source of radiation under the control of a licensee or registrant. Public dose does not include occupational dose or doses received from background radiation, from any medical administration the individual has received, from exposures to individuals administered radioactive materials and released in accordance with rule 3701:1-58-30 of the Administrative Code or equivalent United States nuclear regulatory commission or agreement state regulations, or from voluntary participation in medical research programs.

(126) "Pyrophoric material" means any liquid that ignites spontaneously in dry or moist air at or below 54.4 degrees celsius (one hundred thirty degrees fahrenheit). A pyrophoric solid is any solid material, other than one classed as an explosive, which under normal conditions is liable to cause fires through friction, retained heat from manufacturing or processing, or which can be ignited readily and when ignited burns so vigorously and persistently as to create a serious transportation, handling, or disposal hazard. Included are spontaneously combustible and water-reactive materials.

(127) "Qualitative fit test" or "QLFT" means a pass/fail fit test to assess the adequacy of respirator fit that relies on the individual's response to the test agent.

(128) "Quality factor" or "Q" means the modifying factor, as listed in paragraphs (A) and (B) of rule 3701:1-38-11 of the Administrative Code, that is used to derive dose equivalent from absorbed dose.

(129) "Quantitative fit test" or "QNFT" means an assessment of the adequacy of respirator fit by numerically measuring the amount of leakage into the respirator.

(130) "Quarter" or "quarterly" means a period of time equal to one-fourth of the year observed by the licensee or registrant, approximately thirteen consecutive weeks, providing that the beginning of the first quarter in a year coincides with the starting date of the year and that no day is omitted or duplicated in consecutive quarters.

(131) "Rad" means the special unit of radiation absorbed dose. One rad is equal to an absorbed dose of one hundred ergs per gram, or 0.01 joule per kilogram, or 0.01 gray.

(132) "Radiation" or "ionizing radiation" means alpha particles, beta particles, gamma rays, x-rays, neutrons, high speed electrons, high speed protons, and other particles capable of producing ions. Radiation does not include nonionizing radiation, such as radio or microwaves, or visible, infrared or ultraviolet light.

(133) "Radiation area" means an area, accessible to individuals, in which radiation levels could result in an individual receiving a dose equivalent in excess of 0.05 millisievert (0.005 rem) in one hour at thirty centimeters from the source of radiation or from any surface that the radiation penetrates.

(134) "Radiation-generating equipment" or "RGE" means any manufactured product or device, or component of such a product or device, or any machine or system that during operation can generate or emit radiation, except those that emit radiation only from radioactive material. "Radiation-generating equipment" does not include either of the following:

(a) Diathermy machines;

(b) Microwave ovens, including food service microwave ovens used for commercial and industrial uses, television receivers, electric lamps, and other household appliances and products that generate very low levels of radiation.

(135) "Radiation Safety Officer" or "RSO" means an individual designated by the licensee who has the knowledge and responsibility for the overall radiation safety program at the facility, to include the implementation of the daily radiation safety operations and compliance with the rules.

(136) "Radioactive material" means any solid, liquid or gaseous material that emits ionizing radiation spontaneously. "Radioactive material" includes accelerator-produced and naturally occurring radioactive materials and byproduct, source, and special nuclear material.

(137) "Radioactive waste" means waste containing regulated radioactive material.

(138) "Radioactivity" means the transformation of unstable atoms by the emission of radiation.

(139) "Radiography" means the same as industrial radiography.

(140) "Reference man" means a hypothetical aggregation of human physical and physiological characteristics arrived at by international consensus. These characteristics may be used by researchers and public health workers to standardize results of experiments and to relate biological insult to a common base.

(141) "Registrant" means a person required by Chapter 3748. of the Revised Code to register radiation-generating equipment with the director.

(142) "Rem" means the special unit of any of the quantities expressed as dose equivalent. The dose equivalent in rem is equal to the absorbed dose in rads multiplied by the quality factor (one rem = 0.01 Sv).

(143) "Research and development" means

(a) Theoretical analysis, exploration, or experimentation; or

(b) The extension of investigative findings and theories of a scientific or technical nature into practical application for experimental and demonstration purposes, including the experimental production and testing of models, devices, equipment, materials and processes. "Research and development" does not include the internal or external administration of sources of radiation to human beings.

(144) "Residual radioactivity" means radioactivity in structures, materials, soils, groundwater, and other media at a site resulting from activities under the licensee's control. This includes radioactivity from all licensed and unlicensed sources used by the licensee, but excludes background radiation. It also includes radioactive materials remaining at the site as a result of routine or accidental releases of radioactive material at the site and previous burials at the site, even if those burials were made in accordance with the provisions of 10 C.F.R. 20 (as in effect on the effective date of this rule).

(145) "Respiratory protective equipment or device" means an apparatus, such as a respirator, used to reduce the individual's intake of airborne radioactive materials.

(146) "Restricted area" means an area access to which is limited by the licensee or registrant for the purpose of protecting individuals against undue risks from exposure to sources of radiation. Restricted area does not include areas used as residential quarters, but separate rooms in a residential building may be set apart as a restricted area.

(147) "Roentgen" means the amount of gamma or x-rays required to produce ions resulting in a charge of 0.000258 coulombs per kilogram of air under standard conditions.

(148) "Sanitary sewerage" means a system of public sewers for carrying off wastewater and refuse, but excluding sewage treatment facilities, septic tanks, and leach fields owned or operated by the licensee.

(149) "Sealed source" means radioactive material that is encased in a manner designed to prevent leakage or escape of the radioactive material.

(150) "Sealed source and device registry" means the national registry that contains all the registration certificates, generated by both the United States nuclear regulatory commission and the agreement states, that summarize the radiation safety information for the sealed sources and devices and describe the licensing and use conditions approved for the product.

(151) "Seismic area" means any area where the probability of a horizontal acceleration in rock of more than 0.3 times the acceleration of gravity in two hundred fifty years is greater than ten per cent, as designated by the United States geological survey.

(152) "Self-contained breathing apparatus" or "SCBA" means an atmosphere-supplying respirator for which the breathing air source is designed to be carried by the user.

(153) "Shallow dose equivalent" or "H_S" means the external exposure of the skin of the whole body or the skin of an extremity, is taken as the dose equivalent at a tissue depth of 0.007 centimeter, or seven milligrams per square centimeter.

(154) "Sievert" or "Sv" means the SI unit of any of the quantities expressed as dose equivalent. The dose equivalent in sieverts is equal to the absorbed dose in grays multiplied by the quality factor. One sievert equals one hundred rem.

(155) "Site area emergency" means events may occur, are in progress, or have occurred that could lead to a significant release of radioactive material and that could require a response by off-site response organizations to protect persons off-site.

(156) "Site boundary" means that line beyond which the land or property is not owned, leased, or otherwise controlled by the licensee or registrant.

(157) "Site closure and stabilization" means those actions that are taken upon completion of operations that prepare a disposal site for custodial care and that assure that the disposal site will remain stable and will not need ongoing active maintenance.

(158) "Source material" means uranium, thorium, or any combination thereof in any physical or chemical form, or any ores that contain by weight at least one-twentieth of one per cent (0.05 per cent) of uranium, thorium, or any combination thereof. Source material does not include special nuclear material.

(159) "Sources of radiation" means radioactive material or radiation generating equipment.

(160) "Special form radioactive material" means radioactive material that satisfies the following conditions:

(a) It is either a single solid piece or is contained in a sealed capsule that can be opened only by destroying the capsule;

(b) The piece or capsule has at least one dimension not less than five millimeters (0.2 inch); and

(c) It satisfies the test requirements specified by the United States nuclear regulatory commission in 10 C.F.R. 71.75 (as in effect on the effective date of this rule). A special form encapsulation designed in accordance with the United States nuclear regulatory commission requirements identified in 10 C.F.R. 71.4, in effect on June 30, 1983, and constructed prior to July 1, 1985; a special form encapsulation designed in accordance with the requirements of 10 C.F.R. 71.4 in effect on March 31, 1996, and constructed before April 1, 1998; and special form material that was successfully tested before September 10, 2015 in accordance with the requirements of 10 C.F.R. 71.75(d) of this section in effect before September 10, 2015 may continue to be used. Any other special form encapsulation must meet the specifications of this definition.

(161) "Special nuclear material" means either of the following:

(a) Plutonium, uranium-233, uranium enriched in the isotope 233, or in the isotope 235, and any other material that the United States nuclear regulatory commission determines to be special nuclear material, but does not include source material pursuant to section 51 of the Atomic Energy Act of 1954, 68 Stat 919, 42 USCA 2071, as amended (2005).

(b) Any material artificially enriched by any of the foregoing but does not include source material.

(162) "Special nuclear material in quantities not sufficient to form a critical mass" means uranium enriched in the isotope uranium-235 in quantities not exceeding three hundred fifty grams of contained uranium-235; uranium-233 in quantities not exceeding two hundred grams; plutonium in quantities not exceeding two hundred grams; or any combination of them in accordance with the following formula: for each kind of special nuclear material, determine the ratio between the quantity of that special nuclear material and the quantity specified in this paragraph for the same kind of special nuclear material. The sum of such ratios for all of the kinds of special nuclear material in combination shall not exceed unity.

(163) "Stochastic effect" means health effects that occur randomly and for which the probability of the effect occurring, rather than its severity, is assumed to be a linear function of dose without threshold. Hereditary effects and cancer incidence are examples of stochastic effects.

(164) "Supplied-air respirator" or "SAR" or "airline respirator" means an atmosphere-supplying respirator for which the source of breathing air is not designed to be carried by the user.

(165) "Surface contaminated object" or "SCO" means a solid object that is not itself classed as radioactive material, but which has radioactive material distributed on any of its surfaces. SCO must be in one of two groups with surface activity not exceeding the following limits:

(a) SCO-I: a solid object on which:

(i) The non-fixed contamination on the accessible surface averaged over three hundred square centimeters, or the area of the surface if less than three hundred square centimeters, does not exceed four becquerels per square centimeter (10^-4 microcurie per square centimeter) for beta and gamma and low toxicity alpha emitters, or 0.4 becquerels per square centimeter 10^-5 microcurie per square centimeter) for all other alpha emitters;

(ii) The fixed contamination on the accessible surface averaged over three hundred square centimeters, or the area of the surface if less than three hundred square centimeters, does not exceed forty thousand becquerels per square centimeter (one microcurie per square centimeter) for beta and gamma and low toxicity alpha emitters, or four thousand becquerels per square centimeter (0.1 microcurie per square centimeter) for all other alpha emitters; and

(iii) The non-fixed contamination plus the fixed contamination on the inaccessible surface averaged over three hundred square centimeters, or the area of the surface if less than three hundred square centimeters, does not exceed forty thousand becquerels per square centimeter (one microcurie per square centimeter) for beta and gamma and low toxicity alpha emitters, or four thousand becquerels per square centimeter (0.1 microcurie per square centimeter) for all other alpha emitters.

(b) SCO-II: a solid object on which the limits for SCO-I are exceeded and on which:

(i) The non-fixed contamination on the accessible surface averaged over three hundred square centimeters, or the area of the surface if less than three hundred square centimeter, does not exceed four hundred becquerels per square centimeter (10^-2 microcurie per square centimeter) for beta and gamma and low toxicity alpha emitters, or forty becquerels per square centimeter (10^-3 microcurie per square centimeter) for all other alpha emitters;

(ii) The fixed contamination on the accessible surface averaged over three hundred square centimeters, or the area of the surface if less than three hundred square centimeters, does not exceed eight hundred thousand becquerels per square centimeter (twenty microcuries per square centimeter) for beta and gamma and low toxicity alpha emitters, or eighty thousand becquerels per square centimeter (two microcuries per square centimeter) for all other alpha emitters; and

(iii) The non-fixed contamination plus the fixed contamination on the inaccessible surface averaged over three hundred square centimeters, or the area of the surface if less than three hundred square centimeters, does not exceed eight hundred thousand becquerels per square centimeter (twenty microcuries per square centimeter) for beta and gamma and low toxicity alpha emitters, or eighty thousand becquerels per square centimeter (two microcuries per square centimeter) for all other alpha emitters.

(166) "Survey" means an evaluation of the radiological conditions and potential hazards incident to the production, use, transfer, release, disposal or presence of radioactive material or other sources of radiation. When appropriate, such an evaluation includes a physical survey of the location of radioactive material, or the sources of radiation and measurements or calculations of levels of radiation, or concentrations or quantities of radioactive material present.

(167) "Tight-fitting facepiece" means a respiratory inlet covering that forms a complete seal with the face.

(168) "Total effective dose equivalent" or "TEDE" means the sum of the effective dose equivalent (for external exposures) and the committed effective dose equivalent (for internal exposures).

(169) "Transport index" means the dimensionless number, rounded up to the next tenth, placed on the label of a package, to designate the degree of control to be exercised by the carrier during transportation. The transport index is the number determined by multiplying the maximum radiation level in millisievert per hour at one meter (3.3 feet) from the external surface of the package by one hundred, which is equivalent to the maximum radiation level in millirem per hour at one meter (3.3 feet).

(170) "Type A quantity" means a quantity of radioactive material, the aggregate radioactivity of which does not exceed A₁ for special form radioactive material, or A₂ for normal form radioactive material, where A₁ and A₂ are given in rule 3701:1-50-25 of the Administrative Code.

(171) "Type B quantity" means a quantity of radioactive material greater than a type A quantity.

(172) "Type B package" is defined under "Package."

(173) "United States department of energy" means the department of energy established by the Department of Energy Organization Act, PL 95-91, 91 Stat. 565 (1977), 42 U.S.C. 7101 et seq., as amended (2006), to the extent that the department of energy or its duly authorized representatives, exercises functions formerly vested in the United States atomic energy commission, its chairman, members, officers and components and transferred to the United States energy research and development administration and to the administrator thereof pursuant to Sections 104(b) to (d) of the Energy Reorganization Act of 1974, PL 93-438, 88 Stat. 1233 at 1237 (1974), 42 U.S.C. 5814 and retransferred to the secretary of energy pursuant to Section 301(a) of the Department of Energy Organization Act, PL 95-91, 91 Stat. 565 at 577-578 (1977), 42 U.S.C. 7151.

(174) "Unrestricted area" or "uncontrolled area" means any area, access to which is neither restricted nor controlled by the licensee or registrant.

(175) "User seal check" or "fit check" means an action conducted by the respirator user to determine if the respirator is properly seated to the face. Examples include negative pressure check, positive pressure check, irritant smoke check, or isoamyl acetate check.

(176) "Very high radiation area" means an area, accessible to individuals, in which radiation levels from radiation sources external to the body could result in an individual receiving an absorbed dose in excess of five gray (five hundred rad) in one hour at one meter from a source of radiation or from any surface that the radiation penetrates. At very high doses received at high dose rates, units of absorbed dose, gray and rad, are appropriate, rather than units of dose equivalent, sievert and rem.

(177) "Veterinarian" means an individual licensed by the state of Ohio to practice veterinary medicine pursuant to Chapter 4741. of the Revised Code.

(178) "Waste" means those low-level radioactive wastes containing source, special nuclear, or byproduct material that are acceptable for disposal in a land disposal facility. For the purposes of this definition, low-level radioactive waste means radioactive waste not classified as high-level radioactive waste, transuranic waste, spent nuclear fuel, or byproduct material as defined in paragraph (A)(26)(b) of this rule, or byproduct material as defined in section 11 E. (3) and (4) of the Atomic Energy Act of 1954, 68 Stat. 919, 42 USC 2014, as amended (2005).

(179) "Week" means seven consecutive days starting on Sunday.

(180) "Weighting factor

• W_T" for an organ or tissue, (T), is the proportion of the risk of stochastic effects resulting from irradiation of that organ or tissue to the total risk of stochastic effects when the whole body is irradiated uniformly. For calculating the effective dose equivalent, the values of W_T are:

| Organ doseweighting factors | | | --- | --- | | Organ ortissue | W_T | | Gonads | 0.25 | | Breast | 0.15 | | Red bone marrow | 0.12 | | Lung | 0.12 | | Thyroid | 0.03 | | Bonesurfaces | 0.03 | | Remainder | 0.30^a | | Whole body | 1.00^b |

^\a 0.30 results from 0.06 for each of five "remainder" organs, excluding the skin and the lens of the eye, that receive the highest doses.

^\b for the purpose of weighting the external whole body dose (for adding it to the internal dose) a single weighting factor, W_T = 1.0, has been specified. The use of other weighting factors for external exposure will be approved on a case-by-case basis until such time as specific guidance is issued.

(181) "Whole body" means for purposes of external exposure, head; trunk, including male gonads; arms above the elbow; legs above the knee.

(182) "Worker" means an individual engaged in activities licensed or registered by the department and controlled by a licensee or registrant, but does not include the licensee or registrant.

(183) "Working level" or "WL" means any combination of short-lived radon decay products (for radon-222: polonium-218, lead-214, bismuth-214, and polonium-214; and for radon-220: polonium-216, lead-212, bismuth-212, and polonium-212) in one liter of air that will result in the ultimate emission of 1.3 x 10⁵ million electron volts alpha particle energy.

(184) "Working level month" or "WLM" means a cumulative exposure to one working level for one hundred seventy hours. (Two thousand working hours per year/twelve months per year equals approximately one hundred seventy hours per month.)

(185) "Year" means the period of time beginning in January used to determine compliance with the provisions of this rule. The licensee or registrant may change the starting date of the year used to determine compliance by the licensee or registrant provided that the change is made at the beginning of the year and that no day is omitted or duplicated in consecutive years.

(B) The terms set out in paragraph (A) of this rule may be redefined in other chapters as promulgated pursuant to Chapter 3748. of the Revised Code as used in that chapter only.

Last updated May 13, 2026 at 11:20 AM

History

• Effective: January 20, 2022
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-66-02 General administration obligations for medical radiation-generating equipment.

As used in this rule, "radiation-generating equipment" means radiation-generating equipment used for dental, veterinary, or medical purpose but does not include therapeutic radiation-generating equipment.

(A) The director may, upon application thereof or upon his or her own initiative, grant a variance to the obligations of rules in this chapter as he or she determines is authorized by law, provided that the registrant shows to the satisfaction of the director that there is good cause for the variance, and that the variance will not result in any undue hazard or effect on the public health and safety or environment. The terms, conditions, and expiration of the variance will be set forth in writing by the director. Failure to comply with the terms of the variance may result in immediate revocation of the variance.

(B) An individual will not expose any individual or animal to the useful beam unless ordered by a licensed practitioner acting within his or her scope-of-practice for dental, medical or radiation therapy purposes. Exposing an individual for training, demonstration or other purposes is forbidden unless otherwise specified in rules promulgated under Chapter 4773. or 3748. of the Revised Code.

(C) The handler will assure:

(1) Every individual who performs radiologic procedures on human beings holds the appropriate radiologic license as obligated by Chapter 3701-72 of the Administrative Code and Chapter 4715. of the Revised Code.

(2) Every individual who is licensed to perform radiologic procedures is adequately instructed in the registrant's safe operating procedures and can demonstrate competency in the safe use of the equipment.

(3) The individual responsible for radiation protection (IRRP) is qualified as one of the following:

(a) Ohio licensed to operate radiation-generating equipment;

(b) Dental assistant certified to operate dental radiation-generating equipment;

(c) Registered veterinary technician and trained to operate veterinary radiation-generating equipment;

(d) Certified by the American registry of radiologic technologists in a pathway involving ionizing radiation or certified by the nuclear medicine technologist certification board;

(e) A radiation expert as defined in rule 3701:1-66-01 of the Administrative Code;

(f) A health physicist certified by the American board of health physics; or

(g) An associate's degree or higher in health physics, radiologic science, nuclear medicine or nuclear engineering.

(D) Any radiation-generating equipment that does not meet the provisions set forth in this rule or any other applicable equipment obligations of Chapter 3701:1-66 of the Administrative Code will not be used to irradiate patients unless the director or a radiation expert determines that the non-compliance will not pose a radiation risk and arrangements have been made to promptly correct the non-compliance.

(E) Radiation-generating equipment will bear a warning label on the control panel, by the exposure switch or by the main power switch which cautions individuals that radiation is produced when it is energized.

(F) Unless otherwise specified in this paragraph, radiation-generating equipment will meet the following standards:

(1) On battery-powered x-ray generators, visual means will be provided on the control panel to indicate whether the battery is in a state of charge adequate for proper operation;

(2) The leakage radiation from the diagnostic source assembly measured at a distance of one meter in any direction from the source will not exceed 0.88 milligray air kerma (one hundred milliroentgen exposure) in one hour when the x-ray tube is operated at its leakage technique factors. Compliance will be determined by measurements averaged over an area of one hundred square centimeters with no linear dimension greater than twenty centimeters;

(3) Except for mammographic radiation-generating equipment, the half-value layer (HVL) of the useful beam for a given x-ray tube potential will not be less than the values shown in table 1. If it is necessary to determine such HVL at an x-ray tube potential which is not listed in table 1, linear interpolation or extrapolation may be made;

Table 1.

| X-Ray TubeVoltage (kilovolt peak) | Minimum HVL(millimeter of aluminum) | | | | | --- | --- | --- | --- | --- | | Designed Operating Range | Measured Operating Potential | Specified Dental Systems¹ | I-Other X-Ray Systems² | II - Other X-Ray Systems³ | | Below 51 | 30 | 1.5 | 0.3 | 0.3 | | | 40 | 1.5 | 0.4 | 0.4 | | | 50 | 1.5 | 0.5 | 0.5 | | 51 to70 | 51 | 1.5 | 1.2 | 1.3 | | | 60 | 1.5 | 1.3 | 1.5 | | | 70 | 1.5 | 1.5 | 1.8 | | Above70 | 71 | 2.1 | 2.1 | 2.5 | | | 80 | 2.3 | 2.3 | 2.9 | | | 90 | 2.5 | 2.5 | 3.2 | | | 100 | 2.7 | 2.7 | 3.6 | | | 110 | 3.0 | 3.0 | 3.9 | | | 120 | 3.2 | 3.2 | 4.3 | | | 130 | 3.5 | 3.5 | 4.7 | | | 140 | 3.8 | 3.8 | 5.0 | | | 150 | 4.1 | 4.1 | 5.4 | | ¹ Dental x-raysystems designed for use with intraoral image receptors and manufactured afterDecember 1, 1980. | | | | | | ² Dental x-raysystems designed for use with intraoral image receptors and manufactured beforeor on December 1, 1980, and all other x-ray systems subject to this section andmanufactured before June 10, 2006. | | | | | | ³ All x-ray systems,except dental x-ray systems designed for use with intraoral image receptors,subject to this section and manufactured on or after June 10,2006. | | | | |

(a) For capacitor energy storage equipment, compliance with the obligations of this paragraph will be determined with the system fully charged and a setting of ten milliampere-seconds (mAs) for each exposure; and

(b) The obligated minimal HVL of the useful beam will include the filtration contributed by all materials which are permanently between the source and the patient;

(4) For x-ray systems which have variable kilovolt peak (kVp) setting and variable filtration for the useful beam, a device will link the kVp selector with the filter and will prevent an exposure unless the minimum amount of filtration necessary to produce the HVL obligated by paragraph (F)(3) of this rule is in the useful beam for the given kVp which has been selected;

(5) Where two or more x-ray tubes are controlled by one exposure switch, the tube that has been selected will be clearly indicated prior to initiation of the exposure. This indication will be both on the x-ray control panel and for dental equipment at or near the selected tube housing assembly;

(6) The x-ray tube housing assembly supports will be adjusted such that the tube housing assembly will remain stable during an exposure unless tube housing movement is a designed function of the radiation-generating equipment;

(7) The technique factors to be used during an exposure will be indicated before the exposure begins. If automatic exposure controls are used, the technique factors which are set prior to the exposure will be indicated. This obligation may be met by permanent markings on equipment having fixed technique factors. Indication of technique factors will be visible from the operator's position except in the case of spot films taken during fluoroscopy procedures or dental intraoral or panoral films; and

(8) All position locking, holding, and centering devices on radiation-generating equipment components will function as designed by the manufacturer.

(G) In addition to other applicable radiation safety rules in Chapter 3701:1-66 of the Administrative Code, handlers of radiation-generating equipment will meet the following radiation safety obligations:

(1) Software-based technique selections, a chart, or a combination of the two will be provided in the vicinity of the radiation-generating equipment's control panel which specifies, for examinations performed with that system, the following information:

(a) Patient's body part, radiographic projection, anatomical size or age, and the technique factors to be utilized for each;

(b) Type and size of the image receptor to be used;

(c) Type and focal distance of the grid to be used, if any; and

(d) Source-to-image receptor distance (SID) to be used, except for fluoroscopy, and dental intraoral or panoral radiography;

(2) Except for patients who cannot be moved out of the room, only the staff, ancillary personnel or other persons needed for the medical procedure or training will be in the room during the radiologic procedure. Other than the patient being examined:

(a) All individuals will be positioned such that no part of the body will be struck by the useful beam unless protected by not less than 0.5 millimeter lead equivalent material;

(b) The x-ray operator, other staff, ancillary personnel, and other persons needed for the medical procedure will be protected from the direct scatter radiation by protective aprons or whole body protective barriers of not less than 0.25 millimeter lead equivalent material; and

(c) Human patients who cannot be removed from the room will be protected from the direct scatter radiation by whole body protective barriers of not less than 0.25 millimeter lead equivalent material or will be so positioned that the nearest portion of the body is at least two meters (6.5 feet) from both the tube head and the nearest edge of the image receptor;

(3) If performing a radiologic procedure requires auxiliary support for holding a patient or an image receptor, the handler will ensure the following:

(a) Mechanical holding devices will be used when the procedure permits their use in lieu of having an individual hold the patient or image receptor;

(b) Written safe operating procedures obligated by paragraph (B)(4) of rule 3701:1-66-04 of the Administrative Code will indicate the obligations for selecting someone to hold a patient or image receptor, and the procedure that will be followed. All individuals holding a patient or image receptor during radiation exposures will be at least eighteen years of age; and

(c) No individual will routinely hold patients or image receptors during radiologic procedures;

(4) The facility will have protective aprons and gloves available in sufficient numbers to provide protection to anyone who is involved with x-ray operations;

(5) Any radiation worker participating in fluoroscopic, veterinary, or mobile or portable x-ray procedures is obligated to wear an individual monitoring device unless the IRRP or radiation expert determines it is unlikely the radiation worker will receive in excess of the doses specified in paragraphs (B)(1)(a) to (B)(1)(c) of rule 3701:1-38-14 of the Administrative Code;

(6) The entrance air kerma resulting from the technique used for the specified average adult human patient for routine diagnostic radiography will not exceed the values listed in table 2. The entrance air kerma resulting from the technique used for routine intraoral bitewing exams will not exceed the values listed in table 3. All values of entrance air kerma are specified as free-in-air, without backscatter. The corresponding entrance exposure in milliroentgens is listed in parentheses. Linear extrapolation or interpolation will be used for an x-ray tube potential (kVp) not listed in table 3.;

| Table2. | | | | --- | --- | --- | | Radiographictechnique | Adult thicknesscm | Entrance air kerma mGy(mR) | | Chest (pa),(non-grid) | 23 | 0.26 (30) | | Chest (pa), (grid) | 23 | 0.35(40) | | Abdomen(kub) | 23 | 5.26 (600) | | Lumbo-sacral spine (ap) | 23 | 6.13(700) | | Thoracic spine(ap) | 23 | 3.50 (400) | | Full spine | 23 | 3.50(400) | | Cervical spine(ap) | 13 | 1.75 (200) | | Skull (lateral) | 15 | 1.75(200) | | Foot(dp) | 8 | 0.88 (100) |

| Table3. | | | | --- | --- | --- | | Tube VoltagekVp | D-Speed Film mGy(mR) | F-Speed Film Digital ReceptormGy (mR) | | 50 | 4.82 (550) | 2.45 (280) | | 55 | 4.56(520) | 2.19(250) | | 60 | 4.12 (470) | 1.93 (220) | | 65 | 3.64(415) | 1.66(190) | | 70 | 3.15 (360) | 1.45 (165) | | 75 | 2.72(310) | 1.23(140) | | 80 | 2.28 (260) | 1.01 (115) | | 85 | 2.06(235) | 0.92(105) | | 90 | 1.84 (210) | 0.83 (95) | | 95 | 1.71(195) | 0.74(85) | | 100 | 1.58 (180) | 0.61 (70) |

(7) Procedures and auxiliary equipment designed to minimize patient and radiation worker exposure will be utilized as follows:

(a) For facilities utilizing radiographic film, the speed of the screen and film combinations used will be the fastest speed consistent with the diagnostic objective of the examinations. Film cassettes without intensifying screens will not be used for any routine diagnostic radiography, with the exception of veterinary and specimen radiography;

(b) Radiation-generating equipment subject to rule 3701:1-66-05 of the Administrative Code will not be utilized in procedures where the source-to-skin distance (SSD) is less than thirty centimeters, except for veterinary x-ray systems;

(c) If grids are used between the patient and the image receptor to decrease scatter to the image receptor and improve contrast, the grid will be:

(i) Properly aligned, with the x-ray tube side facing the correct direction, and the grid centered to the central ray; and

(ii) The proper focal distance for the SID being used;

(8) Except for radiation-generating equipment used for veterinary, portable, dental panoral, dental intraoral, lithotripsy, or bone densitometry applications, the operator will be behind a protective barrier, either in a separate room, in a protected booth, or behind a shield and be able to see the patient without leaving the protected barrier; and

(9) Each radiographic image, or a record linked with each radiographic image, will contain the following:

(a) Patient identification;

(b) Date of examination; and

(c) Operator identification.

(H) In addition to other applicable structural shielding obligations in Chapter 3701:1-66 of the Administrative Code, handlers of radiation-generating equipment will:

(1) For all units, except those used for bone densitometry, mammography, dental panoral or dental intraoral radiography:

(a) Use a radiation expert to prepare a shielding design to include specifications for all structural radiation barriers:

(i) Prior to new construction, or renovation; and

(ii) For new radiation-generating equipment installations which might cause a significant increase in radiation hazard.

(b) Prior to patient use, use a radiation expert to determine compliance with exposure levels in accordance with rule 3701:1-38-14 of the Administrative Code by performing:

(i) An area radiation survey for new installation of radiation-generating equipment.

(ii) An area radiation survey for reinstallation or after any change in structural shielding unless, in the documented determination of a radiation expert, the reinstallation or change will not cause a significant increase in radiation hazard.

(c) Use a radiation expert to perform a re-calculation of area radiation survey results after any increase in clinical workload that exceeds the assumptions used in the existing radiation survey.

(d) Obtain a written report of the shielding design and the area radiation survey. A copy of the report will be made available to the department's inspector upon request.

(2) Assure that no individual operates or permits the operation of radiation-generating equipment unless structural shielding and protective barriers are used such that no person other than the patient being examined will receive a total effective dose equivalent in excess of the limits prescribed in rules 3701:1-38-12 and 3701:1-38-13 of the Administrative Code.

(3) Provide a protective barrier either in a separate room, in a protected booth, or use a mobile barrier that will intercept the useful beam and any direct scattered radiation.

(4) Provide a window of lead equivalency affording protection equal to that obligated by the adjacent barrier, a television monitoring system, or a mirror system large enough and so placed that the operator can see the patient without having to leave the protected area during exposure.

(5) Assure the stationary CT and mobile CT radiation-generating equipment used in a fixed location provides for two-way aural communications between the human patient and operator.

(I) Notwithstanding paragraph (H)(1)(b)(ii) of this rule, reinstallation of radiation-generating equipment of the same operating parameters, location and geometry does not obligate another area radiation survey as long as the previous documented area radiation survey is maintained and available for inspection.

(J) In addition to all applicable rules in Chapter 3701:1-66 of the Administrative Code, handlers of radiation-generating equipment will meet the following quality assurance obligations:

(1) X-ray systems and associated components used on humans and certified pursuant to 21 C.F.R. part 1020 (as effective on the effective date of this rule) will be maintained in compliance with applicable requirements of that standard, any modifications to the original components or systems will comply with that standard, and handlers will maintain documentation of compliance between inspections;

(2) The handler will maintain the following information for all radiation-generating equipment for inspection by the department:

(a) User's manuals;

(b) Records of surveys, calibrations, maintenance, and modifications performed on the radiation-generating equipment which will be maintained between inspections; and

(c) A copy of all correspondence with the department regarding each piece of radiation-generating equipment;

(3) Unless otherwise specified in another rule in this chapter, each installation using a piece of radiation-generating equipment and using analog image receptors, such as radiographic film, will have available suitable equipment for handling and processing radiographic images in accordance with the following provisions:

(a) For manually processing film:

(i) Developer and fixer tanks will be constructed of mechanically rigid, corrosion resistant material; and

(ii) The temperature of solutions in the tanks will be maintained within the range of 15.6 to 26.7 degrees Celsius (sixty to eighty degrees Fahrenheit). Film will be developed in accordance with the time-temperature relationships recommended by the film manufacturer, or in absence of such recommendations, with the following time-temperature chart:

| Time-TemperatureChart | | | | --- | --- | --- | | Thermometer Reading (Degrees) | Minimum Developing Time(Minutes) | | | C | F | | | 26.7 | 80 | 2 | | 26.1 | 79 | 2 | | 25.6 | 78 | 2.5 | | 25.0 | 77 | 2.5 | | 24.4 | 76 | 3 | | 23.9 | 75 | 3 | | 23.3 | 74 | 3.5 | | 22.8 | 73 | 3.2 | | 22.2 | 72 | 4 | | 21.7 | 71 | 4 | | 21.1 | 70 | 4.5 | | 20.6 | 69 | 4.5 | | 20.0 | 68 | 5 | | 19.4 | 67 | 5.5 | | 18.9 | 66 | 5.5 | | 18.3 | 65 | 6 | | 17.8 | 64 | 6.5 | | 17.2 | 63 | 7 | | 16.7 | 62 | 8 | | 16.1 | 61 | 8.5 | | 15.6 | 60 | 9.5 |

(iii) Devices will be utilized which will indicate the actual temperature of the developer and signal the passage of a preset time appropriate to the developing time needed;

(b) For automatic processors and other closed processing systems:

(i) Films will be developed in accordance with the time-temperature relationships recommended by the film manufacturer; in the absence of such recommendations, the film will be developed using the following chart:

| Developer Temperature (Degrees) | Minimum Immersion Time^a/ | | | --- | --- | --- | | C | F | Seconds | | 35.5 | 96 | 19 | | 35 | 95 | 20 | | 34.5 | 94 | 21 | | 34 | 93 | 22 | | 33.5 | 92 | 23 | | 33 | 91 | 24 | | 32 | 90 | 25 | | 31.5 | 89 | 26 | | 31 | 88 | 27 | | 30.5 | 87 | 28 | | 30 | 86 | 29 | | 29.5 | 85 | 30 | | ^a/Immersion timeonly, no crossover time included. | | |

(ii) The specified developer temperature and immersion time will be posted in the darkroom, on the automatic processor, or be readily available to the operator;

(c) Processing deviations from the obligations listed above will be documented by the handler in such manner that the obligations of this rule are shown to be met or exceeded, such as with extended processing, and special rapid chemistry;

(d) Film processing solutions will be prepared in accordance with the directions given by the film manufacturer, and will be maintained in strength by replenishment or renewal so that full development is accomplished within the time specified by the manufacturer; and

(4) Pass boxes, if provided, will be so constructed as to exclude light from entering the darkroom when cassettes are placed in or removed from the boxes, and will incorporate adequate shielding from stray radiation to prevent exposure of undeveloped film;

(5) The darkroom will be light tight and use proper safelighting such that any film which would produce an optical density between one and two when exposed in a cassette to x-radiation and then processed will:

(a) Not suffer an increase in optical density greater than 0.1 when exposed in the darkroom for two minutes with all safelights on; and

(b) Not suffer an increase in optical density greater than 0.05 for mammography when exposed to the darkroom for two minutes with all safelights on;

(6) Darkrooms typically used by more than one individual will provide a method to prevent accidental entry of light while undeveloped films are being handled or processed;

(7) Film will be stored in a cool, dry place and will be protected from exposure to stray radiation. Film in open packages will be stored in a light-tight container. If used, daylight film handling boxes will preclude fogging of the film;

(8) Expired x-ray film will not be used for diagnostic radiographs;

(9) Cassettes, intensifying screens, and computed radiographic imaging plates will be:

(a) Cleaned according to manufacturer's specifications or an alternate frequency approved and documented by a radiation expert in the quality assurance program;

(b) Inspected for damage; and

(c) Replaced as necessary to assure radiographs of good diagnostic quality;

(10) For those registrants employing computed and digital radiography imaging systems, the following will apply:

(a) If the computed radiography reader is located in the same room as the radiation-generating equipment and it is not behind a protective barrier, x-ray exposures will not be made during processing;

(b) Computed radiography plates will be processed as soon as possible after exposure, not to exceed eight hours under any circumstances;

(c) Computed radiography plates will be adequately shielded from stray radiation. Registrants will develop a process that will ensure that computed radiography plates are used frequently enough or erased at least weekly so as to produce diagnostic quality images; and

(d) Facilities other than dental, podiatric, and veterinary will complete at least annually image quality evaluations appropriate for the equipment as established by a radiation expert or system manufacturer;

(11) Annual evaluation of the integrity of all necessary protective apparel.

(K) Upon discovery of a medical event, the handler will:

(1) Contact the department regarding the medical event within one business day;

(2) Provide a written report, including the analysis of the medical event, by a radiation expert to the department within fifteen business days of the medical event. The written report will include:

(a) The handler or registrant's name;

(b) The name of the prescribing physician;

(c) A brief description of the event including the body site, dose delivered and any critical structures involved;

(d) Why the event occurred;

(e) The effect, if any, on the individual who received the medical event;

(f) Actions, if any, that have been taken, or are planned, to prevent recurrence; and

(g) Certification that the handler notified the individual, or the individual's responsible relative or guardian, and if not, why not.

(3) Provide a clinical summary to the prescribing physician and patient within fifteen business days; and

(4) Maintain record of the medical event as part of the patient's permanent medical record.

(L) The written report in paragraph (K)(2) of this rule will not contain the individual's name or any other information that could lead to the identification of the individual.

Last updated August 28, 2025 at 8:43 AM

History

• Effective: December 13, 2024
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-66-04

(A) Each registrant will develop, implement and maintain a written quality assurance program in the form of a readily available manual or manuals, either in hard copy format or electronic format. For purposes of this chapter and Chapter 3701:1-67 of the Administrative Code, quality assurance program means a program providing for verification by written procedures such as testing, auditing, and inspection to ensure that deficiencies, deviations, defective equipment, or unsafe practices, or a combination thereof, relating to the use, disposal, management, or manufacture of radiation devices are identified, promptly corrected, and reported to the appropriate regulatory authorities.

(B) The written quality assurance program of each registrant will address and include records to verify implementation of at least the following:

(1) The intervals of and procedures for the evaluation of all radiation-generating equipment to ensure compliance with all applicable rules of this chapter;

(2) Procedures for maintaining compliance with occupational and public exposure limits;

(3) Procedures for notifying the director when individuals are occupationally over-exposed to radiation, pursuant to Chapter 3701:1-38 of the Administrative Code;

(4) Safe operating procedures for each type of radiation-generating equipment to be handled;

(5) Training of operators of each type of radiation-generating equipment to be handled in order to assure competency in the operating procedures;

(6) In addition to the obligations of paragraph (B)(1) of rule 3701:1-38-10 of the Administrative Code, individuals likely to receive an annual occupational dose in excess of one millisievert (one hundred millirem) will be instructed in the following:

(a) The location, boundaries, and purpose of restricted areas; and

(b) A description of the radiation-generating equipment and its location;

(7) The quality control tests to be performed, the frequency of the quality control tests to be performed and the personnel responsible for the performance of the quality control tests as applicable to the radiation-generating equipment type and use;

(8) Policies regarding the state licensure or certification of each person operating radiation-generating equipment as obligated by Chapters 4773. and 4715. of the Revised Code;

(9) The dissemination of quality assurance policies and a method to educate affected workers on those policies and any policy changes;

(10) Radiation workers' role and responsibility for following and supporting the quality assurance program;

(11) Policies regarding personnel protection, including time, distance, and shielding;

(12) Policies regarding occupational exposure of pregnant workers;

(13) Policies regarding radiation safety training for ancillary personnel;

(14) Policies regarding training for personnel with quality control responsibilities;

(15) Policies regarding human patient protection, including screening for pregnancy, exposure of pregnant patients, patient shielding, patient education;

(16) Policies regarding verification of human patient identity and exam to be performed, including identification of the appropriate body part;

(17) Policies to only permit licensed practitioners to order radiographic examinations;

(18) An inventory of radiation-generating equipment, including the location and description of each unit.

(C) In addition to the obligations of paragraphs (A) and (B) of this rule, the quality assurance program of hospital registrants will comply with the following:

(1) A certified radiation expert will conduct oversight and maintenance of quality assurance programs for hospital registrants, by:

(a) Auditing the quality assurance program on an annual basis;

(b) Performing reviews of the quality assurance program each quarter;

(c) Completing and submitting all necessary information with the annual audit form in accordance with paragraph (C)(6) of this rule; and

(d) Serving on the quality assurance committee;

(2) Employees working in the radiation areas will be made aware of the identity, scope of authority, and a method for contacting the certified radiation expert and the individual responsible for radiation protection. This information, or a specific location where this information may be obtained, will be conspicuously posted in each area where radiation-generating equipment is used;

(3) Each hospital registrant will establish a quality assurance committee for the management of the quality assurance program. The members of the quality assurance committee will be approved by an executive administrator. Committee meetings may be attended by the members or similarly qualified, designated alternates. The quality assurance committee will include at least the following members:

(a) A member of the hospital's executive administration;

(b) The individual responsible for radiation protection;

(c) A radiologist or radiation oncologist;

(d) A certified radiation expert representing each of the following as applicable in each hospital;

(i) Radiation therapy services,

(ii) Mammography, or

(iii) Diagnostic radiography other than mammography; and

(e) A management representative of each department of the hospital which has responsibilities involving the handling of radiation-generating equipment;

(4) The quality assurance committee will meet as often as is deemed necessary to carry out its duties, but at least annually. To establish a quorum at least one-half of the committee's membership will be present either in person or by telecommunication, and will include the individual responsible for radiation protection for the hospital, and the member of the executive administration of the hospital. A record of each meeting will be maintained and distributed to each member which will include the following:

(a) The date of the meeting;

(b) An indication of members present; and

(c) A summary of meeting including any recommended actions and ALARA reviews;

(5) Each quarter, the certified radiation expert will submit, to each appointed quality assurance committee member, a review of the quality assurance program, which will contain, as applicable:

(a) Radiation safety policy revisions proposed by the certified radiation expert;

(b) A review of occupational exposure records by the certified radiation expert;

(c) Radiation safety incidents;

(d) Performance evaluation summaries for radiation-generating equipment including a description of any issues found; and

(e) Any corrective actions recommended by the certified radiation expert that are necessary to comply with the obligations of this chapter;

(6) The quality assurance program will be audited at least annually by a certified radiation expert. The certified radiation expert will develop a written report of the audit findings on forms prescribed by the director and submit the report to the quality assurance committee within thirty days of completing the audit. The quality assurance committee will review the audit report and implement any corrective actions determined to be necessary. The certified radiation expert will file the audit report with the director within ninety days of completing the audit. Every audit report will include a determination of whether the quality assurance program properly addresses the matters described in this rule and whether it is being carried out in accordance with the written quality assurance program, and any corrective actions to be taken to comply with the obligations of this chapter. The audit report will become a part of the inspection record.

(D) In addition to the obligations of paragraphs (A) and (B) of this rule, the quality assurance program of registrants performing fluoroscopically-guided interventional other than veterinary procedures, and computed tomography (CT) other than veterinary and cone beam CT procedures will establish a radiation dose review committee in accordance with the following:

(1) The registrant may establish a system-wide committee if the registrant has more than one site;

(2) If the registrant is a subsidiary of a hospital, the obligations of paragraph (D) of this rule may be delegated to the hospital quality assurance committee provided its members meet the obligations of paragraph (D)(3) of this rule;

(3) The radiation dose review committee will include at least the following members:

(a) The individual responsible for radiation protection;

(b) A diagnostic radiation expert;

(c) As applicable, a physician that performs fluoroscopically-guided interventional and/or computed tomography procedures; and

(d) As applicable, a technologist that performs fluoroscopically-guided interventional and/or computed tomography procedures;

(4) A quorum of the radiation dose review committee will meet as often as necessary to carry out its duties, but at least annually. To establish a quorum at least one-half of the committee's membership will be present either in person or by telecommunication, and will include the individual responsible for radiation protection. A record of each meeting will be maintained and include the following:

(a) The date of the meeting;

(b) An indication of members present; and

(c) A summary of meeting including any recommended actions;

(5) The radiation dose review committee for fluoroscopically-guided interventional procedures will establish and implement written policies that include but are not limited to the following:

(a) Identification of individuals who are authorized to use fluoroscopic systems for interventional purpose;

(b) A method to be used to monitor patient radiation dose during fluoroscopically-guided interventional procedures;

(c) Dose notification levels, as appropriate, at which the physician is notified and appropriate actions are taken for patient safety;

(d) Substantial radiation dose level values following nationally recognized standards;

(e) Actions to be taken for cases when a substantial radiation dose level is exceeded which may include patient follow-up; and

(f) Reviewing policies identified in paragraphs (C)(5)(a) to (C)(5)(e) of this rule at least annually;

(6) The radiation dose review committee for computed tomography will determine and review written protocols to improve image quality and minimize patient dose. The review will include acquisition and reconstruction protocols, image quality, and radiation dose. At a minimum, the review will be performed annually and include the following clinical protocols, if performed:

(a) Pediatric head;

(b) Pediatric abdomen;

(c) Adult head;

(d) Adult abdomen;

(e) Adult chest; and

(f) Brain perfusion.

(E) Records obligated by this chapter and Chapter 3701:1-67 of the Administrative Code will be maintained in accordance with the following:

(1) Data and test results of evaluations and calibrations of all radiation-generating equipment for no less than five years;

(2) Data and test results of evaluations of shielding and surroundings of all radiation-generating equipment until the director terminates the registration or five years after the equipment is transferred or disposed;

(3) Maintenance logs for radiation-generating equipment for five years;

(4) Medical event reports involving radiation exposure to individuals for all radiation-generating equipment until the director terminates the registration;

(5) Copies of current licenses or the department's licensure verification web page for everyone who is obligated to possess a license at the facility; and

(6) Biennial calibration certificates or cross calibration documentation for all instruments used to perform area radiation surveys, calibrations, and evaluations for five years.

Last updated December 13, 2024 at 7:31 AM

History

• Effective: December 13, 2024
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-38-14

(A) Each licensee or registrant shall:

(1) Make, or cause to be made, surveys of areas, including the subsurface, that are:

(a) Necessary to comply with this chapter: and

(b) Reasonable under the circumstances to evaluate:

(i) Radiation levels;

(ii) Concentrations or quantities of residual radioactivity; and

(iii) The potential radiological hazards of the radiation levels and residual radioactivity detected.

(2) Notwithstanding paragraph (C) of rule 3701:1-38-20 of the Administrative Code, records from surveys describing the location and amount of subsurface residual radioactivity identified at the site must be kept with records important for decommissioning, and such records must be retained in accordance with paragraph (I) of rule 3701:1-40-17, paragraph (F) of rule 3701:1-44-18, and paragraph (D) of rule 3701:1-56-19 of the Administrative Code, as applicable.

(3) Ensure that instruments and equipment used for quantitative radiation measurements, such as dose rate and effluent monitoring, are calibrated annually for the radiation measured, except as otherwise specified in Chapter 3748. of the Revised Code, rules adopted thereunder, or a license condition.

(4) Ensure that all personnel dosimeters, except for direct and indirect reading dosimeters used to measure the dose to any extremity, that require processing to determine the radiation dose and that are used to comply with paragraph (A) of rule 3701:1-38-12 of the Administrative Code, with other applicable provisions of these regulations, or with conditions specified in a license or registration shall be processed and evaluated by a dosimetry processor that:

(a) Holds a current personnel dosimetry accreditation from the national voluntary laboratory accreditation program of the national institute of standards and technology; and

(b) Is approved in this accreditation process for the type of radiation or radiations included in the national voluntary laboratory accreditation program that most closely approximates the type of radiation or radiations for which the individual wearing the dosimeter is monitored; and

(5) Have procedures in place to minimize the likelihood of a deceptive exposure of an individual monitoring device, and in the event of a suspected deceptive exposure, an investigation should be conducted by the radiation safety officer for licensees or individual responsible for radiation protection for registrants which will lead to corrective action as necessary.

(B) Conditions requiring individual monitoring of external and internal occupational dose are as follows:

(1) Each licensee or registrant shall monitor exposures from sources of radiation at levels sufficient to demonstrate compliance with the occupational dose limits of rule 3701:1-38-12 of the Administrative Code. Each licensee or registrant shall monitor occupational exposure to radiation from sources of radiation under the control of the licensee or registrant and shall supply and require the use of individual monitoring devices by:

(a) Adults likely to receive, in one year from sources of radiation external to the body, a dose in excess of ten per cent of the limits in paragraph (A) of rule 3701:1-38-12 of the Administrative Code;

(b) Minors likely to receive, in one year, from radiation sources external to the body, a deep dose equivalent in excess of one millisievert (0.1 rem), a lens dose equivalent in excess of 1.5 millisievert (0.15 rem), or a shallow dose equivalent to the skin or to the extremities in excess of five millisievert (0.5 rem);

(c) Declared pregnant women likely to receive during the entire pregnancy, from radiation sources external to the body, a deep dose equivalent in excess of one millisievert (0.1 rem); and

(d) Individuals entering a high or very high radiation area.

(2) To determine compliance with paragraph (D) of rule 3701:1-38-12 of the Administrative Code, each licensee shall monitor the occupational intake of radioactive material by and assess the committed effective dose equivalent to:

(a) Adults likely to receive, in one year, an intake in excess of ten per cent of the applicable ALI in appendix C to rule 3701:1-38-12 of the Administrative Code;

(b) Minors likely to receive, in one year, a committed effective dose equivalent in excess of one millisievert (0.1 rem); and

(c) Declared pregnant women likely to receive, during the entire pregnancy, a committed effective dose equivalent in excess of one millisievert (0.1 rem).

(C) Each licensee or registrant shall ensure that any individual who is required to monitor occupational doses in accordance with paragraph (B)(1) of this rule wears an individual monitoring device as follows:

(1) An individual monitoring device, used for monitoring the dose to the whole body, shall be worn at the unshielded location of the whole body likely to receive the highest exposure. When a protective apron is worn, the location of the individual monitoring device is typically at the neck.

(2) An individual monitoring device, used for monitoring the dose to an embryo or fetus of a declared pregnant woman pursuant to paragraph (H) of rule 3701:1-38-12 of the Administrative Code, shall be located at the waist under any protective apron being worn by the woman.

(3) An individual monitoring device, used for monitoring the lens dose equivalent, to demonstrate compliance with paragraph (A) of rule 3701:1-38-12 of the Administrative Code, shall be located at the neck outside any protective apron being worn by the monitored individual, or at an unshielded location close to the eye.

(4) An individual monitoring device, used for monitoring the dose to the extremities, to demonstrate compliance with paragraph (A)(2) of rule 3701:1-38-12 of the Administrative Code, shall be worn on the extremity likely to receive the highest exposure. Each individual monitoring device shall be oriented to measure the highest dose to the extremity being monitored.

(5) When only one individual monitoring device is used to determine the effective dose equivalent for external radiation pursuant to paragraph (A)(4)(b) of rule 3701:1-38-12 of the Administrative Code, it shall be located at the neck outside the protective apron. When a second individual monitoring device is used for the same purpose, it shall be located under the protective apron at the waist. The second individual monitoring device is required for a declared pregnant woman.

Last updated November 2, 2022 at 2:10 PM

History

• Effective: August 30, 2015
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-66-05

The obligations of this rule do not apply to radiation-generating equipment used for dental intraoral or panoral, mammography, bone densitometry, computed tomography, fluoroscopy or spot film imaging, and equipment used in radiation therapy.

(A) General purpose radiographic equipment will meet the following equipment standards:

(1) A means will be provided for limiting the x-ray beam to the image receptor and area of clinical interest;

(2) For radiographic equipment having a variable x-ray field limitation device, the limitation device will have means for independent stepless adjustment of both the length and width of the x-ray field;

(3) For radiographic equipment that employs a light field for visually defining the perimeter of the x-ray field, the light source will be functional and the total misalignment of the edges of the visually defined field with the respective edges of the x-ray field along either the length or width of the visually defined field will not exceed two per cent of the source-to-image distance (SID);

(4) In addition to the obligations of paragraphs (A)(1), (A)(2) and (A)(3) of this rule stationary radiographic equipment having a variable x-ray field limitation device will have:

(a) A means provided to indicate when the axis of the x-ray beam is perpendicular to the plane of the image receptor;

(b) A means provided to align the center of the x-ray field with respect to the center of the image receptor to within two per cent of the SID, when the x-ray beam is perpendicular to the plane of the image receptor;

(c) A means to indicate the SID to within two per cent. If it is a fixed SID, the distance will be indicated with a permanent marking;

(d) The beam limiting device indicate numerically the field size in the plane of the image receptor to which it is adjusted and be accurate within two per cent of the SID; and

(e) Compliance measurements made to discrete SID's and image receptor dimensions in common clinical use, or at any other specific dimensions at which the beam-limiting device or its associated diagnostic x-ray system is uniquely designed to operate;

(5) General purpose radiographic equipment designed with only one image receptor size at a fixed SID will have:

(a) A means to limit the field at the plane of the image receptor to dimensions no greater than those of the image receptor, and to align the center of the x-ray field with the center of the image receptor within two per cent of the SID; or

(b) A means to align the field such that the x-ray field at the plane of the image receptor will not extend beyond any edge of the image receptor;

(6) General purpose radiographic equipment designed with multiple removable or selectable fixed apertures will have:

(a) A means to limit the x-ray field in the plane of the receptor so that such field does not exceed each dimension of the image receptor by more than two per cent of the SID when the axis of the x-ray beam is perpendicular to the plane of the image receptor;

(b) A means to align the center of the x-ray field with the center of the image receptor to within two per cent of the SID or for equipment uniquely designed where the beam axis is intended to be offset from the center of the image receptor, the x-ray field at the plane of the image receptor will not extend beyond the image receptor; and

(c) Paragraphs (A)(6)(a) and (A)(6)(b) of this rule may be met with either:

(i) An assortment of removable, fixed-aperture, beam limiting devices sufficient to meet the obligation for each combination of image receptor size and SID for which the unit is designed with each such device having clear and permanent markings to indicate the image receptor size and SID for which it is designed; or

(ii) A beam-limiting device having multiple fixed apertures sufficient to meet the obligation for each combination of image receptor size and SID for which the unit is designed. Permanent, clearly legible markings will indicate the image receptor size and SID for which each aperture is designed and will indicate which aperture is in position for use;

(7) If a positive beam limitation (PBL) device is used, it will meet the following additional obligations:

(a) The PBL will prevent the production of x-rays when any of the following conditions are met:

(i) Either the length or width of the x-ray field in the plane of the image receptor differs from the corresponding image receptor dimensions by more than three per cent of the SID, except as permitted by paragraph (A)(7)(c) of this rule;

(ii) The sum of the length and width differences as stated in paragraph (A)(7)(a)(i) of this rule without regard to sign exceeds four per cent of the SID; or

(iii) The beam-limiting device is at an SID for which PBL is not designed for sizing;

(b) Compliance with paragraph (A)(7)(a) of this rule will be determined:

(i) When the equipment indicates that the beam axis is perpendicular to the plane of the image receptor; and

(ii) No sooner than five seconds after insertion of the image receptor;

(c) The PBL system will be capable of operation, at the discretion of the operator, such that the size of the field may be made smaller than the size of the image receptor through stepless adjustment of the field size. The minimum field size at a SID of one hundred centimeters will be equal to or less than five centimeters by five centimeters;

(d) The PBL system will be designed such that if a change in image receptor does not cause an automatic return to PBL function as described in paragraph (A)(7)(a) of this rule, then any change of image receptor size or SID will cause an automatic return; and

(e) The PBL system will function as described in paragraph (A)(7) of this rule whenever all the following conditions are met:

(i) The image receptor is inserted into a permanently mounted cassette holder;

(ii) The image receptor length and width are less than fifty centimeters;

(iii) The x-ray beam axis is within plus or minus three degrees of vertical in any direction and the SID is ninety to one hundred thirty centimeters inclusive; or the x-ray beam axis is within plus or minus three degrees of horizontal and the SID is ninety to two hundred five centimeters inclusive;

(iv) The x-ray beam axis is perpendicular to the plane of the image receptor to within plus or minus three degrees; and

(v) Neither tomographic nor stereoscopic radiography is being performed;

(8) A device will be provided to terminate the exposure at a preset time interval, preset product of current and time, preset number of pulses, or preset radiation exposure to the image receptor;

(9) For radiographic equipment that provides manual exposure control, the operator will be able to terminate the exposure at any time unless:

(a) The exposure is 0.5 second or less; or

(b) During serial radiography, means are provided to permit completion of any single exposure of the series in progress;

(10) In the case of radiographic equipment that provides automatic exposure control:

(a) The control panel will indicate when this mode of operation is selected;

(b) The density setting and automatic exposure control detector positions that are selected prior to the exposure will be indicated; and

(c) A visible signal will indicate when an exposure has been terminated at the back-up limit. Manual resetting will be obligated before further automatic timed exposures can be made;

(11) The x-ray control panel will provide visual indication when x-rays are produced and an audible signal will indicate when the exposure has terminated;

(12) The exposure control switch will meet the following obligations:

(a) The switch will be a "dead-man switch;"

(b) It will not be possible to initiate an exposure when the timer is set to the "zero" or "off" position if either position is provided; and

(c) The switch will be permanently mounted in a protected area so that it cannot be operated outside the protected area except for portable, mobile, or veterinary radiation-generating equipment.

(B) In addition to the applicable quality assurance obligations of Chapter 3701:1-66 of the Administrative Code, handlers of general purpose radiographic equipment will comply with the following:

(1) The kilovoltage peak (kVp) accuracy will be within plus or minus ten per cent of the indicated value;

(2) The accuracy of the timing device will be within plus or minus ten per cent of the indicated setting. The timing device will be tested at a minimum of two settings within the operative range of fifty milliseconds to one thousand milliseconds;

(3) The coefficient of variation:

(a) Of the kVp reproducibility for at least four consecutive exposures will not exceed 0.05;

(b) Of the timing device reproducibility for at least four consecutive exposures will not exceed 0.05; and

(c) Of radiation exposure reproducibility for at least four consecutive exposures will not exceed 0.05 for any specific combination of selected technique factors;

(4) For radiographic equipment having independent selection of x-ray tube current (mA), the average ratios of exposure to the indicated mA-seconds (mAs) product obtained at any two consecutive tube current settings will not differ by more than ten per cent of their sum;

(5) For radiographic equipment having a combined x-ray tube current-exposure time product, or mAs selector, but not a separate tube current, or mA selector, the average ratios of exposure to the indicated milliampere-seconds product (milligray/mAs) values obtained at any two consecutive mAs selector settings will not differ by more than ten per cent of their sum;

(6) The average exposure ratio for paragraphs (B)(4) and (B)(5) of this rule will be expressed as follows:

|X₁ - X₂| < 0.10(X₁+X₂)

Where the value of X₁ and X₂ are the average milligray/mAs values obtained at each of the two consecutive tube mA or mAs settings, or at two settings differing by no more than a factor of two where the mA or mAs selector provides continuous selection.

