title-180•Neb. Admin. Code tit. 180 — Control of Radiation
Neb. Admin. Code tit. 180 — Control of Radiation
title-180Neb. Admin. Code tit. 180Regulation
Chapter 1 General Provisions
Neb. Admin. Code tit. 180, ch. 1 General Provisions {#sec-180-nac-1 omnilex-key=us-ne-regs-official--title-180--180 NAC 1}
TITLE 180 CONTROL OF RADIATION
CHAPTER 1 GENERAL PROVISIONS
Effective Date: 6/15/2021
001. SCOPE AND AUTHORITY . Title 180 applies to all persons who receive, possess, use, transfer, own, or acquire: any radiation generating equipment and; any naturally occurring or accelerator produced radioactive material, including special nuclear material in quantities not sufficient to form a critical mass. The regulations are authorized by and implement the Radiation Control Act, Nebraska Revised Statute (Neb. Rev. Stat.) §§ 71-3501 to 71-3520. 10 Code of Federal Regulations (CFR), as published on January 1, 2013; 40 CFR as published on July 1, 2013 and 49 CFR as published on October 1, 2013 and referred throughout this Title are incorporated by reference and available for viewing at the Nebraska Department of Health and Human Services, Radiological Health, 301 Centennial Mall South, 3rd Floor, Lincoln, Nebraska 68509 or from the U.S. Government Printing Office Bookstore, 710 North Capitol Street NW, Washington D.C., 20401.
002. DEFINITIONS . The definitions in the Radiation Control Act and the following definitions apply to all chapters within Title 180 of the Nebraska Administrative Code (NAC).
002.01 A1. The term A1 is the maximum activity of special form radioactive material permitted in a Type A package. This value is either listed in Appendix A of 180 NAC 13, Table A-1, or may be derived as specified in Appendix A of 180 Nebraska Administrative Code (NAC) 013.
002.02 A2. The term A2 is the maximum activity of radioactive material, other than special form, Low Specific Activity (LSA) and Surface Contaminated Object (SCO) material, permitted in a Type A package. These values are either listed in Appendix A of 180 NAC 13, Table A-1, or may be derived as prescribed in Appendix A of 180 NAC 013.
002.03 ABSORBED DOSE (D). The energy imparted by ionizing radiation to matter is described by the term absorbed dose. 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 International System of Units (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.
002.04 ACCELERATOR. An accelerator is 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 1 megaelectron volt. Particle accelerator is an equivalent term.
002.05 ACCELERATOR PRODUCED MATERIAL. Accelerator produced material is any material made radioactive by a particle accelerator.
002.06 ACTIVITY. Activity is the rate of disintegration or transformation or decay of radioactive material. The units of activity are the becquerel (Bq) and the curie (Ci).
002.07 ADULT. An adult is an individual 18 or more years of age.
002.08 AGREEMENT STATE. An agreement state is any state with which the United States Nuclear Regulatory Commission (NRC) or the United States Atomic Energy Commission has entered into an effective agreement under subsection 274b. of the Atomic Energy Act of 1954, as amended (73 Stat. 689). Non-agreement State is any other State.
002.09 AIRBORNE RADIOACTIVE MATERIAL. Airborne radioactive material is any radioactive material dispersed in the air in the form of dusts, fumes, particulates, mists, vapors, or gases.
002.10 AIRBORNE RADIOACTIVITY AREA. Airborne radioactivity area is a room, enclosure, or area in which airborne radioactive materials exist in concentrations:
(A) In excess of the derived air concentrations (DACs) specified in Appendix B, Table I of 180 NAC 4, 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% of the annual limit on intake (ALI) or 12 DAC-hours.
002.11 AS LOW AS REASONABLY ACHIEVABLE (ALARA). As low as reasonably achievable or ALARA is making every reasonable effort to maintain exposures to radiation as far below the dose limits in Title 180 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 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 or registered sources of radiation in the public interest.
002.12 BACKGROUND RADIATION. Background radiation is radiation from cosmic sources; naturally occurring radioactive materials, including radon, except as a decay product of source or special nuclear material; and including 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 sources of radiation from radioactive materials regulated by the Department.
002.13 BECQUEREL (Bq). Becquerel is the International System of Units (SI) unit of activity. One becquerel is equal to 1 disintegration or transformation per second (dps or tps).
002.14 BIOASSAY. A bioassay is 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. For purposes of 180 NAC, radiobioassay is an equivalent term.
002.15 BRACHYTHERAPY. Brachytherapy is a method of radiation therapy in which sealed sources are utilized to deliver a radiation dose at a distance of up to a few centimeters, by surface, intracavitary, or interstitial application.
002.16 BYPRODUCT MATERIAL. Byproduct material is:
(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 material; and (B) The tailings or wastes produced by the extraction or concentration of uranium or thorium from ore processed primarily for its source material content, including discrete surface wastes resulting from uranium or thorium solution extraction processes. Underground ore bodies depleted by solution extraction operations do not constitute byproduct material. (C) Any:
(i) Discrete source of radium-226 that is produced, extracted, or converted after extraction for use for a commercial, medical, or research activity; or (ii) Material that has been made radioactive by use of a particle accelerator; and is produced, extracted, or converted after extraction for use for a commercial, medical, or research activity; and
(D) Any discrete source of naturally occurring radioactive material, other than source material, that:
(i) The United State Nuclear Regulatory Commission, in consultation with the Administrator of the United States Environmental Protection Agency, the United States Secretary of Energy, the Secretary of Homeland Security, and the head of any other appropriate federal agency, determines would pose a threat similar to the threat posed by a discrete source of radium-226 to the public health and safety or the common defense and security; and (ii) Is extracted or converted after extraction for use in a commercial, medical, or research activity.
002.17 CALENDAR QUARTER. A calendar quarter is not less than 12 consecutive weeks nor more than 14 consecutive weeks. The first calendar quarter of each year will begin in January and subsequent calendar quarters will be arranged so that no day is included in more than one calendar quarter and no day in any one year is omitted from inclusion within a calendar quarter. No licensee or registrant may change their method for determining calendar quarters except at the beginning of a year.
002.18 CALIBRATION. Calibration is the determination of:
(A) The response or reading of an instrument relative to a series of known radiation values over the range of the instrument, or (B) The strength of a source of radiation relative to a standard.
002.19 CARRIER. A carrier is 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.
002.20 CHELATING AGENT. A substance containing amine polycarboxylic acids, hydroxycarboxylic acids, gluconic acid, and polycarboxylic acids is a chelating agent.
002.21 COLLECTIVE DOSE. 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 is collective dose.
002.22 COMMITTED DOSE EQUIVALENT (CDE) (HT,50). A committed dose equivalent or CDE is 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 50-year period following the intake.
002.23 COMMITTED EFFECTIVE DOSE EQUIVALENT (CEDE) (HE, 50). A committed effective dose equivalent or CEDE is the sum of the products of the weighting factors applicable to each of the body organs or tissues that are irradiated and the committed dose equivalent to each of these organs or tissues (HE,50 = Σ wT,HT,50).
002.24 CONSTRAINT (DOSE CONSTRAINT). A value above which specified licensee actions are required is a constraint or dose constraint.
002.25 CRITICAL GROUP. A critical group is the group of individuals reasonably expected to receive the greatest exposure to residual radioactivity for any applicable set of circumstances.
002.26 CURIE. That amount of radioactive material which disintegrates at the rate of 37 billion atoms per second is a curie. One curie = 3.7E+10 disintegrations or transformations per second (dps or tps) = 3.7E+10 becquerel (Bq) = 2.22E+12 disintegrations or transformations per minute (dpm or pm).
002.27 DECOMMISSION. To decommission is to remove a facility or site safely from service and reduce residual radioactivity to a level that permits release of the property for unrestricted use or release of the property under restricted conditions and termination of the license.
002.28 DECOMMISSIONING. Final operational activities at a facility to dismantle site structures, to decontaminate site surfaces and remaining structures, to stabilize and contain residual radioactive material, and to carry out any other activities to prepare the site for post-operational care is decommissioning.
002.29 DEEP DOSE EQUIVALENT (DDE) (Hd). Deep dose equivalent is the dose equivalent at a tissue depth of 1 centimeter (1000 mg/cm2) that applies to external whole body exposure.
002.30 DEPLETED URANIUM. Depleted uranium is the source material uranium in which the isotope uranium-235 is less than 0.711 weight percent of the total uranium present. Depleted uranium does not include special nuclear material.
002.31 DISTINGUISHABLE FROM BACKGROUND. The detectable concentration of a radionuclide that is statistically different from the background concentration of a radionuclide in the vicinity of the site or, in the case of structures, in similar materials using adequate measurement technology, survey, and statistical techniques means it is distinguishable from background.
002.32 DISCRETE SOURCE. A discrete source is 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.
002.33 DOSE. Dose is a generic term that means absorbed dose, dose equivalent, effective dose equivalent, committed dose equivalent, committed effective dose equivalent, total organ dose equivalent, or total effective dose equivalent. For purposes of Title 180, radiation dose is an equivalent term.
002.34 DOSE EQUIVALENT (Ht). Dose equivalent is 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 (Sv) and rem.
002.35 DOSE LIMITS. Dose limits are the permissible upper bounds of radiation doses established according to this Title. For purposes of Title 180, limits is an equivalent term.
002.36 EFFECTIVE DOSE EQUIVALENT (EDE) (HE). The sum of the products of the dose equivalent to each organ or tissue (HT) and the weighting factor (wT) applicable to each of the body organs or tissues that are irradiated (HE = Σ wTHT) is the effective dose equivalent.
002.37 EMBRYO OR FETUS. An embryo or fetus is the developing human organism from conception until the time of birth.
002.38 ENTRANCE OR ACCESS POINT. An entrance or access point is any opening through which an individual or extremity of an individual could gain access to radiation areas or to licensed or registered radioactive materials. This includes entry or exit portals of sufficient size to permit human entry, irrespective of their intended use.
002.39 EXPLOSIVE MATERIAL. Explosive material is any chemical compound, mixture, or device which produces a substantial instantaneous release of gas and heat spontaneously or by contact with sparks or flame.
002.40 EXPONENT (E). An exponent indicates that the number 10 is to be raised to a given power. This power is indicated to the right of the symbol E. For example: 3E+4 symbolizes 3 x 10 4 and 3E-4 symbolizes 3 x 10-4.
002.41 EXPOSURE. The act of being exposed to ionizing radiation or to radioactive material is exposure.
002.42 EXPOSURE. Exposure is the quotient of dQ by dm where "dQ" is the absolute value of the total charge of the ions of one sign produced in air when all the electrons (negatrons and positrons) liberated by photons in a volume element of air having mass "dm" are completely stopped in air. The SI unit of exposure is the coulomb per kilogram (C/kg). See subsection 014.01 Units of Exposure and Dose for the special unit. When not underlined or indicated as “exposure” (X) this term has its general meaning.
002.43 EXPOSURE RATE. Exposure rate is the exposure per unit of time, such as roentgen per minute (R/min) or milliroentgen per hour (mR/h).
002.44 EXTERNAL DOSE. An external dose is that portion of the dose equivalent received from any source of radiation outside the body.
002.45 EXTREMITY. The parts of the body including the hand, elbow, arm below the elbow, foot, knee, and leg below the knee is an extremity.
002.46 FORMER UNITED STATES ATOMIC ENERGY COMMISSION (AEC) OR UNITED STATES NUCLEAR REGULATORY COMMISSION (NRC) LICENSED FACILITIES. Nuclear reactors, nuclear fuel reprocessing plants, uranium enrichment plants, or critical mass experimental facilities where Atomic Energy Commission (AEC) or Nuclear Regulatory Commission (NRC) licenses have been terminated are former United States Atomic Energy commission or United States Nuclear Regulatory Commission licensed facilities.
002.47 GENERALLY APPLICABLE ENVIRONMENTAL RADIATION STANDARDS. Standards issued by the United States Environmental Protection Agency (EPA) under the authority of the Atomic Energy Act of 1954, as amended, 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 are generally applicable environmental radiation standards.
002.48 GRAY (Gy). Gray or Gy is the International System of Units (SI) unit of absorbed dose, kerma, and specific energy imparted equal to 1 joule per kilogram. The previous unit of absorbed dose (rad) is being replaced by the gray [1 Gy=100 rad].
002.49 HAZARDOUS WASTE. Those wastes designated as hazardous in 40 CFR Chapter I, Part 261, Subpart A, § 261.2 - 261.4 and Subpart D are hazardous waste.
002.50 HEALING ARTS. Healing arts are diagnostic or healing treatment, or both, of human and animal maladies including but not limited to the following which are duly licensed by the state of Nebraska for the lawful practice of: medicine and its associated specialties, dentistry, veterinary medicine, osteopathy, chiropractic, and podiatry.
002.51 HIGH-LEVEL RADIOACTIVE WASTE. High-level radioactive waste is:
(A) Irradiated reactor fuel; (B) Liquid wastes resulting from the operation of the first cycle solvent extraction system or equivalent and the concentrated wastes from subsequent extraction cycles or the equivalent in a facility for reprocessing irradiated reactor fuel; (C) Solids into which such liquid wastes have been converted; and (D) Other highly radioactive waste material as defined by the U.S. Nuclear Regulatory Commission.
002.52 HIGH RADIATION AREA. 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 1 milliseivert (0.1 rem) in 1 hour at 30 centimeters from the radiation source or 30 centimeters from any surface that the radiation penetrates is a high radiation area.
002.53 HUMAN USE. Human use is the internal or external administration of radiation or radioactive material to human beings.
002.54 INDIAN TRIBE. An Indian tribe is 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, 25 United States Code (U.S.C.) 479a.
002.55 INDIVIDUAL. An individual is any human being.
002.56 INDIVIDUAL MONITORING. Individual monitoring is the assessment of:
(A) Dose equivalent by the use of:
(i) Individual monitoring devices or (ii) Survey data; or
(B) Committed effective dose equivalent by:
(i) Bioassay or (ii) Determination of the time-weighted air concentrations to which an individual has been exposed, that is, DAC-hours. See the definition of DAC-hours in 180 NAC 4.
002.57 INDIVIDUAL MONITORING DEVICES (INDIVIDUAL MONITORING EQUIPMENT). Devices designed to be worn by a single individual for the assessment of dose equivalent such as film badges, thermoluminescence dosimeters (TLD’s), pocket ionization chambers, and personal (“lapel”) air sampling devices are individual monitoring devices. For the purposes of Title 180, personnel dosimeter and dosimeter are equivalent terms.
002.58 INSPECTION. An inspection is an official examination or observation including, but not limited to, tests, surveys, and monitoring to determine compliance with rules, regulations, orders, requirements, and conditions of the Department. The licensee or registrant is notified of any items of noncompliance or recommendations, or both, of the Department.
002.59 INTERLOCK. An interlock is a device arranged or connected such that the occurrence of an event or condition is required before a second event or condition can occur or continue to occur.
002.60 INTERNAL DOSE. An internal dose is that portion of the dose equivalent received from radioactive material taken into the body.
002.61 LENS DOSE EQUIVALENT (LDE). The lens dose equivalent is the dose equivalent from external exposure to the lens of eye taken at a tissue depth of 0.3 centimeter (300 mg/cm2).
002.62 LICENSE. A license is a credential issued by the Department according to the regulations adopted by the Department under 180 NAC.
002.63 LICENSED MATERIAL. Radioactive material received, possessed, used, transferred or disposed of under a general or specific license issued by the Department is licensed material.
002.64 LICENSEE. A licensee is any person who is licensed by the Department according to Title 180 and the Act.
002.65 LIMITS. See Dose Limits.
002.66 LOST OR MISSING SOURCE OF RADIATION. Source of radiation whose location is unknown is a lost or missing source of radiation. This definition includes licensed material that has been shipped but has not reached its planned destination and whose location cannot be readily traced in the transportation system.
002.67 LOW-LEVEL RADIOACTIVE WASTE. Any radioactive waste not defined as high-level radioactive waste, spent nuclear fuel, or byproduct material is low-level radioactive waste.
002.68 MAJOR PROCESSOR. A major processor is a user processing, handling, or manufacturing radioactive material exceeding Type A quantities as unsealed sources or material, or exceeding 4 times Type B quantities as sealed sources, but does not include nuclear medicine programs, universities, industrial radiographers, or small industrial programs. Type A and B quantities are defined in 180 NAC 13-002, and in 10 CFR Chapter I, Part 71, Subpart A, § 71.4.
002.69 MANAGEMENT FACILITY. The land, buildings, and equipment which is intended to be used for the management of radioactive wastes is a management facility.
002.70 MANAGEMENT OF LOW-LEVEL RADIOACTIVE WASTE. The handling, processing, storage, reduction in volume, disposal, or isolation of such waste from the biosphere in any manner is the management of low-level radioactive waste.
002.71 MEMBER OF THE PUBLIC. Any individual except when that individual is receiving an occupational dose is a member of the public.
002.72 MINOR. An individual less than 18 years of age is a minor.
002.73 MIXED WASTE. Low-level radioactive waste that also contains hazardous waste that is identified in Title 128, Nebraska Administrative Code is mixed waste.
002.74 MONITORING. Monitoring is the measurement of radiation, radioactive material concentrations, surface area activities or quantities of radioactive material and the use of the results of these measurements to evaluate potential exposures and doses. For the purposes of Title 180 radiation monitoring and radiation protection monitoring are equivalent terms.
002.75 NATURALLY OCCURING OR ACCELERATOR PRODUCED RADIOACTIVE MATERIAL (NARM). Naturally occurring or accelerator produced radioactive material is any radioactive material that occurs naturally or is produced in an accelerator. It does not include byproduct, source, or special nuclear material.
002.76 NATIONALLY TRACKED SOURCE. A nationally tracked source is a sealed source containing a quantity equal to or greater than Category 1 or Category 2 levels of any radioactive material listed in Appendix H of 180 NAC 4. 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. 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.
002.77 NATURAL RADIOACTIVITY. Natural Radioactivity is radioactivity of naturally occurring nuclides.
002.78 NUCLEAR REGULATORY COMMISSION. The Nuclear Regulatory Commission is the United States Nuclear Regulatory Commission or its duly authorized representatives.
002.79 OCCUPATIONAL DOSE. An occupational dose is the dose received by an individual in the course of employment in which the individual's assigned duties involve exposure to sources of radiation from licensed/registered or unlicensed/unregistered sources of radiation, whether in the possession of the licensee, registrant, or other person. Occupational dose does not include doses received from background radiation, from any medical administration the individual has received, from exposure to individuals administered radioactive material and released in according to 180 NAC 7-037, from voluntary participation in medical research programs, or as a member of the public.
002.80 PACKAGE. A package is the packaging together with its radioactive contents as presented for transport.
002.81 PARTICLE ACCELERATOR. See Accelerator.
002.82 PERSON. For the purposes of Title 180 a person is any individual, corporation, partnership, limited liability company, firm, association, trust, estate, public or private institution, group, agency, political subdivision of this State, any other State or political subdivision or agency thereof, and any legal successor, representative, agent, or agency of the just stated.
002.83 PERSONNEL DOSIMETER. See Individual Monitoring Devices.
002.84 PERSONNEL MONITORING EQUIPMENT. See Individual Monitoring Devices.
002.85 PHARMACIST. See Neb. Rev. Stat. § 38-2832.
002.86 PHYSICIAN. See Neb. Rev. Stat. § 38-2024 to 38-2045.
002.87 POSITRON EMISSION TOMOGRAPHY (PET) RADIONUCLIDE PRODUCTION FACILITY. A facility operating a cyclotron or accelerator for the purpose of producing PET radionuclides is a positron emission tomography radionuclide production facility or PET facility.
002.88 PUBLIC DOSE. A public dose is the dose received by a member of the public from exposure to sources of radiation released by a licensee or registrant, 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 exposure to individuals administered radioactive material and released in according to 180 NAC 7-037, or from voluntary participation in medical research programs.
002.89 PYROPHORIC LIQUID. Pyrophoric liquid is any liquid that ignites spontaneously in dry or moist air at or below 130°F (54.4 °C). 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.
002.90 QUALITY FACTOR (Q). A quality factor or Q is the modifying factor, listed in Tables I and II of 180 NAC 1- 014, that is used to derive dose equivalent from absorbed dose.
002.91 RAD. Rad is the special unit of absorbed dose. One rad is equal to an absorbed dose of 100 erg per gram or 0.01 joule per kilogram (0.01 gray).
002.92 RADIATION. Ionizing and nonionizing radiation is as follows:
(A) Ionizing radiation is gamma rays, x-rays, alpha and beta particles, high-speed electrons, neutrons, protons, and other atomic or nuclear particles or rays, but does not include sound or radiowaves or visible, infrared, or ultraviolet light; and (B) Nonionizing radiation is:
(i) Any electromagnetic radiation which can be generated during the operations of electronic products to such energy density levels as to present a biological hazard to occupational and public health and safety and the environment, other than ionizing electromagnetic radiation, and (ii) Any sonic, ultrasonic, or infrasonic waves which are emitted from an electronic product as a result of the operation of an electronic circuit in such product and to such energy density levels as to present a biological hazard to occupational and public health and safety, and the environment.
002.93 RADIATION AREA. Radiation area is an area, accessible to individuals, in which radiation levels could result in an individual receiving a dose equivalent in excess of 0.05 mSv (0.005 rem) in 1 hour at 30 centimeters from the source of radiation or from any surface that the radiation penetrates.
002.94 RADIATION DOSE. See Dose.
002.95 RADIATION SAFETY OFFICER. An individual who has the knowledge and responsibility to apply appropriate radiation protection regulations is a radiation safety officer.
002.96 RADIOACTIVE MATERIAL. Radioactive material is any material whether solid, liquid, or gas, which emits ionizing radiation spontaneously. Radioactive material includes, but is not limited to, accelerator-produced material, byproduct material, naturally occurring material, source material, and special nuclear material.
002.97 RADIOACTIVITY. Radioactivity is the transformation of unstable atomic nuclei by the emission of radiation.
002.98 RADIOBIOASSAY. See Bioassay.
002.99 REGULATIONS OF THE UNITED STATES DEPARTMENT OF TRANSPORTATION. The regulations in 49 CFR Parts 100-189 are the regulations of the United States Department of Transportation.
002.100 REM. Rem is the special unit of any of the quantities expressed as dose equivalent. The dose equivalent in rem is equal to the absorbed dose in rad multiplied by the quality factor (1 rem = 0.01 Sv).
002.101 RESEARCH AND DEVELOPMENT. Research and development is the:
(A) Theoretical analysis, exploration, or experimentation; or (B) 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 radiation or radioactive material to human beings.
002.102 RESIDUAL RADIOACTIVITY. Residual radioactivity is 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 according to the requirements of 180 NAC 4.
002.103 RESTRICTED AREA. A restricted area is 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.
002.104 ROENTGEN. The term roentgen refers to the special unit of exposure. One roentgen (R) equals 2.58E-4 coulombs per kilogram of air. See “Exposure" and 180 NAC 1-014.
002.105 SEALED SOURCE. A sealed source is radioactive material that is permanently bonded or fixed in a capsule or matrix designed to prevent release and dispersal of the radioactive material.
002.106 SHALLOW DOSE EQUIVALENT (SDE) (HS). The term shallow dose equivalent applies to the external exposure of the skin of the whole body or the skin of an extremity that is taken at a tissue depth of 0.007 centimeter (7mg/cm2).
002.107 SIEVERT (Sv). Sievert is the International System of Units (SI) unit of any of the quantities expressed as dose equivalent. The dose equivalent in sievert is equal to the absorbed dose in gray multiplied by the quality factor (1 Sv = 100 rem).
002.108 SOURCE MATERIAL. Source material is:
(A) Uranium or thorium, or any combination thereof, in any physical or chemical form; or (B) Ores which contain by weight one-twentieth of 1% (0.05%) or more of uranium, thorium or any combination of uranium and thorium. Source material does not include special nuclear material.
002.109 SOURCE MATERIAL MILLING. Source material milling is any processing of ore, including underground solution extraction of unmined ore, primarily for the purpose of extracting or concentrating uranium or thorium there from and which results in the production of source material mill tailings.
002.110 SOURCES OF RADIATION. Sources of radiation are any radioactive material, any radiation-generating equipment or any device or equipment emitting or capable of emitting radiation or radioactive material.
002.111 SPECIAL FORM RADIOACTIVE MATERIAL. Special form radioactive material is 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) At least one dimension of the piece or capsule is not less than 5 millimeters (0.2 inch); and (C) It satisfies the test requirements specified by the United States Nuclear Regulatory Commission. A special form encapsulation designed in according to the United States Nuclear Regulatory Commission requirements in effect on June 30, 1983, and constructed prior to July 1, 1985; a special form encapsulation designed according to the Nuclear Regulatory Commission requirements in effect on March 31, 1996, and constructed prior to April 1, 1998; and special form material that was successfully tested before September 10, 2015 according to the test requirements specified by the United States Nuclear Regulatory Commission in effect before September 10, 2015 may continue to be used. Any other special form encapsulation must meet the specifications of this definition.
002.112 SPECIAL NUCLEAR MATERIAL. Special nuclear material is:
(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, pursuant to the provisions of section 51 of the Atomic Energy Act of 1954, as amended, determines to be special nuclear material, but does not include source material; or (B) Any material artificially enriched by any material listed in part (A) of this definition, but does not include source material.
002.113 SPECIAL NUCLEAR MATERIAL IN QUANTITIES NOT SUFFICIENT TO FORM A CRITICAL MASS. Special nuclear material in quantities not sufficient to form a critical mass is uranium enriched in the isotope U-235 in quantities not exceeding 350 grams of contained U-235; uranium-233 in quantities not exceeding 200 grams; plutonium in quantities not exceeding 200 grams; or any combination of them according to 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 above for the same kind of special nuclear material. The sum of such ratios for all of the kinds of special nuclear material in combination must not exceed 1. The following quantities in combination would not exceed the limitation and are within the formula:
002.114 SPENT NUCLEAR FUEL. Irradiated nuclear fuel that has undergone at least one year of decay since being used as a source of energy in a power reactor is spent nuclear fuel. Spent nuclear fuel includes the special nuclear material, byproduct material, source material, and other radioactive material associated with fuel assemblies.
002.115 SURVEY. A survey is an evaluation of the radiological conditions and potential hazards incident to the production, use, transfer, release, disposal, or presence of sources of radiation. When appropriate, such evaluation includes, but is not limited to, tests, physical examinations, and measurements of levels of radiation or concentrations of radioactive material present.
002.116 TEST. A test is the process of verifying compliance with an applicable regulation.
002.117 TOTAL EFFECTIVE DOSE EQUIVALENT (TEDE). The sum of the effective dose equivalent (for external exposures) and the committed effective dose equivalent (for internal exposures) is a total effective dose equivalent.
002.118 TOTAL ORGAN DOSE EQUIVALENT (TODE). The sum of the deep dose equivalent and the committed dose equivalent to the organ receiving the highest dose as described in 180 NAC 4-052.01, item A is a total organ dose equivalent.
002.119 TRANSURANIC WASTE. Radioactive waste material containing alpha-emitting radioactive elements, with radioactive half-lives greater than five years, having an atomic number greater than 92 in concentrations in excess of 100 nanocuries per gram is transuranic waste.
002.120 TRIBAL OFFICIAL. A tribal official is the highest ranking individual that represents Tribal leadership, such as the Chief, President, or Tribal Council leadership.