(C) In addition to the applicable radiation safety rules in Chapter 3701:1-38 and rules 3701:1-66-02 and 3701:1-66-04 of the Administrative Code, the operator of general purpose radiographic equipment will limit the useful beam to the area of clinical interest, not to exceed the size of the image receptor by more than two per cent of the source-to-image distance.

(D) Handlers of mobile or portable radiation-generating equipment will not be obligated to comply with the obligations of paragraph (H) of rule 3701:1-66-02 of the Administrative Code, and will comply with the following:

(1) Mobile and portable radiation-generating equipment which are:

(a) Used continuously for greater than one week in the same location, such as a room or suite, will have the x-ray control permanently mounted behind a protected barrier so that the operator can remain entirely behind the protected barrier and see the patient without leaving the protective barrrier during the entire exposure; or

(b) Used for less than one week at the same location will be provided with either a protective barrier at least 6.5 feet high for operator protection that allows the operator to see the patients without leaving the protective barrier during exposures, or means will be provided to allow the operator to be at least six feet from the tube housing assembly during exposures and the operator will wear a protective apron of not less than 0.25 millimeter lead equivalent when making exposures;

(2) Radiation emitted from the x-ray tube when a capacitor energy storage system is fully charged and the exposure switch, timer, or any discharge mechanism is not activated will not exceed an air kerma of 0.26 microgray in one minute at five centimeters from any accessible surface of the diagnostic source assembly, with the beam-limiting device fully open; and

(3) A tube stand or other mechanical support will be used so that the x-ray tube housing assembly will not be hand-held during exposures.

(E) Handlers of stationary veterinary radiation-generating equipment will not be obligated to comply with the obligations of paragraph (H)(4) of rule 3701:1-66-02 of the Administrative Code. However, stationary veterinary radiation-generating equipment will be provided with either a 6.5 foot high protective barrier for operator protection during exposures, or will be provided with means to allow the operator to be at least six feet from the tube housing assembly during exposures. If the operator or assistant is not behind the protective barrier, a lead apron of not less than 0.25 millimeter lead equivalent will be worn when making exposures.

(F) Handlers of mobile or portable veterinary radiation-generating equipment will not be obligated to comply with the obligations of paragraph (H) of rule 3701:1-66-02 of the Administrative Code. However, mobile or portable veterinary radiation-generating equipment will be provided with either a 6.5 foot high protective barrier for operator protection during exposures, or will be provided with means to allow the operator to be at least six feet from the tube housing assembly during exposures. If the operator or assistant is not behind the protective barrier, a lead apron of not less than 0.25 millimeter lead equivalent will be worn when making exposures.

(G) Handlers of certified radiation-generating equipment specifically designed by the manufacturer to be hand-held during radiographic exposures will not be obligated to comply with the obligations of paragraph (H) of rule 3701:1-66-02 of the Administrative Code. The handler will develop and implement safe operating procedures as part of the quality assurance program specified in rule 3701:1-66-04 of the Administrative Code, which will address and document at least the following:

(1) Hand-held radiation-generating equipment will be used for intraoral, extremity or small animal purposes only;

(2) Examination specific source-to-image distances will be developed and implemented to assure the useful beam is limited to the area of clinical interest or no larger than the image receptor;

(3) Operators of the hand-held radiation-generating equipment and individuals participating in the x-ray procedure will be protected from direct scatter radiation by protective aprons of not less than 0.25 millimeter lead equivalent material;

(4) If the hand-held radiation-generating equipment is designed with a back scatter shield, the backscatter shield will be in place during all radiographic exposures;

(5) Storage and security procedures will be developed and implemented to assure hand-held radiation-generating equipment is secured against unauthorized use or removal when not under the control and constant surveillance of the handler;

(6) Hand-held radiation generating equipment will not be used in hallways or waiting rooms; and

(7) Operator training will include documented specific instruction to the x-ray operator regarding:

(a) Not placing any part of their body into the useful beam unless protected by not less than 0.5 millimeter lead equivalent material;

(b) The proper use of source-to-image distance for the examination to assure the size of the radiation beam is no larger than necessary;

(c) Ensuring that all individuals obligated for the examination are wearing the appropriate lead equivalent aprons and no bystanders are in the vicinity;

(d) The areas of use, proper storage and security procedures for the hand-held radiation-generating equipment; and

(e) The use of the dead-man switch and software safety devices such as locks and sensors.

Last updated December 13, 2024 at 7:32 AM

History

• Effective: December 13, 2024
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-38-12

(A) Except in the case of a planned special exposure pursuant to paragraph (F) of this rule, a licensee or registrant shall limit the occupational dose received by an individual adult, as follows:

(1) An annual limit, which is the more limiting of:

(a) The total effective dose equivalent being equal to 0.05 sievert (five rem); or

(b) The sum of the deep dose equivalent and the committed dose equivalent to any individual organ or tissue other than the lens of the eye being equal to 0.5 sievert (fifty rem).

(2) The annual limits to the lens of the eye, to the skin of the whole body, and to the skin of the extremities, which are:

(a) A lens dose equivalent of 0.15 sievert (fifteen rem), and

(b) A shallow-dose equivalent of 0.5 sievert (fifty rem) to the skin of the whole body or to the skin of any extremity.

(3) Doses received in excess of the annual limits, including doses received during accidents, emergencies, and planned special exposures, shall be subtracted from the limits for planned special exposures that the individual may receive during the current calendar year and during the individual's lifetime in accordance with paragraph (F)(5) of this rule.

(4) When the external exposure is determined by measurement with an external personal monitoring device, the deep-dose equivalent must be used in place of the effective dose equivalent, unless the effective dose equivalent is determined by a dosimetry method approved by the director. The assigned deep-dose equivalent must be for the part of the body receiving the highest exposure.

(a) The assigned shallow-dose equivalent must be the dose averaged over the contiguous ten square centimeters of skin receiving the highest exposure. The deep-dose equivalent, lens-dose equivalent, and shallow-dose equivalent may be assessed from surveys or other radiation measurements for the purpose of demonstrating compliance with the occupational dose limits, if the individual monitoring device was not in the region of highest potential exposure, or the results of individual monitoring are unavailable; or

(b) When a protective apron is worn while working with radiation-generating equipment and monitoring is conducted as specified in paragraph (C)(1) of rule 3701:1-38-14 of the Administrative Code, the effective dose equivalent for external radiation shall be determined as follows:

(i) When only one individual monitoring device is used and it is located at the neck outside the protective apron, the reported deep dose equivalent value multiplied by 0.3 shall be the effective dose equivalent for external radiation; or

(ii) When two individual monitoring devices are worn, one under the protective apron at the waist and the other outside the protective apron at the neck, the effective dose equivalent for external radiation shall be assigned the value of the sum of the deep dose equivalent reported for the individual monitoring device located at the waist under the protective apron multiplied by 1.5 and the deep dose equivalent reported for the individual monitoring device located at the neck outside the protective apron multiplied by 0.04; or

(iii) Through the use of computational methods endorsed by the "American National Standards Institute", recommended by the "National Council on Radiation Protection and Measurements", or approved by the director.

(5) Derived air concentration (DAC) and annual limit on intake (ALI) values are specified in appendix C to this rule and may be used by the licensee to determine the individual's dose and to demonstrate compliance with the occupational dose limits. Appendices A and B are explanatory supplements to appendix C to this rule. Notwithstanding the annual dose limits, the licensee shall limit the soluble uranium intake by an individual to ten milligrams in a week in consideration of chemical toxicity.

(6) In accordance with paragraph (E) of this rule, the licensee or registrant shall reduce the dose that an individual may be allowed to receive in the current year by the amount of occupational dose received while employed by any other person.

(B) Compliance with requirements for summation of external and internal doses shall be in accordance with the following:

(1) If the licensee is required to monitor under both paragraphs (B)(1) and (B)(2) of rule 3701:1-38-14 of the Administrative Code, the licensee shall demonstrate compliance with the dose limits by summing external and internal doses. If the licensee is required to monitor only under paragraph (B)(1) or only under paragraph (B)(2) of rule 3701:1-38-14 of the Administrative Code, then summation is not required to demonstrate compliance with the dose limits. The licensee may demonstrate compliance with the requirements for summation of external and internal doses by meeting one of the conditions specified in paragraph (B)(2) of this rule and the conditions in paragraphs (B)(3) and (B)(4) of this rule. The dose equivalents for the lens of the eye, the skin, and the extremities are not included in the summation, but are subject to separate limits.

(2) If the only intake of radionuclides is by inhalation, the total effective dose equivalent limit is not exceeded if the sum of the deep dose equivalent divided by the total effective dose equivalent limit, plus one of the following does not exceed unity:

(a) The sum of the fractions of the inhalation ALI for each radionuclide; or

(b) The total number of derived air concentration-hours, or DAC-hours, for all radionuclides divided by two thousand; or

(c) The sum of the calculated committed effective dose equivalents to all significantly irradiated organs or tissues (T) calculated from bioassay data using appropriate biological models and expressed as a fraction of the annual limit. For purposes of this requirement, an organ or tissue is deemed to be significantly irradiated if, for that organ or tissue, the product of the weighting factors, W_T, and the committed dose equivalent, H_T,50, per unit intake is greater than ten per cent of the maximum weighted value of H_T,50, that is, W_TH_T,50, per unit intake for any organ or tissue.

(3) If the occupationally exposed individual also receives an intake of radionuclides by oral ingestion greater than ten percent of the applicable oral ALI, the licensee shall account for this intake and include it in demonstrating compliance with the limits set forth in paragraph (A) of this rule.

(4) The licensee shall evaluate and, to the extent practical, account for intakes through wounds or skin absorption. The intake through intact skin has been included in the calculation of DAC for hydrogen-3 and does not need to be further evaluated or accounted for pursuant to this paragraph.

(C) Determination of external dose from airborne radioactive material shall be in accordance with the following:

(1) When determining the dose from airborne radioactive material, the licensee shall include the contribution to the deep dose equivalent, lens dose equivalent, and shallow dose equivalent from external exposure to the radioactive cloud as specified in appendix C to this rule, footnotes ^A and ^B.

(2) The licensee should not use airborne radioactivity measurements or DAC values as the primary means to assess the deep dose equivalent when the airborne radioactive material includes radionuclides other than noble gases, or if the cloud of airborne radioactive material is not relatively uniform. The determination of the deep dose equivalent to an individual should be based upon measurements using instruments or individual monitoring devices.

(D) Determination of internal exposure shall be in accordance with the following:

(1) For purposes of assessing dose used to determine compliance with occupational dose equivalent limits, the licensee shall, when required under paragraph (B) of rule 3701:1-38-14 of the Administrative Code, take suitable and timely measurements of:

(a) Concentrations of radioactive materials in air in work areas; or

(b) Quantities of radionuclides in the body; or

(c) Quantities of radionuclides excreted from the body; or

(d) Combinations of these measurements.

(2) Unless respiratory protective equipment is used, as provided in paragraph (C) of rule 3701:1-38-16 of the Administrative Code or the assessment of intake is based on bioassays, the licensee shall assume that an individual inhales radioactive material at the airborne concentration in which the individual is present.

(3) When specific information on the physical and biochemical properties of the radionuclides taken into the body or the behavior of the material in an individual is known, the licensee may:

(a) Use that information to calculate the committed effective dose equivalent, and, if used, the licensee shall document that information in the individual's record; and

(b) Upon prior approval of the department, adjust the DAC or ALI values to reflect the actual physical and chemical characteristics of airborne radioactive material, for example, aerosol size distribution or density; and

(c) Separately assess the contribution of fractional intakes of Class D, W, or Y compounds of a given radionuclide to the committed effective dose equivalent as specified in appendix A to this rule.

(4) If the licensee chooses to assess intakes of Class Y material using the measurements given in paragraph (D)(1)(b) or (D)(1)(c) of this rule in order to make additional measurements basic to the assessments, the licensee may delay the recording and reporting of the assessments for periods up to seven months, unless otherwise required by paragraph (B)(2) or (C) of rule 3701:1-38-21 of the Administrative Code.

(5) If the identity and concentration of each radionuclide in a mixture are known, the fraction of the DAC applicable to the mixture for use in calculating DAC-hours shall be either:

(a) The sum of the ratios of the concentration to the appropriate DAC value, that is, D, W, or Y, from appendix C to this rule for each radionuclide in the mixture; or

(b) The ratio of the total concentration for all radionuclides in the mixture to the most restrictive DAC value for any radionuclide in the mixture.

(6) If the identity of each radionuclide in a mixture is known, but the concentration of one or more of the radionuclides in the mixture is not known, the DAC for the mixture shall by the most restrictive DAC of any radionuclide in the mixture.

(7) When a mixture of radionuclides in air exists, a licensee may disregard certain radionuclides in the mixture if all of the following occur:

(a) The licensee uses the total activity of the mixture in demonstrating compliance with the dose limits in paragraph (A) of this rule and in complying with the monitoring requirements in paragraph (B) of rule 3701:1-38-14 of the Administrative Code;

(b) The concentration of any radionuclide disregarded is less than ten percent of its DAC; and

(c) The sum of these percentages for all of the radionuclides disregarded in the mixture does not exceed thirty percent.

(8) When determining the committed effective dose equivalent, the licensee may consider the following:

(a) In order to calculate the committed effective dose equivalent, the licensee may assume that the inhalation of one ALI, or an exposure of two thousand DAC-hours, results in a committed effective dose equivalent of 0.05 sievert (five rem), for radionuclides that have their ALIs or DACs based on the committed effective dose equivalent; or

(b) For an ALI and the associated DAC determined by the nonstochastic organ dose limit of 0.5 sievert (fifty rem), the intake of radionuclides that would result in a committed effective dose equivalent of 0.05 sievert (five rem), that is, the stochastic ALI, is listed in parentheses in table I of appendix C to this rule. The licensee may, as a simplifying assumption, use the stochastic ALI to determine committed effective dose equivalent. However, if the licensee uses the stochastic ALI, the licensee shall also demonstrate that the limit in paragraph (A)(1)(b) of this rule is met.

(E) Determination of prior occupational dose shall be made in accordance with the following:

(1) For each individual who is likely to receive an annual occupational dose requiring monitoring pursuant to paragraph (B) of rule 3701:1-38-14 of the Administrative Code, the licensee or registrant shall determine the occupational radiation dose received during the current year.

(2) Prior to permitting an individual to participate in a planned special exposure, the licensee shall determine:

(a) The internal and external doses from all previous planned special exposures; and

(b) All doses in excess of the limits, including doses received during accidents and emergencies, received during the lifetime of the individual.

(3) In complying with the requirements of paragraph (E)(1) or (E)(2) of this rule, a licensee or registrant may:

(a) Accept, as a record of the occupational dose that the individual received during the current year, a written signed statements from the individual, or from the individual's most recent employer for work involving radiation exposure, that discloses the nature and the amount of any occupational dose that the individual may have received during the current year;

(b) Accept, as the record of lifetime cumulative radiation dose, a current department form entitled "lifetime occupational exposure history" or equivalent, signed by the individual and countersigned by an appropriate official of the most recent employer for work involving radiation exposure, or the individual's current employer, if the individual is not employed by the licensee or registrant; and

(c) Obtain reports of the individual's dose equivalent from the most recent employer for work involving radiation exposure, or the individual's current employer, if the individual is not employed by the licensee or registrant, by telephone, telegram, facsimile, e-mail or letter. The licensee or registrant shall request a written verification of the dose data if the authenticity of the transmitted report cannot be established.

(4) The licensee or registrant shall record the exposure history, as required by paragraph (A) of this rule, on a form provided by the department or other clear and legible record, of all the information required on that form. The form or record shall show each period in which the individual received occupational exposure to radiation or radioactive material and shall be signed by the individual who received the exposure. For each period for which the licensee or registrant obtains reports, the licensee or registrant shall use the dose shown in the report in preparing the exposure history form. For any period in which the licensee or registrant does not obtain a report, the licensee or registrant shall place a notation on the exposure history form indicating the periods of time for which data are not available.

(5) If the licensee or registrant is unable to obtain a complete record of an individual's current and previously accumulated occupational dose, the licensee or registrant shall assume:

(a) In establishing administrative controls pursuant to paragraph (A)(6) of this rule for the current year, that the allowable dose limit for the individual is reduced by 12.5 millisievert (1.25 rem), for each quarter for which records were unavailable and the individual was engaged in activities that could have resulted in occupational radiation exposure; and

(b) That the individual is not available for planned special exposures.

(6) The licensee or registrant shall retain the records on the exposure history form until the department terminates each pertinent license or registration requiring this record. The licensee or registrant shall retain records used in preparing the exposure history form for three years after the record is made.

(F) A planned special exposure may be authorized by a licensee in accordance with this paragraph. A licensee may authorize an adult worker to receive doses in addition to and accounted for separately from the doses received under the limits specified in paragraph (A) of this rule provided that each of the following is satisfied:

(1) The licensee authorizes a planned special exposure only in an exceptional situation when alternatives that might avoid the higher exposure are unavailable or impractical;

(2) The licensee and employer, if the employer is not the licensee, specifically authorizes the planned special exposure, in writing, before the exposure occurs;

(3) Before a planned special exposure, the licensee ensures that each individual involved is:

(a) Informed of the purpose of the planned operation; and

(b) Informed of the estimated doses and associated potential risks and specific radiation levels or other conditions that might be involved in performing the task; and

(c) Instructed in the measures to be taken to keep the dose ALARA considering other risks that may be present;

(4) Prior to permitting an individual to participate in a planned special exposure, the licensee ascertains prior doses as required by paragraph (E)(2) of this rule during the lifetime of the individual for each individual involved;

(5) The licensee shall not authorize a planned special exposure that would cause an individual to receive a dose from all planned special exposures and all doses in excess of the limits to exceed:

(a) The numerical values of any of the dose limits in paragraph (A) of this rule in any calendar year; and

(b) Five times the annual dose limits specified in paragraph (A) of this rule during the individual's lifetime;

(6) The licensee maintains records of the conduct of a planned special exposure in accordance with paragraph (E) of rule 3701:1-38-20 of the Administrative Code and submits a written report in accordance with paragraph (D) of rule 3701:1-38-21 of the Administrative Code;

(7) The licensee records the best estimate of the dose resulting from the planned special exposure in the individual's record and informs the individual, in writing, of the dose within thirty days from the date of the planned special exposure. The dose from planned special exposures shall not be considered in controlling future occupational dose of the individual pursuant to paragraph (A)(1) of this rule, but shall be included in evaluations required by paragraphs (F)(4) and (F)(5) of this rule.

(G) Occupational dose limits for minors shall be ten per cent of the annual occupational dose limits specified for adult workers in paragraph (A) of this rule.

(H) Dose equivalent to an embryo or fetus shall be in accordance with the following:

(1) The licensee or registrant shall ensure that the dose equivalent to an embryo or fetus during the entire pregnancy, due to occupational exposure of a declared pregnant woman, does not exceed five millisievert (0.5 rem). Records shall be maintained in accordance with paragraph (I) of rule 3701:1-38-20 of the Administrative Code.

(2) The licensee or registrant shall make efforts to avoid substantial variation above a uniform monthly exposure rate to a declared pregnant woman so as to satisfy the limit in paragraph (H)(1) of this rule.

(3) The dose equivalent to the embryo or fetus is the sum of:

(a) The deep-dose equivalent to the declared pregnant woman; and

(b) The dose equivalent to the embryo or fetus resulting from radionuclides in the embryo or fetus and from radionuclides in the declared pregnant woman.

(4) If the declared pregnant woman's exposure includes exposure from radiation generating equipment and a protective apron is worn, the dose equivalent to an embryo or fetus shall be taken as the sum of:

(a) The dose equivalent to the embryo or fetus from radionuclides in the embryo or fetus and radionuclides in the declared pregnant woman; and

(b) The dose equivalent that is most representative of the dose to the embryo or fetus from external radiation, that is, in the mother's lower torso region.

(i) If multiple measurements have not been made, assignment of the highest deep dose equivalent for the declared pregnant woman shall be the dose to the embryo or fetus, in accordance with paragraph (A)(4) of this rule; or

(ii) If multiple measurements have been made, assignment of the deep dose equivalent for the declared pregnant woman from the individual monitoring device which is most representative of the dose to the embryo or fetus shall be the dose to the embryo or fetus. Assignment of the highest deep dose equivalent for the declared pregnant woman to the embryo or fetus is not required unless that dose is also the most representative deep dose equivalent for the region of the embryo or fetus.

(5) If by the time the woman declares pregnancy to the licensee or registrant, the dose equivalent to the embryo or fetus has exceeded five millisievert, or 0.5 rem, the licensee or registrant shall be deemed to be in compliance with paragraph (A) of this rule, provided that the additional dose equivalent to the embryo or fetus does not exceed 0.5 millisievert (0.05 rem), during the remainder of the pregnancy.

View AppendixView AppendixView Appendix

Last updated November 2, 2022 at 2:10 PM

History

• Effective: October 4, 2010
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-38-13

(A) Each licensee or registrant shall conduct operations so that:

(1) The total effective dose equivalent to individual members of the public from the licensed or registered operation does not exceed one millisievert (0.1 rem) in a year, exclusive of the dose contribution from the following:

(a) Background radiation;

(b) Radiation attributable to any medical administration the individual has received;

(c) Exposure to an individual that was administered radioactive materials and has been released in accordance with rule 3701:1-58-30 of the Administrative Code or equivalent United States nuclear regulatory agency or agreement state regulations;

(d) Voluntary participation in medical research programs;

(e) The licensee's disposal of radioactive material into sanitary sewerage in accordance with paragraph (D) of rule 3701:1-38-19 of the Administrative Code; and

(2) The dose in any unrestricted area from external sources, exclusive of the dose contribution from patients administered radioactive material and released in accordance with rule 3701:1-58-30 of the Administrative Code or equivalent United States nuclear regulatory agency or agreement state regulations, does not exceed 0.02 millisievert (0.002 rem) in any one hour.

(B) If the licensee or registrant permits members of the public to have access to controlled or restricted areas, the limits for members of the public continue to apply to those individuals.

(C) A licensee, registrant, or an applicant for a license or registration may apply for prior department authorization to operate up to an annual dose limit for an individual member of the public of five millisievert (0.5 rem). This application shall include the following information:

(1) Demonstration of the need for and the expected duration of operation in excess of the limit set forth in paragraph (A) of this rule;

(2) The licensee's or registrant's program to assess and control dose within the five millisievert (0.5 rem) annual limit; and

(3) The procedures that the registrant or licensee will follow to maintain the dose ALARA.

(4) Notwithstanding paragraph (A)(1) of this rule, a licensee may permit visitors to an individual who cannot be released, under rule 3701:1-58-30 of the Administrative Code, to receive a radiation dose greater than one millisievert (0.1 rem) if:

(a) The radiation dose received does not exceed five millisievert (0.5 rem); and

(b) The authorized user, as defined in Chapter 3701:1-58 of the Administrative Code, has determined before the visit that it is appropriate.

(D) In addition to the requirements of paragraphs (A) and (B) of this rule:

(1) A licensee subject to the provisions of the United States environmental protection agency's generally applicable environmental radiation standards in 40 C.F.R. 190 (as in effect on the effective date of this rule), shall also comply with those standards.

(2) The department may impose additional restrictions on radiation levels in unrestricted areas and on the total quantity of radionuclides that a licensee may release in effluents in order to restrict the collective dose.

(E) The licensee or registrant shall demonstrate compliance with dose limits for individual members of the public.

(1) The licensee or registrant shall make or cause to be made surveys of radiation levels in unrestricted and controlled areas and radioactive materials in effluents released to unrestricted and controlled areas to demonstrate compliance with the dose limits for individual members of the public in paragraph (A) of this rule.

(2) A licensee or registrant shall show compliance with the annual dose limit in paragraph (A) of this rule by:

(a) Demonstrating by measurement or calculation that the total effective dose equivalent to the individual likely to receive the highest dose from the licensed or registered operation does not exceed the annual dose limit; or

(b) Demonstrating that:

(i) The annual average concentrations of radioactive material released in gaseous and liquid effluents at the boundary of the unrestricted area do not exceed the values specified in appendix C to rule 3701:1-38-12 of the Administrative Code; and

(ii) If an individual were continuously present in an unrestricted area, the dose from external sources would not exceed 0.02 millisievert (0.002 rem) in an hour and 0.5 millisievert (0.05 rem) in a year.

(3) Upon approval from the department, the licensee may adjust the effluent concentration values in appendix C to rule 3701:1-38-12 of the Administrative Code for members of the public, to take into account the actual physical and chemical characteristics of the effluents, such as aerosol size distribution, solubility, density, radioactive decay equilibrium, or chemical form.

Last updated January 20, 2022 at 8:47 AM

History

• Effective: January 20, 2022
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-67-08

In addition to the rules in Chapters 3701:1-38 and 3701:1-67 of the Administrative Code, handlers shall comply with paragraphs (A) to (L) of this rule.

(A) Therapy equipment subject to the rules in Chapter 3701:1-67 of the Administrative Code shall be provided with such primary and secondary barriers as are necessary to ensure compliance with rules 3701:1-38-12 and 3701:1-38-13 of the Administrative Code which prescribe occupational and public dose limits respectively. Specifically:

(1) All wall, floor, and ceiling areas struck by the useful beam shall have primary barriers; and

(2) Secondary barriers shall be provided in all wall, floor, and ceiling areas not having primary barriers.

(B) Treatment room design shall provide for:

(1) Continuous two-way aural communication between the patient and the operator at the control panel; and

(2) Continuous observation of the patient during irradiation. This viewing system shall be so located that the operator can observe the patient from the control panel. Therapy equipment shall not be used for patient irradiation unless at least one viewing system is operational.

(C) For therapy equipment operating above 150kV, treatment rooms shall meet the following:

(1) All protective barriers shall be fixed, except for entrance access doors to the treatment room or movable beam interceptors;

(2) The control panel shall be located outside the treatment room or in a totally enclosed booth, which has a ceiling, inside the room; and

(3) Interlocks shall be provided such that all entrance doors, including doors to any interior booths if applicable, shall be closed before treatment can be initiated or continued. If the radiation beam is interrupted by any door opening, it shall not be possible to restore the machine to operation without closing the door and reinitiating irradiation by manual action at the control panel.

(D) For therapy equipment operating at or above one MV, treatment rooms shall meet the following:

(1) In addition to other requirements specified in Chapter 3701:1-67 of the Administrative Code, the control panel shall:

(a) Be located outside the treatment room;

(b) Provide an indication of whether electrical power is available at the control panel and if activation of the radiation is possible;

(c) Provide an indication of whether radiation is being produced; and

(d) Include an access control or locking device that will prevent unauthorized use of the therapy equipment;

(2) Treatment room entrances shall be provided with warning lights in a readily observable position near the outside of all access doors, which will state in words when the useful beam is on;

(3) Interlocks shall be provided such that all access controls are activated before treatment can be initiated or continued. If the radiation beam is interrupted by any access control, it shall not be possible to restore the therapy equipment to operation without resetting the access control and reinitiating irradiation by manual action at the control panel;

(4) If the shielding material in any protective barrier requires the presence of a beam interceptor to ensure compliance with paragraph (A) and paragraph (B) of rule 3701:1-38-13 of the Administrative Code, interlocks shall be provided to prevent the production of radiation, unless the beam interceptor is in place, whenever the useful beam is directed at the designated barrier(s);

(5) At least one emergency power cutoff switch shall be located in the radiation therapy room and shall terminate all equipment electrical power including radiation and mechanical motion. This switch is in addition to the termination switch required on the treatment control panel. All emergency power cutoff switches shall include a manual reset so that the therapy equipment cannot be restarted from the unit's control console without resetting the emergency cutoff switch; and

(6) All safety interlocks shall be designed so that any defect or component failure in the safety interlock system prevents or terminates operation of the therapy equipment.

(E) A qualified medical physicist shall design shielding, verify shielding design or verify that the existing shielding is adequate for installation of therapy equipment.

(F) The facility design information for all new installations of therapy equipment or installations of equipment of higher energy or capable of producing a larger maximum useful beam into a room not previously designed for that energy or beam size shall be submitted to the department prior to installation of the therapy equipment. The minimum facility design information that shall be submitted is listed in the appendix to this rule.

(G) An area radiation survey of all new facilities, and existing facilities not previously surveyed, shall be performed by, or under the direct supervision of a qualified medical physicist using an operable radiation measurement survey instrument calibrated in accordance with rule 3701:1-67-07 of the Administrative Code.

(H) The area radiation survey shall be performed with the therapy equipment in the "beam-on" condition using the largest clinically available treatment field and a scattering phantom in the useful beam when evaluating secondary protective barriers and no phantom in the useful beam when evaluating primary protective barriers to verify that:

(1) Radiation levels in restricted areas are not likely to cause personnel exposures in excess of the limits specified in rule 3701:1-38-12 of the Administrative Code; and

(2) Radiation levels in unrestricted areas do not exceed the limits specified in rule 3701:1-38-13 of the Administrative Code.

(I) In addition to the requirements of paragraphs (G) and (H) of this rule, an area radiation survey shall also be performed by a qualified medical physicist or directly supervised by a qualified medical physicist prior to any subsequent medical use and:

(1) After making any change in the treatment room shielding;

(2) After making any change in the location of the therapy equipment within the treatment room except for portable contact therapy equipment, electronic brachytherapy equipment or portable external beam radiation therapy equipment capable of electron production only;

(3) After relocating the therapy equipment except for portable contact therapy equipment, electronic brachytherapy equipment or portable external beam radiation therapy equipment capable of electron production only;

(4) Before using the therapy equipment in a manner that could result in increased radiation levels in areas outside the external beam radiation therapy treatment room; or

(5) After changes are made to the therapy equipment, the therapy equipment shielding, or the treatment room shielding following a survey that failed to ensure compliance with the requirements of this rule.

(6) Determination of residual activity for all therapy equipment capable of generating photon and electron energies above ten MV shall be performed to determine compliance with occupational dose limits prior to machining, removing, or working on therapy equipment components which may have become activated due to photo- neutron production.

(J) If the results of the area radiation surveys required by paragraphs (G) to (I) of this rule indicate any radiation levels in excess of the respective limits, the handler shall lock the control in the "off" position and not use the unit:

(1) Except as may be necessary to repair, replace, or test the therapy equipment, the therapy equipment shielding, or the treatment room shielding;

(2) Until either the equipment is provided with appropriate beam directional interlocks or additional radiation shielding is added to ensure compliance with rules 3701:1-38-12 and 3701:1-38-13 of the Administrative Code;

(3) Until implementation of administrative controls to reduce radiation levels below the respective limits; or

(4) Until the handler has requested and received a variance from the department that authorizes radiation levels in unrestricted areas greater than those permitted by rules 3701:1-38-12 and 3701:1-38-13 of the Administrative Code.

(K) The area radiation survey record shall indicate:

(1) All instances where the facility, in the opinion of the qualified medical physicist, is in violation of applicable regulations;

(2) The date of the measurements;

(3) The reason the survey is required;

(4) The manufacturer's name, model number and serial number of the therapy equipment;

(5) The manufacturers' names, model numbers, serial numbers, and dates of calibration of the instruments used to measure radiation levels;

(6) A plan of the areas surrounding the treatment room that were surveyed;

(7) The measured dose rate at a representative number of points in each area expressed in microsieverts (millirem) per hour;

(8) The calculated maximum level of radiation over a period of one week for each restricted and unrestricted area; and

(9) The name and signature of the individual responsible for conducting the survey.

(L) Maintain a record of each shielding design and area radiation survey for the duration of the registration and make the records and measurements available upon request during an inspection.

View Appendix

Last updated September 1, 2022 at 8:27 AM

History

• Effective: September 1, 2022
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-67-09

In addition to the rules in Chapters 3701:1-38 and 3701:1-67 of the Administrative Code, handlers shall comply with paragraphs (A) to (H) of this rule.

(A) For therapy equipment subject to this chapter, a qualified medical physicist shall develop a documented quality assurance (QA) program using the appropriate "American Association of Physicists in Medicine" (AAPM) reports or the "National Council of Radiation Protection" (NCRP) report as a basis.

(1) The quality assurance program shall:

(a) Identify each QA performance test to be performed;

(b) Describe the procedures used to complete each QA performance test;

(c) Describe the method used to document the results of each QA performance test;

(d) Identify the frequency of each QA performance test; and

(e) Specify the acceptable action limits and safety tolerance limits for each QA performance test result and the action to be taken when exceeded.

(2) Any variation from the identified tests, frequency or tolerance limits specified in the appropriate AAPM or NCRP reports shall be based on a documented history of therapy equipment performance, therapy equipment clinical utilization, or inherent therapy equipment design and be justified by the qualified medical physicist in the quality assurance program. Should the qualified medical physicist decide to change the frequency or tolerance limit of a particular test, the decision should be validated with an appreciable history of that test or rationale.

(3) Any QA performance test result exceeding a factor of two from the tolerances in AAPM or NCRP documents shall require immediate action prior to further treatment.

(B) Perform QA performance tests in accordance with the written procedures established by the qualified medical physicist and comply with the following:

(1) The authorized physician and qualified medical physicist shall be immediately notified if any QA performance test result exceeds a safety tolerance limit set by the qualified medical physicist. The cause for a parameter exceeding the safety tolerance limit shall be investigated before the system is used for patient irradiation. The medical physicist in collaboration with the authorized physician shall determine whether medical treatment may continue safely or be interrupted until corrected;

(2) Use a dosimetry system described in rule 3701:1-67-07 of the Administrative Code to perform absolute-dose related QA performance tests required by this rule;

(3) Have the qualified medical physicist review and sign the results of each QA performance test within a month of the date that the test was performed, by an individual other than the qualified medical physicist; and

(4) Ensure that safety QA tests are performed monthly on the following:

(a) Electrical interlocks at each external beam radiation therapy room entrance;

(b) The "beam-on" and termination switches;

(c) All beam indicator lights;

(d) Patient audio visual viewing system; and

(e) If applicable, electrically operated treatment room doors from inside and outside the treatment room.

(C) As used in this rule, "calibration" means the determination of the exposure or dose per unit time or absorbed dose per monitor unit (MU) under specified conditions as described by the qualified medical physicist in the quality assurance program. Calibration shall be performed:

(1) Before the first medical use following installation or reinstallation;

(2) Annually; and

(3) Before medical use under the following conditions:

(a) Whenever QA performance test results indicate the radiation output differs by more than five per cent from the calibration value obtained during the most recent annual QA performance tests and the difference cannot be reconciled. Calibration of therapy equipment with multi-energy capabilities is required only for those modes and/or energies that are not within their acceptable range; and

(b) Following any major mechanical, electrical or software based alterations affecting the radiation source, its housing, power supply or controls or after replacement of the radiation source. If an alteration or replacement does not affect all energies, calibration shall be performed on the affected energy that is in most frequent clinical use at the facility. The remaining energies may be validated with quality assurance check procedures against the criteria in paragraph (C)(3)(a) of this rule.

(D) For therapy equipment operating at less than one megavolt (MV):

(1) The qualified medical physicist shall use NCRP report 69, Dosimetry of X-Ray and Gamma Ray Beams for Radiation Therapy in the Energy Range 10 keV to 50MeV (1981) for commissioning, initial QA performance testing and to meet the requirements of paragraph (A) of this rule. The term "QA performance test", as used in paragraph (D) of this rule, shall have the same meaning as the term "check" in the NCRP report.

(2) Commissioning and initial QA performance testing shall be completed prior to medical use following installation or reinstallation.

(3) Commissioning, initial and annual QA performance tests shall be performed by or under direct supervision of a qualified medical physicist.

(E) For therapy equipment operating at or above one megavolt (MV):

(1) The qualified medical physicist shall use the "AAPM Code of Practice for Radiotherapy Accelerators: AAPM Report No. 47 (AAPM report 47)," prepared by "Radiation Therapy Task Group 45" (this publication can be obtained from the American association of physicists in medicine, 1631 Prince st, Alexandria, VA 22314, telephone (301) 209-3350, http://www.aapm.org/pubs/reports) and the manufacturer's contractual specifications as a basis for acceptance testing and commissioning.

(2) To meet the requirements of paragraph (A) of this rule, the qualified medical physicist shall use:

(a) The "Comprehensive QA for Radiation Oncology: Report of AAPM Radiation Therapy Committee Task Group No. 40: AAPM Report No. 46 (AAPM report 46)" (this publication can be obtained from the American association of physicists in medicine, 1631 Prince st, Alexandria, VA 22314, telephone (301) 209-3350, http://www.aapm.org/pubs/reports).

(b) "Task Group 142 report: Quality assurance of medical accelerators" (this publication can be obtained from the American association of physicists in medicine, 1631 Prince st, Alexandria, VA 22314, telephone (301) 209-3350, http://www.aapm.org/pubs/reports) for therapy equipment provided with asymmetric jaws, multileaf collimation, dynamic or virtual wedges, planar imaging devices, tomographic imaging devices or those used for stereotactic radiosurgery, stereotactic body radiation therapy, total body photon irradiation or intensity-modulated radiotherapy.

(c) The "Intraoperative radiation therapy using mobile electron linear accelerators: Report of AAPM Radiation Therapy Committee Task Group No. 72" (this publication can be obtained from the American association of physicists in medicine, 1631 Prince st, Alexandria, VA 22314, telephone (301) 209-3350, http://www.aapm.org/pubs/reports) for mobile electron linear accelerator therapy equipment.

(d) The "Report of AAPM TG 135: Quality assurance for robotic radiosurgery" (this publication can be obtained from the American association of physicists in medicine, 1631 Prince st, Alexandria, VA 22314, telephone (301) 209-3350, http://www.aapm.org/pubs/reports) for robotic radiosurgery therapy equipment.

(e) The "Quality control and assurance for tomotherapy: An update to Task Group Report 148" (this publication can be obtained from the American association of physicists in medicine, 1631 Prince st, Alexandria, VA 22314, telephone (301) 209-3350, http://www.aapm.org/pubs/reports) for helical tomotherapy equipment.

(f) The "Comprehensive proton therapy machine quality assurance AAPM Task Group 224" (this publication can be obtained from the American association of physicists in medicine, 1631 Prince st, Alexandria, VA 22314, telephone (301) 209-3350, http://www.aapm.org/pubs/reports) for proton therapy equipment.

(3) Acceptance testing, commissioning and baseline QA performance testing shall be completed prior to medical use following installation or reinstallation.

(4) Acceptance testing, commissioning, baseline and annual QA performance tests shall be performed by or under direct supervision of a qualified medical physicist.

(5) An independent verification of the calibration of all photon beams and a sample of available electron beams shall be performed annually by:

(a) A second radiation expert using a dosimetry system other than the dosimetry system that was used during the annual calibration; or

(b) A national institute of science and technology traceable third-party dosimetry service or an equivalent method which is capable of measuring doses with an accuracy within five per cent.

(6) Proper operation of each emergency power cutoff switch shall be verified annually. If more than one switch is installed, they may be evaluated on a rotating basis throughout the year.

(F) For image guidance systems and conventional or virtual simulation:

(1) The qualified medical physicist shall use the "Comprehensive QA for Radiation Oncology: Report of AAPM Radiation Therapy Committee Task Group No. 40: AAPM Report No. 46 (AAPM report 46)" (this publication can be obtained from the American association of physicists in medicine, 1631 Prince st, Alexandria, VA 22314, telephone (301) 209-3350, http://www.aapm.org/pubs/reports) to meet the requirements of paragraph (A) of this rule for a conventional simulator.

(2) The qualified medical physicist shall use the "Quality assurance for computed tomography simulators and the computed tomography-simulation process: Report of the AAPM Radiation Therapy Committee Task Group No. 66: AAPM Report No. 83 (AAPM report 83)" (this publication can be obtained from the American association of physicists in medicine, 1631 Prince st, Alexandria, VA 22314, telephone (301) 209-3350, http://www.aapm.org/pubs/reports) for acceptance testing, commissioning and to meet the requirements of paragraph (A) of this rule for a virtual simulator.

(3) The qualified medical physicist shall use the "Quality assurance for image-guided radiation therapy utilizing CT-based technologies AAPM Task Group 179" (this publication can be obtained from the American association of physicists in medicine, 1631 Prince st, Alexandria, VA 22314, telephone (301) 209-3350, http://www.aapm.org/pubs/reports) to meet the requirements of paragraph (A) of this rule for CT-based image guidance systems.

(4) Acceptance testing, commissioning, initial QA performance testing, annual QA performance testing and semiannual (if appropriate) QA performance testing shall be performed by or under the direct supervision of a qualified medical physicist.

(G) For therapy equipment used for IMRT, patient specific treatment QC shall be performed before the first fraction is delivered unless extenuating circumstances are documented by the medical physicist. If a direct measurement for individual plans is not performed, the checks shall include both a dose calculation second check and a method to validate patient plan transfer and deliverability to the treatment unit.

(H) Maintain a record of each QA performance test result for three years and acceptance testing, commissioning and each calibration for the duration of the registration. The records shall include:

(1) The date of the QA test or calibration;

(2) The manufacturer's name, model number, and serial number of the therapy equipment;

(3) The manufacturer's name, model numbers and serial numbers for the instrument(s) used to measure the radiation output of the therapy equipment; and

(4) The signature of the individual who performed the QA performance test or calibration.

Last updated August 24, 2026 at 7:40 AM

History

• Effective: August 20, 2026
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-38-10

(A) Posting of notices to workers.

(1) Each licensee or registrant shall post current copies of the following documents:

(a) All applicable rules promulgated pursuant to Chapters 3748. and 4773. of the Revised Code;

(b) The license or certificate of registration, including, any conditions or documents incorporated by reference into a license and amendments thereto;

(c) The safe operating procedures applicable to activities under the license or registration; and

(d) Any notice of violation involving radiological working conditions, proposed imposition of civil or administrative monetary penalty, or order issued pursuant to rule 3701:1-38-06 of the Administrative Code and any response from the licensee or registrant. Such document shall be posted within five working days after receipt of the document. The licensee's or registrant's response, if any, shall be posted within five working days after dispatch of the document to the director. Such documents shall remain posted for a minimum of five working days or until action correcting the violation has been completed, whichever is later.

(e) The Ohio department of health, bureau of environmental health and radiation protection issued form titled "Notice to Employees."

(2) If posting of a document specified in paragraphs (A)(1)(a) to (A)(1)(c) of this rule is not practical, the licensee or registrant may post a notice which describes the document and states where it may be readily examined.

(3) Documents, notices, or forms posted pursuant to paragraph (A) of this rule shall appear in a sufficient number of places to permit individuals engaged in licensed or registered activity under the license or registration to observe them on the way to or from any particular work location to which the document applies, shall be conspicuous, and shall be replaced if defaced or altered.

(B) Instruction to workers.

(1) The licensee or registrant shall, with respect to all individuals likely to receive an annual TEDE occupational dose in excess of one millisievert (one hundred millirem):

(a) Keep such individuals informed of the storage, transfer, or use of sources of radiation in the licensee's or registrant's workplace;

(b) Instruct such individuals in the health effects associated with exposure to radiation or radioactive material to the individual and potential offspring, in precautions or procedures to minimize exposure, and in the purposes and functions of protective devices employed;

(c) Instruct such individuals in, and instruct such individuals to observe, to the extent within the individual's control, the applicable provisions of rules promulgated under Chapter 3748. of the Revised Code and any license conditions for the protection of personnel from exposures to radiation or radioactive material;

(d) Instruct each such individual of his or her responsibility to report promptly to the licensee or registrant any condition which may constitute, lead to, or cause a violation of Chapter 3748. of the Revised Code, the rules promulgated thereunder, any license condition, or order, and any unnecessary exposure to radiation or radioactive material;

(e) Instruct such individuals in the appropriate response to warnings made in the event of any unusual occurrence or malfunction that may involve exposure to radiation or radioactive material; and

(f) Advise such individuals of any radiation exposure reports furnished pursuant to paragraph (C) of this rule.

(2) In determining those individuals subject to the requirements of paragraph (B)(1) of this rule, licensees and registrants shall take into consideration assigned activities during normal and abnormal situations involving exposure to radiation and radioactive materials which can reasonably be expected to occur during the life of the facility. The extent of these instructions shall be commensurate with potential radiological health protection problems present in the workplace.

(C) Notifications and reports to individuals.

(1) Radiation exposure data for an individual and the results of any measurements, analyses, and calculations of radioactive material deposited or retained in the body of an individual shall be reported to the individual as specified in this rule. The information reported shall include data and results obtained pursuant to Chapter 3748. of the Revised Code or rules adopted thereunder, an order, or license condition as shown in records maintained by the licensee or registrant pursuant to paragraph (H) of rule 3701:1-38-20 of the Administrative Code. Each notification and report shall:

(a) Be in writing;

(b) Include appropriate identifying data such as the name of the licensee or registrant, the name of the individual, and the individual's identification number, preferably social security number;

(c) Include the individual's exposure information; and

(d) Contain the statement: "This report is furnished to you under the provisions of rule 3701:1-38-10 of the Administrative Code. You should preserve this report for further reference."

(2) Each licensee or registrant shall make dose information available to workers as shown in records maintained by the licensee under the provisions of paragraph (H) of rule 3701:1-38-20 of the Administrative Code. The licensee or registrant shall provide an annual report to each individual monitored under rule 3701:1-38-14 of the Administrative Code, of the dose received in that monitoring year if:

(a) The individual's occupational dose exceeds one millisievert (one hundred millirem) TEDE or one millisievert (one hundred millirem) to any individual organ or tissue; or

(b) The individual requests his or her annual dose report.

(3) Each licensee or registrant shall furnish reports to workers.

(a) At the request of a worker formerly engaged in activities controlled by the licensee or registrant, each licensee or registrant shall furnish to the worker a report of the worker's exposure to sources of radiation:

(i) As shown in records maintained by the licensee or registrant pursuant to rule 3701:1-38-20 of the Administrative Code for each year the worker was required to be monitored under the provisions of rule 3701:1-38-14 of the Administrative Code; and

(ii) For each year the worker was required to be monitored under the monitoring requirements in effect prior to August 31, 1999.

(b) This report must be furnished within thirty days from the time the request is made or within thirty days after the exposure of the individual has been determined by the licensee or registrant, whichever is later. This report must cover the period of time that the worker's activities involved exposure to sources of radiation licensed or registered by the director and must include the dates and locations of licensed or registered activities in which the worker participated during this period.

(4) When a licensee or registrant is required pursuant to paragraphs (A) to (C) of rule 3701:1-38-21 of the Administrative Code to report to the director any exposure of an individual to sources of radiation, the licensee or the registrant shall also provide the individual a written report on the exposure data included in the report to the director. This report must be transmitted no later than the transmittal to the director.

(5) At the request of a worker who is terminating employment with the licensee or registrant that involved exposure to sources of radiation during the current calendar quarter or the current year, each licensee or registrant shall provide at termination to each worker, or to the worker's designee, a written report regarding the radiation dose received by that worker from operations of the licensee or registrant during the current calendar year or fraction thereof. If the most recent individual monitoring results are not available at that time, a written estimate of the dose must be provided together with a clear indication that this is an estimate.

Last updated November 2, 2022 at 2:09 PM

History

• Effective: May 17, 2018
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-66-06 Dental radiation-generating equipment.

(A) Dental equipment will meet the following equipment standards:

(1) For dental intraoral equipment, a means will be provided to limit the source-to-skin distance (SSD) to not less than eighteen centimeters;

(2) For dental intraoral equipment, the x-ray field at the minimum SSD will be containable in a circle having a diameter of no more than seven centimeters;

(3) A means will be provided to terminate the exposure at a preset time interval, a preset product of current and time, a preset number of pulses, or a preset radiation exposure to the image receptor;

(4) The exposure control switch will meet the following obligations:

(a) The switch will be of the "dead-man" type;

(b) The operator will be able to terminate the exposure at any time during an exposure of greater than one-half second. Except during panoramic radiography, termination of the exposure will cause automatic resetting of the timer to its initial setting or to zero; and

(c) It will not be possible to make an exposure when the timer is set to "zero" or "off" position if either position is provided;

(5) The kVp accuracy will be within plus or minus ten per cent of the indicated value;

(6) For manual exposures, the accuracy of the timing device will be within plus or minus ten per cent of the indicated setting. The timing device will be tested at a minimum of two settings within the operative range of fifty milliseconds to one thousand milliseconds;

(7) Visual indication will be provided whenever x-rays are produced. Certified equipment also will provide audible indication to the operator while x-rays are produced or on termination of the exposure; and

(8) The coefficient of variation for reproducibility of kVp, timing, and radiation exposure will not exceed 0.05 for four consecutive exposures.

(B) Handlers of dental intraoral and panoral equipment are exempt from paragraph (H) of rule 3701:1-66-02 of the Administrative Code and will comply with the following:

(1) All areas struck by the useful beam will be provided with primary barriers;

(2) When intraoral or panoral units are in adjacent human patient occupied rooms or areas, protective barriers will be provided between the rooms or areas, unless safety procedures are documented and implemented to obligate that no human patients will be present in the adjacent rooms or areas while exposures are being made;

(3) Intraoral and panoral units will be provided with a protective barrier for the operator or will be so arranged that the operator is located at a minimum distance of six feet from the patient and out of the useful beam. The operator's position will be arranged so that the operator views the patient during the entire exposure; and

(4) When the operator is behind a protective barrier, a viewing system will be provided large enough and so placed that the operator can see the patient without having to leave the protected area during exposure.

(C) In addition to the radiation safety obligations listed in rule 3701:1-66-02 of the Administrative Code, handlers of dental equipment will not permit any individual to hold any part of the x-ray tube housing, cone, or mechanical support of the x-ray tube during exposure.

(D) In addition to the quality assurance obligations of rules 3701:1-66-02 and 3701:1-66-04 of the Administrative Code, handlers of dental radiation-generating equipment, with the exception of dental equipment used in hospitals, will conduct annual evaluations of x-ray operators to include the following:

(1) Positioning of the x-ray tube;

(2) Image processing;

(3) Operator location during x-ray exposure;

(4) Appropriate radiologic protocol; and

(5) Applicable regulatory obligations.

(E) Handlers of dental panoral equipment will comply with all obligations of paragraphs (A) to (D) of this rule, except for paragraphs (A)(1) and (A)(2) of this rule, and will comply with the following:

(1) Dental panoral x-ray machines will be certified pursuant to 21 C.F.R. part 1020 (as effective on the effective date of this rule); and

(2) The x-ray field will be limited to the dimensions of the slit in the image receptor holder or limited to the dimensions of the active portion of the image receptor.

(F) Except for dental equipment used for panoral use, handlers of radiographic equipment used for extraoral dental procedures will comply with the obligations of paragraphs (A) and (B) of rule 3701:1-66-05 of the Administrative Code.

(G) Fluoroscopy without image intensification will not be used for dental examinations. Handlers of image intensified fluoroscopic equipment will comply with the applicable obligations of rule 3701:1-66-07 of the Administrative Code.

(H) Handlers of dental cone-beam CT radiation-generating equipment will comply with the applicable obligations of rule 3701:1-66-10 of the Administrative Code, except paragraph (H)(3) of rule 3701:1-66-02 of the Administrative Code if a radiation expert has determined that the public dose limit specified in rule 3701:1-38-13 of the Administrative Code are not exceeded.

(I) Handlers of hand-held radiation-generating equipment used for dental procedures will meet the obligations of paragraphs (A), (B), and (D) of this rule, and will develop and implement safe operating procedures as part of the quality assurance program specified in rule 3701:1-66-04 of the Administrative Code, which will address at least the following:

(1) Hand-held radiation-generating equipment will be used for intraoral purposes only;

(2) Operators of the hand-held radiation-generating equipment will wear a full lead apron of not less than 0.25 millimeter lead equivalent;

(3) Hand-held radiation-generating equipment will be equipped with a backscatter shield of not less than 0.25 millimeters lead equivalent and 15.2 centimeters in diameter that is positioned as close as practicable to the distal end of the device;

(4) Storage and security procedures will be developed and implemented to assure hand-held radiation-generating equipment is secured against unauthorized use or removal when not under the control and constant surveillance of the registrant;

(5) Operator training, as obligated in paragraph (B)(5) of rule 3701:1-66-04 of the Administrative Code, will include documented specific instruction to the x-ray operator regarding not placing any part of their body into the useful beam and ensuring there are no bystanders within a radius of at least six feet from the patient being examined during exposure; and

(6) Hand-held radiation-generating equipment will not be used in hallways or waiting rooms.

(J) Dental equipment will not be operated at less than a measured fifty-one kVp.

(K) Dental equipment used by veterinarians will comply with all obligations of this rule except paragraphs (A)(1), (D), (E), (I) and (J) of this rule. Additionally, the useful beam will be limited to the area of clinical interest.

(L) Extraoral dental equipment used by veterinarians will follow the obligations of paragraph (F) of rule 3701:1-66-05 of the Administrative Code.

Last updated December 13, 2024 at 7:32 AM

History

• Effective: December 13, 2024
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-66-07

(A) Fluoroscopic equipment will meet the following standards:

(1) Unless the United States food and drug administration (FDA) has granted a variance for specific fluoroscopic equipment, the source-to-skin distance (SSD) for fluoroscopy equipment will not be less than:

(a) Thirty-eight centimeters on stationary fluoroscopic equipment unless a particular procedure application prevents that distance, in which case the SSD will not be less than twenty centimeters;

(b) Thirty centimeters on mobile fluoroscopic equipment unless a particular procedure prevents that distance, in which case it will not be less than twenty centimeters; and

(c) Nineteen centimeters for c-arm type fluoroscopic equipment having a maximum source-to-image distance (SID) less than forty-five centimeters unless a particular procedure prevents that distance, in which case it will not be less than ten centimeters. Such systems will be used for extremity or dental purposes only;

(2) For c-arm fluoroscopic equipment equipped with a removable spacer cone, the spacer cone will be attached to the x-ray source during use at all times unless it interferes with the clinical procedure;

(3) The fluoroscopic imaging assembly will be provided with a primary protective barrier which intercepts the entire cross-section of the useful beam at any SID and will prevent further exposures when the primary barrier is not in the path of the entire x-ray beam;

(4) All fluoroscopic equipment will provide intensified imaging. As used in this rule "intensified imaging" will include the use of digital image receptors;

(5) Fluoroscopic equipment will meet the following field limitation specifications:

(a) For fluoroscopic equipment manufactured before June 10, 2006, the following applies:

(i) Neither the length nor the width of the x-ray field in the plane of the image receptor will exceed that of the visible area of the image receptor by more than three per cent of the SID. The sum of the excess length and the excess width will be no greater than four per cent of the SID; and

(ii) For rectangular x-ray fields used with circular image receptors, the error in alignment will be determined along the length and width dimensions of the x-ray field which pass through the center of the visible area of the image receptor;

(b) For fluoroscopic equipment with a circular image receptor manufactured on or after June 10, 2006, the maximum area of the x-ray field in the plane of the circular image receptor will conform with one of the following obligations:

(i) When any linear dimension of the visible area of the image receptor measured through the center of the visible area is less than or equal to thirty-four centimeters in any direction, at least eighty per cent of the area of the x-ray field will overlap the visible area of the image receptor; or

(ii) When any linear dimension of the visible area of the image receptor measured through the center of the visible area is greater than thirty-four centimeters in any direction, the x-ray field measured along the direction of greatest misalignment with the visible area of the image receptor will not extend beyond the edge of the visible area of the image receptor by more than two centimeters;

(c) For fluoroscopic equipment with a rectangular image receptor manufactured on or after June 10, 2006, the following applies:

(i) Neither the length nor the width of the x-ray field in the plane of the image receptor will exceed that of the visible area of the image receptor by more than three per cent of the SID. The sum of the excess length and the excess width will be no greater than four per cent of the SID; and

(ii) The error in alignment will be determined along the length and width dimensions of the x-ray field which pass through the center of the visible area of the image receptor;

(d) If the fluoroscopic x-ray field size is adjusted automatically as the SID or image receptor size is changed, a capability may be provided for overriding the automatic adjustment in case of system failure. If it is so provided, a signal visible at the operator's position will indicate whenever the automatic field adjustment is overridden. Each such system failure override switch will be clearly labeled as follows:

"For X-ray Field Limitation System Failure;"

(e) Beam-limiting devices will be provided with a means for stepless adjustment of the x-ray field; and

(f) Stepless adjustment will, at the greatest SID, provide continuous field sizes from the maximum obtainable to a field size of five centimeters by five centimeters or less;

(6) Timers will meet the following specifications:

(a) A means will be provided to preset the cumulative on-time timer of the fluoroscopic tube. The maximum cumulative time of the timer will not exceed five minutes without resetting;

(b) The timer will terminate the exposure or emit a signal audible to the operator when the exposure time reaches a maximum of five minutes. The signal will continue to sound while x-rays are produced until the timer is reset;

(c) For x-ray controls manufactured on or after June 10, 2006, there will be provided for each fluoroscopic tube:

(i) A display of the fluoroscopic irradiation time at the operator's working position. This display will function independently of the audible signal described in paragraph (A)(6)(c)(ii) of this rule. The following obligations apply:

(a) When the x-ray tube is activated, the fluoroscopic irradiation time in minutes and tenths of minutes will be continuously displayed and updated at least once every six seconds;

(b) The fluoroscopic irradiation time will also be displayed within six seconds of termination of an exposure and remain displayed until reset; and

(c) Means will be provided to reset the display to zero prior to the beginning of a new examination or procedure;

(ii) A signal audible to the operator will sound for each passage of five minutes of fluoroscopic irradiation time during an examination or procedure. The signal will sound until manually reset or, if automatically reset, for at least two seconds;

(7) X-ray production in the fluoroscopic mode will be controlled by a device which requires continuous pressure by the operator for the entire time of any exposure. When recording serial fluoroscopic images, the operator will be able to terminate the x-ray exposure at any time, but means may be provided to permit completion of any single exposure of the series in progress;

(8) Fluoroscopic systems will meet the following air kerma rate limits:

(a) Fluoroscopic equipment provided with only automatic exposure rate control, or provided with both automatic exposure rate control and manual mode capabilities, will not exceed an air kerma rate of eighty-eight milligray per minute (ten roentgens per minute exposure rate) in either mode at any combination of tube potential and current, at the measurement point specified in paragraph (C)(6) of this rule;

(b) Fluoroscopic equipment provided with only manual mode capabilities will not exceed an air kerma rate of forty-four milligray per minute (five roentgens per minute exposure rate) at any combination of tube potential and current, at the measurement point specified in paragraph (C)(6) of this rule; and

(c) For fluoroscopic equipment that is provided with high-level control, and the high-level control is activated, the air kerma rate will not exceed one hundred seventy-six milligray per minute (twenty roentgens per minute exposure rate) at any combination of tube potential and current, at the measurement point specified in paragraph (C)(6) of this rule;

(i) For all fluoroscopy equipment that is provided with high-level control, special means of activation of high level control, such as manual pressure applied continuously by the operator, will be needed to avoid accidental use; and

(ii) A continuous signal audible to the operator will indicate that high level control is being employed;

(9) During fluoroscopy and cinefluorography the x-ray tube potential and current will be continuously indicated;

(10) For undertable fluoroscopic equipment, a shielding device of at least 0.25 millimeter lead equivalent will cover the bucky-slot;

(11) For undertable fluoroscopic equipment, protective drapes, or other devices, at least 0.25 millimeter lead equivalent will be provided between the patient and the individual operating the fluoroscopic equipment to intercept scattered radiation which would otherwise reach the fluoroscopist and others near the x-ray unit, except when such drapes or other devices would compromise the sterile field. Such devices will not substitute for wearing obligated protective apparel;

(12) Radiography using the fluoroscopic imaging assembly will meet the following specifications:

(a) A means will be provided between the source and the patient which will automatically limit the x-ray field at the time the exposure is initiated to no more than the portion of the image receptor selected by the operator for spot films or radiographic images. If the x-ray field size is less than the size of the selected portion of the image receptor, the field size will not open automatically to the size of the selected portion of the image receptor unless the operator has selected such a mode of operation;

(b) Neither the length nor the width of the x-ray field in the plane of the image receptor will differ from the corresponding dimensions of the selected portion of the image receptor by more than three per cent of the SID when adjusted for full coverage of the selected portion of the image selector;

(c) The center of the x-ray field in the plane of the image receptor will be aligned with the center of the selected portion of the image receptor to within two per cent of the SID; and

(d) Means will be provided to reduce the x-ray field size in the plane of the image receptor to a size smaller than the selected portion of the image receptor. The minimum field size at the greatest SID will not exceed five centimeters by five centimeters;

(13) Fluoroscopic equipment manufactured on or after June 10, 2006, will display at the operator's working position the air kerma rate (AKR) and cumulative air kerma in accordance with the following obligations:

(a) When the x-ray tube is activated and the number of images produced per unit time is greater than six images per second, the AKR in milligrays per minute will be continuously displayed and updated at least once every second;

(b) The cumulative air kerma in units of milligrays will be displayed either within five seconds of termination of an exposure or displayed continuously and updated at least once every five seconds;

(c) The display of the AKR will be clearly distinguishable from the display of the cumulative air kerma;

(d) The AKR and cumulative air kerma will represent the value for conditions of free-in-air irradiation at one of the following reference locations specified according to the type of fluoroscope;

(i) For fluoroscopes with x-ray source below the x-ray table, x-ray source above the table, or of lateral type, the reference location will be the respective locations specified in paragraph (C)(6)(a), (C)(6)(b) or (C)(6)(d) of this rule; or

(ii) For C-arm fluoroscopes, the reference location will be fifteen centimeters from the isocenter toward the x-ray source along the beam axis. Alternatively, the reference location will be at a point specified by the manufacturer to represent the location of the intersection of the x-ray beam with the patient's skin;

(e) Means will be provided to reset to zero the display of cumulative air kerma prior to the commencement of a new examination or procedure; and

(f) The displayed AKR and cumulative air kerma will not deviate from the actual values by more than plus or minus thirty-five per cent;

(14) Fluoroscopic equipment manufactured on or after June 10, 2006 will be equipped with means to display a last image hold (LIH) image following termination of the fluoroscopic exposure:

(a) For a LIH image obtained by retaining pre-termination fluoroscopic images, if the number of images and method of combining images are selectable by the user, the selection will be indicated prior to initiation of the fluoroscopic exposure;

(b) For a LIH image obtained by initiating a separate radiographic exposure at termination of the fluoroscopic imaging, the technique factors for the LIH image will be selectable prior to the fluoroscopic exposure, and the combination selected will be indicated prior to initiation of the fluoroscopic exposure; and

(c) Means will be provided to clearly indicate to the user whether a displayed image is the LIH radiograph or fluoroscopy. Display of the LIH radiograph will be replaced by the fluoroscopic image concurrently with re-initiation of the fluoroscopic exposure unless separate displays are provided.

(B) In addition to other applicable radiation safety rules adopted pursuant to Chapter 3748. of the Revised Code, handlers of fluoroscopic radiation-generating equipment will comply with the following:

(1) Any individual who is in the room during the fluoroscopic procedure will be adequately protected by standing behind a whole body protective barrier or will wear a protective lead apron of not less than 0.25 millimeter lead equivalent. If a handler's radiation expert includes documented evidence and specifies in the quality assurance program a distance and time interval in the room from the source at which an individual is unlikely to receive a total effective dose equivalent of greater than two millirem in any one hour or one hundred millirem in a year, the handler can forgo the use of a protective barrier or lead apron for that time at that distance;

(2) Protective lead or lead equivalent gloves will be used by individuals who are obligated to have their hands in the useful beam; and

(3) Handlers of fluoroscopic equipment used for interventional or cardiac procedures or on pediatric or pregnant patients will maintain a record of:

(a) Cumulative air kerma or dose area product used for each examination, if the display of either is available on the fluoroscopic equipment; or

(b) The following items if the cumulative air kerma or dose area product is not displayed on the fluoroscopic equipment:

(i) Mode of operation such as high-level or pulsed mode;

(ii) Cumulative fluoroscopic exposure time; and

(iii) Number of radiographs and number of acquisitions.

(C) In addition to other applicable quality assurance obligations of Chapter 3701:1-66 of the Administrative Code, handlers of fluoroscopic equipment will comply with the following:

(1) Handlers will designate and utilize a radiation expert who will develop in writing and perform fluoroscopic image quality evaluations appropriate for the fluoroscopic equipment including written procedures to include time intervals and system conditions for the evaluation of image quality;

(2) On new installations or reinstallations of existing equipment prior to patient exposure, handlers will utilize a radiation expert to perform the following:

(a) Radiographic device tests to determine compliance with allowable limits as specified in paragraph (A)(12) of this rule;

(b) Fluoroscopic image quality evaluations as specified in paragraph (C)(1) of this rule;

(c) Air kerma rate tests as specified in paragraph (C)(6) of this rule;

(d) High contrast and low contrast resolution evaluations in both fluoroscopic and radiographic modes;

(e) Five minute timer evaluations; and

(f) Evaluation of the accuracy of technique factor indicators and integrated radiation dose displays;

(3) After initial evaluations of fluoroscopic equipment have been performed, the test and evaluations in paragraph (C)(2) of this rule will be performed by a radiation expert annually;

(4) After repair or replacement of any component of the fluoroscopic equipment which may alter the radiation output or image quality, prior to patient use, a radiation expert will perform and document measurements of air kerma rates as specified in paragraph (C)(6) of this rule and image quality as specified in paragraph (C)(1) of this rule unless in the documented determination of a radiation expert, the repair or replacement will not cause a significant change in radiation output or significant degradation of image quality as specified in the quality assurance program;

(a) The radiation expert may designate qualified individuals to perform and document the measurements specified in paragraphs (C)(6) and (C)(1) of this rule;

(b) The radiation expert will provide the criteria for qualifying these designees in the quality assurance program; and

(c) The radiation expert's approval of the designee's test results will be documented within thirty days;

(5) The results of all tests performed in accordance with paragraphs (C)(2) to (C)(4) of this rule will:

(a) Include the technique factors used in determining such results;

(b) Include the name of the individual performing the measurements;

(c) Include the date the measurements were performed; and

(d) Be maintained by the IRRP between inspections for review by the department;

(6) Compliance with air kerma rate allowable limits in paragraph (A)(8) of this rule will be determined as follows:

(a) If the source is below the x-ray table, the air kerma rate will be measured at one centimeter above the tabletop or cradle;

(b) If the source is above the x-ray table, the air kerma rate will be measured at thirty centimeters above the tabletop with the end of the beam limiting device or spacer positioned as closely as possible to the point of measurement;

(c) For c-arm type fluoroscopic equipment, the air kerma rate will be measured at thirty centimeters from the input surface of the image receptor with the source positioned at any SID;

(d) For fixed SID lateral fluoroscopes attached to the x-ray table, the maximum air kerma rate will be measured at a point fifteen centimeters from the centerline of the x-ray table and in the direction of the x-ray source with the end of the beam-limiting device or spacer positioned as closely as possible to the point of measurement. If the table top is moveable, it will be positioned as closely as possible to the lateral x-ray source, with the end of the beam-limiting device or spacer no closer than fifteen centimeters to the centerline of the table;

(e) For c-arm type fluoroscopic equipment having a SID less than forty-five centimeters, the air kerma rate will be determined at the minimum SSD; and

(f) The maximum air kerma rate will be determined with the kVp, mA and/or other selectable parameters adjusted to those settings which give the maximum air kerma rate. X-ray systems that incorporate automatic exposure control will have sufficient attenuative material placed in the useful beam to produce the maximum exposure rate of the system.

(D) Handlers of mobile fluoroscopic equipment will not be obligated to comply with the obligations of paragraphs (A)(10), and (A)(11) of this rule and paragraph (H) of rule 3701:1-66-02 of the Administrative Code.

(E) Handlers of c-arm fluoroscopic equipment having a maximum SID less than forty-five centimeters will not be obligated to comply with the obligations of paragraphs (A)(5)(e), (A)(5)(f), (A)(10), (A)(11), and (A)(12) of this rule and paragraph (H) of rule 3701:1-66-02 of the Administrative Code. In addition, if a radiation expert has specified in the registrant's quality assurance program that an individual is unlikely to receive a total effective dose equivalent of greater than two millirem in any one hour or one hundred millirem in a year, the handler will not be obligated to comply with the obligations of paragraph (B)(1) of this rule.

(F) All individuals operating fluoroscopic equipment, and individuals likely to receive an annual effective dose equivalent in excess of one millisievert (one hundred millirem) from participating in fluoroscopic procedures, will receive at least two hours of radiation protection training specific to fluoroscopy in addition to the training obligated by rule 3701:1-38-10 of the Administrative Code prior to performing or participating in fluoroscopic procedures. Additionally, each individual will receive one hour of re-training whenever the individual receives in excess of thirty per cent of the allowable occupational dose measured over one calendar year.

(G) The training obligated by paragraph (F) of this rule will be approved by the registrant's designated radiation expert, and be specific to the type of fluoroscopic equipment used. Documentation of receiving the training obligated by paragraph (F) of this rule will be retained by the registrant and be available for review upon inspection. At a minimum, training topics will include, but not be limited to:

(1) Principles and operation of the fluoroscopic equipment to be used;

(2) Fluoroscopic and radiographic outputs of each mode of operation, including high-level control options clinically used;

(3) Dose management, including dose reduction techniques for fluoroscopic equipment;

(4) Safe operating procedures of each piece of fluoroscopic equipment that may be used by each individual.

(5) Units of measurement and dose, including dose-area product values and air kerma;

(6) Radiation protection methods for patient and staff;

(7) Basic properties of radiation; and

(8) Biological effects of radiation.

(H) Fluoroscopic equipment used for radiation therapy procedures is regulated pursuant to rule 3701:1-67-09 of the Administrative Code.

(I) Computed tomography scanners equipped with fluoroscopic capabilities are regulated pursuant to rule 3701:1-66-10 of the Administrative Code.

Last updated December 13, 2024 at 7:32 AM

History

• Effective: December 13, 2024
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-66-10

This rule applies to mobile and stationary computed tomography (CT) radiation-generating equipment, except for fluoroscopy units with CT capability, CT units used exclusively for radiotherapy simulation, and CT units integrated with linear accelerators.

(A) CT radiation-generating equipment will be maintained to meet the following equipment standards:

(1) The operator will be able to terminate x-ray exposure at any time during a scan or series of scans of greater than 0.5 second duration;

(2) In the case of premature termination of the x-ray exposure by the operator, the CT radiation-generating equipment will need the operator to reset CT conditions of operation prior to the initiation of another scan;

(3) The CT x-ray control and gantry will provide visual indication whenever x-rays are produced;

(4) If the x-ray production period is less than 0.5 second, the indication of x-ray production will be actuated for at least 0.5 second. Visual indicators at or near the gantry will be discernible from any point external to the patient opening where insertion of any part of the human body into the primary beam is possible;

(5) Each emergency button or switch will be clearly labeled as to its function;

(6) The CT radiation-generating equipment will be designed such that the CT conditions of operation are indicated prior to the initiation of a scan or a scan sequence;

(7) The indicated table increment will not deviate from the actual table increment by more than one millimeter;

(8) Means will be provided to permit visual determination of the location of the tomographic plane or a reference plane. A reference plane may be offset from the location of the tomographic plane(s);

(9) If a device using a light source is used to satisfy paragraph (A)(8) of this rule, the light source will provide illumination levels sufficient to permit visual determination of the location of the tomographic plane or reference plane under ambient light conditions of up to five hundred lux; and

(10) The total error in the indicated location of the tomographic plane or reference plane will not exceed five millimeters.

(B) In addition to paragraph (G) of rule 3701:1-66-02 of the Administrative Code, handlers of CT radiation-generating equipment will meet the following radiation safety obligations:

(1) Techniques will be provided in the vicinity of the control panel or on a pre-programmed menu, based on patient age, weight, body mass index, or patient dimensions, as appropriate, that specifies for each routine examination the CT conditions of operation, including techniques specific to pediatric patient examinations, if applicable;

(2) The limits of radiation dose will not exceed a volume computed tomography dose index (CTDIvol):

(a) Eighty milligray (eight rad) for the facility's routine adult head scan;

(b) Thirty milligray (three rad) for the facility's routine adult or seventy kilogram (one hundred fifty-four pound) abdomen scan;

(c) Twenty milligray (two rad) for the facility's routine pediatric five-year old or eighteen kilogram (forty pound) abdomen scan; and

(d) Forty milligray (four rad) for the facility's routine (one-year old) pediatric head scan;

(3) If the results of the quality control tests, the image quality evaluations, or the radiation dose measurements exceed a tolerance limit established by a radiation expert, use of the CT radiation-generating equipment on patients will be limited to those uses permitted by written instruction of a radiation expert;

(4) Mobile CT radiation-generating equipment, except for stationary CT radiation-generating equipment installed in a van, trailer, or mobile vehicle and operator behind a protective control booth, will be provided with protective curtains of not less than 0.25 millimeter lead equivalent that completely surrounds the gantry bore during exposures, unless the protective curtains interfere with the sterile field of a surgical procedure; and

(5) Any individual who is in the room during a CT exposure will stand clear of the gantry bore, and will stand behind a whole body protective barrier or wear a protective lead apron of not less than 0.25 millimeter lead equivalent.

(C) In addition to other applicable quality assurance obligations in rule 3701:1-66-04 of the Administrative Code, handlers of CT radiation-generating equipment will comply with the following quality assurance obligations:

(1) The handler will designate and utilize a radiation expert who will:

(a) Perform measurements of the radiation dose and image quality prior to medical use:

(i) Upon installation;

(ii) After repair or replacement of any component of the CT equipment which may alter the radiation output or image quality, prior to medical use, a radiation expert will perform and document measurements of radiation output, using a method specified by a radiation expert in the quality assurance program, and image quality as specified in paragraph (C)(1)(c) of this rule unless in the documented determination of a radiation expert, the repair or replacement will not cause a significant change in radiation output or significant degradation of image quality as defined in the quality assurance program according to paragraph (C)(1)(c) of this rule.

(a) The radiation expert may designate qualified individuals to perform and document the measurements specified in paragraph (C)(1)(a)(ii) of this rule;

(b) The criteria for qualifying the designees specified in paragraph (C)(1)(a)(ii)(a) of this rule will be specified by a radiation expert in the quality assurance program; and

(c) The radiation expert's approval of the designee's test results will be documented within thirty days;

(b) Perform measurements of radiation dose annually;

(c) Perform evaluations of image quality at least annually using a CT phantom which has the capability of providing an indication of CT number accuracy for at least three materials. The evaluation of image quality will include CT number accuracy and uniformity, noise, artifacts, radiation beam width, resolution for low and high contrast, alignment light accuracy, and table travel accuracy; and

(d) Develop the written quality control program conducted by the CT technologist appropriate for the evaluation of the CT system that includes the tests and allowable tolerance limits. The quality control evaluation for image quality will include the use of a water equivalent phantom, and at a minimum, the evaluation of artifacts, noise, and CT number accuracy. The evaluation of image quality will be at a minimum completed weekly;

(2) Written records of all image quality evaluations and radiation dose measurements will be maintained between inspections for review by the department's inspector;

(3) The images for quality will be retained until a new image quality evaluation is performed as follows:

(a) Photographic copies of the images obtained from the image display device; or

(b) Images stored in digital form on a storage medium compatible with the CT x-ray system;

(4) In consultation with a radiation expert, develop and implement a written program for radiation dose optimization and scan protocol review. The protocol review will include perfusion studies, if performed. The written program will be audited by a radiation expert on an annual basis;

(5) Radiation dose measurements will be performed using clinical protocols representative of the utilization of the CT unit. If protocols are estimated, measurements will be based on a sample of actual patient data. The specific CT conditions of operation will be documented for each protocol:

(a) Radiation dose measurements will be expressed in terms of CTDIvol;

(b) Radiation dose measurements will be performed using a CT dosimetry phantom that meets the following specifications and conditions of use:

(i) The CT dosimetry phantom will be a right circular cylinder of a material having approximate tissue equivalence of one gram per cubic centimeter. The phantom will be at least fourteen centimeters in length and will have diameters of thirty-two centimeters for measuring radiation dose from the adult abdomen scan protocol and sixteen centimeters for measuring radiation dose from the head and pediatric abdomen scan protocols;

(ii) The CT dosimetry phantom will provide a means for the placement of a dosimeter along the axis of rotation and along a line parallel to the axis of rotation on the outer surface or within one centimeter from the outer surface and within the phantom. Means for the placement of dosimeters or alignment devices at other locations may be provided;

(iii) Any effects on the doses measured due to the removal of phantom material to accommodate dosimeters will be accounted for through appropriate corrections to the reported data or included in the statement of maximum deviation for the values obtained using the phantom; and

(iv) All dose measurements will be performed with the CT dosimetry phantom placed on the patient couch or support device without additional attenuation materials present;

(c) Radiation dose measurements will be performed with a calibrated dosimetry system. The calibration of such system will be traceable to a national standard, or cross-calibrated with a dosimetry system whose calibration is traceable to a national standard. Records of these calibrations will be readily available for review upon inspection. The dosimetry system will have been calibrated within the preceding two years; and

(d) Obligations of paragraphs (C)(5)(a) and (C)(5)(b) of this rule may be satisfied by an alternative nationally-recognized standard for CT dosimetry. If an alternate dosimetry method is used, a radiation expert will document the procedures in the written quality assurance program.

(D) Cone beam computed tomography (CBCT) scanners and hybrid imaging systems, with the exception of CBCT units integrated with linear accelerators, will comply with the following rules:

(1) Under the guidance of a radiation expert, handlers of CBCT units will develop and implement a written quality control testing program to include test procedures, test frequencies, and tolerance limits;

(2) The written quality control testing program will include an annual testing component to be performed by a radiation expert. This annual testing component will be performed upon installation of new CBCT units and annually thereafter;

(3) The annual tests to be performed by a radiation expert will include an assessment of radiation dose and an evaluation of image quality;

(4) Records of all quality control tests will be documented and retained between inspections;

(5) CBCT scanners are exempt from paragraphs (B)(2) and (C)(5) of this rule; and

(6) SPECT/CT and PET/CT units used exclusively for hybrid imaging will be in compliance with paragraph (B)(2) of this rule if protocols used to scan the head satisfy the limits of paragraph (B)(2)(a) of this rule and protocols used to scan the abdomen satisfy the limits of paragraph (B)(2)(b) of this rule.

(E) Micro-CT units equipped with an x-ray tube enclosure designed to exclude personnel from its interior during x-ray generation will be exempt from paragraphs (A) to (D) of this rule, and will comply with the obligations set forth in rule 3701:1-68-06 of the Administrative Code.

(F) Mobile CT radiation-generating equipment permanently mounted on a base with wheels or castors for moving while completely assembled and not used in one place are exempt from paragraphs (H)(4) and (H)(5) of rule 3701:1-66-02 of the Administrative Code.

(G) Handlers of CT radiation-generating equipment used for veterinary purposes are exempt from the obligations of paragraphs (B)(2) and (C)(4) of this rule.

Last updated December 13, 2024 at 7:32 AM

History

• Effective: December 13, 2024
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-66-08 Mammography radiation-generating equipment.

This rule provides standards for radiation-generating equipment used for screening and diagnostic mammography, and mammography equipment used for invasive localization and stereotactically-guided breast biopsy purposes, except as provided by paragraphs (E) and (F) of this rule. In addition, a handler of mammography radiation-generating equipment that uses either stationary or mobile installations, will comply with all applicable standards in 21 C.F.R. part 1020 (as effective on the effective date of this rule).

(A) In addition to meeting the applicable equipment standards in rule 3701:1-66-02 of the Administrative Code, a handler performing screening or diagnostic mammography will have a valid certificate issued by the U.S. department of health and human services, pursuant to the Mammography Quality Standards Reauthorization Act of 1998, Public Law 105-248, and 21 C.F.R. Part 900 (as effective on the effective date of this rule).

(B) A handler of all types of mammography radiation-generating equipment will comply with the shielding obligations in paragraphs (H)(2) to (H)(4) of rule 3701:1-66-02 of the Administrative Code.

(C) In addition to applicable radiation safety obligations in rules adopted pursuant to Chapter 3748. of the Revised Code and rule 3701:1-66-02 of the Administrative Code, a handler of all types of screening and diagnostic mammography radiation-generating equipment will comply with the following:

(1) When a film/screen mammography system is used, clinical films will be processed as soon as possible, but not to exceed twenty-four hours from the time the first clinical image is taken. Facilities utilizing batch processing will:

(a) Use a container to transport clinical films that will protect the film from exposure to light, excessive heat and radiation; and

(b) Maintain a log to include date and identification of each patient, time of first exposure of each batch, and date and time of each batch processing;

(2) Individuals who perform mammography procedures on human beings will hold an Ohio radiographer license in accordance with Chapter 3701-72 of the Administrative Code and will meet at least one of the following qualifications:

(a) Documented evidence of having completed the forty contact hours of training obligated by 21 C.F.R. 900.12(a)(2)(ii); or

(b) Hold advanced certification in mammography issued by the "American Registry of Radiologic Technologists."

(D) In addition to all applicable quality assurance obligations in rules 3701:1-66-02 and 3701:1-66-04 of the Administrative Code, the facility will maintain phantom and quality control images for three months.

(E) Radiation-generating equipment designed for mammography, but used exclusively for radiography of tissue from a biopsy, will be exempt from paragraphs (A) to (D) of this rule, and will comply with paragraphs (E), (H)(2), (H)(3) and (J) of rule 3701:1-66-02 of the Administrative Code.

(F) Radiation-generating equipment used for radiography of tissue from a biopsy and equipped with an x-ray tube enclosure designed to exclude personnel from its interior during x-ray generation will be exempt from paragraphs (A) to (E) of this rule, and will comply with the obligations set forth in rule 3701:1-68-06 of the Administrative Code.

(G) Quality control testing by a radiation expert will be conducted on mammography radiation-generating equipment used for invasive localization or having stereotactically-guided breast biopsy capability. Quality control testing for stereotactically-guided breast biopsy equipment will follow the "American College of Radiology (ACR) Practice Parameter for the Performance of Stereotactic-Guided Breast Interventional Procedures" (as revised in 2016). This document is available from the "American College of Radiology, 1891 Preston White Drive, Reston, Virginia 20191, telephone (703) 648-8900."

(1) The radiation expert will meet the obligations of the aforementioned ACR guideline; and

(2) The radiation expert will document and verify that the facility is taking proper corrective actions when results of the quality control tests indicate the need.

Last updated December 13, 2024 at 7:32 AM

History

• Effective: December 13, 2024
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-68-06

In addition to the applicable rules in this chapter and Chapter 3701:1-38 of the Administrative Code, handlers of cabinet systems will comply with the following:

(A) All cabinet system will meet the following equipment standards:

(1) Radiation emitted from a cabinet system will not exceed an exposure of 4.4 microgray (0.5 milliroentgen) in one hour at any point five centimeters outside the external surface.

(2) Cabinet systems provided with at least one port will be designed such that the insertion of any part of the human body through any port into the primary beam will not be possible.

(3) Cabinet systems provided with at least one aperture will be designed such that the insertion of any part of the human body through any aperture will not be possible.

(4) Safety Interlocks:

(a) Each door will have a minimum of two safety interlocks. One, but not both of theobligated interlocks will be such that door opening results in physical disconnection of the energy supply circuit to the high-voltage generator, and such disconnection will not be dependent upon any moving part other than the door;

(b) Each access panel will have at least one safety interlock;

(c) Following interruption of x-ray generation by the functioning of any safety interlock, use of a control provided in accordance with paragraph (A)(6)(b) of this rule will be necessary for resumption of x-ray generation; and

(d) Failure of any single part of the enclosed fail-safe system will not cause failure of more than one obligated safety interlock.

(5) A ground fault will not result in the generation of x-rays.

(6) Controls and indicators will provide:

(a) A key-actuated control to ensure that x-ray generation is not possible with the key removed;

(b) A control or controls to initiate and terminate the generation of x-rays other than by functioning of a safety interlock or the main power control;

(c) Two independent means which indicate when and only when x-rays are being generated, unless the x-ray generation period is less than one-half second, in which case the indicators will be activated for one-half second, and which are discernible from any point at which initiation of x-ray generation is possible. Failure of a single part of the cabinet system will not cause failure of both indicators to perform their intended function. One, but not both, of the indicators obligated by this paragraph may be a milliammeter labeled to indicate x-ray tube current. All other indicators will be legibly labeled "X-RAY ON";

(d) Additional means other than milliammeters which indicate when and only when x-rays are being generated, unless the x-ray generation period is less than one-half second in which case the indicators will be activated for one-half second, as needed to insure that at least one indicator is visible from each door, access panel, and port, and is legibly labeled "X-RAY ON"; and

(e) Warning labels:

(i) There will be permanently affixed or inscribed on the cabinet x-ray system at the location of any controls which can be used to initiate x-ray generation, a clearly legible and visible label bearing the statement: "CAUTION: X-RAYS PRODUCED WHEN ENERGIZED."

(ii) There will be permanently affixed or inscribed on the cabinet x-ray system adjacent to each port a clearly legible and visible label bearing the statement: "CAUTION: DO NOT INSERT ANY PART OF THE BODY WHEN SYSTEM IS ENERGIZED - X-RAY HAZARD."

(B) In addition to the obligations specified in paragraph (A) of this rule, cabinet systems that are designed to admit humans will provide:

(1) A control within the enclosure for preventing and terminating x-ray generation, which is electrically and/or mechanically separated from the interlock system and cannot be reset, overridden or bypassed from the outside of the enclosure.

(2) No means by which x-ray generation can be initiated from within the enclosure.

(3) Audible and visible warning signals within the enclosure that are actuated for at least ten seconds immediately prior to the first initiation of x-ray generation after closing any door designed to admit humans. Failure of any single part of the cabinet system will not cause failure of both the audible and visible warning signals.

(4) A visible warning signal within the enclosure which remains actuated when and only when x-rays are being generated, unless the x-ray generation period is less than one-half second in which case the indicators will be activated for one-half second.

(5) All entrances into the enclosure will be provided with a conspicuously visible warning device, which operates only when radiation is being produced.

(6) Signs indicating the meaning of the warning signals provided pursuant to paragraphs (B)(3) and (B)(4) of this rule and containing instructions for the use of the control provided pursuant to paragraph (B)(1) of this rule. These signs will be legible, accessible to view, and illuminated when the main power control is in the "on" position.

(7) A means for a person within the enclosure to be able to egress at all times.

(C) In addition to the obligations specified in paragraph (A) of this rule, non-human security screening systems and cabinet x-ray systems with accessible openings will:

(1) Have means to ensure operator presence at the control area in a position which permits surveillance of the openings and doors during generation of x-radiation.

(2) During an exposure or preset succession of exposures of one-half second or greater duration, provide the means to enable the operator to terminate the exposure or preset succession of exposures at any time.

(3) During an exposure or preset succession of exposures of less than one-half second duration, may provide the means to allow completion of the exposure in progress but will enable the operator to prevent additional exposures.

(D) Cabinet systems will be evaluated and the results recorded every three months not to exceed fourteen weeks, by individuals qualified according to paragraph (H) of rule 3701:1-68-02 of the Administrative Code, unless the system has been locked out and tagged "DO NOT USE" and is under the administrative control of the IRRP:

(1) The evaluation will verify:

(a) Proper functioning of each interlock, control, indicator and warning signal; and

(b) Each label is legible and properly affixed in the appropriate location.

(2) If an interlock, control, indicator or warning signal fails, it will be immediately labeled as defective and repaired or replaced within seven calendar days.

(E) Radiation area surveys will be performed and the results recorded to confirm compliance with paragraph (A)(1) of this rule and paragraph (A) of rule 3701:1-38-14 of the Administrative Code in accordance with the following:

(1) Upon installation of the equipment;

(2) During the performance of maintenance, calibration and other procedures if the procedures obligate the presence of a primary beam; and

(3) Any time a visual inspection of the cabinet system reveals an abnormal condition.

(F) A physical radiation survey will be made after each radiographic exposure and before entry of personnel into a cabinet system designed to admit humans to verify that the radiation-generating equipment is not still producing radiation.

(1) Personnel devices providing an audible signal when activated by radiation will be acceptable for the survey, provided:

(a) Proper operation of the audible detection device is checked and recorded daily;

(b) The audible device is designed so as to clearly indicate entry into a 0.02 mSv (two mrem) per hour or greater radiation field; and

(c) All personnel working with the cabinet system are equipped with such a device; or

(2) Stationary area monitors providing an audible signal when activated by radiation will be acceptable for the survey, provided:

(a) Proper operation of the stationary detection device is checked and recorded daily;

(b) The stationary device is designed so as to clearly indicate entry into a 0.02 mSv (two mrem) per hour or greater radiation field; and

(c) Stationary area monitors are evaluated annually to determine that the audible signal operates at a 0.02 mSv (two mrem) per hour radiation field.

(G) The "Individual Responsible for Radiation Protection" (IRRP) will be qualified in accordance with paragraph (H) of rule 3701:1-68-02 of the Administrative Code.

Last updated June 30, 2023 at 12:42 AM

History

• Effective: June 30, 2023
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-66-11 Medical bone densitometry radiation-generating equipment.

(A) Handlers of bone densitometry equipment will assure that the equipment is certified by the manufacturer in accordance with the obligations of 21 C.F.R. part 1010.2, (as effective on the effective date of this rule), and maintained in accordance with the manufacturer's specifications.

(B) In addition to other applicable radiation safety obligations in Chapters 3701:1-38 and 3701:1-66 of the Administrative Code, the operator of bone densitometry equipment will be positioned at least one meter (3.3 feet) from the primary beam or behind a protective barrier containing a minimum of 0.25 millimeter of lead equivalent materials.

(C) In addition to other applicable quality assurance obligations in rules 3701:1-66-02 and 3701:1-66-04 of the Administrative Code, handlers of bone densitometry equipment will comply with the following:

(1) The quality assurance program will include quality control test records which will be maintained between inspections and will include the following:

(a) A list of the tests to be performed as specified by the manufacturer;

(b) The frequency of performance as specified by the manufacturer;

(c) The acceptability limits for each test as specified by the manufacturer; and

(d) A brief description of the procedures and test equipment to be used for each test;

(2) Maintain a readily available copy of the manufacturer's operating manual; and

(3) The operator will advise the patient that the bone densitometry examination is a type of x-ray procedure.

Last updated December 13, 2024 at 7:33 AM

History

• Effective: December 13, 2024
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-66-16 Security screening systems.

(A) Definitions for the purpose of this rule:

(1) "Ambient dose equivalent area product (ADAP)" will be determined using the american national standards institute publication "ANSI/HPS N43.17-2009 Radiation Safety for Personnel Security Screening Systems Using X-Ray or Gamma Radiation."

(2) "Interlock" means a device preventing the start or continued operation of equipment that could cause a radiation hazard.

(3) "Mode of operation" means a selectable set of technique factors or machine settings that is pre-determined by the manufacturer for a specific purpose.

(4) "Scan" means the operation necessary to produce one image (e.g., front view) from one radiation source. One radiation source simultaneously producing multiple images also constitutes one scan. Two sources simultaneously producing two images constitute two scans. In some cases several scans may be necessary for a single screening of the subject.

(5) "Screening" means the sum of radiation exposures or scans necessary to image objects concealed on all sides of the body as intended by the system design under normal conditions:

(a) For backscatter systems a screening typically consists of four scans, one from each side.

(b) For transmission systems a screening typically consists of one scan.

(c) For portal systems a screening consists of a complete pass through the inspection zone.

(6) "Security screening system" means radiation-generating equipment used for the purpose of screening individuals including those that are in the custody of a law enforcement agency to identify contraband items that would present a security threat within a secured facility perimeter.

(7) "Technique factors" means the x-ray settings including:

(a) The peak kilovoltage applied to the x-ray tube;

(b) The electric current passing through the x-ray tube; and

(c) The scan time.

(B) Security screening systems will meet the following equipment standards:

(1) Indicators that light only when a scan is in process will be provided and clearly visible to all security screening system operators and anyone approaching the restricted area;

(2) Power to the system will be controlled by a key switch;

(3) A device to terminate x-ray exposure at any time during a scan;

(4) Access panels to x-ray source and detector will be provided with at least one safety interlock;

(5) Operational safety interlocks will terminate the x-ray exposure in the event of any system problem that could result in abnormal or unintended radiation emission;

(6) Following any premature termination, the security screening system will prevent resumption of x-ray generation until the normal control sequence is reset for a new scan;

(7) Equipment designed to control the exposure output using multiple modes of operation will indicate the selected mode prior to each scan;

(8) Technique factors can not be adjustable and will be preset by the manufacturer for each mode of operation;

(9) A means will be provided to terminate the exposure at a preset time interval or exposure;

(10) When the x-ray tube is operated at its maximum rated tube current for the maximum kilovoltage, the leakage dose will not be greater than 2.5 microsievert (0.25 millirem) in any one hour at any point thirty centimeters from any external surface; and

(11) The primary x-ray beam will be attenuated by at least one millimeter of aluminum- equivalent total filtration.

(C) Handlers of security screening systems will comply with the following administrative and radiation safety obligations:

(1) No individual will be exposed to the useful beam unless authorized by a law enforcement agency for security benefit;

(2) No individual will be exposed to the useful beam for demonstration or frivolous purpose;

(3) The individual responsible for radiation protection will ensure that all operators are trained in the safe operation of the security screening systems;

(4) Any radiation-generating equipment that does not meet the provisions set forth in this rule will not be used to irradiate individuals unless the director determines that the continued use will not pose a radiation risk and arrangements have been made to promptly correct the deficiency;

(5) The handler will follow the manufacturer's recommended maintenance schedule;

(6) Radiation-generating equipment will bear a warning label on the control panel or by the exposure switch which cautions individuals that radiation is produced when it is energized; and

(7) All position locking, holding, and centering devices on radiation-generating equipment components will function as designed by the manufacturer.

(D) Handlers of security screening systems will comply with the obligations of rule 3701:1-66-04 of the Administrative Code, except for paragraphs (B)(8), (B)(15), (B)(16), (B)(17) and (C). In addition, the written quality assurance program will include the following:

(1) Policy banning the frivolous use of security screening systems where no security benefit is to be derived;

(2) Policy obligating individuals undergoing screening to be positioned per manufacturer recommendations when using transmission security screening systems;

(3) Policy banning the exposure of pregnant women;

(4) Policy banning the exposure of minors;

(5) Policy that operator training will follow the topics listed in the "Personnel Training" section of the american national standards institute publication "ANSI/HPS N43.17-2009 Radiation Safety for Personnel Security Screening Systems Using X-Ray or Gamma Radiation;"

(6) For general-use full-body security screening systems capable of delivering a maximum effective dose equivalent less than or equal to 0.1 microsievert (ten microrem) per scan: policies and records to show that administrative controls are applied to limit the number of screenings received by any individual such that the reference effective dose equivalent will not exceed:

(a) 0.25 microseivert (twenty-five microrem) per screening; and

(b) Two hundred fifty microsievert (twenty-five millirem) over any twelve month period;

(7) For limited-use full-body security screening systems capable of delivering a maximum effective dose equivalent greater than 0.1 microsievert (ten microrem) per scan: policies and records to show that administrative controls are applied to limit the number of screenings received by any individual such that the reference effective dose equivalent will not exceed:

(a) Ten microsievert (one millirem) per screening; and

(b) Two hundred fifty microsievert (twenty-five millirem) over any twelve month period;

(8) For general-use partial-body security imaging systems capable of delivering a maximum effective dose equivalent less than or equal to 0.1 microsievert (ten microrem) per scan: policies and records to show that administrative controls will be applied to limit the number of screenings received by any individual, such that:

(a) The ADAP will not exceed 0.03 microsievert per square meter (three microrem per square meter) per scan; and

(b) The total number of scans received at the facility in a twelve month period will not exceed N, where N = seventy-five microsievert per square meter per ADAP (seven thousand five hundred microrem per square meter per ADAP);

(9) For limited-use partial-body security imaging systems capable of delivering a maximum effective dose equivalent greater than 0.1 microsievert (ten microrem) per scan: policies and records to show that administrative controls will be applied to limit the number of screenings received by any individual, such that:

(a) The ADAP will not exceed three microsievert per square meter (three hundred microrem per square meter) per scan; and

(b) The total number of scans received at the facility in a twelve month period will not exceed N, where N = seventy-five microsievert per square meter per ADAP (seven thousand five hundred microrem per square meter per ADAP).

(E) Facility, design, shielding and restricted area obligations:

(1) A clearly marked restricted area will be established. The dose outside of the restricted area will not exceed twenty microsievert (two millirem) in any one hour;

(2) A means will be provided for the operator responsible for initiating the scan to maintain a full visual surveillance of the screening and restricted area; and

(3) Engineering or administrative controls will be provided to ensure that individuals do not reenter the scanning area from the exit while x-rays are being produced.

(F) A health physicist, a radiation expert or a qualified individual designated by a radiation expert will use the american national standards institute publication "ANSI/HPS N43.17-2009 Radiation Safety for Personnel Security Screening Systems Using X-ray or Gamma Radiation" to determine reference dose equivalent limits, as specified in paragraphs (D)(6) and (D)(7) of this rule, and ADAP, as specified in paragraphs (D)(8) and (D)(9) of this rule, as follows:

(1) Upon installation;

(2) Annually; and

(3) After any maintenance or change that may affect the reference effective dose or ADAP.

(G) Screening systems capable of delivering an effective dose equivalent greater than ten microsievert (one millirem) per scan will not be used for non-medical screening of human beings for security purposes.

Last updated February 17, 2026 at 7:59 AM

History

• Effective: February 16, 2026
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-66-17 Medical screening and research.

This rule provides standards for self-referral screening and medical research. Notwithstanding paragraph (B) of rule 3701:1-66-02 of the Administrative Code:

(A) Any person proposing to conduct a self-referral screening program using radiation-generating equipment will not initiate such a program without prior approval by the department. When requesting such approval, that person will submit information on a form prescribed by the department. If any information submitted to the department becomes invalid or not current, the department will be immediately notified in writing.

(B) No person will use radiation-generating equipment to conduct research on human beings unless the research has been approved by an institutional review board (IRB) as obligated by 45 CFR Part 46 (as effective on the effective date of this rule) and 21 CFR Part 56 (as effective on the effective date of this rule).

(C) Nothing in this rule relieves registrants from complying with the other obligations of this chapter.

Last updated December 13, 2024 at 7:33 AM

History

• Effective: December 13, 2024
• Promulgated Under: 119.03

Chapter 3701:1-67 External Beam Radiation Therapy Equipment

Ohio Adm.Code 3701:1-67-01 Definitions.

(A) Terms defined in rule 3701:1-38-01 of the Administrative Code shall have the same meaning when used in Chapter 3701:1-67 of the Administrative Code except for:

(1) Terms redefined within this rule which shall be used within Chapter 3701:1-67 of the Administrative Code; and

(2) Terms redefined in specific rules in Chapter 3701:1-67 of the Administrative Code, are for use within that specific rule only.

(B) As used in this chapter:

(1) "Absorbed dose" means the mean energy imparted by ionizing radiation to matter. Absorbed dose is determined as the quotient of dE by dM, where dE is the mean energy imparted by ionizing radiation to matter of mass dM. The SI unit of absorbed dose is joule per kilogram and the special name of the unit of absorbed dose is the gray (Gy). The previously used special unit of absorbed dose (rad) is being replaced by the gray.

(2) "Absorbed dose rate" means absorbed dose per unit time, for machines with timers, or dose monitor unit per unit time for linear accelerators.

(3) "Air kerma" means the sum of the initial kinetic energy of all charged ionizing particles liberated by uncharged ionizing radiation in a given mass of air. The unit for air kerma is joules per kilogram which is given the special name of gray (Gy). To determine air kerma in Gy from exposure in units of roentgens (R) multiply exposure by the conversion factor 0.00876 Gy/R.

(4) "Authorized physician" means an individual qualified in accordance with paragraph (C) of rule 3701:1-67-02 of the Administrative Code or an individual qualified in accordance with Chapter 4741. of the Revised Code to practice veterinary medicine.

(5) "Beam axis" means the axis of rotation of the beam limiting device.

(6) "Beam-limiting device" means a field defining collimator, integral to the therapy equipment, which provides a means to restrict the dimensions of the useful beam.

(7) "Beam monitoring system" means a system installed in the radiation head to detect and measure the radiation present in the useful beam.

(8) "Beam scattering foil" means a thin piece of material, usually metallic, placed in the beam to scatter a beam of electrons in order to provide a more uniform electron distribution in the useful beam.

(9) "Computed tomography" or " (CT)" means an imaging procedure that uses multiple x-ray transmission measurements and a computer program to generate tomographic images of a patient or material.

(10) "Contact therapy system" means a therapeutic radiation machine that is a type of electronic brachytherapy device.

(11) "Control panel" means that part of the radiation-generating equipment control system used to initiate and terminate the beam.

(12) "Control system" means the collective hardware and software components used for determining and selecting the treatment parameters and monitor the course of treatment.

(13) "Conventional simulator" means any x-ray system designed to reproduce the geometric conditions of the radiation therapy equipment.

(14) "Daily" means each treatment day before the evaluated equipment component is used clinically.

(15) "Direct supervision" means to be physically present at the same address and available to respond to the needs of something or someone.

(16) "Dose monitoring system" means

(a) "Primary dose monitoring system" means a system which will monitor the useful beam during irradiation and which will terminate irradiation when a pre-selected number of dose monitor units have been delivered.

(b) "Secondary dose monitoring system" means a system which will terminate irradiation in the event of failure of the primary dose monitoring system.

(17) "Dose rate" means absorbed dose per unit time, for machines with timers, or monitor unit per unit time for linear accelerators.

(18) "Electronic brachytherapy" means a method of radiation therapy where an electrically generated source of ionizing radiation is placed in or near the tumor or target tissue to deliver therapeutic radiation dosage.

(19) "Electronic brachytherapy device" means the system used to deliver electronic brachytherapy including the x-ray tube, the control mechanism, the cooling system, and the power source.

(20) "Electronic brachytherapy source" means the x-ray tube component used in an electronic brachytherapy device.

(21) "External beam radiation therapy" means therapeutic irradiation in which the source of radiation is at a distance from the body.

(22) "Field-flattening filter" means a filter used to homogenize the absorbed dose rate over the radiation field.

(23) "Filter" means material placed in the useful beam to preferentially attenuate selected radiations.

(24) "Gantry" means that part of a radiation therapy system supporting and allowing movements of the radiation head about a center of rotation.

(25) "Individual responsible for radiation protection (IRRP)" means an individual designated by the registrant who has the knowledge and responsibility for overall radiation safety and the quality assurance program at the facility, to include daily radiation safety operations and compliance with the rules.

(26) "Intensity Modulated Radiation Therapy (IMRT)" means radiation therapy that uses non-uniform radiation beam intensities which have been determined by various computer-based optimization techniques.

(27) "Interlock" means a device preventing the start or continued operation of equipment unless certain predetermined conditions prevail.

(28) "Interruption of irradiation" means the stopping of irradiation with the possibility of continuing irradiation without resetting of operating conditions via the control system.

(29) "Irradiation" means the exposure of a living being or matter to ionizing radiation.

(30) "Isocenter" means the center of the sphere through which the useful beam axis passes while the gantry moves through its full range of motions.

(31) "Leakage radiation" means radiation emanating from the radiation therapy system except for the useful beam.

(32) "Light field" means the area illuminated by light, simulating the radiation field.

(33) "Medical Event" means an event that meets the criteria in paragraph (B) or (C) of rule 3701:1-67-12 of the Administrative Code.

(34) "Megavolt" or "(MV)" or "mega electron volt (MeV)" means the energy equal to that acquired by a particle with one electron charge in passing through a potential difference of one million volts in a vacuum. Current convention is to use MV for photons and MeV for electrons.

(35) "Mobile Electronic Brachytherapy Service" means transportation of an electronic brachytherapy device to provide electronic brachytherapy at an address that is not the address of record.

(36) "Monitor unit" or "(MU)" means a unit response from the beam monitoring system from which the absorbed dose can be calculated.

(37) "Monthly" means at least once each calendar month, not to exceed forty-five days from previous event.

(38) "Moving beam radiation therapy" means radiation therapy with any planned displacement of radiation field or patient relative to each other, or with any planned change of absorbed dose distribution. It includes arc, skip, conformal, intensity modulation and rotational therapy.

(39) "Nominal treatment distance" means:

(a) For electron irradiation, the distance from the scattering foil, virtual source, or exit window of the electron beam to the entrance surface of the irradiated object along the central axis of the useful beam.

(b) For x-ray irradiation, the virtual source or target to isocenter distance along the central axis of the useful beam. For non-isocentric equipment, this distance shall be that specified by the manufacturer.

(40) "Patient" means an individual or animal subjected to radiation from therapy equipment for the purposes of medical therapy.

(41) "Peak tube potential" means the maximum value of the potential difference across the x-ray tube during an exposure.

(42) "Phantom" means an object behaving in essentially the same manner as tissue, with respect to absorption or scattering of the ionizing radiation in question.

(43) "Prescribed dose" means the total dose and dose per fraction as documented in the written directive. The prescribed dose is an estimation from measured data from a piece of therapy equipment using assumptions that are clinically acceptable for that treatment technique and historically consistent with the clinical calculations previously used for patients treated with the same clinical technique.

(44) "Protective barrier" means a barrier of radiation absorbing material(s) used to reduce radiation exposure. The types of protective barriers are as follows:

(a) "Primary protective barrier" means the material, excluding filters, placed in the useful beam.

(b) "Secondary protective barrier" means the material which attenuates stray radiation.

(45) "Qualified Medical Physicist" means an individual qualified in accordance with paragraph (D) of rule 3701:1-67-02 of the Administrative Code.

(46) "Radiation detector or detector" means a device which, in the presence of radiation provides, by either direct or indirect means, a signal or other indication suitable for use in measuring one or more quantities of incident radiation.

(47) "Radiation head" means the structure from which the useful beam emerges.

(48) "Radiation therapy service" means the structural unit of a health care organization which provides radiation therapy.

(49) "Radiation therapy" means the use of ionizing radiation, including external beam radiation therapy (teletherapy), or intraoperative radiation therapy and radioactive materials for therapeutic administration as authorized on a radioactive materials license issued by the director pursuant to Chapter 3701:1-58 of the Administrative Code in the treatment of human illness.

(50) "Redundant beam monitoring system" means a combination of two independent dose monitoring systems in which each system is designed to terminate irradiation in accordance with a pre-selected number of dose monitor units.

(51) "Shutter" means a device attached to the tube housing assembly which can intercept the useful beam and which has a lead equivalency not less than that of the tube housing assembly.

(52) "Signature" or "sign" means an identifier that authenticates the person who made it.

(53) "Simulator" or "radiation therapy simulation system" means any x-ray system intended for localizing the volume to be exposed during radiation therapy and establishing the position and size of the therapeutic irradiation field.

(54) "Source" means the point of origin of the useful radiation beam.

(55) "Stationary beam radiation therapy" means radiation therapy without displacement of one or more mechanical axes relative to the patient during irradiation.

(56) "Stereotactic radiosurgery service" means the structural unit of a health care organization which provides stereotactic radiosurgery.

(57) "Stereotactic radiosurgery" means the closed-skull destruction of a precisely defined intracranial or extracranial target by beam(s) of ionizing radiation in which the total dose is administered during a single treatment session.

(58) "Stray radiation" means the sum of leakage and scattered radiation.

(59) "Target" means that part of an x-ray tube or accelerator onto which a beam of accelerated particles is directed to produce ionizing radiation or other particles.

(60) "Target-skin distance" or "(TSD)" means the distance measured along the beam axis from the center of the front surface of the x-ray target and/or electron virtual source to the surface of the irradiated object or patient.

(61) "Technique factors" means any combination of the following which determines the exposure rate: kVp, mA, time, x-ray pulses, or the product of tube current and exposure time in mAs.

(62) "Tenth-value layer" or "(TVL)" means the thickness of a specified material which attenuates X-radiation or gamma radiation to an extent such that the air kerma rate, exposure rate, or absorbed dose rate is reduced to one-tenth of the value measured without the material at the same point.

(63) "Termination of irradiation" means the stopping of irradiation in a fashion which will not permit continuance of irradiation without the resetting of operating conditions via the control system.

(64) "Therapy equipment" means x-ray or electron-producing equipment designed and used for external beam radiation therapy. For the purpose of these regulations, devices used to administer electronic brachytherapy or contact therapy shall also be considered therapy equipment.

(65) "Treatment site" means the description of the specific tissue volume intended to receive a radiation dose, as described in the written directive and treatment plan.

(66) "Tube" means an x-ray tube, unless otherwise specified.

(67) "Tube housing assembly" means the tube housing with tube installed. It includes high-voltage and/or filament transformers and other appropriate elements when such are contained within the tube housing.

(68) "Useful beam" or "radiation field" means the radiation emanating from the tube housing port or the radiation head and passing through the aperture of the beam limiting device when the exposure controls are in a mode to cause the therapy equipment to produce radiation.

(69) "Virtual Simulator" means a computed tomography (CT) unit used in conjunction with relevant software which recreates the treatment machine; and that allows import, manipulation, display, and storage of images from CT and/or other imaging modalities.

(70) "Virtual source" means a point from which radiation appears to originate.

(71) "Wedge" means a device which effects continuous change in transmission over all or a part of the useful beam.

(72) "Weekly" means once per calendar week in which the evaluated equipment component has or will be used clinically, unless the equipment component was not evaluated during the prior week. If the equipment component was not evaluated during the prior week, "weekly" means once per calendar week before the evaluated equipment component is used clinically.

(73) "Written directive" means a documented order for the administration of radiation to a specific patient or human research subject, as specified in paragraph (B) of rule 3701:1-67-04 of the Administrative Code.

(74) "X-ray tube" means any electron tube which is designed to be used primarily for the production of x-rays.

Last updated August 24, 2026 at 7:41 AM

History

• Effective: August 20, 2026
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-38-01

(A) As used in this chapter and all other rules promulgated pursuant to Chapter 3748. of the Revised Code:

(1) "A₁" means the maximum activity of special form radioactive material permitted in a type A package. These values are listed in rule 3701:1-50-25 of the Administrative Code, or may be derived in accordance with the procedure prescribed in rule 3701:1-50-25 of the Administrative Code.

(2) "A₂" means the maximum activity of radioactive material, other than special form, low specific activity and surface contaminated object material, permitted in a type A package. These values are listed in rule 3701:1-50-25 of the Administrative Code, or may be derived in accordance with the procedure prescribed in rule 3701:1-50-25 of the Administrative Code.

(3) "Absorbed dose" means the energy imparted by ionizing radiation per unit mass of irradiated material. The units of absorbed dose are the gray, or Gy, and the rad.

(4) "Accelerator or charged particle accelerator" means any of a class of radiation generating equipment designed to electronically accelerate atomic or sub-atomic particles for subsequent bombardment of targets.

(5) "Accelerator-produced radioactive material" means any material made radioactive by a particle accelerator.

(6) "Activity" means the rate of disintegration or transformation or decay of radioactive material. The units of activity are the becquerel, or Bq, and the curie, or Ci.

(7) "Address of use" means the building or buildings that are identified on the license or registration and where the source of radiation may be received, used, prepared, or stored, except for temporary job sites.

(8) "Administrative controls" means mechanisms used to protect health and minimize damage to life and property through the use of written policies, procedures, instructions, training, observation of work practices, and related compliance audits.

(9) "Administrative monetary penalty" means a monetary penalty assessed by the director under section 3748.05 of the Revised Code and in compliance with rules adopted thereunder, to emphasize the need for lasting remedial action and to deter future violations.

(10) "Adult" means an individual eighteen or more years of age.

(11) "Agreement state" means any state with which the United States nuclear regulatory commission or the atomic energy commission has entered into an effective agreement under subsection 274B of the Atomic Energy Act of 1954, 68 Stat. 919, 42 U.S.C. 2021, as amended (1978). Non-agreement state means any other state.

(12) "Airborne radioactive material" means radioactive material dispersed in the air in the form of dusts, fumes, particulates, mists, vapors, or gases.

(13) "Airborne radioactivity area" means a room, enclosure, or area in which airborne radioactive materials, composed wholly or partly of licensed material, exist in concentrations:

(a) In excess of the derived air concentrations (DACs) specified in appendix C to rule 3701:1-38-12 of the Administrative Code, or

(b) To such a degree that an individual present in the area without respiratory protective equipment could exceed, during the hours an individual is present in a week, an intake of 0.6 per cent of the annual limit on intake or twelve DAC-hours.

(14) "Air-purifying respirator" means a respirator with an air-purifying filter, cartridge, or canister that removes specific air contaminants by passing ambient air through the air-purifying element.

(15) "ALARA" or "as low as is reasonably achievable" means every reasonable effort to maintain exposures to radiation as far below the dose limits as is practical consistent with the purpose for which the licensed or registered activity is undertaken, taking into account the state of technology, the economics of improvements in relation to benefits to the public health and safety, and other societal and socioeconomic considerations, and in relation to utilization of nuclear energy and licensed materials and registered activities in the public interest.

(16) "Alert" means events may occur, are in progress, or have occurred that could lead to a release of radioactive material but that the release is not expected to require a response by off-site response organizations to protect persons off-site.

(17) "Annual limit on intake" or "ALI" means the derived limit for the amount of radioactive material taken into the body of an adult worker by inhalation or ingestion in a year. ALI is the smaller value of intake of a given radionuclide in a year by the reference man that would result in a committed effective dose equivalent of 0.05 sievert (five rem) or a committed dose equivalent of 0.5 sievert (fifty rem) to any individual organ or tissue. ALI values for intake by ingestion and by inhalation of selected radionuclides are given in appendix C to rule 3701:1-38-12 of the Administrative Code.

(18) "Annually" means either

(a) At intervals not to exceed one year; or

(b) Once per year, at about the same time each year, plus or minus one month.

(19) "Area of use" means a portion of an address of use that has been set aside for the purpose of receiving, preparing, using, or storing sources of radiation.

(20) "Assigned protection factor" or "APF" means the expected workplace level of respiratory protection that would be provided by a properly functioning respirator or a class of respirators to properly fitted and trained users. Operationally, the inhaled concentration can be estimated by dividing the ambient airborne concentration by the APF.

(21) "Atmosphere-supplying respirator" means a respirator that supplies the respirator user with breathing air from a source independent of the ambient atmosphere, and includes supplied air respirators, or SARs, and self-contained breathing apparatus, or SCBA, units.

(22) "Atomic energy commission" or "AEC" means the federal agency created by the Atomic Energy Act of 1954, 68 Stat. 919, 42 U.S.C. 2011, as amended (1964), and was the predecessor agency to the current United States nuclear regulatory commission.

(23) "Background radiation" means radiation from cosmic sources; naturally occurring radioactive materials, including radon, except as a decay product of source or special nuclear material, and global fallout as it exists in the environment from the testing of nuclear explosive devices or from past nuclear accidents such as Chernobyl that contribute to background radiation and are not under the control of the licensee. "Background radiation" does not include radiation from radioactive materials regulated by the department.

(24) "Becquerel" or "Bq" means the SI unit of activity. One becquerel is equal to one disintegration per second.

(25) "Bioassay" or "radiobioassay" means the determination of kinds, quantities or concentrations, and, in some cases, the locations of radioactive material in the human body, whether by direct measurement, in vivo counting, or by analysis and evaluation of materials excreted or removed from the human body.

(26) "Byproduct material" means

(a) Any radioactive material, except special nuclear material, yielded in or made radioactive by exposure to the radiation incident to the process of producing or utilizing special nuclear materials; or

(b) The tailings or wastes produced by the extraction or concentration of uranium or thorium from any ore processed primarily for its source material content, including discrete surface wastes resulting from solution extraction processes. Underground ore bodies depleted by such solution extraction do not constitute byproduct material within the definition.

(27) "Chelating agent" means a chemical compound or mixture that enhances the removal of radioactive material from the body, water or similar applications. Typical chelating agents include amine polycarboxylic acids such as EDTA or DTPA; hydroxy-carboxylic acids; and polycarboxylic acids such as citric acid, carbolic acid, and gluconic acid.

(28) "Chiropractor" means an individual licensed by the state of Ohio to practice chiropractic medicine pursuant to Chapter 4734. of the Revised Code.

(29) "Class" or "lung class" or "inhalation class" means a classification scheme for inhaled material according to its rate of clearance from the pulmonary region of the lung. Materials are classified as D, W, or Y, which applies to a range of clearance half-times: for class D, days, of less than ten days, for class W, weeks, from ten to one hundred days, and for class Y, years, of greater than one hundred days.

(30) "Collective dose" means the sum of the individual doses received in a given period of time by a specified population from exposure to a specified source of radiation.

(31) "Commencement of construction" means taking any action defined as "construction" or any other activity at the site of a facility subject to the rules promulgated pursuant to Chapter 3748. of the Revised Code that has a reasonable nexus to radiological health and safety.

(32) "Committed dose equivalent" or "H_T,50" means the dose equivalent to organs or tissues of reference, T, that will be received from an intake of radioactive material by an individual during the fifty year period following the intake.

(33) "Committed effective dose equivalent" or "H_E,50" means the sum of the products of the weighting factors applicable to each of the body organs or tissues, W_T, that are irradiated and the committed dose equivalent to each of these organs or tissues (H_{E, 50} = W_TH_T,50).