1 = 200Pu) 50(grams + 200233)-U 50(grams + 350235)-U contained 175(grams
002.121 UNITED STATES DEPARTMENT OF ENERGY. The United States Department of Energy is the Department of Energy established by Public Law 95-91, August 4, 1977, 91 Stat. 565, 42 U.S.C. 7101 et seq., to the extent that the Department 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 § 104(b), (c) and (d) of the Energy Reorganization Act of 1974 (Public Law 93-438, October 11, 1974, 88 Stat. 1233 at 1237, 42 U.S.C. 5814, effective January 19, 1975) and retransferred to the Secretary of Energy pursuant to § 301(a) of the Department of Energy Organization Act (Public Law 95-91, August 4, 1977, 91 Stat. 565 at 577-578, 42 U.S.C. 7151, effective October 1, 1977.)
002.122 UNREFINED AND UNPROCESSED ORE. Ore in its natural form prior to any processing, such as grinding, roasting, beneficiating, or refining is unrefined and unprocessed ore.
002.123 UNRESTRICTED AREA. An unrestricted area is an area, access to which is neither limited nor controlled by the licensee or registrant. Uncontrolled area is an equivalent term.
002.124 WASTE. Waste is 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, mill tailings, discrete sources of Radium 226, and discrete sources of naturally occurring radioactive material.
002.125 WASTE HANDLING LICENSEES. Persons licensed to receive and store radioactive wastes prior to disposal and/or persons licensed to dispose of radioactive waste are waste handling licensees.
002.126 WEEK. Seven consecutive days starting on Sunday is a week.
002.127 WHOLE BODY. The whole body for purposes of external exposure, includes the head, trunk including male gonads, arms above the elbow, or legs above the knee.
002.128 WORKER. A worker is an individual engaged in work under a license or registration issued by the Department and controlled by a licensee or registrant, but does not include the licensee or registrant.
002.129 WORKING LEVEL (WL).Working level or WL is any combination of short-lived radon daughters in 1 liter of air that will result in the ultimate emission of 1.3E+5 MeV of potential alpha particle energy. The short-lived radon daughters are -- 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.
002.130 WORKING LEVEL MONTH (WLM). Working level month or WLM is an exposure to 1 working level for 170 hours -- 2,000 working hours per year divided by 12 months per year is approximately equal to 170 hours per month.
002.131 YEAR. A year is the period of time beginning in January used to determine compliance with the provisions of Title 180 regulations. 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.
003. EXEMPTIONS . The following are exempted from Title 180:
003.01 GENERAL PROVISION. The Department may, upon application or on its own initiative, grant exemptions or exceptions from the requirements of Title 180 if it determines the exemption or exception is authorized by law and is consistent with Neb. Rev. Stat. § 71-3507(4).
003.02 UNITED STATES DEPARTMENT OF ENERGY CONTRACTORS AND UNITED STATES NUCLEAR REGULATORY COMMISSION CONTRACTORS. Any United States Department of Energy contractor or subcontractor and any United States Nuclear Regulatory Commission contractor or subcontractor of the following categories operating within this State is exempt from Title 180 to the extent that such contractor or subcontractor under his contract receives, possesses, uses, transfers, or acquires sources of radiation:
(A) Prime contractors performing work for the United States Department of Energy at United States Government-owned or -controlled sites, including the transportation of sources of radiation to or from such sites and the performance of contract services during temporary interruptions of such transportation; (B) Prime contractors of the United States Department of Energy performing research in, or development, manufacture, storage, testing, or transportation of, atomic weapons or their components; (C) Prime contractors of the United States Department of Energy using or operating nuclear reactors or other nuclear devices in a United States Government-owned vehicle or vessel; and (D) Any other prime contractor or subcontractor of the United States Department of Energy or of the United States Nuclear Regulatory Commission when the State and the United States Nuclear Regulatory Commission jointly determine:
(i) That the exemption of the prime contractor or subcontractor is authorized by law; and (ii) 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.
004. RECORDS . Each licensee and registrant must maintain records showing the receipt, transfer, and disposal of all sources of radiation. Additional record requirements are specified elsewhere in Title 180.
005. INSPECTIONS . Each licensee and registrant must allow the Department at all reasonable times an opportunity to inspect sources of radiation and the premises and facilities where sources of radiation are used or stored and make available to the Department for inspection, upon reasonable notice, records that are required to be maintained under Title 180. The Department may also make and retain copies of those records.
006. TESTS . When directed by the Department each licensee and registrant must perform or must allow the Department to perform, any tests the Department finds appropriate or necessary. This includes, but is not limited to, tests of:
(A) Sources of radiation; (B) Facilities where sources of radiation are used or stored; (C) Radiation detection and monitoring instruments; and (D) Other equipment and devices used in connection with use or storage of licensed or registered sources of radiation.
007. ADDITIONAL REQUIREMENTS . In addition to Title 180 the Department may impose additional requirements on licensees or registrants it finds appropriate or necessary to minimize danger to public health and safety or property. These additional requirements can be imposed by rule, regulation, or order.
008. VIOLATIONS . See Neb. Rev. Stat. §§ 71-3517.
009. IMPOUNDING . See Neb. Rev. Stat. §§ 71-3516.
010. PROHIBITED USES . Use of the following is prohibited:
(A) A hand-held fluoroscopic screen must not be used with x-ray equipment unless it has been listed in the Registry of Sealed Source and Devices or accepted for certification by the United States Food and Drug Administration, Center for Devices and Radiological Health. (B) A shoe-fitting fluoroscopic device.
011. TESTS FOR LEAKAGE AND CONTAMINATION OF SEALED SOURCES . Licensees and registrants must test sealed sources for leakage and contamination.
011.01 Sealed sources must be tested so that:
(A) Each sealed source, except as specified in 180 NAC 1-011.02, is tested for leakage or contamination and the test results are received before the sealed source is put into use unless the licensee or registrant has a certificate from the transferor indicating that the sealed source was tested within six months before transfer to the licensee or registrant. (B) 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 approved by the Department, after evaluation of information specified by 180 NAC 3-014.12 (C) and (D) of Title 180, or by an Agreement State, or the U.S. Nuclear Regulatory Commission. (C) 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 approved by the Department, after evaluation of information specified by 180 NAC 3-014.12 (C) and (D) of Title 180, or by an Agreement State, or the U.S. Nuclear Regulatory Commission. (D) Each sealed source that is required to be tested for leakage or contamination is tested at any other time there is reason to suspect that the sealed source might have been damaged or might be leaking. The licensee or registrant must assure that the sealed source is tested for leakage or contamination before further use. (E) Tests for leakage for all sealed sources, except brachytherapy sources manufactured to contain radium, must be capable of detecting the presence of 185 Bq (0.005 μCi) of radioactive material on a test sample. Test samples must be taken from the sealed source or from the surfaces of the container in 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. (F) The test for leakage for brachytherapy sources manufactured to contain radium must be capable of detecting an absolute leakage rate of 37 Bq (0.001 μCi) of radon-222 in a 24 hour period when the collection efficiency for radon-222 and its daughters has been determined with respect to collection method, volume and time. (G) Tests for contamination from radium daughters must be taken on the interior surface of brachytherapy source storage containers and must be capable of detecting the presence of 185 Bq (0.005 μCi) of a radium daughter which has a half-life greater than four days.
011.02 EXEMPTION. A licensee or registrant does not need to perform tests for leakage or contamination on the following sealed sources:
(A) Sealed sources containing only radioactive material with a half-life of less than 30 days; (B) Sealed sources containing only radioactive material as a gas; (C) Sealed sources containing 3.7 MBq (100 μCi) or less of beta or photon-emitting material or 370 kBq (10 μCi) or less of alpha-emitting material; (D) Sealed sources containing only hydrogen-3; (E) Seeds of iridium-192 encased in nylon ribbon; and (F) Sealed sources, except teletherapy and brachytherapy sources, which are stored, not being used and identified as in storage. The licensee or registrant must, 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.
011.03 PERSONS PERFORMING TESTS. Tests for leakage or contamination from sealed sources must be performed by persons specifically authorized by the Department, an Agreement State, or the United States Nuclear Regulatory Commission to perform such services.
011.04 UNITS. Test results must be kept in units of Becquerel or microcurie and maintained for inspection by the Department.
011.05 LEAKING SOURCES. The following must be considered evidence that the sealed source is leaking:
(A) The presence of 185 Bq (0.005 μCi) or more of removable contamination on any test sample. (B) Leakage of 37 Bq (0.001 μCi) of radon-22 per 24 hours for brachytherapy sources manufactured to contain radium. (C) The presence of removable contamination resulting from the decay of 185 Bq (0.005 μCi) or more of radium.
011.06 USE OF LEAKING SOURCES. The licensee or registrant must immediately withdraw a leaking sealed source from use and must take action to prevent the spread of contamination. The leaking sealed source must be repaired or disposed of according to Title 180.
011.07 REPORTS OF LEAKING SOURCES. Reports of test results for leaking or contaminated sealed sources must be made as required by 180 NAC 4-064 by the licensee or registrant.
011.08 STORAGE OF SEALED SOURCES. No sealed source may be stored for a period of more than three years without being tested for leakage or contamination by the licensee or registrant.
012. COMMUNICATIONS . All communications and reports concerning Title 180, and applications should be addressed to:
Nebraska Department of Health and Human Services Division of Public Health Radiological Health 301 Centennial Mall South P.O. Box 95026 Lincoln, Nebraska 68509-5026
013. CITIZENSHIP ATTESTATION . All applicants, licensees, and registrants, must meet the requirements set out in Neb. Rev. Stat. §§ 4-108 through 4-114, unless the applicant, licensee, or registrant is not an individual.
014. UNITS OF EXPOSURE AND DOSE . As used in Title 180:
014.01 COULOMB PER KILOGRAM. The unit of exposure is the coulomb per kilogram (C/kg) of air. One roentgen is equal to 2.58E-4 coulomb per kilogram of air.
014.02 UNITS OF DOSE. The units of dose are:
(A) Gray (Gy); (B) Rad; (C) Rem; and (D) Sievert.
014.03 QUALITY FACTORS. The quality factors for converting absorbed dose to dose equivalent are shown in Table I.
TABLE I
QUALITY FACTORS AND ABSORBED DOSE EQUIVALENCIES
| | Quality Factor | Absorbed Dose Equal to | | --- | --- | --- | | TYPE OF RADIATION | (Q) | a Unit Dose Equivalent | | X, gamma, or beta radiation and high-energy 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 |
Absorbed dose in gray is equal to 1 Sv or the absorbed dose in rad equal to 1 rem.
014.04 NEUTRON FLUENCE RATE. If it is more convenient to measure the neutron fluence rate than to determine the neutron dose equivalent rate in rems per hour or sieverts per hour, as provided in 180 NAC 1-014.03, 0.01 Sv (1 rem) of neutron radiation of unknown energies may, for purposes of Title 180, be assumed to result from a total fluence of 25 million neutrons per square centimeter incident upon the body. If sufficient information exists to estimate the approximate energy distribution of the neutrons, the licensee or registrant may use the fluence rate per unit dose equivalent or the appropriate Q value from Table II to convert a measured tissue dose in gray or rad to dose equivalent in sievert or rem.
TABLE II
MEAN QUALITY FACT0RS, Q, AND FLUENCE PER UNIT DOSE EQUIVALENT FOR MONOENERGETIC NEUTRONS
| Neutron Energy (MeV) | Quality Factor (Q) | Fluence per Unit Dose Equivalent (neutrons cm-2 rem-1) | Fluence per Unit Dose Equivalent (neutrons cm-2 sievert-1) | | | --- | --- | --- | --- | --- | | (thermal) | 2.5E-8 | 2 | 980E+6 | 980E+8 | | | 1E-7 | 2 | 980E+6 | 980E+8 | | | 1E-6 | 2 | 810E+6 | 810E+8 | | | 1E-5 | 2 | 810E+6 | 810E+8 | | | 1E-4 | 2 | 840E+6 | 840E+8 | | | 1E-3 | 2 | 980E+6 | 980E+8 | | | 1E-2 | 2.5 | 1010E+6 | 1010E+8 | | | 1E-1 | 7.5 | 170E+6 | 170E+8 | | | 5E-1 | 11 | 39E+6 | 39E+8 | | | 1 | 11 | 27E+6 | 27E+8 | | | 2.5 | 9 | 29E+6 | 29E+8 | | | 5 | 8 | 23E+6 | 23E+8 | | | 7 | 7 | 24E+6 | 24E+8 | | | 10 | 6.5 | 24E+6 | 24E+8 | | | 14 | 7.5 | 17E+6 | 17E+8 | | | 20 | 8 | 16E+6 | 16Ex8 | | | 40 | 7 | 14E+6 | 14E+8 | | | 60 | 5.5 | 16E+6 | 16E+8 | | | 1E+2 | 4 | 20E+6 | 20E+8 | | | 2E+2 | 3.5 | 19E+6 | 19E+8 | | | 3E+2 | 3.5 | 16E+6 | 16E+8 | | | 4E+2 | 3.5 | 14E+6 | 14E+8 |
The value of quality factor (Q) at the point where the dose equivalent is maximum in a 30-centimeter diameter cylinder tissue-equivalent phantom.
The fluence per unit dose equivalent is monoenergetic neutrons incident normally on a 30-centimeter diameter cylinder tissue-equivalent phantom.
015. UNITS OF ACTIVITY . For the purposes of Title 180, activity is expressed in the System of International Units (SI) unit of becquerel (Bq) or in the special unit of curie (Ci), or their multiples, or disintegrations or transformations per unit of time.
History
- Effective 2021-06-15
Chapter 2 Registration of Radiation Generating Equipment Facilities and Services
Neb. Admin. Code tit. 180, ch. 2 Registration of Radiation Generating Equipment Facilities and Services {#sec-180-nac-2 omnilex-key=us-ne-regs-official--title-180--180 NAC 2}
Effective Date: 10/20/2020
001. SCOPE AND AUTHORITY . 180 Nebraska Administrative Code (NAC) 2 provides for the registration of radiation generating equipment facilities and for the registration of persons installing, repairing, calibrating, demonstrating, selling radiation generating equipment. Person providing service consultations on radiation protection, health physics, radiation measurements, area surveys and facility shielding reviews are also registered. These regulations are authorized by and implement the Nebraska Radiation Control Act, Nebraska Revised Statute (Neb. Rev. Stat.) §§ 71-3501 to 71-3520. In addition to the requirements of 180 NAC 2, all registrants are subject to the applicable provisions of 180 NAC 1, 4, 5, 6, 8, 9, 10, 15, 18, and 20.
002. DEFINITIONS . The following definitions apply to this chapter.
002.01 ASSEMBLER. An assembler is any person engaged in the business of assembling, replacing, or installing one or more components into an x-ray system or subsystem. The term includes the owner of an x-ray system or their employees or agent who assembles components into an x-ray system that is subsequently used to provide professional or commercial services.
002.02 CONSULTATION. Consultation is the act of providing professional or expert advice on radiological matters.
002.03 FACILITY. A facility is the location at which one or more radiation generating devices or sources of radiation are installed or located within one building, vehicle, or under one roof and are under the same administrative control.
002.04 INSTALLATION OR INSTALL. Installation is the assembly, placement, or other actions including, but not limited to, initial calibration or operability checks that allow a radiation machine to be used in a new location or after being moved from one location to another.
002.05 RADIATION SAFETY OFFICER (RSO). A radiation safety officer (RSO) is an individual who has the knowledge of and the authority and responsibility to apply appropriate radiation protection regulations and practices, who is specifically named on a certificate of registration, and who is the primary contact with the Department.
002.06 SERVICE. Service is the repair, calibration, routine maintenance or other checks or examinations performed on a radiation machine, other than those actions taken during the installation of a radiation machine.
002.07 STORAGE. Storage is a condition where a device or source has been made inoperable.
003. EXEMPTIONS . The following exemptions apply to this chapter.
003.01 ELECTRONIC EQUIPMENT. Electronic equipment that produces radiation incidental to its operation for other purposes is exempt from the registration and notification requirements of this chapter as long as the dose equivalent rate averaged over an area of 10 square centimeters does not exceed 0.5 millirem (5 micro Sieverts) per hour at 5 centimeters from any accessible surface of equipment.
003.02 IN TRANSIT OR STORAGE. Radiation generating equipment while in transit or storage is exempt from the requirements of this chapter.
003.03 INOPERABLE EQUIPMENT. Inoperable x-ray radiation generating equipment is exempt from the requirements of this chapter. For the purpose of this chapter, an inoperable radiation machine is one that cannot be energized, without repair or modification, when connected to a power supply.
003.04 FORECLOSURE, BANKRUPTCY, OR OTHER DEFAULT OF PAYMENT. A person that takes possession of a radiation machine as the result of foreclosure, bankruptcy, or other default of payment may possess the machine without registering it. If the machine is energized, it must be under the supervision of a person registered according to this section and must be energized only to demonstrate that the machine is operable for sale, lease, or transfer purposes.
003.05 TELEVISION RECEIVERS. Domestic television receivers are exempt from the requirements of this chapter.
004. APPLICATION FOR REGISTRATION OF RADIATION GENERATING EQUIPMENT FACILITIES . A person with radiation generating equipment at a facility must apply for registration with the Department.
004.01 APPLICATION. The applicant must:
(A) Submit a complete application provided by the Department within 30 days of installation of radiation generating equipment; and (B) Include a non-refundable fee as specified in 180 NAC 18-008.
004.02 RADIATION SAFETY OFFICER. The applicant must designate a radiation safety officer on the application form. The radiation safety officer must carry out the following responsibilities:
(A) Prepare operating and safety procedures and keeping them updated; (B) Inform the Department of lost or stolen radiation generating equipment or overexposures; (C) Know radiation protection policies and procedures; (D) Stop unsafe practices; (E) Keep records; (F) Train employees; and (G) Ensure that these regulations are followed.
004.03 RADIATION GENERATING EQUIPMENT SERVICES. The registrant must prohibit any person from furnishing radiation generating equipment services, as described in 180 NAC 2-005.04, until that person provides evidence that they are registered with the Department as required by 180 NAC 2-005. A list of these registrants is available from the Department.
005. APPLICATION FOR REGISTRATION OF SERVICES OF RADIATION GENERATING EQUIPMENT . A person who is engaged in the business of installing radiation generating equipment or is engaged in the business of providing radiation generating equipment servicing, radiation measurements, or other services must apply for registration of services with the Department.
005.01 APPLICATION. The applicant must:
(A) Submit a complete application provided by the Department at least 30 days prior to furnishing any service; and (B) Include a non-refundable fee as specified in 180 NAC 18-008. (C) Provide additional information requested by the Department to determine whether the registration should be issued or denied.
005.02 DOCUMENTATION. The applicant must specify for each individual providing services on the registration application:
(A) That each individual has read and understands the requirements of this chapter; and (B) The services each individual is applying for; and (C) The training and experience that qualifies the individual to perform the services that have been specified on the application for that individual. The applicant must submit to the Department documentation of the specific training and experience, as required by 180 NAC 15-004, or 15-014, or both, that qualifies each individual to provide the type of service they will be providing.
005.03 SERVICE TYPES. Applicants must be registered and be trained to provide each of the types of services they perform. The types of services are:
(A) INSTALLATION OR SERVICE. Installation or service includes installation and assembly, including initial calibration, and the service or repair of radiation generating equipment and associated radiation generating equipment components. It also includes the measurement of radiation generating equipment output. A person performing installation or service must meet the requirements of 180 NAC 15-014;
(B) CALIBRATION. Calibration includes a check, adjustment, or systematically bringing radiation generating equipment into manufacturer’s specifications. A person performing calibration of:
(i) Diagnostic radiation generating equipment other than computed tomography (CT) or cone beam computed tomography (CBCT) must meet the requirements of 180 NAC 15-014; (ii) Computed tomography (CT) or cone beam computed tomography (CBCT) must meet the requirements of 180 NAC 15.004.01 or 180 NAC 15.004.02; (iii) Therapeutic radiation generating equipment must meet the training requirements 180 NAC 15-004.01; and (iv) Nonmedical radiation generating equipment must meet the training requirements of 180 NAC 15-014;
(C) REVIEW OR CONSULTATION. Review or consultation includes area surveys, shielding reviews, and health physics consultations. A person performing review or consultation services of:
(i) Diagnostic radiation generating equipment other than computed tomography (CT) and cone beam computed tomography (CBCT) must meet the training requirements of 180 NAC 15-004.01, 180 NAC 15.004.02, or 180 NAC 15-004.03; (ii) Computed tomography (CT) or cone beam computed tomography (CBCT) must meet the training requirements of 180 NAC 15-004.01 or 180 NAC 15.004.02; (iii) Therapeutic radiation generating equipment must meet the training requirements of 180 NAC 15-004.01; and (iv) Non-medical radiation generating equipment must meet the training requirements of 180 NAC 15-004.02;
(D) DEMONSTRATION. Persons demonstrating radiation generating equipment that includes energizing the radiation generating equipment must meet the requirements 180 NAC 15-014; and
(E) SALES. Sales the selling of radiation generating equipment. No training is required.
005.04 LIMITATION. A person may not perform services that are not specifically stated for that person on the certificate of registration issued by the Department.
005.05 INSTRUCTION MANUALS, SPECIFICATIONS AND OTHER INFORMATION. A person performing installation or service to radiation generating equipment must provide the registrant with instruction manuals, manufacturer specifications, and other information, as required by Part 21 Code of Federal Regulations (CFR) as published on April 1, 2017, and Title 180, which are applicable to the newly installed x-ray systems or components.
006. ADDITIONAL REQUIREMENTS . Registrants must comply with conditions in the certificate of registration or other requirements incorporated by rule, regulation or order regarding the registrant's receipt, possession, use, and transfer of radiation generating equipment, radiation source servicing, radiation measurements, or services that the Department determines are necessary to:
(A) Minimize danger to occupational and public health and safety; and (B) Prevent loss or theft of radiation generating equipment subject to Title 180.
007. SPECIFIC TERMS AND CONDITIONS OF CERTIFICATES OF REGISTRATION . A certificate of registration issued under this chapter is subject to the provisions of Neb. Rev. Stat. §§ 71-3501 to 17-3520, and to these regulations.
007.01 TRANSFER OF REGISTRATION. A certificate of registration issued under 180 NAC 2 cannot be transferred, assigned, or in any manner disposed of, either voluntarily or involuntarily, to any person unless the Department authorizes the transfer in writing.
007.02 LOCATION AND PURPOSE LIMITATION. A person registered by the Department for radiation generating equipment use under 180 NAC 2 must confine use and possession of the registered radiation generating equipment to the locations and purposes authorized in the certificate of registration.
007.03 COMPLIANCE. The registrant is responsible for complying with Title 180 and any conditions of the certificate of registration.
008. RESPONSIBILITES OF THE REGISTRANT . The responsibilities of the registrant are as follows.
008.01 NOTIFICATION. The registrant must notify the Department in writing within 30 days of any change that would make the information contained in the application for registration no longer accurate.
008.02 TEMPORARY USE OF RADIATION GENERATING EQUIPMENT. Radiation generating equipment used for clinical trial evaluations, temporary replacement, or demonstration may be used for up to 60 days without registration. Radiation generating equipment used for more than 60 days for those purposes must be registered.
008.03 BANKRUPTCY. In the event of a voluntary or involuntary petition for bankruptcy the registrant must notify the Department, in writing, immediately following the filing of a voluntary or involuntary petition for bankruptcy. The notification must include:
(A) The bankruptcy court that the petition for bankruptcy was filed and the date of the filing of the petition; and (B) A copy of the petition for bankruptcy to the Department.
008.04 APPROVAL NOT IMPLIED. No person, in any advertisement, will refer to the fact that their facility is registered with the Department in agreement with 180 NAC 2-004, and no person will state or imply that any activity under that registration has been approved by the Department.
009. EXPIRATION OF CERTIFICATES OF REGISTRATION . Each certificate of registration will expire at the end of the day on the expiration date stated on the registration. Expiration does not relieve the registrant of the requirements of Title 180.
010. RENEWAL OF CERTIFICATE OF REGISTRATION . Application for renewal of Registration must be filed according to 180 NAC 2-004 or 180 NAC 2-005.
010.01 TERMINATION OF REGISTRATION. If a registrant does not renew the certificate of registration as required by this chapter on or before the expiration date on the certificate of registration, the registrant must notify the Department and:
(A) Request termination of the certificate of registration in writing; (B) Submit a record of disposition of the radiation generating equipment, and (C) Pay any outstanding fees per 180 NAC 18-008.
011. ASSEMBLER OR TRANSFER OBLIGATION . A person who sells, leases, transfers, lends, disposes, assembles, or installs radiation generating equipment or components which affect radiation output in this State must notify the Department within 15 days of:
(A) The full name and address of persons who have received this equipment; (B) The manufacturer, model, and serial number of each radiation generating equipment transferred; and (C) The date of transfer of radiation generating equipment.
011.01 ASSEMBLER’S REPORT. In the case of diagnostic x-ray systems which contain certified components, the registrant may submit a copy of the assembler's report (Form FDA 2579) prepared in compliance with requirements of 21 CFR §1020.30(d), in place of any other report by the assembler.
011.02 REQUIREMENTS OF ASSEMBLER’S. No person may make, sell, lease, transfer, lend, assemble, or install radiation generating equipment or the components used in connection with radiation generating equipment unless those components and equipment, when properly placed in operation, meet the requirements of Title 180.
012. OUT-OF-STATE RADIATION GENERATING EQUIPMENT . Whenever any radiation generating equipment registered in another state or by the federal government is to be brought into the State, for any temporary use, the person proposing to bring the equipment into the State must give written notice to the Department at least three working days before the equipment is to be used in the State. The notice must include the:
(A) Type of radiation generating equipment; (B) Nature, duration, and scope of use; (C) Exact location or locations where the radiation generating equipment is to be used; and (D) State or states where the equipment is registered.
012.01 HARDSHIP. If the three working days period would impose an undue hardship on the person, the Department may grant permission to proceed sooner.
012.02 REQUIREMENTS FOR USE OF OUT-OF-STATE RADIATION GENERATING EQUIPMENT. A person referred to in 180 NAC 2-012 must:
(A) Comply with all applicable regulations of the Department; (B) Supply the Department with other information as the Department may request; (C) Not operate within the State on a temporary basis in excess of 180 calendar days per year; and, (D) Submit the appropriate fee as specified in 180 NAC 18-008.
History
- Effective 2020-10-20
Chapter 3 Licensing of Radioactive Material
Neb. Admin. Code tit. 180, ch. 3 Licensing of Radioactive Material {#sec-180-nac-3 omnilex-key=us-ne-regs-official--title-180--180 NAC 3}
Effective Date: 6/15/2021
001. SCOPE AND AUTHORITY . 180 Nebraska Administrative Code (NAC) 3 provides for the licensing of radioactive material. No person may manufacture, produce, receive, possess, use, transfer, own, dispose or acquire radioactive material except as authorized in a specific or general license issued according to 180 NAC 3 or as otherwise provided in 180 NAC 3, 5, 7, 9, 14, 19 or 24. The regulations are authorized by and implement the Radiation Control Act, Nebraska Revised Statute (Neb. Rev. Stat.) §§ 71-3501 to 71-3520.
001.01 ADDITIONAL REQUIREMENTS. In addition to the requirements of 180 NAC 3, all licensees are subject to the requirements of 180 NAC 1, 4, 10, 13, 15, and 18.