(34) "Consortium" means an association of medical use licensees and a PET radionuclide production facility in the same geographical area that jointly own or share in the operation and maintenance cost of the PET radionuclide production facility that produces PET radionuclides for use in producing radioactive drugs within the consortium for noncommercial distributions among its associated members for medical use. The PET radionuclide production facility within the consortium must be located at an educational institution or a medical facility.

(35) "Constraint" or "dose constraint" means a value above which specified licensee actions are required.

(36) "Construction" means the installation of foundations, or in-place assembly, erection, fabrication, or testing for any structure, system, or component of a facility or activity subject to the rules promulgated pursuant to Chapter 3748. of the Revised Code that are related to radiological safety or security. The term "construction" does not include:

(a) Changes for temporary use of the land for public recreational purposes;

(b) Site exploration, including necessary borings to determine foundation conditions or other preconstruction monitoring to establish background information related to the suitability of the site, the environmental impacts of construction or operation, or the protection of environmental values;

(c) Preparation of the site for construction of the facility, including clearing of the site, grading, installation of drainage, erosion and other environmental mitigation measures, and construction of temporary roads and borrow areas;

(d) Erection of fences and other access control measures that are not related to the safe use of, or security of, radiological materials subject to the rules promulgated pursuant to Chapter 3748. of the Revised Code;

(e) Excavation;

(f) Erection of support buildings (e.g. construction equipment storage sheds, warehouse and shop facilities, utilities, concrete mixing plants, docking and unloading facilities, and office buildings) for use in connection with the construction of the facility;

(g) Building of service facilities (e.g. paved roads, parking lots, railroad spurs, exterior utility and lighting systems, potable water systems, sanitary sewerage treatment facilities, and transmission lines);

(h) Procurement or fabrication of components or portions of the proposed facility occurring at other than the final, in-place location at the facility; or

(i) Taking any other action that has no reasonable nexus to radiological health and safety.

(37) "Controlled area" means an area, outside of a restricted area but inside the site boundary, access to which can be limited by the licensee or registrant for any reason.

(38) "Critical group" means the group of individuals reasonably expected to receive the greatest exposure to residual radioactivity for any applicable set of circumstances.

(39) "Curie" or "Ci" means a unit of activity. One curie equals 3.7 x 10¹⁰ disintegrations per second equals 3.7 x 10¹⁰ becquerels equals 2.22 x 10¹² disintegrations per minute.

(40) "Cyclotron" means a particle accelerator in which the charged particles travel in an outward spiral or circular path. A cyclotron accelerates charged particles at energies usually in excess of ten megaelectron volts and is commonly used for production of short half-life radionuclides for medical use.

(41) "Declared pregnant woman" means a woman who has voluntarily informed the licensee or registrant, in writing, of her pregnancy and the estimated date of conception. The declaration remains in effect until the declared pregnant woman withdraws the declaration in writing or is no longer pregnant.

(42) "Decommission" means to safely remove any licensed operation from service and reduce residual radioactivity to a level that permits release of the licensee's property for unrestricted use and termination of the license.

(43) "Dedicated check source" means a radioactive source that is used to assure the consistent performance of a radiation detection or measurement device over several months or years.

(44) "Deep dose equivalent" or "H_d" applies to external whole body exposure, and means the dose equivalent at a tissue depth of one centimeter, one thousand milligram per square centimeter.

(45) "Demand respirator" means an atmosphere-supplying respirator that admits breathing air to the facepiece only when a negative pressure is created inside the facepiece by inhalation.

(46) "Dentist" means an individual licensed by the state of Ohio to practice dentistry under Chapter 4715. of the Revised Code.

(47) "Department" means the Ohio department of health.

(48) "Depleted uranium" means uranium containing less uranium-235 than the naturally occurring distribution of uranium isotopes.

(49) "Derived air concentration" or "DAC" means the concentration of a given radionuclide in air which, if breathed by the reference man for a working year of two thousand hours under conditions of light work, results in an intake of one ALI. The condition of light work is inhaling 1.2 cubic meters of air per hour for two thousand hours in a year. DAC values are given in appendix C to rule 3701:1-38-12 of the Administrative Code.

(50) "Derived air concentration-hour or DAC-hour" means the product of the concentration of radioactive material in air, which is expressed as a fraction or multiple of the derived air concentration for each radionuclide, and the time of exposure to that radionuclide, in hours. A licensee or registrant may take two thousand DAC-hours to represent one ALI, equivalent to a committed effective dose equivalent of 0.05 Sv (five rem).

(51) "Direct reading dosimeter" means a device that measures radiation dose that does not require another device to read the measured radiation dose. Examples of direct reading dosimeters include pocket dosimeters and electronic dosimeters.

(52) "Director" means the director of health or a designee or authorized representative of the director.

(53) "Discipline" means a branch of knowledge or of teaching.

(54) "Discrete source" means a radionuclide that has been processed so that its concentration within a material has been purposely increased for use for commercial, medical, or research activities.

(55) "Disposable respirator" means a respirator for which maintenance is not intended and that is designed to be discarded after excessive breathing resistance, sorbent exhaustion, physical damage, or end-of service-life renders it unsuitable for use. Examples of this type of respirator are a disposable half-mask respirator or a disposable escape-only self-contained breathing apparatus.

(56) "Dose" or "radiation dose" is a generic term that means absorbed dose, dose equivalent, effective dose equivalent, committed effective dose equivalent, or total effective dose equivalent as defined in other paragraphs of this rule.

(57) "Dose equivalent" or "H_T" means the product of the absorbed dose in tissue, quality factor, and all other necessary modifying factors at the location of interest. The units of dose equivalent are the sievert and rem.

(58) "Dose limits" or "limits" means the permissible upper bounds of radiation doses established in accordance with these regulations but excludes background radiation and medical exposure.

(59) "Dosimetry processor" means a person that processes and evaluates individual monitoring devices in order to determine the radiation dose delivered to the monitoring devices.

(60) "Effective dose equivalent" or "H_E" means the sum of the products of the dose equivalent to each organ or tissue, H_T, and the weighting factor, W_T, applicable to each of the body organs or tissues that are irradiated: (H_E = ∑W_TH_T).

(61) "Embryo" or "fetus" means the developing human organism from conception until time of birth.

(62) "Engineering controls" means mechanisms used to protect health and minimize damage to life and property through engineering specifications, design, and construction of the product or facility including all of the security and safety features. This includes, but is not limited to, auxiliary security and safety features such as additional external shielding, barriers, and operational interlocks with associated processes.

(63) "Entrance" or "access point" means any opening through which an individual or extremity of an individual could gain access to radiation areas or to licensed radioactive materials or registered radiation generating equipment. This includes entry or exit portals of sufficient size to permit human entry, irrespective of their intended use.

(64) "Explosive material" means any chemical compound, mixture or device which produces a substantial instantaneous release of gas and heat spontaneously or by contact with sparks or flame.

(65) "Exposure" means being exposed to sources of ionizing radiation.

(66) "External dose" means that portion of the dose equivalent received from radiation sources outside the body.

(67) "Extremity" means hand, elbow, arm below the elbow, foot, knee, or leg below the knee.

(68) "Eye dose equivalent" means the same as lens dose equivalent.

(69) "Facility" means all buildings, equipment, structures and other stationary items that, in addition to the meaning defined in division (H) of section 3748.01 of the Revised Code, are:

(a) Located on a single site or on contiguous or adjacent sites and are operated by the same person and have common corporate or business interests; or

(b) Portions of a building or structure which are operated by the same person and have common corporate or business interests.

(70) "Filtering facepiece" or "dust mask" means a negative pressure particulate respirator with a filter as an integral part of the facepiece or with the entire facepiece composed of the filtering medium, not equipped with elastomeric sealing surfaces and adjustable straps.

(71) "Fissile material" means the radionuclides uranium-233, uranium-235, plutonium-239, and plutonium-241, or any combination of these radionuclides. Fissile material means the fissile nuclides themselves, not material containing fissile nuclides. Unirradiated natural uranium and depleted uranium and natural uranium or depleted uranium that has been irradiated in thermal reactors only, are not included in this definition. Certain exclusions from fissile material controls are provided in rule 3701:1-50-13 of the Administrative Code.

(72) "Fit factor" means quantitative estimate of the fit of a particular respirator to a specific individual, and typically estimates the ratio of the concentration of a substance in ambient air to its concentration inside the respirator when worn.

(73) "Fit test" means the use of a protocol to qualitatively or quantitatively evaluate the fit of a respirator on an individual.

(74) "Generally applicable environmental radiation standards" means standards issued by the United States environmental protection agency under the authority of the Atomic Energy Act of 1954, 68 Stat. 919, 42 U.S.C. 2011, as amended (2005), that impose limits on radiation exposures or levels, or concentrations or quantities of radioactive material, in the general environment outside the boundaries of locations under the control of persons possessing or using radioactive material.

(75) "Gray" or "Gy" means the SI unit of absorbed dose. One gray is equal to an absorbed dose of one joule per kilogram (one hundred rads).

(76) "Handle" means receive, possess, use, store, transfer, install, service, or dispose of sources of radiation unless possession is solely for the purpose of transportation.

(77) "Handler" means a facility that handles sources of radiation unless possession is solely for the purpose of transportation.

(78) "Hazardous waste" means those wastes designated as hazardous by rule 3745-51-03 of the Administrative Code.

(79) "Helmet" means a rigid respiratory inlet covering that also provides head protection against impact and penetration.

(80) "High radiation area" means an area, accessible to individuals, in which radiation levels from radiation sources external to the body could result in an individual receiving a dose equivalent in excess of one millisievert (0.1 rem) in one hour at thirty centimeters from the radiation source or thirty centimeters from any surface that the radiation penetrates.

(81) "Hood" means a respiratory inlet covering that completely covers the head and neck and may also cover portions of the shoulders and torso.

(82) "Individual" means any human being.

(83) "Individual monitoring" means

(a) The assessment of dose equivalent by the use of devices designed to be worn by an individual;

(b) The assessment of committed effective dose equivalent by bioassay or by determination of the time-weighted air concentrations to which an individual has been exposed, i.e. DAC-hours; or

(c) The assessment of dose equivalent by the use of survey data.

(84) "Individual monitoring devices" means devices designed to be worn by a single individual for the assessment of dose equivalent such as film badges; thermoluminescent dosimeters; optically stimulated luminescent dosimeters; pocket ionization chambers; and personal air sampling devices.

(85) "Industrial radiography" means the examination of the structure of materials by nondestructive methods, utilizing sealed sources of radioactive material or radiation-generating equipment.

(86) "Internal dose" means that portion of the dose equivalent received from radioactive material taken into the body.

(87) "Irradiator" means a facility that uses radioactive sealed sources for the irradiation of objects or materials and in which radiation dose rates exceeding five grays (five hundred rads) per hour exist at one meter from the sealed radioactive source in air or water, as applicable for the irradiator type, but does not include irradiators in which both the sealed source and the area subject to irradiation are contained within a device and are not accessible to personnel.

(88) "Lens dose equivalent" or "eye dose equivalent" means the external exposure of the lens of the eye and is taken as the dose equivalent at a tissue depth of 0.3 centimeters; i.e. three hundred milligrams per square centimeter.

(89) "License" means a license issued by the nuclear regulatory commission, the director, or another agreement state in accordance with rules adopted by those organizations.

(90) "Licensee" means a person to whom a license is issued.

(91) "Licensed activity" means an activity authorized by a radioactive material license which is essential to achieving the purpose for which the license was issued or amended.

(92) "Licensed material" means radioactive material received, possessed, used, transferred or disposed of under a general or specific license.

(93) "Loose-fitting facepiece" means a respiratory inlet covering that is designed to form a partial seal with the face.

(94) "Lost or missing licensed source of radiation" means a licensed source of radiation whose location is unknown. It includes material that has been shipped but has not reached its destination and whose location cannot be readily traced in the transportation system.

(95) "Low-level radioactive waste" or "LLRW," also "low-level waste," or "LLW" means radioactive waste which is not high-level radioactive waste, spent nuclear fuel, NARM, or byproduct material as defined in section 11 E. (2) of the Atomic Energy Act of 1954 68 Stat. 919, 42 U.S.C. 2011, as amended (2005), but is radioactive material that the United States nuclear regulatory commission classifies as low-level radioactive waste.

(96) "Low specific activity material" or "LSA" means radioactive material with limited specific activity which is nonfissile or is excepted under rule 3701:1-50-13 of the Administrative Code, and which satisfies the descriptions and limits set forth below. Shielding materials surrounding the LSA material may not be considered in determining the estimated average specific activity of the package contents. LSA must be in one of three groups:

(a) LSA - I.

(i) Uranium and thorium ores, concentrates of uranium and thorium ores, and other ores containing naturally occurring radioactive radionuclides that are intended to be processed for the use of these radionuclides;

(ii) Natural uranium, depleted uranium, natural thorium or their compounds or mixtures, provided they are unirradiated and in solid or liquid form;

(iii) Radioactive material other than fissile material, for which the A₂ value is unlimited; or

(iv) Other radioactive material in which the activity is distributed throughout and the estimated average specific activity does not exceed thirty times the value for exempt material activity concentration determined in accordance with rule 3701:1-50-25 of the Administrative Code.

(b) LSA-II.

(i) Water with tritium concentration up to 0.8 terabecquerels per liter (twenty curies per liter); or

(ii) Other material in which the activity is distributed throughout and the estimated average specific activity does not exceed ( 10^-4 A₂) per gram for solids and gases, and (10^-5 A₂) per gram for liquids.

(c) LSA-III. Solids (e.g., consolidated wastes, activated materials), excluding powders, that satisfy the requirements of 10 C.F.R. 71.77 (as in effect on the effective date of this rule), in which:

(i) The radioactive material is distributed throughout a solid or a collection of solid objects, or is essentially uniformly distributed in a solid compact binding agent (such as concrete, bitumen, ceramic, etc.);

(ii) The radioactive material is relatively insoluble, or it is intrinsically contained in a relatively insoluble material, so that even under loss of packaging, the loss of radioactive material per package by leaching, when placed in water for seven days, would not exceed (0.1 x A₂); and

(iii) The estimated average specific activity of the solid, excluding any shielding material, does not exceed (0.002 x A₂) per gram.

(97) "Management" means the chief executive officer or other individual having the authority to manage, direct, or administer the licensee's activities, or those persons' delegate or delegates.

(98) "Medical institution" means an organization in which more than one medical discipline is practiced.

(99) "Medical use" means the intentional internal or external administration of radioactive material or the radiation therefrom to patients or human research subjects under the supervision of an authorized user.

(100) "Member of the public" means any individual except when that individual is receiving an occupational dose.

(101) "Minor" means an individual less than eighteen years of age.

(102) "Monitoring" or "radiation monitoring" or "radiation protection monitoring" means the measurement of radiation levels, concentrations, surface area concentrations or quantities of radioactive material and the use of the results of these measurements to evaluate potential exposures and doses.

(103) "NARM" or "naturally occurring or accelerator-produced radioactive material" means naturally occurring or accelerator-produced radioactive material, including naturally occurring material that is technologically enhanced, and those nuclides that are generated in a charged particle accelerator, but does not include source material, byproduct material, or special nuclear material.

(104) "NARM licensing state" means any state with regulations equivalent to the suggested state regulations for control of radiation relating to, and an effective program for, the regulatory control of NARM and which has been granted final designation by the conference of radiation control program directors, inc.

(105) "Nationally tracked source" means a sealed source containing a quantity equal to or greater than "Category 1" or "Category 2" levels of any radioactive material listed in the appendix to rule 3701:1-38-25 of the Administrative Code. In this context a sealed source is defined as radioactive material that is sealed in a capsule or closely bonded, in a solid form and which is not exempt from regulatory control. It does not mean material encapsulated solely for disposal, or nuclear material contained in any fuel assembly, subassembly, fuel rod, or fuel pellet. "Category 1" nationally tracked sources are those containing radioactive material at a quantity equal to or greater than the "Category 1" threshold. "Category 2" nationally tracked sources are those containing radioactive material at a quantity equal to or greater than the "Category 2" threshold but less than the "Category 1" threshold.

(106) "Negative pressure respirator" or "tight fitting respirator" means a respirator in which the air pressure inside the facepiece is negative during inhalation with respect to the ambient air pressure outside the respirator.

(107) "Nonstochastic effect" or "deterministic effect" means health effects, the severity of which varies with the dose and for which a threshold is believed to exist. Radiation-induced cataract formation is an example of a nonstochastic effect.

(108) "NORM" or "naturally occurring radioactive material" means any nuclide that is radioactive in its natural physical state, but does not include source material, byproduct material, or special nuclear material.

(109) "Normal form radioactive material" means radioactive material that has not been demonstrated to qualify as special form radioactive material.

(110) "Nuclear regulatory commission" means the federal agency established by Title II of the Energy Reorganization Act of 1974, 88 Stat. 1233, 42 U.S.C.A. 5801, as amended (2005), comprising the members of the commission and all offices, employees, and representatives authorized to act in any case or matter related to licensing and related regulatory function previously assigned to the AEC.

(111) "Occupational dose" means the dose received by an individual in the course of employment in which the individual's assigned duties involve exposure to radiation or radioactive material from licensed and unlicensed sources of radiation, whether in the possession of the licensee or other person. Occupational dose does not include doses received from background radiation, from any medical administration the individual has received, from exposures to individuals administered radioactive materials and released in accordance with rule 3701:1-58-30 of the Administrative Code or equivalent United States nuclear regulatory commission or agreement state regulations, from voluntary participation in medical research programs, or as a member of the public.

(112) "Package" means the packaging together with its radioactive contents as presented for transport.

(a) Fissile material package or type AF package, type BF package, type B(U)F package, or type B(M)F package means a fissile material packaging together with its fissile material contents.

(b) Type A package means a type A packaging together with its radioactive contents. A type A package is defined and must comply with the United States department of transportation regulations in 49 C.F.R. 173 (as in effect on the effective date of this rule).

(c) Type B package means a type B packaging together with its radioactive contents. On approval, a type B package design is designated by the United States nuclear regulatory commission as B(U) unless the package has a maximum normal operating pressure of more than seven hundred kilopascals (one hundred pounds per square inch) gauge or a pressure relief device that would allow the release of radioactive material to the environment under the tests specified in 10 C.F.R. 71.73 (hypothetical accident conditions) (as in effect on the effective date of this rule), in which case it will receive a designation B(M). B(U) refers to the need for unilateral approval of international shipments; B(M) refers to the need for multilateral approval of international shipments. There is no distinction made in how packages with these designations may be used in domestic transportation. To determine their distinction for international transportation, see United States department of transportation regulations in 49 C.F.R. 173 (as in effect on the effective date of this rule). A type B package approved before September 6, 1983, was designated only as type B. Limitations on its use are specified in 10 C.F.R. 71.19 (as in effect on the effective date of this rule).

(113) "Packaging" means the assembly of components necessary to ensure compliance with the packaging requirements of rule 49 C.F.R. 173 Subpart I (as in effect on the effective date of this rule). It may consist of one or more receptacles, absorbent materials, spacing structures, thermal insulation, radiation shielding, and devices for cooling or absorbing mechanical shocks. The vehicle, tie-down system and auxiliary equipment may be designated as part of the packaging.

(114) "Particle accelerator" means any machine capable of accelerating electrons, protons, deuterons, or other charged particles in a vacuum and of discharging the resultant particulate or other radiation into a medium at energies usually in excess of one megaelectron volt. For purposes of this definition, "accelerator" is an equivalent term.

(115) "Person" means any individual, corporation, association, business enterprise, or other legal entity either public or private and any legal successor, representative, agent, or agency of that individual, corporation, association, business enterprise, or other legal entity. Person also includes the United States, states, political subdivisions of states, and any department, agency, or instrumentality of the United States or a state, except the U.S. department of energy or the U.S. nuclear regulatory commission where the state regulation of radioactive material by either of those agencies is prohibited by federal law.

(116) "Personnel dosimeter", means a device that measures radiation dose that is processed and evaluated by an accredited "National Voluntary Laboratory Accreditation Program" (NVLAP) processor. Examples of personnel dosimeters include film badges, thermo-luminescent dosimeters (TLD), and optically stimulated luminescence (OSL) dosimeters.

(117) "Pharmacist" means a person who is licensed by the state of Ohio to practice pharmacy pursuant to Chapter 4731. of the Revised Code.

(118) "Physician" means a person who is licensed pursuant to Chapter 4731. of the Revised Code to practice medicine or surgery or osteopathic medicine or surgery.

(119) "Planned special exposure" means an infrequent exposure to radiation, separate from and in addition to the annual dose limits.

(120) "Podiatrist" means an individual licensed by the state of Ohio to practice podiatry pursuant to Chapter 4731. of the Revised Code.

(121) "Positive pressure respirator" means a respirator in which the pressure inside the respiratory inlet covering exceeds the ambient air pressure outside the respirator.

(122) "Positron Emission Tomography (PET) radionuclide production facility" means a facility operating a cyclotron or accelerator for the purpose of producing PET radionuclides.

(123) "Powered air-purifying respirator" or "PAPR" means an air-purifying respirator that uses a blower to force the ambient air through air purifying elements to the inlet covering.

(124) "Pressure demand respirator" means a positive pressure atmosphere supplying respirator that admits breathing air to the facepiece when the positive pressure is reduced inside the facepiece by inhalation.

(125) "Public dose" means the dose received by a member of the public from exposure to radiation and/or radioactive material released by the licensee, or to any other source of radiation under the control of a licensee or registrant. Public dose does not include occupational dose or doses received from background radiation, from any medical administration the individual has received, from exposures to individuals administered radioactive materials and released in accordance with rule 3701:1-58-30 of the Administrative Code or equivalent United States nuclear regulatory commission or agreement state regulations, or from voluntary participation in medical research programs.

(126) "Pyrophoric material" means any liquid that ignites spontaneously in dry or moist air at or below 54.4 degrees celsius (one hundred thirty degrees fahrenheit). A pyrophoric solid is any solid material, other than one classed as an explosive, which under normal conditions is liable to cause fires through friction, retained heat from manufacturing or processing, or which can be ignited readily and when ignited burns so vigorously and persistently as to create a serious transportation, handling, or disposal hazard. Included are spontaneously combustible and water-reactive materials.

(127) "Qualitative fit test" or "QLFT" means a pass/fail fit test to assess the adequacy of respirator fit that relies on the individual's response to the test agent.

(128) "Quality factor" or "Q" means the modifying factor, as listed in paragraphs (A) and (B) of rule 3701:1-38-11 of the Administrative Code, that is used to derive dose equivalent from absorbed dose.

(129) "Quantitative fit test" or "QNFT" means an assessment of the adequacy of respirator fit by numerically measuring the amount of leakage into the respirator.

(130) "Quarter" or "quarterly" means a period of time equal to one-fourth of the year observed by the licensee or registrant, approximately thirteen consecutive weeks, providing that the beginning of the first quarter in a year coincides with the starting date of the year and that no day is omitted or duplicated in consecutive quarters.

(131) "Rad" means the special unit of radiation absorbed dose. One rad is equal to an absorbed dose of one hundred ergs per gram, or 0.01 joule per kilogram, or 0.01 gray.

(132) "Radiation" or "ionizing radiation" means alpha particles, beta particles, gamma rays, x-rays, neutrons, high speed electrons, high speed protons, and other particles capable of producing ions. Radiation does not include nonionizing radiation, such as radio or microwaves, or visible, infrared or ultraviolet light.

(133) "Radiation area" means an area, accessible to individuals, in which radiation levels could result in an individual receiving a dose equivalent in excess of 0.05 millisievert (0.005 rem) in one hour at thirty centimeters from the source of radiation or from any surface that the radiation penetrates.

(134) "Radiation-generating equipment" or "RGE" means any manufactured product or device, or component of such a product or device, or any machine or system that during operation can generate or emit radiation, except those that emit radiation only from radioactive material. "Radiation-generating equipment" does not include either of the following:

(a) Diathermy machines;

(b) Microwave ovens, including food service microwave ovens used for commercial and industrial uses, television receivers, electric lamps, and other household appliances and products that generate very low levels of radiation.

(135) "Radiation Safety Officer" or "RSO" means an individual designated by the licensee who has the knowledge and responsibility for the overall radiation safety program at the facility, to include the implementation of the daily radiation safety operations and compliance with the rules.

(136) "Radioactive material" means any solid, liquid or gaseous material that emits ionizing radiation spontaneously. "Radioactive material" includes accelerator-produced and naturally occurring radioactive materials and byproduct, source, and special nuclear material.

(137) "Radioactive waste" means waste containing regulated radioactive material.

(138) "Radioactivity" means the transformation of unstable atoms by the emission of radiation.

(139) "Radiography" means the same as industrial radiography.

(140) "Reference man" means a hypothetical aggregation of human physical and physiological characteristics arrived at by international consensus. These characteristics may be used by researchers and public health workers to standardize results of experiments and to relate biological insult to a common base.

(141) "Registrant" means a person required by Chapter 3748. of the Revised Code to register radiation-generating equipment with the director.

(142) "Rem" means the special unit of any of the quantities expressed as dose equivalent. The dose equivalent in rem is equal to the absorbed dose in rads multiplied by the quality factor (one rem = 0.01 Sv).

(143) "Research and development" means

(a) Theoretical analysis, exploration, or experimentation; or

(b) The extension of investigative findings and theories of a scientific or technical nature into practical application for experimental and demonstration purposes, including the experimental production and testing of models, devices, equipment, materials and processes. "Research and development" does not include the internal or external administration of sources of radiation to human beings.

(144) "Residual radioactivity" means radioactivity in structures, materials, soils, groundwater, and other media at a site resulting from activities under the licensee's control. This includes radioactivity from all licensed and unlicensed sources used by the licensee, but excludes background radiation. It also includes radioactive materials remaining at the site as a result of routine or accidental releases of radioactive material at the site and previous burials at the site, even if those burials were made in accordance with the provisions of 10 C.F.R. 20 (as in effect on the effective date of this rule).

(145) "Respiratory protective equipment or device" means an apparatus, such as a respirator, used to reduce the individual's intake of airborne radioactive materials.

(146) "Restricted area" means an area access to which is limited by the licensee or registrant for the purpose of protecting individuals against undue risks from exposure to sources of radiation. Restricted area does not include areas used as residential quarters, but separate rooms in a residential building may be set apart as a restricted area.

(147) "Roentgen" means the amount of gamma or x-rays required to produce ions resulting in a charge of 0.000258 coulombs per kilogram of air under standard conditions.

(148) "Sanitary sewerage" means a system of public sewers for carrying off wastewater and refuse, but excluding sewage treatment facilities, septic tanks, and leach fields owned or operated by the licensee.

(149) "Sealed source" means radioactive material that is encased in a manner designed to prevent leakage or escape of the radioactive material.

(150) "Sealed source and device registry" means the national registry that contains all the registration certificates, generated by both the United States nuclear regulatory commission and the agreement states, that summarize the radiation safety information for the sealed sources and devices and describe the licensing and use conditions approved for the product.

(151) "Seismic area" means any area where the probability of a horizontal acceleration in rock of more than 0.3 times the acceleration of gravity in two hundred fifty years is greater than ten per cent, as designated by the United States geological survey.

(152) "Self-contained breathing apparatus" or "SCBA" means an atmosphere-supplying respirator for which the breathing air source is designed to be carried by the user.

(153) "Shallow dose equivalent" or "H_S" means the external exposure of the skin of the whole body or the skin of an extremity, is taken as the dose equivalent at a tissue depth of 0.007 centimeter, or seven milligrams per square centimeter.

(154) "Sievert" or "Sv" means the SI unit of any of the quantities expressed as dose equivalent. The dose equivalent in sieverts is equal to the absorbed dose in grays multiplied by the quality factor. One sievert equals one hundred rem.

(155) "Site area emergency" means events may occur, are in progress, or have occurred that could lead to a significant release of radioactive material and that could require a response by off-site response organizations to protect persons off-site.

(156) "Site boundary" means that line beyond which the land or property is not owned, leased, or otherwise controlled by the licensee or registrant.

(157) "Site closure and stabilization" means those actions that are taken upon completion of operations that prepare a disposal site for custodial care and that assure that the disposal site will remain stable and will not need ongoing active maintenance.

(158) "Source material" means uranium, thorium, or any combination thereof in any physical or chemical form, or any ores that contain by weight at least one-twentieth of one per cent (0.05 per cent) of uranium, thorium, or any combination thereof. Source material does not include special nuclear material.

(159) "Sources of radiation" means radioactive material or radiation generating equipment.

(160) "Special form radioactive material" means radioactive material that satisfies the following conditions:

(a) It is either a single solid piece or is contained in a sealed capsule that can be opened only by destroying the capsule;

(b) The piece or capsule has at least one dimension not less than five millimeters (0.2 inch); and

(c) It satisfies the test requirements specified by the United States nuclear regulatory commission in 10 C.F.R. 71.75 (as in effect on the effective date of this rule). A special form encapsulation designed in accordance with the United States nuclear regulatory commission requirements identified in 10 C.F.R. 71.4, in effect on June 30, 1983, and constructed prior to July 1, 1985; a special form encapsulation designed in accordance with the requirements of 10 C.F.R. 71.4 in effect on March 31, 1996, and constructed before April 1, 1998; and special form material that was successfully tested before September 10, 2015 in accordance with the requirements of 10 C.F.R. 71.75(d) of this section in effect before September 10, 2015 may continue to be used. Any other special form encapsulation must meet the specifications of this definition.

(161) "Special nuclear material" means either of the following:

(a) Plutonium, uranium-233, uranium enriched in the isotope 233, or in the isotope 235, and any other material that the United States nuclear regulatory commission determines to be special nuclear material, but does not include source material pursuant to section 51 of the Atomic Energy Act of 1954, 68 Stat 919, 42 USCA 2071, as amended (2005).

(b) Any material artificially enriched by any of the foregoing but does not include source material.

(162) "Special nuclear material in quantities not sufficient to form a critical mass" means uranium enriched in the isotope uranium-235 in quantities not exceeding three hundred fifty grams of contained uranium-235; uranium-233 in quantities not exceeding two hundred grams; plutonium in quantities not exceeding two hundred grams; or any combination of them in accordance with the following formula: for each kind of special nuclear material, determine the ratio between the quantity of that special nuclear material and the quantity specified in this paragraph for the same kind of special nuclear material. The sum of such ratios for all of the kinds of special nuclear material in combination shall not exceed unity.

(163) "Stochastic effect" means health effects that occur randomly and for which the probability of the effect occurring, rather than its severity, is assumed to be a linear function of dose without threshold. Hereditary effects and cancer incidence are examples of stochastic effects.

(164) "Supplied-air respirator" or "SAR" or "airline respirator" means an atmosphere-supplying respirator for which the source of breathing air is not designed to be carried by the user.

(165) "Surface contaminated object" or "SCO" means a solid object that is not itself classed as radioactive material, but which has radioactive material distributed on any of its surfaces. SCO must be in one of two groups with surface activity not exceeding the following limits:

(a) SCO-I: a solid object on which:

(i) The non-fixed contamination on the accessible surface averaged over three hundred square centimeters, or the area of the surface if less than three hundred square centimeters, does not exceed four becquerels per square centimeter (10^-4 microcurie per square centimeter) for beta and gamma and low toxicity alpha emitters, or 0.4 becquerels per square centimeter 10^-5 microcurie per square centimeter) for all other alpha emitters;

(ii) The fixed contamination on the accessible surface averaged over three hundred square centimeters, or the area of the surface if less than three hundred square centimeters, does not exceed forty thousand becquerels per square centimeter (one microcurie per square centimeter) for beta and gamma and low toxicity alpha emitters, or four thousand becquerels per square centimeter (0.1 microcurie per square centimeter) for all other alpha emitters; and

(iii) The non-fixed contamination plus the fixed contamination on the inaccessible surface averaged over three hundred square centimeters, or the area of the surface if less than three hundred square centimeters, does not exceed forty thousand becquerels per square centimeter (one microcurie per square centimeter) for beta and gamma and low toxicity alpha emitters, or four thousand becquerels per square centimeter (0.1 microcurie per square centimeter) for all other alpha emitters.

(b) SCO-II: a solid object on which the limits for SCO-I are exceeded and on which:

(i) The non-fixed contamination on the accessible surface averaged over three hundred square centimeters, or the area of the surface if less than three hundred square centimeter, does not exceed four hundred becquerels per square centimeter (10^-2 microcurie per square centimeter) for beta and gamma and low toxicity alpha emitters, or forty becquerels per square centimeter (10^-3 microcurie per square centimeter) for all other alpha emitters;

(ii) The fixed contamination on the accessible surface averaged over three hundred square centimeters, or the area of the surface if less than three hundred square centimeters, does not exceed eight hundred thousand becquerels per square centimeter (twenty microcuries per square centimeter) for beta and gamma and low toxicity alpha emitters, or eighty thousand becquerels per square centimeter (two microcuries per square centimeter) for all other alpha emitters; and

(iii) The non-fixed contamination plus the fixed contamination on the inaccessible surface averaged over three hundred square centimeters, or the area of the surface if less than three hundred square centimeters, does not exceed eight hundred thousand becquerels per square centimeter (twenty microcuries per square centimeter) for beta and gamma and low toxicity alpha emitters, or eighty thousand becquerels per square centimeter (two microcuries per square centimeter) for all other alpha emitters.

(166) "Survey" means an evaluation of the radiological conditions and potential hazards incident to the production, use, transfer, release, disposal or presence of radioactive material or other sources of radiation. When appropriate, such an evaluation includes a physical survey of the location of radioactive material, or the sources of radiation and measurements or calculations of levels of radiation, or concentrations or quantities of radioactive material present.

(167) "Tight-fitting facepiece" means a respiratory inlet covering that forms a complete seal with the face.

(168) "Total effective dose equivalent" or "TEDE" means the sum of the effective dose equivalent (for external exposures) and the committed effective dose equivalent (for internal exposures).

(169) "Transport index" means the dimensionless number, rounded up to the next tenth, placed on the label of a package, to designate the degree of control to be exercised by the carrier during transportation. The transport index is the number determined by multiplying the maximum radiation level in millisievert per hour at one meter (3.3 feet) from the external surface of the package by one hundred, which is equivalent to the maximum radiation level in millirem per hour at one meter (3.3 feet).

(170) "Type A quantity" means a quantity of radioactive material, the aggregate radioactivity of which does not exceed A₁ for special form radioactive material, or A₂ for normal form radioactive material, where A₁ and A₂ are given in rule 3701:1-50-25 of the Administrative Code.

(171) "Type B quantity" means a quantity of radioactive material greater than a type A quantity.

(172) "Type B package" is defined under "Package."

(173) "United States department of energy" means the department of energy established by the Department of Energy Organization Act, PL 95-91, 91 Stat. 565 (1977), 42 U.S.C. 7101 et seq., as amended (2006), to the extent that the department of energy or its duly authorized representatives, exercises functions formerly vested in the United States atomic energy commission, its chairman, members, officers and components and transferred to the United States energy research and development administration and to the administrator thereof pursuant to Sections 104(b) to (d) of the Energy Reorganization Act of 1974, PL 93-438, 88 Stat. 1233 at 1237 (1974), 42 U.S.C. 5814 and retransferred to the secretary of energy pursuant to Section 301(a) of the Department of Energy Organization Act, PL 95-91, 91 Stat. 565 at 577-578 (1977), 42 U.S.C. 7151.

(174) "Unrestricted area" or "uncontrolled area" means any area, access to which is neither restricted nor controlled by the licensee or registrant.

(175) "User seal check" or "fit check" means an action conducted by the respirator user to determine if the respirator is properly seated to the face. Examples include negative pressure check, positive pressure check, irritant smoke check, or isoamyl acetate check.

(176) "Very high radiation area" means an area, accessible to individuals, in which radiation levels from radiation sources external to the body could result in an individual receiving an absorbed dose in excess of five gray (five hundred rad) in one hour at one meter from a source of radiation or from any surface that the radiation penetrates. At very high doses received at high dose rates, units of absorbed dose, gray and rad, are appropriate, rather than units of dose equivalent, sievert and rem.

(177) "Veterinarian" means an individual licensed by the state of Ohio to practice veterinary medicine pursuant to Chapter 4741. of the Revised Code.

(178) "Waste" means those low-level radioactive wastes containing source, special nuclear, or byproduct material that are acceptable for disposal in a land disposal facility. For the purposes of this definition, low-level radioactive waste means radioactive waste not classified as high-level radioactive waste, transuranic waste, spent nuclear fuel, or byproduct material as defined in paragraph (A)(26)(b) of this rule, or byproduct material as defined in section 11 E. (3) and (4) of the Atomic Energy Act of 1954, 68 Stat. 919, 42 USC 2014, as amended (2005).

(179) "Week" means seven consecutive days starting on Sunday.

(180) "Weighting factor

• W_T" for an organ or tissue, (T), is the proportion of the risk of stochastic effects resulting from irradiation of that organ or tissue to the total risk of stochastic effects when the whole body is irradiated uniformly. For calculating the effective dose equivalent, the values of W_T are:

| Organ doseweighting factors | | | --- | --- | | Organ ortissue | W_T | | Gonads | 0.25 | | Breast | 0.15 | | Red bone marrow | 0.12 | | Lung | 0.12 | | Thyroid | 0.03 | | Bonesurfaces | 0.03 | | Remainder | 0.30^a | | Whole body | 1.00^b |

^\a 0.30 results from 0.06 for each of five "remainder" organs, excluding the skin and the lens of the eye, that receive the highest doses.

^\b for the purpose of weighting the external whole body dose (for adding it to the internal dose) a single weighting factor, W_T = 1.0, has been specified. The use of other weighting factors for external exposure will be approved on a case-by-case basis until such time as specific guidance is issued.

(181) "Whole body" means for purposes of external exposure, head; trunk, including male gonads; arms above the elbow; legs above the knee.

(182) "Worker" means an individual engaged in activities licensed or registered by the department and controlled by a licensee or registrant, but does not include the licensee or registrant.

(183) "Working level" or "WL" means any combination of short-lived radon decay products (for radon-222: polonium-218, lead-214, bismuth-214, and polonium-214; and for radon-220: polonium-216, lead-212, bismuth-212, and polonium-212) in one liter of air that will result in the ultimate emission of 1.3 x 10⁵ million electron volts alpha particle energy.

(184) "Working level month" or "WLM" means a cumulative exposure to one working level for one hundred seventy hours. (Two thousand working hours per year/twelve months per year equals approximately one hundred seventy hours per month.)

(185) "Year" means the period of time beginning in January used to determine compliance with the provisions of this rule. The licensee or registrant may change the starting date of the year used to determine compliance by the licensee or registrant provided that the change is made at the beginning of the year and that no day is omitted or duplicated in consecutive years.

(B) The terms set out in paragraph (A) of this rule may be redefined in other chapters as promulgated pursuant to Chapter 3748. of the Revised Code as used in that chapter only.

Last updated May 13, 2026 at 11:20 AM

History

• Effective: January 20, 2022
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-67-02

(A) The handler shall be responsible for directing the operation of the therapy equipment to ensure that the requirements of Chapter 3701:1-67 of the Administrative Code are met.

(B) The handler shall not use therapy equipment that does not meet the provisions of Chapter 3701:1-67 of the Administrative Code to irradiate patients, or use therapy equipment that has not received U.S. food and drug administration clearance or pre-market approval.

(C) For any therapy equipment subject to Chapter 3701:1-67 of the Administrative Code, the handler shall require the physician or veterinarian who authorizes use of the therapy equipment to be:

(1) Certified in one of the following:

(a) Radiation oncology or therapeutic radiology by the "American Board of Radiology" or combined diagnostic and therapeutic radiology program by the "American Board of Radiology" prior to 1976;

(b) Radiation oncology by the "American Osteopathic Board of Radiology";

(c) Radiology, with specialization in radiotherapy, as a British "Fellow of the Faculty of Radiology" or "Fellow of the Royal College of Radiology";

(d) Therapeutic radiology by the "Canadian Royal College of Physicians and Surgeons";

(e) Radiation oncology by the "American College of Veterinary Radiology"; or

(2) In active practice of therapeutic radiology, and has completed two hundred hours of instruction in basic radiation techniques applicable to the use of an external beam radiation therapy unit, five hundred hours of supervised work experience, and supervised clinical experience.

(a) To satisfy the requirement for instruction, the classroom and laboratory training shall include:

(i) Radiation physics and instrumentation;

(ii) Radiation protection;

(iii) Mathematics pertaining to the use and measurement of ionization radiation; and

(iv) Radiation biology.

(b) To satisfy the requirement for supervised work experience, training shall be under the supervision of a board certified authorized physician who meets the qualifications of paragraph (C)(1) of this rule, and shall include:

(i) Review of the calibration measurements and quality assurance performance testing;

(ii) Evaluation of prepared treatment plans and calculation of treatment times/patient treatment settings;

(iii) Using administrative controls to prevent medical events;

(iv) Implementing emergency procedures to be followed in the event of the abnormal operation of an external beam radiation therapy unit or console; and

(v) Checking and using radiation survey meters.

(c) To satisfy the requirement for a period of supervised clinical experience, training shall include one year in a formal training program and an additional two years of clinical experience in therapeutic radiology under the supervision of an authorized physician.

(i) The one year in a formal training program must be approved by either:

(a) The "Residency Review Committee in Radiation Oncology" for "Radiology of the Accreditation Council for Graduate Medical Education"; or

(b) The "Committee on Postdoctoral Training" of the "American Osteopathic Association."

(ii) The additional two years of clinical experience in therapeutic radiology under the supervision of an authorized physician shall include:

(a) Examining patients and reviewing their case histories to determine their suitability for external beam radiation therapy treatment, and any limitations or contraindications;

(b) Selecting proper dose and how it is to be administered;

(c) Calculating the therapy equipment doses and collaborating with the authorized physician in the review of patients' progress and consideration of the need to modify originally prescribed doses and treatment plans as warranted by patients' reaction to radiation; and

(d) Post-administration follow-up and review of case histories.

(d) For veterinary radiation oncology, completion of a formal training program approved by the "Executive Council" of the "American College of Veterinary Radiology" shall satisfy the requirement for supervised clinical experience.

(D) For any therapy equipment subject to Chapter 3701:1-67 of the Administrative Code, the handler shall require the qualified medical physicist to:

(1) Be certified by the "American Board of Radiology" in one of the following:

(a) Therapeutic radiological physics;

(b) Therapeutic Medical Physics;

(c) Radiological physics; or

(2) Be certified by the "American Board of Medical Physics in Radiation Oncology Physics";

(3) Be certified by the "Canadian College of Medical Physics in Radiation Oncology Physics"; or

(4) Meet all of the following:

(a) Hold a master's or doctor's degree in physics, medical physics, other physical science, engineering, or applied mathematics from an accredited college or university;

(b) Have completed one year of full time training in medical physics and an additional year of full time work experience under the supervision of a board certified medical physicist who meets the qualifications of paragraph (D)(1), (D)(2) or (D)(3) of this rule at a medical institution;

(i) This training and work experience shall be conducted in clinical radiation facilities that provide high-energy external beam radiation therapy with photons and electrons with energies greater than or equal to one MV or one MeV; and

(ii) The individual shall have performed the tasks listed in rules 3701:1-67-08 and 3701:1-67-09 of the Administrative Code under the supervision of a qualified medical physicist during the year of work experience.

(c) Obtain certification pursuant to paragraph (D)(1), (D)(2), or (D)(3) of this rule within six years of qualifying under paragraph (D)(4) of this rule.

(E) For any therapy equipment subject to Chapter 3701:1-67 of the Administrative Code, the handler shall require:

(1) Every individual who performs radiation therapy procedures on human beings holds a valid radiation therapist license as required by Chapter 3701-72 of the Administrative Code;

(2) Every individual who performs radiation therapy procedures is adequately instructed in the handler's safe operating procedures and can demonstrate competency in the safe use of the equipment; and

(3) The names and training of all personnel currently operating the therapy equipment shall be kept on file at the facility. The names and training of former operators shall be retained for a period of at least three years beyond the last date they were authorized to operate the therapy equipment at that facility.

(F) The handler's written safe operating procedures shall be developed by a qualified medical physicist to include any operation restrictions for the therapy equipment. The written safe operating procedures shall be available in the control area of the therapy equipment, in hard copy or electronic format, and the operator shall be able to demonstrate familiarity with these procedures. The written safe operating procedures shall address at least the following:

(1) The therapy equipment shall not be used for irradiation of patients unless the applicable requirements of rule 3701:1-67-09 of the Administrative Code have been met;

(2) Therapy equipment shall not be left unattended unless secured to prevent unauthorized use;

(3) When a patient must be held in position for radiation therapy, mechanical supporting or restraining devices shall be used;

(4) When only adjustable beam limiting devices are used for patient positioning purposes, the position and shape of the radiation field shall be indicated by a light field. The therapy equipment shall not be used for irradiation of patients unless the light field is operational;

(5) The therapy equipment shall not be used for patient irradiation unless at least one viewing system is operational;

(6) The therapy equipment shall not be used for irradiation of patients unless continuous two-way aural communication is possible;

(7) The equipment shall only be operated as designed by the manufacturer;

(8) No individual other than the patient shall be in the treatment room during treatment or during any irradiation for testing or calibration purposes from therapy equipment operating above one hundred fifty kV. At energies less than or equal to one hundred fifty kV, any individual, other than the patient, in the treatment room shall be protected by a barrier sufficient to meet the requirements of rule 3701:1-38-12 of the Administrative Code;

(9) For equipment operating at less than one megavolt (MV), the tube housing assembly shall not be held by an individual during operation unless the assembly is designed to require such holding and the peak tube potential of the system does not exceed fifty kV. In such cases, the holder shall wear protective gloves and an apron of not less than 0.5 millimeters lead equivalency at one hundred kV; and

(10) How to contact the qualified medical physicist for problems or emergencies, as well as the specific actions, if any, to be taken until the qualified medical physicist can be contacted.

(G) An individual shall not expose another individual to the useful beam unless ordered by a licensed practitioner acting within his or her scope-of-practice for dental, medical or radiation therapy purposes. Exposing an individual for training, demonstration or other purposes is prohibited unless otherwise specified in rules promulgated under Chapter 4773. or 3748. of the Revised Code.

(H) All individuals associated with the operation of therapy equipment shall be instructed in and shall comply with the provisions of the handler's quality management program. In addition to the requirements in Chapter 3701:1-67 of the Administrative Code, these individuals are also subject to the applicable requirements in Chapter 3701:1-38 and rule 3701:1-66-04 of the Administrative Code.

(I) The handler shall assure the individual responsible for radiation protection (IRRP) is qualified as one of the following:

(1) Ohio licensed to operate radiation-generating equipment excluding general x-ray machine operators;

(2) Registered veterinary technician and trained to operate veterinary radiation-generating equipment;

(3) Certified by the American registry of radiologic technologists in a pathway involving ionizing radiation or certified by the nuclear medicine technologist certification board;

(4) A radiation expert as defined in rule 3701:1-66-01 of the Administrative Code;

(5) A health physicist certified by the American board of health physics; or

(6) An associate's degree or higher in health physics, radiologic science, nuclear medicine or nuclear engineering.

(J) The handler shall maintain the following information in a separate file or package for each piece of therapy equipment, for inspection by the department:

(1) Report of acceptance testing and commissioning;

(2) Records of all surveys, calibrations, and quality assurance performance testing of the therapeutic radiation machine required by Chapter 3701:1-67 of the Administrative Code, as well as the names of people who performed such activities;

(3) Records of maintenance and/or modifications performed on each piece of therapy equipment, as well as the names of people who performed such services; and

(4) Name and signature of the qualified medical physicist or authorized individual, as delineated in the quality assurance manual, authorizing the return of the therapy equipment to clinical use after any service or intervention that significantly affects patient treatment.

(K) The director may, upon application thereof or upon his or her own initiative, grant a variance to the requirements of this chapter as he or she determines is authorized by law, provided that the handler shows to the satisfaction of the director that there is good cause for the variance, and that the variance shall not result in any undue hazard or effect on the public health and safety. The terms, conditions, and expiration of the variance shall be set forth in writing by the director. Failure to comply with the terms of the variance may result in immediate revocation of the variance.

Last updated August 24, 2026 at 7:41 AM

History

• Effective: August 20, 2026
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-67-12

(A) A handler shall report any medical event resulting from intervention of a human patient or human research subject in which the administration of radiation from therapy equipment results, or will result, in unintended permanent functional damage to an organ or a physiological system as determined by a physician.

(B) A handler shall report, as a medical event, any treatment deviation, except for a treatment deviation that results from intervention by a human patient or human research subject, in which the administration of radiation from therapy equipment involves:

(1) The wrong patient; where wrong patient means administration of radiation to an individual using a treatment plan intended for another patient or human research subject; or

(2) The wrong treatment; where wrong treatment means administration of radiation to a human patient or human research subject that does not conform to the written directive and the approved treatment plan; and

(a) The administered dose over the entire treatment course differs from the prescribed dose as stated in the written directive by more than ten per cent for treatment courses consisting of three or fewer fractions; or

(b) The administered dose over the entire treatment course differs from the prescribed dose by more than twenty per cent for treatment courses consisting of more than three fractions; or

(c) The administered dose over any five consecutive fractions differs from the prescribed dose by more than thirty per cent; or

(d) The administered dose to any critical structure:

(i) Exceeds the critical dose limit established in the written directive or approved treatment plan by twenty per cent or more; and

(ii) Has the potential to cause serious harm according to the current published recommendations from a recognized national professional organization with expertise in radiation oncology; or

(3) An error in the approved treatment plan or process that was identified after the administration of radiation and resulted in a dose difference described in paragraph (B)(2)(a), (B)(2)(b), (B)(2)(c) or (B)(2)(d) of this rule.

(C) For purposes of paragraphs (B)(2)(a), (B)(2)(b) and (B)(2)(c) of this rule, "administered dose" means:

(1) The D₉₅ (minimum dose to ninety-five per cent of the prescribed volume) for computer treatment plans; or

(2) The dose to the prescription point for treatments prescribed to a point.

(D) The handler shall notify the department by telephone no later than the next calendar day after the handler ascertains that a medical event occurred.

(E) The handler shall submit a written report to the department within fifteen days after the initial report of the medical event. The written report must include:

(1) The handler or registrant name;

(2) The name of the prescribing physician;

(3) A brief description of the event;

(4) Why the event occurred;

(5) The effect, if any, on the individual who received the medical event;

(6) Actions, if any, that have been taken, or are planned, to prevent recurrence; and

(7) Certification that the handler notified the individual, or the individual's responsible relative or guardian, and if not, why not.

(F) The report shall not contain the individual's name or any other information that could lead to the identification of the individual.

(G) The handler shall provide notification of the medical event to the referring physician and also notify the individual who is the subject of the medical event no later than twenty-four hours after its discovery, unless the authorized user and/or referring physician personally informs the handler either that he or she will inform the individual or that, based on medical judgment, telling the individual would be harmful. The handler is not required to notify the individual without first consulting the authorized user and/or referring physician. If the referring physician or the affected individual cannot be reached within twenty-four hours, the handler shall notify the individual as soon as possible thereafter. The handler may not delay any appropriate medical care for the individual, including any necessary remedial care as a result of the medical event, because of any delay in notification. To meet the requirements of this paragraph, the notification of the individual who is the subject of the medical event may be made instead to that individual's responsible relative or guardian. If a verbal notification is made, the handler shall inform the individual or appropriate responsible relative or guardian that a written description of the event can be obtained from the handler upon request. The handler shall provide such a written description if requested.

(H) Aside from the notification requirement, nothing in this section affects any rights or duties of handlers, registrants and physicians in relation to each other, to individuals affected by the medical event, or to that individual's responsible relatives or guardians.

(I) The handler shall retain a record of each medical event report with an identification link to the individual who is the subject of the medical event for the duration of the registration.

Last updated September 1, 2022 at 8:27 AM

History

• Effective: September 1, 2022
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-67-04

(A) Each handler of therapy equipment subject to the requirements of Chapter 3701:1-67 of the Administrative Code, shall develop, implement, and maintain a quality management program to provide high confidence that radiation will be administered as directed by the physician or veterinarian authorizing its use.

(B) The quality management program shall address, as a minimum, the following specific objectives regarding written directives:

(1) A written directive must be dated and signed by a physician or veterinarian authorizing its use prior to the administration of radiation. If because of the patient's condition, a delay in the order to provide a written revision to an existing written directive would jeopardize the patient's health, an oral revision to an existing written directive will be acceptable, provided that the oral revision is documented as soon as possible in the patient's record and a revised written directive is signed by an authorized physician within forty-eight hours of the oral revision;

(2) The written directive must contain the patient or human research subject's name, the type and energy of the beam, the total dose, dose per fraction, treatment site, and number of fractions;

(3) A written revision to an existing written directive may be made provided that the revision is dated and signed by an authorized physician prior to the administration of the therapy equipment dose, or the next fractional dose; and

(4) The handler shall retain a copy of the written directive for seven years.

(C) The quality management program will address, as a minimum, the following specific objectives regarding radiation therapy services:

(1) Each radiation therapy service will evaluate the patient and assess the treatment site(s):

(a) The evaluation will be conducted by an authorized physician and will include a medical history, a physical examination, a review of the patient's diagnostic studies and reports, and, when appropriate, consultation by the authorized physician with the referring physician;

(b) The assessment of the treatment site(s) will include location, the extent, and stage of the disease;

(c) The authorized physician will establish the doses desired throughout the treatment site and set dose limits to critical structures. The authorized physician will establish the critical structures associated with the treatment site. Treatment will meet the goals of the authorized physician; and

(d) The authorized physician will describe in detail and sign all treatment applications. The authorized physician will be notified of any changes that may be necessary in the planned schedule of treatment.

(2) Each radiation therapy service will:

(a) Provide or arrange for appropriate radiation treatment localization, simulation and verification;

(b) Provide or arrange for isodose treatment planning with complex analyses generated in appropriate cases;

(c) Provide accurate calculation of doses and dose distribution;

(d) Provide a system for independent checking of initial dose calculations. The check will be conducted before the third fraction, or before twenty per cent of the total dose when the treatment schedule provides less than ten fractions. The independent check includes utilizing another individual or method approved and documented by the medical physicist to verify dose calculations;

(e) Conduct ongoing reviews of accumulating doses;

(f) Conduct prescribed imaging prior to the second treatment and check the prescribed imaging at least every ten treatments;

(g) Conduct a chart and imaging review weekly;

(h) Accurately chart treatment doses;

(i) Maintain records of pertinent data used in planning the specific treatment for a patient in the patient's medical record; and

(j) Provide devices to aid in positioning and immobilizing the patient. Normal tissue shield, compensating filters, wedges, and other aids will be provided as medically appropriate.

(D) The quality management program will address the following specific objectives regarding stereotactic radiosurgery services: The authorized physician will establish the doses desired throughout the treatment site and set limits of doses to critical structures The authorized physician will establish the critical structures associated with the treatment site. Treatment deliveries will meet the specifications of the authorized physician;

(E) The handler shall develop, implement, and maintain for the duration of the registration, written procedures to provide high confidence that:

(1) Prior to the administration of each radiation treatment, the patient's or human research subject's identity is verified by more than one method as the individual named in the written directive;

(2) Each administration is in accordance with the written directive;

(3) The final plans of treatment and related calculations are in accordance with the respective written directives by:

(a) Checking the parameters and the results of the primary calculation with a secondary method to verify they are correct and in accordance with the written directive; and

(b) Verifying that the planned parameters are correctly transferred to the treatment charts; and

(4) Unintended treatment deviations from the written directive, approved treatment plan, or errors in the approved treatment plan or process that was identified after the administration of radiation are identified, documented, evaluated and appropriate action is taken.

(F) The handler shall retain records of unintended treatment deviations from the written directive or approved treatment plan for seven years. The record must contain the following:

(1) The identification number of the individual who is the subject of the unintended deviation;

(2) A brief description of the deviation and why it occurred; and

(3) The actions, if any, taken to prevent recurrence.

Last updated August 24, 2026 at 7:41 AM

History

• Effective: August 20, 2026
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-67-08

In addition to the rules in Chapters 3701:1-38 and 3701:1-67 of the Administrative Code, handlers shall comply with paragraphs (A) to (L) of this rule.

(A) Therapy equipment subject to the rules in Chapter 3701:1-67 of the Administrative Code shall be provided with such primary and secondary barriers as are necessary to ensure compliance with rules 3701:1-38-12 and 3701:1-38-13 of the Administrative Code which prescribe occupational and public dose limits respectively. Specifically:

(1) All wall, floor, and ceiling areas struck by the useful beam shall have primary barriers; and

(2) Secondary barriers shall be provided in all wall, floor, and ceiling areas not having primary barriers.

(B) Treatment room design shall provide for:

(1) Continuous two-way aural communication between the patient and the operator at the control panel; and

(2) Continuous observation of the patient during irradiation. This viewing system shall be so located that the operator can observe the patient from the control panel. Therapy equipment shall not be used for patient irradiation unless at least one viewing system is operational.

(C) For therapy equipment operating above 150kV, treatment rooms shall meet the following:

(1) All protective barriers shall be fixed, except for entrance access doors to the treatment room or movable beam interceptors;

(2) The control panel shall be located outside the treatment room or in a totally enclosed booth, which has a ceiling, inside the room; and

(3) Interlocks shall be provided such that all entrance doors, including doors to any interior booths if applicable, shall be closed before treatment can be initiated or continued. If the radiation beam is interrupted by any door opening, it shall not be possible to restore the machine to operation without closing the door and reinitiating irradiation by manual action at the control panel.

(D) For therapy equipment operating at or above one MV, treatment rooms shall meet the following:

(1) In addition to other requirements specified in Chapter 3701:1-67 of the Administrative Code, the control panel shall:

(a) Be located outside the treatment room;

(b) Provide an indication of whether electrical power is available at the control panel and if activation of the radiation is possible;

(c) Provide an indication of whether radiation is being produced; and

(d) Include an access control or locking device that will prevent unauthorized use of the therapy equipment;

(2) Treatment room entrances shall be provided with warning lights in a readily observable position near the outside of all access doors, which will state in words when the useful beam is on;

(3) Interlocks shall be provided such that all access controls are activated before treatment can be initiated or continued. If the radiation beam is interrupted by any access control, it shall not be possible to restore the therapy equipment to operation without resetting the access control and reinitiating irradiation by manual action at the control panel;

(4) If the shielding material in any protective barrier requires the presence of a beam interceptor to ensure compliance with paragraph (A) and paragraph (B) of rule 3701:1-38-13 of the Administrative Code, interlocks shall be provided to prevent the production of radiation, unless the beam interceptor is in place, whenever the useful beam is directed at the designated barrier(s);

(5) At least one emergency power cutoff switch shall be located in the radiation therapy room and shall terminate all equipment electrical power including radiation and mechanical motion. This switch is in addition to the termination switch required on the treatment control panel. All emergency power cutoff switches shall include a manual reset so that the therapy equipment cannot be restarted from the unit's control console without resetting the emergency cutoff switch; and

(6) All safety interlocks shall be designed so that any defect or component failure in the safety interlock system prevents or terminates operation of the therapy equipment.