001.02 10 CODE OF FEDERAL REGULATIONS (CFR). 10 Code of Federal Regulations (CFR), as published on January 1, 2013 and referred throughout this Chapter are incorporated by reference and available for viewing at the Nebraska Department of Health and Human Services, Radiological Health, 301 Centennial Mall South, 3rd Floor, Lincoln, Nebraska 68509.
002. DEFINITIONS . The following definitions apply to this chapter.
002.01 ALERT. An alert is an event that may occur, is in progress, or has occurred that could lead to a release of radioactive material but that the release is not expected to require a response by offsite response organizations to protect person’s offsite.
002.02 CONSORTIUM. A consortium is an association of medical use licensees and a positron emission tomography (PET) radionuclide production facility in the same geographical area that jointly own or share in the operation and maintenance cost of the positron emission tomography (PET) radionuclide production facility that produces positron emission tomography (PET) radionuclides for use in producing radioactive drugs within the consortium for noncommercial distributions among its associated members for medical use. The positron emission tomography (PET) radionuclide production facility within the consortium must be located at an educational institution or a Federal facility or a medical facility.
002.03 SITE AREA EMERGENCY. A site area emergency is an event that may occur, is in progress, or has occurred that could lead to a significant release of radioactive material and that could require a response by offsite response organizations to protect person’s offsite.
002.04 PRINCIPAL ACTIVITIES. Principal activities are activities authorized by the license which are essential to achieving the purpose or purposes for which the license was issued or amended. Storage during which no license material is accessed for use or disposal and activities incidental to decontamination or decommissioning are not principal activities.
002.05 TECHNOLOGICALLY ENHANCED NATURALLY OCCURRING RADIOACTIVE MATERIAL (TENORM). Technologically enhanced naturally occurring radioactive material (TENORM) is naturally occurring radioactive material whose radionuclide concentration are increased by or as a result of past or present human practices. Technologically enhanced naturally occurring radioactive material (TENORM) does not include background radiation or the natural radioactivity of rocks or soils. Technologically enhanced naturally occurring radioactive material (TENORM) does not include “source material” and “byproduct material.”
002.06 UNREFINED AND UNPROCESSED ORE. Unrefined and unprocessed ore is 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.
003. SOURCE MATERIAL EXEMPTIONS . This section addresses source material exemptions.
003.01 ANY CHEMICAL MIXTURE, COMPOUND, SOLUTION, OR ALLOY IN WHICH THE SOURCE MATERIAL IS BY WEIGHT LESS THAN 1/20 OF 1% (0.05 %) OF THE MIXTURE, COMPOUND, SOLUTION, OR ALLOY. Any person is exempt from 180 NAC 3 to the extent that the person receives, possesses, uses, owns, or transfers source material in any chemical mixture, compound, solution, or alloy in which the source material is by weight less than 1/20 of 1% (0.05 %) of the mixture, compound, solution, or alloy.
003.02 UNREFINED AND UNPROCESSED ORE CONTAINING SOURCE MATERIAL. Any person is exempt from 180 NAC 3 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, the person must not refine or process such ore.
003.03 THORIUM, URANIUM, AND SOURCE MATERIAL CONTAINED IN GLASSWARE AND CERAMICS. Any person is exempt from the requirements of the 180 NAC 3 and 4, and 10 to the extent that the person receives, possesses, uses, or transfers:
(A) Any quantities of thorium contained in:
(i) Incandescent gas mantles; (ii) Vacuum tubes; (iii) Welding rods; (iv) Electric lamps for illuminating purposes provided that each lamp does not contain more than 50 milligrams of thorium; (v) Germicidal lamps, sunlamps, and lamps for outdoor or industrial lighting provided that each lamp does not contain more than 2 grams of thorium; (vi) Rare earth metals and compounds, mixtures, and products containing not than 0.25% by weight thorium, uranium, or any combination of these; or (vii) Personnel neutron dosimeters, provided that each dosimeter does not contain more than 50 milligrams of thorium;
(B) Source material contained in the following products:
(i) Glazed ceramic tableware manufactured before August, 27, 2013, provided that the glaze contains not more than 20% by weight source material; (ii) Glassware, containing not more than 2% by weight source material or for glassware manufactured before August 27, 2013, 10 percent by weight source material; but not including commercially manufactured glass brick, pane glass, ceramic tile or other glass, or ceramic used in construction; (iii) Glass enamel or glass enamel frit containing not more than 10% 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. On July 25, 1983, the exemption of glass enamel or glass enamel frit was suspended. The exemption was eliminated on September 11, 1984; or (iv) Piezoelectric ceramic containing not more than 2% by weight source material;
(C) Photographic film, negatives, and prints containing uranium or thorium; (D) Any finished product or part fabricated of, or containing, tungsten-thorium or magnesium-thorium alloys, provided that the thorium content of the alloy does not exceed 4% by weight and that the exemption contained in this subpart does not authorize the chemical, physical, or metallurgical treatment or processing of any such product or part; (E) 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:
(i) Each counterweight has been impressed with the following legend clearly legible through any plating or other covering: "DEPLETED URANIUM". The requirements specified in 180 NAC 3-003.03(E)(ii) and (E)(iii) need not be met by counter weights manufactured prior to December 31, 1969; provided, that such counter weights were manufactured under a specific license issued by the Atomic Energy Commission and were impressed with the legend, required by CFR 40.13 (c)(5)(ii) in effect on June 30, 1969; (ii) Each counterweight is durably and legibly labeled or marked with the identification of the manufacturer and the statement: "UNAUTHORIZED ALTERATIONS PROHIBITED", and (iii) The exemption contained in this division does not authorize the chemical, physical, or metallurgical treatment or processing of any such counterweights other than repair or restoration of any plating or other covering;
(F) Natural or depleted uranium metal used as shielding constituting part of any shipping container, provided that:
(i) The shipping container is conspicuously and legibly impressed with the legend "CAUTION - RADIOACTIVE SHIELDING - URANIUM", and (ii) The uranium metal is encased in mild steel or equally fire resistant metal of minimum wall thickness of one-eighth inch (3.2mm);
(G) Thorium or uranium contained in or on finished optical lenses and mirrors, provided that each lens or mirror does not contain more than 10% by weight of thorium or uranium or, for lenses manufactured before August 27, 2013, 30% by weight of thorium; and that the exemption contained 180 NAC 3-003.03(G) does not authorize either:
(i) 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 (ii) 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;
(H) Thorium contained in any finished aircraft engine part containing nickel-thoria alloy, provided that:
(i) the thorium is dispersed in the nickel-thoria alloy in the form of finely divided thoria, thorium dioxide, and (ii) the thorium content in the nickel-thoria alloy does not exceed 4% by weight; and
(I) No person may initially transfer for sale or distribution a product containing source material to persons exempt under this 180 NAC 3-003.03, or equivalent regulations of an U.S. Nuclear Regulatory Commission (NRC) or Agreement State, unless authorized by a license issued under 10 CFR 40.52 to initially transfer such products for sale or distribution.
(i) Persons initially distributing source material in products covered by the exemptions in 180 NAC 3-003.03 before the effective date of these regulations, without specific authorization may continue such distribution for 1 year beyond this date. Initial distribution may also be continued until the U.S. Nuclear Regulatory Commission (NRC) takes final action on a pending application for license or license amendment to specifically authorize distribution submitted no later than 1 year beyond this date; (ii) Persons authorized to manufacture, process, or produce these materials or products containing source material by the U.S. Nuclear Regulatory Commission (NRC) or an Agreement State, and persons who import finished products or parts, for sale or distribution must be authorized by a license issued under 180 NAC 10 CFR 40.52 for distribution only and are exempt from the requirements of 180 NAC 4 and 10, and 180 NAC 3-011(A) and (B).
003.04 MANUFACTURE OF PRODUCTS. The exemptions in 180 NAC 3-003.03 do not authorize the manufacture of any of the products described.
003.05 TRANSPORT AND STORAGE EXEMPTIONS. Common and contract carriers, freight forwarders, warehouse personnel, and the U.S. Postal Service are exempt from the regulations in 180 NAC 3, 7, and 24 to the extent that they transport or store radioactive material in the regular course of carriage for another or storage incident previously mentioned.
004. RADIOACTIVE MATERIAL OTHER THAN SOURCE MATERIAL EXEMPTIONS . This section addresses exemptions for radioactive material other than source material.
004.01 EXEMPT CONCENTRATIONS. This subsection addresses exempt concentrations.
004.01(A) APPENDIX 3-A CONCENTRATIONS. Other than as provided in 3-004.01(C) and (D), any person is exempt from 180 NAC 3 to the extent that such person receives, possesses, uses, transfers, owns or acquires products containing radioactive material introduced in concentrations not in excess of those listed in 180 NAC 3, Appendix 3-A.
004.01(B) IMPORTATION. 180 NAC 3-004.01 must not be deemed to authorize the import of radioactive material or products containing radioactive material.
004.01(C) PRODUCTS. A manufacturer, processor, or producer of a product or material is exempt from the requirements for a license in 180 NAC 3-004, 3-005, 3-006, 3-008, 3-013, 3-014, 3-016 through 3-024, 180 NAC 5, 7, 14 and 19 to the extent that they transfer radioactive material contained in a product or material in concentrations not in excess of those specified in 180 NAC 3, Appendix 3-A and introduced into the product or material by a licensee holding a specific license issued by the U.S. Nuclear Regulatory Commission (NRC) 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.
004.01(D) TRANSFER TO EXEMPT PERSONS. 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 180 NAC 3-004.01(A) or equivalent regulations of the U.S. Nuclear Regulatory Commission (NRC), or any Agreement State, other than according to a specific license issued according to 10 CFR 32.11.
004.02 EXEMPT QUANTITIES. This subsection address exempt quantities.
004.02(A) APPENDIX 3B QUANTITIES. Other than as provided in 180 NAC 3-004.02(C) through (E), any person is exempt from Title 180 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 180 NAC 3, Appendix 3-B.
004.02(B) PRIOR ACQUISITION. Any person who possesses radioactive material received or acquired, prior to September 25, 1971, according to the general license provided in 180 NAC 3-008 or similar general license of the U.S. Nuclear Regulatory Commission (NRC) or another Agreement State is exempt from the requirements for a license set forth in Title 180 if that person possesses, uses, or transfers such radioactive material.
004.02(C) COMMERCIAL DISTRIBUTION. 180 NAC 3-004.02 does not authorize the production, packaging, repackaging, or transfer of radioactive material for purposes of commercial distribution, or the incorporation of radioactive material into products intended for commercial distribution.
004.02(D) TRANSFER TO EXEMPT PERSONS. No person may, for purposes of commercial distribution, transfer radioactive material in the individual quantities set forth in 180 NAC 3, Appendix 3-B knowing or having reason to believe that such quantities of radioactive material will be transferred to persons exempt under 180 NAC 3-004.02 or equivalent regulations of the U.S. Nuclear Regulatory Commission (NRC), or any Agreement State, other than according to a specific license issued by the U.S. Nuclear Regulatory Commission (NRC) according to 10 CFR 32.18 which license states that the radioactive material may be transferred by the licensee to persons exempt under 180 NAC 3-004.02 or the equivalent regulations of the U.S. Nuclear Regulatory Commission (NRC), or any Agreement State.
004.02(E) AGGREGATION. No person may, for purposes of producing an increase radiation level combine quantities of radioactive material covered by this exemption so that the aggregate quantity exceeds the limits set forth in 180 NAC 3, Appendix 3-B, other than for radioactive material combined within a device placed in use before May 3, 1999, or as otherwise permitted by the regulation in 180 NAC 3.
004.03 EXEMPT ITEMS. This subsection addresses exempt items.
004.03(A) CERTAIN ITEMS CONTAINING RADIOACTIVE MATERIAL. The following requirements apply to certain items containing radioactive material.
004.03(A)(i) EXEMPT PRODUCTS. Other than 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 for distribution the following products containing radioactive material any person is exempt from Title 180 to the extent that the person receives, possesses, uses, transfers, owns, or acquires the following products.
004.03(A)(i)(1) TIMEPIECES OR HANDS OR DIALS. Timepieces or hands or dials containing not more than the following specified quantities of radioactive material and not exceeding the following specified radiation dose rate:
(a) 925 megabecquerel (MBq) (25 millicuries) of tritium per timepiece; (b) 185 MBq (5 millicuries) of tritium per hand; (c) 555 MBq (15 millicuries) of tritium per dial. Bezels are included when used as part of the dial; (d) 3.7 MBq (100 μCi) of promethium-147 per watch or 7.4 MBq (200 μCi) of promethium-147 per any other timepiece; (e) 0.74 MBq (20 μCi) of promethium-147 per watch hand or 1.48 MBq (40 μCi) of promethium-147 per other timepiece hand; (f) 2.22 MBq (60 μCi) of promethium-147 per watch dial or 4.44 MBq (120 μCi) of promethium-147 per other timepiece dial. Bezels are included when used as part of the dial; (g) 0.037 MBq (1 μCi) of radium per timepiece in intact timepieces manufactured prior to August 22, 1981; and (h) The radiation dose rate from hands and dials containing promethium-147 will not exceed the following, when measured through 50 milligrams per square centimeter of absorber:
(i) For wrist watches, 1 microgray (μGy) (0.1 millirad) per hour at 10 centimeters from any surface; (ii) For pocket watches, 1 μGy (0.1 millirad) per hour at 1 centimeter from any surface; and (iii) For any other timepiece, 2 μGy (0.2 millirad) per hour at 10 centimeters from any surface.
004.03(A)(i)(2) STATIC ELIMINATION DEVICES AND ION GENERATING TUBES. Static elimination devices and ion generating tubes:
(a) Static elimination devices which contain, as a sealed source or sources, radioactive material consisting of a total of not more than 18.5 MBq (500 μCi) of polonium 210 per device; (b) Ion generating tubes designed for ionization of air that contain, as a sealed source or sources, radioactive material consisting of a total of not more than 18.5 MBq (500 µCi) of polonium 210 per device or of a total of not more than 1.85 gigabecquerel (GBq) (50 millicurie (mCi)) of hydrogen 3 (tritium) per device; and (c) Such devices previously authorized for use under the general license and equivalent regulations of the Department, the U.S. Nuclear Regulatory Commission (NRC), or Agreement States and manufactured, tested, and labeled by the manufacturer according to the specifications contained in a specific license issued by the Department, Agreement State or the U.S. Nuclear Regulatory Commission (NRC) are now exempt.
004.03(A)(i)(3) PRECISION BALANCES. Precision balances containing not more than 37 MBq (1 millicurie) of tritium per balance or not more than 18.5 MBq (0.5 millicurie) of tritium per balance part manufactured before December 17, 2007.
004.03(A)(i)(4) RESERVED.
004.03(A)(i)(5) MARINE COMPASSES. Marine compasses containing not more than 27.8 GBq (750 millicuries) of tritium gas and other marine navigational instruments containing not more than 9.25 GBq (250 millicuries) of tritium gas manufactured before December 17, 2007.
004.03(A)(i)(6) RESERVED.
004.03(A)(i)(7) ELECTRON TUBES. Electron tubes, provided that each tube does not contain more than one of the following specified quantities of radioactive material. Additionally, the levels of radiation from each electron tube containing radioactive material must not exceed 10 μGy (1 millirad) per hour at 1 centimeter from any surface when measured through 7 milligrams per square centimeter of absorber. For purposes of 180 NAC 3-004.03(A)(i)(7) 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:
(a) 5.55 GBq (150 millicuries) of tritium per microwave receiver protector tube or 370 MBq (10 millicuries) of tritium per any other electron tube; (b) 37 kilobecquerel (kBq) (1 μCi) of cobalt-60; (c) 185 kBq (5 μCi) of nickel-63; (d) 1.11 MBq (30 μCi) of krypton-85; (e) 185 kBq (5 μCi) of cesium-137; and (f) 1.11 MBq (30 μCi) of promethium-147.
004.03(A)(i)(8) IONIZING RADIATION MEASURING INSTRUMENTS. 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 specified in 180 NAC 3, Appendix 3-B; (b) Each instrument contains no more than 10 exempt quantities. An instrument's source or sources 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 180 NAC 3, Appendix 3-B provided that the sum of such fractions does not exceed unity; and (c) For americium-241, 1.85 kBq (0.05 μCi) is considered an exempt quantity under 180 NAC, Appendix 3-B.
004.03(A)(i)(9) IONIZATION CHAMBER SMOKE DETECTORS. Ionization chamber smoke detectors containing not more than 1 micocurie (μCi) of americium-241 per detector in the form of a foil and designed to protect life and property from fires.
004.03(A)(ii) INCORPORATE RADIOACTIVE MATERIAL INTO PRODUCTS OR INITIALLY TRANSFER FOR SALE OR DISTRIBUTION. Any person who desires to apply radioactive material to, or to incorporate radioactive material into, the products exempted in 180 NAC 3-004.03(A)(i) or who desires to initially transfer for sale or distribution such products containing radioactive material, must apply for a specific license according to 10 CFR 32.14, which license states that the product may be distributed by the licensee to persons exempt from the regulations according to 180 NAC 3-004.03(A)(i).
004.03(B) SELF-LUMINOUS PRODUCTS CONTAINING RADIOACTIVE MATERIAL. The following requirements apply to self-luminous containing radioactive material.
004.03(B)(i) TRITIUM, KRYPTON-85, OR PROMETHIUM-147. Tritium, krypton-85, or promethium-147. Other than persons who manufacture, process, produce, or initially transfer for sale or distribution self-luminous products containing tritium, krypton-85, or promethium-147, any person is exempt from Title 180 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, imported, or transferred according to a specific license issued by the U.S. Nuclear Regulatory Commission (NRC) according to § 32.22 of 10 CFR 32, which license authorizes the transfer of the product to persons who are exempt from regulatory requirements. The exemption in 180 NAC 3-004.03(B) does not apply to tritium, krypton-85, or promethium-147 used in products for frivolous purposes or in toys or adornments.
004.03(B)(ii) RADIUM-226. Any person is exempt from Title 180 to the extent that such person receives, possesses, uses, transfers, or owns articles containing less than 3.7 kBq (0.1 μCi) of radium-226 which were acquired prior to August 22, 1982.
004.03(B)(iii) MANUFACTURE, PROCESS, PRODUCE OR INITIALLY TRANSFER FOR SALE OR DISTRIBUTION. 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 under 180 NAC 3-004.03(B)(i), must apply for a license according to 10 CFR 32.22, and for a certificate of registration per 10 CFR 32.210.
004.03(C) GAS AND AEROSOL DETECTORS CONTAINING RADIOACTIVE MATERIAL. The following requirements apply to gas and aerosol detectors containing radioactive material.
004.03(C)(i) EXEMPT RECEIPT. Other than persons who manufacture, process, produce or initially transfer for sale or distribution gas and aerosol detectors containing radioactive material, any person is exempt from Title 180 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 according to a specific license issued by the U.S. Nuclear Regulatory Commission (NRC) according to 10 CFR 32.26, which license authorizes the initial transfer of the product for use under 180 NAC 3-004.03. This exemption also covers gas and aerosol detectors manufactured or distributed before November 30, 2007 as specified in a specific license issued by a State under comparable provision to 10 CFR 32.26 authorizing distribution detectors to persons exempt from regulatory requirements.
004.03(C)(ii) MANUFACTURE, PROCESS, PRODUCE OR INITIALLY TRANSFER FOR USE. Any person who desires to manufacture, process, or produce gas and aerosol detectors containing radioactive material, or to initially transfer such products for use as specified in 180 NAC 3-004.03(C)(i) must apply for a license as specified in 10 CFR 32.26, and for a certificate of registration specified in 10 CFR 32.210.
004.03(D) TECHNOLOGICALLY ENHANCED NATURALLY OCCURRING RADIOACTIVE MATERIAL (TENORM). Persons who receive, possess, use, process, transfer, distribute, or dispose of Technologically Enhanced Naturally Occurring Radioactive Material (TENORM) are exempt from the requirements of 180 NAC 3 with respect to any combination of radium-226 and radium-228 if the material contain, or are contaminated at, concentrations less than 5 pCi/gram (185 becquerel per kilogram) excluding natural background. The progeny of the exempt Technologically Enhanced Naturally Occurring Radioactive Material (TENORM) radium-226 and radium-228 are also exempt.
004.03(E) CERTAIN INDUSTRIAL DEVICES. The following requirements apply to certain industrial devices.
004.03(E)(i) EXEMPT DETECTING, MEASURING, GAUGING, OR CONTROLLING DEVICES AND CERTAIN DEVICES FOR PRODUCING AN IONIZED ATMOSPHERE. Other than 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 in the Radiation Control Act and 180 NAC to the extent that such 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 according to a specific license issued by the U.S. Nuclear Regulatory Commission (NRC) according to 10 CFR 32.30, which license authorizes the initial transfer of the device for use under 180 NAC 004.03(E). This exemption does not cover sources not incorporated into a device, such as calibration and reference sources.
004.03(E)(ii) MANUFACTURE, PROCESS, PRODUCE, OR INITIALLY TRANSFER FOR SALE OR DISTRIBUTION. Any person who desires to manufacture, process, produce, or initially transfer for sale or distribution industrial devices containing radioactive material for use under 180 NAC 3-004.03(E)(i) must apply for a license from the U.S. Nuclear Regulatory Commission (NRC) according to 10 CFR 32.30 and for a certificate of registration as specified in 10 CFR 32.210.
005. TYPES OF LICENSES . This section addresses the two types of licenses, general and specific.
005.01 GENERAL LICENSES. Provided in 180 NAC 3, general licenses are effective without the filing of applications with the Department or the issuance of licensing documents to the particular persons. However, registration or certification with the Department may be required by the particular general license. The general licensee is subject to all other applicable portions of Title 180 and any limitations based on the type and quantity of radioactive material of the general license.
005.02 SPECIFIC LICENSES. Specific Licenses require the submission of an application to the Department and the issuance of a licensing document by the Department. The licensee is subject to all applicable portions of Title 180 as well as any limitations based on quantities and types of radioactive materials, proposed use and upon the training and experience of the user or users specified in the licensing document.
006. RADIOACTIVE DRUG: CAPSULES CONTAINING CARBON-14 UREA FOR “IN VIVO” DIAGNOSTIC USE FOR HUMANS . This section addresses radioactive drugs containing carbon-14 urea for “in vivo” diagnostic use for humans.
006.01 EXEMPTIONS. Other than as provided in 180 NAC 3-006.02, any person is exempt from the requirements for a license set forth in the Act and from the regulations in 180 NAC 3 and 7 provided that such person receives, possesses, uses, transfers, owns or acquires capsules containing 37 kBq (1 μCi) Carbon-14 urea, allowing for nominal variation that may occur during the manufacturing process, each for “in vivo” diagnostic use for humans.
006.02 RESEARCH INVOLVING HUMAN SUBJECTS. Any person who desires to use the capsules for research involving human subjects must apply for and receive a specific license according to 180 NAC 7.
006.03 COMMERCIAL DISTRIBUTION. Any person who desires to manufacture, prepare, process, produce, package, repackage, or transfer for commercial distribution such capsules must apply for and receive a specific license from the U.S. Nuclear Regulatory Commission (NRC) according to 10 CFR 32.21.
006.04 ADDITIONAL REQUIREMENTS. Nothing in 180 NAC 3-006 relieves persons from complying with applicable U.S. Food and Drug Administration (FDA), other Federal, and State requirements governing receipt, administration, and use of drugs.
007. GENERAL LICENSES - SOURCE MATERIAL . This section addresses general licenses for source material.
007.01 GENERAL LICENSE ISSUED. A general license is 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:
(A) No more than 3.3 pounds (1.5 kg) of uranium and thorium in dispersible forms 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 180 NAC 3-007.01 may not receive more than a total of 15.4 pounds (7 kg) of uranium and thorium in any one calendar year; (B) No more than a total of 15.4 pounds (7 kg) of uranium and thorium at any one time. A person authorized to possess, use, and transfer source material under 180 NAC 3-007.01 may not receive more than a total of 154 pounds (70 kg) 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 180 NAC 3-007.01 unless it is accounted for under the limits of 180 NAC 3-007.01(A); (C) No more than 15.4 pounds (7 kg) of uranium, removed during the treatment of drinking water, at any one time. A person may not remove more than 154 pounds (70 kg) of uranium from drinking water during a calendar year under this paragraph; or (D) No more than 15.4 pounds (7 kg) 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 154 pounds (70 kg) of source material in any one calendar year.
007.02 LIMITATIONS. Any person who receives, possesses, uses, or transfers source material as specified in the general license in 180 NAC 3-007.01:
(A) Is prohibited from administering source material, or the resulting radiation, either externally or internally, to human beings except as may be authorized by the Department in a specific license. (B) Must not abandon such source material. Source material may be disposed of as follows:
(i) A cumulative total of 1.1 pounds (0.5 kg) 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 180 NAC 3-007.02 is exempt from the requirements to obtain a license under 180 NAC 3 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 180 NAC 3; or (ii) As specified in 180 NAC 4-039.
(C) Is subject to the provisions in 180 NAC 1-005, 1-006, 1-008, 1-012, 1-014, 3-001.01, 3-002, 3-017.01 through 3.017.05, 3-017.10, 3-025, 3-026, 3-027, 3-030, 10-002 and 10-007.03. (D) Must not export such source material other than as specified in 10 CFR 110.
007.03 MINIMIZE CONTAMINATION. Any person who receives possesses, uses, or transfers source material as specified in 180 NAC 3-007.01 must 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 must notify the Department at the address listed in 180 NAC 1-012, about such contamination and may consult with the Department 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 180 NAC 4-016.
007.04 DEPLETED URANIUM IN INDUSTRIAL PRODUCTS AND DEVICES. The following requirements apply to depleted uranium in industrial products and devices:
007.04(A) CONCENTRATED MASS IN A SMALL VOLUME. A general license is issued to receive, acquire, possess, use, or transfer, as specified in the provisions of 180 NAC 3-007.04(B) through (E), 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.
007.04(B) APPLICABILITY. The general license in 180 NAC 3-007.04(A) applies only to industrial products or devices which have been manufactured either as specified in a specific license issued to the manufacturer of the products or devices according to 180 NAC 3-014.13 or as specified in a specific license issued to the manufacturer by the U.S. Nuclear Regulatory Commission (NRC) or an Agreement State which authorizes manufacture of the products or devices for distribution to persons generally licensed by the U.S. Nuclear Regulatory Commission (NRC) or an Agreement State.
007.04(C) FILING REQUIREMENTS. Persons who receive, acquire, possess, or use depleted uranium according to the general license established by 180 NAC 3-007.04(A) must:
(i) File Department Form NRH-11 "Certificate - Use of Depleted Uranium Under General License," with the Department. The form must be submitted within 30 days after the first receipt or acquisition of such depleted uranium. Form NRH-11 is set out as Attachment 2 of this Chapter. The registrant must furnish on Department Form NRH-11 the following information and such other information as may be required by that form:
(1) Name and address of the general licensee; (2) A statement that the general licensee has developed and will maintain procedures designed to establish physical control over the depleted uranium described in 180 NAC 3-007.04(A) 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 (3) Name and title, address, and telephone number of the individual duly authorized to act for and on behalf of the general licensee in supervising the procedures identified in 180 NAC 3-007.04(C)(i)(2); and
(ii) Report in writing to the Department any changes in information furnished by him or her in Department Form NRH-11 "Certificate - Use of Depleted Uranium Under General License.” The report must be submitted within 30 days after the effective date of such change.