(E) A qualified medical physicist shall design shielding, verify shielding design or verify that the existing shielding is adequate for installation of therapy equipment.

(F) The facility design information for all new installations of therapy equipment or installations of equipment of higher energy or capable of producing a larger maximum useful beam into a room not previously designed for that energy or beam size shall be submitted to the department prior to installation of the therapy equipment. The minimum facility design information that shall be submitted is listed in the appendix to this rule.

(G) An area radiation survey of all new facilities, and existing facilities not previously surveyed, shall be performed by, or under the direct supervision of a qualified medical physicist using an operable radiation measurement survey instrument calibrated in accordance with rule 3701:1-67-07 of the Administrative Code.

(H) The area radiation survey shall be performed with the therapy equipment in the "beam-on" condition using the largest clinically available treatment field and a scattering phantom in the useful beam when evaluating secondary protective barriers and no phantom in the useful beam when evaluating primary protective barriers to verify that:

(1) Radiation levels in restricted areas are not likely to cause personnel exposures in excess of the limits specified in rule 3701:1-38-12 of the Administrative Code; and

(2) Radiation levels in unrestricted areas do not exceed the limits specified in rule 3701:1-38-13 of the Administrative Code.

(I) In addition to the requirements of paragraphs (G) and (H) of this rule, an area radiation survey shall also be performed by a qualified medical physicist or directly supervised by a qualified medical physicist prior to any subsequent medical use and:

(1) After making any change in the treatment room shielding;

(2) After making any change in the location of the therapy equipment within the treatment room except for portable contact therapy equipment, electronic brachytherapy equipment or portable external beam radiation therapy equipment capable of electron production only;

(3) After relocating the therapy equipment except for portable contact therapy equipment, electronic brachytherapy equipment or portable external beam radiation therapy equipment capable of electron production only;

(4) Before using the therapy equipment in a manner that could result in increased radiation levels in areas outside the external beam radiation therapy treatment room; or

(5) After changes are made to the therapy equipment, the therapy equipment shielding, or the treatment room shielding following a survey that failed to ensure compliance with the requirements of this rule.

(6) Determination of residual activity for all therapy equipment capable of generating photon and electron energies above ten MV shall be performed to determine compliance with occupational dose limits prior to machining, removing, or working on therapy equipment components which may have become activated due to photo- neutron production.

(J) If the results of the area radiation surveys required by paragraphs (G) to (I) of this rule indicate any radiation levels in excess of the respective limits, the handler shall lock the control in the "off" position and not use the unit:

(1) Except as may be necessary to repair, replace, or test the therapy equipment, the therapy equipment shielding, or the treatment room shielding;

(2) Until either the equipment is provided with appropriate beam directional interlocks or additional radiation shielding is added to ensure compliance with rules 3701:1-38-12 and 3701:1-38-13 of the Administrative Code;

(3) Until implementation of administrative controls to reduce radiation levels below the respective limits; or

(4) Until the handler has requested and received a variance from the department that authorizes radiation levels in unrestricted areas greater than those permitted by rules 3701:1-38-12 and 3701:1-38-13 of the Administrative Code.

(K) The area radiation survey record shall indicate:

(1) All instances where the facility, in the opinion of the qualified medical physicist, is in violation of applicable regulations;

(2) The date of the measurements;

(3) The reason the survey is required;

(4) The manufacturer's name, model number and serial number of the therapy equipment;

(5) The manufacturers' names, model numbers, serial numbers, and dates of calibration of the instruments used to measure radiation levels;

(6) A plan of the areas surrounding the treatment room that were surveyed;

(7) The measured dose rate at a representative number of points in each area expressed in microsieverts (millirem) per hour;

(8) The calculated maximum level of radiation over a period of one week for each restricted and unrestricted area; and

(9) The name and signature of the individual responsible for conducting the survey.

(L) Maintain a record of each shielding design and area radiation survey for the duration of the registration and make the records and measurements available upon request during an inspection.

View Appendix

Last updated September 1, 2022 at 8:27 AM

History

• Effective: September 1, 2022
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-67-09

In addition to the rules in Chapters 3701:1-38 and 3701:1-67 of the Administrative Code, handlers shall comply with paragraphs (A) to (H) of this rule.

(A) For therapy equipment subject to this chapter, a qualified medical physicist shall develop a documented quality assurance (QA) program using the appropriate "American Association of Physicists in Medicine" (AAPM) reports or the "National Council of Radiation Protection" (NCRP) report as a basis.

(1) The quality assurance program shall:

(a) Identify each QA performance test to be performed;

(b) Describe the procedures used to complete each QA performance test;

(c) Describe the method used to document the results of each QA performance test;

(d) Identify the frequency of each QA performance test; and

(e) Specify the acceptable action limits and safety tolerance limits for each QA performance test result and the action to be taken when exceeded.

(2) Any variation from the identified tests, frequency or tolerance limits specified in the appropriate AAPM or NCRP reports shall be based on a documented history of therapy equipment performance, therapy equipment clinical utilization, or inherent therapy equipment design and be justified by the qualified medical physicist in the quality assurance program. Should the qualified medical physicist decide to change the frequency or tolerance limit of a particular test, the decision should be validated with an appreciable history of that test or rationale.

(3) Any QA performance test result exceeding a factor of two from the tolerances in AAPM or NCRP documents shall require immediate action prior to further treatment.

(B) Perform QA performance tests in accordance with the written procedures established by the qualified medical physicist and comply with the following:

(1) The authorized physician and qualified medical physicist shall be immediately notified if any QA performance test result exceeds a safety tolerance limit set by the qualified medical physicist. The cause for a parameter exceeding the safety tolerance limit shall be investigated before the system is used for patient irradiation. The medical physicist in collaboration with the authorized physician shall determine whether medical treatment may continue safely or be interrupted until corrected;

(2) Use a dosimetry system described in rule 3701:1-67-07 of the Administrative Code to perform absolute-dose related QA performance tests required by this rule;

(3) Have the qualified medical physicist review and sign the results of each QA performance test within a month of the date that the test was performed, by an individual other than the qualified medical physicist; and

(4) Ensure that safety QA tests are performed monthly on the following:

(a) Electrical interlocks at each external beam radiation therapy room entrance;

(b) The "beam-on" and termination switches;

(c) All beam indicator lights;

(d) Patient audio visual viewing system; and

(e) If applicable, electrically operated treatment room doors from inside and outside the treatment room.

(C) As used in this rule, "calibration" means the determination of the exposure or dose per unit time or absorbed dose per monitor unit (MU) under specified conditions as described by the qualified medical physicist in the quality assurance program. Calibration shall be performed:

(1) Before the first medical use following installation or reinstallation;

(2) Annually; and

(3) Before medical use under the following conditions:

(a) Whenever QA performance test results indicate the radiation output differs by more than five per cent from the calibration value obtained during the most recent annual QA performance tests and the difference cannot be reconciled. Calibration of therapy equipment with multi-energy capabilities is required only for those modes and/or energies that are not within their acceptable range; and

(b) Following any major mechanical, electrical or software based alterations affecting the radiation source, its housing, power supply or controls or after replacement of the radiation source. If an alteration or replacement does not affect all energies, calibration shall be performed on the affected energy that is in most frequent clinical use at the facility. The remaining energies may be validated with quality assurance check procedures against the criteria in paragraph (C)(3)(a) of this rule.

(D) For therapy equipment operating at less than one megavolt (MV):

(1) The qualified medical physicist shall use NCRP report 69, Dosimetry of X-Ray and Gamma Ray Beams for Radiation Therapy in the Energy Range 10 keV to 50MeV (1981) for commissioning, initial QA performance testing and to meet the requirements of paragraph (A) of this rule. The term "QA performance test", as used in paragraph (D) of this rule, shall have the same meaning as the term "check" in the NCRP report.

(2) Commissioning and initial QA performance testing shall be completed prior to medical use following installation or reinstallation.

(3) Commissioning, initial and annual QA performance tests shall be performed by or under direct supervision of a qualified medical physicist.

(E) For therapy equipment operating at or above one megavolt (MV):

(1) The qualified medical physicist shall use the "AAPM Code of Practice for Radiotherapy Accelerators: AAPM Report No. 47 (AAPM report 47)," prepared by "Radiation Therapy Task Group 45" (this publication can be obtained from the American association of physicists in medicine, 1631 Prince st, Alexandria, VA 22314, telephone (301) 209-3350, http://www.aapm.org/pubs/reports) and the manufacturer's contractual specifications as a basis for acceptance testing and commissioning.

(2) To meet the requirements of paragraph (A) of this rule, the qualified medical physicist shall use:

(a) The "Comprehensive QA for Radiation Oncology: Report of AAPM Radiation Therapy Committee Task Group No. 40: AAPM Report No. 46 (AAPM report 46)" (this publication can be obtained from the American association of physicists in medicine, 1631 Prince st, Alexandria, VA 22314, telephone (301) 209-3350, http://www.aapm.org/pubs/reports).

(b) "Task Group 142 report: Quality assurance of medical accelerators" (this publication can be obtained from the American association of physicists in medicine, 1631 Prince st, Alexandria, VA 22314, telephone (301) 209-3350, http://www.aapm.org/pubs/reports) for therapy equipment provided with asymmetric jaws, multileaf collimation, dynamic or virtual wedges, planar imaging devices, tomographic imaging devices or those used for stereotactic radiosurgery, stereotactic body radiation therapy, total body photon irradiation or intensity-modulated radiotherapy.

(c) The "Intraoperative radiation therapy using mobile electron linear accelerators: Report of AAPM Radiation Therapy Committee Task Group No. 72" (this publication can be obtained from the American association of physicists in medicine, 1631 Prince st, Alexandria, VA 22314, telephone (301) 209-3350, http://www.aapm.org/pubs/reports) for mobile electron linear accelerator therapy equipment.

(d) The "Report of AAPM TG 135: Quality assurance for robotic radiosurgery" (this publication can be obtained from the American association of physicists in medicine, 1631 Prince st, Alexandria, VA 22314, telephone (301) 209-3350, http://www.aapm.org/pubs/reports) for robotic radiosurgery therapy equipment.

(e) The "Quality control and assurance for tomotherapy: An update to Task Group Report 148" (this publication can be obtained from the American association of physicists in medicine, 1631 Prince st, Alexandria, VA 22314, telephone (301) 209-3350, http://www.aapm.org/pubs/reports) for helical tomotherapy equipment.

(f) The "Comprehensive proton therapy machine quality assurance AAPM Task Group 224" (this publication can be obtained from the American association of physicists in medicine, 1631 Prince st, Alexandria, VA 22314, telephone (301) 209-3350, http://www.aapm.org/pubs/reports) for proton therapy equipment.

(3) Acceptance testing, commissioning and baseline QA performance testing shall be completed prior to medical use following installation or reinstallation.

(4) Acceptance testing, commissioning, baseline and annual QA performance tests shall be performed by or under direct supervision of a qualified medical physicist.

(5) An independent verification of the calibration of all photon beams and a sample of available electron beams shall be performed annually by:

(a) A second radiation expert using a dosimetry system other than the dosimetry system that was used during the annual calibration; or

(b) A national institute of science and technology traceable third-party dosimetry service or an equivalent method which is capable of measuring doses with an accuracy within five per cent.

(6) Proper operation of each emergency power cutoff switch shall be verified annually. If more than one switch is installed, they may be evaluated on a rotating basis throughout the year.

(F) For image guidance systems and conventional or virtual simulation:

(1) The qualified medical physicist shall use the "Comprehensive QA for Radiation Oncology: Report of AAPM Radiation Therapy Committee Task Group No. 40: AAPM Report No. 46 (AAPM report 46)" (this publication can be obtained from the American association of physicists in medicine, 1631 Prince st, Alexandria, VA 22314, telephone (301) 209-3350, http://www.aapm.org/pubs/reports) to meet the requirements of paragraph (A) of this rule for a conventional simulator.

(2) The qualified medical physicist shall use the "Quality assurance for computed tomography simulators and the computed tomography-simulation process: Report of the AAPM Radiation Therapy Committee Task Group No. 66: AAPM Report No. 83 (AAPM report 83)" (this publication can be obtained from the American association of physicists in medicine, 1631 Prince st, Alexandria, VA 22314, telephone (301) 209-3350, http://www.aapm.org/pubs/reports) for acceptance testing, commissioning and to meet the requirements of paragraph (A) of this rule for a virtual simulator.

(3) The qualified medical physicist shall use the "Quality assurance for image-guided radiation therapy utilizing CT-based technologies AAPM Task Group 179" (this publication can be obtained from the American association of physicists in medicine, 1631 Prince st, Alexandria, VA 22314, telephone (301) 209-3350, http://www.aapm.org/pubs/reports) to meet the requirements of paragraph (A) of this rule for CT-based image guidance systems.

(4) Acceptance testing, commissioning, initial QA performance testing, annual QA performance testing and semiannual (if appropriate) QA performance testing shall be performed by or under the direct supervision of a qualified medical physicist.

(G) For therapy equipment used for IMRT, patient specific treatment QC shall be performed before the first fraction is delivered unless extenuating circumstances are documented by the medical physicist. If a direct measurement for individual plans is not performed, the checks shall include both a dose calculation second check and a method to validate patient plan transfer and deliverability to the treatment unit.

(H) Maintain a record of each QA performance test result for three years and acceptance testing, commissioning and each calibration for the duration of the registration. The records shall include:

(1) The date of the QA test or calibration;

(2) The manufacturer's name, model number, and serial number of the therapy equipment;

(3) The manufacturer's name, model numbers and serial numbers for the instrument(s) used to measure the radiation output of the therapy equipment; and

(4) The signature of the individual who performed the QA performance test or calibration.

Last updated August 24, 2026 at 7:40 AM

History

• Effective: August 20, 2026
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-38-12

(A) Except in the case of a planned special exposure pursuant to paragraph (F) of this rule, a licensee or registrant shall limit the occupational dose received by an individual adult, as follows:

(1) An annual limit, which is the more limiting of:

(a) The total effective dose equivalent being equal to 0.05 sievert (five rem); or

(b) The sum of the deep dose equivalent and the committed dose equivalent to any individual organ or tissue other than the lens of the eye being equal to 0.5 sievert (fifty rem).

(2) The annual limits to the lens of the eye, to the skin of the whole body, and to the skin of the extremities, which are:

(a) A lens dose equivalent of 0.15 sievert (fifteen rem), and

(b) A shallow-dose equivalent of 0.5 sievert (fifty rem) to the skin of the whole body or to the skin of any extremity.

(3) Doses received in excess of the annual limits, including doses received during accidents, emergencies, and planned special exposures, shall be subtracted from the limits for planned special exposures that the individual may receive during the current calendar year and during the individual's lifetime in accordance with paragraph (F)(5) of this rule.

(4) When the external exposure is determined by measurement with an external personal monitoring device, the deep-dose equivalent must be used in place of the effective dose equivalent, unless the effective dose equivalent is determined by a dosimetry method approved by the director. The assigned deep-dose equivalent must be for the part of the body receiving the highest exposure.

(a) The assigned shallow-dose equivalent must be the dose averaged over the contiguous ten square centimeters of skin receiving the highest exposure. The deep-dose equivalent, lens-dose equivalent, and shallow-dose equivalent may be assessed from surveys or other radiation measurements for the purpose of demonstrating compliance with the occupational dose limits, if the individual monitoring device was not in the region of highest potential exposure, or the results of individual monitoring are unavailable; or

(b) When a protective apron is worn while working with radiation-generating equipment and monitoring is conducted as specified in paragraph (C)(1) of rule 3701:1-38-14 of the Administrative Code, the effective dose equivalent for external radiation shall be determined as follows:

(i) When only one individual monitoring device is used and it is located at the neck outside the protective apron, the reported deep dose equivalent value multiplied by 0.3 shall be the effective dose equivalent for external radiation; or

(ii) When two individual monitoring devices are worn, one under the protective apron at the waist and the other outside the protective apron at the neck, the effective dose equivalent for external radiation shall be assigned the value of the sum of the deep dose equivalent reported for the individual monitoring device located at the waist under the protective apron multiplied by 1.5 and the deep dose equivalent reported for the individual monitoring device located at the neck outside the protective apron multiplied by 0.04; or

(iii) Through the use of computational methods endorsed by the "American National Standards Institute", recommended by the "National Council on Radiation Protection and Measurements", or approved by the director.

(5) Derived air concentration (DAC) and annual limit on intake (ALI) values are specified in appendix C to this rule and may be used by the licensee to determine the individual's dose and to demonstrate compliance with the occupational dose limits. Appendices A and B are explanatory supplements to appendix C to this rule. Notwithstanding the annual dose limits, the licensee shall limit the soluble uranium intake by an individual to ten milligrams in a week in consideration of chemical toxicity.

(6) In accordance with paragraph (E) of this rule, the licensee or registrant shall reduce the dose that an individual may be allowed to receive in the current year by the amount of occupational dose received while employed by any other person.

(B) Compliance with requirements for summation of external and internal doses shall be in accordance with the following:

(1) If the licensee is required to monitor under both paragraphs (B)(1) and (B)(2) of rule 3701:1-38-14 of the Administrative Code, the licensee shall demonstrate compliance with the dose limits by summing external and internal doses. If the licensee is required to monitor only under paragraph (B)(1) or only under paragraph (B)(2) of rule 3701:1-38-14 of the Administrative Code, then summation is not required to demonstrate compliance with the dose limits. The licensee may demonstrate compliance with the requirements for summation of external and internal doses by meeting one of the conditions specified in paragraph (B)(2) of this rule and the conditions in paragraphs (B)(3) and (B)(4) of this rule. The dose equivalents for the lens of the eye, the skin, and the extremities are not included in the summation, but are subject to separate limits.

(2) If the only intake of radionuclides is by inhalation, the total effective dose equivalent limit is not exceeded if the sum of the deep dose equivalent divided by the total effective dose equivalent limit, plus one of the following does not exceed unity:

(a) The sum of the fractions of the inhalation ALI for each radionuclide; or

(b) The total number of derived air concentration-hours, or DAC-hours, for all radionuclides divided by two thousand; or

(c) The sum of the calculated committed effective dose equivalents to all significantly irradiated organs or tissues (T) calculated from bioassay data using appropriate biological models and expressed as a fraction of the annual limit. For purposes of this requirement, an organ or tissue is deemed to be significantly irradiated if, for that organ or tissue, the product of the weighting factors, W_T, and the committed dose equivalent, H_T,50, per unit intake is greater than ten per cent of the maximum weighted value of H_T,50, that is, W_TH_T,50, per unit intake for any organ or tissue.

(3) If the occupationally exposed individual also receives an intake of radionuclides by oral ingestion greater than ten percent of the applicable oral ALI, the licensee shall account for this intake and include it in demonstrating compliance with the limits set forth in paragraph (A) of this rule.

(4) The licensee shall evaluate and, to the extent practical, account for intakes through wounds or skin absorption. The intake through intact skin has been included in the calculation of DAC for hydrogen-3 and does not need to be further evaluated or accounted for pursuant to this paragraph.

(C) Determination of external dose from airborne radioactive material shall be in accordance with the following:

(1) When determining the dose from airborne radioactive material, the licensee shall include the contribution to the deep dose equivalent, lens dose equivalent, and shallow dose equivalent from external exposure to the radioactive cloud as specified in appendix C to this rule, footnotes ^A and ^B.

(2) The licensee should not use airborne radioactivity measurements or DAC values as the primary means to assess the deep dose equivalent when the airborne radioactive material includes radionuclides other than noble gases, or if the cloud of airborne radioactive material is not relatively uniform. The determination of the deep dose equivalent to an individual should be based upon measurements using instruments or individual monitoring devices.

(D) Determination of internal exposure shall be in accordance with the following:

(1) For purposes of assessing dose used to determine compliance with occupational dose equivalent limits, the licensee shall, when required under paragraph (B) of rule 3701:1-38-14 of the Administrative Code, take suitable and timely measurements of:

(a) Concentrations of radioactive materials in air in work areas; or

(b) Quantities of radionuclides in the body; or

(c) Quantities of radionuclides excreted from the body; or

(d) Combinations of these measurements.

(2) Unless respiratory protective equipment is used, as provided in paragraph (C) of rule 3701:1-38-16 of the Administrative Code or the assessment of intake is based on bioassays, the licensee shall assume that an individual inhales radioactive material at the airborne concentration in which the individual is present.

(3) When specific information on the physical and biochemical properties of the radionuclides taken into the body or the behavior of the material in an individual is known, the licensee may:

(a) Use that information to calculate the committed effective dose equivalent, and, if used, the licensee shall document that information in the individual's record; and

(b) Upon prior approval of the department, adjust the DAC or ALI values to reflect the actual physical and chemical characteristics of airborne radioactive material, for example, aerosol size distribution or density; and

(c) Separately assess the contribution of fractional intakes of Class D, W, or Y compounds of a given radionuclide to the committed effective dose equivalent as specified in appendix A to this rule.

(4) If the licensee chooses to assess intakes of Class Y material using the measurements given in paragraph (D)(1)(b) or (D)(1)(c) of this rule in order to make additional measurements basic to the assessments, the licensee may delay the recording and reporting of the assessments for periods up to seven months, unless otherwise required by paragraph (B)(2) or (C) of rule 3701:1-38-21 of the Administrative Code.

(5) If the identity and concentration of each radionuclide in a mixture are known, the fraction of the DAC applicable to the mixture for use in calculating DAC-hours shall be either:

(a) The sum of the ratios of the concentration to the appropriate DAC value, that is, D, W, or Y, from appendix C to this rule for each radionuclide in the mixture; or

(b) The ratio of the total concentration for all radionuclides in the mixture to the most restrictive DAC value for any radionuclide in the mixture.

(6) If the identity of each radionuclide in a mixture is known, but the concentration of one or more of the radionuclides in the mixture is not known, the DAC for the mixture shall by the most restrictive DAC of any radionuclide in the mixture.

(7) When a mixture of radionuclides in air exists, a licensee may disregard certain radionuclides in the mixture if all of the following occur:

(a) The licensee uses the total activity of the mixture in demonstrating compliance with the dose limits in paragraph (A) of this rule and in complying with the monitoring requirements in paragraph (B) of rule 3701:1-38-14 of the Administrative Code;

(b) The concentration of any radionuclide disregarded is less than ten percent of its DAC; and

(c) The sum of these percentages for all of the radionuclides disregarded in the mixture does not exceed thirty percent.

(8) When determining the committed effective dose equivalent, the licensee may consider the following:

(a) In order to calculate the committed effective dose equivalent, the licensee may assume that the inhalation of one ALI, or an exposure of two thousand DAC-hours, results in a committed effective dose equivalent of 0.05 sievert (five rem), for radionuclides that have their ALIs or DACs based on the committed effective dose equivalent; or

(b) For an ALI and the associated DAC determined by the nonstochastic organ dose limit of 0.5 sievert (fifty rem), the intake of radionuclides that would result in a committed effective dose equivalent of 0.05 sievert (five rem), that is, the stochastic ALI, is listed in parentheses in table I of appendix C to this rule. The licensee may, as a simplifying assumption, use the stochastic ALI to determine committed effective dose equivalent. However, if the licensee uses the stochastic ALI, the licensee shall also demonstrate that the limit in paragraph (A)(1)(b) of this rule is met.

(E) Determination of prior occupational dose shall be made in accordance with the following:

(1) For each individual who is likely to receive an annual occupational dose requiring monitoring pursuant to paragraph (B) of rule 3701:1-38-14 of the Administrative Code, the licensee or registrant shall determine the occupational radiation dose received during the current year.

(2) Prior to permitting an individual to participate in a planned special exposure, the licensee shall determine:

(a) The internal and external doses from all previous planned special exposures; and

(b) All doses in excess of the limits, including doses received during accidents and emergencies, received during the lifetime of the individual.

(3) In complying with the requirements of paragraph (E)(1) or (E)(2) of this rule, a licensee or registrant may:

(a) Accept, as a record of the occupational dose that the individual received during the current year, a written signed statements from the individual, or from the individual's most recent employer for work involving radiation exposure, that discloses the nature and the amount of any occupational dose that the individual may have received during the current year;

(b) Accept, as the record of lifetime cumulative radiation dose, a current department form entitled "lifetime occupational exposure history" or equivalent, signed by the individual and countersigned by an appropriate official of the most recent employer for work involving radiation exposure, or the individual's current employer, if the individual is not employed by the licensee or registrant; and

(c) Obtain reports of the individual's dose equivalent from the most recent employer for work involving radiation exposure, or the individual's current employer, if the individual is not employed by the licensee or registrant, by telephone, telegram, facsimile, e-mail or letter. The licensee or registrant shall request a written verification of the dose data if the authenticity of the transmitted report cannot be established.

(4) The licensee or registrant shall record the exposure history, as required by paragraph (A) of this rule, on a form provided by the department or other clear and legible record, of all the information required on that form. The form or record shall show each period in which the individual received occupational exposure to radiation or radioactive material and shall be signed by the individual who received the exposure. For each period for which the licensee or registrant obtains reports, the licensee or registrant shall use the dose shown in the report in preparing the exposure history form. For any period in which the licensee or registrant does not obtain a report, the licensee or registrant shall place a notation on the exposure history form indicating the periods of time for which data are not available.

(5) If the licensee or registrant is unable to obtain a complete record of an individual's current and previously accumulated occupational dose, the licensee or registrant shall assume:

(a) In establishing administrative controls pursuant to paragraph (A)(6) of this rule for the current year, that the allowable dose limit for the individual is reduced by 12.5 millisievert (1.25 rem), for each quarter for which records were unavailable and the individual was engaged in activities that could have resulted in occupational radiation exposure; and

(b) That the individual is not available for planned special exposures.

(6) The licensee or registrant shall retain the records on the exposure history form until the department terminates each pertinent license or registration requiring this record. The licensee or registrant shall retain records used in preparing the exposure history form for three years after the record is made.

(F) A planned special exposure may be authorized by a licensee in accordance with this paragraph. A licensee may authorize an adult worker to receive doses in addition to and accounted for separately from the doses received under the limits specified in paragraph (A) of this rule provided that each of the following is satisfied:

(1) The licensee authorizes a planned special exposure only in an exceptional situation when alternatives that might avoid the higher exposure are unavailable or impractical;

(2) The licensee and employer, if the employer is not the licensee, specifically authorizes the planned special exposure, in writing, before the exposure occurs;

(3) Before a planned special exposure, the licensee ensures that each individual involved is:

(a) Informed of the purpose of the planned operation; and

(b) Informed of the estimated doses and associated potential risks and specific radiation levels or other conditions that might be involved in performing the task; and

(c) Instructed in the measures to be taken to keep the dose ALARA considering other risks that may be present;

(4) Prior to permitting an individual to participate in a planned special exposure, the licensee ascertains prior doses as required by paragraph (E)(2) of this rule during the lifetime of the individual for each individual involved;

(5) The licensee shall not authorize a planned special exposure that would cause an individual to receive a dose from all planned special exposures and all doses in excess of the limits to exceed:

(a) The numerical values of any of the dose limits in paragraph (A) of this rule in any calendar year; and

(b) Five times the annual dose limits specified in paragraph (A) of this rule during the individual's lifetime;

(6) The licensee maintains records of the conduct of a planned special exposure in accordance with paragraph (E) of rule 3701:1-38-20 of the Administrative Code and submits a written report in accordance with paragraph (D) of rule 3701:1-38-21 of the Administrative Code;

(7) The licensee records the best estimate of the dose resulting from the planned special exposure in the individual's record and informs the individual, in writing, of the dose within thirty days from the date of the planned special exposure. The dose from planned special exposures shall not be considered in controlling future occupational dose of the individual pursuant to paragraph (A)(1) of this rule, but shall be included in evaluations required by paragraphs (F)(4) and (F)(5) of this rule.

(G) Occupational dose limits for minors shall be ten per cent of the annual occupational dose limits specified for adult workers in paragraph (A) of this rule.

(H) Dose equivalent to an embryo or fetus shall be in accordance with the following:

(1) The licensee or registrant shall ensure that the dose equivalent to an embryo or fetus during the entire pregnancy, due to occupational exposure of a declared pregnant woman, does not exceed five millisievert (0.5 rem). Records shall be maintained in accordance with paragraph (I) of rule 3701:1-38-20 of the Administrative Code.

(2) The licensee or registrant shall make efforts to avoid substantial variation above a uniform monthly exposure rate to a declared pregnant woman so as to satisfy the limit in paragraph (H)(1) of this rule.

(3) The dose equivalent to the embryo or fetus is the sum of:

(a) The deep-dose equivalent to the declared pregnant woman; and

(b) The dose equivalent to the embryo or fetus resulting from radionuclides in the embryo or fetus and from radionuclides in the declared pregnant woman.

(4) If the declared pregnant woman's exposure includes exposure from radiation generating equipment and a protective apron is worn, the dose equivalent to an embryo or fetus shall be taken as the sum of:

(a) The dose equivalent to the embryo or fetus from radionuclides in the embryo or fetus and radionuclides in the declared pregnant woman; and

(b) The dose equivalent that is most representative of the dose to the embryo or fetus from external radiation, that is, in the mother's lower torso region.

(i) If multiple measurements have not been made, assignment of the highest deep dose equivalent for the declared pregnant woman shall be the dose to the embryo or fetus, in accordance with paragraph (A)(4) of this rule; or

(ii) If multiple measurements have been made, assignment of the deep dose equivalent for the declared pregnant woman from the individual monitoring device which is most representative of the dose to the embryo or fetus shall be the dose to the embryo or fetus. Assignment of the highest deep dose equivalent for the declared pregnant woman to the embryo or fetus is not required unless that dose is also the most representative deep dose equivalent for the region of the embryo or fetus.

(5) If by the time the woman declares pregnancy to the licensee or registrant, the dose equivalent to the embryo or fetus has exceeded five millisievert, or 0.5 rem, the licensee or registrant shall be deemed to be in compliance with paragraph (A) of this rule, provided that the additional dose equivalent to the embryo or fetus does not exceed 0.5 millisievert (0.05 rem), during the remainder of the pregnancy.

View AppendixView AppendixView Appendix

Last updated November 2, 2022 at 2:10 PM

History

• Effective: October 4, 2010
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-66-04

(A) Each registrant will develop, implement and maintain a written quality assurance program in the form of a readily available manual or manuals, either in hard copy format or electronic format. For purposes of this chapter and Chapter 3701:1-67 of the Administrative Code, quality assurance program means a program providing for verification by written procedures such as testing, auditing, and inspection to ensure that deficiencies, deviations, defective equipment, or unsafe practices, or a combination thereof, relating to the use, disposal, management, or manufacture of radiation devices are identified, promptly corrected, and reported to the appropriate regulatory authorities.

(B) The written quality assurance program of each registrant will address and include records to verify implementation of at least the following:

(1) The intervals of and procedures for the evaluation of all radiation-generating equipment to ensure compliance with all applicable rules of this chapter;

(2) Procedures for maintaining compliance with occupational and public exposure limits;

(3) Procedures for notifying the director when individuals are occupationally over-exposed to radiation, pursuant to Chapter 3701:1-38 of the Administrative Code;

(4) Safe operating procedures for each type of radiation-generating equipment to be handled;

(5) Training of operators of each type of radiation-generating equipment to be handled in order to assure competency in the operating procedures;

(6) In addition to the obligations of paragraph (B)(1) of rule 3701:1-38-10 of the Administrative Code, individuals likely to receive an annual occupational dose in excess of one millisievert (one hundred millirem) will be instructed in the following:

(a) The location, boundaries, and purpose of restricted areas; and

(b) A description of the radiation-generating equipment and its location;

(7) The quality control tests to be performed, the frequency of the quality control tests to be performed and the personnel responsible for the performance of the quality control tests as applicable to the radiation-generating equipment type and use;

(8) Policies regarding the state licensure or certification of each person operating radiation-generating equipment as obligated by Chapters 4773. and 4715. of the Revised Code;

(9) The dissemination of quality assurance policies and a method to educate affected workers on those policies and any policy changes;

(10) Radiation workers' role and responsibility for following and supporting the quality assurance program;

(11) Policies regarding personnel protection, including time, distance, and shielding;

(12) Policies regarding occupational exposure of pregnant workers;

(13) Policies regarding radiation safety training for ancillary personnel;

(14) Policies regarding training for personnel with quality control responsibilities;

(15) Policies regarding human patient protection, including screening for pregnancy, exposure of pregnant patients, patient shielding, patient education;

(16) Policies regarding verification of human patient identity and exam to be performed, including identification of the appropriate body part;

(17) Policies to only permit licensed practitioners to order radiographic examinations;

(18) An inventory of radiation-generating equipment, including the location and description of each unit.

(C) In addition to the obligations of paragraphs (A) and (B) of this rule, the quality assurance program of hospital registrants will comply with the following:

(1) A certified radiation expert will conduct oversight and maintenance of quality assurance programs for hospital registrants, by:

(a) Auditing the quality assurance program on an annual basis;

(b) Performing reviews of the quality assurance program each quarter;

(c) Completing and submitting all necessary information with the annual audit form in accordance with paragraph (C)(6) of this rule; and

(d) Serving on the quality assurance committee;

(2) Employees working in the radiation areas will be made aware of the identity, scope of authority, and a method for contacting the certified radiation expert and the individual responsible for radiation protection. This information, or a specific location where this information may be obtained, will be conspicuously posted in each area where radiation-generating equipment is used;

(3) Each hospital registrant will establish a quality assurance committee for the management of the quality assurance program. The members of the quality assurance committee will be approved by an executive administrator. Committee meetings may be attended by the members or similarly qualified, designated alternates. The quality assurance committee will include at least the following members:

(a) A member of the hospital's executive administration;

(b) The individual responsible for radiation protection;

(c) A radiologist or radiation oncologist;

(d) A certified radiation expert representing each of the following as applicable in each hospital;

(i) Radiation therapy services,

(ii) Mammography, or

(iii) Diagnostic radiography other than mammography; and

(e) A management representative of each department of the hospital which has responsibilities involving the handling of radiation-generating equipment;

(4) The quality assurance committee will meet as often as is deemed necessary to carry out its duties, but at least annually. To establish a quorum at least one-half of the committee's membership will be present either in person or by telecommunication, and will include the individual responsible for radiation protection for the hospital, and the member of the executive administration of the hospital. A record of each meeting will be maintained and distributed to each member which will include the following:

(a) The date of the meeting;

(b) An indication of members present; and

(c) A summary of meeting including any recommended actions and ALARA reviews;

(5) Each quarter, the certified radiation expert will submit, to each appointed quality assurance committee member, a review of the quality assurance program, which will contain, as applicable:

(a) Radiation safety policy revisions proposed by the certified radiation expert;

(b) A review of occupational exposure records by the certified radiation expert;

(c) Radiation safety incidents;

(d) Performance evaluation summaries for radiation-generating equipment including a description of any issues found; and

(e) Any corrective actions recommended by the certified radiation expert that are necessary to comply with the obligations of this chapter;

(6) The quality assurance program will be audited at least annually by a certified radiation expert. The certified radiation expert will develop a written report of the audit findings on forms prescribed by the director and submit the report to the quality assurance committee within thirty days of completing the audit. The quality assurance committee will review the audit report and implement any corrective actions determined to be necessary. The certified radiation expert will file the audit report with the director within ninety days of completing the audit. Every audit report will include a determination of whether the quality assurance program properly addresses the matters described in this rule and whether it is being carried out in accordance with the written quality assurance program, and any corrective actions to be taken to comply with the obligations of this chapter. The audit report will become a part of the inspection record.

(D) In addition to the obligations of paragraphs (A) and (B) of this rule, the quality assurance program of registrants performing fluoroscopically-guided interventional other than veterinary procedures, and computed tomography (CT) other than veterinary and cone beam CT procedures will establish a radiation dose review committee in accordance with the following:

(1) The registrant may establish a system-wide committee if the registrant has more than one site;

(2) If the registrant is a subsidiary of a hospital, the obligations of paragraph (D) of this rule may be delegated to the hospital quality assurance committee provided its members meet the obligations of paragraph (D)(3) of this rule;

(3) The radiation dose review committee will include at least the following members:

(a) The individual responsible for radiation protection;

(b) A diagnostic radiation expert;

(c) As applicable, a physician that performs fluoroscopically-guided interventional and/or computed tomography procedures; and

(d) As applicable, a technologist that performs fluoroscopically-guided interventional and/or computed tomography procedures;

(4) A quorum of the radiation dose review committee will meet as often as necessary to carry out its duties, but at least annually. To establish a quorum at least one-half of the committee's membership will be present either in person or by telecommunication, and will include the individual responsible for radiation protection. A record of each meeting will be maintained and include the following:

(a) The date of the meeting;

(b) An indication of members present; and

(c) A summary of meeting including any recommended actions;

(5) The radiation dose review committee for fluoroscopically-guided interventional procedures will establish and implement written policies that include but are not limited to the following:

(a) Identification of individuals who are authorized to use fluoroscopic systems for interventional purpose;

(b) A method to be used to monitor patient radiation dose during fluoroscopically-guided interventional procedures;

(c) Dose notification levels, as appropriate, at which the physician is notified and appropriate actions are taken for patient safety;

(d) Substantial radiation dose level values following nationally recognized standards;

(e) Actions to be taken for cases when a substantial radiation dose level is exceeded which may include patient follow-up; and

(f) Reviewing policies identified in paragraphs (C)(5)(a) to (C)(5)(e) of this rule at least annually;

(6) The radiation dose review committee for computed tomography will determine and review written protocols to improve image quality and minimize patient dose. The review will include acquisition and reconstruction protocols, image quality, and radiation dose. At a minimum, the review will be performed annually and include the following clinical protocols, if performed:

(a) Pediatric head;

(b) Pediatric abdomen;

(c) Adult head;

(d) Adult abdomen;

(e) Adult chest; and

(f) Brain perfusion.

(E) Records obligated by this chapter and Chapter 3701:1-67 of the Administrative Code will be maintained in accordance with the following:

(1) Data and test results of evaluations and calibrations of all radiation-generating equipment for no less than five years;

(2) Data and test results of evaluations of shielding and surroundings of all radiation-generating equipment until the director terminates the registration or five years after the equipment is transferred or disposed;

(3) Maintenance logs for radiation-generating equipment for five years;

(4) Medical event reports involving radiation exposure to individuals for all radiation-generating equipment until the director terminates the registration;

(5) Copies of current licenses or the department's licensure verification web page for everyone who is obligated to possess a license at the facility; and

(6) Biennial calibration certificates or cross calibration documentation for all instruments used to perform area radiation surveys, calibrations, and evaluations for five years.

Last updated December 13, 2024 at 7:31 AM

History

• Effective: December 13, 2024
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-66-01

(A) As used in this chapter:

(1) "Air kerma" means the sum of the initial kinetic energy of all charged ionizing particles liberated by uncharged ionizing radiation in a given mass of air. The unit for air kerma is joules per kilogram which is given the special name of gray (Gy). To determine air kerma in Gy from exposure in units of roentgens (R) multiply exposure by the conversion factor 0.00876 Gy/R.

(2) "Air kerma rate" or "(AKR)" means the air kerma per unit time.

(3) "Aluminum equivalent" means the thickness of type 1100 aluminum alloy affording the same attenuation, under specified conditions, as the material in question.

(4) "Automatic exposure control" or "(AEC)" means a device which automatically controls one or more technique factors in order to obtain a specific quantity of radiation at a preselected location.

(5) "Beam-limiting device" means a collimator which provides a means to restrict the dimensions of the x-ray field.

(6) "Bone densitometry equipment" means radiation-generating equipment used for the medical purpose of quantifying bone density and mineral content by x-ray measurements through the bone and adjacent tissues.

(7) "C-arm fluoroscope" means a fluoroscopic x-ray system in which the image receptor and the x-ray tube housing assembly are connected or coordinated to maintain a spatial relationship. Such a system allows a change in the direction of the beam axis with respect to the patient without moving the patient.

(8) "Calibration" means the determination of the response or reading of an instrument relative to a series of known radiation values over the range of the instrument, or the radiation output of a source of radiation relative to a standard.

(9) "Coefficient of variation" means the ratio of the standard deviation to the mean value of the observations.

(10) "Collimator" means a device or mechanism by which the x-ray beam is restricted in size.

(11) "Computed radiography" means a system that utilizes a photostimulable phosphor (PSP) plate for capturing radiographic images. The components of the system include, at a minimum, the PSP plate and a computed radiography reader which laser scans the exposed plate, collects the stimulated light and ultimately creates the digital image.

(12) "Computed tomography" or "(CT)" means an imaging procedure that uses multiple x-ray transmission measurements and computer programs to generate tomographic images.

(13) "Control panel" means that part of the radiation-generating equipment used for setting the technique factors.

(14) "CT conditions of operation" means all selectable parameters governing the operation of CT radiation-generating equipment including, but not limited to, nominal image thickness, filtration, milliampere (mA), kilovoltage peak (kVp), and scan time.

(15) "CT noise" means the per cent standard deviation of the fluctuations in CTN expressed as a percentage of the attenuation coefficient of water.

(16) "CT number" or "(CTN)" means the number used to represent the x-ray attenuation associated with each elemental area of the CT image.

(17) "Cumulative air kerma" means the total air kerma accrued from the beginning of an examination or procedure and includes all contributions from fluoroscopic and radiographic irradiation.

(18) "Dead-man switch" means a switch so constructed that a circuit closing contact can be maintained only by continuous pressure on the switch by the operator.

(19) "Dental equipment" means radiation-generating equipment used for dental radiography.

(20) "Digital radiography" or "(DR)" means a general radiography system that utilizes an imaging plate to capture and produce a digital image for immediate viewing without the use of a laser scanning cassette reader.

(21) "Direct scattered radiation" means scattered radiation which has been deviated once in direction only by materials irradiated by the useful beam.

(22) "Executive administration" means individuals employed in the hospital's administration and having the authority to expend capital funds, approve personnel actions, and implement changes to hospital policy and procedure.

(23) "Filter" means material placed in the useful beam to preferentially attenuate selected radiations.

(24) "Fluoroscopic irradiation time" means the cumulative duration of x-ray tube activation in any fluoroscopic mode of operation.

(25) Fluoroscopic equipment" means radiation-generating equipment used for real time imaging of internal structures for medical purposes.

(26) "Fluoroscopically-guided interventional (FGI) procedures" means an interventional diagnostic or therapeutic procedure performed via percutaneous or other access routes, usually with local anesthesia or intravenous sedation, which uses external ionizing radiation in the form of fluoroscopy to localize or characterize a lesion, diagnostic site, or treatment site, to monitor the procedure, and to control and document therapy. This statement is focused on the FGI subset of potentially high-dose procedures.

(27) "Fluoroscopy" means a technique for generating x-ray images and presenting them simultaneously and continuously as visible images.

(28) "Full time training in medical physics" means having been engaged in the practice of clinical medical physics for a minimum of eighteen hundred hours within twelve consecutive months, under the supervision of a board-certified medical physicist.

(29) "Full time work experience" means a minimum of eighteen hundred hours of work experience earned within twelve consecutive months.

(30) "General purpose radiographic equipment" means stationary, mobile, and portable radiation-generating equipment used for medical purpose, but does not include dental intraoral, panoral, mammography, bone densitometry, computed tomography, fluoroscopy or spot film imaging and equipment used in radiation therapy.

(31) "Half-value layer (HVL)" means the thickness of specified material which attenuates the beam of radiation to an extent such that the AKR is reduced by one-half of its original value.

(32) "Hand-held radiation-generating equipment" means x-ray equipment that is specifically designed to be held in the hand during operation.

(33) "Handle" means receive, possess, use, store, transfer, install, service, or dispose of radiation-generating equipment unless possession is solely for the purpose of transportation.

(34) "Hybrid imaging system" means a combination of systems that separately produce anatomic and functional images in very close temporal proximity without the need for patient repositioning and allow images to be co-registered and fused. These systems may be used for purposes including, but not limited to, attenuation correction, localization, registration, or fusion, but not used independently for diagnosis.

(35) "Image intensifier" means a device, installed in its housing, which instantaneously converts an x-ray pattern into a corresponding light image of higher intensity.

(36) "Image receptor" means any device that transforms incident x-ray photons into either a visible image or another form that can be made into a visible image by further transformation. In those cases, where means are provided to preselect a portion of the image receptor, the term "image receptor" means the preselected portion of the device.

(37) "Individual responsible for radiation protection (IRRP)" means an individual designated by the registrant who has the knowledge and responsibility for overall radiation safety and the quality assurance program at the facility, to include daily radiation safety operations and compliance with the rules.

(38) "Interventional procedure" means an invasive procedure that utilizes radiation-generating equipment for diagnostic or therapeutic purposes.

(39) "Kilovoltage peak (kVp)" means the maximum value of the electrical potential difference between the cathode and the anode of the x-ray tube during an exposure.

(40) "Last image hold" means an image obtained either by retaining one or more fluoroscopic images, which may be temporarily integrated, at the end of a fluoroscopic exposure or by initiating a separate and distinct radiographic exposure automatically and immediately in conjunction with termination of the fluoroscopic exposure.

(41) "Lateral fluoroscope" means the portion of a biplane system consisting of an x-ray tube housing assembly and an image receptor that are fixed in position to produce a horizontal x-ray beam.

(42) "Lead equivalent" means the thickness of lead affording the same attenuation, under specified conditions, as the material in question.

(43) "Leakage radiation" means all radiation coming from within the x-ray tube housing except the useful beam.

(44) "Licensed practitioner" means an individual licensed by the state of Ohio pursuant to:

(a) Chapter 4715. of the Revised Code to practice dentistry;

(b) Chapter 4731. of the Revised Code to practice medicine or surgery or osteopathic medicine or surgery;

(c) Chapter 4731. of the Revised Code to practice podiatry;

(d) Chapter 4741. of the Revised Code to practice veterinary medicine;

(e) Chapter 4734. of the Revised Code to practice chiropractic medicine; and

(f) Chapter 4723. of the Revised Code to practice as an advanced practice registered nurse within the scope of practice of his or her collaborating physician and in accordance with the standard care arrangement and under the appropriate level of supervision.

(g) Chapter 4730. of the Revised Code to practice as a physician assistant within the scope of practice of his or her supervising physician and in accordance with the utilization plan approved by the state medical board.

(45) "Light field" means that area of the intersection of the light beam from the beam-limiting device and one of the set of planes parallel to and including the plane of the image receptor, whose perimeter is the locus of points at which the illumination is one-fourth of the maximum in the intersection.

(46) "Medical event" means one or more of the following criteria have occurred to a human patient:

(a) Unintended skin dose to the same area in a single procedure greater than 2 sievert (200 rem);

(b) Unintended dose other than skin dose in a single procedure greater than:

(i) 0.5 sievert (50 rem) to any organ; or

(ii) 0.05 sievert (5 rem) effective dose equivalent;

(c) Wrong patient or wrong site for entire procedure when the resultant dose is:

(i) Greater than 0.5 sievert (50 rem) to any organ; or

(ii) Effective dose equivalent greater than or equal to 0.05 sievert (5 rem).

(47) "Medical, Medical use" or "Medical purpose" means using radiation-generating equipment to irradiate human beings or animals for dental, diagnostic, localization, or other healing arts purposes.

(48) "Milliampere (mA)" means the measurement of tube current which reflects the number of electrons flowing from the cathode to the anode of an x-ray tube during x-ray production.

(49) "Mobile radiation-generating equipment" means x-ray equipment permanently mounted on a base with wheels or castors for moving while completely assembled and is not used in a fixed location.

(50) "Patient" means an individual or animal subjected to radiation for the purposes of examination or therapy.

(51) "Portable radiation-generating equipment" means radiation-generating equipment designed to be hand-carried.

(52) "Primary protective barrier" means a barrier sufficient to attenuate the useful beam to the specified radiation level.

(53) "Protective apron" means an apron made of radiation-attenuating materials used to reduce radiation exposure.

(54) "Protective barrier" means a barrier of radiation-attenuating materials used to reduce radiation exposure.

(55) "Protective glove" means a glove made of radiation-attenuating materials used to reduce radiation exposure.

(56) "Radiation expert" means an individual who meets the qualifications of:

(a) Applicable paragraphs of rule 3701:1-66-03 of the Administrative Code;

(b) Paragraph (D) of rule 3701-83-45 of the Administrative Code, for any facility providing radiation therapy services;

(c) Paragraph (C)(3) of rule 3701-83-52 of the Administrative Code for CT equipment, or paragraph (F)(3) of rule 3701-83-52 of the Administrative Code for fluoroscopy, at any facility providing CT or fluoroscopy services; or

(d) 21 C.F.R. 900.12(a)(3) (as effective on the effective date of this rule) for any facility providing mammography services.

(57) "Radiation worker" means an individual engaged in activities registered by the department and controlled by the registrant.

(58) "Reference plane" means a plane which is displaced from and parallel to the computed tomographic plane.

(59) "Scan" means the complete process of collecting x-ray transmission data for the production of a tomogram. Data can be collected simultaneously during a single scan for the production of one or more tomograms.

(60) "Scan sequence" means a pre-selected set of two or more scans performed consecutively under pre-selected CT conditions of operation.

(61) "Scattered radiation" means radiation that, during passage through matter, has been deviated in direction.

(62) "Secondary protective barrier" means a barrier sufficient to attenuate stray ionizing radiation to a specified level.

(63) "Source" means the point of origin of the useful radiation beam.

(64) "Source-to-image receptor distance" or "(SID)" means the distance from the source to the center of the input surface of the image receptor.

(65) "Source-to-skin distance" or "(SSD)" means the distance between the source and the skin of the patient.

(66) "Spot film" means a radiograph which is made during a fluoroscopic examination to permanently record conditions which exist during the fluoroscopic procedure.

(67) "Stationary radiation-generating equipment" means equipment which is installed in a fixed location.

(68) "Stray radiation" means leakage radiation or scattered radiation.

(69) "Table increment" means the amount of relative displacement of the patient with respect to the CT x-ray system between successive scans measured along the direction of such displacement.

(70) "Technique factors" means any combination of the following which determines the exposure rate: kVp, mA, time, x-ray pulses, or the product of tube current and exposure time in mAs.

(71) "Tomogram" means the depiction of the radiation attenuation properties of a section through a body.

(72) "Tomographic plane" means that geometric plane which is identified as corresponding to the output tomogram.

(73) "Tube housing assembly" means the tube housing with tube installed. It includes high voltage or filament transformers and other appropriate elements when they are contained within the tube housing.

(74) "Unintended Dose" or "Unintended Skin Dose" means a patient radiation dose resulting from an error or equipment malfunction during a procedure.

(75) "Useful beam" means that part of the radiation which passes through the window, aperture, cone, or other collimating device of the source housing.

(76) "Veterinary radiation-generating equipment" means radiation-generating equipment used for veterinary radiography.

(77) "Visible area" means that portion of the input surface of the image receptor over which incident x-ray photons are producing a visible image.

(78) "X-ray field" means that area of the intersection of the useful beam and any one of the set of planes parallel to and including the plane of the image receptor, whose perimeter is the locus of points at which the air kerma rate is one-fourth of the maximum in the intersection.

(B) Terms appearing in this chapter, which are not defined in this rule, may be defined in rule 3701:1-38-01 of the Administrative Code.

Last updated February 17, 2026 at 7:59 AM

History

• Effective: February 16, 2026
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-67-05 Standards for therapy equipment operating at less than one megavolt (MV).

As used in this rule, "therapy equipment" means therapy equipment operating below one megavolt (MV). In addition to the rules in Chapters 3701:1-38 and 3701:1-67 of the Administrative Code, handlers of therapy equipment shall comply with the following:

(A) When the x-ray tube is operated at its maximum rated tube current for the maximum kilovoltage (kV), the leakage air kerma rate shall not exceed the value specified at the distance specified for that classification of therapy equipment.

(1) For five kV to fifty kV systems, the leakage air kerma rate measured at any position five centimeters from the tube housing assembly shall not exceed one milligray (one hundred millirad) in any one hour.

(2) For greater than fifty kV and less than one MV systems, the leakage air kerma rate measured at a distance of one meter from the target in any direction shall not exceed one centigray (one rad) in any one hour. This air kerma rate measurement may be averaged over areas no larger than one hundred square centimeters. In addition, the air kerma rate at a distance of five centimeters from the surface of the tube housing assembly shall not exceed thirty centigrays (thirty rad) per hour.

(3) For each piece of therapy equipment, the handler shall determine, or obtain from the manufacturer, the leakage radiation existing at the positions specified in paragraphs (A)(1) and (A)(2) of this rule for the specified operating conditions. Records on leakage radiation measurements shall be maintained at the installation for inspection by the department.

(B) Permanent diaphragms or cones used for limiting the useful beam shall provide at least the same degree of attenuation as required for the tube housing assembly.

(C) Requirements for adjustable or removable beam limiting devices include:

(1) All adjustable or removable beam limiting devices, diaphragms, cones or blocks shall not transmit more than five per cent of the useful beam for the most penetrating beam used; and

(2) When adjustable beam limiting devices are used, the position and shape of the radiation field shall be indicated by a light beam.

(D) The filter system shall be so designed that:

(1) Filters can not be accidentally displaced at any possible tube orientation;

(2) An interlock system prevents irradiation if the proper filter is not in place;

(3) The air kerma rate escaping from the filter slot shall not exceed one centigray (one rad) per hour at one meter under any operating conditions; and

(4) Each filter shall be marked as to its material of construction and its thickness.

(E) Requirements for tube immobilization include:

(1) The x-ray tube shall be so mounted that it cannot accidentally turn or slide with respect to the housing aperture; and

(2) The tube housing assembly shall be capable of being immobilized for stationary portal treatments unless the unit is designed to be hand-held and the peak tube potential of the system does not exceed fifty kV.

(F) The tube housing assembly shall be so marked that it is possible to determine the location of the source to within five millimeters, and such marking shall be readily accessible for use during calibration procedures.

(G) Contact therapy tube housing assemblies shall have a removable shield of material, equivalent in attenuation to 0.5 millimeters of lead at one hundred kV, which can be positioned over the entire useful beam exit port during periods when the beam is not in use.

(H) A suitable irradiation control device shall be provided to terminate the irradiation after a pre-set time interval.

(1) A timer with a display shall be provided by the treatment control system. The timer shall have a pre-set time selector and an elapsed time or time remaining indicator;

(2) The timer shall be a cumulative timer that activates with an indication of "beam-on" and retains its reading after irradiation is interrupted or terminated. After irradiation is terminated and before irradiation can be reinitiated, it shall be necessary to reset the elapsed time indicator;

(3) The timer shall terminate irradiation when a pre-selected time has elapsed, if any dose monitoring system present has not previously terminated irradiation;

(4) The timer shall permit accurate pre-setting and determination of exposure times as short as one second;

(5) The timer shall not permit an exposure if set at zero;

(6) The timer shall not activate until the shutter is opened if irradiation is controlled by a shutter mechanism unless calibration includes a timer error correction to compensate for mechanical lag; and

(7) The timer shall be accurate to within one per cent of the selected value or one second, whichever is greater.

(I) The control system, in addition to the displays required by other provisions in this rule, shall have:

(1) An indication of whether electrical power is available to the control system and if activation of the x-ray tube is possible;

(2) An indication of whether x-rays are being produced;

(3) A means for indicating x-ray tube potential and current;

(4) The means for terminating an exposure at any time;

(5) A locking device which will prevent unauthorized use of the therapy equipment;

(6) A positive display of specific filter(s) in the beam; and

(7) A warning label which cautions individuals that radiation is produced when the therapy equipment is energized.

(J) When a control system may energize more than one x-ray tube:

(1) It shall be possible to activate only one x-ray tube at any time;

(2) There shall be an indication at the control panel identifying which x-ray tube is selected to enable irradiation; and

(3) There shall be an indication at the tube housing assembly when that tube is selected to enable irradiation.

(K) There shall be a means of determining the central axis target-to-skin distance (TSD) to within one centimeter and of reproducing this measurement to within two millimeters thereafter.

(L) Unless it is possible to bring the x-ray output to the prescribed exposure parameters within five seconds after the x-ray "on" switch is energized, the beam shall be attenuated by a shutter. In addition, after the unit is at operating parameters, the shutter shall be controlled by the operator from the control panel. An indication of shutter position shall appear at the control panel.

(M) Therapy equipment having a beryllium or other low-filtration window shall be clearly labeled as such upon the tube housing assembly and shall be provided with a permanent warning device on the control panel that is activated when no additional filtration is present, to indicate that the dose rate is very high.

Last updated July 25, 2023 at 8:25 AM

History

• Effective: March 1, 2016
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-67-06 Standards for therapy equipment operating at or above one megavolt (MV).

As used in this rule, "therapy equipment" means photon therapy systems and electron therapy systems operating at or above one megavolt (MV). In addition to the rules in Chapters 3701:1-38 and 3701:1-67 of the Administrative Code, handlers of therapy equipment shall comply with the following:

(A) Upon installation of therapy equipment, acceptance testing shall be performed to verify that the equipment complies with all manufacturer specifications. In the event that manufacturer specifications are unavailable for reference, all therapy equipment shall be tested to ensure compliance with the standards of this rule. Any modification of equipment that occurs pursuant to initial acceptance testing shall entail appropriate retesting in order to re-determine compliance with applicable manufacturer standards or standards of this rule.

(B) Leakage radiation outside the maximum useful beam in photon and electron modes shall not exceed the manufacturer specifications, or in the absence of the manufacturer specifications:

(1) The absorbed dose due to leakage radiation, excluding neutrons, at any point outside the maximum sized useful beam, but within a circular plane of radius two meters which is perpendicular to and centered on the central axis of the useful beam at the nominal treatment distance, such as patient plane, shall not exceed a maximum of 0.2 per cent and an average of 0.1 per cent of the absorbed dose on the central axis of the beam at the nominal treatment distance. Measurements shall be averaged over an area not exceeding one hundred square centimeters at a minimum of sixteen points uniformly distributed in the plane;

(2) Except for the area defined in paragraph (B)(1) of this rule, the absorbed dose due to leakage radiation, excluding neutrons, at one meter from the electron path between the electron source and the target or electron window shall not exceed 0.5 per cent of the absorbed dose on the central axis of the beam at the nominal treatment distance. Measurements shall be averaged over an area not exceeding one hundred square centimeters;

(3) For equipment manufactured after July 21, 2014, the neutron absorbed dose outside the useful beam shall be in compliance with "International Electrotechnical Commission Document 60601-2-1:2009/AMD1:2014 (IEC 60601-2-1:2009/AMD1:2014)," (IEC) documents which, may be purchased from the "IEC National Committee of United States of America, ANSI, 25 West 43rd Street, 4th Floor, New York, New York, 10036," telephone (212) 642-4900, http://www.iec.ch/. Evidence of a product conformity assessment (CA) showing the parameter referenced in this rule is in compliance with IEC 60601-2-1:2009/AMD1:2014 shall be considered adequate to meet the requirements of this rule; and

(4) For each piece of therapy equipment, the handler shall determine, or obtain from the manufacturer, the leakage radiation existing at the positions specified in paragraphs (B)(1) and (B)(2) of this rule for the specified operating conditions. Records on leakage radiation measurements shall be maintained at the installation for inspection by the department.

(C) Leakage radiation through beam limiting devices shall not exceed the manufacturer specifications, or in the absence of the manufacturer specifications, shall meet the following:

(1) Using photon radiation, all adjustable or interchangeable beam limiting devices shall attenuate the useful beam such that at the nominal treatment distance, the maximum absorbed dose anywhere in the area shielded by the beam limiting device(s) shall not exceed two per cent of the maximum absorbed dose on the central axis of the useful beam measured in a one hundred square centimeter radiation field, or maximum available field size if less than one hundred square centimeters;

(2) Using electron radiation, all adjustable or interchangeable electron applicators shall attenuate the radiation, including but not limited to photon radiation generated by electrons incident on the beam limiting device and electron applicator and other parts of the radiation head, such that the absorbed dose in a plane perpendicular to the central axis of the useful beam at the nominal treatment distance shall not exceed:

(a) A maximum of two per cent and average of 0.5 per cent of the absorbed dose on the central axis of the useful beam at the nominal treatment distance. This limit shall apply beyond a line seven centimeters outside the periphery of the useful beam; and

(b) A maximum of ten per cent of the absorbed dose on the central axis of the useful beam at the nominal treatment distance. This limit shall apply beyond a line two centimeters outside the periphery of the useful beam; and

(3) Measurements of leakage radiation for:

(a) Photon radiation shall have measurements through the beam limiting devices made with the beam limiting devices closed and any residual aperture blocked by at least two tenth value layers of suitable absorbing material. In the case of overlapping beam limiting devices, the leakage radiation through each set shall be measured independently at the depth of maximum dose. Measurements shall be made using a radiation detector of area not exceeding ten square centimeters; and

(b) Electron radiation shall have measurements through the electron applicators made with the electron beam directed into the air and using a radiation detector of area up to but not exceeding one square centimeter suitably protected against radiation which has been scattered from material beyond the radiation detector. Measurements shall be made using one centimeter of water equivalent build up material.

(D) Filters and wedges shall comply with the following:

(1) Each wedge that is removable from the system shall be clearly marked with an identification number. For removable wedges, the nominal wedge angle shall appear on the wedge or wedge tray, if it is permanently mounted to the tray. If the wedge or wedge tray is significantly damaged, the wedge transmission factor shall be redetermined;

(2) If the absorbed dose rate information required by paragraph (I) of this rule relates exclusively to operation with a field flattening filter or beam scattering foil in place, such foil or filter shall be removable only by authorized service personnel; and

(3) For equipment manufactured after June 01, 2013, which utilizes wedges, interchangeable field flattening filters, or interchangeable beam scattering foils:

(a) Irradiation shall not be possible until a selection of a wedge or a positive selection to use "no wedge" has been made via the treatment control system, either manually or automatically;

(b) An interlock system shall be provided to prevent irradiation if the filter selected is not in the correct position;

(c) A display shall be provided by the treatment control system showing the wedges, interchangeable field flattening filter(s), or interchangeable beam scattering foil(s) in use; and

(d) An interlock shall be provided to prevent irradiation if any filter or beam scattering foil selection operation carried out in the treatment room does not agree with the filter or beam scattering foil selection operation carried out via the treatment control system.

(E) For equipment manufactured after July 21, 2014, x-ray stray radiation in the useful electron beam, absorbed dose at the surface during x-ray irradiation and stray neutron radiation in the useful x-ray beam shall be in compliance with "International Electrotechnical Commission (IEC) Document 60601-2-1:2009/AMD1:2014," (IEC) documents which, may be purchased from the "IEC National Committee of United States of America, ANSI, 25 West 43rd Street, 4th Floor, New York, New York, 10036," telephone (212) 642-4900, http://www.iec.ch/. Evidence of a product CA showing the parameters referenced in this rule are in compliance with IEC 60601-2-1:2009/AMD1:2014 shall be considered adequate to meet the requirements of this rule.

(F) All therapy equipment subject to the requirements of this rule shall be provided with redundant beam monitoring systems. The detectors for these systems shall be fixed in the useful beam during treatment to indicate the dose rate.

(1) Each redundant beam monitoring system shall be provided with an independently powered integrating dose meter. Alternatively, dose meters with shared components may be used if the production of radiation is terminated upon failure of any common components.

(2) The detector and the system into which that detector is incorporated shall meet the following requirements:

(a) Each detector shall form part of a beam monitoring system from whose readings the absorbed dose at a reference point can be calculated;

(b) Each beam monitoring system shall be capable of independently monitoring, interrupting, and terminating irradiation;

(c) For equipment manufactured after June 01, 2013, the design of the beam monitoring systems shall ensure that the:

(i) Malfunctioning of one system shall not affect the correct functioning of the other system(s); and

(ii) Failure of either system shall terminate irradiation or prevent the initiation of radiation; and

(d) Each beam monitoring system shall have a legible treatment control system display. For therapy equipment manufactured after February 15, 2001, each display shall:

(i) Maintain a reading until intentionally reset;

(ii) Have only one scale and no electrical or mechanical scale multiplying factors;

(iii) Utilize a design such that increasing dose is displayed by increasing numbers; and

(iv) In the event of power failure, the beam monitoring information required in paragraph (F)(2)(d)(iii) of this rule, displayed by the control system at the time of failure shall be retrievable in at least one system for a twenty minute period of time.

(G) The following requirements shall be met for beam symmetry:

(1) A bent-beam linear accelerator with beam flattening filter(s) subject to the requirements of this rule shall be provided with auxiliary device(s) to monitor beam symmetry;

(2) The device(s) referenced in paragraph (G)(1) of this rule, shall be able to detect field asymmetry greater than ten per cent; and

(3) The device(s) referenced in paragraph (G)(1) of this rule, shall be configured to terminate irradiation if the specifications in paragraph (G)(2) of this rule, cannot be maintained.

(H) The following requirements shall be met for the selection and display of monitor units:

(1) Irradiation shall not be possible until a new selection of a number of monitor units has been made via the treatment control system;

(2) The pre-selected number of monitor units shall be displayed by the treatment control system until reset manually for the next irradiation;

(3) After termination of irradiation, it shall be necessary to reset the dosimeter display before subsequent treatment can be initiated; and

(4) For therapy equipment manufactured after June 01, 2013, it shall be necessary for the operator to reset the pre-selected monitor units after each termination of an irradiation and before a new irradiation can be initiated.

(I) For therapy equipment manufactured after June 01, 2013, a system shall be provided from whose readings the air kerma rate or absorbed dose rate at a reference point can be calculated. The radiation detectors specified in paragraph (F) of this rule may form part of this system. In addition:

(1) The monitor unit rate shall be displayed by the treatment control system;

(2) If the therapy equipment can deliver under any conditions an air kerma rate or absorbed dose rate at the nominal treatment distance more than twice the maximum value specified by the manufacturer, a device shall be provided which terminates irradiation when the air kerma rate or absorbed dose rate exceeds a value twice the specified maximum. The dose rate at which the irradiation will be terminated shall be a record maintained by the handler;

(3) If the therapy equipment can deliver under any fault condition(s) an air kerma rate or absorbed dose rate at the nominal treatment distance more than ten times the maximum value specified by the manufacturer, a device shall be provided to prevent the air kerma rate or absorbed dose rate anywhere in the radiation field from exceeding twice the specified maximum value and to terminate irradiation if the excess absorbed dose at the nominal treatment distance exceeds four gray (four hundred rad); and

(4) For each piece of therapy equipment, the handler shall determine, or obtain from the manufacturer, the maximum value(s) specified in paragraphs (I)(2) and (I)(3) of this rule, for the specified operating conditions. Records of these maximum value(s) shall be maintained at the installation for inspection by the department.

(J) During stationary beam radiation therapy, termination of irradiation by the beam monitoring systems shall meet the following requirements:

(1) The primary system shall terminate irradiation when the pre-selected number of monitor units set via the control system has been detected by the system;

(2) The secondary system shall be capable of terminating irradiation when not more than fifteen per cent or forty monitor units above the pre-selected number of monitor units set via the control system has been detected by the system; and

(3) For equipment manufactured after February 15, 2001, a treatment control system indicator shall show which monitoring system has terminated irradiation.

(K) It shall be possible to terminate irradiation and equipment movement or go from an interruption condition to termination condition at any time from the operator's position at the treatment control panel.

(L) If the therapy equipment has an interrupt mode, it shall be possible to interrupt irradiation and equipment movements at any time from the treatment control panel. Following an interruption, it shall be possible to restart irradiation by operator action without any reselection of operating conditions. If any change is made of a pre-selected value during an interruption, irradiation and equipment movements shall be automatically terminated.

(M) A suitable irradiation control system shall be provided to terminate the irradiation after a pre-set time interval and shall meet the following requirements:

(1) A timer shall be provided which has a treatment control system display. The timer shall have a pre-set time selector and an elapsed time indicator;

(2) The timer shall be a cumulative timer that activates with an indication of "BEAM-ON" and retains its reading after irradiation is interrupted or terminated. After irradiation is terminated and before irradiation can be reinitiated, it shall be necessary to reset the elapsed time indicator; and

(3) The timer shall terminate irradiation when a pre-selected time has elapsed, if the dose monitoring systems have not previously terminated irradiation.

(N) Therapy equipment capable of both x-ray therapy and electron therapy shall meet the following additional requirements:

(1) Irradiation shall not be possible until a selection of radiation type (x-rays or electrons) has been made via the treatment control system;

(2) The radiation type selected shall be displayed by the treatment control system before and during irradiation;

(3) An interlock system shall be provided to ensure that the therapy equipment can principally emit only the radiation type that has been selected;

(4) An interlock system shall be provided to prevent irradiation with x-rays, except to obtain an image, when electron applicators are fitted;

(5) An interlock system shall be provided to prevent irradiation with electrons when accessories specific for x-ray therapy are fitted; and

(6) An interlock system shall be provided to prevent irradiation if any selected operations carried out in the treatment room do not agree with the operations selected via the treatment control system.

(O) Therapy equipment capable of generating radiation beams of different energies shall meet the following requirements:

(1) Irradiation shall not be possible until a selection of energy has been made via the treatment control system;

(2) The nominal energy value selected shall be displayed by the treatment control system until reset manually for the next irradiation. After termination of irradiation, it shall be necessary to reset the nominal energy value selected before subsequent treatment can be initiated; and

(3) Irradiation shall not be possible until the appropriate flattening filter or scattering foil for the selected energy is in its proper location.

(4) For therapy equipment manufactured after July 21, 2014, the selection of energy shall be in compliance with "International Electrotechnical Commission (IEC) Document 60601-2-1:2009/AMD1:2014," (IEC) document which, may be purchased from the "IEC National Committee of United States of America, ANSI, 25 West 43rd Street, 4th Floor, New York, New York, 10036," telephone (212) 642-4900, http://www.iec.ch/. Evidence of a product CA showing the parameter referenced in this rule is in compliance with IEC 60601-2-1:2009/AMD1:2014 shall be considered adequate to meet the requirements of this rule.

(P) Therapy equipment capable of both stationary beam radiation therapy and moving beam radiation therapy shall meet the following requirements:

(1) Irradiation shall not be possible until a selection of stationary beam radiation therapy or moving beam radiation therapy has been made via the treatment control system;

(2) The mode of operation shall be displayed by the treatment control system;

(3) An interlock system shall be provided to ensure that the therapy equipment can operate only in the mode that has been selected;

(4) An interlock system shall be provided to prevent irradiation if any selected parameter in the treatment room does not agree with the parameter displayed by the treatment control system;

(5) Moving beam radiation therapy shall be controlled to obtain the selected relationships between incremental monitor units and incremental movement. For therapy equipment manufactured after June 01, 2013:

(a) An interlock system shall be provided to terminate irradiation if the number of monitor units delivered in any ten degrees of rotation or one centimeter of linear motion differs by more than twenty per cent from the selected value;

(b) Where angle terminates the irradiation in moving beam radiation therapy, the monitor units delivered shall differ by less than five per cent from the monitor unit value selected;

(c) An interlock shall be provided to prevent motion of more than five degrees or one centimeter beyond the selected limits during moving beam radiation therapy;

(d) An interlock shall be provided to require that a selection of direction be made via the treatment control system in all units which are capable of both clockwise and counter-clockwise moving beam radiation therapy; and

(e) Moving beam radiation therapy shall be controlled with both primary position sensors and secondary position sensors to obtain the selected relationships between incremental monitor units and incremental movement;

(6) Where the beam monitor system terminates the irradiation in moving beam radiation therapy, the termination of irradiation shall be as required by paragraph (J) of this rule; and

(7) For equipment manufactured after the effective date of this rule, an interlock system shall be provided to terminate irradiation if movement:

(a) Occurs during stationary beam radiation therapy; or

(b) Does not start or stops during moving beam radiation therapy unless such stoppage is a pre-planned function.

(Q) The control panel shall have a warning label which cautions individuals that radiation is produced when the therapy equipment is energized.

Last updated July 25, 2023 at 8:26 AM

History

• Effective: March 1, 2016
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-67-07 Survey and dosimetry instruments.

(A) The handler shall ensure each facility location authorized to use therapy equipment shall have available appropriately calibrated portable survey equipment, which is capable of measuring doses over the range ten microsievert (one mrem) per hour to ten millisievert (one thousand mrem) per hour. The survey instrument(s) shall be operable and calibrated in accordance with rule 3701:1-67-07 of the Administrative Code.

(B) The handler shall ensure that the survey instruments used to show compliance with Chapter 3701:1-67 of the Administrative Code have been calibrated before first use, at intervals not to exceed twelve months, and following repair.

(C) To satisfy the requirements of paragraph (B) of this rule, the handler shall ensure that the survey instruments are:

(1) Calibrated on all required scale readings up to ten millisieverts (one thousand millirem) per hour with an appropriate radiation source that is traceable to the "National Institute of Standards and Technology" (NIST); and

(2) Calibrated on at least two points on each scale to be calibrated. These points should be at approximately one-third and two-thirds of full-scale.

(D) To satisfy the requirements of paragraph (C) of this rule, the handler shall:

(1) Consider a point as calibrated if the indicated dose rate differs from the calculated dose rate by not more than ten per cent; and

(2) Consider a point as calibrated if the indicated dose rate differs from the calculated dose rate by not more than twenty per cent if a correction factor or graph is conspicuously attached to the instrument.

(E) The handler may obtain the services of individuals licensed by the department, the United States nuclear regulatory commission, or agreement state to perform calibrations of survey instruments.

(F) The handler shall retain a record of each calibration for three years. The record shall include:

(1) A description of the calibration procedure; and

(2) A description of the source used and the certified dose rates from the source, and the rates indicated by the instrument being calibrated, the correction factors deduced from the calibration data, the name and signature of the individual who performed the calibration, and the date of calibration.

(G) The handler shall have a calibrated primary dosimetry system available for use. The system shall have been calibrated by the "National Institute for Standards and Technology" (NIST) or by an "American Association of Physicists in Medicine" (AAPM) "Accredited Dosimetry Calibration Laboratory" (ADCL). The calibration shall have been performed within the previous twenty-four months and after any servicing that may have affected system calibration.

(1) For beams with energies greater than one MV (one MeV), the dosimetry system shall have been calibrated for cobalt-60; or

(2) For beams with energies equal to or less than one MV (one MeV), the dosimetry system shall have been calibrated at an energy or energy range appropriate for the radiation being measured.

(H) The handler may have a secondary dosimetry system for quality assurance check measurements available for use. The system may either be calibrated according to the requirements of paragraph (G) of this rule or compared with a system that has been calibrated in accordance with paragraph (G) of this rule. If compared, the comparison shall have been performed within the previous twelve months and after each servicing that may have affected system calibration. The quality assurance check system may be the same system used to meet the requirement in paragraph (G) of this rule.

(I) The handler shall maintain a record of each dosimetry system calibration or comparison required by paragraph (G) and paragraph (H) of this rule for the duration of the registration. For each calibration or comparison, the record shall include:

(1) The date;

(2) The manufacturers' names, model numbers, and serial numbers of the instruments that were calibrated or compared;

(3) The correction factors that were determined;

(4) The names of the individuals who performed the calibration or comparison; and

(5) Evidence that any comparison was performed by, or under the direct supervision and in the physical presence of, a qualified medical physicist.

Last updated July 25, 2023 at 8:26 AM

History

• Effective: June 1, 2013
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-38-13

(A) Each licensee or registrant shall conduct operations so that:

(1) The total effective dose equivalent to individual members of the public from the licensed or registered operation does not exceed one millisievert (0.1 rem) in a year, exclusive of the dose contribution from the following:

(a) Background radiation;

(b) Radiation attributable to any medical administration the individual has received;

(c) Exposure to an individual that was administered radioactive materials and has been released in accordance with rule 3701:1-58-30 of the Administrative Code or equivalent United States nuclear regulatory agency or agreement state regulations;

(d) Voluntary participation in medical research programs;

(e) The licensee's disposal of radioactive material into sanitary sewerage in accordance with paragraph (D) of rule 3701:1-38-19 of the Administrative Code; and

(2) The dose in any unrestricted area from external sources, exclusive of the dose contribution from patients administered radioactive material and released in accordance with rule 3701:1-58-30 of the Administrative Code or equivalent United States nuclear regulatory agency or agreement state regulations, does not exceed 0.02 millisievert (0.002 rem) in any one hour.

(B) If the licensee or registrant permits members of the public to have access to controlled or restricted areas, the limits for members of the public continue to apply to those individuals.

(C) A licensee, registrant, or an applicant for a license or registration may apply for prior department authorization to operate up to an annual dose limit for an individual member of the public of five millisievert (0.5 rem). This application shall include the following information:

(1) Demonstration of the need for and the expected duration of operation in excess of the limit set forth in paragraph (A) of this rule;

(2) The licensee's or registrant's program to assess and control dose within the five millisievert (0.5 rem) annual limit; and

(3) The procedures that the registrant or licensee will follow to maintain the dose ALARA.

(4) Notwithstanding paragraph (A)(1) of this rule, a licensee may permit visitors to an individual who cannot be released, under rule 3701:1-58-30 of the Administrative Code, to receive a radiation dose greater than one millisievert (0.1 rem) if:

(a) The radiation dose received does not exceed five millisievert (0.5 rem); and

(b) The authorized user, as defined in Chapter 3701:1-58 of the Administrative Code, has determined before the visit that it is appropriate.

(D) In addition to the requirements of paragraphs (A) and (B) of this rule:

(1) A licensee subject to the provisions of the United States environmental protection agency's generally applicable environmental radiation standards in 40 C.F.R. 190 (as in effect on the effective date of this rule), shall also comply with those standards.

(2) The department may impose additional restrictions on radiation levels in unrestricted areas and on the total quantity of radionuclides that a licensee may release in effluents in order to restrict the collective dose.

(E) The licensee or registrant shall demonstrate compliance with dose limits for individual members of the public.

(1) The licensee or registrant shall make or cause to be made surveys of radiation levels in unrestricted and controlled areas and radioactive materials in effluents released to unrestricted and controlled areas to demonstrate compliance with the dose limits for individual members of the public in paragraph (A) of this rule.

(2) A licensee or registrant shall show compliance with the annual dose limit in paragraph (A) of this rule by:

(a) Demonstrating by measurement or calculation that the total effective dose equivalent to the individual likely to receive the highest dose from the licensed or registered operation does not exceed the annual dose limit; or

(b) Demonstrating that:

(i) The annual average concentrations of radioactive material released in gaseous and liquid effluents at the boundary of the unrestricted area do not exceed the values specified in appendix C to rule 3701:1-38-12 of the Administrative Code; and

(ii) If an individual were continuously present in an unrestricted area, the dose from external sources would not exceed 0.02 millisievert (0.002 rem) in an hour and 0.5 millisievert (0.05 rem) in a year.

(3) Upon approval from the department, the licensee may adjust the effluent concentration values in appendix C to rule 3701:1-38-12 of the Administrative Code for members of the public, to take into account the actual physical and chemical characteristics of the effluents, such as aerosol size distribution, solubility, density, radioactive decay equilibrium, or chemical form.

Last updated January 20, 2022 at 8:47 AM

History

• Effective: January 20, 2022
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-67-10 Electronic brachytherapy.

In addition to the rules in Chapters 3701:1-38 and 3701:1-67 of the Administrative Code, handlers of electronic brachytherapy equipment shall comply with paragraphs (A) to (N) of this rule.

(A) Electronic brachytherapy devices shall be subject to the requirements of this rule, and shall be exempt from the requirements of rule 3701:1-67-05 of the Administrative Code.

(1) An electronic brachytherapy device that does not meet the requirements of this rule shall not be used for irradiation of patients; and

(2) An electronic brachytherapy device shall only be utilized for human use applications specifically approved by the United States food and drug administration unless participating in a research study approved by the handler's institutional review board.

(B) Each facility location authorized to use an electronic brachytherapy device in accordance with the requirements of this rule shall possess appropriately calibrated portable monitoring equipment. As a minimum, such equipment shall include a portable radiation measurement survey instrument capable of measuring dose rates over the range ten microsievert (one millirem) per hour to ten millisievert (one rem) per hour. Each survey instrument shall be operable and calibrated in accordance with rule 3701:1-67-07 of the Administrative Code for the applicable electronic brachytherapy source energy.

(C) In addition to shielding adequate to meet requirements of rule 3701:1-67-08 of the Administrative Code, the treatment room shall meet the following design requirements:

(1) If applicable, provisions shall be made to prevent simultaneous operation of more than one piece of therapy equipment in a treatment room;

(2) Access to the treatment room shall be controlled by a door at each entrance;

(3) Each treatment room shall have provisions to permit continuous aural communication and visual observation of the patient from the treatment control panel during irradiation. The electronic brachytherapy device shall not be used for patient irradiation unless the patient can be observed;

(4) For electronic brachytherapy devices capable of operating below fifty kV, radiation shielding for the staff in the treatment room shall be available, either as a portable shield or as localized shielded material around the treatment site; and

(5) For electronic brachytherapy devices capable of operating at greater than one hundred fifty kV:

(a) The control panel shall be located outside the treatment room; and

(b) Electrical interlocks shall be provided for all door(s) to the treatment room that will:

(i) Prevent the operator from initiating the treatment cycle unless each treatment room entrance door is closed;

(ii) Cause the source to be shielded when an entrance door is opened; and

(iii) Prevent the source from being exposed following an interlock interruption until all treatment room entrance doors are closed and the source on-off control is reset at the console.

(D) Electrical safety for electronic brachytherapy devices shall include the following:

(1) The high voltage transformer shall be electrically isolated to prevent electrical and magnetic interference with the surrounding environment and ancillary equipment.

(2) The high voltage transformer shall be isolated from personnel, including the operator, and the environment by a protective housing that can only be accessed through a cover requiring a tool for access or with electrical interlocks to prevent operation while open.

(3) The high voltage transformer shall have appropriate safety labels warning personnel of potential electrical shock and/or heat related injuries.

(4) Electronic brachytherapy devices shall be in compliance with the following "International Electrotechnical Commission" (IEC) documents which, may be purchased from the "IEC National Committee of United States of America, ANSI, 25 West 43rd Street, 4th Floor, New York, New York, 10036, telephone (212) 642-4900, http://www.iec.ch/":

(a) IEC 60601-1:2005, "General requirements for basic safety and essential performance";

(b) IEC 60601-1-2:2007, "General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests";

(c) IEC 60601-2-8:2010, "Particular requirements for basic safety and essential performance of therapeutic X-ray equipment operating in the range 10 kV to 1 MV"; and

(d) IEC 60601-2-17:2013, "Particular requirements for the safety of automatically-controlled brachytherapy afterloading equipment."

(E) The control panel, in addition to the displays required by other provisions in this rule, shall:

(1) Provide an indication of whether electrical power is available at the control panel and if activation of the electronic brachytherapy source is possible;

(2) Provide an indication of whether x-rays are being produced;

(3) Provide a means for indicating electronic brachytherapy source potential and current;

(4) Provide the means for terminating an exposure at any time;

(5) Include an access control or locking device that will prevent unauthorized use of the electronic brachytherapy device; and

(6) Bear a warning label indicating that radiation is produced when the therapy equipment is energized and that the equipment may be dangerous to patients and operators unless safety and operating instructions are observed.

(F) A suitable irradiation control device or timer shall be provided to terminate the irradiation after a pre-set time interval or integrated charge on a dosimeter-based monitor and satisfy the following:

(1) A timer shall be provided at the treatment control panel and shall indicate planned setting and the time elapsed or remaining;

(2) The timer shall not permit an exposure if set at zero;

(3) The timer shall be a cumulative device that activates with an indication of "BEAM ON" and retains its reading after irradiation is interrupted or terminated. After irradiation is terminated and before irradiation can be reinitiated, it shall be necessary to reset the elapsed time indicator;

(4) The timer shall terminate irradiation when a pre-selected time has elapsed, if any dose monitoring system has not previously terminated irradiation;

(5) The timer shall permit setting of exposure times as short as 0.1 second; and

(6) The timer shall be accurate to within one per cent of the selected value or 0.1 second, whichever is greater.

(G) The services of a qualified medical physicist shall be required in facilities having electronic brachytherapy devices.

(1) The qualified medical physicist shall be responsible for:

(a) Evaluation of the output from the electronic brachytherapy source;

(b) Generation of the necessary dosimetric information;

(c) Supervision and review of treatment calculations prior to initial treatment of any treatment site;

(d) Establishing the periodic and day-of-use quality assurance checks and reviewing the data from those checks as required in paragraph (K) of this rule;

(e) Consultation with the authorized physician or veterinarian in treatment planning, as needed;

(f) Performing calculations/assessments regarding patient treatments that may constitute a misadministration: and

(g) Developing a quality assurance program.

(2) If the qualified medical physicist is not a full-time employee of the handler, the operating procedures required by paragraph (H) of this rule, shall also specifically address how the qualified medical physicist is to be contacted for problems or emergencies, as well as the specific actions, if any, to be taken until the qualified medical physicist can be contacted.

(H) Operating procedures for electronic brachytherapy devices subject to the requirements of this rule shall include:

(1) Only individuals approved by the authorized physician or veterinarian, individual responsible for radiation protection, or qualified medical physicist shall be present in the treatment room during treatment;

(2) Electronic brachytherapy devices shall not be made available for medical use unless the requirements of paragraph (G) of rule 3701:1-67-08 of the Administrative Code, and paragraphs (I) and (J) of this rule have been met;

(3) The electronic brachytherapy device shall be inoperable, either by hardware or password, when unattended by qualified staff or service personnel;

(4) During operation, the electronic brachytherapy device operator shall monitor the position of all persons in the treatment room, and all persons entering the treatment room, to prevent entering persons from unshielded exposure from the treatment beam;

(5) If a patient must be held in position during treatment, mechanical supporting or restraining devices shall be used;

(6) Written procedures shall be developed, implemented, and maintained for responding to an abnormal situation. These procedures shall include:

(a) Instructions for responding to electronic brachytherapy device failures and the names of the individuals responsible for implementing corrective actions; and

(b) The names and telephone numbers of the authorized physicians or veterinarians, the designated qualified medical physicist, and the individual responsible for radiation protection to be contacted if the device or console operates abnormally.

(7) A copy of the current operating and emergency procedures shall be physically located at the electronic brachytherapy device control console. If the control console is integral to the electronic brachytherapy device, the required procedures shall be kept where the operator is located during electronic brachytherapy device operation;

(8) Instructions shall be posted at the electronic brachytherapy device control console or alternate location identified in paragraph (H)(7) of this rule, to inform the operator of the names and telephone numbers of the authorized physicians or veterinarians, the qualified medical physicist, and the individual responsible for radiation protection to be contacted if the device or console operates abnormally; and

(9) The individual responsible for radiation protection, or his/her designee, and an authorized physician or veterinarian shall be notified as soon as possible if the patient has a medical emergency, suffers injury or dies. The individual responsible for radiation protection or the qualified medical physicist shall inform the manufacturer of the event.

(I) Safety precautions for electronic brachytherapy devices subject to the requirements of this rule, shall include:

(1) A qualified medical physicist shall determine which persons in the treatment room require monitoring when the beam is energized;

(2) An authorized physician or veterinarian and a qualified medical physicist shall be physically present during the entire duration of all patient treatments involving the electronic brachytherapy device;

(3) When shielding is required by paragraph (C)(4) of this rule, a qualified medical physicist shall designate shield locations sufficient to meet the requirements of rule 3701:1-38-12 of the Administrative Code, for any individual, other than the patient, in the treatment room; and

(4) All personnel in the treatment room are required to remain behind shielding during treatment. A qualified medical physicist shall approve any deviation from this requirement and shall designate alternative radiation safety protocols, compatible with patient safety, to provide an equivalent degree of protection.

(J) Electronic brachytherapy source calibration measurements for an electronic brachytherapy device subject to the requirements of this rule shall include the following:

(1) Calibration of the electronic brachytherapy source output shall be performed by, or under the direct supervision of, a qualified medical physicist;

(2) Calibration of the electronic brachytherapy source output shall be made for each electronic brachytherapy source, or after any repair affecting the x-ray beam generation, or when indicated by the electronic brachytherapy source quality assurance checks;

(3) Calibration of the electronic brachytherapy source output shall utilize a dosimetry system described in paragraph (G) of rule 3701:1-67-07 of the Administrative Code;

(4) Calibration of the electronic brachytherapy source output shall include, as applicable, determination of:

(a) The output within two per cent of the expected value, if applicable, or determination of the output if there is no expected value;

(b) Timer and linearity over the typical range of use;

(c) Proper operation of back-up exposure control devices;

(d) Evaluation that the relative dose distribution about the source is within five per cent of that expected; and

(e) Source positioning accuracy to within one millimeter within the applicator;

(5) Calibration of the x-ray source output required by paragraphs (J)(1) to (J)(4) of this rule shall be in accordance with current published recommendations from a recognized national professional association with expertise in electronic brachytherapy (when available). In the absence of a calibration protocol published by a national professional association, the manufacturer's calibration protocol shall be followed; and

(6) A record of each calibration in an auditable form for as long as the therapy facility exists. The record shall include:

(a) The date of the calibration;

(b) The manufacturer's name, model number and serial number for the electronic brachytherapy device and a unique identifier for its electronic brachytherapy source;

(c) The model numbers and serial numbers of the instrument(s) used to calibrate the electronic brachytherapy device; and

(d) The name and signature of the qualified medical physicist responsible for performing the calibration.

(K) Periodic and day-of-use quality assurance checks for electronic brachytherapy devices subject to the requirements of this rule shall include the following:

(1) Quality assurance checks shall be performed on each electronic brachytherapy device:

(a) At the beginning of each day of use;

(b) Each time the device is moved to a new room or site, where site is intended to include each day of use at each operating location for a self-contained electronic brachytherapy unit transported in a van or trailer; and

(c) After each x-ray tube installation.

(2) The handler shall perform periodic quality assurance checks required by paragraph (K)(1) of this rule in accordance with procedures established by the qualified medical physicist;

(3) To satisfy the requirements of paragraph (K)(1) of this rule, radiation output quality assurance checks shall include, as a minimum:

(a) Verification that output of the electronic brachytherapy source falls within three per cent of expected values, as appropriate for the device, as determined by;

(i) Output as a function of time, or

(ii) Output as a function of setting on a monitor chamber.

(b) Verification of the consistency of the dose distribution to within three per cent of that found during calibration required by paragraph (J) of this rule; and

(c) Validation of the operation of positioning methods to ensure that the treatment dose exposes the intended location within one millimeter; and

(4) The handler shall use a dosimetry system that has been intercompared within the previous twelve months with the dosimetry system described in paragraph (B) of rule 3701:1-67-07 of the Administrative Code to make the quality assurance checks required in paragraph (K)(3) of this rule;

(5) The handler shall review the results of each radiation output quality assurance check according to the following procedures:

(a) An authorized physician or veterinarian and qualified medical physicist shall be immediately notified if any parameter is not within its acceptable tolerance. The electronic brachytherapy device shall not be made available for subsequent medical use until the qualified medical physicist has determined that all parameters are within their acceptable tolerances;

(b) If all radiation output quality assurance check parameters appear to be within their acceptable range, the quality assurance check shall be reviewed and signed by either the authorized physician or veterinarian or qualified medical physicist within two days; and

(c) The qualified medical physicist shall review and sign the results of each radiation output quality assurance check at intervals not to exceed thirty days.

(6) To satisfy the requirements of paragraph (K)(1) of this rule, safety device quality assurance checks shall, at a minimum, assure:

(a) Proper operation of radiation exposure indicator lights on the electronic brachytherapy device and on the control console;

(b) Proper operation of viewing and intercom systems in each electronic brachytherapy facility, if applicable;

(c) Proper operation of radiation monitors, if applicable;

(d) The integrity of all cables, catheters or parts of the device that carry high voltages; and

(e) Connecting guide tubes, transfer tubes, transfer-tube-applicator interfaces, and treatment spacers are free from any defects that interfere with proper operation.

(7) If the results of the safety device quality assurance checks required in paragraph (K)(6) of this rule indicate the malfunction of any system, the handler shall secure the control console in the "OFF" position and not use the electronic brachytherapy device except as may be necessary to repair, replace, or check the malfunctioning system.

(8) The handler shall maintain a record of each quality assurance check required by paragraphs (K)(3) and (K)(7) of this rule in an auditable form for three years.

(a) The record shall include:

(i) The date of the quality assurance check;

(ii) The manufacturer's name, model number, and serial number for the electronic brachytherapy device;

(iii) The name and signature of the individual who performed the periodic quality assurance check; and

(iv) The date, name and signature of the qualified medical physicist who reviewed the quality assurance check;

(b) For radiation output quality assurance checks required by paragraph (K)(3) of this rule, the record shall also include:

(i) The unique identifier for the electronic brachytherapy source; and

(ii) The manufacturer's name, model number, and serial number for the instrument(s) used to measure the radiation output of the electronic brachytherapy device.

(L) The handler shall perform acceptance testing on the treatment planning system of electronic brachytherapy-related computer systems in accordance with current published recommendations from a recognized national professional association with expertise in electronic brachytherapy (when available). In the absence of an acceptance testing protocol published by a national professional association, the manufacturer's acceptance testing protocol shall be followed.

(1) Acceptance testing shall be performed by, or under the direct supervision of, a qualified medical physicist. At a minimum, the acceptance testing shall include, as applicable, verification of:

(a) The source-specific input parameters required by the dose calculation algorithm;

(b) The accuracy of dose, dwell time, and treatment time calculations at representative points;

(c) The accuracy of isodose plots and graphic displays;

(d) The accuracy of the software used to determine radiation source positions from radiographic images; and

(e) If the treatment-planning system is different from the treatment-delivery system, the accuracy of electronic transfer of the treatment delivery parameters to the treatment delivery unit from the treatment planning system.

(2) The position indicators in the applicator shall be compared to the actual position of the source or planned dwell positions, as appropriate, at the time of commissioning.

(3) Prior to each patient treatment regimen, the parameters for the treatment shall be evaluated and approved by the authorized physician or veterinarian and the qualified medical physicist for correctness through means independent of that used for the determination of the parameters.

(M) Training for electronic brachytherapy devices subject to the requirements of this rule shall include the following:

(1) A handler shall provide instruction, initially and at least annually, to all individuals who operate the electronic brachytherapy device, as appropriate to the individual's assigned duties, in the operating procedures identified in paragraph (H) of this rule. If the interval between patients exceeds one year, retraining of the individuals shall be provided.

(2) In addition to the requirements of paragraph (C) of rule 3701:1-67-02 of the Administrative Code, for authorized physicians or veterinarians of electronic brachytherapy equipment and paragraph (D) of rule 3701:1-67-02 of the Administrative Code, for qualified medical physicists, these individuals shall also receive device specific instruction initially from the manufacturer, and annually from either the manufacturer or other qualified trainer. The training shall be of a duration recommended by a recognized national professional association with expertise in electronic brachytherapy (when available). In the absence of any training protocol recommended by a national professional association, the manufacturer's training protocol shall be followed. The training shall include, but not be limited to:

(a) Device-specific radiation safety requirements;

(b) Device operation;

(c) Clinical use for the types of use approved by the United States food and drug administration;

(d) Emergency procedures, including an emergency drill; and

(e) The handler's quality assurance program.

(3) A handler shall retain a record of individuals receiving instruction required by paragraphs (M)(1) and (M)(2) for three years. The record shall include:

(a) A list of the topics covered;

(b) The date of the instruction;

(c) The name(s) of the attendee(s); and

(d) The name(s) of the individual(s) who provided the instruction.

(N) A handler providing mobile electronic brachytherapy service shall, as a minimum:

(1) Check all survey instruments before medical use at each address of use or on each day of use, whichever is more restrictive.

(2) Account for the electronic brachytherapy source in the electronic brachytherapy device before departure from the client's address.

(3) Perform, at each location on each day of use, all of the required quality assurance checks specified in paragraph (K) of this rule to assure proper operation of the device.

Last updated September 1, 2022 at 8:27 AM

History

• Effective: September 1, 2022
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-67-11 Other uses of electronic radiation-generating equipment for therapeutic purposes.

A person shall not utilize, for therapeutic purposes, any electronic radiation-generating equipment that is not appropriately regulated under any existing category of therapy equipment, until:

(A) The handler has, at a minimum, provided the department with:

(1) A detailed description of the therapy equipment and its intended application(s);

(2) Facility design requirements, including shielding and access control;

(3) Documentation of appropriate training for authorized physicians, veterinarians and qualified medical physicists;

(4) Methodology for measurement of dosages to be administered to patients or human research subjects;

(5) Documentation regarding calibration, maintenance, and repair of the therapy equipment, as well as instruments and equipment necessary for radiation safety;

(6) Radiation safety precautions and instructions; and

(7) Other information requested by the department in its review of the application; and

(B) The handler has received written approval from the department to utilize the therapy equipment in accordance with the rules and specific conditions the department considers necessary to assure safe operation and to provide adequate radiation protection.

Last updated July 25, 2023 at 8:26 AM

History

• Effective: March 1, 2016
• Promulgated Under: 119.03

Chapter 3701:1-68 Industrial Radiation Equipment

Ohio Adm.Code 3701:1-68-01 Definitions.

(A) As used in this chapter:

(1) "Access panel" means any barrier or panel which is designed to be removed or opened for maintenance or service purposes, needs tools to open, and permits access to the interior of an enclosed fail-safe system.

(2) "Analytical system" means non-medical radiation-generating equipment used to determine properties of materials being measured or analyzed. Analytical systems include, but are not limited to, gauging, x-ray diffraction, and x-ray fluorescence equipment.

(3) "Aperture" means any opening in the external surface of a cabinet or analytical system, other than a port, which remains open during generation of radiation.

(4) "Cabinet system" means non-medical radiation-generating equipment, which is installed in a shielded enclosure that excludes all personnel, including extremities, from the primary beam during the generation of radiation.

(5) "Calibration" means the determination of the response or reading of an instrument relative to a series of known radiation values over the range of the instrument.

(6) "Collimator" means a device or mechanism by which the x-ray beam is restricted in size.

(7) "Control panel" or "control console" means that part of the non-medical radiation-generating equipment used for setting the technique factors.

(8) "Door" means any barrier which is designed to be movable or opened during routine operations, does not generally need tools to open, and permits access to the interior of an enclosed fail-safe system. For the purposes of paragraph (A)(4)(a) of rule 3701:1-68-06 of the Administrative Code, inflexible hardware rigidly affixed to the door will be considered part of the door.

(9) "External surface" means the outside surface of a cabinet system or analytical system, including the high-voltage generator, doors, access panels, latches, control knobs, and other permanently mounted hardware and including the plane across any aperture or port.

(10) "Fail-safe characteristics" means a design feature which prevents emergence of the primary beam, upon failure of a safety or warning device.

(11) "Gauging Unit" means non-medical radiation-generating equipment designed and manufactured for the purpose of detecting, measuring or controlling thickness, density, or interface location.

(12) "Ground fault" means an accidental electrical grounding of an electrical conductor.

(13) "Hand-held system" means non-medical radiation-generating equipment that is specifically designed to be held in the hand during operation. Hand-held systems include analytical and radiographic systems.

(14) "Independent certifying organization" means an independent organization that meets all of the criteria of the appendix to rule 3701:1-68-02 of the Administrative Code.

(15) "Individual responsible for radiation protection (IRRP)" means an individual designated by the registrant who has the knowledge and responsibility for the radiation protection program at the facility, to include the implementation of the daily radiation safety operations and compliance with the rules.

(16) "Irradiation system" means non-medical radiation-generating equipment used to alter the chemical, biological, or physical properties of materials or to sterilize materials.

(17) "Local components" means parts of an analytical system and includes areas that are struck by x-rays such as radiation source housings, port and shutter assemblies, collimators, sample holders, cameras, goniometers, detectors, and shielding, but does not include power supplies, transformers, amplifiers, readout devices, and control panels.

(18) "Locked out and tagged" means a process for equipment security and safety in which non-medical radiation-generating equipment is locked to prevent operation and tagged with specific information as to why it is not to be used.

(19) "Miniature radioscopic system" means an imaging system with a fixed source and detector configuration that provides a maximum source to image distance of less than forty-five centimeters (eighteen inches) and is not capable of creating a dose rate to any individual forty-five centimeters (eighteen inches) from the primary beam that exceeds twenty microsievert (two millirem) per hour.

(20) "Non-human security screening system" means a non-human use cabinet x-ray system with accessible openings designed for the detection of weapons, bombs, or contraband concealed in baggage, mail, packages or other commodities.

(21) "Non-medical radiation-generating equipment" means any x-ray equipment other than a security screening system designed to scan individuals, or those used on patients or human research subjects for medical or therapy purposes.

(22) "Open-beam analytical system" means an analytical system configured such that an individual could place any part of his or her body in the primary beam during normal operation.

(23) "Particle accelerator system" means non-medical radiation-generating equipment designed for, or capable of, accelerating charged particles.

(24) "Permanent radiographic installation" means a radiographic system enclosed in a shielded room, cell or vault not located at a temporary job site.

(25) "Port" means any opening in the outside surface of a cabinet system or analytical system which is designed to remain open, during generation of radiation, for the purpose of conveying material to be irradiated into and out of the enclosure, or for partial insertion for irradiation of an object whose dimensions do not permit complete insertion into the enclosure.

(26) "Primary beam" means radiation which passes through the collimator in the radiation source housing by a direct path from the radiation source.

(27) "Radiation Expert" means an individual who meets the qualifications of paragraph (E)(2) of 3701:1-68-02 of the Administrative Code

(28) "Radiographer" means an individual who operates or personally supervises the operation of radiographic systems, related equipment, or radiation survey instruments for radiographic operations.

(29) "Radiographer's assistant" means an individual who, under the personal supervision of a radiographer operates radiographic systems, related equipment, or radiation survey instruments for radiographic operations.

(30) "Radiographic system" means non-medical radiation-generating equipment used to examine the macroscopic structures of material. Radiographic systems include radiographic and radioscopic equipment.

(31) "Shutter" means a device, fixed to any radiation source housing to intercept the primary beam.

(32) "Temporary job site" means a location where radiographic operations are performed and where radiographic systems may be stored other than the locations of use authorized on the registration.

(B) Terms appearing in this chapter, which are not defined in this rule, may be defined in rule 3701:1-38-01 of the Administrative Code.

Last updated June 30, 2023 at 12:42 AM

History

• Effective: June 30, 2023
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-68-06

In addition to the applicable rules in this chapter and Chapter 3701:1-38 of the Administrative Code, handlers of cabinet systems will comply with the following:

(A) All cabinet system will meet the following equipment standards:

(1) Radiation emitted from a cabinet system will not exceed an exposure of 4.4 microgray (0.5 milliroentgen) in one hour at any point five centimeters outside the external surface.

(2) Cabinet systems provided with at least one port will be designed such that the insertion of any part of the human body through any port into the primary beam will not be possible.

(3) Cabinet systems provided with at least one aperture will be designed such that the insertion of any part of the human body through any aperture will not be possible.

(4) Safety Interlocks:

(a) Each door will have a minimum of two safety interlocks. One, but not both of theobligated interlocks will be such that door opening results in physical disconnection of the energy supply circuit to the high-voltage generator, and such disconnection will not be dependent upon any moving part other than the door;

(b) Each access panel will have at least one safety interlock;

(c) Following interruption of x-ray generation by the functioning of any safety interlock, use of a control provided in accordance with paragraph (A)(6)(b) of this rule will be necessary for resumption of x-ray generation; and

(d) Failure of any single part of the enclosed fail-safe system will not cause failure of more than one obligated safety interlock.

(5) A ground fault will not result in the generation of x-rays.

(6) Controls and indicators will provide:

(a) A key-actuated control to ensure that x-ray generation is not possible with the key removed;

(b) A control or controls to initiate and terminate the generation of x-rays other than by functioning of a safety interlock or the main power control;

(c) Two independent means which indicate when and only when x-rays are being generated, unless the x-ray generation period is less than one-half second, in which case the indicators will be activated for one-half second, and which are discernible from any point at which initiation of x-ray generation is possible. Failure of a single part of the cabinet system will not cause failure of both indicators to perform their intended function. One, but not both, of the indicators obligated by this paragraph may be a milliammeter labeled to indicate x-ray tube current. All other indicators will be legibly labeled "X-RAY ON";

(d) Additional means other than milliammeters which indicate when and only when x-rays are being generated, unless the x-ray generation period is less than one-half second in which case the indicators will be activated for one-half second, as needed to insure that at least one indicator is visible from each door, access panel, and port, and is legibly labeled "X-RAY ON"; and

(e) Warning labels:

(i) There will be permanently affixed or inscribed on the cabinet x-ray system at the location of any controls which can be used to initiate x-ray generation, a clearly legible and visible label bearing the statement: "CAUTION: X-RAYS PRODUCED WHEN ENERGIZED."

(ii) There will be permanently affixed or inscribed on the cabinet x-ray system adjacent to each port a clearly legible and visible label bearing the statement: "CAUTION: DO NOT INSERT ANY PART OF THE BODY WHEN SYSTEM IS ENERGIZED - X-RAY HAZARD."

(B) In addition to the obligations specified in paragraph (A) of this rule, cabinet systems that are designed to admit humans will provide:

(1) A control within the enclosure for preventing and terminating x-ray generation, which is electrically and/or mechanically separated from the interlock system and cannot be reset, overridden or bypassed from the outside of the enclosure.

(2) No means by which x-ray generation can be initiated from within the enclosure.

(3) Audible and visible warning signals within the enclosure that are actuated for at least ten seconds immediately prior to the first initiation of x-ray generation after closing any door designed to admit humans. Failure of any single part of the cabinet system will not cause failure of both the audible and visible warning signals.

(4) A visible warning signal within the enclosure which remains actuated when and only when x-rays are being generated, unless the x-ray generation period is less than one-half second in which case the indicators will be activated for one-half second.

(5) All entrances into the enclosure will be provided with a conspicuously visible warning device, which operates only when radiation is being produced.

(6) Signs indicating the meaning of the warning signals provided pursuant to paragraphs (B)(3) and (B)(4) of this rule and containing instructions for the use of the control provided pursuant to paragraph (B)(1) of this rule. These signs will be legible, accessible to view, and illuminated when the main power control is in the "on" position.

(7) A means for a person within the enclosure to be able to egress at all times.

(C) In addition to the obligations specified in paragraph (A) of this rule, non-human security screening systems and cabinet x-ray systems with accessible openings will:

(1) Have means to ensure operator presence at the control area in a position which permits surveillance of the openings and doors during generation of x-radiation.

(2) During an exposure or preset succession of exposures of one-half second or greater duration, provide the means to enable the operator to terminate the exposure or preset succession of exposures at any time.

(3) During an exposure or preset succession of exposures of less than one-half second duration, may provide the means to allow completion of the exposure in progress but will enable the operator to prevent additional exposures.

(D) Cabinet systems will be evaluated and the results recorded every three months not to exceed fourteen weeks, by individuals qualified according to paragraph (H) of rule 3701:1-68-02 of the Administrative Code, unless the system has been locked out and tagged "DO NOT USE" and is under the administrative control of the IRRP:

(1) The evaluation will verify:

(a) Proper functioning of each interlock, control, indicator and warning signal; and

(b) Each label is legible and properly affixed in the appropriate location.

(2) If an interlock, control, indicator or warning signal fails, it will be immediately labeled as defective and repaired or replaced within seven calendar days.

(E) Radiation area surveys will be performed and the results recorded to confirm compliance with paragraph (A)(1) of this rule and paragraph (A) of rule 3701:1-38-14 of the Administrative Code in accordance with the following:

(1) Upon installation of the equipment;

(2) During the performance of maintenance, calibration and other procedures if the procedures obligate the presence of a primary beam; and

(3) Any time a visual inspection of the cabinet system reveals an abnormal condition.

(F) A physical radiation survey will be made after each radiographic exposure and before entry of personnel into a cabinet system designed to admit humans to verify that the radiation-generating equipment is not still producing radiation.

(1) Personnel devices providing an audible signal when activated by radiation will be acceptable for the survey, provided:

(a) Proper operation of the audible detection device is checked and recorded daily;

(b) The audible device is designed so as to clearly indicate entry into a 0.02 mSv (two mrem) per hour or greater radiation field; and

(c) All personnel working with the cabinet system are equipped with such a device; or

(2) Stationary area monitors providing an audible signal when activated by radiation will be acceptable for the survey, provided:

(a) Proper operation of the stationary detection device is checked and recorded daily;

(b) The stationary device is designed so as to clearly indicate entry into a 0.02 mSv (two mrem) per hour or greater radiation field; and

(c) Stationary area monitors are evaluated annually to determine that the audible signal operates at a 0.02 mSv (two mrem) per hour radiation field.

(G) The "Individual Responsible for Radiation Protection" (IRRP) will be qualified in accordance with paragraph (H) of rule 3701:1-68-02 of the Administrative Code.

Last updated June 30, 2023 at 12:42 AM

History

• Effective: June 30, 2023
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-68-02

(A) Each handler of non-medical radiation-generating equipment will develop, implement and maintain a writtenradiation protection program in the form of a readily available manual or manuals, either in hard copy, printed format or electronic format. For the purpose of this chapter, radiation protection program means written policies and procedures such as testing, auditing and inspection to assure compliance with applicable rules of the Administrative Code. The written radiation protection program will at least address the following:

(1) The evaluation and maintenance of non-medical radiation-generating equipment in accordance with the manufacturer's recommendations;

(2) Radiation monitoring obligations such as, surveys, occupational exposure limits and procedures regarding the use of area and personnel monitoring;

(3) Facility compliance with occupational, pregnant worker and public exposure limits, to include notifying the director when individuals are occupationally over-exposed to radiation, pursuant to rule 3701:1-38-12 and rule 3701:1-38-21 of the Administrative Code;

(4) How radiation protection policies and policy changes are made available to the affected workers;

(5) Radiation safety training for ancillary personnel, to include:

(a) Potential hazards of being present in a restricted area;

(b) Location, boundaries, and purpose of restricted areas; and

(c) The identification of all radiation areas, warning signs, and warning lights;

(6) Banning the use of non-medical radiation-generating equipment to intentionally irradiate human beings for any purpose;

(7) Banning the operation of non-medical radiation-generating equipment if the provisions set forth in this rule or any other applicable obligations of Chapter 3701:1-68 of the Administrative Code are not met;

(8) Obligating operators of permanent radiographic installations and cabinet systems that are designed to admit humans to verify no individual is present in the room during radiation exposure;

(9) A current listing of all non-medical radiation-generating equipment, including the location and description of each system;

(10) Data and test results of the evaluation of the shielding and surroundings of all non-medical radiation-generating equipment;

(11) Maintenance logs and incident reports for each non-medical radiation-generating equipment system;

(12) Current copies of valid certification identification cards, issued by the independent program referenced in paragraph (C)(2)(a) of this rule, for each radiographer;

(13) Maintaining records obligated by this chapter, according to the following provisions:

(a) Determination of an individual's radiation exposure following an event where that individual's pocket dosimeter was found off-scale, or that individual's electronic personnel dosimeter read greater than two millisieverts (two hundred millirem) will be maintained until the director terminates the registration;

(b) Calculation of an individual's radiation exposure from the time of issuance to the time of damage or loss of a personnel dosimeter will be maintained until the director terminates the registration;

(c) In accordance with rule 3701:1-38-20 of the Administrative Code, dosimetry reports received from accredited NVLAP personnel dosimeter processors will be kept until the director terminates the registration;

(d) Area radiation surveys conducted at any site other than a temporary job site will be maintained until the director terminates the registration;

(e) Operator training and refresher training will be maintained until the employment of the operator has been terminated or three years, whichever is longer;

(f) All other records generated pursuant to the obligations of this chapter will be maintained for no less than three years;

(g) Check, test or evaluation records will include the date of the check or test, the name of the inspector, the equipment involved, any problems found, and what repair and/or maintenance, if any, was performed; and

(h) Each record will be legible throughout the specified retention period. The record may be the original or a reproduced copy or a microform provided that the copy or microform is authenticated by authorized personnel and that the microform is capable of reproducing a clear copy throughout the obligated retention period. The record may also be stored in electronic media with the capability for producing legible, accurate, and complete records during the obligated retention period. Records, such as letters, drawings, and specifications, will include all pertinent information, such as stamps, initials, and signatures. The registrant will maintain adequate safeguards against tampering with and loss of records.

(14) Obligating non-medical radiation-generating equipment to be kept locked at all times, to prevent tampering or removal by unauthorized personnel, except when under the direct surveillance of the operator, or as may be otherwise authorized pursuant to this rule.

(B) Survey instruments and dosimeter obligations:

(1) Radiation survey instruments will be calibrated:

(a) For the type of radiation to be monitored;

(b) Within the preceding six months for radiographic operations conducted at temporary job sites and twelve months for all other operations;

(c) After each instrument servicing other than battery replacement;

(d) Such that accuracy within plus or minus twenty per cent can be demonstrated;

(e) At two points located approximately one third and two thirds of full-scale on each scale for linear scale instruments;

(f) At midrange of each decade, and at two points of at least one decade for logarithmic scale instruments; and

(g) At appropriate points for digital instruments.

(2) Direct reading dosimeters will:

(a) Have a range from zero to two millisieverts (two hundred millirem);

(b) Read within plus or minus twenty per cent of the true radiation exposure; and

(c) Be checked for correct response to radiation at periods not to exceed twelve months.

(3) Personnel dosimeters, except for direct and indirect reading dosimeters used to measure the dose to any extremity, that need processing to determine the radiation dose will be processed and evaluated by a dosimetry processor that holds a current personnel dosimetry accreditation from the "National Voluntary Laboratory Accreditation Program" (NVLAP) of the national institute of standards and technology.

(4) The results of all survey instrument and direct reading dosimeter calibration will be recorded.

(C) Radiographic systems will be operated by radiographers and radiographer's assistants who meet the following:

(1) No individual will act as a radiographer or radiographer's assistant unless such individual has been instructed in, and has demonstrated understanding by successful completion of a written examination and competency by successful completion of a practical examination in the subjects identified in this paragraph. Training will be presented on a formal basis and will include the following subjects:

(a) Fundamentals of radiation safety and methods of controlling radiation;

(i) Time;

(ii) Distance;

(iii) Shielding; and

(iv) Collimation;

(b) Characteristics of radiation;

(c) Units of radiation dose;

(i) Significance of radiation dose; and

(ii) Radiation protection standards;

(d) Biological effects of radiation;

(e) Levels of radiation from sources of radiation;

(f) Applicable obligations of state regulations;

(g) Registrant's written operating and emergency procedures;

(h) Operation, inspection, maintenance and control of non-medical radiation-generating equipment to be used;

(i) Use of radiation survey instruments;

(i) Operation;

(ii) Calibration; and

(iii) Limitations;

(j) Survey techniques;

(k) Use of personnel monitoring equipment, to include;

(i) Distribution, wearing and exchange procedures;

(ii) Typically expected exposure levels; and

(iii) Methods to keep exposure levels as low as reasonably achievable; and

(l) Case histories of non-medical radiation-generating equipment accidents.

(2) Certification obligations for radiographers:

(a) Radiographers will be certified through an independent program approved by the United States nuclear regulatory commission, the "Conference of Radiation Control Program Directors Inc.," or equivalent certification approved by the director in accordance with the obligations in the appendix to this rule; and

(b) Prior to any individual acting as a radiographer, he or she will demonstrate one month of prior on-the-job experience.

(D) The handler will provide refresher training for operators of radiographic systems at intervals not to exceed twelve months.

(1) The training will include, as a minimum:

(a) Any results of internal inspections;

(b) New procedures or equipment;

(c) New or revised regulations;

(d) Any accidents or errors that have been observed; and

(e) Opportunities for attendees to ask safety questions.

(2) The training will be recorded and include, as a minimum:

(a) A list of the topics discussed during the refresher training;

(b) The dates the training was conducted; and

(c) The names of the instructors and attendees.

(E) The individual responsible for radiation protection (IRRP) for radiographic systems will:

(1) Be qualified as an industrial radiographer in accordance with paragraphs (C)(1) and (C)(2) of this rule; or

(2) Hold an associate's degree or higher in health physics, radiologic science, nuclear medicine, nuclear engineering or other ionizing radiation-related discipline.

(F) The specific duties and authorities of the individual responsible for radiation protection (IRRP) include, but are not limited to:

(1) Overseeing and approving all phases of the training program for operators, ensuring that appropriate and effective radiation protection practices are taught; and

(2) Ensuring that operations are conducted safely and to assume control for instituting corrective actions when necessary.

(G) In addition to the obligations of paragraph (F) of this rule, the specific duties and authorities of the individual responsible for radiation protection (IRRP) of radiographic systems addressed in rule 3701:1-68-03 of the Administrative Code include, but are not limited to:

(1) Establishing and overseeing all operating, emergency, and ALARA procedures as obligated by Chapter 3701:1-38 of the Administrative Code, and reviewing them regularly to ensure that the procedures in use conform to current regulatory obligations, and to the registration conditions;

(2) Ensuring that obligated radiation surveys are performed and recorded in accordance with the Administrative Code, including any corrective measures when levels of radiation exceed established limits;

(3) Ensuring that personnel monitoring devices are calibrated and used properly by occupationally-exposed personnel, that records are kept of the monitoring results, and that timely notifications are made as obligated by paragraph (C) of rule 3701:1-38-21 of the Administrative Code; and

(4) Auditing each radiographer and radiographer's assistant at intervals not to exceed six months to ensure that the applicable paragraphs of the Ohio Administrative Code and the registrant's operating and emergency procedures are followed.

(a) The audit will:

(i) Include observation of the performance of each radiographer and radiographer's assistant during an actual non-medical radiographic operation, and

(ii) Provide that, if a radiographer or a radiographer's assistant has not participated in a non-medical radiographic operation for more than six months since the last audit, the radiographer or radiographer's assistant will demonstrate knowledge of the training obligations of paragraphs (C)(1)(h), (C)(1)(i) and (C)(1)(j) of this rule by a practical examination before the individual can participate in a radiographic operation.

(b) The director may consider alternatives in those situations where the individual serves as both radiographer and individual responsible for radiation protection.