007.04(D) LIMITATIONS. A person who receives, acquires, possesses, or uses depleted uranium according to the general license established by 180 NAC 3-007.04(A) must:
(i) Not introduce such depleted uranium, in any form, into a chemical, physical, or metallurgical treatment or process, other than a treatment or process for repair or restoration of any plating or other covering of the depleted uranium; (ii) Not abandon such depleted uranium; (iii) Transfer or dispose of such depleted uranium only by transfer as specified in the provisions of 180 NAC 3-025 and 4-039. In the case where the transferee receives the depleted uranium according to the general license established by 180 NAC 3-007.04(A), the transferor must furnish the transferee a copy of these regulations and a copy of Department Form NRH-11. In the case where the transferee receives the depleted uranium according to a general license contained in the U.S. Nuclear Regulatory Commission (NRC) or Agreement State's regulation equivalent to 180 NAC 3-007.04(A), the transferor must furnish the transferee a copy of Title 180 and a copy of Department Form NRH-11 accompanied by a note explaining that use of the product or device is regulated by the U.S. Nuclear Regulatory Commission (NRC) or Agreement State under requirements substantially the same as those in Title 180; and (iv) Within 30 days of any transfer, report in writing to the Department the name and address of the person receiving the depleted uranium according to such transfer.
007.04(E) EXEMPTION. Any person receiving, acquiring, possessing, using, or transferring depleted uranium according to the general license established by 180 NAC 3-007.04(A) is exempt from the requirements of 180 NAC 4 and 10 with respect to the depleted uranium covered by that general license.
007.05 EXTERNAL OR INTERNAL ADMINSTRATION PROHIBITED. Persons who receive, possess, use, or transfer source material according to the general license in 180 NAC 3-007.01 are prohibited from administering source material, or the resulting radiation, either externally or internally, to human beings except as may be authorized by the Department in a specific license.
007.06 EXEMPTIONS. Any person who receives, possesses, uses, or transfers source material as specified in the general license granted in 180 NAC 3-007.01 is exempt from the provisions of 180 NAC 3, 4 and 10 to the extent that such receipt, possession, use, and transfer are within the terms of this general license, except that such person must comply with the provisions of 180 NAC 4-016 and 4-039 to the extent necessary to meet the provisions of 180 NAC 3-007.02(B) and 3-007.03. However, this exemption does not apply to any person who also holds a specific license issued under this 180 NAC 3.
007.07 TRANSFER OR DISTRIBUTION. No person may initially transfer or distribute source material to persons generally licensed under paragraph 180 NAC 3-007.01, (A) and (B), or equivalent regulations of the U.S. Nuclear Regulatory Commission (NRC) or an Agreement State, unless authorized by a specific license issued as specified in 180 NAC 3-007.08 or equivalent provisions of the U.S. Nuclear Regulatory Commission (NRC) or an Agreement State. This prohibition does not apply to analytical laboratories returning processed samples to the client who initially provided the sample. Initial distribution of source material to persons generally licensed by 180 NAC 3-007.01 on or before the date of these regulations, without specific authorization may continue for 1 year beyond this date. Distribution may also be continued until the Department takes final action on a pending application for license or license amendment to specifically authorize distribution submitted one year after the effective date of these regulations.
007.08 APPLICANTS. An applicant for a specific license to initially transfer source material for use under 180 NAC 3-007.01 or equivalent regulations the U.S. Nuclear Regulatory Commission (NRC) or of an Agreement State, must:
(A) Satisfy the general requirements specified in 180 NAC 3-011; and (B) Submits adequate information on, and the Department approves the methods to be used for quality control, labeling, and providing safety instructions to recipients.
007.09 LABELING, INFORMATION AND REPORTS. Each person licensed under 180 NAC 3-007.08 must:
(A) 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) Ensure that the quantities and concentrations of source material are as labeled and indicated in any transfer records; (C) Provide the information specified in 180 NAC 3-007.09 to each person to whom source material is transferred for use under 180 NAC 3-007.01 or equivalent provisions in the U.S. Nuclear Regulatory Commission (NRC) or Agreement State regulations. 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:
(i) A copy of 180 NAC 3-007.01 and 3-025, or relevant equivalent regulations of the U.S. Nuclear Regulatory Commission (NRC) or an Agreement State; and (ii) Appropriate radiation safety precautions and instructions relating to handling, use, storage, and disposal of the material;
(D) Each person licensed under 180 NAC 3-007.08 must report transfers as follows:
(i) File a report with the Manager, Office of Radiological Health, Nebraska Department of Health and Human Services, 301 Centennial Mall South, P.O. Box 95026, Lincoln, NE 68509. The report must include the following information:
(1) The name, address, and license number of the person who transferred the source material; (2) For each general licensee under 180 NAC 3-007.02 or equivalent U.S. Nuclear Regulatory Commission (NRC) or Agreement State provisions to whom greater than 50 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 is distributed; a responsible agent, by name, 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 (3) The total quantity of each type and physical form of source material transferred in the reporting period to all such generally licensed recipients;
(ii) File a report with each responsible U.S. Nuclear Regulatory Commission (NRC) and Agreement State agency that identifies all persons, operating under provisions equivalent to 180 NAC 3-007.01, to whom greater than 50 grams (0.11 pounds) of source material has been transferred within a single calendar quarter. The report must include the following information specific to those transfers made to the U.S. Nuclear Regulatory Commission (NRC) or Agreement State being reported to:
(1) The name, address, and license number of the person who transferred the source material; (2) The name and address of the general licensee to whom source material was distributed; a responsible agent, by name, 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; (3) 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 or U.S. Nuclear Regulatory Commission (NRC); and
(iii) Submit each report by January 31 of each year covering all transfers for the previous calendar year. If no transfers were made to persons generally licensed under 180 NAC 3-007.01 or equivalent U.S. Nuclear Regulatory Commission (NRC) or Agreement State provisions during the current period, a report must be submitted to the Commission indicating so. If no transfers have been made to general licensees in a particular Agreement State during the reporting period, this information must be reported to the responsible Agreement State agency upon request of the agency; and
(E) Each person licensed under 180 NAC 3-007.08 must maintain all information that supports the reports required by this 180 NAC 3-007 concerning each transfer to a general licensee for a period of 1 year after the event is included in a report to the Department, U.S. Nuclear Regulatory Commission (NRC) or to an Agreement State agency.
008. GENERAL LICENSES - RADIOACTIVE MATERIAL OTHER THAN SOURCE MATERIAL .
This section addresses general licenses pertaining to radioactive material other than source material.
008.01 RESERVED.
008.02 RESERVED.
008.03 RESERVED.
008.04 CERTAIN DETECTING, MEASURING, GAUGING OR CONTROLLING DEVICES AND CERTAIN DEVICES FOR PRODUCING LIGHT OR AN IONIZED ATMOSPHERE. Persons possessing radioactive material in devices under 180 NAC 3-008.04 before January 1975, may continue to possess, use, or transfer that material according to the labeling requirements of 180 NAC 3-008.04 in effect on January 14, 1975. The following applies to certain detecting, measuring, gauging or controlling devices and certain devices for producing light or an ionized atmosphere.
008.04(A) GENERAL LICENSE ISSUED. A general license is issued to commercial and industrial firms, and to research, educational and medical institutions, individuals in the conduct of their business, and state or local government agencies to own, receive, acquire, possess, use or transfer as specified in the provisions of 180 NAC 3-008.04(B), (C), and (D), radioactive material, excluding special nuclear 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.
008.04(B) APPLICABILITY. The general license in 180 NAC 3-008.04(A) applies only to radioactive material contained in devices which have been manufactured or initially transferred and labeled according to the specification contained in a specific license issued under 180 NAC 3-014.04; or an equivalent specific license issued by the U. S. Nuclear Regulatory Commission (NRC) or an Agreement State with provisions comparable to 180 NAC 3-014.04. The devices must have been received from one of the specific licensees described in this paragraph or through a transfer made under 180 NAC 3-008.04(C)(ix).
008.04(C) GENERAL REQUIREMENTS. Any person who owns, receives, acquires, possesses, uses, or transfers radioactive material in a device according to the general license in 180 NAC 3-008.04(A) must meet the following requirements.
008.04(C)(i) LABELS. 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 comply with all instructions and precautions provided by such labels.
008.04(C)(ii) LEAK TESTS. Assure that the device is tested for leakage of radioactive material and proper operation of the on or off mechanism, or both, and indicator, if any, at no longer than six-month intervals or at such other intervals as are specified in the label, however,
(1) Devices containing only krypton need not be tested for leakage of radioactive material, and (2) Devices containing only tritium or not more than 3.7 MBq (100 μCi) of other beta or gamma emitting material or 0.37 MBq (10 μCi) 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.
008.04(C)(iii) LEAK TEST FREQUENCY. Assure that the tests required by 180 NAC 3-008.04(C)(ii) and other testing, installation, servicing, and removal from installation involving the radioactive materials, its shielding or containment, are performed:
(1) According to the instructions provided by the labels; or (2) By a person holding an applicable specific license from the Department, the U.S. Nuclear Regulatory Commission (NRC), or an Agreement State to perform such activities.
008.04(C)(iv) RECORDS. Maintain records showing compliance with the requirements of 180 NAC 3-008.04(C)(ii) and (C)(iii). The records must show the results of the tests. The records also must show the dates of performance of, and the names of persons performing, testing, installation, servicing, and removal from installation concerning the radioactive material, its shielding or containment. The licensee must retain these records as follows:
(1) Each record of tests for leakage of radioactive material required by 180 NAC 3-008.04, (C)(ii) must be retained for three years after the next required leak test is performed or until the sealed source is transferred or disposed of; (2) Each record of tests of the on or off mechanism, or both, and indicator required by 180 NAC 3-008.04, (C)(ii) must be retained for three years after the next required test of the on or off mechanism, or both and indicator is performed or until the sealed source is transferred or disposed of; and (3) Each record which is required by 180 NAC 3-008.04, (C)(iii) must be retained for a period of three years from the date of the recorded event or until the device is transferred or disposed of.
008.04(C)(v) SUSPEND OPERATION. 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 or off mechanism, or both, or indicator, or upon the detection of 185 Bq (0.005 μCi) 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 by this Department, the U.S. Nuclear Regulatory Commission (NRC) or by an Agreement State. 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 Department, the U.S. Nuclear Regulatory Commission (NRC) or an Agreement State. A report containing a brief description of the event and the remedial action taken; and, in the case of detection of 185 Bq (0.005 μCi) 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 Department within 30 days. Under these circumstances, the criteria set out in 180 NAC 4-016, “Radiological Criteria for Unrestricted Use,” may be applicable, as determined by the Department on a case-by-case basis.
008.04(C)(vi) ABANDONMENT. Not abandon the device containing radioactive material.
008.04(C)(vii) EXPORT. Not export the device containing radioactive material other than as specified in 10 CFR 110.
008.04(C)(viii) TRANSFER OF DEVICES CONTAINING RADIOACTIVE MATERIAL. Transfer or dispose of devices only as follows.
008.04(C)(viii)(1) EXPORT. Transfer or dispose of the device containing radioactive material only by export as provided by 180 NAC 3-008.04(C)(vii) by transfer to another general licensee as authorized in paragraph 180 NAC 3-008.04(C)(ix), or to a person authorized to receive the device by a specific license issued under 180 NAC 3, or 180 NAC 12 that authorized waste collection, or equivalent regulations of the U.S. Nuclear Regulatory Commission (NRC) or an Agreement State, or as otherwise approved under 180 NAC 3-008.04(C)(viii).
008.04(C)(viii)(2) REPORT. Furnish a report to the Department within 30 days after the transfer of a device to a specific licensee or export. The report must contain:
(a) The identification of the device by manufacturer's (or initial transferor's) name, model number, and serial number; (b) The name, address, and license number of the person receiving the device (license number not applicable if exported); and (c) The date of the transfer.
008.04(C)(viii)(3) APPROVAL. Obtain written Department approval before transferring the device to any other specific licensee not specifically identified in 180 NAC 3-008.04(C)(viii)(1). 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:
(a) 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; (b) Removes, alters, covers, or clearly and unambiguously augments the existing label otherwise required by 180 NAC 3-008.04(C)(i) so that the device is labeled in compliance with 180 NAC 4-036; however the manufacturer, model number, and serial number must be retained; (c) 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 (d) Reports the transfer under paragraph 180 NAC 3-008.04(C)(viii)(2).
008.04(C)(ix) TRANSFER TO ANOTHER GENERAL LICENSEE. Transfer the device to another general licensee only if:
(1) The device remains in use at a particular location. In such case the transferor must give the transferee a copy of 180 NAC 3-008.01, 3-030, 4-057, and 4-058, and any safety documents identified in the label of the device. Within 30 days of the transfer, the transferor must report to the Department:
(a) The manufacturer’s or initial transferor’s name; (b) The model number and the serial number of the device transferred; (c) The transferee’s name and mailing address for the location of use; and (d) The name, title, and phone number of the responsible individual identified by the transferee according to 180 NAC 3-008.04, (C)(xii). To have knowledge of and authority to take actions to ensure compliance with the appropriate regulations and requirements; or
(2) 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.
008.04(C)(x) INCIDENTS, THEFT OR LOSS. Comply with the provisions of 180 NAC 4-057 and 4-058 for reporting radiation incidents, theft, or loss of licensed material, but will be exempt from the other reporting requirements of 180 NAC 4 and 10.
008.04(C)(xi) RESPOND TO REQUESTS FOR INFORMATION. Respond to written requests from the Department to provide information relating to the general license within 30 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 must, within the same time period, request a longer period to supply information by submitting a letter to the Radioactive Material Program Manager, Nebraska Department of Health and Human Services, 301 Centennial Mall South, P.O. Box 95026, Lincoln, NE 68509-5026 and provide written justification as to why it cannot comply.
008.04(C)(xii) NAME AN INDIVIDUAL RESPONSIBLE. Appoint an individual responsible for having knowledge of the appropriate regulations and requirements and the authority for taking required actions to comply with appropriate regulations and requirements. The general licensee, through this individual, must ensure the day-to-day compliance with appropriate regulations and requirements. This appointment does not relieve the general licensee of any of its responsibility in this regard.
008.04(C)(xiii) REGISTER GENERAL LICENSE DEVICES. General license devices must be registered as follows.
008.04(C)(xiii)(1) INITIAL REGISTRATION. Register, according to 180 NAC 3-008.04(C)(xiii)(2) and (3), devices containing at least 370 MBq (10 mCi) of cesium-137, 3.7 MBq (0.1 mCi) of strontium-90, 37 MBq (1 mCi) of cobalt-60, 3.7 MBq (0.1 mCi) of radium-226, or 37 MBq (1 mCi) of americium-241 or any other transuranic, based on the activity indicated on the label. Each address for a location of use, as described in 180 NAC 3-008.04(C)(xiii)(3)(d) represents a separate general licensee and requires a separate registration and fee.
008.04(C)(xiii)(2) ANNUAL REGISTRATION. If in possession of a device meeting the criteria of 180 NAC 3-008.04, (C)(xiii)(1), must register these devices annually with the Department and must pay the fee required by 180 NAC 18. Registration must be done by verifying, correcting, or adding to the information provided in a request for registration received from the Department. The registration information must be submitted to the Department within 30 days of the date of the request for registration or as otherwise indicated in the request. In addition, a general licensee holding devices that meet the criteria of 180 NAC 3-008.04, (C)(xiii)(1) is subject to the bankruptcy notification requirement in 180 NAC 3-017.05.
008.04(C)(xiii)(3) REQUIRED INFORMATION. In registering devices, the general licensee must furnish the following information and any other information specifically requested by the Department:
(a) Name and mailing address of the general licensee. (b) Information about each device: the manufacturer, or initial transferor, model number, serial number, the radionuclide and activity (as indicated on the label). (c) Name, title, and telephone number of the responsible person designated as a representative of the general licensee in 180 NAC 3-008.04(C)(xii). (d) Address or location at which the device or devices are used or stored. For portable devices, the address of the primary place of storage. (e) Certification by the responsible representative of the general licensee that the information concerning the device or devices has been verified through a physical inventory and checking of label information. (f) Certification by the responsible representative of the general licensee that they are aware of the requirements of the general license.
008.04(C)(xiii)(4) TEMPORARY DEVICES. Persons generally licensed by an Agreement State or the U.S. Nuclear Regulatory Commission (NRC), with respect to devices meeting the criteria in paragraph 180 NAC 3-008.04, (C)(xiii)(1) are not subject to registration requirements if the devices are used in areas subject to Department jurisdiction for a period less than 180 days in any calendar year. The Department will not request registration information from such licensees.
008.04(C)(xiv) REPORT CHANGES. Report changes to the mailing address for the location of use (including change in name of general licensee) to the Radioactive Materials Program Manager, Nebraska Department of Health and Human Services, 301 Centennial Mall South, P.O. Box 95026, Lincoln, NE 68509-5026 within 30 days of the effective date of the change. For a portable device, a report of address change is only required for a change in the device's primary place of storage.
008.04(C)(xv) UNUSED DEVICES. Not hold unused devices for longer than 2 years. If devices with shutters are not being used, the shutter must be locked in the closed position. The testing required by 180 NAC 3-008.04, (C)(ii) 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.
008.04(D) MANUFACTURE OR IMPORT. The general license in 180 NAC 3-008.04(A) does not authorize the manufacture or import of devices containing radioactive material.
008.04(E) APPLICABLE PROVISIONS. The general license provided in 180 NAC 3-008.04(A) is subject to the provisions of 180 NAC 1-004 through 1-009, 180 NAC 3-017, 3-025, 3-027, and 180 NAC 13.
008.05 LUMINOUS SAFETY DEVICES FOR AIRCRAFT. With respect to luminous safety devices for aircraft, the following requirements apply.
008.05(A) GENERAL LICENSE ISSUED. A general license is issued to own, receive, acquire, possess, and use tritium or promethium-147 contained in luminous safety devices for use in aircraft, provided:
(i) Each device contains not more than 370 GBq (10 curies) of tritium or 11.1 GBq (300 mCi) of promethium-147; and (ii) Each device has been manufactured, assembled or initially transferred according to a specific license issued by the U.S. Nuclear Regulatory Commission (NRC), or each device has been manufactured or assembled according to the specifications contained in a specific license issued by the Department or any Agreement State to the manufacturer or assembler of such device according to licensing requirements equivalent to those in 10 CFR 30.33 and 32.53.
008.05(B) EXEMPTION. Persons who own, receive, acquire, possess, or use luminous safety devices according to the general license in 180 NAC 3-008.05(A) are exempt from the requirements of 180 NAC 4 and 10 other than that they must comply with the provisions of 180 NAC 4-057 and 4-058.
008.05(C) LIMITATION. This general license does not authorize the manufacture, assembly, repair, or import of luminous safety devices containing tritium or promethium-147.
008.05(D) PROMETHIUM-147 CONTAINED IN INSTRUMENT DIALS. This general license does not authorize ownership, receipt, acquisition, possession or use of promethium-147 contained in instrument dials.
008.05(E) ADDITIONAL REQUIREMENTS. This general license is subject to the provisions of 180 NAC 1-004 through 1-009, 180 NAC 3-017, 3-025, 3-027, and 13.
008.05(F) EXPORT. This general license does not authorize the export of luminous safety devices containing tritium or promethium-147.
008.06 OWNERSHIP OF RADIOACTIVE MATERIAL. A general license is issued to own radioactive material without regard to quantity. Despite any other provisions of 180 NAC 3, this general license does not authorize the manufacture, production, transfer, receipt, possession or use of radioactive material.
008.07 CALIBRATION AND REFERENCE SOURCES. The following applies to calibration and reference sources.
008.07(A) AMERICIUM-241. A general license is issued to those persons listed below to own, receive, acquire, possess, use, and transfer, according to the provisions of 180 NAC 3-008.07(D) and (E), americium-241 in the form of calibration or reference sources:
(i) Any person who holds a specific license issued by the Department which authorizes the licensee to receive, possess, use, and transfer radioactive material; and (ii) Any person who holds a specific license issued by the U.S. Nuclear Regulatory Commission (NRC) which authorizes the licensee to receive, possess, use, and transfer special nuclear material.
008.07(B) PLUTONIUM. A general license is issued to own, receive, possess, use, and transfer plutonium in the form of calibration or reference sources according to the provisions of 180 NAC 3-008.07(D) and (E) to any person who holds a specific license issued by the Department which authorizes the licensee to receive, possess, use, and transfer radioactive material.
008.07(C) RADIUM-226. A general license is issued to own, receive, possess, use, and transfer radium-226 in the form of calibration or reference sources according to the provisions of 180 NAC 3-008.07(D) and (E) to any person who holds a specific license issued by the Department which authorizes the licensee to receive, possess, use, and transfer radioactive material.
008.07(D) APPLICABILITY. The general licenses in 180 NAC 3-008.07(A) through (C) apply only to calibration or reference sources which have been manufactured according to the specifications contained in a specific license issued to the manufacturer or importer of the sources by the U.S. Nuclear Regulatory Commission (NRC) according to 10 CFR 30.33, according to the specifications contained in a specific license issued to the manufacturer by the Department, or any Agreement State according to licensing requirements equivalent to those contained in 10 CFR 30.33.
008.07(E) ADDITIONAL REQUIREMENTS. The general licenses provided in 180 NAC 3-008.07(A) through (C). are subject to the provisions of 180 NAC 1-004 through 1-009, 180 NAC 3-017, 3-025, 3-027, 180 NAC 4, 10, and 13. In addition, persons who own, receive, acquire, possess, use or transfer one or more calibration or reference sources according to these general licenses must:
(i) Not possess at any one time, at any one location of storage or use, more than 185 kBq (5 μCi) of americium-241, 185 kBq (5 μCi) of plutonium, and 185 kBq (5 μCi) of radium-226 in such sources; (ii) 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, showing only the name of the appropriate material.
The receipt, possession, use and transfer of this source Model _______, Serial No. _______, are subject to a general license and the regulations of the U.S. Nuclear Regulatory Commission (NRC) or of a State with which the Commission (NRC) has entered into an agreement for the exercise of regulatory authority. Do not remove this label.
CAUTION - RADIOACTIVE MATERIAL - THIS SOURCE CONTAINS (RADIUM-226) (AMERICIUM-241) (PLUTONIUM) DO NOT TOUCH RADIOACTIVE PORTION OF THIS SOURCE.
Name of manufacturer or importer
(iii) Not transfer, abandon, or dispose of such source other than by transfer to a person authorized by a license from the Department, the U.S. Nuclear Regulatory Commission (NRC), or any other Agreement State to receive the source; (iv) Store such source, other than when the source is being used, in a closed container adequately designed and constructed to contain americium-241, plutonium, or radium-226 which might otherwise escape during storage; and (v) Not use such source for any purpose other than the calibration of radiation detectors or the standardization of other sources.
008.07(F) MANUFACTURE PROHIBITED. These general licenses do not authorize the manufacture of calibration or reference sources containing americium-241, plutonium, or radium-226.
008.08 RESERVED.
008.09 GENERAL LICENSE FOR USE OF RADIOACTIVE MATERIAL FOR CERTAIN IN VITRO CLINICAL OR LABORATORY TESTING. The following applies to the general license for use of radioactive material for certain in vitro clinical or laboratory testing.
008.09(A) GENERAL LICENSE ISSUED. A general license is 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, according to the provisions of 180 NAC 3-008.09 (B) through (F), the following radioactive materials in prepackaged units for use in in vitro clinical or laboratory tests not involving internal or external administration of radioactive material, or the resulting radiation, to human beings or animals:
(i) Iodine-125, iodine-131, selenium-75, cobalt-57, and carbon-14 in units not exceeding 370 kBq (10 μCi) each; (ii) Hydrogen-3 (tritium), in units not exceeding 1.85 MBq (50 μCi) each; (iii) Iron-59, in units not exceeding 740 kBq (20 μCi) each; or (iv) Mock Iodine-125 reference or calibration sources, in units not exceeding 1.85 kBq (0.05 μCi) of iodine-129 and 1.85 Bq (0.005 μCi) of americium-241 each. (v) Colbalt-57, in units not exceeding 0.37 MBq (10 μCi) each.
008.09(B) CERTIFICATE REQUIRED. No person receives, acquires, possesses, uses or transfers radioactive material according to the general license established by 180 NAC 3-008.09(A) until they file Department Form NRH-17, "Certificate - In Vitro Testing with Radioactive Material Under General License", with the Department and received from the Department a validated copy of Department Form NRH-17 with certification number assigned. Department Form NRH-17 is set out as Attachment 3 of this chapter. The physician, veterinarian, clinical laboratory or hospital must furnish on Department Form NRH-17 the following information and such other information as may be required by that form:
(i) Name and address of the physician, veterinarian, clinical laboratory or hospital; (ii) The location of use; and (iii) A statement that the physician, veterinarian in the practice of veterinary medicine, clinical laboratory or hospital has appropriate radiation measuring instruments to carry out in vitro clinical or laboratory tests with radioactive material as authorized under the general license in 180 NAC 3-008.09(A) and that such tests will be performed only by personnel competent in the use of such instruments and in the handling of the radioactive material;
008.09(C) ADDITIONAL REQUIREMENTS. A person who receives, acquires, possesses or uses radioactive material according to the general license established by 180 NAC 3-008.09(A) must comply with the following:
(i) The general licensee must not possess at any one time, according to the general license in 180 NAC 3-008.09(A) at any one location of storage or use a total amount of iodine-125, iodine-131, iron-59, cobalt-57 and selenium-75 in excess of 7.4 MBq (200 µCi); (ii) The general licensee must store the radioactive material, until used, in the original shipping container or in a container providing equivalent radiation protection; (iii) The general licensee must use the radioactive material only for the uses authorized by 180 NAC 3-008.09(A); (iv) The general licensee must not transfer the radioactive material to a person who is not authorized to receive it according to a license issued by the Department, the U.S. Nuclear Regulatory Commission (NRC), or any Agreement State, nor transfer the radioactive material in any manner other than in the unopened, labeled shipping container as received from the supplier; and (v) The general licensee must dispose of the Mock Iodine-125 reference or calibration sources described in 180 NAC 3-008.09, (A)(iv) as required by 180 NAC 4-039 and 4-044.
008.09(D) LIMITATIONS. The general licensee must not receive, acquire, possess, or use radioactive material according to 180 NAC 3-008.09(A):
(i) Other than as prepackaged units which are labeled according to the provisions of an applicable specific license issued according to 180 NAC 3-014.08 or according to the provisions of a specific license issued by the U.S. Nuclear Regulatory Commission (NRC), or any Agreement State which authorizes the manufacture and distribution of iodine-125, iodine-131, carbon-14, hydrogen-3 (tritium), iron-59, selenium-75, cobalt-57, or Mock Iodine-125 to persons generally licensed under 180 NAC 3-008.09 or its’ equivalent, and (ii) Unless the following statement, or 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 is 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 resulting radiation, to human beings or animals. Its receipt, acquisition, possession, use, and transfer are subject to the regulations and a general license of the U.S. Nuclear Regulatory Commission (NRC) or of a State with which the Commission has entered into an agreement for the exercise of regulatory authority.
Name of Manufacturer
008.09(E) CHANGES. The physician, veterinarian in the practice of veterinary medicine, clinical laboratory or hospital possessing or using radioactive material under the general license of 180 NAC 3-008.09(A) must report in writing to the Department, any changes in the information furnished by him or her in the "Certificate - In Vitro Testing with Radioactive Material Under General License", Department Form NRH-17. The report must be furnished within 30 days after the effective date of such change.
008.09(F) MOCK IODINE-125. Any person using radioactive material according to the general license of 180 NAC 3-008.09(A) is exempt from the requirements of 180 NAC 4 and 10 with respect to radioactive material covered by that general license, other than such persons using the Mock Iodine-125 described in 180 NAC 3-008.09(A)(iv) must comply with the provisions of 180 NAC 4-039, 4-057, and 4-058.
008.10 ICE DETECTION DEVICES. The following applies to ice detection devices.
008.10(A) GENERAL LICENSE ISSUED. A general license is 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 MBq (50 μCi) of strontium-90 and each device has been manufactured or imported according to a specific license issued by the U.S. Nuclear Regulatory Commission (NRC) or each device has been manufactured according to the specifications contained in a specific license issued by the Department or any Agreement State to the manufacturer of such device according to licensing requirements equivalent to those in 10 CFR 32.61.
008.10(B) REQUIREMENTS. Persons who own, receive, acquire, possess, use, or transfer strontium-90 contained in ice detection devices according to the general license in 180 NAC 3-008.10(A):
(i) Must 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 from the U.S. Nuclear Regulatory Commission (NRC) or an Agreement State to manufacture or service such devices; or must dispose of the device according to the provisions of 180 NAC 4-039; (ii) Must 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 upon; and (iii) Are exempt from the requirements of 180 NAC 4 and 10 other than such persons must comply with the provisions of 180 NAC 4-039, 4-057, and 4-058.
008.10(C) LIMITATIONS. This general license does not authorize the manufacture, assembly, disassembly, repair or import of strontium-90 in ice detection devices.
008.10(D) ADDITIONAL REQUIREMENTS. This general license is subject to the provisions of 180 NAC 1-004 through 1-009, 180 NAC 3-017, 180 NAC 3-025, 180 NAC 3-027, and 180 NAC 13.
008.11 GENERAL LICENSE FOR CERTAIN ITEMS AND SELF-LUMINOUS PRODUCTS CONTAINING RADIUM-226. The following applies to general licenses for certain items and self luminous products containing radium-226:
008.11(A) GENERAL LICENSE ISSUED. A general license is issued to any person to acquire, receive, possess, use, or transfer, according to the provisions of 180 NAC 3-008.11(B), 3-008.11(C) and 3-008.11(D), radium-226 contained in the following products manufactured prior to November 30, 2007:
(i) 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 19th and early 20th centuries, such as radium emanator jars, revigators, radium water jars, radon generators, refrigerator cards, radium bath salts, and healing pads. (ii) Intact timepieces containing greater than 0.037 MBq (1 μCi), nonintact timepieces, and timepiece hands and dials no longer installed in timepieces. (iii) Luminous items installed in air, marine, or land vehicles. (iv) All other luminous products, provided that no more than 100 items are used or stored at the same location at any one time. (v) Small radium sources containing no more than 0.037 MBq (1 μCi) 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 U.S. Nuclear Regulatory Commission (NRC).
008.11(B) EXEMPTIONS. Persons who acquire, receive, possess, use, or transfer radioactive material under the general license issued in 180 NAC 3-008.11(A) are exempt from the provisions of 180 NAC 4, 10, 3-026 and 3-030, to the extent that the receipt, possession, use, or transfer of radioactive material is within the terms of the general license; provided, however, that this exemption must not be deemed to apply to any such person specifically licensed under 180 NAC 3.
008.11(C) REQUIREMENTS AND LIMITATIONS. Any person who acquires, receives, possesses, uses, or transfers radioactive material according to the general license in 180 NAC 3-008.11(A) must:
(i) Notify the Department if there is 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 of Public Health of the Nebraska Department of Health and Human Services, P.O. Box 95026, Lincoln, NE 68509 within 30 days. (ii) Not abandon products containing radium-226. The product, and any radioactive material from the product, may only be disposed of according to 180 NAC 4-039 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 U.S. Nuclear Regulatory Commission (NRC). (iii) Not export products containing radium-226 other than according to 10 CFR 110. (iv) Dispose of products containing radium-226 at a disposal facility authorized to dispose of radioactive material according to any Federal or State solid or hazardous waste law, including the Solid Waste Disposal Act, as authorized under the Energy Policy Act of 2005, by transfer to a person authorized to receive radium-226 by a specific license issued under 180 NAC 3, or equivalent regulations of this Department or an Agreement State, or U.S. Nuclear Regulatory Commission (NRC). (v) Respond to written requests from the Department to provide information relating to the general license within 30 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 must, within that same time period, request a longer period to supply the information by providing the Director of Public Health of the Nebraska Department of Health and Human Services, by an appropriate method listed in 180 NAC 1-012, a written justification for the request.
008.11(D) MANUFACTURE, ASSEMBLY, DISASSEMBLY, REPAIR, OR IMPORT OF PRODUCTS. The general license in 180 NAC 3-008.11(A) does not authorize the manufacture, assembly, disassembly, repair, or import of products containing radium-226, other than timepieces that may be disassembled and repaired.
009. RESERVED .
010. FILING APPLICATION FOR SPECIFIC LICENSES . This section addresses filing application for specific licenses.
010.01 APPLICATION FORMS. Applications for specific licenses must be filed on form NRH-7 for all medical licenses and form NRH-5 for all other licenses. Form NRH-5 is set out as Attachment 1 of this chapter.
010.02 ADDITIONAL STATEMENTS. The Department may at any time after the filing of the original application require further statements in order to enable the Department to determine whether the application should be granted or denied or whether a license should be modified or revoked.
010.03 AUTHORIZED SIGNATURE. Each application must be signed by the applicant or licensee or a person duly authorized to act for and on their behalf.
010.04 LICENSE REQUEST. An application for a license may include a request for a license authorizing one or more activities.
010.05 RESERVED.
010.06 RESERVED.
010.07 DECOMMISIONING PLAN. As provided by 180 NAC 3-018 certain applications for specific licenses filed under 180 NAC 3, 5, and 7, must contain a proposed decommissioning funding plan or a certification of financial assurance for decommissioning.
010.08 APPLICATION REQUIREMENTS. Applications must include:
(A) Other than as provided in 180 NAC 3-010.08(B) through (D), 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 source must either:
(i) Identify the source or device by manufacturer and model number as registered with the U.S. Nuclear Regulatory Commission (NRC) under 10 CFR 32.210 or with an Agreement State, or for source or a device containing radium-226 or accelerator-produced radioactive material with the U.S. Nuclear Regulatory Commission (NRC) or an Agreement State under provisions comparable to 10 CFR § 32.210; or (ii) Contain the information identified in 10 CFR 32.210(c); or
(B) For sources or devices manufactured prior to October 23, 2012 that are not registered with the U.S. Nuclear Regulatory Commission (NRC) under 10 CFR § 32.210 or with an Agreement State, and for which the applicant is unable to provide all categories of information specified in 10 CFR § 32.210(c), the applicant must provide:
(i) All available information identified in 10 CFR § 32.210(c) concerning the source, and, if applicable, the device; and (ii) 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;
(C) For sealed sources and devices allowed to be distributed without registration of safety information per 10 CFR §32.210(g)(1), the applicant may supply only the manufacturer, model number, and radionuclide and quantity; or (D) 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 source and device.
010.09 EMERGENCY PLANS. Emergency plans must adhere to the following:
010.09(A) EVALUATION OR EMERGENCY PLAN. Each application to possess radioactive materials in unsealed form, on foils or plated sources, or sealed in glass in excess of the quantities in 180 NAC 3, Appendix 3-E "Quantities of Radioactive Materials Requiring Consideration of the Need for an Emergency Plan for Responding to a Release" must contain either:
(i) An evaluation showing that the maximum dose to a person offsite due to a release of radioactive materials would not exceed 0.01 sievert (Sv) (1 rem) effective dose equivalent or 0.05 sievert (Sv) (5 rem) to the thyroid; or (ii) An emergency plan for responding to a release of radioactive material;
010.09(B) CONSIDERATIONS. One or more of the following factors may be used to support an evaluation submitted under 180 NAC 3-010.09 (A):
(i) The radioactive material is physically separated so that only a portion could be involved in an accident; (ii) All or part of the radioactive material is not subject to release during an accident because of the way it is stored or packaged; (iii) The release fraction in the respirable size range would be lower than the release fraction shown in 180 NAC 3, Appendix 3-E due to the chemical or physical form of the material; (iv) The solubility of the radioactive material would reduce the dose received; (v) Facility design or engineered safety features in the facility would cause the release fraction to be lower than shown in 180 NAC 3, Appendix 3-E; (vi) Operating restrictions or procedures would prevent a release fraction as large as that shown in 180 NAC 3; or (vii) Other factors appropriate for the specific facility;
010.09(C) EMERGENCY PLAN CONTENTS. An emergency plan for responding to a release of radioactive material submitted under 180 NAC 3-010.09 must include the following information:
(i) FACILITY DESCRIPTION. A brief description of the licensee's facility and area near the site; (ii) TYPES OF ACCIDENTS. An identification of each type of radioactive materials accident for which protective actions may be needed; (iii) CLASSIFICATION OF ACCIDENTS. A classification system for classifying accidents as alerts or site area emergencies; (iv) DETECTION OF ACCIDENTS. Identification of the means of detecting each type of accident in a timely manner; (v) MITIGATION OF CONSEQUENCES. 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; (vi) ASSESSMENT OF RELEASES. A brief description of the methods and equipment to assess releases of radioactive materials; (vii) RESPONSIBILITIES. A brief description of the responsibilities of licensee personnel should an accident occur, including identification of personnel responsible for promptly notifying offsite response organizations and the Department; also responsibilities for developing, maintaining, and updating the plan; (viii) NOTIFICATION AND COORDINATION. 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 must to be established. The notification and coordination must be planned so that unavailability of some personnel, parts of the facility, and some equipment will not prevent the notification and coordination. The licensee must also commit to notify 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 of complying with the requirements under the Emergency Planning and Community Right-to-Know Act of 1986, Title III, P. L. 99-499 or other state or federal reporting requirements; (ix) INFORMATION TO BE COMMUNICATED. 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. (x) TRAINING. 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 must familiarize personnel with site-specific emergency procedures. Also, the training must thoroughly prepare site personnel for their responsibilities in the event of accident scenarios postulated as most probable for the specific site, including the use of team training for such scenarios. (xi) SAFE SHUTDOWN. A brief description of the means of restoring the facility to a safe condition after an accident. (xii) EXERCISES. Provisions for conducting quarterly communications checks with offsite response organizations and biennial onsite exercises to test response to simulated emergencies. Quarterly communications checks with offsite response organizations must include the check and update of all necessary telephone numbers. The licensee must 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 must not be known to most exercise participants. The licensee must 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. (xiii) HAZARDOUS CHEMICALS. A certification that the applicant has met its responsibilities under the Emergency Planning and Community Right-to-Know Act of 1986, Title III, P. L. 99-499, if applicable to the applicant's activities at the proposed place of use of the radioactive material.
010.09(D) OFFSITE RESPONSE ORGANIZATIONS. The licensee must allow the offsite response organizations, expected to respond in case of an accident, 60 days to comment on the licensee's emergency plan before submitting it to the Department. The licensee must provide any comments received within the 60 days to the Department with the emergency plan.
010.11 POSITRON EMISSION TOMOGRAPHY (PET) RADIOACTIVE DRUG PRODUCTION APPLICATION. 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 under 180 NAC 7 or equivalent Agreement State or U.S. Nuclear Regulatory Commission (NRC) requirements must include:
(A) A request for authorization for the production of Positron Emission Tomography (PET) radionuclides or evidence of an existing license issued under 180 NAC 3, U.S. Nuclear Regulatory Commission (NRC) or Agreement State requirements for a Positron Emission Tomography (PET) radionuclide production facility within its consortium from which it receives Positron Emission Tomography (PET) radionuclides. (B) Evidence that the applicant is qualified to produce radioactive drugs for medical use by meeting one of the criteria in 180 NAC 3-014.10(A)(ii), (C) Identification of individual or individuals authorized to prepare the Positron Emission Tomography (PET) radioactive drugs if the applicant is a pharmacy, and documentation that each individual meets the requirements of an authorized nuclear pharmacist according to 180 NAC 3-014.10(B)(ii). (D) Information identified in 180 NAC 3-014.10(A)(iii) on the Positron Emission Tomography (PET) drugs to be noncommercially transferred to members of its consortium.
011. GENERAL REQUIREMENTS FOR THE ISSUANCE OF SPECIFIC LICENSES . An applicant for a specific license must:
(A) Be qualified by reason of training and experience to use the material in question for the purpose requested according to Title 180 in such a manner as to minimize danger to public health and safety or property; (B) Have proposed equipment, facilities, and procedures are adequate to minimize danger to the public health and safety or property; (C) Demonstrate that the issuance of the license will not be inimical to the health and safety of the public; and (D) Satisfy any applicable special requirements in 180 NAC 3-013, 180 NAC 3-014, or 180 NAC 3-015, 180 NAC 5, 180 NAC 7, 180 NAC 12, 180 NAC 14 or 180 NAC 19.
011.01 ENVIRONMENTAL REPORT, COMMENCEMENT OF CONSTRUCTION. In the case of an application for a license to receive and possess radioactive material for commercial waste management, source material milling, or for the conduct of any other activity which the Department determines will significantly affect the quality of the environment, the Department, before commencement of construction of the plant or facility in which the activity will be conducted, has concluded, after weighing the environmental, economic, technical and other benefits against environmental costs and considering available alternatives, 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 is 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" 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 environmental values.
011.02 FINANCIAL SURETY ARRANGEMENTS FOR SITE RECLAMATION. The following applies to financial surety arrangements for site reclamation.
011.02(A) FINANCIAL SURETY. Financial surety arrangements for site reclamation which may consist of surety bonds, cash deposits, certificates of deposit, deposits of government securities, letters or lines of credit, or any combination of the above for the categories of licensees listed in 180 NAC 3-011.02 must be established to ensure the protection of the public health and safety in the event of abandonment, default, or other inability of the licensee to meet the requirements of the Act.
011.02(A)(i) COST ESTIMATES. The amount of funds to be ensured by such surety arrangements must be based on Department approved cost estimates equal to meet the requirements of 180 NAC 3-011.02(A).
011.02(A)(ii) SELF INSURANCE PROHIBITED. Self insurance, or any arrangement which essentially constitutes self insurance, will not satisfy the surety requirement since this provides no additional assurance other than that which already exists through license requirements.
011.02(B) LICENSE ISSUANCE. The arrangements required in 180 NAC 3-011.02(A). must be established prior to issuance of the license to assure that sufficient funds will be available to carry out the decontamination and decommissioning of the facility, other than as provided in 180 NAC 3-011.02(C).
011.02(C) LICENSE AMENDMENT. If the application is made to amend an existing license to fall within the purview of 180 NAC 3-011.02 then the financial surety arrangements for site reclamation must be established prior to the issuance of the amendment.
011.02(D) APPLICABILITY. The following specific licensees are required to make financial surety arrangements:
(i) Major processors; (ii) Waste management licensees, other than the commercial disposal of low-level radioactive waste in a disposal facility, designated by the Central Interstate Low-Level Radioactive Waste Compact Commission; (iii) Former U.S. Atomic Energy Commission or U.S. Nuclear Regulatory Commission (NRC) licensed facilities; (iv) Source material milling operations; and (v) All others other than persons exempt according to 180 NAC 3-011.02(E).
011.02(E) EXEMPT ENTITIES. The following persons are exempt from the requirements of 180 NAC 3-011.02(A) because they are exempt from licensure:
(i) All State, local, or other government agencies unless they are subject to 180 NAC 3-011.02(D)(ii) or (D)(iv), (ii) Persons authorized to possess no more than 1,000 times the quantity specified in 180 NAC 3, Appendix 3-B or combination of radioactive material listed therein as given in 180 NAC 3, Appendix 3-B, Note 1.; (iii) Persons authorized to possess hydrogen-3 contained as hydrogen gas in a sealed source; or (iv) Persons authorized to possess radioactive noble gases in sealed sources with no radioactive daughter product with half-life greater than 30 days.
011.02(F) LONG-TERM CARE REQUIREMENTS. A long-term care fund must be established by the following specific licensees prior to the issuance of the license or prior to the termination of the license if the applicant chooses at the time of the licensure to provide a surety in lieu of a long-term care fund:
(i) Waste management licensees; and (ii) Source material milling and mill tailings licensees.
012. RESERVED .
013. SPECIAL REQUIREMENTS FOR SPECIFIC LICENSES OF BROAD SCOPE . 180 NAC 3-013 prescribes requirements for the issuance of specific licenses of broad scope for radioactive material, also known as "broad licenses" and certain regulations governing holders of such licenses:
013.01 BROAD LICENSE TYPES. The different types of broad licenses are as follows.
013.01(A) TYPE A SPECIFIC LICENSE OF BROAD SCOPE. A Type A specific license of broad scope 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 any authorized purpose. The quantities specified are usually in the multicurie range, and the limits are based on types of radioactive materials, proposed use and upon the training and experience of the user or users.
013.01(B) TYPE B SPECIFIC LICENSE OF BROAD SCOPE. A Type B specific license of broad scope is a specific license authorizing receipt, acquisition, ownership, possession, use and transfer of any chemical or physical form of radioactive material specified in 180 NAC 3, Appendix 3-C for any authorized purpose. 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 180 NAC 3, Appendix 3-C, Column I. If two or more radionuclides are possessed thereunder, the possession limit for each is determined as follows: For each radionuclide, determine the ratio of the quantity possessed to the applicable quantity specified in 180 NAC 3, Appendix 3-C, Column l, for that radionuclide. The sum of the ratios for all radionuclides possessed under the license must not exceed unity.
013.01(C) TYPE C SPECIFIC LICENSE OF BROAD SCOPE. A Type C specific license of broad scope is a specific license authorizing receipt, acquisition, ownership, possession, use and transfer of any chemical or physical form of radioactive material specified in 180 NAC 3, Appendix 3-C for any authorized purpose. The possession limit for a Type C broad license, if only one radionuclide is possessed thereunder, is the quantity specified for that radionuclide in 180 NAC 3, Appendix 3-C, Column II. If two or more radionuclides are possessed thereunder, the possession limit is determined for each as follows: For each radionuclide determine the ratio of the quantity possessed to the applicable quantity specified in 180 NAC 3, Appendix 3-C, Column II for that radionuclide. The sum of the ratios for all radionuclides possessed under the license must not exceed unity.
013.02 TYPE A SPECIFIC LICENSE OF BROAD SCOPE. An applicant for Type A specific license of broad scope must:
(A) Satisfy the general requirements specified in 180 NAC 3-011; (B) Have engaged in a reasonable number of activities involving the use of radioactive material; and (C) Establish 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:
(i) 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 material; (ii) The appointment of a radiation safety officer who is qualified in training and experience in radiation protection consistent with the requirements of training specified in 180 NAC 15-005.01, and who is available for advice and assistance on radiation safety matters; and (iii) Authorized users designated by the Radiation Safety Committee must have formal training and experience in the safe handling of radioactive material consistent with the requirements of training specified in 180 NAC 15-005.02; and (iv) The establishment of appropriate administrative procedures to assure:
(1) Control of procurement and use of radioactive material; (2) Completion of safety evaluations of proposed uses of radioactive material which takes into consideration such matters as the adequacy of facilities and equipment, training and experience of the user, and the operating or handling procedures; and (3) Review, approval, and recording by the radiation safety committee of safety evaluations of proposed uses prepared according to 180 NAC 3-013.02(C)(iv)(2) prior to use of the radioactive material.
013.03 TYPE B SPECIFIC LICENSE OF BROAD SCOPE. An applicant for Type B specific license of broad scope must:
(A) Satisfy the general requirements specified in 180 NAC 3-011; and (B) Establish 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:
(i) The appointment of a radiation safety officer who is qualified by training and experience in radiation protection consistent with the requirements of training specified in 180 NAC 15-005.01 and who is available for advice and assistance on radiation safety matters, (ii) Authorized users must have formal training and experience in the safe handling of radioactive material consistent with the requirements of training specified in 180 NAC 15-005.02; and (iii) The establishment of appropriate administrative procedures to assure:
(1) Control of procurement and use of radioactive material, (2) 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 (3) Review, approval, and recording by the radiation safety officer of safety evaluations of proposed uses prepared according to 180 NAC 3-013.03, (B)(iii) prior to use of the radioactive material.
013.04 TYPE C SPECIFIC LICENSE OF BROAD SCOPE. An applicant for a Type C specific license of broad scope must:
(A) Satisfy the general requirements specified in 180 NAC 3-011; (B) Submit a statement that radioactive material will be used only by, or under the direct supervision of, individuals who have received:
(i) A college degree at the bachelor level, or equivalent training and experience, in the physical or biological sciences or in engineering, and (ii) At least 40 hours of formal training and 160 hours experience in the safe handling of radioactive material, 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) Establish 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.
013.05 PROPOSED USE AND CONDITIONS. Specific licenses of broad scope are subject to, based on quantities and types of radioactive materials, proposed use and upon the training and experience of the user or users, to the following conditions:
(A) Unless specifically authorized, persons licensed according to 180 NAC 3-013 must not:
(i) Conduct tracer studies in the environment involving direct release of radioactive material; (ii) Receive, acquire, own, possess, use or transfer devices containing 3.7 petabecquerel (PBq) (100,000 curies) or more of radioactive material in sealed sources used for irradiation of materials; (iii) Conduct activities for which a specific license issued by the Department under 180 NAC 3-014, 3-015 or 180 NAC 7, and 12 is required; or (iv) 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 180 NAC 3-013.05 is 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 180 NAC 3-013.05 is 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 180 NAC 3-013.05(D) is 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 180 NAC 3-013.04.
014. SPECIAL REQUIREMENTS FOR A SPECIFIC LICENSE TO MANUFACTURE, ASSEMBLE, REPAIR, OR DISTRIBUTE COMMODITIES, PRODUCTS, OR DEVICES WHICH CONTAIN RADIOACTIVE MATERIAL . This section addresses special requirements for a specific license to manufacture, assemble, repair, or distribute commodities, products, or devices which contain radioactive material.
014.01 RESERVED.
014.02 TRANSFER TO EXEMPT PERSONS. 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 180 NAC 3.004.01 or equivalent regulation of an Agreement State or U.S. Nuclear Regulatory Commission (NRC), other than according to a license issued under 10 CFR 32.11.
014.03 LICENSING THE INCORPORATION OF NATURALLY OCCURRING ACCELERATOR-PRODUCED RADIOACTIVE MATERIAL INTO GAS AND AEROSOL DETECTORS. An applicant for a specific license authorizing the incorporation of NARM into gas and aerosol detectors to be distributed to persons exempt under 180 NAC 3-004.03(C) must satisfy the requirements of 10 CFR 32.26. The maximum quantity of radium-226 in each device must not exceed 3.7 kBq (0.1 μCi).
014.04 LICENSING THE MANUFACTURE AND DISTRIBUTION OF DEVICES TO PERSONS GENERALLY LICENSED UNDER 180 NAC 3-008.04. The following is applicable to licensing the manufacture and distribution of devices to person generally licensed under 180 NAC 3-008.04.
014.04(A) APPLICATION. An applicant for a specific license to manufacture or distribute devices containing radioactive material, excluding special nuclear material, to persons generally licensed under 180 NAC 3-008.04 or equivalent regulations of the U.S. Nuclear Regulatory Commission (NRC), or an Agreement State must:
(i) Satisfy the general requirements of 180 NAC 3-011; (ii) Submit 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:
(1) The device can be safely operated by persons not having training in radiological protection; (2) 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 10% of the annual limits specified in 180 NAC 4-005.01; and (3) 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 following organ doses:
| Whole body; head and trunk; active blood-forming organs; gonads; or lens of eye | 150 millisievert (mSv) (15 rems) | | --- | --- | | Hands and forearms; feet and ankles; localized areas of skin averaged over areas no larger than 1 square centimeter | 2 sievert (Sv) (200 rems) | | Other organs | 500 millisievert (mSv) (50 rems) |
(iii) Label each device so that each device bears a durable, legible, clearly visible label or labels approved by the Department, which contain in a clearly identified and separate statement:
(1) 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; (2) The requirement, or lack of requirement, for leak testing, or for testing any on or off mechanism, or both, and indicator, including the maximum time interval for such testing, and the identification of radioactive material by isotope, quantity of radioactivity, and date of determination of the quantity; and (3) The information called for in the following statement, as appropriate in the same or substantially similar form:
The receipt, possession, use, and transfer of this device Model _______ , Serial No. ______9, are subject to a general license or the equivalent and the regulations of the U.S. Nuclear Regulatory Commission (NRC) or a state with which the U.S. Nuclear Regulatory Commission (NRC) has entered into an agreement for the exercise of regulatory authority. This label must be maintained on the device in a legible condition. Removal of this label is prohibited.
CAUTION - RADIOACTIVE MATERIAL
Name of Manufacturer or Distributor
The model, serial number, and name of manufacturer or distributor may be omitted from this label provided the information is elsewhere specified and labeling affixed to the device;
(iv) Label 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 180 NAC 4-033.01, and the name of the manufacturer or initial distributor; (v) Label each device meeting the criteria of 180 NAC 3-008.04, (C)(xiii)(1) so that it bears a permanent, 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 180 NAC 4-033.01; and (vi) Register the device in the Sealed Source and Device Registry.
014.04(B) ALTERNATE LEAK TESTING INTERVALS. 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 or off mechanism, or both, and indicator, if any, or for leakage of radioactive material or for both, the applicant must include in the 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 or off mechanism, or both, and indicator. In determining the acceptable interval for the test for leakage of radioactive material, the information at will be considered which includes, but is not limited to:
(i) Primary containment or source capsule; (ii) Protection of primary containment; (iii) Method of sealing containment; (iv) Containment construction materials; (v) Form of contained radioactive material; (vi) Maximum temperature withstood during prototype tests; (vii) Maximum pressure withstood during prototype tests; (viii) Maximum quantity of contained radioactive material; (ix) Radiotoxicity of contained radioactive material; and (x) Operating experience with identical devices or similarly designed and constructed devices.
014.04(C) GENERAL LICENSEE INSTALLATION AND LEAK TESTING. In the event the applicant desires that the general licensee under 180 NAC 3-008.04, or under equivalent regulations of U.S. Nuclear Regulatory Commission (NRC), 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 or off mechanism, or both, and indicator, or remove the device from installation, the applicant must include in the application written instructions to be followed by the general licensee, estimated calendar quarter doses associated with such activity or activities, and bases for such estimates. The submitted information must demonstrate that performance of such 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 10% of the annual limits specified in 180 NAC 4-005.01.
014.04(D) CONDITIONS OF TRANSFER. Licensees must meet the following conditions for transferring a device for use under a general license in 180 NAC 3-008.04.
014.04(D)(i) DEVICE CONTAINING RADIOACTIVE MATERIAL. If a device containing radioactive material is to be transferred for use under the general license in 180 NAC 3-008.04, each person that is licensed under 180 NAC 3-014.04 must 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 the general license contained in 180 NAC 3-008.04(C)(ii) through (iv) or (C)(xiii) do not apply to the particular device, those paragraphs may be omitted; (2) A copy of 180 NAC 3-008.01, 180 NAC 3-030, 180 NAC 4-057 and 4-058; (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; and (5) An indication that the Department’s policy is to issue high civil penalties for improper disposal.