(c) In those operations where a single individual serves as both radiographer and individual responsible for radiation protection, and performs all radiographic operations, an audit program is not needed.

(d) A record of the audit will include, as a minimum:

(i) The identity of the radiographer or radiographer's assistant audited;

(ii) A list showing the items checked; and

(iii) Any non-compliance observed by the individual responsible for radiation protection.

(H) Operators of analytical, cabinet, hand-held and miniature radioscopic systems are exempt from the obligations of paragraphs (C), (D), and (E) of this rule, and will be obligated to receive training and demonstrated competence in the following:

(1) The safe operation procedures for the equipment;

(2) Precautions and measures to take to minimize radiation exposure;

(3) Significance of the various radiation warning, safety devices, and interlocks incorporated into the systems, or the reasons they have not been installed on certain parts of the systems and the extra precautions needed in such cases;

(4) Recognition of the potential hazards of use, biological effects of radiation, radiation risks, and recognition of signs and symptoms of an acute localized exposure;

(5) Procedures for reporting an actual or suspected accidental exposure or other radiation safety concerns, such as any unusual occurrence or malfunction that may involve exposure to radiation; and

(6) Performing surveys where applicable.

(I) Operators of permanent radiographic installations that meet the design obligations of rule 3701:1-68-06 of the Administrative Code and operators of radiographic particle accelerators, or bomb detection systems are obligated to meet the training topics of paragraph (C)(1) of this rule, but are exempt from the obligations of paragraphs (C)(2) and (E) of this rule.

(J) The director may, upon application thereof or upon his or her own initiative, grant a variance to the obligations of this chapter as he or she determines is authorized by law, provided that the registrant shows to the satisfaction of the director that there is good cause for the variance, and that the variance will not result in any undue hazard or effect on the public health and safety or environment. The terms, conditions, and expiration of the variance will be set forth in writing by the director. Failure to comply with the terms of the variance may result in immediate revocation of the variance.

View Appendix

Last updated June 30, 2023 at 12:42 AM

History

• Effective: June 30, 2023
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-38-01

(A) As used in this chapter and all other rules promulgated pursuant to Chapter 3748. of the Revised Code:

(1) "A₁" means the maximum activity of special form radioactive material permitted in a type A package. These values are listed in rule 3701:1-50-25 of the Administrative Code, or may be derived in accordance with the procedure prescribed in rule 3701:1-50-25 of the Administrative Code.

(2) "A₂" means the maximum activity of radioactive material, other than special form, low specific activity and surface contaminated object material, permitted in a type A package. These values are listed in rule 3701:1-50-25 of the Administrative Code, or may be derived in accordance with the procedure prescribed in rule 3701:1-50-25 of the Administrative Code.

(3) "Absorbed dose" means the energy imparted by ionizing radiation per unit mass of irradiated material. The units of absorbed dose are the gray, or Gy, and the rad.

(4) "Accelerator or charged particle accelerator" means any of a class of radiation generating equipment designed to electronically accelerate atomic or sub-atomic particles for subsequent bombardment of targets.

(5) "Accelerator-produced radioactive material" means any material made radioactive by a particle accelerator.

(6) "Activity" means the rate of disintegration or transformation or decay of radioactive material. The units of activity are the becquerel, or Bq, and the curie, or Ci.

(7) "Address of use" means the building or buildings that are identified on the license or registration and where the source of radiation may be received, used, prepared, or stored, except for temporary job sites.

(8) "Administrative controls" means mechanisms used to protect health and minimize damage to life and property through the use of written policies, procedures, instructions, training, observation of work practices, and related compliance audits.

(9) "Administrative monetary penalty" means a monetary penalty assessed by the director under section 3748.05 of the Revised Code and in compliance with rules adopted thereunder, to emphasize the need for lasting remedial action and to deter future violations.

(10) "Adult" means an individual eighteen or more years of age.

(11) "Agreement state" means any state with which the United States nuclear regulatory commission or the atomic energy commission has entered into an effective agreement under subsection 274B of the Atomic Energy Act of 1954, 68 Stat. 919, 42 U.S.C. 2021, as amended (1978). Non-agreement state means any other state.

(12) "Airborne radioactive material" means radioactive material dispersed in the air in the form of dusts, fumes, particulates, mists, vapors, or gases.

(13) "Airborne radioactivity area" means a room, enclosure, or area in which airborne radioactive materials, composed wholly or partly of licensed material, exist in concentrations:

(a) In excess of the derived air concentrations (DACs) specified in appendix C to rule 3701:1-38-12 of the Administrative Code, or

(b) To such a degree that an individual present in the area without respiratory protective equipment could exceed, during the hours an individual is present in a week, an intake of 0.6 per cent of the annual limit on intake or twelve DAC-hours.

(14) "Air-purifying respirator" means a respirator with an air-purifying filter, cartridge, or canister that removes specific air contaminants by passing ambient air through the air-purifying element.

(15) "ALARA" or "as low as is reasonably achievable" means every reasonable effort to maintain exposures to radiation as far below the dose limits as is practical consistent with the purpose for which the licensed or registered activity is undertaken, taking into account the state of technology, the economics of improvements in relation to benefits to the public health and safety, and other societal and socioeconomic considerations, and in relation to utilization of nuclear energy and licensed materials and registered activities in the public interest.

(16) "Alert" means events may occur, are in progress, or have occurred that could lead to a release of radioactive material but that the release is not expected to require a response by off-site response organizations to protect persons off-site.

(17) "Annual limit on intake" or "ALI" means the derived limit for the amount of radioactive material taken into the body of an adult worker by inhalation or ingestion in a year. ALI is the smaller value of intake of a given radionuclide in a year by the reference man that would result in a committed effective dose equivalent of 0.05 sievert (five rem) or a committed dose equivalent of 0.5 sievert (fifty rem) to any individual organ or tissue. ALI values for intake by ingestion and by inhalation of selected radionuclides are given in appendix C to rule 3701:1-38-12 of the Administrative Code.

(18) "Annually" means either

(a) At intervals not to exceed one year; or

(b) Once per year, at about the same time each year, plus or minus one month.

(19) "Area of use" means a portion of an address of use that has been set aside for the purpose of receiving, preparing, using, or storing sources of radiation.

(20) "Assigned protection factor" or "APF" means the expected workplace level of respiratory protection that would be provided by a properly functioning respirator or a class of respirators to properly fitted and trained users. Operationally, the inhaled concentration can be estimated by dividing the ambient airborne concentration by the APF.

(21) "Atmosphere-supplying respirator" means a respirator that supplies the respirator user with breathing air from a source independent of the ambient atmosphere, and includes supplied air respirators, or SARs, and self-contained breathing apparatus, or SCBA, units.

(22) "Atomic energy commission" or "AEC" means the federal agency created by the Atomic Energy Act of 1954, 68 Stat. 919, 42 U.S.C. 2011, as amended (1964), and was the predecessor agency to the current United States nuclear regulatory commission.

(23) "Background radiation" means radiation from cosmic sources; naturally occurring radioactive materials, including radon, except as a decay product of source or special nuclear material, and global fallout as it exists in the environment from the testing of nuclear explosive devices or from past nuclear accidents such as Chernobyl that contribute to background radiation and are not under the control of the licensee. "Background radiation" does not include radiation from radioactive materials regulated by the department.

(24) "Becquerel" or "Bq" means the SI unit of activity. One becquerel is equal to one disintegration per second.

(25) "Bioassay" or "radiobioassay" means the determination of kinds, quantities or concentrations, and, in some cases, the locations of radioactive material in the human body, whether by direct measurement, in vivo counting, or by analysis and evaluation of materials excreted or removed from the human body.

(26) "Byproduct material" means

(a) Any radioactive material, except special nuclear material, yielded in or made radioactive by exposure to the radiation incident to the process of producing or utilizing special nuclear materials; or

(b) The tailings or wastes produced by the extraction or concentration of uranium or thorium from any ore processed primarily for its source material content, including discrete surface wastes resulting from solution extraction processes. Underground ore bodies depleted by such solution extraction do not constitute byproduct material within the definition.

(27) "Chelating agent" means a chemical compound or mixture that enhances the removal of radioactive material from the body, water or similar applications. Typical chelating agents include amine polycarboxylic acids such as EDTA or DTPA; hydroxy-carboxylic acids; and polycarboxylic acids such as citric acid, carbolic acid, and gluconic acid.

(28) "Chiropractor" means an individual licensed by the state of Ohio to practice chiropractic medicine pursuant to Chapter 4734. of the Revised Code.

(29) "Class" or "lung class" or "inhalation class" means a classification scheme for inhaled material according to its rate of clearance from the pulmonary region of the lung. Materials are classified as D, W, or Y, which applies to a range of clearance half-times: for class D, days, of less than ten days, for class W, weeks, from ten to one hundred days, and for class Y, years, of greater than one hundred days.

(30) "Collective dose" means the sum of the individual doses received in a given period of time by a specified population from exposure to a specified source of radiation.

(31) "Commencement of construction" means taking any action defined as "construction" or any other activity at the site of a facility subject to the rules promulgated pursuant to Chapter 3748. of the Revised Code that has a reasonable nexus to radiological health and safety.

(32) "Committed dose equivalent" or "H_T,50" means the dose equivalent to organs or tissues of reference, T, that will be received from an intake of radioactive material by an individual during the fifty year period following the intake.

(33) "Committed effective dose equivalent" or "H_E,50" means the sum of the products of the weighting factors applicable to each of the body organs or tissues, W_T, that are irradiated and the committed dose equivalent to each of these organs or tissues (H_{E, 50} = W_TH_T,50).

(34) "Consortium" means an association of medical use licensees and a PET radionuclide production facility in the same geographical area that jointly own or share in the operation and maintenance cost of the PET radionuclide production facility that produces PET radionuclides for use in producing radioactive drugs within the consortium for noncommercial distributions among its associated members for medical use. The PET radionuclide production facility within the consortium must be located at an educational institution or a medical facility.

(35) "Constraint" or "dose constraint" means a value above which specified licensee actions are required.

(36) "Construction" means the installation of foundations, or in-place assembly, erection, fabrication, or testing for any structure, system, or component of a facility or activity subject to the rules promulgated pursuant to Chapter 3748. of the Revised Code that are related to radiological safety or security. The term "construction" does not include:

(a) Changes for temporary use of the land for public recreational purposes;

(b) Site exploration, including necessary borings to determine foundation conditions or other preconstruction monitoring to establish background information related to the suitability of the site, the environmental impacts of construction or operation, or the protection of environmental values;

(c) Preparation of the site for construction of the facility, including clearing of the site, grading, installation of drainage, erosion and other environmental mitigation measures, and construction of temporary roads and borrow areas;

(d) Erection of fences and other access control measures that are not related to the safe use of, or security of, radiological materials subject to the rules promulgated pursuant to Chapter 3748. of the Revised Code;

(e) Excavation;

(f) Erection of support buildings (e.g. construction equipment storage sheds, warehouse and shop facilities, utilities, concrete mixing plants, docking and unloading facilities, and office buildings) for use in connection with the construction of the facility;

(g) Building of service facilities (e.g. paved roads, parking lots, railroad spurs, exterior utility and lighting systems, potable water systems, sanitary sewerage treatment facilities, and transmission lines);

(h) Procurement or fabrication of components or portions of the proposed facility occurring at other than the final, in-place location at the facility; or

(i) Taking any other action that has no reasonable nexus to radiological health and safety.

(37) "Controlled area" means an area, outside of a restricted area but inside the site boundary, access to which can be limited by the licensee or registrant for any reason.

(38) "Critical group" means the group of individuals reasonably expected to receive the greatest exposure to residual radioactivity for any applicable set of circumstances.

(39) "Curie" or "Ci" means a unit of activity. One curie equals 3.7 x 10¹⁰ disintegrations per second equals 3.7 x 10¹⁰ becquerels equals 2.22 x 10¹² disintegrations per minute.

(40) "Cyclotron" means a particle accelerator in which the charged particles travel in an outward spiral or circular path. A cyclotron accelerates charged particles at energies usually in excess of ten megaelectron volts and is commonly used for production of short half-life radionuclides for medical use.

(41) "Declared pregnant woman" means a woman who has voluntarily informed the licensee or registrant, in writing, of her pregnancy and the estimated date of conception. The declaration remains in effect until the declared pregnant woman withdraws the declaration in writing or is no longer pregnant.

(42) "Decommission" means to safely remove any licensed operation from service and reduce residual radioactivity to a level that permits release of the licensee's property for unrestricted use and termination of the license.

(43) "Dedicated check source" means a radioactive source that is used to assure the consistent performance of a radiation detection or measurement device over several months or years.

(44) "Deep dose equivalent" or "H_d" applies to external whole body exposure, and means the dose equivalent at a tissue depth of one centimeter, one thousand milligram per square centimeter.

(45) "Demand respirator" means an atmosphere-supplying respirator that admits breathing air to the facepiece only when a negative pressure is created inside the facepiece by inhalation.

(46) "Dentist" means an individual licensed by the state of Ohio to practice dentistry under Chapter 4715. of the Revised Code.

(47) "Department" means the Ohio department of health.

(48) "Depleted uranium" means uranium containing less uranium-235 than the naturally occurring distribution of uranium isotopes.

(49) "Derived air concentration" or "DAC" means the concentration of a given radionuclide in air which, if breathed by the reference man for a working year of two thousand hours under conditions of light work, results in an intake of one ALI. The condition of light work is inhaling 1.2 cubic meters of air per hour for two thousand hours in a year. DAC values are given in appendix C to rule 3701:1-38-12 of the Administrative Code.

(50) "Derived air concentration-hour or DAC-hour" means the product of the concentration of radioactive material in air, which is expressed as a fraction or multiple of the derived air concentration for each radionuclide, and the time of exposure to that radionuclide, in hours. A licensee or registrant may take two thousand DAC-hours to represent one ALI, equivalent to a committed effective dose equivalent of 0.05 Sv (five rem).

(51) "Direct reading dosimeter" means a device that measures radiation dose that does not require another device to read the measured radiation dose. Examples of direct reading dosimeters include pocket dosimeters and electronic dosimeters.

(52) "Director" means the director of health or a designee or authorized representative of the director.

(53) "Discipline" means a branch of knowledge or of teaching.

(54) "Discrete source" means a radionuclide that has been processed so that its concentration within a material has been purposely increased for use for commercial, medical, or research activities.

(55) "Disposable respirator" means a respirator for which maintenance is not intended and that is designed to be discarded after excessive breathing resistance, sorbent exhaustion, physical damage, or end-of service-life renders it unsuitable for use. Examples of this type of respirator are a disposable half-mask respirator or a disposable escape-only self-contained breathing apparatus.

(56) "Dose" or "radiation dose" is a generic term that means absorbed dose, dose equivalent, effective dose equivalent, committed effective dose equivalent, or total effective dose equivalent as defined in other paragraphs of this rule.

(57) "Dose equivalent" or "H_T" means the product of the absorbed dose in tissue, quality factor, and all other necessary modifying factors at the location of interest. The units of dose equivalent are the sievert and rem.

(58) "Dose limits" or "limits" means the permissible upper bounds of radiation doses established in accordance with these regulations but excludes background radiation and medical exposure.

(59) "Dosimetry processor" means a person that processes and evaluates individual monitoring devices in order to determine the radiation dose delivered to the monitoring devices.

(60) "Effective dose equivalent" or "H_E" means the sum of the products of the dose equivalent to each organ or tissue, H_T, and the weighting factor, W_T, applicable to each of the body organs or tissues that are irradiated: (H_E = ∑W_TH_T).

(61) "Embryo" or "fetus" means the developing human organism from conception until time of birth.

(62) "Engineering controls" means mechanisms used to protect health and minimize damage to life and property through engineering specifications, design, and construction of the product or facility including all of the security and safety features. This includes, but is not limited to, auxiliary security and safety features such as additional external shielding, barriers, and operational interlocks with associated processes.

(63) "Entrance" or "access point" means any opening through which an individual or extremity of an individual could gain access to radiation areas or to licensed radioactive materials or registered radiation generating equipment. This includes entry or exit portals of sufficient size to permit human entry, irrespective of their intended use.

(64) "Explosive material" means any chemical compound, mixture or device which produces a substantial instantaneous release of gas and heat spontaneously or by contact with sparks or flame.

(65) "Exposure" means being exposed to sources of ionizing radiation.

(66) "External dose" means that portion of the dose equivalent received from radiation sources outside the body.

(67) "Extremity" means hand, elbow, arm below the elbow, foot, knee, or leg below the knee.

(68) "Eye dose equivalent" means the same as lens dose equivalent.

(69) "Facility" means all buildings, equipment, structures and other stationary items that, in addition to the meaning defined in division (H) of section 3748.01 of the Revised Code, are:

(a) Located on a single site or on contiguous or adjacent sites and are operated by the same person and have common corporate or business interests; or

(b) Portions of a building or structure which are operated by the same person and have common corporate or business interests.

(70) "Filtering facepiece" or "dust mask" means a negative pressure particulate respirator with a filter as an integral part of the facepiece or with the entire facepiece composed of the filtering medium, not equipped with elastomeric sealing surfaces and adjustable straps.

(71) "Fissile material" means the radionuclides uranium-233, uranium-235, plutonium-239, and plutonium-241, or any combination of these radionuclides. Fissile material means the fissile nuclides themselves, not material containing fissile nuclides. Unirradiated natural uranium and depleted uranium and natural uranium or depleted uranium that has been irradiated in thermal reactors only, are not included in this definition. Certain exclusions from fissile material controls are provided in rule 3701:1-50-13 of the Administrative Code.

(72) "Fit factor" means quantitative estimate of the fit of a particular respirator to a specific individual, and typically estimates the ratio of the concentration of a substance in ambient air to its concentration inside the respirator when worn.

(73) "Fit test" means the use of a protocol to qualitatively or quantitatively evaluate the fit of a respirator on an individual.

(74) "Generally applicable environmental radiation standards" means standards issued by the United States environmental protection agency under the authority of the Atomic Energy Act of 1954, 68 Stat. 919, 42 U.S.C. 2011, as amended (2005), that impose limits on radiation exposures or levels, or concentrations or quantities of radioactive material, in the general environment outside the boundaries of locations under the control of persons possessing or using radioactive material.

(75) "Gray" or "Gy" means the SI unit of absorbed dose. One gray is equal to an absorbed dose of one joule per kilogram (one hundred rads).

(76) "Handle" means receive, possess, use, store, transfer, install, service, or dispose of sources of radiation unless possession is solely for the purpose of transportation.

(77) "Handler" means a facility that handles sources of radiation unless possession is solely for the purpose of transportation.

(78) "Hazardous waste" means those wastes designated as hazardous by rule 3745-51-03 of the Administrative Code.

(79) "Helmet" means a rigid respiratory inlet covering that also provides head protection against impact and penetration.

(80) "High radiation area" means an area, accessible to individuals, in which radiation levels from radiation sources external to the body could result in an individual receiving a dose equivalent in excess of one millisievert (0.1 rem) in one hour at thirty centimeters from the radiation source or thirty centimeters from any surface that the radiation penetrates.

(81) "Hood" means a respiratory inlet covering that completely covers the head and neck and may also cover portions of the shoulders and torso.

(82) "Individual" means any human being.

(83) "Individual monitoring" means

(a) The assessment of dose equivalent by the use of devices designed to be worn by an individual;

(b) The assessment of committed effective dose equivalent by bioassay or by determination of the time-weighted air concentrations to which an individual has been exposed, i.e. DAC-hours; or

(c) The assessment of dose equivalent by the use of survey data.

(84) "Individual monitoring devices" means devices designed to be worn by a single individual for the assessment of dose equivalent such as film badges; thermoluminescent dosimeters; optically stimulated luminescent dosimeters; pocket ionization chambers; and personal air sampling devices.

(85) "Industrial radiography" means the examination of the structure of materials by nondestructive methods, utilizing sealed sources of radioactive material or radiation-generating equipment.

(86) "Internal dose" means that portion of the dose equivalent received from radioactive material taken into the body.

(87) "Irradiator" means a facility that uses radioactive sealed sources for the irradiation of objects or materials and in which radiation dose rates exceeding five grays (five hundred rads) per hour exist at one meter from the sealed radioactive source in air or water, as applicable for the irradiator type, but does not include irradiators in which both the sealed source and the area subject to irradiation are contained within a device and are not accessible to personnel.

(88) "Lens dose equivalent" or "eye dose equivalent" means the external exposure of the lens of the eye and is taken as the dose equivalent at a tissue depth of 0.3 centimeters; i.e. three hundred milligrams per square centimeter.

(89) "License" means a license issued by the nuclear regulatory commission, the director, or another agreement state in accordance with rules adopted by those organizations.

(90) "Licensee" means a person to whom a license is issued.

(91) "Licensed activity" means an activity authorized by a radioactive material license which is essential to achieving the purpose for which the license was issued or amended.

(92) "Licensed material" means radioactive material received, possessed, used, transferred or disposed of under a general or specific license.

(93) "Loose-fitting facepiece" means a respiratory inlet covering that is designed to form a partial seal with the face.

(94) "Lost or missing licensed source of radiation" means a licensed source of radiation whose location is unknown. It includes material that has been shipped but has not reached its destination and whose location cannot be readily traced in the transportation system.

(95) "Low-level radioactive waste" or "LLRW," also "low-level waste," or "LLW" means radioactive waste which is not high-level radioactive waste, spent nuclear fuel, NARM, or byproduct material as defined in section 11 E. (2) of the Atomic Energy Act of 1954 68 Stat. 919, 42 U.S.C. 2011, as amended (2005), but is radioactive material that the United States nuclear regulatory commission classifies as low-level radioactive waste.

(96) "Low specific activity material" or "LSA" means radioactive material with limited specific activity which is nonfissile or is excepted under rule 3701:1-50-13 of the Administrative Code, and which satisfies the descriptions and limits set forth below. Shielding materials surrounding the LSA material may not be considered in determining the estimated average specific activity of the package contents. LSA must be in one of three groups:

(a) LSA - I.

(i) Uranium and thorium ores, concentrates of uranium and thorium ores, and other ores containing naturally occurring radioactive radionuclides that are intended to be processed for the use of these radionuclides;

(ii) Natural uranium, depleted uranium, natural thorium or their compounds or mixtures, provided they are unirradiated and in solid or liquid form;

(iii) Radioactive material other than fissile material, for which the A₂ value is unlimited; or

(iv) Other radioactive material in which the activity is distributed throughout and the estimated average specific activity does not exceed thirty times the value for exempt material activity concentration determined in accordance with rule 3701:1-50-25 of the Administrative Code.

(b) LSA-II.

(i) Water with tritium concentration up to 0.8 terabecquerels per liter (twenty curies per liter); or

(ii) Other material in which the activity is distributed throughout and the estimated average specific activity does not exceed ( 10^-4 A₂) per gram for solids and gases, and (10^-5 A₂) per gram for liquids.

(c) LSA-III. Solids (e.g., consolidated wastes, activated materials), excluding powders, that satisfy the requirements of 10 C.F.R. 71.77 (as in effect on the effective date of this rule), in which:

(i) The radioactive material is distributed throughout a solid or a collection of solid objects, or is essentially uniformly distributed in a solid compact binding agent (such as concrete, bitumen, ceramic, etc.);

(ii) The radioactive material is relatively insoluble, or it is intrinsically contained in a relatively insoluble material, so that even under loss of packaging, the loss of radioactive material per package by leaching, when placed in water for seven days, would not exceed (0.1 x A₂); and

(iii) The estimated average specific activity of the solid, excluding any shielding material, does not exceed (0.002 x A₂) per gram.

(97) "Management" means the chief executive officer or other individual having the authority to manage, direct, or administer the licensee's activities, or those persons' delegate or delegates.

(98) "Medical institution" means an organization in which more than one medical discipline is practiced.

(99) "Medical use" means the intentional internal or external administration of radioactive material or the radiation therefrom to patients or human research subjects under the supervision of an authorized user.

(100) "Member of the public" means any individual except when that individual is receiving an occupational dose.

(101) "Minor" means an individual less than eighteen years of age.

(102) "Monitoring" or "radiation monitoring" or "radiation protection monitoring" means the measurement of radiation levels, concentrations, surface area concentrations or quantities of radioactive material and the use of the results of these measurements to evaluate potential exposures and doses.

(103) "NARM" or "naturally occurring or accelerator-produced radioactive material" means naturally occurring or accelerator-produced radioactive material, including naturally occurring material that is technologically enhanced, and those nuclides that are generated in a charged particle accelerator, but does not include source material, byproduct material, or special nuclear material.

(104) "NARM licensing state" means any state with regulations equivalent to the suggested state regulations for control of radiation relating to, and an effective program for, the regulatory control of NARM and which has been granted final designation by the conference of radiation control program directors, inc.

(105) "Nationally tracked source" means a sealed source containing a quantity equal to or greater than "Category 1" or "Category 2" levels of any radioactive material listed in the appendix to rule 3701:1-38-25 of the Administrative Code. In this context a sealed source is defined as radioactive material that is sealed in a capsule or closely bonded, in a solid form and which is not exempt from regulatory control. It does not mean material encapsulated solely for disposal, or nuclear material contained in any fuel assembly, subassembly, fuel rod, or fuel pellet. "Category 1" nationally tracked sources are those containing radioactive material at a quantity equal to or greater than the "Category 1" threshold. "Category 2" nationally tracked sources are those containing radioactive material at a quantity equal to or greater than the "Category 2" threshold but less than the "Category 1" threshold.

(106) "Negative pressure respirator" or "tight fitting respirator" means a respirator in which the air pressure inside the facepiece is negative during inhalation with respect to the ambient air pressure outside the respirator.

(107) "Nonstochastic effect" or "deterministic effect" means health effects, the severity of which varies with the dose and for which a threshold is believed to exist. Radiation-induced cataract formation is an example of a nonstochastic effect.

(108) "NORM" or "naturally occurring radioactive material" means any nuclide that is radioactive in its natural physical state, but does not include source material, byproduct material, or special nuclear material.

(109) "Normal form radioactive material" means radioactive material that has not been demonstrated to qualify as special form radioactive material.

(110) "Nuclear regulatory commission" means the federal agency established by Title II of the Energy Reorganization Act of 1974, 88 Stat. 1233, 42 U.S.C.A. 5801, as amended (2005), comprising the members of the commission and all offices, employees, and representatives authorized to act in any case or matter related to licensing and related regulatory function previously assigned to the AEC.

(111) "Occupational dose" means the dose received by an individual in the course of employment in which the individual's assigned duties involve exposure to radiation or radioactive material from licensed and unlicensed sources of radiation, whether in the possession of the licensee or other person. Occupational dose does not include doses received from background radiation, from any medical administration the individual has received, from exposures to individuals administered radioactive materials and released in accordance with rule 3701:1-58-30 of the Administrative Code or equivalent United States nuclear regulatory commission or agreement state regulations, from voluntary participation in medical research programs, or as a member of the public.

(112) "Package" means the packaging together with its radioactive contents as presented for transport.

(a) Fissile material package or type AF package, type BF package, type B(U)F package, or type B(M)F package means a fissile material packaging together with its fissile material contents.

(b) Type A package means a type A packaging together with its radioactive contents. A type A package is defined and must comply with the United States department of transportation regulations in 49 C.F.R. 173 (as in effect on the effective date of this rule).

(c) Type B package means a type B packaging together with its radioactive contents. On approval, a type B package design is designated by the United States nuclear regulatory commission as B(U) unless the package has a maximum normal operating pressure of more than seven hundred kilopascals (one hundred pounds per square inch) gauge or a pressure relief device that would allow the release of radioactive material to the environment under the tests specified in 10 C.F.R. 71.73 (hypothetical accident conditions) (as in effect on the effective date of this rule), in which case it will receive a designation B(M). B(U) refers to the need for unilateral approval of international shipments; B(M) refers to the need for multilateral approval of international shipments. There is no distinction made in how packages with these designations may be used in domestic transportation. To determine their distinction for international transportation, see United States department of transportation regulations in 49 C.F.R. 173 (as in effect on the effective date of this rule). A type B package approved before September 6, 1983, was designated only as type B. Limitations on its use are specified in 10 C.F.R. 71.19 (as in effect on the effective date of this rule).

(113) "Packaging" means the assembly of components necessary to ensure compliance with the packaging requirements of rule 49 C.F.R. 173 Subpart I (as in effect on the effective date of this rule). It may consist of one or more receptacles, absorbent materials, spacing structures, thermal insulation, radiation shielding, and devices for cooling or absorbing mechanical shocks. The vehicle, tie-down system and auxiliary equipment may be designated as part of the packaging.

(114) "Particle accelerator" means any machine capable of accelerating electrons, protons, deuterons, or other charged particles in a vacuum and of discharging the resultant particulate or other radiation into a medium at energies usually in excess of one megaelectron volt. For purposes of this definition, "accelerator" is an equivalent term.

(115) "Person" means any individual, corporation, association, business enterprise, or other legal entity either public or private and any legal successor, representative, agent, or agency of that individual, corporation, association, business enterprise, or other legal entity. Person also includes the United States, states, political subdivisions of states, and any department, agency, or instrumentality of the United States or a state, except the U.S. department of energy or the U.S. nuclear regulatory commission where the state regulation of radioactive material by either of those agencies is prohibited by federal law.

(116) "Personnel dosimeter", means a device that measures radiation dose that is processed and evaluated by an accredited "National Voluntary Laboratory Accreditation Program" (NVLAP) processor. Examples of personnel dosimeters include film badges, thermo-luminescent dosimeters (TLD), and optically stimulated luminescence (OSL) dosimeters.

(117) "Pharmacist" means a person who is licensed by the state of Ohio to practice pharmacy pursuant to Chapter 4731. of the Revised Code.

(118) "Physician" means a person who is licensed pursuant to Chapter 4731. of the Revised Code to practice medicine or surgery or osteopathic medicine or surgery.

(119) "Planned special exposure" means an infrequent exposure to radiation, separate from and in addition to the annual dose limits.

(120) "Podiatrist" means an individual licensed by the state of Ohio to practice podiatry pursuant to Chapter 4731. of the Revised Code.

(121) "Positive pressure respirator" means a respirator in which the pressure inside the respiratory inlet covering exceeds the ambient air pressure outside the respirator.

(122) "Positron Emission Tomography (PET) radionuclide production facility" means a facility operating a cyclotron or accelerator for the purpose of producing PET radionuclides.

(123) "Powered air-purifying respirator" or "PAPR" means an air-purifying respirator that uses a blower to force the ambient air through air purifying elements to the inlet covering.

(124) "Pressure demand respirator" means a positive pressure atmosphere supplying respirator that admits breathing air to the facepiece when the positive pressure is reduced inside the facepiece by inhalation.

(125) "Public dose" means the dose received by a member of the public from exposure to radiation and/or radioactive material released by the licensee, or to any other source of radiation under the control of a licensee or registrant. Public dose does not include occupational dose or doses received from background radiation, from any medical administration the individual has received, from exposures to individuals administered radioactive materials and released in accordance with rule 3701:1-58-30 of the Administrative Code or equivalent United States nuclear regulatory commission or agreement state regulations, or from voluntary participation in medical research programs.

(126) "Pyrophoric material" means any liquid that ignites spontaneously in dry or moist air at or below 54.4 degrees celsius (one hundred thirty degrees fahrenheit). A pyrophoric solid is any solid material, other than one classed as an explosive, which under normal conditions is liable to cause fires through friction, retained heat from manufacturing or processing, or which can be ignited readily and when ignited burns so vigorously and persistently as to create a serious transportation, handling, or disposal hazard. Included are spontaneously combustible and water-reactive materials.

(127) "Qualitative fit test" or "QLFT" means a pass/fail fit test to assess the adequacy of respirator fit that relies on the individual's response to the test agent.

(128) "Quality factor" or "Q" means the modifying factor, as listed in paragraphs (A) and (B) of rule 3701:1-38-11 of the Administrative Code, that is used to derive dose equivalent from absorbed dose.

(129) "Quantitative fit test" or "QNFT" means an assessment of the adequacy of respirator fit by numerically measuring the amount of leakage into the respirator.

(130) "Quarter" or "quarterly" means a period of time equal to one-fourth of the year observed by the licensee or registrant, approximately thirteen consecutive weeks, providing that the beginning of the first quarter in a year coincides with the starting date of the year and that no day is omitted or duplicated in consecutive quarters.

(131) "Rad" means the special unit of radiation absorbed dose. One rad is equal to an absorbed dose of one hundred ergs per gram, or 0.01 joule per kilogram, or 0.01 gray.

(132) "Radiation" or "ionizing radiation" means alpha particles, beta particles, gamma rays, x-rays, neutrons, high speed electrons, high speed protons, and other particles capable of producing ions. Radiation does not include nonionizing radiation, such as radio or microwaves, or visible, infrared or ultraviolet light.

(133) "Radiation area" means an area, accessible to individuals, in which radiation levels could result in an individual receiving a dose equivalent in excess of 0.05 millisievert (0.005 rem) in one hour at thirty centimeters from the source of radiation or from any surface that the radiation penetrates.

(134) "Radiation-generating equipment" or "RGE" means any manufactured product or device, or component of such a product or device, or any machine or system that during operation can generate or emit radiation, except those that emit radiation only from radioactive material. "Radiation-generating equipment" does not include either of the following:

(a) Diathermy machines;

(b) Microwave ovens, including food service microwave ovens used for commercial and industrial uses, television receivers, electric lamps, and other household appliances and products that generate very low levels of radiation.

(135) "Radiation Safety Officer" or "RSO" means an individual designated by the licensee who has the knowledge and responsibility for the overall radiation safety program at the facility, to include the implementation of the daily radiation safety operations and compliance with the rules.

(136) "Radioactive material" means any solid, liquid or gaseous material that emits ionizing radiation spontaneously. "Radioactive material" includes accelerator-produced and naturally occurring radioactive materials and byproduct, source, and special nuclear material.

(137) "Radioactive waste" means waste containing regulated radioactive material.

(138) "Radioactivity" means the transformation of unstable atoms by the emission of radiation.

(139) "Radiography" means the same as industrial radiography.

(140) "Reference man" means a hypothetical aggregation of human physical and physiological characteristics arrived at by international consensus. These characteristics may be used by researchers and public health workers to standardize results of experiments and to relate biological insult to a common base.

(141) "Registrant" means a person required by Chapter 3748. of the Revised Code to register radiation-generating equipment with the director.

(142) "Rem" means the special unit of any of the quantities expressed as dose equivalent. The dose equivalent in rem is equal to the absorbed dose in rads multiplied by the quality factor (one rem = 0.01 Sv).

(143) "Research and development" means

(a) Theoretical analysis, exploration, or experimentation; or

(b) The extension of investigative findings and theories of a scientific or technical nature into practical application for experimental and demonstration purposes, including the experimental production and testing of models, devices, equipment, materials and processes. "Research and development" does not include the internal or external administration of sources of radiation to human beings.

(144) "Residual radioactivity" means radioactivity in structures, materials, soils, groundwater, and other media at a site resulting from activities under the licensee's control. This includes radioactivity from all licensed and unlicensed sources used by the licensee, but excludes background radiation. It also includes radioactive materials remaining at the site as a result of routine or accidental releases of radioactive material at the site and previous burials at the site, even if those burials were made in accordance with the provisions of 10 C.F.R. 20 (as in effect on the effective date of this rule).

(145) "Respiratory protective equipment or device" means an apparatus, such as a respirator, used to reduce the individual's intake of airborne radioactive materials.

(146) "Restricted area" means an area access to which is limited by the licensee or registrant for the purpose of protecting individuals against undue risks from exposure to sources of radiation. Restricted area does not include areas used as residential quarters, but separate rooms in a residential building may be set apart as a restricted area.

(147) "Roentgen" means the amount of gamma or x-rays required to produce ions resulting in a charge of 0.000258 coulombs per kilogram of air under standard conditions.

(148) "Sanitary sewerage" means a system of public sewers for carrying off wastewater and refuse, but excluding sewage treatment facilities, septic tanks, and leach fields owned or operated by the licensee.

(149) "Sealed source" means radioactive material that is encased in a manner designed to prevent leakage or escape of the radioactive material.

(150) "Sealed source and device registry" means the national registry that contains all the registration certificates, generated by both the United States nuclear regulatory commission and the agreement states, that summarize the radiation safety information for the sealed sources and devices and describe the licensing and use conditions approved for the product.

(151) "Seismic area" means any area where the probability of a horizontal acceleration in rock of more than 0.3 times the acceleration of gravity in two hundred fifty years is greater than ten per cent, as designated by the United States geological survey.

(152) "Self-contained breathing apparatus" or "SCBA" means an atmosphere-supplying respirator for which the breathing air source is designed to be carried by the user.

(153) "Shallow dose equivalent" or "H_S" means the external exposure of the skin of the whole body or the skin of an extremity, is taken as the dose equivalent at a tissue depth of 0.007 centimeter, or seven milligrams per square centimeter.

(154) "Sievert" or "Sv" means the SI unit of any of the quantities expressed as dose equivalent. The dose equivalent in sieverts is equal to the absorbed dose in grays multiplied by the quality factor. One sievert equals one hundred rem.

(155) "Site area emergency" means events may occur, are in progress, or have occurred that could lead to a significant release of radioactive material and that could require a response by off-site response organizations to protect persons off-site.

(156) "Site boundary" means that line beyond which the land or property is not owned, leased, or otherwise controlled by the licensee or registrant.

(157) "Site closure and stabilization" means those actions that are taken upon completion of operations that prepare a disposal site for custodial care and that assure that the disposal site will remain stable and will not need ongoing active maintenance.

(158) "Source material" means uranium, thorium, or any combination thereof in any physical or chemical form, or any ores that contain by weight at least one-twentieth of one per cent (0.05 per cent) of uranium, thorium, or any combination thereof. Source material does not include special nuclear material.

(159) "Sources of radiation" means radioactive material or radiation generating equipment.

(160) "Special form radioactive material" means radioactive material that satisfies the following conditions:

(a) It is either a single solid piece or is contained in a sealed capsule that can be opened only by destroying the capsule;

(b) The piece or capsule has at least one dimension not less than five millimeters (0.2 inch); and

(c) It satisfies the test requirements specified by the United States nuclear regulatory commission in 10 C.F.R. 71.75 (as in effect on the effective date of this rule). A special form encapsulation designed in accordance with the United States nuclear regulatory commission requirements identified in 10 C.F.R. 71.4, in effect on June 30, 1983, and constructed prior to July 1, 1985; a special form encapsulation designed in accordance with the requirements of 10 C.F.R. 71.4 in effect on March 31, 1996, and constructed before April 1, 1998; and special form material that was successfully tested before September 10, 2015 in accordance with the requirements of 10 C.F.R. 71.75(d) of this section in effect before September 10, 2015 may continue to be used. Any other special form encapsulation must meet the specifications of this definition.

(161) "Special nuclear material" means either of the following:

(a) Plutonium, uranium-233, uranium enriched in the isotope 233, or in the isotope 235, and any other material that the United States nuclear regulatory commission determines to be special nuclear material, but does not include source material pursuant to section 51 of the Atomic Energy Act of 1954, 68 Stat 919, 42 USCA 2071, as amended (2005).

(b) Any material artificially enriched by any of the foregoing but does not include source material.

(162) "Special nuclear material in quantities not sufficient to form a critical mass" means uranium enriched in the isotope uranium-235 in quantities not exceeding three hundred fifty grams of contained uranium-235; uranium-233 in quantities not exceeding two hundred grams; plutonium in quantities not exceeding two hundred grams; or any combination of them in accordance with the following formula: for each kind of special nuclear material, determine the ratio between the quantity of that special nuclear material and the quantity specified in this paragraph for the same kind of special nuclear material. The sum of such ratios for all of the kinds of special nuclear material in combination shall not exceed unity.

(163) "Stochastic effect" means health effects that occur randomly and for which the probability of the effect occurring, rather than its severity, is assumed to be a linear function of dose without threshold. Hereditary effects and cancer incidence are examples of stochastic effects.

(164) "Supplied-air respirator" or "SAR" or "airline respirator" means an atmosphere-supplying respirator for which the source of breathing air is not designed to be carried by the user.

(165) "Surface contaminated object" or "SCO" means a solid object that is not itself classed as radioactive material, but which has radioactive material distributed on any of its surfaces. SCO must be in one of two groups with surface activity not exceeding the following limits:

(a) SCO-I: a solid object on which:

(i) The non-fixed contamination on the accessible surface averaged over three hundred square centimeters, or the area of the surface if less than three hundred square centimeters, does not exceed four becquerels per square centimeter (10^-4 microcurie per square centimeter) for beta and gamma and low toxicity alpha emitters, or 0.4 becquerels per square centimeter 10^-5 microcurie per square centimeter) for all other alpha emitters;

(ii) The fixed contamination on the accessible surface averaged over three hundred square centimeters, or the area of the surface if less than three hundred square centimeters, does not exceed forty thousand becquerels per square centimeter (one microcurie per square centimeter) for beta and gamma and low toxicity alpha emitters, or four thousand becquerels per square centimeter (0.1 microcurie per square centimeter) for all other alpha emitters; and

(iii) The non-fixed contamination plus the fixed contamination on the inaccessible surface averaged over three hundred square centimeters, or the area of the surface if less than three hundred square centimeters, does not exceed forty thousand becquerels per square centimeter (one microcurie per square centimeter) for beta and gamma and low toxicity alpha emitters, or four thousand becquerels per square centimeter (0.1 microcurie per square centimeter) for all other alpha emitters.

(b) SCO-II: a solid object on which the limits for SCO-I are exceeded and on which:

(i) The non-fixed contamination on the accessible surface averaged over three hundred square centimeters, or the area of the surface if less than three hundred square centimeter, does not exceed four hundred becquerels per square centimeter (10^-2 microcurie per square centimeter) for beta and gamma and low toxicity alpha emitters, or forty becquerels per square centimeter (10^-3 microcurie per square centimeter) for all other alpha emitters;

(ii) The fixed contamination on the accessible surface averaged over three hundred square centimeters, or the area of the surface if less than three hundred square centimeters, does not exceed eight hundred thousand becquerels per square centimeter (twenty microcuries per square centimeter) for beta and gamma and low toxicity alpha emitters, or eighty thousand becquerels per square centimeter (two microcuries per square centimeter) for all other alpha emitters; and

(iii) The non-fixed contamination plus the fixed contamination on the inaccessible surface averaged over three hundred square centimeters, or the area of the surface if less than three hundred square centimeters, does not exceed eight hundred thousand becquerels per square centimeter (twenty microcuries per square centimeter) for beta and gamma and low toxicity alpha emitters, or eighty thousand becquerels per square centimeter (two microcuries per square centimeter) for all other alpha emitters.

(166) "Survey" means an evaluation of the radiological conditions and potential hazards incident to the production, use, transfer, release, disposal or presence of radioactive material or other sources of radiation. When appropriate, such an evaluation includes a physical survey of the location of radioactive material, or the sources of radiation and measurements or calculations of levels of radiation, or concentrations or quantities of radioactive material present.

(167) "Tight-fitting facepiece" means a respiratory inlet covering that forms a complete seal with the face.

(168) "Total effective dose equivalent" or "TEDE" means the sum of the effective dose equivalent (for external exposures) and the committed effective dose equivalent (for internal exposures).

(169) "Transport index" means the dimensionless number, rounded up to the next tenth, placed on the label of a package, to designate the degree of control to be exercised by the carrier during transportation. The transport index is the number determined by multiplying the maximum radiation level in millisievert per hour at one meter (3.3 feet) from the external surface of the package by one hundred, which is equivalent to the maximum radiation level in millirem per hour at one meter (3.3 feet).

(170) "Type A quantity" means a quantity of radioactive material, the aggregate radioactivity of which does not exceed A₁ for special form radioactive material, or A₂ for normal form radioactive material, where A₁ and A₂ are given in rule 3701:1-50-25 of the Administrative Code.

(171) "Type B quantity" means a quantity of radioactive material greater than a type A quantity.

(172) "Type B package" is defined under "Package."

(173) "United States department of energy" means the department of energy established by the Department of Energy Organization Act, PL 95-91, 91 Stat. 565 (1977), 42 U.S.C. 7101 et seq., as amended (2006), to the extent that the department of energy or its duly authorized representatives, exercises functions formerly vested in the United States atomic energy commission, its chairman, members, officers and components and transferred to the United States energy research and development administration and to the administrator thereof pursuant to Sections 104(b) to (d) of the Energy Reorganization Act of 1974, PL 93-438, 88 Stat. 1233 at 1237 (1974), 42 U.S.C. 5814 and retransferred to the secretary of energy pursuant to Section 301(a) of the Department of Energy Organization Act, PL 95-91, 91 Stat. 565 at 577-578 (1977), 42 U.S.C. 7151.

(174) "Unrestricted area" or "uncontrolled area" means any area, access to which is neither restricted nor controlled by the licensee or registrant.

(175) "User seal check" or "fit check" means an action conducted by the respirator user to determine if the respirator is properly seated to the face. Examples include negative pressure check, positive pressure check, irritant smoke check, or isoamyl acetate check.

(176) "Very high radiation area" means an area, accessible to individuals, in which radiation levels from radiation sources external to the body could result in an individual receiving an absorbed dose in excess of five gray (five hundred rad) in one hour at one meter from a source of radiation or from any surface that the radiation penetrates. At very high doses received at high dose rates, units of absorbed dose, gray and rad, are appropriate, rather than units of dose equivalent, sievert and rem.

(177) "Veterinarian" means an individual licensed by the state of Ohio to practice veterinary medicine pursuant to Chapter 4741. of the Revised Code.

(178) "Waste" means those low-level radioactive wastes containing source, special nuclear, or byproduct material that are acceptable for disposal in a land disposal facility. For the purposes of this definition, low-level radioactive waste means radioactive waste not classified as high-level radioactive waste, transuranic waste, spent nuclear fuel, or byproduct material as defined in paragraph (A)(26)(b) of this rule, or byproduct material as defined in section 11 E. (3) and (4) of the Atomic Energy Act of 1954, 68 Stat. 919, 42 USC 2014, as amended (2005).

(179) "Week" means seven consecutive days starting on Sunday.

(180) "Weighting factor

• W_T" for an organ or tissue, (T), is the proportion of the risk of stochastic effects resulting from irradiation of that organ or tissue to the total risk of stochastic effects when the whole body is irradiated uniformly. For calculating the effective dose equivalent, the values of W_T are:

| Organ doseweighting factors | | | --- | --- | | Organ ortissue | W_T | | Gonads | 0.25 | | Breast | 0.15 | | Red bone marrow | 0.12 | | Lung | 0.12 | | Thyroid | 0.03 | | Bonesurfaces | 0.03 | | Remainder | 0.30^a | | Whole body | 1.00^b |

^\a 0.30 results from 0.06 for each of five "remainder" organs, excluding the skin and the lens of the eye, that receive the highest doses.

^\b for the purpose of weighting the external whole body dose (for adding it to the internal dose) a single weighting factor, W_T = 1.0, has been specified. The use of other weighting factors for external exposure will be approved on a case-by-case basis until such time as specific guidance is issued.

(181) "Whole body" means for purposes of external exposure, head; trunk, including male gonads; arms above the elbow; legs above the knee.

(182) "Worker" means an individual engaged in activities licensed or registered by the department and controlled by a licensee or registrant, but does not include the licensee or registrant.

(183) "Working level" or "WL" means any combination of short-lived radon decay products (for radon-222: polonium-218, lead-214, bismuth-214, and polonium-214; and for radon-220: polonium-216, lead-212, bismuth-212, and polonium-212) in one liter of air that will result in the ultimate emission of 1.3 x 10⁵ million electron volts alpha particle energy.

(184) "Working level month" or "WLM" means a cumulative exposure to one working level for one hundred seventy hours. (Two thousand working hours per year/twelve months per year equals approximately one hundred seventy hours per month.)

(185) "Year" means the period of time beginning in January used to determine compliance with the provisions of this rule. The licensee or registrant may change the starting date of the year used to determine compliance by the licensee or registrant provided that the change is made at the beginning of the year and that no day is omitted or duplicated in consecutive years.

(B) The terms set out in paragraph (A) of this rule may be redefined in other chapters as promulgated pursuant to Chapter 3748. of the Revised Code as used in that chapter only.

Last updated May 13, 2026 at 11:20 AM

History

• Effective: January 20, 2022
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-38-12

(A) Except in the case of a planned special exposure pursuant to paragraph (F) of this rule, a licensee or registrant shall limit the occupational dose received by an individual adult, as follows:

(1) An annual limit, which is the more limiting of:

(a) The total effective dose equivalent being equal to 0.05 sievert (five rem); or

(b) The sum of the deep dose equivalent and the committed dose equivalent to any individual organ or tissue other than the lens of the eye being equal to 0.5 sievert (fifty rem).

(2) The annual limits to the lens of the eye, to the skin of the whole body, and to the skin of the extremities, which are:

(a) A lens dose equivalent of 0.15 sievert (fifteen rem), and

(b) A shallow-dose equivalent of 0.5 sievert (fifty rem) to the skin of the whole body or to the skin of any extremity.

(3) Doses received in excess of the annual limits, including doses received during accidents, emergencies, and planned special exposures, shall be subtracted from the limits for planned special exposures that the individual may receive during the current calendar year and during the individual's lifetime in accordance with paragraph (F)(5) of this rule.

(4) When the external exposure is determined by measurement with an external personal monitoring device, the deep-dose equivalent must be used in place of the effective dose equivalent, unless the effective dose equivalent is determined by a dosimetry method approved by the director. The assigned deep-dose equivalent must be for the part of the body receiving the highest exposure.

(a) The assigned shallow-dose equivalent must be the dose averaged over the contiguous ten square centimeters of skin receiving the highest exposure. The deep-dose equivalent, lens-dose equivalent, and shallow-dose equivalent may be assessed from surveys or other radiation measurements for the purpose of demonstrating compliance with the occupational dose limits, if the individual monitoring device was not in the region of highest potential exposure, or the results of individual monitoring are unavailable; or

(b) When a protective apron is worn while working with radiation-generating equipment and monitoring is conducted as specified in paragraph (C)(1) of rule 3701:1-38-14 of the Administrative Code, the effective dose equivalent for external radiation shall be determined as follows:

(i) When only one individual monitoring device is used and it is located at the neck outside the protective apron, the reported deep dose equivalent value multiplied by 0.3 shall be the effective dose equivalent for external radiation; or

(ii) When two individual monitoring devices are worn, one under the protective apron at the waist and the other outside the protective apron at the neck, the effective dose equivalent for external radiation shall be assigned the value of the sum of the deep dose equivalent reported for the individual monitoring device located at the waist under the protective apron multiplied by 1.5 and the deep dose equivalent reported for the individual monitoring device located at the neck outside the protective apron multiplied by 0.04; or

(iii) Through the use of computational methods endorsed by the "American National Standards Institute", recommended by the "National Council on Radiation Protection and Measurements", or approved by the director.

(5) Derived air concentration (DAC) and annual limit on intake (ALI) values are specified in appendix C to this rule and may be used by the licensee to determine the individual's dose and to demonstrate compliance with the occupational dose limits. Appendices A and B are explanatory supplements to appendix C to this rule. Notwithstanding the annual dose limits, the licensee shall limit the soluble uranium intake by an individual to ten milligrams in a week in consideration of chemical toxicity.

(6) In accordance with paragraph (E) of this rule, the licensee or registrant shall reduce the dose that an individual may be allowed to receive in the current year by the amount of occupational dose received while employed by any other person.

(B) Compliance with requirements for summation of external and internal doses shall be in accordance with the following:

(1) If the licensee is required to monitor under both paragraphs (B)(1) and (B)(2) of rule 3701:1-38-14 of the Administrative Code, the licensee shall demonstrate compliance with the dose limits by summing external and internal doses. If the licensee is required to monitor only under paragraph (B)(1) or only under paragraph (B)(2) of rule 3701:1-38-14 of the Administrative Code, then summation is not required to demonstrate compliance with the dose limits. The licensee may demonstrate compliance with the requirements for summation of external and internal doses by meeting one of the conditions specified in paragraph (B)(2) of this rule and the conditions in paragraphs (B)(3) and (B)(4) of this rule. The dose equivalents for the lens of the eye, the skin, and the extremities are not included in the summation, but are subject to separate limits.

(2) If the only intake of radionuclides is by inhalation, the total effective dose equivalent limit is not exceeded if the sum of the deep dose equivalent divided by the total effective dose equivalent limit, plus one of the following does not exceed unity:

(a) The sum of the fractions of the inhalation ALI for each radionuclide; or

(b) The total number of derived air concentration-hours, or DAC-hours, for all radionuclides divided by two thousand; or

(c) The sum of the calculated committed effective dose equivalents to all significantly irradiated organs or tissues (T) calculated from bioassay data using appropriate biological models and expressed as a fraction of the annual limit. For purposes of this requirement, an organ or tissue is deemed to be significantly irradiated if, for that organ or tissue, the product of the weighting factors, W_T, and the committed dose equivalent, H_T,50, per unit intake is greater than ten per cent of the maximum weighted value of H_T,50, that is, W_TH_T,50, per unit intake for any organ or tissue.

(3) If the occupationally exposed individual also receives an intake of radionuclides by oral ingestion greater than ten percent of the applicable oral ALI, the licensee shall account for this intake and include it in demonstrating compliance with the limits set forth in paragraph (A) of this rule.

(4) The licensee shall evaluate and, to the extent practical, account for intakes through wounds or skin absorption. The intake through intact skin has been included in the calculation of DAC for hydrogen-3 and does not need to be further evaluated or accounted for pursuant to this paragraph.

(C) Determination of external dose from airborne radioactive material shall be in accordance with the following:

(1) When determining the dose from airborne radioactive material, the licensee shall include the contribution to the deep dose equivalent, lens dose equivalent, and shallow dose equivalent from external exposure to the radioactive cloud as specified in appendix C to this rule, footnotes ^A and ^B.

(2) The licensee should not use airborne radioactivity measurements or DAC values as the primary means to assess the deep dose equivalent when the airborne radioactive material includes radionuclides other than noble gases, or if the cloud of airborne radioactive material is not relatively uniform. The determination of the deep dose equivalent to an individual should be based upon measurements using instruments or individual monitoring devices.

(D) Determination of internal exposure shall be in accordance with the following:

(1) For purposes of assessing dose used to determine compliance with occupational dose equivalent limits, the licensee shall, when required under paragraph (B) of rule 3701:1-38-14 of the Administrative Code, take suitable and timely measurements of:

(a) Concentrations of radioactive materials in air in work areas; or

(b) Quantities of radionuclides in the body; or

(c) Quantities of radionuclides excreted from the body; or

(d) Combinations of these measurements.

(2) Unless respiratory protective equipment is used, as provided in paragraph (C) of rule 3701:1-38-16 of the Administrative Code or the assessment of intake is based on bioassays, the licensee shall assume that an individual inhales radioactive material at the airborne concentration in which the individual is present.

(3) When specific information on the physical and biochemical properties of the radionuclides taken into the body or the behavior of the material in an individual is known, the licensee may:

(a) Use that information to calculate the committed effective dose equivalent, and, if used, the licensee shall document that information in the individual's record; and

(b) Upon prior approval of the department, adjust the DAC or ALI values to reflect the actual physical and chemical characteristics of airborne radioactive material, for example, aerosol size distribution or density; and

(c) Separately assess the contribution of fractional intakes of Class D, W, or Y compounds of a given radionuclide to the committed effective dose equivalent as specified in appendix A to this rule.

(4) If the licensee chooses to assess intakes of Class Y material using the measurements given in paragraph (D)(1)(b) or (D)(1)(c) of this rule in order to make additional measurements basic to the assessments, the licensee may delay the recording and reporting of the assessments for periods up to seven months, unless otherwise required by paragraph (B)(2) or (C) of rule 3701:1-38-21 of the Administrative Code.

(5) If the identity and concentration of each radionuclide in a mixture are known, the fraction of the DAC applicable to the mixture for use in calculating DAC-hours shall be either:

(a) The sum of the ratios of the concentration to the appropriate DAC value, that is, D, W, or Y, from appendix C to this rule for each radionuclide in the mixture; or

(b) The ratio of the total concentration for all radionuclides in the mixture to the most restrictive DAC value for any radionuclide in the mixture.

(6) If the identity of each radionuclide in a mixture is known, but the concentration of one or more of the radionuclides in the mixture is not known, the DAC for the mixture shall by the most restrictive DAC of any radionuclide in the mixture.

(7) When a mixture of radionuclides in air exists, a licensee may disregard certain radionuclides in the mixture if all of the following occur:

(a) The licensee uses the total activity of the mixture in demonstrating compliance with the dose limits in paragraph (A) of this rule and in complying with the monitoring requirements in paragraph (B) of rule 3701:1-38-14 of the Administrative Code;

(b) The concentration of any radionuclide disregarded is less than ten percent of its DAC; and

(c) The sum of these percentages for all of the radionuclides disregarded in the mixture does not exceed thirty percent.

(8) When determining the committed effective dose equivalent, the licensee may consider the following:

(a) In order to calculate the committed effective dose equivalent, the licensee may assume that the inhalation of one ALI, or an exposure of two thousand DAC-hours, results in a committed effective dose equivalent of 0.05 sievert (five rem), for radionuclides that have their ALIs or DACs based on the committed effective dose equivalent; or

(b) For an ALI and the associated DAC determined by the nonstochastic organ dose limit of 0.5 sievert (fifty rem), the intake of radionuclides that would result in a committed effective dose equivalent of 0.05 sievert (five rem), that is, the stochastic ALI, is listed in parentheses in table I of appendix C to this rule. The licensee may, as a simplifying assumption, use the stochastic ALI to determine committed effective dose equivalent. However, if the licensee uses the stochastic ALI, the licensee shall also demonstrate that the limit in paragraph (A)(1)(b) of this rule is met.

(E) Determination of prior occupational dose shall be made in accordance with the following:

(1) For each individual who is likely to receive an annual occupational dose requiring monitoring pursuant to paragraph (B) of rule 3701:1-38-14 of the Administrative Code, the licensee or registrant shall determine the occupational radiation dose received during the current year.

(2) Prior to permitting an individual to participate in a planned special exposure, the licensee shall determine:

(a) The internal and external doses from all previous planned special exposures; and

(b) All doses in excess of the limits, including doses received during accidents and emergencies, received during the lifetime of the individual.

(3) In complying with the requirements of paragraph (E)(1) or (E)(2) of this rule, a licensee or registrant may:

(a) Accept, as a record of the occupational dose that the individual received during the current year, a written signed statements from the individual, or from the individual's most recent employer for work involving radiation exposure, that discloses the nature and the amount of any occupational dose that the individual may have received during the current year;

(b) Accept, as the record of lifetime cumulative radiation dose, a current department form entitled "lifetime occupational exposure history" or equivalent, signed by the individual and countersigned by an appropriate official of the most recent employer for work involving radiation exposure, or the individual's current employer, if the individual is not employed by the licensee or registrant; and

(c) Obtain reports of the individual's dose equivalent from the most recent employer for work involving radiation exposure, or the individual's current employer, if the individual is not employed by the licensee or registrant, by telephone, telegram, facsimile, e-mail or letter. The licensee or registrant shall request a written verification of the dose data if the authenticity of the transmitted report cannot be established.