014.04(D)(ii) RADIOACTIVE MATERIAL. If radioactive material is to be transferred in a device for use under an equivalent general license of the U.S. Nuclear Regulatory Commission (NRC) or an Agreement State, each person that is licensed under 180 NAC 3-014.04 must 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 the 180 NAC 3-008.01, 180 NAC 3-008.04, 180 NAC 4-057 and 058 or a copy of equivalent U.S. Nuclear Regulatory Commission (NRC) or Agreement State's regulations. If a copy of the U.S. Nuclear Regulatory Commission (NRC) regulations is provided to a prospective general licensee in lieu of the Department’s or Agreement State's regulations, it must be accompanied by a note explaining that use of the device is regulated by the U.S. Nuclear Regulatory Commission (NRC) or an Agreement State; if certain paragraphs of the regulations do not apply to the particular device, those paragraphs may be omitted; (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; and (4) The name or title, address, and phone number of the contact at the Department, U.S. Nuclear Regulatory Commission (NRC) or Agreement State from which additional information may be obtained.
014.04(D)(iii) ALTERNATIVE APPROACH. An alternative approach to informing customers may be proposed by the licensee for approval by the Department.
014.04(D)(iv) LABELING. Each device that is transferred after April 12, 2003 must meet the labeling requirements in 180 NAC 3-014.04(A)(iii) through (iv).
014.04(D)(v) BANKRUPTCY. If a notification of bankruptcy has been made under 180 NAC 3-017.05 or the license is to be terminated, each person licensed under 180 NAC 3-014.04 must provide, upon request, to the Department, the U.S. Nuclear Regulatory Commission (NRC) and to any appropriate Agreement State, records of final disposition required under 180 NAC 3-014.04(E)(iii).
014.04(E) MATERIAL TRANSFER REPORTS AND RECORDS. Licensees initially transferring devices to generally licensed persons must:
(i) Report all transfers of devices to persons for use under the general license in 180 NAC 3-008.04 and all receipts of devices from persons licensed under 180 NAC 3-008.04 to the Radioactive Material Program Manager, Nebraska Department of Health and Human Services, Radiological Health, 301 Centennial Mall South, P.O. Box 95026, Lincoln, NE 68509-5026. The report must be submitted on a quarterly basis on the Form NRH 653, “Transfers of Industrial Devices Report'' or in a clear and legible report containing all of the data required by the form. Form NRH 653 is set out in Attachment 5 of this chapter.
(1) The required information for transfers to general licensees includes:
(a) The identity of each general licensee by name and mailing location of use, an alternate address for the general licensee must 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 regulations 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 or persons; (3) For devices received from a 180 NAC 3-008.04 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 180 NAC 3-008.04 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 30 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; and (7) If no transfers have been made to or from persons generally licensed under 180 NAC 3-008.04 during the reporting period, the report must so indicate;
(ii) Report all transfers of devices to persons for use under a general license in an U.S. Nuclear Regulatory Commission (NRC) or Agreement State's regulations that are equivalent to 180 NAC 3-008.04 and all receipts of devices from general licensees in the U.S. Nuclear Regulatory Commission (NRC) or Agreement State's jurisdiction to the U.S. Nuclear Regulatory Commission (NRC) or responsible Agreement State agency. The report must be submitted on the Department’s Form 653, “Transfers of Industrial Devices Report'' or in a clear and legible report 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 must 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 regulations 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 or persons; (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 30 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 U.S. Nuclear Regulatory Commission (NRC) or a particular Agreement State during the reporting period, this information must be reported to the U.S. Nuclear Regulatory Commission (NRC) or responsible Agreement State agency upon request of the Department; and
(iii) Maintain all information concerning transfers and receipts of devices that supports the reports required by this 180 NAC 3-014.04(E). Records required by 180 NAC 3-014.04(E) must be maintained for a period of 3 years following the date of the recorded event.
014.05 SPECIAL REQUIREMENTS FOR THE MANUFACTURE, ASSEMBLY, OR REPAIR OF LUMINOUS SAFETY DEVICES FOR USE IN AIRCRAFT. An applicant for a specific license to manufacture, assemble, or repair luminous safety devices containing tritium or promethium-147 for use in aircraft, for distribution to persons generally licensed under 180 NAC 3-008.05 must:
(A) Satisfy the general requirements specified in 180 NAC 3-011; (B) Satisfy the requirements of 10 CFR 32.53 through 32.56; and (C) Have a radiation safety officer or authorized user that meets the training and experience requirements specified in 180 NAC 15-008.01.
014.06 SPECIAL REQUIREMENTS FOR LICENSE TO MANUFACTURE CALIBRATION SOURCES CONTAINING AMERICIUM-241, PLUTONIUM OR RADIUM-226 FOR DISTRIBUTION TO PERSONS GENERALLY LICENSED UNDER 180 NAC 3-008.07. An applicant for a specific license to manufacture or initially transfer calibration and reference sources containing americium-241, plutonium or radium-226 for distributions to persons generally licensed under 180 NAC 3-008.07 must:
(A) Satisfy the general requirement of 180 NAC 3-011; (B) Satisfy the requirements of 10 CFR 32.57 through 32.59; and (C) Have a radiation safety officer or authorized user that meets the training and experience requirements specified in 180 NAC 15-008.01.
014.07 RESERVED.
014.08 MANUFACTURE AND DISTRIBUTION OF RADIOACTIVE MATERIAL FOR CERTAIN IN VITRO CLINICAL OR LABORATORY TESTING UNDER GENERAL LICENSE. For a specific license to manufacture or distribute radioactive material for use under the general license of 180 NAC 3-008.09, the applicant must:
(A) Satisfy the general requirements specified in 180 NAC 3-011; (B) Prepare the radioactive material for distribution in prepackaged units of:
(i) Iodine-125 in units not exceeding 370 kBq (10 μCi) each; (ii) Iodine-131 in units not exceeding 370 kBq (10 μCi) each; (iii) Carbon-14 in units not exceeding 370 kilobecquerel (kBq) (10 microcuries) each; (iv) Hydrogen-3 (tritium) in units not exceeding 1.85 MBq (50 μCi) each; (v) Iron-59 in units not exceeding 740 kBq (20 μCi) each; (vi) Cobalt-57 in units not exceeding 370 kBq (10 μCi) each; (vii) Selenium-75 in units not exceeding 370 kBq (10 μCi) each; and (viii) Mock Iodine-125 in units not exceeding 1.85 kBq (0.05 μCi) of iodine-129 and 185 Bq (0.005 μCi) of americium-241 each;
(C) Label each prepackaged unit with a durable, clearly visible label:
(i) Identifying the radioactive contents as to chemical form and radionuclide, and indicating that the amount of radioactivity does not exceed 370 kBq (10 μCi) of iodine-125, iodine-131, carbon-14, cobalt-57, or selenium-75; 1.85 MBq (50 μCi) of hydrogen-3 (tritium); 740 kBq (20 μCi) of iron-59; or Mock Iodine-125 in units not exceeding 1.85 kBq (0.05 μCi) of iodine-129 and 185 Bq (0.005 μCi) of americium-241 each or colbalt-57 in units not exceeding 0.37 MBq (10 μCi); and (ii) Displaying the radiation caution symbol described in 180 NAC 4-033.01 and the words, "CAUTION, RADIOACTIVE MATERIAL" and "Not for Internal or External Use in Humans or Animals";
(D) Include 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 resulting radiation, to human beings or animals. Its receipt, acquisition, possession, use, and transfer are subject to the regulations and a general license of the U.S. Nuclear Regulatory Commission (NRC) or of a State with which the Commission has entered into an agreement for the exercise of regulatory authority.
Name of Manufacturer
(E) Affix a label 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 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 180 NAC 4-039; and (F) Demonstrate that the radiation safety officer or authorized user has training and experience requirements consistent with training specified in 180 NAC 15-009.01.
014.09 LICENSING THE MANUFACTURE AND DISTRIBUTION OF ICE DETECTION DEVICES CONTAINING STRONTIUM 90. An applicant for a specific license to manufacture and distribute ice detection devices to persons generally licensed under 180 NAC 3-008.10 must satisfy the general requirements of 180 NAC 3-011, the criteria of 10 CFR 32.61, and 32.62. The radiation safety officer or authorized user must have training and experience requirements specified in 180 NAC 15-008.01.
014.10 MANUFACTURE, PREPARATION, OR TRANSFER FOR COMMERCIAL DISTRIBUTION OF RADIOACTIVE DRUGS CONTAINING RADIOACTIVE MATERIAL FOR MEDICAL USE UNDER 180 NAC 7. The following requirements apply to the manufacture, preparation, or transfer for commercial distribution of radioactive drugs containing radioactive material for medical use under 180 NAC 7.
014.10(A) APPLICATION. An applicant for a specific license to manufacture, prepare, or transfer for commercial distribution radioactive drugs containing radioactive material for use by persons authorized according to 180 NAC 7, must:
(i) Satisfy the general requirements specified in 180 NAC 3-011; (ii) Submit evidence that the applicant is at least one of the following:
(1) Registered with the U.S. Food and Drug Administration (FDA) as the owner or operator of a drug establishment that engages in the manufacture, preparation, propagation, compounding, or processing of a drug under 21 CFR 207.17(a) (2) Registered or licensed with a state agency as a drug manufacturer; (3) Licensed according to 175 NAC 8, Pharmacies; (4) Operating as a nuclear pharmacy within a Federal medical institution; or (5) A Positron Emission Tomography (PET) drug production facility registered with the Department;
(iii) Submit 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 (iv) Commit to the following labeling requirements:
(1) 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 100 days, the time may be omitted; and (2) 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.
014.10(B) DRUG MANUFACTURERS AND PHARMACIES. A licensee described by 180 NAC 3-014.10, (A)(ii)(3) or (A)(ii)(4):
(i) May prepare radioactive drugs for medical use, as defined in 180 NAC 7-002, provided that the radioactive drug is prepared by either an authorized nuclear pharmacist, according to 180 NAC 3-014.10(A)(ii) and (iv), or an individual under the supervision of an authorized nuclear pharmacist according to 180 NAC 7-018; (ii) May allow a pharmacist to work as an authorized nuclear pharmacist if:
(1) This individual qualifies as an authorized nuclear pharmacist as defined in 180 NAC 7-002; (2) This individual meets the requirements specified in 180 NAC 7-024.02 and 7-027 and the licensee has received an approved license amendment identifying this individual as an authorized nuclear pharmacist, or (3) This individual is designated as an authorized nuclear pharmacist according to 180 NAC 3-014.10(B)(iii);
(iii) May be permitted to perform the actions authorized in 180 NAC 3-014.10(B)(i) and (ii) despite more restrictive language in license conditions; (iv) Reserved; (v) May designate a pharmacist, as defined in 180 NAC 1-002, as an authorized nuclear pharmacist if the individual is identified as of the effective date of these regulations, as an “authorized user” on a nuclear pharmacy license issued by the Department under 180 NAC 3 if:
(1) The individual was a nuclear pharmacist preparing only radioactive drugs containing accelerator-produced radioactive material, and (2) 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 U.S. Nuclear Regulatory Commission (NRC); and
(vi) Must provide to the Department a copy of each individual’s:
(1) Certification by a specialty board whose certification process has been recognized by the Department, U.S. Nuclear Regulatory Commission (NRC), or any Agreement State according to 7-024.01 with the written attestation signed by a preceptor as required by 7-024.03; or (2) The Department, the U.S. Nuclear Regulatory Commission (NRC), or any Agreement State license, or (3) U.S. Nuclear Regulatory Commission (NRC) master materials licensee permit, or (4) The permit issued by a licensee or U.S. Nuclear Regulatory Commission (NRC) master material permittee of broad scope, or the authorization from a commercial nuclear pharmacy authorized to list its own authorized nuclear pharmacist, or (5) 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 U.S. Nuclear Regulatory Commission (NRC); and (6) State pharmacy licensure or registration, no later than 30 days after the date that the licensee allows, according to 180 NAC 3-014.10, (B)(ii)(1) and (3), the individual to work as an authorized nuclear pharmacist.
014.10(C) INSTRUMENTATION. A licensee must possess and use instrumentation to measure the radioactivity of radioactive drugs. The licensee must have procedures for use of the instrumentation. The licensee must 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 must:
(i) 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 (ii) Check each instrument for constancy and proper operation at the beginning of each day of use.
014.10(D) ADDITIONAL REQUIREMENTS. Nothing in 180 NAC 3-014.10 relieves the licensee from complying with applicable U.S. Food and Drug Administration (FDA), other Federal, and State requirements governing radioactive drugs.
014.10(E) ELUATE CONTAMINATION TESTING. Each licensee preparing technetium-99m radiopharmaceuticals from molybdenum-99/technetium-99m generators or rubidium-82 from strontium-82/rubidium-82 generators must test the generator eluates for molybdenum-99 breakthrough or strontium-82 and strontium-85 contamination, respectively, according to 180 NAC 7-045. The licensee must record the results of each test and retain each record for 3 years after the record is made. The licensee must report the results of any test that exceeds the permissible concentration listed in 180 NAC 7-045 at the time of generator elution, according to 180 NAC 7-120.
014.10(F) POSITRON EMISSION TOMOGRAPHY (PET). Licensees authorized under 180 NAC 3-010.11 to produce Positron Emission Tomography (PET) radioactive drugs for noncommercial transfer to medical use licensees in its consortium must:
(i) Comply with applicable U.S. Food and Drug Administration (FDA), other Federal, and State requirements governing radioactive drugs; (ii) Satisfy the labeling requirements in 180 NAC 3-014.10(A)(iv) for each Positron Emission Tomography (PET) radioactive drug transport radiation shield and each syringe, vial, or other container; (iii) Possess and use instrumentation to measure the radioactivity of the Positron Emission Tomography (PET) radioactive drugs and meet the procedural, radioactivity measurement, instrument test, instrument check, and instrument adjustment requirements in 180 NAC 3-014.10(C). (iv) Require that any individual that prepares Positron Emission Tomography (PET) radioactive drugs in a pharmacy to be:
(1) An authorized nuclear pharmacist that meets the requirements in 180 NAC 3-014.10, (B)(ii); or (2) An individual under the supervision of an authorized nuclear pharmacist according to 180 NAC 7-018; and
(v) Meet the requirements of 180 NAC 3-014(B)(vi).
014.10(G) LABELING. A licensee must satisfy the labeling requirements in 180 NAC 3-014.10(A)(iv).
014.11 RESERVED.
014.12 MANUFACTURE AND DISTRIBUTION OF SOURCES OR DEVICES CONTAINING RADIOACTIVE MATERIAL FOR MEDICAL USE. An applicant for a specific license to manufacture and distribute sources and devices containing radioactive material to persons licensed according to 180 NAC 7 for use as a calibration, transmission or reference source or for the uses listed in 180 NAC 7-055, 7-065, 7-067 and 7-085 must:
(A) Satisfy the general requirements in 180 NAC 3-011. (B) Submit sufficient information regarding each type of source or device pertinent to an evaluation of its radiation safety, including:
(i) The radioactive material contained, its chemical and physical form, and amount; (ii) Details of design and construction of the source or device; (iii) 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; (iv) For devices containing radioactive material, the radiation profile of a prototype device; (v) Details of quality control procedures to assure that production sources and devices meet the standards of the design and prototype tests; (vi) Procedures and standards for calibrating sources and devices; (vii) Legend and methods for labeling sources and devices as to their radioactive content; and (viii) 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.
(C) Affix a label 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 Department has approved distribution of the (name of the source or device) to persons licensed to use radioactive material identified in 180 NAC 7-032, 7-055, 7-065 and 7-067 as appropriate, and to persons who hold an equivalent license issued by the U.S. Nuclear Regulatory Commission (NRC) or an Agreement State. (D) Register the source or device in the Sealed Source and Device Registry. (E) Include in their application sufficient information to demonstrate that a 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 if the applicant desires that the source or device be required to be tested for leakage of radioactive material at intervals longer than six months; (F) Provide information to the Department to support a determination that the acceptable interval for test of leakage of radioactive material is longer than six months. The information includes, but is not limited to:
(i) Primary containment or source capsule; (ii) Protection of primary containment; (iii) Method of sealing containment; (iv) Containment construction materials; (v) Form of contained radioactive material; (vi) Maximum temperature withstood during prototype tests; (vii) Maximum pressure withstood during prototype tests; (viii) Maximum quantity of contained radioactive material; (ix) Radiotoxicity of contained radioactive material; and (x) Operating experience with identical sources or devices or similarly designed and constructed sources or devices; and
(G) Demonstrate that radiation safety officer or authorized user has training and experience requirements consistent with training specified in 180 NAC 15-008.01.
014.13 REQUIREMENTS FOR LICENSE TO MANUFACTURE AND DISTRIBUTE INDUSTRIAL PRODUCTS CONTAINING DEPLETED URANIUM FOR MASS-VOLUME APPLICATIONS. The following requirements are applicable for license to manufacture and distribute industrial products containing depleted uranium for mass-volume applications.
014.13(A) APPLICATION. An applicant for a specific license to manufacture industrial products and devices containing depleted uranium for use according to 180 NAC 3-007.04 or equivalent regulations of the U.S. Nuclear Regulatory Commission (NRC) or an Agreement State must:
(i) Satisfy the general requirements specified in 180 NAC 3-011; (ii) Submit 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 any period of one year a radiation dose in excess of 10% of the annual limits specified in 180 NAC 4-005.01; and (iii) Submit 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.
014.13(B) DEMONSTRATION. In the case of an industrial product or device whose unique benefits are questionable the licensee must demonstrate that the product or device combines a high degree of utility and low probability of uncontrolled disposal and dispersal of significant quantities of depleted uranium into the environment.
014.13(C) END USE. Any application for a specific license under 180 NAC 3-014.13 must demonstrate that the end use or uses of the industrial product or device can be reasonably foreseen.
014.13(D) ADDITIONAL REQUIREMENTS. Each person licensed according to 180 NAC 3-014.13(A) must:
(i) 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; (ii) Label or mark each unit to: (a) Identify the manufacturer of the product or device and the number of the license under which the product or device was manufactured, the fact that the product or device contains depleted uranium, and the quantity of depleted uranium in each product or device; and (b) State that the receipt, possession, use, and transfer of the product or device are subject to a general license or the equivalent and the regulations of the U.S. Nuclear Regulatory Commission (NRC) or of an Agreement State; (iii) 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"; (iv) Furnish:
(1) A copy of the general license contained in 180 NAC 3-007.04 and a copy of Department Form NRH-11 to each person to whom the licensee transfers depleted uranium in a product or device for use according to the general license contained in 180 NAC 3-007.04; or (2) A copy of the general license contained in the U.S. Nuclear Regulatory Commission (NRC) or Agreement State's regulation equivalent to 180 NAC 3-007.04 and a copy of the U.S. Nuclear Regulatory Commission (NRC) or Agreement State's certificate; or alternatively, furnish a copy of the general license contained in 180 NAC 3-007.04 and a copy of Department Form NRH-11 to each person to whom the licensee transfers depleted uranium in a product or device for use according to the general license of the U.S. Nuclear Regulatory Commission (NRC) or an Agreement State, with a note explaining that use of the product or device is regulated by the U.S. Nuclear Regulatory Commission (NRC) or an Agreement State under requirements substantially the same as those in 180 NAC 3-007.04;
(v) Report to the Department all transfers of industrial products or devices to persons for use under the general license in 180 NAC 3-007.04. Such report must identify each general licensee by name and address, an individual by name and position who may constitute a point of contact between the Department 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 must be submitted within 30 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 180 NAC 3-007.04 during the reporting period, the report must so indicate; and (vi) File a report which identifies each general licensee by name and address, an individual by name and position who may constitute a point of contact between the agency and the general licensee, the type and model number of the device transferred, and the quantity of depleted uranium contained in the product or device. The report must be submitted within 30 days after the end of each calendar quarter in which such product or device is transferred to the generally licensed person. The licensee must report:
(1) To the U.S. Nuclear Regulatory Commission (NRC) all transfers of industrial products or devices to persons for use under the U.S. Nuclear Regulatory Commission (NRC) general license in 10 CFR 40.25; (2) To the responsible State agency all transfers of devices manufactured and distributed according to 180 NAC 3-014.13 for use under a general license in that State's regulations equivalent to 180 NAC 3-007.04; (3) To the U.S. Nuclear Regulatory Commission (NRC) if no transfers have been made by the licensees during the reporting period; and (4) To the responsible Agreement State Agency, upon the request of the Department, if no transfers have been made to general licensees within a particular Agreement State during the reporting period;
(vii) Keep records showing the name, address, and point of contact for each general licensee to whom the licensee transfers depleted uranium in industrial products or devices for use according to the general license provided in 180 NAC 3-008.04 or equivalent regulations of the U.S. Nuclear Regulatory Commission (NRC) or of an Agreement State. The records must be maintained for a period of two years 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; and (viii) Demonstrate that the radiation safety officer or authorized user have training and experience consistent with the requirements of training specified in 180 NAC 15-008.01.
014.14 SERIALIZATION OF NATIONALLY TRACKED SOURCES. Each licensee who manufactures a nationally tracked source after February 6, 2007, must assign a unique serial number to each nationally tracked source. Serial numbers must be composed only of alpha-numeric characters.
014.15 RESERVED.
015. SPECIAL REQUIREMENTS FOR ISSUANCE OF SPECIFIC LICENSES FOR SOURCE MATERIAL MILLING . In addition to the requirements set forth in 180 NAC 3-011, a specific license for source material milling must meet the other conditions specified below.
015.01 APPLICATION. An Application for a License to Receive Title to, Receive, Possess, and Use Source Material for Milling or Radioactive Material as Defined in 180 NAC 1-002 must include the following:
(A) A description of the proposed project or action; (B) Area/site characteristics including geology, topography, hydrology, and (C) Radiological and nonradiological impacts of the proposed project or action, including waterway and groundwater impacts; (D) Environmental effects of accidents; (E) Long-term impacts including decommissioning, decontamination, and reclamation; and meteorology; and (F) Site and project alternatives.
015.02 ENVIRONMENTAL COSTS. According to 180 NAC 3-011.01, the applicant must not commence construction of the project until the Department has weighed the environmental, economic, technical, and other benefits against the environmental costs and has concluded that the issuance of the license is appropriate.
015.03 PRE-OPERATIONAL MONITORING PROGRAM. At least 1 full year prior to any major site construction, a pre-operational monitoring program must be conducted to provide complete baseline data on a milling site and its environs. Throughout the construction and operating phases of the mill, an operational monitoring program must be conducted to measure or evaluate compliance with applicable standards and regulations; to evaluate performance of control systems and procedures; to evaluate environmental impacts of operation; and to detect potential long-term effects.
015.04 FINANCIAL SURETY. Prior to issuance of the license, the applicant must establish financial surety arrangements consistent with the requirements of 180 NAC 3-011.02.
015.04(A) SURETY ARRANGEMENTS. The amount of funds to be ensured by financial surety arrangements will be based on Department-approved cost estimates in an approved plan for decontamination and decommissioning of mill buildings and the milling site to levels which would allow unrestricted use of these areas upon decommissioning, and the reclamation of tailings or waste disposal areas. The licensee must submit this plan in conjunction with an environmental report that addresses the expected environmental impacts of the milling operation, decommissioning and tailings reclamation, and that evaluates alternatives for mitigating these impacts. In establishing specific surety arrangements, the licensee's cost estimates will take into account total costs that would be incurred if an independent contractor were hired to perform the decommissioning and reclamation work. In order to avoid unnecessary duplication and expense, the Department may accept financial sureties that have been consolidated with financial surety arrangements established to meet requirements of other Federal or State agencies or local governing bodies for such decommissioning, decontamination, reclamation, and long-term site surveillance, provided such arrangements are considered adequate to satisfy these requirements and that portion of the surety which covers the decommissioning and reclamation of the mill, mill tailings site and associated areas, and the long-term funding charge are clearly identified. The licensee's surety mechanism will be reviewed annually by the Department to assure that sufficient funds will be available for completion of the reclamation plan if the work had to be performed by an independent contractor. The amount of surety liability must be adjusted to recognize any increases or decreases resulting from inflation, changes in engineering plans, activities performed, and any other conditions affecting costs. Regardless of whether reclamation is phased through the life of the operation or takes place at the end of operations, an appropriate portion of surety liability will be retained until final compliance with the reclamation plan is determined. This will yield a surety that is at least sufficient at all times to cover the costs of decommissioning, decontamination, and reclamation of the areas that are expected to be disturbed before the next license renewal. The term of the surety mechanism must be open ended, unless it can be demonstrated that another arrangement would provide an equivalent level of assurance. This assurance could be provided with a surety instrument which is written for a specified period of time which must be automatically renewed unless the surety agent notifies the beneficiary, the State regulatory agency, and the principal, the licensee, some reasonable time prior to the renewal date of their intention not to renew. In such a situation, the surety requirement still exists and the licensee would be required to submit an acceptable replacement surety within a brief period of time to allow at least 60 days for the regulatory agency to collect.
015.04(B) LICENSE TERMINATION. The total amount of funds for reclamation or long term surveillance and control will 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 a license. Such funds include, but are not limited to, sums collected for long term surveillance and control. 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.
015.05 PROCEDURES. The applicant must provide procedures describing the means employed to meet the following requirements during the operational phase of any project:
(A) Milling operations must be conducted so that all effluent releases are below the limits of 180 NAC 4 and are as low as is reasonably achievable; (B) The mill operator must conduct daily inspections of any tailings or waste retention systems. Such inspections must be conducted by a qualified engineer or scientist. Records of such inspections must be maintained for review by the Department; and (C) The mill operator must immediately notify the Department of the following:
(i) Any failure in a tailings or waste retention system which results in a release of tailings or waste into unrestricted areas; and (ii) Any unusual conditions or conditions not contemplated in the design of the retention system which, if not corrected, could lead to failure of the system and result in a release of tailings or waste into unrestricted areas.
015.06 CONTINUED SURVEILLANCE REQUIREMENTS FOR SOURCE MATERIAL MILLINGS HAVING RECLAIMED RESIDUES. The following is required of continued surveillance for source material millings having reclaimed residues.
015.06(A) ONGOING MAINTENANCE. The final disposition of tailings or wastes at source material milling sites must be such that the need for ongoing active maintenance is not necessary to preserve isolation. As a minimum, annual site inspections must be conducted by the government agency retaining ultimate custody of the site where tailings or wastes are stored to confirm the integrity of the stabilized tailings or waste systems and to determine the need, if any, for maintenance and monitoring. Results of the inspection must be reported to the Department within 60 days following each inspection. The Department may require more frequent site inspections, if, on the basis of a site-specific evaluation, such a need appears necessary due to the features of a particular tailings or waste disposal system.
015.06(B) ADDITIONAL FUNDING. If site surveillance or control requirements at a particular site are determined, on the basis of a site-specific evaluation, to be significantly greater than those specified in, 180 NAC 3-015.06(A) additional funding requirements may be specified by the Department. The charge will be reviewed annually to recognize or adjust for inflation.