(4) The licensee or registrant shall record the exposure history, as required by paragraph (A) of this rule, on a form provided by the department or other clear and legible record, of all the information required on that form. The form or record shall show each period in which the individual received occupational exposure to radiation or radioactive material and shall be signed by the individual who received the exposure. For each period for which the licensee or registrant obtains reports, the licensee or registrant shall use the dose shown in the report in preparing the exposure history form. For any period in which the licensee or registrant does not obtain a report, the licensee or registrant shall place a notation on the exposure history form indicating the periods of time for which data are not available.

(5) If the licensee or registrant is unable to obtain a complete record of an individual's current and previously accumulated occupational dose, the licensee or registrant shall assume:

(a) In establishing administrative controls pursuant to paragraph (A)(6) of this rule for the current year, that the allowable dose limit for the individual is reduced by 12.5 millisievert (1.25 rem), for each quarter for which records were unavailable and the individual was engaged in activities that could have resulted in occupational radiation exposure; and

(b) That the individual is not available for planned special exposures.

(6) The licensee or registrant shall retain the records on the exposure history form until the department terminates each pertinent license or registration requiring this record. The licensee or registrant shall retain records used in preparing the exposure history form for three years after the record is made.

(F) A planned special exposure may be authorized by a licensee in accordance with this paragraph. A licensee may authorize an adult worker to receive doses in addition to and accounted for separately from the doses received under the limits specified in paragraph (A) of this rule provided that each of the following is satisfied:

(1) The licensee authorizes a planned special exposure only in an exceptional situation when alternatives that might avoid the higher exposure are unavailable or impractical;

(2) The licensee and employer, if the employer is not the licensee, specifically authorizes the planned special exposure, in writing, before the exposure occurs;

(3) Before a planned special exposure, the licensee ensures that each individual involved is:

(a) Informed of the purpose of the planned operation; and

(b) Informed of the estimated doses and associated potential risks and specific radiation levels or other conditions that might be involved in performing the task; and

(c) Instructed in the measures to be taken to keep the dose ALARA considering other risks that may be present;

(4) Prior to permitting an individual to participate in a planned special exposure, the licensee ascertains prior doses as required by paragraph (E)(2) of this rule during the lifetime of the individual for each individual involved;

(5) The licensee shall not authorize a planned special exposure that would cause an individual to receive a dose from all planned special exposures and all doses in excess of the limits to exceed:

(a) The numerical values of any of the dose limits in paragraph (A) of this rule in any calendar year; and

(b) Five times the annual dose limits specified in paragraph (A) of this rule during the individual's lifetime;

(6) The licensee maintains records of the conduct of a planned special exposure in accordance with paragraph (E) of rule 3701:1-38-20 of the Administrative Code and submits a written report in accordance with paragraph (D) of rule 3701:1-38-21 of the Administrative Code;

(7) The licensee records the best estimate of the dose resulting from the planned special exposure in the individual's record and informs the individual, in writing, of the dose within thirty days from the date of the planned special exposure. The dose from planned special exposures shall not be considered in controlling future occupational dose of the individual pursuant to paragraph (A)(1) of this rule, but shall be included in evaluations required by paragraphs (F)(4) and (F)(5) of this rule.

(G) Occupational dose limits for minors shall be ten per cent of the annual occupational dose limits specified for adult workers in paragraph (A) of this rule.

(H) Dose equivalent to an embryo or fetus shall be in accordance with the following:

(1) The licensee or registrant shall ensure that the dose equivalent to an embryo or fetus during the entire pregnancy, due to occupational exposure of a declared pregnant woman, does not exceed five millisievert (0.5 rem). Records shall be maintained in accordance with paragraph (I) of rule 3701:1-38-20 of the Administrative Code.

(2) The licensee or registrant shall make efforts to avoid substantial variation above a uniform monthly exposure rate to a declared pregnant woman so as to satisfy the limit in paragraph (H)(1) of this rule.

(3) The dose equivalent to the embryo or fetus is the sum of:

(a) The deep-dose equivalent to the declared pregnant woman; and

(b) The dose equivalent to the embryo or fetus resulting from radionuclides in the embryo or fetus and from radionuclides in the declared pregnant woman.

(4) If the declared pregnant woman's exposure includes exposure from radiation generating equipment and a protective apron is worn, the dose equivalent to an embryo or fetus shall be taken as the sum of:

(a) The dose equivalent to the embryo or fetus from radionuclides in the embryo or fetus and radionuclides in the declared pregnant woman; and

(b) The dose equivalent that is most representative of the dose to the embryo or fetus from external radiation, that is, in the mother's lower torso region.

(i) If multiple measurements have not been made, assignment of the highest deep dose equivalent for the declared pregnant woman shall be the dose to the embryo or fetus, in accordance with paragraph (A)(4) of this rule; or

(ii) If multiple measurements have been made, assignment of the deep dose equivalent for the declared pregnant woman from the individual monitoring device which is most representative of the dose to the embryo or fetus shall be the dose to the embryo or fetus. Assignment of the highest deep dose equivalent for the declared pregnant woman to the embryo or fetus is not required unless that dose is also the most representative deep dose equivalent for the region of the embryo or fetus.

(5) If by the time the woman declares pregnancy to the licensee or registrant, the dose equivalent to the embryo or fetus has exceeded five millisievert, or 0.5 rem, the licensee or registrant shall be deemed to be in compliance with paragraph (A) of this rule, provided that the additional dose equivalent to the embryo or fetus does not exceed 0.5 millisievert (0.05 rem), during the remainder of the pregnancy.

View AppendixView AppendixView Appendix

Last updated November 2, 2022 at 2:10 PM

History

• Effective: October 4, 2010
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-38-21

(A) The licensee or registrant shall report stolen, lost, or missing licensed or registered sources of radiation to the director in accordance with the following:

(1) Telephone reports shall be made as follows:

(a) To the bureau of environmental health and radiation protection point of contact (POC) in accordance with the form "Notice to Employees" issued by the director.

(b) In the case of a licensee, he or she shall make contact:

(i) Immediately after the licensee determines that licensed radioactive material is stolen, lost, or missing in an aggregate quantity equal to or greater than one thousand times the quantity specified in the appendix to rule 3701:1-38-18 of the Administrative Code under such circumstances that it appears to the licensee that an exposure could result to individuals in unrestricted areas;

(ii) Within thirty days after its occurrence becomes known to the licensee, lost, stolen, or missing licensed radioactive material in an aggregate quantity greater than ten times the quantity specified in the appendix to rule 3701:1-38-18 of the Administrative Code that is still missing.

(c) In the case of a registrant, he or she shall make contact immediately after it becomes known that radiation-generating equipment has been stolen, lost, or is missing.

(2) Written reports shall be made as follows:

(a) Each licensee or registrant required to make a report pursuant to paragraph (A)(1) of this rule shall, within thirty days after making the telephone report, make a written report to the director setting forth the following information, where applicable:

(i) A description of the licensed or registered source of radiation involved, including, for radioactive material, the kind, quantity, and chemical and physical form, and in the case of radiation-generating equipment, the manufacturer, model and serial number, type and maximum energy of the radiation emitted;

(ii) A description of the circumstances under which the loss or theft occurred;

(iii) A statement of disposition, or probable disposition, of the licensed or registered source of radiation involved;

(iv) Exposures of individuals to radiation, circumstances under which the exposures occurred, and the possible total effective dose equivalent to persons in unrestricted areas;

(v) Actions that have been taken, or will be taken, to recover the source of radiation; and

(vi) Procedures or measures that have been, or will be, adopted to ensure against a recurrence of the loss or theft of licensed or registered sources of radiation.

(b) Subsequent to filing the written report, the licensee or registrant shall also report additional substantive information on the loss or theft within thirty days after the licensee or registrant learns of such information.

(c) The licensee or registrant shall prepare any report filed with the director pursuant to this rule so that names of individuals who may have received exposure to radiation are stated in a separate and detachable portion of the report.

(B) Notification of incidents shall be made as follows:

(1) Excluding prescribed medical doses to patients, each licensee or registrant shall immediately report each event involving a source of radiation possessed by the licensee or registrant that may have caused or threatens to cause any of the following conditions:

(a) An individual receiving:

(i) A total effective dose equivalent of 0.25 sievert (twenty-five rem) or more;

(ii) A lens dose equivalent of 0.75 sievert (seventy-five rem) or more; or

(iii) A shallow dose equivalent to the skin or extremities or a total organ dose equivalent of 2.5 sievert (two hundred fifty rem) or more; or

(b) The release of radioactive material, inside or outside of a restricted area that, had an individual been present for twenty-four hours, the individual could have received an intake five times the occupational ALI. This provision does not apply to locations where personnel are not normally stationed during routine operations, such as hot-cells or process enclosures.

(2) Each licensee or registrant shall report to the director, within twenty-four hours of discovery, each event involving loss of control of a licensed or registered source of radiation possessed by the licensee or registrant that may have caused, or threatens to cause, any of the following:

(a) An individual to receive, in a period of twenty-four hours:

(i) A total effective dose equivalent exceeding 0.05 sievert (five rem);

(ii) An lens dose equivalent exceeding 0.15 sievert (fifteen rem); or

(iii) A shallow dose equivalent to the skin or extremities or a total organ dose equivalent exceeding 0.5 sievert (fifty rem); or

(b) The release of radioactive material, inside or outside of a restricted area that, had an individual been present for twenty-four hours, the individual could have received an intake in excess of one occupational ALI. This provision does not apply to locations where personnel are not normally stationed during routine operations, such as hot-cells or process enclosures.

(3) Licensees or registrants shall make the reports required by paragraphs (B)(1) and (B)(2) of this rule to the POC by telephone to the department and shall confirm the initial contact by telegram, mailgram, electronic mail, or facsimile to the director.

(4) The licensee or registrant shall prepare each report filed with the director pursuant to this rule so that names of individuals who have received exposure to sources of radiation are stated in a separate and detachable portion of the report.

(5) The provisions of paragraph (B) of this rule do not apply to doses that result from planned special exposures, provided such doses are within the limits for planned special exposures and are reported in accordance with this paragraph.

(C) Reports of exposures, radiation levels, and concentrations of radioactive material exceeding the limits shall be made by the licensee or registrant as follows:

(1) Reportable events that are specified in this paragraph shall, in addition to the notification requirements in paragraph (B) of this rule, be reported to the director in writing within thirty days after learning of any of the following occurrences:

(a) Incidents for which notification is required by paragraph (B) of this rule and with doses in excess of any of the following:

(i) The occupational dose limits for adults in paragraphs (A)(1) and (A)(2) of rule 3701:1-38-12 of the Administrative Code;

(ii) The occupational dose limits for a minor in paragraph (G) of rule 3701:1-38-12 of the Administrative Code;

(iii) The limits for an embryo or fetus of a declared pregnant woman in paragraph (H) of rule 3701:1-38-12 of the Administrative Code;

(iv) The limits for an individual member of the public in paragraph (A) of rule 3701:1-38-13 of the Administrative Code;

(v) Any applicable limit in the license or registration; or

(vi) The ALARA constraints for air emissions established under paragraph (D)(4) of rule 3701:1-38-11 of the Administrative Code; or

(b) Levels of radiation or concentrations of radioactive material in:

(i) A restricted area in excess of applicable limits in the license or registration; or

(ii) An unrestricted area in excess of ten times the applicable limit set forth in this chapter or in the license or registration, whether or not involving exposure of any individual in excess of the limits in paragraph (A) of rule 3701:1-38-13 of the Administrative Code; or

(c) For licensees subject to the provisions of the United States environmental protection agency generally applicable environmental radiation standards in 40 C.F.R. 190 (as in effect on the effective date of this rule), levels of radiation or releases of radioactive material in excess of those standards, or of license conditions related to those standards.

(2) Each report required by this rule shall describe the extent of exposure of individuals to radiation and radioactive material, including, as appropriate:

(a) Estimates of each individual's dose, the level of radiation and concentration of radioactive material involved, and the cause of the elevated exposure, dose rate, or concentration; and

(b) Corrective steps taken or planned to ensure against a recurrence, including the schedule for achieving conformance with applicable limits, ALARA constraints, generally applicable environmental standards, and associated license or registration conditions.

(3) Each report filed pursuant to this rule shall include, for each occupationally overexposed individual, the name, social security account number, and date of birth of the individual. In the case of the limit for an embryo or fetus in paragraph (H) of rule 3701:1-38-12 of the Administrative Code, the identifiers should be those of the declared pregnant woman. The report shall be prepared so that information on each individual is stated in a separate and detachable portion of the report.

(4) All licensees or registrants who make reports pursuant to this rule shall submit the report in writing to the director.

(D) Reports of planned special exposures shall be submitted by the licensee in a written report to the director within thirty days following any planned special exposure conducted in accordance with paragraph (F) of rule 3701:1-38-12 of the Administrative Code, informing the director that a planned special exposure was conducted and indicating the date the planned special exposure occurred and the information required by paragraph (G) of rule 3701:1-38-20 of the Administrative Code.

(E) When a licensee or registrant is required pursuant to paragraph (C) or (D) of this rule to report to the director any exposure of an identified occupationally exposed individual, or an identified member of the public, to radiation or radioactive material, the licensee or registrant shall also provide the individual a report on his or her exposure data included in the report to the director. This report shall be transmitted no later than the transmittal to the director, and shall comply with the provisions of paragraph (C)(1) of rule 3701:1-38-10 of the Administrative Code.

(F) A report of a leaking or contaminated sealed source shall be filed by the licensee with the director within five days of the test results, if the test reveals the presence of one hundred eighty-five becquerels (0.005 microcurie) or more of removable contamination. The report shall include the equipment involved, the test results and the corrective action taken.

Last updated January 20, 2022 at 8:48 AM

History

• Effective: January 20, 2022
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-38-20

(A) Each licensee or registrant shall use the SI units becquerel, gray, sievert and coulomb per kilogram, or the special units curie, rad, rem and roentgen, including multiples and subdivisions, and shall clearly indicate the units of all quantities on records required by this chapter. The licensee or registrant shall make a clear distinction among the quantities entered on the records such as, total effective dose equivalent, total organ dose equivalent, shallow dose equivalent, lens dose equivalent, deep dose equivalent, or committed effective dose equivalent.

(B) Each licensee or registrant shall maintain records of the radiation protection program, including the provisions of the program and audits and other reviews of program content and implementation. The licensee or registrant shall retain the records of the provisions of the program until the department terminates each license or registration pertinent to the record. The licensee or registrant shall retain all the other records required by this paragraph for three years after the record is made.

(C) Records of surveys showing the results of surveys and calibrations required by paragraph (A) of rule 3701:1-38-14 and paragraph (F) of rule 3701:1-38-18 of the Administrative Code shall be maintained and retained by the licensee or registrant for three years after the record is made.

(D) The licensee or registrant shall retain each of the following records until the department terminates each license or registration pertinent to the record:

(1) Records of the results of surveys to determine the dose from external sources of radiation used, in the absence of or in combination with individual monitoring data, in the assessment of individual dose equivalents;

(2) Records of the results of measurements and calculations used to determine individual intakes of radioactive material and used in the assessment of internal dose;

(3) Records showing the results of air sampling, surveys, and bioassays required pursuant to paragraphs (C)(2)(a) and (C)(2)(b) of rule 3701:1-38-16 of the Administrative Code; and

(4) Records of the results of measurements and calculations used to evaluate the release of radioactive effluents to the environment.

(E) Records of tests for leakage or contamination of sealed sources shall be kept in units of becquerel or microcurie, or multiples thereof, and maintained for inspection by the department for at least three years after the records are made.

(F) Records of prior occupational dose and exposure history as required in paragraph (E) of rule 3701:1-38-12 of the Administrative Code shall be recorded by the licensee or registrant on a form provided by the department entitled "lifetime occupational exposure history" in accordance with the instructions for completing this form, or in clear and legible records containing all the information required by the same form. The licensee or registrant shall maintain these records until the department terminates each license or registration pertinent to this record. The licensee or registrant shall retain records used in preparing the form for three years after the record is made.

(G) Records of planned special exposures as required in paragraph (F) of rule 3701:1-38-12 of the Administrative Code shall be maintained by the licensee:

(1) The licensee shall maintain records that describe the following:

(a) The exceptional circumstances requiring the use of a planned special exposure;

(b) The name of the management official who authorized the planned special exposure and a copy of the signed authorization;

(c) What actions were necessary;

(d) Why the actions were necessary;

(e) What precautions were taken to assure that doses were maintained ALARA;

(f) What individual and collective doses were expected to result; and

(g) The doses actually received in the planned special exposure.

(2) The licensee shall retain the records until the department terminates each license pertinent to these records.

(H) Records of individual dose monitoring results shall be maintained by each licensee or registrant for each individual for whom monitoring is required pursuant to paragraph (B) of rule 3701:1-38-14 of the Administrative Code, and records of doses received during planned special exposures, accidents, and emergency conditions. Assessments of dose equivalent and records made using units in effect before the effective date of these rules need not be changed.

(1) These records shall include, when applicable:

(a) The deep dose equivalent to the whole body, lens dose equivalent, shallow dose equivalent to the skin, and shallow dose equivalent to the extremities;

(b) The estimated intake or radionuclides as provided in paragraph (B) of rule 3701:1-38-12 of the Administrative Code;

(c) The committed effective dose equivalent assigned to the intake of radionuclides; and

(d) The specific information used to calculate the committed effective dose equivalent pursuant to paragraph (D)(8) of rule 3701:1-38-12 of the Administrative Code; and

(e) The total effective dose equivalent when required by paragraph (B) of rule 3701:1-38-12 of the Administrative Code; and

(f) The total of the deep dose equivalent and the committed dose to the organ receiving the highest total dose.

(2) The licensee or registrant shall make entries of the records specified in paragraph (H) of this rule at least annually.

(I) Each licensee or registrant shall maintain the records specified in paragraph (H) of this rule on department form entitled "occupational exposure record for a monitoring period" in accordance with the instructions for completing this form, or in clear and legible records containing all the information required by the same form. The licensee or registrant shall maintain the records of dose to an embryo or fetus with the records of dose to the declared pregnant woman. The declaration of pregnancy shall also be kept on file, but may be maintained separately from the dose records. The licensee or registrant shall retain each required form or record until the department terminates each license or registration pertinent to the record.

(J) Each licensee or registrant shall maintain records sufficient to demonstrate compliance with the dose limits for individual members of the public specified in paragraph (A) of rule 3701:1-38-13 of the Administrative Code. Each licensee or registrant shall retain the records required by paragraph (H) of this rule until the department terminates each license or registration pertinent to the record.

(K) Records of the disposal of licensed material shall be maintained by each licensee in accordance with paragraphs (C), (D), (F), and (G) of rule 3701:1-38-19, and Chapter 3701:1-54 of the Administrative Code. The licensee shall retain the records required by this paragraph until the department terminates each pertinent license that requires the record.

(L) Records of tests performed on entry control devices located in a very high radiation area shall be maintained by each licensee in accordance with Chapter 3701:1-52 of the Administrative Code or registrant in accordance with Chapters 3701:1-66, 3701:1-67, and 3701:1-68 of the Administrative Code. These records must include the date, time, and results of each such test of function. The licensee or registrant shall retain the records required by this paragraph for at least three years after the record is made.

(M) Each record required by this chapter shall be legible throughout the specified retention period. The record shall be the original or a reproduced copy or a microform, provided that the copy or microform is authenticated by authorized personnel and that the microform is capable of producing a clear copy throughout the required retention period. The record may also be stored in electronic media with the capability for producing legible, accurate, and complete records during the required retention period. Records, such as letters, drawings, and specifications, shall include all pertinent information, such as stamps, initials, and signatures. The licensee or registrant shall maintain adequate safeguards against tampering with and loss of records.

Last updated January 20, 2022 at 8:48 AM

History

• Effective: January 20, 2022
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-68-03

In addition to the applicable rules in this chapter and Chapter 3701:1-38 of the Administrative Code, handlers of radiographic systems will comply with the following:

(A) Radiographic systems will meet the following equipment standards:

(1) A lock designed to prevent unauthorized or accidental production of ionizing radiation will be provided.

(2) A readily visible warning light, labeled with the words "X-RAY ON" or words or symbols having a similar intent, will be located on or near the x-ray source and its controls and will be illuminated when the x-ray source is energized.

(3) All radiographic systems will be labeled with a readily discernible sign or signs bearing the radiation symbol and the words:

(a) "CAUTION - HIGH INTENSITY X-RAY BEAM," or appropriate words having a similar intent, on or near the x-ray source housing; and

(b) "CAUTION - THIS EQUIPMENT PRODUCES RADIATION WHEN ENERGIZED," or appropriate words having a similar intent, near any switch or control that directly energizes the unit.

(4) Permanent radiographic installations will be equipped with the following:

(a) Failsafe interlocks at each entrance used for personnel access to the high radiation area;

(b) A visible signal that is activated when radiation is produced; and

(c) An audible signal that is activated when an attempt is made to enter the high radiation area while radiation is being produced.

(5) The exposure switch of hand-held radiographic systems will meet the following:

(a) The switch will be of the "dead-man" type;

(b) The operator will be able to terminate the exposure at any time during an exposure of greater than one-half second; and

(c) It will not be possible to make an exposure when the timer is set to "zero" or "off" position if either position is provided.

(B) Handlers of radiographic systems will comply with the following radiation safety obligations:

(1) Sufficient calibrated and operable radiation survey instruments will be maintained to make physical radiation surveys as obligated by this rule and rule 3701:1-38-14 of the Administrative Code. Radiation survey instruments obligated by this rule will have a range such that 0.2 millisievert (two millirem) per hour through 0.01 sievert (one rem) per hour can be measured.

(2) Radiation area surveys will be performed and the results recorded to confirm compliance with paragraph (A) of rule 3701:1-38-14 of the Administrative Code in accordance with the following:

(a) Upon installation;

(b) After any changes in shielding or the radiographic system that is part of permanent radiographic installation; and

(c) Each time the radiographic system has been moved to an area that has yet to be evaluated for radiation levels at temporary job sites.

(3) A physical radiation survey will be made after each radiographic exposure to verify that the radiation-generating equipment is not still producing radiation unless:

(a) Personnel devices providing an audible signal when activated by radiation and proper operation of the audible detection device is check and recorded daily;

(i) The audible device will be designed so as to clearly indicate entry into a 0.02 mSv (two mrem) per hour or greater radiation field; and

(ii) All personnel working with the radiation-generating equipment will be provided with such a device; or

(b) Stationary area monitors providing an audible signal when activated by radiation will be acceptable and proper operation of the stationary detection device is checked and recorded daily;

(i) The stationary device will be designed so as to clearly indicate entry into a 0.02 mSv (two mrem) per hour or greater radiation field; and

(ii) Stationary area monitors will be evaluated annually to verify that the audible signal activates in a 0.02 mSv (two mrem) per hour radiation field.

(4) A utilization log will be maintained between inspections showing the following information for each radiographic system used:

(a) Manufacturer, model number, and serial number;

(b) Locations and dates of use;

(c) Operating voltage, tube current, and exposure time for each radiographic exposure; and

(d) Identity of the operator.

(5) Operating and emergency procedures will include instructions in at least the following:

(a) Inspection, maintenance and operability checks of radiographic systems and radiation survey instruments;

(b) Minimizing additional exposure of individuals in the event of an accident;

(c) Notifying proper personnel in the event of an accident; and

(d) Identifying and reporting defects and noncompliance according to the obligations of rule 3701:1-38-23 of the Administrative Code, involving:

(i) The failure of any component, which is critical to safe operation of the device to properly perform its intended function;

(ii) The failure of an indicator on non-medical radiation-generating equipment to show that radiation is being produced;

(iii) The failure of an exposure switch to terminate production of radiation when turned to the off position; or

(iv) The failure of a safety interlock to terminate x-ray production.

(6) At least two qualified individuals will be present at a temporary job site when a radiographic system is being used. At least one of the individuals will be the radiographer to whom the radiographic system is assigned and the other individual will be either a radiographer or a radiographer's assistant.

(7) No individual other than a radiographer or a radiographer's assistant who is under the personal supervision of a radiographer will manipulate controls or operate equipment used in radiographic operations. The personal supervision will include:

(a) The radiographer's physical presence at the site where the radiographic system is being used;

(b) The availability of the radiographer to give immediate assistance if obligated; and

(c) The radiographer's direct observation of the radiographer's assistant's performance of the operations referred to in this rule.

(8) The handler will not permit any individual to act as a radiographer or as a radiographer's assistant unless, at all times during radiographic operations, each such individual wears, on the trunk of the body, an appropriate direct reading dosimeter and a personnel dosimeter. Analog pocket dosimeters will be recharged at the start of each shift. Electronic dosimeters will be battery-tested at the beginning of each shift. Each personnel dosimeter will be assigned to and worn by only one individual and the handler will assure that:

(a) Direct reading dosimeters are read and exposures are recorded at the beginning and end of each shift.

(b) If an individual's pocket dosimeter is found to be off-scale, or the electronic personnel dosimeter reads greater than two millisieverts (two hundred mrem), the individual's personnel dosimeter will be sent for processing within twenty-four hours. In addition, the individual will not resume work associated with the use of x-ray sources until a determination of the individual's radiation exposure has been made. This determination will be made by the individual responsible for radiation protection (IRRP) or the IRRP's designee and the results of this determination will be recorded.

(9) The handler will not permit any individual to perform radiographic operations unless, at all times during radiographic operations, each such individual wears, on the trunk of the body, a personnel monitoring device that will be calibrated for the x-ray energies being utilized.

(a) Personnel dosimeters will be exchanged monthly unless the IRRP has performed an evaluation that indicates a longer frequency is adequate; in this instance the frequency will not exceed three months.

(b) If a personnel dosimeter is lost or damaged, the worker will cease work immediately until a replacement personnel dosimeter is provided and the exposure is calculated for the time period from issuance to loss or damage of the personnel dosimeter. This calculation will be made by the IRRP or the IRRP's designee. The results of the calculated exposure and the time period for which the personnel dosimeter was lost or damaged will be recorded.

(i) After replacement, each personnel dosimeter will be returned to the supplier for processing within fourteen calendar days of the end of the monitoring period; or

(ii) In circumstances that make it impossible to return each personnel dosimeter in fourteen calendar days, such circumstances will be recorded.

(10) During each radiographic operation, the radiographer, radiographer's assistant or operator will maintain surveillance of the operation to protect against unauthorized entry into a high radiation area, except:

(a) When the high radiation area is equipped with interlocks and signals as described in paragraph (A)(4) of this rule; or

(b) When the high radiation area is locked to protect against unauthorized or accidental entry.

(11) When performing radiographic operations at a location other than a permanent radiographic installation having the control devices specified in paragraph (B)(10) of this rule, the industrial radiographer will be responsible for:

(a) Posting signs bearing the radiation symbol and the words "CAUTION HIGH RADIATION AREA" at the perimeter of the calculated high radiation area;

(b) Restricting access by using appropriate barriers, such as rope or tape, and posting signs bearing the radiation symbol and the words "CAUTION RADIATION AREA" at the perimeter of the restricted area; and

(c) Maintaining constant visual surveillance of the restricted area boundary to prevent access by unauthorized personnel.

(C) In addition to the radiation protection obligations in rule 3701:1-68-02 of the Administrative Code, handlers of radiographic systems will comply with the following:

(1) Radiation survey instrumentation described in paragraph (B)(1) of this rule will be checked and the results recorded at the beginning of each work shift using check sources or other appropriate means to ensure it is operating accurately. If any check conducted reveals the radiation survey instrumentation is not operating accurately, the instrument will not be used to meet the survey obligations of paragraph (B)(2) of this rule.

(2) Radiographic systems will be checked and the results recorded prior to each shift of use to ensure all necessary labeling is present and identify any obvious defects. If any check conducted reveals damage to components critical to radiation safety, the device will be locked out and tagged "DO NOT USE" until repairs have been made.

(3) Entrance interlocks and signals described in paragraph (A)(4) of this rule, will be tested and the results recorded at the beginning of each day of equipment use to ensure proper operation. If an entrance interlock or signal is operating improperly, it will be immediately labeled as defective and repaired or replaced within seven calendar days. The facility may continue operations during this seven-day period, provided the handler implements the continuous surveillance obligations of this rule.

(4) The following documents and records will be available for inspection at each temporary job site:

(a) Appropriate certificate of registration;

(b) Operating and emergency procedures;

(c) Applicable rules promulgated pursuant to Chapter 3748. of the Revised Code;

(d) Surveys obligated pursuant to this rule and rule 3701:1-38-14 of the Administrative Code for the period of operation at the site;

(e) Daily dosimetry for the period of operation at the site;

(f) The latest calibration records for the specific survey instruments and direct reading dosimeters in use at the site. Acceptable records include tags or labels which are affixed to the survey instrument or dosimeter; and

(g) Radiation survey instrumentation checks and radiographic system checks for devices in use at the site.

(D) Handlers of radiographic systems used for bomb detection purposes:

(1) Will be exempt from paragraphs (B)(1) to (B)(3), (B)(6) to (B)(11), (C)(1) to (C)(3) and (C)(4)(d) to (C)(4)(g) of this rule.

(2) May change the interval for calibrating radiation survey instruments as specified in paragraph (B)(1)(b) of rule 3701:1-68-02 of the Administrative Code to annual; and

(3) Will evaluate radiographic systems and record the results of the evaluations, at least annually, to assure proper functioning of components important to safety unless the radiation-generating equipment has been locked out and tagged "DO NOT USE" and is under the administrative control of the IRRP.

(E) Handlers of hand-held radiographic systems will:

(1) Be exempt from paragraphs (B)(1) to (B)(3), (B)(6) to (B)(11), (C)(1) to (C)(3) and (C)(4)(d) to (C)(4)(g) of this rule.

(2) Evaluate the radiographic systems and record the results of the evaluation, at least annually, to assure proper functioning of components important to safety unless the radiation-generating equipment has been locked out and tagged "DO NOT USE" and is under the administrative control of the IRRP.

(3) Obligate the IRRP to document and implement safe operating procedures to include, but not be limited to:

(a) Using specific administrative controls to prevent unauthorized access or use of the system;

(b) Requiring the backscatter shield to be in place during all radiographic exposures, if the manufacturer of the hand-held radiation-generating equipment provides a backscatter shield; and

(c) Assuring that the system remains in direct control of the authorized operator and the operator will not aim the primary beam at him/herself or at any individual during exposure;

(d) Establishing and maintaining a restricted area of at least six feet opposite the side of the material being exposed;

(e) Banning individuals from holding material or the image receptor in their hand during exposure;

(f) Operating of software and trigger lock; and

(g) Requiring operators to wear assigned ring badges on the hand closest to the primary beam.

Last updated June 30, 2023 at 12:42 AM

History

• Effective: June 30, 2023
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-38-14

(A) Each licensee or registrant shall:

(1) Make, or cause to be made, surveys of areas, including the subsurface, that are:

(a) Necessary to comply with this chapter: and

(b) Reasonable under the circumstances to evaluate:

(i) Radiation levels;

(ii) Concentrations or quantities of residual radioactivity; and

(iii) The potential radiological hazards of the radiation levels and residual radioactivity detected.

(2) Notwithstanding paragraph (C) of rule 3701:1-38-20 of the Administrative Code, records from surveys describing the location and amount of subsurface residual radioactivity identified at the site must be kept with records important for decommissioning, and such records must be retained in accordance with paragraph (I) of rule 3701:1-40-17, paragraph (F) of rule 3701:1-44-18, and paragraph (D) of rule 3701:1-56-19 of the Administrative Code, as applicable.

(3) Ensure that instruments and equipment used for quantitative radiation measurements, such as dose rate and effluent monitoring, are calibrated annually for the radiation measured, except as otherwise specified in Chapter 3748. of the Revised Code, rules adopted thereunder, or a license condition.

(4) Ensure that all personnel dosimeters, except for direct and indirect reading dosimeters used to measure the dose to any extremity, that require processing to determine the radiation dose and that are used to comply with paragraph (A) of rule 3701:1-38-12 of the Administrative Code, with other applicable provisions of these regulations, or with conditions specified in a license or registration shall be processed and evaluated by a dosimetry processor that:

(a) Holds a current personnel dosimetry accreditation from the national voluntary laboratory accreditation program of the national institute of standards and technology; and

(b) Is approved in this accreditation process for the type of radiation or radiations included in the national voluntary laboratory accreditation program that most closely approximates the type of radiation or radiations for which the individual wearing the dosimeter is monitored; and

(5) Have procedures in place to minimize the likelihood of a deceptive exposure of an individual monitoring device, and in the event of a suspected deceptive exposure, an investigation should be conducted by the radiation safety officer for licensees or individual responsible for radiation protection for registrants which will lead to corrective action as necessary.

(B) Conditions requiring individual monitoring of external and internal occupational dose are as follows:

(1) Each licensee or registrant shall monitor exposures from sources of radiation at levels sufficient to demonstrate compliance with the occupational dose limits of rule 3701:1-38-12 of the Administrative Code. Each licensee or registrant shall monitor occupational exposure to radiation from sources of radiation under the control of the licensee or registrant and shall supply and require the use of individual monitoring devices by:

(a) Adults likely to receive, in one year from sources of radiation external to the body, a dose in excess of ten per cent of the limits in paragraph (A) of rule 3701:1-38-12 of the Administrative Code;

(b) Minors likely to receive, in one year, from radiation sources external to the body, a deep dose equivalent in excess of one millisievert (0.1 rem), a lens dose equivalent in excess of 1.5 millisievert (0.15 rem), or a shallow dose equivalent to the skin or to the extremities in excess of five millisievert (0.5 rem);

(c) Declared pregnant women likely to receive during the entire pregnancy, from radiation sources external to the body, a deep dose equivalent in excess of one millisievert (0.1 rem); and

(d) Individuals entering a high or very high radiation area.

(2) To determine compliance with paragraph (D) of rule 3701:1-38-12 of the Administrative Code, each licensee shall monitor the occupational intake of radioactive material by and assess the committed effective dose equivalent to:

(a) Adults likely to receive, in one year, an intake in excess of ten per cent of the applicable ALI in appendix C to rule 3701:1-38-12 of the Administrative Code;

(b) Minors likely to receive, in one year, a committed effective dose equivalent in excess of one millisievert (0.1 rem); and

(c) Declared pregnant women likely to receive, during the entire pregnancy, a committed effective dose equivalent in excess of one millisievert (0.1 rem).

(C) Each licensee or registrant shall ensure that any individual who is required to monitor occupational doses in accordance with paragraph (B)(1) of this rule wears an individual monitoring device as follows:

(1) An individual monitoring device, used for monitoring the dose to the whole body, shall be worn at the unshielded location of the whole body likely to receive the highest exposure. When a protective apron is worn, the location of the individual monitoring device is typically at the neck.

(2) An individual monitoring device, used for monitoring the dose to an embryo or fetus of a declared pregnant woman pursuant to paragraph (H) of rule 3701:1-38-12 of the Administrative Code, shall be located at the waist under any protective apron being worn by the woman.

(3) An individual monitoring device, used for monitoring the lens dose equivalent, to demonstrate compliance with paragraph (A) of rule 3701:1-38-12 of the Administrative Code, shall be located at the neck outside any protective apron being worn by the monitored individual, or at an unshielded location close to the eye.

(4) An individual monitoring device, used for monitoring the dose to the extremities, to demonstrate compliance with paragraph (A)(2) of rule 3701:1-38-12 of the Administrative Code, shall be worn on the extremity likely to receive the highest exposure. Each individual monitoring device shall be oriented to measure the highest dose to the extremity being monitored.

(5) When only one individual monitoring device is used to determine the effective dose equivalent for external radiation pursuant to paragraph (A)(4)(b) of rule 3701:1-38-12 of the Administrative Code, it shall be located at the neck outside the protective apron. When a second individual monitoring device is used for the same purpose, it shall be located under the protective apron at the waist. The second individual monitoring device is required for a declared pregnant woman.

Last updated November 2, 2022 at 2:10 PM

History

• Effective: August 30, 2015
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-38-23

(A) As used in this rule:

(1) "Basic component" means:

(a) A structure, system, or component, or part thereof that affects their safety function, that is directly procured by the licensee or registrant of facility or activity subject to the rules promulgated pursuant to Chapter 3748. of the Revised Code and in which a defect or failure to comply with any rule promulgated pursuant to Chapter 3748. of the Revised Code, order issued by the director, or license issued by the department could create a substantial safety hazard; and

(b) Safety-related design, analysis, inspection, testing, fabrication, replacement of parts, or consulting services that are associated with the component hardware whether these services are performed by the component supplier or others.

(2) "Commercial grade item" means an item that is:

(a) Not subject to design or specification requirements that are unique to those facilities or activities;

(b) Used in applications other than those facilities or activities; and

(c) To be ordered from the manufacturer or supplier on the basis of specifications set forth in the manufacturer's published product description, such as a catalog.

(3) "Constructing" or "construction" means the analysis, design, manufacture, fabrication, placement, erection, installation, modification, inspection, or testing of a facility or activity which is subject to this rule and consulting services related to the facility or activity that are safety related.

(4) "Dedication" means an item has been received and designated for use as a basic component.

(5) "Defect" means:

(a) A deviation in a basic component delivered to a purchaser for use in a facility or an activity subject to this rule, if, on the basis of an evaluation, the deviation could create a substantial safety hazard; or

(b) The installation, use, or operation of a basic component containing a defect as defined in this paragraph.

(6) "Deviation" means a departure form the manufacturer's specification's or technical specifications as part of a license or registration issued by the department for a given safety device or safety system associated with that device.

(7) "Discovery" means the completion of the documentation first identifying the existence of a deviation or failure to comply potentially associated with a substantial safety hazard within the evaluation procedures discussed in paragraph (G) of this rule.

(8) "Evaluation" means the process of determining whether a particular deviation could create a substantial hazard or determining whether a failure to comply is associated with a substantial safety hazard.

(9) "Failure to comply" means a failure to meet the requirements of any of the following that could create a substantial safety hazard:

(a) A rule promulgated pursuant to Chapter 3748. of the Revised Code;

(b) An order issued by the director; or

(c) License issued by the department.

(10) "Operating" or "operation" means the operation of a facility or the conduct of a licensed or registered activity which is subject to this rule and consulting services related to operations that are safety related.

(11) "Responsible officer" means:

(a) The president, vice-president or other individual in the organization of a corporation, partnership, or other entity who is vested with executive authority over activities subject to this rule, or

(b) An individual who is appointed or elected according to law, who is authorized to manage and direct the affairs of a corporation, partnership or other entity. In the case of an individual proprietorship, responsible officer means the individual.

(12) "Substantial safety hazard" means a loss of safety function to the extent that there is a major reduction in the degree of protection provided to either public health and safety or the environment, for any facility or activity licensed or registered pursuant to Chapter 3748. of the Revised Code.

(13) "Supplying" or "supplies" means contractually responsible for a basic component used or to be used in a facility or activity which is subject to this rule.

(B) This rule establishes procedures and requirements for implementation of section 3748.04 of the Revised Code, which applies to reporting of defects in equipment used for licensed or registered activities. Any responsible corporate officer of a firm constructing, owning, operating or supplying the components of any facility or activity which is licensed, registered, or otherwise regulated pursuant to Chapter 3748. of the Revised Code, obtaining information reasonably indicating either of the following, shall notify the director within twenty-four hours:

(1) That the facility, activity or basic component supplied to such facility or activity fails to comply with any applicable rule, regulation, order, registration, or license of the department relating to substantial safety hazards; or

(2) That the facility, activity, or basic component supplied to such facility or activity contains defects, which could create a substantial safety hazard.

(C) This rule applies, except as specifically provided otherwise in Chapter 3748. of the Revised Code, to each individual, partnership, corporation, or other entity licensed or registered pursuant to Chapter 3748. of the Revised Code to possess, use, or transfer within the state of Ohio source material, radioactive material, special nuclear material, or to construct, manufacture, possess, own, operate or transfer within the state of Ohio any radiation-generating equipment and to each responsible officer of such a licensee or registrant. This rule applies also to each individual, corporation, partnership or other entity doing business within the state of Ohio, that supplies basic components for a facility or activity licensed, under Chapter 3748. of the Revised Code.

(D) Nothing in this rule should be deemed to preclude either an individual, a manufacturer, or a supplier of a commercial grade item not subject to this rule from reporting to the director, a known or suspected defect or failure to comply and, as authorized by law, the identity of anyone so reporting will be withheld from disclosure. The department will accept collect telephone calls from individuals who wish to speak to department representatives concerning radiation safety-related problems.

(E) Each individual, partnership, corporation, dedicating entity, or other entity subject to this rule shall post current copies of this rule and procedures adopted pursuant to this rule. These documents must be posted in a conspicuous position on any premises within the state of Ohio where the activities subject to this rule are conducted. If posting of this rule or the procedures adopted pursuant to this rule is not practicable, the licensee, registrant, or firm subject to this rule may post a notice which describes the rules and procedures, including the name of the individual to whom reports may be made, and where the rules and procedures may be examined.

(F) The director may, upon application of any interested person or upon the director's own initiative, grant such exemptions from the requirements of this rule as the director determines to be authorized by law and will not endanger public health and safety or the environment, and are otherwise in the public interest. Suppliers of commercial grade items are exempt from the provisions of this rule to the extent that they supply commercial grade items.

(G) Each individual, corporation, partnership, dedicating entity, or other entity subject to this rule shall adopt appropriate procedures to:

(1) Initiate evaluations of deviations and failures to comply that are associated with substantial safety hazards as soon as practicable, but no later than ten days from the date of discovery of the deviation or failure to comply. The director shall be notified of any such deviation or failure to comply in accordance with paragraph (B) of this rule.

(2) Evaluate a reportable defect or failure to comply that could create a substantial safety hazard, were it to remain uncorrected, within thirty days of its discovery, except as provided by paragraph (G)(3) of this rule.

(3) Ensure that if an evaluation of an identified deviation or failure to comply potentially associated with a substantial safety hazard cannot be completed within thirty days from discovery of the deviation or failure to comply, an interim report is prepared and submitted to the director through a responsible corporate officer. The interim report should describe the deviation or failure to comply that is being evaluated and should also state when the evaluation will be completed. This interim report must be submitted in writing within thirty days of discovery of the deviation or failure to comply; and

(4) Ensure that a responsible corporate officer subject to this rule is informed as soon as practicable, and, in all cases, within five working days after completion of the evaluation described in this paragraph if the construction or operation of a facility or activity, or a basic component supplied for such facility or activity either fails to comply with any applicable rule, regulation, order, or license or registration of the department relating to a substantial safety hazard, or contains a defect.

(H) If the deviation or failure to comply is discovered by a supplier of basic components, or services associated with basic components, and the supplier determines that it does not have the capability to perform the evaluation to determine if a defect exists, then the supplier must inform the purchasers or affected licensees or registrants within five working days of this determination so that the purchasers or affected licensees or registrants may evaluate the deviation or failure to comply, pursuant to paragraph (G) of this rule. Nothing in this rule shall be deemed to require manufacturers or suppliers to adopt or maintain procedures for defect identification and evaluation, where the item or service is not dedicated for purposes of licensed or registered activities or equipment. Instead, such is the responsibility of the registrant or licensee, in accordance with paragraph (B) of this rule.

(I) A responsible corporate officer subject to this rule must notify the director within thirty days when he or she obtains information reasonably indicating a failure to comply or a defect affecting:

(1) The construction or operation of a facility or any activity within the state of Ohio that is subject to the licensing or registration requirements under Chapter 3748. of the Revised Code and that is within the facility's responsibility; or

(2) A basic component that is within the facility's responsibility and is supplied for a facility or an activity within the state of Ohio that is subject to the licensing requirements of Chapter 3748. of the Revised Code.

(J) The notification required by paragraphs (B) and (I) of this rule shall include the following information, to the extent known:

(1) Name and address of the individual or individuals informing the director.

(2) Identification of the facility, the activity, or the basic component supplied for such facility or such activity within the state of Ohio which fails to comply or contains a defect.

(3) Identification of the firm constructing the facility or supplying the basic component which fails to comply or contains a defect.

(4) Nature of the defect or failure to comply and the safety hazard which is created or could be created by such defect or failure to comply.

(5) The date on which the information of such defect or failure to comply was obtained.

(6) In the case of a basic component which contains a defect or fails to comply, the number and location of all such components in use at, supplied for, or being supplied for one or more facilities or activities subject to this rule.

(7) The corrective action which has been, is being, or will be taken; the name of the individual or organization responsible for the action; and the length of time that has been or will be taken to complete the action.

(8) Any advice related to the defect or failure to comply about the facility, activity, or basic component that has been, is being, or will be given to purchasers or licensees.

(K) The responsible corporate officer may authorize an individual to provide the notification required by paragraph (J) of this rule, provided that, this shall not relieve the responsible corporate officer of his or her responsibility under this paragraph. Individuals subject to this rule may be required by the director to supply additional information related to a defect or failure to comply. Department action to obtain additional information may be based on reports of defects from other reporting entities.

(L) Each individual, corporation, partnership, or other entity subject to this rule shall prepare and maintain records necessary to accomplish the requirements of this rule, including retaining evaluations of all deviations and failures to comply for a minimum of five years after the date of the evaluation. Each individual, corporation, partnership, dedicating entity, or other entity subject to this rule shall permit the department the opportunity to inspect records pertaining to basic components that relate to the identification and evaluation of deviations, and the reporting of defects and failures to comply, including any advice given to purchasers or licensees on the placement, erection, installation, operation, maintenance, modification, or inspection of a basic component.

(M) Suppliers of basic components must retain any notifications sent to purchasers and affected licenses for a minimum of five years after the date of the notification. Suppliers of basic components must retain a record of the purchasers of basic components for ten years after delivery of the basic component or service associated with a basic component.

Last updated November 2, 2022 at 2:11 PM

History

• Effective: September 1, 2011
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-68-04 Non-medical analytical systems.

In addition to the applicable rules in this chapter and Chapter 3701:1-38 of the Administrative Code, handlers of analytical systems will comply with the following:

(A) Analytical systems will meet the following equipment standards:

(1) Open-beam analytical systems will;

(a) Provide an automatic shut-off feature that prevents any part of a person's body from being exposed to the primary x-ray beam path; or

(b) Request a variance from the director to include:

(i) The reason a device or an automatic shut-off feature cannot be used; and

(ii) A description of the alternative methods that will be employed to minimize the possibility of an accidental exposure, including procedures to assure that the operators and others in the area will be informed of the absence of safety devices.

(2) Analytical system installed after February 10, 2006, will be provided with a readily visible warning light labeled with the words "X-RAY ON" or symbols having a similar intent, and be located near the x-ray source and its controls and be illuminated when the x-ray source is energized. In addition, open-beam analytical system will be provided with a readily discernible indication of:

(a) X-ray source power "on-off" status located near the x-ray source housing, if the primary beam is controlled in this manner; or

(b) Shutter "open-closed" status located near each collimator on the x-ray source housing, if the primary beam is controlled in this manner.

(3) Except for gauging units, open-beam analytical systems installed after February 10, 2006, will have warning devices, or a system of warning devices, such as lights with fail-safe characteristics.

(4) All analytical systems will conspicuously display a clearly legible label or labels bearing the radiation symbol and the words "CAUTION - THIS EQUIPMENT PRODUCES RADIATION WHEN ENERGIZED" or appropriate words having a similar intent, near any switch or control that directly energizes the unit. Open-beam analytical systems will have an additional warning label on or near the x-ray housing with the radiation symbol with the words "CAUTION - HIGH INTENSITY X-RAY BEAM" or appropriate words having a similar intent.

(5) Each x-ray source housing installed on or after August 1, 2011 will be equipped with an interlock that shuts off the radiation beamwhen the housing is opened. For each x-ray source housing installed prior to August 1, 2011 and not equipped with an interlock, administrative controls will be instituted to include that the power will be disconnected before any disassembly.

(6) Unused beam ports on x-ray source housings will be secured in the closed position, or mechanically blocked.

(7) All analytical systems other than open-beam analytical systems will be supplied with a protective cabinet which limits leakage radiation measured at a distance of five centimeters from any external surface such that it is not capable of producing a dose in excess of 2.5 microsievert (0.25 millirem) in one hour.

(B) Handlers of analytical systems will comply with the following radiation safety obligations:

(1) The facility's individual responsible for radiation protection (IRRP) will document and implement operating procedures relative to radiation safety. The IRRP will be qualified in accordance with paragraph (H) of rule 3701:1-68-02 of the Administrative Code. The IRRP will assure and document that all operators of analytical systems have received appropriate training. No individual will be permitted to operate analytical systems in any manner other than that specified in the procedures unless such individual has obtained written approval of the IRRP.

(2) Any temporary alteration to safety devices, such as by-passing interlocks or removing shielding will be recorded. This record will:

(a) Contain such information as date the alteration was made, type of alteration, length of time alteration remained in place, and signature of the individual who made the alteration and the individual who restored the safety device to the original condition; and

(b) Be approved, and signed in advance for a specified period of time by the individual responsible for radiation protection, and posted near the x-ray source housing with the signatures of approval.

(3) Except as specified in paragraph (B)(2) of this rule, no operation involving removal of covers, shielding materials or x-ray source housings or modifications to shutters, collimators, or beam stops will be performed without ascertaining that the x-ray source is off and will remain off until safe conditions have been restored. The x-ray source power switch, in conjunction with appropriate interlocks, will be used for routine shutdown in preparation for repairs.

(C) In addition to the radiation protection obligations in rule 3701:1-68-02 of the Administrative Code, handlers of analytical systems will comply with the following:

(1) The local components of an analytical system will be located, arranged, and include sufficient shielding or access control such that no radiation levels exist in any area surrounding the local component group which could result in a dose to an individual present therein in excess of the dose limits given in Chapter 3701:1-38 of the Administrative Code. These levels will be met at any specified radiation source rating.

(2) Radiation area surveys of all analytical systems will be performed and the results recorded to confirm compliance with paragraph (A) of rule 3701:1-38-14 the Administrative Code:

(a) Upon installation;

(b) Following any change in the initial arrangement, number, or type of local components in the system;

(c) Following any maintenance requiring the disassembly or removal of a local component in the system;

(d) During the performance of maintenance and alignment procedures if the procedures obligate the presence of a primary beam when any local component in the system is disassembled or removed;

(e) Any time a visual inspection of the local components in the system reveals an abnormal condition; and

(f) Whenever personnel monitoring reports show an unexplained increase over the previous monitoring period or the readings are approaching the limits specified in rules adopted pursuant to Chapter 3701:1-38 of the Administrative Code.

(3) Analytical systems will be evaluated and the results recorded at least every six months by individuals qualified according to paragraph (H) of rule 3701:1-68-02 of the Administrative Code, unless the system has been locked out and tagged "DO NOT USE."

(a) The evaluation will verify:

(i) Proper functioning of each interlock and warning light; and

(ii) Each tag and label is legible and properly affixed in the appropriate location.

(b) If an interlock or light is not functioning properly, it will be immediately labeled as defective and repaired or replaced within seven calendar days.

(4) Finger or wrist radiation monitoring devices will be provided to and will be used by:

(a) Operators of open-beam analytical systems without provisions for engineering controls as provided in paragraph (A)(1) of this rule; and

(b) Personnel maintaining analytical systems if the maintenance procedures include the presence of an external radiation beam when any local component in the analytical system is disassembled or removed.

(D) Handlers of gauging units will be exempt from the obligations of paragraphs (C)(2)(c) to (C)(2)(e) of this rule.

(E) Handlers of hand-held analytical systems will:

(1) Be exempt from the obligations of paragraphs (A)(1) and (A)(3) of this rule;

(2) Obligate the IRRP to document and implement safe operating procedures to include, but not be limited to:

(a) Using specific administrative controls to prevent unauthorized access or use of the system;

(b) Assuring that the system remains in direct control of the authorized operator;

(c) Banning individuals from holding a sample in their hand during irradiation;

(d) Operating of software, trigger locks and proximity sensors;

(e) Using analyzer stands when the sample fits or when the part does not completely cover the beam port;

(f) Taking precautions during irradiation to prevent exposure of the operator or other individuals;

(g) Establishing and maintaining a restricted area of at least three feet opposite the side of the sample being exposed;

(h) Having alternative engineering and administrative safety controls that effectively prevent personnel exposure to the primary beam; and

(i) Requiring operators to wear assigned ring badges on the hand closest to the primary beam.

Last updated June 30, 2023 at 12:42 AM

History

• Effective: June 30, 2023
• Promulgated Under: 119.03

Ohio Adm.Code 3701:1-68-05 Non-medical particle accelerator systems.

In addition to the applicable rules in this chapter and Chapter 3701:1-38 of the Administrative Code, handlers of particle accelerator systems will comply with the following :

(A) Radiation-generating equipment used for particle acceleration will meet the following equipment standards:

(1) All safety instrumentation, readouts, and controls on the particle accelerator control console will be clearly identified and easily discernible.

(2) Each safety interlock will be on a circuit which allows it to operate independently of all other safety interlocks.

(3) All safety systems or interlocks will be designed so that any defect or component failure in the safety interlock system prevents production of radiation by the accelerator.

(4) If a safety interlock system has been tripped, it will only be possible to resume operation of the particle accelerator by manually resetting controls at the position where the safety interlock has been tripped, and at the control console.

(5) Each particle accelerator will bear a warning label on the control console which cautions individuals that radiation is produced when it is energized, and any other warning label obligated by rules adopted pursuant to Chapter 3701:1-38 of the Administrative Code.

(B) Handlers of particle accelerator systems will comply with the following radiation safety obligations:

(1) Each particle accelerator installation will be provided with such shielding as is necessary to assure compliance with the applicable rules adopted pursuant to Chapter 3701:1-38 of the Administrative Code.

(2) Each entrance into a target room or other high radiation area will be provided with a safety interlock that shuts down the machine in the event of any barrier penetration.

(3) Each high radiation area will have an audible and visual signal which will be activated for at least fifteen seconds prior to the possible creation of such a high radiation area. Such signals will be clearly discernible in all high radiation areas.

(4) Each location designated as a high radiation area, and each entrance to such location, will be equipped with visible signals that illuminate when, and only when the high-voltage portion of the machine is being energized.

(5) An emergency power cutoff switch will be located and easily identifiable in all high radiation areas and will include a manual reset so that the accelerator cannot be restarted from the accelerator control panel without resetting the cutoff switch.

(6) Appropriate portable monitoring equipment, which is operable and has been appropriately calibrated for the types of radiation being produced, will be available at each particle accelerator facility. Such equipment will be calibrated at intervals not to exceed one year and after each servicing and repair.

(7) The handler will not permit any individual to operate a particle accelerator system unless, at all times during operations, each operator is supplied with and wears an appropriate direct reading dosimeter and personnel dosimeter. Analog pocket dosimeters will be recharged at the start of each shift. Electronic dosimeters will be battery-tested at the beginning of each shift. Each personnel dosimeter will be assigned to and worn by only one individual and the handler will assure that:

(a) Direct reading dosimeters are read and exposures are recorded at the beginning and end of each shift.

(b) If an individual's pocket dosimeter is found to be off-scale, or the electronic personnel dosimeter reads greater than two millisieverts (two hundred mrem), the individual's personnel dosimeter will be sent for processing within twenty-four hours. In addition, the individual will not resume work associated with the use of a particle accelerator system until a determination of the individual's radiation exposure has been made. This determination will be made by the individual responsible for radiation protection (IRRP) or the IRRP's designee. The results of this determination will be recorded.

(c) Personnel dosimeters will be exchanged monthly unless the IRRP has performed an evaluation that indicates a longer frequency is adequate; in this instance the frequency will not exceed three months.

(d) If a personnel dosimeter is lost or damaged, the worker will cease work immediately until a replacement personnel dosimeter is provided and the exposure is calculated for the time period from issuance to loss or damage of the personnel dosimeter. This calculation will be made by the IRRP or the IRRP's designee. The results of the calculated exposure and the time period for which the personnel dosimeter was lost or damaged will be recorded:

(i) After replacement, each personnel dosimeter will be returned to the supplier for processing within fourteen calendar days of the end of the monitoring period; or

(ii) In circumstances that make it impossible to return each personnel dosimeter in fourteen calendar days, such circumstances will be recorded.

(8) The safety interlock system will not be used to turn off the particle accelerator beam, except in an emergency or when testing of the safety interlock system.

(9) If, for any reason, it is necessary to intentionally bypass a safety interlock or interlocks, such action will be:

(a) Authorized by the IRRP;

(b) Recorded in a permanent log;

(c) Posted as a written notice at the accelerator control panel; and

(d) Terminated as soon as possible.

(10) The particle accelerator will be secured when not in operation to prevent unauthorized use.

(C) In addition to the radiation protection obligations in rule 3701:1-68-02 of the Administrative Code, handlers of particle accelerator systems will comply with the following:

(1) A radiation expert, with education and experience acceptable to the director, will be consulted in the design of a particle accelerator installation and called upon to perform a radiation survey when the accelerator is first capable of producing radiation.

(2) A radiation shielding survey will be performed and recorded by aradiation expert, with education and experience acceptable to the director, when changes have been made in shielding, operation, equipment, or occupancy of adjacent areas.

(3) All surveys will be made in accordance with the written procedures established by a radiation expert, with education and experience acceptable to the director.

(4) Portable monitoring equipment will be tested for proper operation and the results recorded daily.

(5) Particle accelerator systems will be evaluated and the results recorded at least every three months not to exceed fourteen weeks, by individuals qualified according to paragraph (I) of rule 3701:1-68-02 of the Administrative Code, unless the system has been locked out and tagged "DO NOT USE" and is under administrative control of the IRRP:

(a) The evaluation will verify:

(i) Proper functioning of interlocks and warning devices; and

(ii) Each label is legible and properly affixed in the appropriate location.

(b) In the event the safety equipment is operating improperly, it will be immediately reported to the IRRP and will be repaired or replaced and never bypassed so as to enable radiation production.

(6) Radiation levels in all high radiation areas will be continuously monitored. The monitoring devices will be electrically independent of the accelerator control and safety interlock systems and capable of providing a readout at the control panel.

(7) A copy of the current operating and the emergency procedures will be maintained at the particle accelerator system control panel.

(D) The IRRP will be qualified in accordance with paragraph (I) of rule 3701:1-68-02 of the Administrative Code. In addition to the obligations of paragraph (F) of rule 3701:1-68-02 of the Administrative Code, the specific duties and authority of the IRRP for particle accelerator systems include, but are not limited to:

(1) Termination of the operations if such action is deemed necessary to minimize danger to public health and safety.

(2) The development and maintenance of a particle accelerator handbook that describes the electrical circuits and the associated interlock systems. This handbook will be kept current as to any changes in the system.

(3) Documenting that individuals have demonstrated competency in the use of the particle accelerator, related equipment, and radiation survey instruments that will be used to monitor the particle accelerator at that facility.

Last updated June 30, 2023 at 12:42 AM

History

• Effective: June 30, 2023
• Promulgated Under: 119.03