016. ISSUANCE OF SPECIFIC LICENSES . This section addresses the issuance of specific licenses.
016.01 DETERMINATION OF ACCEPTABLE REQUIREMENTS. Upon a determination that an application meets the requirements of the Act and the regulations of the Department, the Department will issue a specific license authorizing the proposed activity in such form and containing such conditions and limitations as it deems appropriate or necessary, based on quantities and types of radioactive materials, proposed use and upon the training and experience of the user or users.
016.02 INCORPORATION OF ADDITIONAL REQUIREMENTS AND CONDITIONS. The Department may incorporate in any license at the time of issuance, or after by appropriate rule, regulation, or order, such additional requirements and conditions with respect to the licensee's receipt, possession, use and transfer of radioactive material including the requirement of reports, keeping of records and to provide for inspections as it deems appropriate or necessary in order to:
(A) Minimize danger to public health and safety or property; and (B) Prevent loss or theft of material subject to 180 NAC 3-016.02.
017. SPECIFIC TERMS AND CONDITIONS OF LICENSE . This section addresses specific terms and conditions of license.
017.01 APPLICIBILITY. Each license issued according to 180 NAC 3, 5, 7, 12, 14 and 19 will be subject to all the provisions of the Act, now or after in effect, and to all rules, regulations, and orders of the Department.
017.02 LICENSE TRANSFER. To transfer a license, the following requirements apply:
(A) No license issued or granted under 180 NAC 3, 5, 7, 12, 14, and 19 and no right to possess or utilize radioactive material granted by any license issued according to 180 NAC 3, 5, 7, 12, 14, and 19 may 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 Department, after securing full information find that the transfer is according to the provisions of the Act, and gives its consent in writing; and (B) An application for transfer of license must include:
(i) The identity, technical and financial qualifications of the proposed transferee; and (ii) Financial assurance for decommissioning information required by 180 NAC 3-018.
017.03 LOCATION AND PURPOSES. Each person licensed by the Department according to,180 NAC 3, 5, 7, 12, 14, and 19 must confine use and possession of the material licensed to the locations and purposes authorized in the license.
017.04 NOTIFICATION OF DISCONTINUANCE. Each licensee must notify the Department in writing when the licensee decides to permanently discontinue all activities involving materials under the license. This notification requirement applies to all specific licenses issued under, 180 NAC 3, 5, 7, 12, 14, and 19.
017.05 BANKRUPTCY NOTIFICATION. Each general licensee that is required to register by 180 NAC 3-005 and each specific licensee must notify the Department, in writing, immediately 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), set out as Attachment 6 and incorporated by this reference, 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), set out as Attachment 6 and incorporated by this reference, of the licensee; and (D) 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.
018. FINANCIAL ASSURANCE AND RECORDKEEPING FOR DECOMMISSIONING . This section addresses financial assurance and recordkeeping for decommissioning.
018.01 DECOMMISSIONING FUNDING PLAN. The following requirements apply to the submission of decommissioning funding plans.
018.01(A) UNSEALED RADIOACTIVE MATERIAL. Each holder of, or applicant for a specific license authorizing the possession and use of unsealed radioactive material of half-life greater than 120 days and in quantities exceeding 105 times the applicable quantities set forth in 180 NAC 4, Appendix 4-F must submit a decommissioning funding plan as described in 180 NAC 3-018.05. The decommissioning funding plan must also be submitted when a combination of isotopes is involved if R divided by 105 is greater than 1, unity rule, where R is defined here as the sum of the ratios of the quantity of each isotope to the applicable value in Appendix 4-F of 180 NAC 4.
018.01(B) SEALED SOURCES OR PLATED FOILS. Each holder of, or applicant for any specific license authorizing the possession and use of sealed sources or plated foils of half-life greater than 120 days and in quantities exceeding 1012 times the applicable quantities set forth in 180 NAC 4, Appendix 4-F, or when a combination of isotopes is involved if R, as defined in 180 NAC 3-018.01(A), divided by 1012 is greater than 1, must submit a decommissioning funding plan as described in 180 NAC 3-018.05.
018.02 DECOMMISSIONING FUNDING PLAN OR CERTIFICATION OF FINANCIAL ASSURANCE. Each holder of, or applicant for a specific license authorizing possession and use of radioactive material of half-life greater than 120 days and in quantities specified in 180 NAC 3-018.04 must either:
(A) Submit a decommissioning funding plan as described in 180 NAC 3-018.05; or (B) Submit a certification that financial assurance for decommissioning has been provided in the amount prescribed by 180 NAC 3-018.04 using one of the methods described in 180 NAC 3-018.06. 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 prior to the receipt of radioactive 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 180 NAC 3-018.06 must be submitted to the Department before receipt of radioactive material. If the applicant does not defer execution of the financial instrument, the applicant must submit to the Department as part of the certification, a signed original of the financial instrument obtained to satisfy the requirements of 180 NAC 3-018.06.
018.03 WASTE COLLECTORS, WASTE PROCESSORS AND LICENSEES HAVING SITES WITH RESIDUAL RADIOACTIVITY. The following requirements apply to waste collectors and waste processors and sites unable to meet radiological criteria for unrestricted release.
018.03(A) WASTE COLLECTOR AND WASTE PROCESSORS. Waste collector and waste processors, as defined in 180 NAC 4, Appendix 4-D, must provide financial assurance in an amount based on a decommissioning funding plan as described in 180 NAC 3-018.05. The decommissioning funding plan must include the cost of disposal of the maximum amount, in curies, of radioactive material permitted by license, and the cost of disposal of the maximum quantity, by volume, of radioactive material which could be present at the licensee’s facility at any time, in addition to the cost to remediate the licensee’s site to meet the license termination criteria of 180 NAC 3.
018.03(B) LICENSEES HAVING SITES WITH RESIDUAL RADIOACTIVITY. If, in surveys made under 180 NAC 4-021.01, residual radioactivity in the facility and environment, including the subsurface, is detected at levels that would, if left uncorrected, prevent the site from meeting the 180 NAC 4-016 criteria for unrestricted use, the licensee must provide financial assurance in an amount based on a decommissioning funding plan as described in 180 NAC 3-018.05 within one year of when the survey is completed.
018.04 TABLE OF REQUIRED AMOUNTS OF FINANCIAL ASSURANCE FOR DECOMMISSIONING BY QUANTITY OF MATERIAL. Licensees having possession limits exceeding the upper bound of this table must base financial assurance on a decommission funding plan.
| Greater than 104 but less than or equal to 105 times the applicable quantities of 180 NAC 4, Appendix 4-F in unsealed form. (For a combination of isotopes, if R, as defined in 180 NAC 3-018.01, (A) divided by 104 is greater than 1 but R divided by 105 is less than or equal to 1.) | $1,125,000 | | --- | --- | | Greater than 103 but less than or equal to 104 times the applicable quantities of 180 NAC 4, Appendix 4-F in unsealed form. (For a combination of isotopes, if R, as defined in 180 NAC 3-018.01, (A) divided by 103 is greater than 1 but R divided by 104 is less than or equal to 1.) | $225,000 | | Greater than 1010 but less than or equal to 1012 times the applicable quantities of 180 NAC 4, Appendix 4-F in sealed sources or plated foils. (For a combination of isotopes, if R, as defined in180 NAC 3-018.01, (A) divided by 1010 is greater than 1, but R divided by 1012 is less than or equal to 1.) | $113,000 |
018.05 REQUIREMENTS FOR REVIEW AND APPROVAL. 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:
(i) The cost of an independent contractor to perform all decommissioning activities; (ii) The cost of meeting the 180 NAC 4-016 criteria for unrestricted use, provided that, if the applicant or licensee can demonstrate its ability to meet the provisions of 180 NAC 4-017, the cost estimate may be based on meeting the 180 NAC 4-017 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;
(2) Identification of and justification for using the key assumptions contained in the decommissioning cost estimate (DCE); (3) A description of the method of assuring funds for decommissioning from 180 NAC 3-018.06, 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 180 NAC 3-018.06, unless a previously submitted and accepted financial instrument continues to cover the cost estimate for decommissioning.
018.05(A) DECOMMISSIONING FUNDING PLAN RESUBMISSION. 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 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:
(i) Spills of radioactive material producing additional residual radioactivity in onsite subsurface material; (ii) Waste inventory increasing above the amount previously estimated; (iii) Waste disposal costs increasing above the amount previously estimated; (iv) Facility modifications; (v) Changes in authorized possession limits; (vi) Actual remediation costs that exceed the previous cost estimate; (vii) Onsite disposal; and (viii) Use of a settling pond.
018.06 FINANCIAL INSTRUMENT. The financial instrument must include the licensee's name, license number, and the name, address, and other contact information of the issuer, and, if a trust is used, the trustee. When any of the foregoing information changes, the licensee must, within 30 days, submit financial instruments reflecting such changes. The financial instrument submitted must be a signed original or signed original duplicate, other than where a copy of the signed original is specifically permitted. Financial assurance for decommissioning must be provided by one or more of the following methods.
018.06(A) PREPAYMENT. 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 must be made into a trust account, and the trustee and trust must be acceptable to the Department.
018.06(B) 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, or letter 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 180 NAC 3, Appendix 3-F. For commercial corporation 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 180 NAC 3 Appendix 3-D. 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 180 NAC 3, Appendix 3-G. 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 180 NAC 3, Appendix 3H. Other than for an external sinking fund, a parent company guarantee or 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 section. A guarantee by the applicant or licensee may not be used 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:
(i) 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 90 days or more prior to the renewal date, the issuer notifies the Department, 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 Department within 30 days after receipt of notification of cancellation; (ii) The surety method or insurance must be payable to a trust established for decommissioning costs. The trustee and trust must be acceptable to the Department. 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; and (iii) The surety method or insurance must remain in effect until the Department has terminated the license.
018.06(C) EXTERNAL SINKING FUND. 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. If the other guarantee method is used, no surety or insurance may be combined with the external sinking fund. The surety insurance, or other guarantee provisions must be as stated in 180 NAC 3-018.06(B).
018.06(D) STATEMENT OF INTENT. 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 the Table in 180 NAC 3-018.04, and indicating that funds for decommissioning will be obtained when necessary.
018.06(E) GOVERNMENT ENTITY ASSUMING CUSTODY AND OWNERSHIP. When a governmental entity is assuming custody and ownership of a site, an arrangement that is deemed acceptable by such governmental entity.
018.07 RECORDS OF INFORMATION IMPORTANT TO THE DECOMMISSIONING OF THE FACILITY. Each person licensed under 180 NAC 3, 5, 7, 12, 14 and 19 must keep records of information important to the decommissioning of the facility in an identified location until the site is released for unrestricted use. Before licensed activities are transferred or assigned according to 180 NAC 3-017.02, licensees must transfer all records described in 180 NAC 3-018.07 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 important to decommissioning consists of:
(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 must include any known information on identification of involved nuclides, quantities, forms, and concentrations; (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 required drawings are referenced, each relevant document need not be indexed individually. If drawings are not available, the licensee must substitute appropriate records of available information concerning these areas and locations; (C) A list contained in a single document and updated every 2 years, for areas other than areas containing only sealed sources, provided the sources have not leaked or no contamination remains after any leak, or radioactive materials having only half-lives of less than 65 days. The list must include the following:
(i) All areas designated and formerly designated as restricted areas as defined under 180 NAC 1-002; (ii) All areas outside of restricted areas that require documentation under 180 NAC 3-018.07, (A); (iii) All areas outside of restricted areas where current and previous wastes have been buried as documented under 180 NAC 4-054; and (iv) All areas outside of restricted areas which contain material such that, if the license expired, the licensee would be required to either decontaminate the area to unrestricted release levels or apply for approval for disposal under 180 NAC 4-040; and
(D) 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.
018.08 DECOMMISSIONING FUNDING PLAN FOR APPLICATIONS AUTHORIZING POSSESSION AND USE OF MORE THAN 100 mCi OF SOURCE MATERIAL IN A READILY DISPERSIBLE FORM. Each person applying for a specific license authorizing the possession and use of more than 100 mCi of source material in a readily dispersible form must submit a decommissioning funding plan as described in 180 NAC 3-018.05.
018.09 DECOMMISSIONING FUNDING PLAN FOR APPLICATIONS AUTHORIZING POSSESSION AND USE OF GREATER THAN 10 mCi BUT LESS THAN OR EQUAL TO 100 mCi OF SOURCE MATERIAL IN A READILY DISPERSIBLE FORM. Each person applying for a specific license authorizing the possession and use of quantities of source material greater than 10 mCi but less than or equal to 100 mCi in a readily dispersible form must either:
(A) Submit a decommissioning funding plan as described in 180 NAC 3-018.05; or (B) Submit a certification that financial assurance for decommissioning has been provided in the amount of $225,000 using one of the methods described in 180 NAC 3-018.06. 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 180 NAC 3-018.06 must be submitted to Department prior to receipt of licensed material. If the applicant does not defer execution of the financial instrument, the applicant must submit to Department, as part of the certification, a signed original of the financial instrument obtained to satisfy the requirements of 180 NAC 3-18.06.
018.10 FINANCIAL ASSURANCE FUNDS. In providing financial assurance under 180 NAC 3-018, each licensee must use the financial assurance funds only for decommissioning activities and each licensee must monitor the balance of funds held to account for market variations. The licensee must replenish the funds, and report such actions to the Department, as follows:
(A) If, at the end of a calendar quarter, the fund balance is below the amount necessary to cover the cost of decommissioning, but is not below 75 percent of the cost, the licensee must increase the balance to cover the cost, and must do so within 30 days after the end of the calendar quarter; (B) If, at any time, the fund balance falls below 75 percent of the amount necessary to cover the cost of decommissioning, the licensee must increase the balance to cover the cost, and must do so within 30 days of the occurrence; and (C) Within 30 days of taking the actions required by 180 NAC 3-018.10(A) or (B), the licensee must provide a written report of such actions to the Department and state the new balance of the fund.
019. EXPIRATION AND TERMINATION OF LICENSES AND DECOMMISSIONING OF SITES AND SEPARATE BUILDINGS OR OUTDOOR AREAS . This section addresses the expiration and termination of licenses and decommissioning of sites and separate buildings or outdoor areas.
019.01 EXPIRATION. 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 180 NAC 3-020 not less than 30 days before the expiration date stated in the existing license. If an application for renewal has been filed at least 30 days prior to the expiration date stated in the existing license, the existing license expires at the end of the day on which the Department makes a final determination to deny the renewal application or if the determination states an expiration date, the expiration date stated in the determination.
019.02 REVOCATION. Each specific license revoked by the Department expires at the end of the day on the date of the Department’s final determination to revoke the license, or on the expiration date stated in the determination, or as otherwise provided by Department Order.
019.03 WRITTEN NOTIFICATION OF TERMINATION. Each specific license continues in effect, beyond the expiration date if necessary, with respect to possession of radioactive material until the Department notifies the licensee in writing that the license is terminated. During this time, the licensee must:
(A) Limit actions involving radioactive material to those related to decommissioning; and (B) Continue to control entry to restricted area until they are suitable for release according to Department requirements.
019.04 NOTIFICATIONS. Within 60 days of the occurrence of any of the following, consistent with the administrative directions in 180 NAC 1-012, each licensee must provide notification to the Department in writing of such occurrence, 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 according to Department requirements, or submit within 12 months of notification a decommissioning plan, if required by 180 NAC 3-019.07 and begin decommissioning upon approval of that plan if:
(A) The license has expired according to 180 NAC 3-019.01 and 3-019.02; (B) The licensee has decided to permanently cease principal activities, as defined in 180 NAC 3-002, at the entire site or in any separate building or outdoor area that contains residual radioactivity such that the building or outdoor area is unsuitable for release according to Department requirements; (C) No principal activities under the license have been conducted for a period of 24 months; or (D) No principal activities have been conducted for a period of 24 months in any separate building or outdoor area that contains residual radioactivity such that the building or outdoor area is unsuitable for release according to Department requirements.
019.05 FINANCIAL ASSURANCE MAINTENANCE. Coincident with the notification required by 180 NAC 3-019.04, the licensee must maintain in effect all decommissioning financial assurances established by the licensee according to 180 NAC 3-018 in conjunction with a license issuance or renewal or as required by 180 NAC 3-019.05. The amount of the financial assurance must be increased, or may be decreased, as appropriate, to cover the detailed cost estimate for decommissioning established according to 180 NAC 3-019.07(D)(v). Additionally:
(A) Any licensee who has not provided financial assurance to cover the detailed cost estimate submitted with the decommissioning plan must do so; and (B) 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 Department.
019.06 EXTENSION REQUEST. The Department may grant a request to extend the time periods established in 180 NAC 3-019.04 if the Department determines that the request demonstrates that this 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 30 days before notification according to 180 NAC 3-019.04. The schedule for decommissioning set forth in 180 NAC 3-019.04 may not commence until the Department has made a determination on the request.
019.07 DECOMMISSIONING PLANS. The following applies to decommissioning plan submission.
019.07(A) REQUIREMENTS FOR SUBMISSION. 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 Department and these procedures could increase potential health and safety impacts to workers or to the public; as in the following cases:
(i) Procedures would involve techniques not applied routinely during cleanup or maintenance operations; (ii) Workers could be entering areas not normally occupied where surface contamination and radiation levels are significantly higher than routinely encountered during operation; (iii) Procedures could result in significantly greater airborne concentrations of radioactive materials than are present during operation; or (iv) Procedures could result in significantly greater releases of radioactive materials to the environment than those associated with operation.
019.07(B) ALTERNATE SCHEDULE. An alternate schedule for submittal of a decommissioning plan required according to 180 NAC 3-019.04 must demonstrate 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.
019.07(C) PRIOR APPROVAL REQUIRED. Procedures specified in 180 NAC 3-019.07(A) with potential health and safety impacts may not be carried out prior to the approval of the decommissioning plan.
019.07(D) REQUIRED ITEMS. The proposed decommissioning plan for the site or separate building or outdoor area must include:
(i) A description of the conditions of the site or separate building or outdoor area sufficient to evaluate the acceptability of the plan; (ii) A description of planned decommissioning activities; (iii) A description of methods used to ensure the protection of workers and the environment against radiation hazards during decommissioning; (iv) A description of the planned final radiation survey; and (v) 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 (vi) For decommissioning plans calling for completion of decommissioning later than 24 months after plan approval, the plan must include a justification for the delay based on the criteria in 180 NAC 3-019.09.
019.07(E) COMPLETION AND PROTECTION. The proposed decommissioning plan must demonstrate 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.
019.08 DECOMMISSIONING COMPLETION SCHEDULE. Other than provided in 180 NAC 3-019.09, licensees must:
(A) Complete decommissioning of the site or separate building or outdoor area as soon as possible but no later than 24 months following the initiation of decommissioning; and
(B) Request license termination as soon as possible but no later than 24 months following the initiation of decommissioning when decommissioning involves the entire site.
019.09 ALTERNATE SCHEDULE OF COMPLETION. Licensees may request an alternative schedule for completion of decommissioning of the site or separate building or outdoor area, and license termination. The following information must be submitted for consideration:
(A) Whether it is technically feasible to complete decommissioning within the allotted 24 month period; (B) Whether sufficient waste disposal capacity is available to allow completion of decommissioning within the allotted 24 month period; (C) Whether a significant volume reduction in wastes requiring disposal will be achieved by allowing short-lived radionuclides to decay; (D) Whether a significant reduction in radiation exposure to workers can be achieved by allowing short-lived radionuclides to decay; and (E) 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.
019.10 FINAL STEP IN DECOMMISSIONING. As the final step in decommissioning, the licensee must:
(A) Certify the disposition of all licensed material, including accumulated wastes, by submitting a completed Department Form NRH-60 or equivalent information. Form NRH-60 is set out as Attachment 4 of this chapter; and (B) 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 that the premises are suitable for release in some other manner. The licensee must, as appropriate:
(i) Report levels of gamma radiation in units of millisieverts (mSv) (microroentgen) per hour at one meter from surfaces, and report levels of radioactivity, including alpha and beta, in units of MBq (disintegrations per minute or μCi) per 100 square centimeters, removable and fixed, for surfaces, MBq (μCi) per milliliter for water, Bq (picocuries) per gram for solids such as soil or concrete; and (ii) Specify the survey instrument or instruments used and certify that each instrument is properly calibrated and tested.
019.11 TERMINATION. Specific licenses, including expired licenses, will be terminated by written notice to the licensee provided:
(A) Radioactive material has been properly disposed; (B) Reasonable effort has been made to eliminate residual radioactive contamination, if present; (C) Demonstration of suitability for release.
(i) A radiation survey has been performed which demonstrates that the premises are suitable for release according to Department requirements; or (ii) Other information submitted by the licensee is sufficient to demonstrate that the premises are suitable for release according to Department requirements; and
(D) Records required by 180 NAC 3-030.06 and 3-030.08 have been received.
020. RENEWAL OF LICENSES . This section addresses the renewal of licenses.
020.01 APPLICATION. Applications for renewal of specific licenses must be filed according to 180 NAC 3-010.
020.02 EXPIRATION. In any case in which a licensee, not less than 30 days prior to expiration of the existing license, has filed an application in proper form for renewal or for a new license authorizing the same activities, such existing license will not expire until the application has been finally determined by the Department.
021. AMENDMENT OF LICENSES AT REQUEST OF LICENSEE . Applications for amendment of a license must be filed according to 180 NAC 3-010 and must specify the respects in which the licensee desires their license to be amended and the grounds for such amendment.
022. DEPARTMENT ACTION ON APPLICATIONS TO RENEW AND AMEND . In considering an application by a licensee to renew or amend their license, the Department will apply the criteria set forth in 180 NAC 3-011, 3-013 or 3-014, and 3-015 and in 180 NAC 5, 7, 12, 14 or 19 as applicable.
023. RESERVED .
024. RESERVED .
025. TRANSFER OF MATERIAL . This section addresses the transfer of material.
025.01 LIMITATIONS. No licensee may transfer radioactive material other than as authorized according to 180 NAC 3-025.
025.02 AUTHORIZATION FOR TRANSFER. Except as otherwise provided in his or her license and subject to the provisions of 180 NAC 3-025.03 and 3-025.04, any licensee may transfer radioactive material:
(A) To the Department, only after receiving prior approval; (B) To the U.S. Department of Energy; (C) To any person exempt from the regulations to the extent permitted under such exemption; (D) To any person authorized to receive such material under terms of a general license or its equivalent, or a specific license or equivalent licensing document, issued by the Department, the U.S. Nuclear Regulatory Commission (NRC), or any Agreement State, or to any person otherwise authorized to receive such material by the Federal Government or any agency thereof, the Department, or any Agreement State; (E) As otherwise authorized by the Department in writing; or (F) To the agency in any Agreement State which regulates radioactive material according to an agreement under § 274 of the Atomic Energy Act of 1954.
025.03 VERIFICATION OF TRANSFEREE’S LICENSE. Before transferring radioactive material to a specific licensee of the Department, the U.S. Nuclear Regulatory Commission (NRC), or an Agreement State, or to a general licensee who is required to register with the Department, the U.S. Nuclear Regulatory Commission (NRC), or an Agreement State prior to receipt of the radioactive material, the licensee transferring the material must verify that the transferee's license authorizes the receipt of the type, form, and quantity of radioactive material to be transferred.
025.04 METHODS OF TRANSFEREE LICENSE VERIFICATION. The following methods for the verification required by 180 NAC 3-025.03 are acceptable:
(A) The transferor may have in their possession, and read, a current copy of the transferee's specific license or registration certificate; (B) The transferor may have in their possession a written certification by the transferee that the person is authorized by license or registration certificate to receive the type, form, and quantity of radioactive material to be transferred, specifying the license or registration certificate number, issuing agency, and expiration date; (C) For emergency shipments the transferor may accept oral certification by the transferee that the person is authorized by license or registration certificate to receive the type, form, and quantity of radioactive 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; (D) The transferor may obtain other sources of information compiled by a reporting service from official records of the Department, the U.S. Nuclear Regulatory Commission (NRC), the licensing agency of an Agreement State as to the identity of licensees and the scope and expiration dates of licenses and registration; or (E) When none of the methods of verification described in 180 NAC 3-025.04(A) through (D) 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 Department, the U.S. Nuclear Regulatory Commission (NRC), or the licensing agency of an Agreement State that the transferee is licensed to receive the radioactive material.
025.05 PREPARATION FOR SHIPMENT AND TRANSPORT. Preparation for shipment and transport of radioactive material must be according to the provisions of 180 NAC 13.
026. REPORTING REQUIREMENTS . This section addresses reporting requirements.
026.01 IMMEDIATE REPORT. Each licensee must notify the Department 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 radioactive material that could exceed regulatory limits. Events may include, but are not limited to fires, explosions, toxic gas releases.
026.02 TWENTY-FOUR HOUR REPORT. Each licensee must notify the Department within 24 hours after the discovery of any of the following events involving radioactive material.
026.02(A) UNPLANNED CONTAMINATION EVENT. An unplanned contamination event that:
(i) Requires access to the contaminated area, by workers or the public, to be restricted for more than 24 hours by imposing additional radiological controls or by prohibiting entry into the area; (ii) Involves a quantity of material greater than five times the lowest annual limit on intake specified in 180 NAC 4, Appendix 4-B for the material; and (iii) Has access to the area restricted for a reason other than to allow isotopes with a half-life of less than 24 hours to decay prior to decontamination.
026.02(B) EQUIPMENT IS DISABLED OR FAILS TO FUNCTION AS DESIGNED. An event in which equipment is disabled or fails to function as designed when:
(i) 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; (ii) The equipment is required to be available and operable when it is disabled or fails to function; and (iii) No redundant equipment is available and operable to perform the required safety function;
026.02(C) UNPLANNED MEDICAL TREATMENT AT A MEDICAL FACILITY OF AN INDIVIDUAL WITH SPREADABLE RADIOACTIVE CONTAMINATION. 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.
026.02(D) UNPLANNED FIRE OR EXPLOSION. An unplanned fire or explosion damaging any radioactive material or any device, container, or equipment containing radioactive material when:
(i) The quantity of radioactive material involved is greater than five times the lowest annual limit on intake specified in 180 NAC 4, Appendix 4-B for the material; and (ii) The damage affects the integrity of the radioactive material or its container.
026.03 PREPARATION AND SUBMISSION OF REPORTS. Reports made by licensees in response to the requirements of 180 NAC 3-026.03 must be made as follows.
026.03(A) TELEPHONE REPORTS. Licensees must make reports required by 180 NAC 3-026.01 and 3-026.02 by telephone to the Department. The telephone number for the Department is (402) 471-2168 during business hours or (402) 479-4921 after business hours. To the extent that the information is available at the time of notification, the information provided in these reports must include:
(i) The caller's name and call back telephone number; (ii) A description of the event, including date and time; (iii) The exact location of the event; (iv) The isotopes, quantities, and chemical and physical form of the radioactive material involved; and (v) Any personnel radiation exposure data available.
026.03(B) WRITTEN FOLLOW-UP REPORT. Each licensee who makes a report required by 180 NAC 3-026.01 or 180 NAC 3-026.02 must submit a written follow-up report within 30 days of the initial report. Written reports prepared according 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:
Nebraska Department of Health and Human Services Division of Public Health, Radiological Health 301 Centennial Mall South P.O. Box 95026 Lincoln, NE 68509-5026
The reports must include the following:
(i) A description of the event, including the probable cause and the manufacturer and model number, if applicable, of any equipment that failed or malfunctioned; (ii) The exact location of the event; (iii) The isotopes, quantities, and chemical and physical form of the radioactive material involved; (iv) Date and time of the event; (v) Corrective actions taken or planned and the results of any evaluations or assessments; and (vi) The extent of exposure of individuals to radiation or to radioactive materials without identification of individuals by name.
027. MODIFICATION AND REVOCATION OF LICENSES . The terms and conditions of all licenses will be subject to amendment, revision, modification, limitation, suspension or revocation under the following conditions.
027.01 AMENDMENTS TO THE RADIATION CONTROL ACT. Amendments to the Radiation Control Act or the rules and regulations adopted according to the Act.
027.02 VOLUNTARY APPLICATION. Voluntary application for license amendment, revision, modification, limitation, suspension or surrender made by the licensee.
027.03 DISCIPLINARY ACTION. Disciplinary action according to the Act.
027.04 EMERGENCY ORDER. According to emergency order as provided by § 71-3513(6) of the Act.
028. RECIPROCAL RECOGNITION OF LICENSES . This section addresses reciprocal recognition of licenses.
028.01 LICENSES OF RADIOACTIVE MATERIAL EXCEPT SPECIAL NUCLEAR MATERIAL IN QUANTITIES SUFFICIENT TO FORM A CRITICAL MASS. The following applies to licenses of radioactive material except special nuclear material in quantities sufficient to form a critical mass.
028.01(A) CONDUCT OF LICENSED ACTIVITIES. Subject to Title 180, any person who holds a specific license from the U.S. Nuclear Regulatory Commission (NRC) or any Agreement State, and 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, is granted a general license to conduct the activities authorized in such licensing document within this State for a period not in excess of 180 days in any 12 consecutive months provided that:
(i) The licensing document does not limit the activity authorized by such document to specified installations or locations; (ii) The out-of-state licensee notifies the Department in writing at least three (3) days prior to engaging in such activity. Such notification must include:
(1) Name of company for whom services will be performed, an individual to be contacted representing the company and telephone number; (2) The exact location, start date, duration, and type of activity to be conducted; (3) The name or names, documentation of training, and in-state address or addresses of the individual or individuals performing the activity; (4) The identification of the sources of radiation to be used; (5) A copy of the pertinent license; (6) A copy of the licensee's operating and emergency procedures; (7) An annual fee according to 180 NAC 18; and (8) The out-of-state licensee notifies the Department of changes in work locations, radioactive material, or work activities different from the information contained on the initial notification. If, for a specific case, the three day period would impose an undue hardship on the out-of-state licensee, the licensee may, upon application to the Department, obtain permission to proceed sooner. The Department may waive the requirement for filing additional written notifications during the remainder of the calendar year following the receipt of the initial notification from a person engaging in activities under the general license provided in 180 NAC 3-028.01.
(iii) The out-of-state licensee complies with all applicable regulations of the Department and with all the terms and conditions of the licensing document, except any such terms and conditions which may be inconsistent with applicable regulations of the Department; (iv) The out-of-state licensee maintains a current copy of the appropriate license, and all amendments previously mentioned, issued by the Department; (v) The out-of-state licensee supplies such other information as the Department may request; and (vi) The out-of-state licensee must not transfer or dispose of radioactive material possessed or used under the general license provided in 180 NAC 3-028.01(A) except by transfer to a person:
(1) Specifically licensed by the Department or by the U.S. Nuclear Regulatory Commission (NRC) to receive such material, or (2) Exempt from the requirements for a license for such material under 180 NAC 3-004.01.
028.01(B) INSTALLATION, TRANSFER, DEMONSTRATION OR SERVICE. Despite the provisions of 180 NAC 3-028.01(A) any person who holds a specific license issued by the U.S. Nuclear Regulatory Commission (NRC) or an Agreement State authorizing the holder to manufacture, transfer, install, or service a device described in 180 NAC 3-008.04, within areas subject to the jurisdiction of the licensing body is granted a general license to install, transfer, demonstrate or service such a device in this State provided that:
(i) Such person must file a report with the Department within 30 days after the end of each calendar quarter in which any device is transferred to or installed in this State. Each report must identify each general licensee to whom the device is transferred by name and address, the type and model of device transferred, and the quantity and type of radioactive material contained in the device; (ii) The device has been manufactured, labeled, installed, and serviced according to applicable provisions of the specific license issued to such person by the U.S. Nuclear Regulatory Commission (NRC) or an Agreement State; (iii) Such person must assure that any labels required to be affixed to the device under regulations of the authority which licensed manufacture of the device bear a statement that "Removal of this label is prohibited"; and (iv) The holder of the specific license must furnish to each general licensee to whom the person transfers the device or on whose premises the person installs the device a copy of the general license contained in 180 NAC 3-008.04.
028.01(C) LIMITATIONS. The Department may withdraw, limit, or qualify its acceptance of any specific license or equivalent licensing document issued by another agency, or any product distributed according to such licensing document, upon determining that such action is necessary in order to achieve compliance with Title 180 or to prevent undue hazard to public health and safety or property.
028.02 RECOGNITION OF AGREEMENT STATE LICENSEES. The requirements for the recognition of Agreement State licenses are as follows:
(A) Before radioactive materials can be used at a temporary job site within the State at any Federal facility, the jurisdictional status of the job site must be determined. If the jurisdictional status is unknown, the Federal agency must be contacted to determine if the job site is under exclusive Federal jurisdiction.
(i) In areas of exclusive Federal jurisdiction, the general license is subject to all the applicable rules, regulations, orders and fees of the U.S. Nuclear Regulatory Commission (NRC); and (ii) Authorizations for use of radioactive materials at job sites under exclusive Federal jurisdiction must be obtained from the U.S. Nuclear Regulatory Commission (NRC) by either (1) filing a U.S. Nuclear Regulatory Commission (NRC) Form-241 according to 10 CFR 150.20(b); or (2) by applying for a specific U.S. Nuclear Regulatory Commission (NRC) license; and
(B) Before radioactive material can be used at a temporary job site in another State, authorization must be obtained for the State if it is an Agreement State, or from the U.S. Nuclear Regulatory Commission (NRC) for any non-Agreement State, either by filing for reciprocity or applying for a specific license.
029. RESERVED .
030. RECORDS . This section addresses the requirements governing the retention of records showing the receipt, use, transfer, and disposal of radioactive material.
030.01 RECORDS SHOWING THE RECEIPT, USE, TRANSFER, AND DISPOSAL OF RADIOACTIVE MATERIAL. Each person who receives radioactive material according to a license issued according to 180 NAC 3, 5, 7, 12, 14, and 19 must keep records showing the receipt, use, transfer, and disposal of such radioactive material.
030.02 RECORD MAINTENANCE. Records which are required according to 180 NAC 3-030.01 must be maintained for the period specified by the appropriate regulation. If a retention period is not otherwise specified by regulation such records must be maintained for a period of one year after the records of the licensee have been inspected by the Department unless any litigation, claim, negotiation, audit, licensure action, or other action involving the records has been initiated before the expiration of the one-year period, in which case the records must be retained until the completion of the action and resolution of all issues, or until the end of the regular one-year period, whichever is later.
030.03 RECORDS OF RECEIPT OF RADIOACTIVE MATERIAL MAINTENANCE. Records of receipt of radioactive material which must be maintained according to 180 NAC 3-030.01 will be maintained as long as the licensee retains possession of the radioactive material and for five years following transfer, or disposition of the radioactive material. Additionally:
(A) Records of transfer of radioactive material must be maintained by the licensee who transferred the material until license termination; (B) Records of disposal of radioactive material must be maintained according to 180 NAC 4-054; and (C) If radioactive material is combined or mixed with other licensed material and subsequently treated in a manner which makes direct correlation of a receipt record with a transfer, export, or disposition record impossible, evaluative techniques such as first-in-first-out may be used for purposes of the records retention requirements of 180 NAC 3-030.
030.04 RECORD STORAGE. Records which must be maintained according to 180 NAC 3-030.01 may be the original or reproduced copy of microform if such 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 Department regulations. The record may also be stored in electronic media with the capability for producing legible, accurate and complete record 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 must maintain adequate safeguards against tampering with and loss of records.
030.05 REGULATION CONFLICT. If there is a conflict between the Department's regulations in 180 NAC 3, license condition, or other written Department approval or authorization pertaining to the retention period for the same type of record, the retention period specified in 180 NAC 3-030 for such records will apply unless the Department according to 180 NAC 1-003.01 has granted a specific exemption from the record retention requirements specified in 180 NAC 3-030.05.
030.06 DISPOSAL AND SURVEY RECORDS OF LICENSED MATERIAL. Prior to license termination, each licensee authorized to possess radioactive material with a half-life greater than 120 days, in an unsealed form, must forward the following records to the Department:
(A) Records of disposal of licensed material made under 180 NAC 4-040, 4-041, 4-042, and 4-043; and (B) Records required by 180 NAC 4-048.02(D).
030.07 TRANSFER OR ASSIGNMENT OF LICENSED ACTIVITIES. If licensed activities are transferred or assigned according to 180 NAC 3-017.02, each licensee authorized to possess radioactive material with a half-life greater than 120 days, in an unsealed form, must 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, 180 NAC 3-038, 3-039, 3-040, 3-041; and (B) Records required by 180 NAC 4-048.02(D).
030.08 RECORDS OF INFORMATION IMPORTANT TO THE DECOMMISSIONING OF THE FACILITY. Prior to license termination, each licensee must forward the records required by 180 NAC 3-018.07 to the Department.
031. REGISTRATION OF PRODUCT INFORMATION . This section addresses registration of product information.
031.01 REQUEST FOR EVALUATION. Any manufacturer or initial distributor of a sealed source or device containing a sealed source must submit a request to the Department for evaluation of radiation safety information about its product and for its registration.
031.02 REQUEST FOR REVIEW. The request for review must be sent to the Department at the address in 180 NAC 1-012.
031.03 REQUIREMENTS FOR REQUEST FOR REVIEW OF A SEALED SOURCE OR A DEVICE. 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.
031.04 STANDARDS AND CRITERIA. The Department 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 Department will formulate reasonable standards and criteria with the help of the manufacturer or distributor. The Department will 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. 10 CFR 32, Subpart A includes specific criteria that apply to certain exempt products, 180 NAC 3-014.04 through 3-014.09 includes specific criteria applicable to certain generally licensed devices, and 180 NAC 3-014.10, 3-014.12, and 3.014.14 includes specific provisions that apply to certain specifically licensed items.
031.05 CERTIFICATE OF REGISTRATION. After completion of the evaluation, the Department 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.
031.06 LIMITATION. The person submitting the request for evaluation and registration of safety information about the product must manufacture and distribute the product according to:
(A) The statements and representations, including quality control program, contained in the request; and (B) The provisions of the registration certificate.
031.07 AUTHORITY TO MANUFACTURE OR INITIALLY DISTRIBUTE A SEALED SOURCE OR DEVICE TO SPECIFIC LICENSEES. 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:
(A) Calibration and reference sources containing no more than:
(i) 37 MBq (1 mCi), for beta or gamma emitting radionuclides; or (ii) 0.37 MBq (10 μCi), for alpha emitting radionuclides;
(B) 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
(i) The intended recipients are licensed under 180 NAC 3-013, U.S. Nuclear Regulatory Commission (NRC) 10 CFR 33 or comparable provisions of an Agreement State; (ii) The recipients are authorized for research and development; or (iii) The sources and devices are to be built to the unique specifications of the particular recipient and contain no more than 740 GBq (20 Ci) of tritium or 7.4 GBq (200 mCi) of any other radionuclide.
031.08 ADDITIONAL REVIEW. After the certificate is issued, the Department may conduct additional review as it determines is necessary to ensure compliance with current regulatory standards. In conducting its review, the Department will complete its evaluation according to criteria specified in 180 NAC 3-031. The certificate holder must provide any additional information requested by the Department.
032. INACTIVATION OF CERTIFICATES OF REGISTRATION OF SEALED SOURCES AND DEVICES . This section addresses the inactivation of certificates of registration of sealed sources and devices.
032.01 REQUEST FOR INACTIVATION OF REGISTRATION. A certificate holder who no longer manufactures or initially transfers any of the sealed source or sources or device or devices covered by a particular certificate issued by the Department must request inactivation of the registration certificate. Such a request must be made to the Department and must normally be made no later than two years after initial distribution of all of the source or sources or device or devices 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 must request inactivation of the certificate within 90 days of this determination and briefly describe the circumstances of the delay.
032.02 TERMINATION OF SPECIFIC LICENSE. If a distribution license is to be terminated according to 180 NAC 3-019, the licensee must request inactivation of its registration certificates associated with that distribution license before the Department will terminate the license. Such a request for inactivation of certificate or certificates must indicate that the license is being terminated and include the associated specific license number.
032.03 INACTIVATED CERTIFICATE. 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 according to any conditions in the certificate, including in the case of an inactive certificate.
APPENDIX 3-A
EXEMPT CONCENTRATIONS:
| Element (atomic number) | Isotope | Column I Gas Concentration µCi / ml* | Column II **Liquid and Solid Concentration µCi / ml **** | | --- | --- | --- | --- | | Antimony (51) | Sb-122 | | 3E-4 | | | Sb-124 | | 2E-4 | | Sb-125 | | 1E-3 | | | Argon (18) | Ar-37 | 1E-3 | | | | Ar-41 | 4E-7 | | | Arsenic (33) | As-73 | | 5E-3 | | | As-74 | | 5E-4 | | As-76 | | 2E-4 | | | As-77 | | 8E-4 | | | Barium (56) | Ba-131 | | 2E-3 | | | Ba-140 | | 3E-4 | | Beryllium (4) | Be-7 | | 2E-2 | | Bismuth (83) | Bi-206 | | 4E-4 | | Bromine (35) | Br-82 | 4E-7 | 3E-3 | | Cadmium (48) | Cd-109 | | 2E-3 | | | Cd-115m | | 3E-4 | | Cd-115 | | 3E-4 | | | Calcium (20) | Ca-45 | | 9E-5 | | | Ca-47 | | 5E-4 | | Carbon (6) | C-14 | 1E-6 | 8E-3 | | Cerium (58) | Ce-141 | | 9E-4 | | | Ce-143 | | 4E-4 | | Ce-144 | | 1E-4 | | | Cesium (55) | Cs-131 | | 2E-2 | | | Cs-134m | | 6E-2 | | Cs-134 | | 9E-5 | | | Chlorine (17) | Cl-38 | 9E-7 | 4E-3 | | Chromium (24) | Cr-51 | | 2E-2 | | Cobalt (27) | Co-57 | | 5E-3 |
| | Co-58 | | 1E-3 | | --- | --- | --- | --- | | Co-60 | | 5E-4 | | | Copper (29) | Cu-64 | | 3E-3 | | Dysprosium (66) | Dy-165 | | 4E-3 | | | Dy-166 | | 4E-4 | | Erbium (68) | Er-169 | | 9E-4 | | | Er-171 | | 1E-3 | | Europium (63) | Eu-152 (T/2=9.2hrs) | | 6E-4 | | | Eu-155 | | 2E-3 | | Fluorine (9) | F-18 | 2E-6 | 8E-3 | | Gadolinium (64) | Gd-153 | | 2E-3 | | | Gd-159 | | 8E-4 | | Gallium (31) | Ga-72 | | 4E-4 | | Germanium (32) | Ge-71 | | 2E-2 | | Gold (79) | Au-196 | | 2E-3 | | | Au-198 | | 5E-4 | | Au-199 | | 2E-3 | | | Hafnium (72) | Hf-181 | | 7E-4 | | Hydrogen (1) | H-3 | 5E-6 | 3E-2 | | Indium (49) | In-113m | | 1E-2 | | | In-114m | | 2E-4 | | Iodine (53) | I-126 | 3E-9 | 2E-5 | | | I-131 | 3E-9 | 2E-5 | | I-132 | 8E-8 | 6E-4 | | | I-133 | 1E-8 | 7E-5 | | | I-134 | 2E-7 | 1E-3 | | | Iridium (77) | Ir-190 | | 2E-3 | | | Ir-192 | | 4E-4 | | Ir-194 | | 3E-4 | | | Iron (26) | Fe-55 | | 8E-3 | | | Fe-59 | | 6E-4 | | Krypton (36) | Kr-85m | 1E-6 | | | | Kr-85 | 3E-6 | |
| Lanthanum (57) | La-140 | | 2E-4 | | --- | --- | --- | --- | | Lead (82) | Pb-203 | | 4E-3 | | Lutetium (71) | Lu-177 | | 1E-3 | | Manganese (25) | Mn-52 | | 3E-4 | | | Mn-54 | | 1E-3 | | Mn-56 | | 1E-3 | | | Mercury (80) | Hg-197m | | 2E-3 | | | Hg-197 | | 3E-3 | | Hg-203 | | 2E-4 | | | Molybdenum (42) | Mo-99 | | 2E-3 | | Neodymium (60) | Nd-147 | | 6E-4 | | | Nd-149 | | 3E-3 | | Nickel (28) | Ni-65 | | 1E-3 | | Niobium (Columbium)(41) | Nb-95 | | 1E-3 | | | Nb-97 | | 9E-3 | | Osmium (76) | Os-185 | | 7E-4 | | | Os-191m | | 3E-2 | | Os-191 | | 2E-3 | | | Os-193 | | 6E-4 | | | Palladium (46) | Pd-103 | | 3E-3 | | | Pd-109 | | 9E-4 | | Phosphorus (15) | P-32 | | 2E-4 | | Platinum (78) | Pt-191 | | 1E-3 | | | Pt-193m | | 1E-2 | | Pt-197m | | 1E-2 | | | Pt-197 | | 1E-3 | | | Potassium (19) | K-42 | | 3E-3 | | Praseodymium (59) | Pr-142 | | 3E-4 | | | Pr-143 | | 5E-4 | | Promethium (61) | Pm-147 | | 2E-3 | | | Pm-149 | | 4E-4 | | Rhenium (75) | Re-183 | | 6E-3 | | | Re-186 | | 9E-4 |
| | Re-188 | | 6E-4 | | --- | --- | --- | --- | | Rhodium (45) | Rh-103m | | 1E-1 | | | Rh-105 | | 1E-3 | | Rubidium (37) | Rb-86 | | 7E-4 | | Ruthenium (44) | Ru-97 | | 4E-3 | | | Ru-103 | | 8E-4 | | Ru-105 | | 1E-3 | | | Ru-106 | | 1E-4 | | | Samarium (62) | Sm-153 | | 8E-4 | | Scandium (21) | Sc-46 | | 4E-4 | | | Sc-47 | | 9E-4 | | Sc-48 | | 3E-4 | | | Selenium (34) | Se-75 | | 3E-3 | | Silicon (14) | Si-31 | | 9E-3 | | Silver (47) | Ag-105 | | 1E-3 | | | Ag-110m | | 3E-4 | | Ag-111 | | 4E-4 | | | Sodium (11) | Na-24 | | 2E-3 | | Strontium (38) | Sr-85 | | 1E-3 | | | Sr-89 | | 1E-4 | | Sr-91 | | 7E-4 | | | Sr-92 | | 7E-4 | | | Sulfur (16) | S-35 | 9E-8 | 6E-4 | | Tantalum (73) | Ta-182 | | 4E-4 | | Technetium (43) | Tc-96m | | 1E-1 | | | Tc-96 | | 1E-3 | | Tellurium (52) | Te-125m | | 2E-3 | | | Te-127m | | 6E-4 | | Te-127 | | 3E-3 | | | Te-129m | | 3E-4 | | | Te-131m | | 6E-4 | | | Te-132 | | 3E-4 | | | Terbium (65) | Tb-160 | | 4E-4 |
| Thallium (81) | Tl-200 | | 4E-3 | | --- | --- | --- | --- | | | Tl-201 | | 3E-3 | | Tl-202 | | 1E-3 | | | Tl-204 | | 1E-3 | | | Thulium (69) | Tm-170 | | 5E-4 | | | Tm-171 | | 5E-3 | | Tin (50) | Sn-113 | | 9E-4 | | | Sn-125 | | 2E-4 | | Tungsten (Wolfram)(74) | W-181 | | 4E-3 | | | W-187 | | 7E-4 | | Vanadium (23) | V-48 | | 3E-4 | | Xenon (54) | Xe-131m | 4E-6 | | | | Xe-133 | 3E-6 | | | Xe-135 | 1E-6 | | | | Ytterbium (70) | Yb-175 | | 1E-3 | | Yttrium (39) | Y-90 | | 2E-4 | | | Y-91m | | 3E-2 | | Y-91 | | 3E-4 | | | Y-92 | | 6E-4 | | | Y-93 | | 3E-4 | | | Zinc (30) | Zn-65 | | 1E-3 | | | Zn-69m | | 7E-4 | | Zn-69 | | 2E-2 | | | Zirconium (40) | Zr-95 | | 6E-4 | | | Zr-97 | | 2E-4 | | Beta or gamma emitting radioactive material not listed above with half-life less than 3 years | | 1E-10 | 1E-6 |
*Values are given in Column I only for those materials normally used as gases. ** µCi /gm for solids.
Many radioisotopes disintegrate into isotopes which are also radioactive. In expressing the concentrations in 180 NAC 3, Appendix 003-A the activity stated is that of the parent isotope and takes into account the daughters.
For purposes of 180 NAC 3-004 where there is involved a combination of isotopes, the limit for the combination must be derived as follows: Determine for each isotope in the product the ratio between the concentration present in the product and the exempt concentration established in Appendix 003-A for the specific isotope when not in combination. The sum of such ratios may not exceed "1", or unity.
Concentration of Isotope A in Product + Concentration of Isotope B in Product = ≤1 Exempt concentration of Isotope A Exempt concentration of Isotope B
To convert µCi /ml to SI units of MBq per liter multiply the above value by 37.
Zirconium (40) Zr-97 2E-4 µCi /ml multiplied by 37 is equivalent to 74E+4 MBq/l)
APPENDIX 3-B
Radioactive Material .................................................................... Microcuries
EXEMPT QUANTITIES
Antimony-122 (Sb 122) ………..................................................................... 100 Antimony-124 (Sb 124) ………........................................................................10 Antimony-125 (Sb 125) ………........................................................................10 Arsenic-73 (As 73) …………..........................................................................100 Arsenic-74 (As 74) …………............................................................................10 Arsenic-76 (As 76) ………...............................................................................10 Arsenic-77 (As 77) …………..........................................................................100 Barium-131 (Ba 131)………….........................................................................10 Barium-133 (Ba 133)………….........................................................................10 Barium-140 (Ba 140).......................................................................................10 Bismuth-210 (Bi 210) ........................................................................................1 Bromine-82 (Br 82) .........................................................................................10 Cadmium-109 (Cd 109)………….....................................................................10 Cadmium-115m (Cd 115m)………..................................................................10 Cadmium-115 (Cd 115)................................................................................ 100 Calcium-45 (Ca 45)..........................................................................................10 Calcium-47 (Ca 47)..........................................................................................10 Carbon-14 (C 14)...........................................................................................100 Cerium-141 (Ce 141) ....................................................................................100 Cerium-143 (Ce 143) ....................................................................................100 Cerium-144 (Ce 144) ........................................................................................1 Cesium-129 (Cs 129).....................................................................................100 Cesium-131 (Cs 131)................................................................................. 1,000 Cesium-134m (Cs 134m).............................................................................. 100 Cesium-134 (Cs 134).........................................................................................1 Cesium-135 (Cs 135).......................................................................................10 Cesium-136 (Cs 136).......................................................................................10 Cesium-137 (Cs 137).......................................................................................10 Chlorine-36 (Cl 36)..........................................................................................10 Chlorine-38 (Cl 38)..........................................................................................10 Chromium-51 (Cr 51) ................................................................................ 1,000 Cobalt-57 (Co 57) .........................................................................................100 Cobalt-58m (Co 58m)......................................................................................10 Cobalt-58 (Co 58) ...........................................................................................10 Cobalt-60 (Co 60) .............................................................................................1 Copper-64 (Cu 64).........................................................................................100 Dysprosium-165 (Dy 165) ...............................................................................10 Dysprosium-166 (Dy 166) ………................................................................. 100 Erbium-169 (Er 169)......................................................................................100 Erbium-171 (Er 171)......................................................................................100 Europium-152 (Eu 152) 9.2h......................................................................... 100 Europium-152 (Eu 152) 13 yr.............................................................................1 Europium-154 (Eu 154).....................................................................................1 Europium-155 (Eu 155)...................................................................................10 Fluorine-18 (F 18) ..................................................................................... 1,000 Gadolinium-153 (Gd 153)................................................................................10 Gadolinium-159 (Gd 159)............................................................................. 100 Gallium-67 (Ga 67) .......................................................................................100 Gallium-72 (Ga 72) .........................................................................................10 Germanium 68 (Ge 68) ...................................................................................10 Germanium-71 (Ge 71)................................................................................. 100 Gold 195 (Au 195)............................................................................................10 Gold-198 (Au 198) ........................................................................................100 Gold-199 (Au 199) ........................................................................................100 Hafnium-181 (Hf 181)......................................................................................10 Holmium-166 (Ho 166)..................................................................................100 Hydrogen-3 (H 3) ...................................................................................... 1,000 Indium-111 (In 111).......................................................................................100 Indium-113m (In 113m)................................................................................. 100 Indium-114m (In 114m)...................................................................................10 Indium-115m (In 115m)................................................................................. 100 Indium-115 (In 115).........................................................................................10 Iodine-123 (I 123)..........................................................................................100 Iodine-125 (I 125)..............................................................................................1 Iodine-126 (I 126)..............................................................................................1 Iodine-129 (I 129)...........................................................................................0.1 Iodine-131 (I 131)..............................................................................................1 Iodine-132 (I 132)............................................................................................10 Iodine-133 (I 133)..............................................................................................1 Iodine-134 (I 134)............................................................................................10 Iodine-135 (I 135)............................................................................................10 Iridium-192 (Ir 192) .........................................................................................10 Iridium-194 (Ir 194) .......................................................................................100 Iron-52 (Fe 52).................................................................................................10 Iron-55 (Fe 55)...............................................................................................100 Iron-59 (Fe 59).................................................................................................10 Krypton-85 (Kr 85) ........................................................................................100 Krypton-87 (Kr 87) ..........................................................................................10 Lanthanum-140 (La 140).................................................................................10 Lutetium-177 (Lu 177)...................................................................................100 Manganese-52 (Mn 52)...................................................................................10 Manganese-54 (Mn 54)...................................................................................10 Manganese-56 (Mn 56)...................................................................................10 Mercury-197m (Hg 197m)............................................................................. 100 Mercury-197 (Hg 197)....................................................................................100 Mercury-203 (Hg 203)......................................................................................10 Molybdenum-99 (Mo 99)............................................................................... 100 Neodymium-147 (Nd 147)............................................................................. 100 Neodymium-149 (Nd 149)............................................................................. 100 Nickel-59 (Ni 59) ...........................................................................................100 Nickel-63 (Ni 63) .............................................................................................10 Nickel-65 (Ni 65) ...........................................................................................100 Niobium-93m (Nb 93m)...................................................................................10 Niobium-95 (Nb 95).........................................................................................10 Niobium-97 (Nb 97).........................................................................................10 Osmium-185 (Os 185).....................................................................................10 Osmium-191m (Os 191m)............................................................................ 100 Osmium-191 (Os 191)...................................................................................100 Osmium-193 (Os 193)...................................................................................100 Palladium-103 (Pd 103) ............................................................................... 100 Palladium-109 (Pd 109) ............................................................................... 100 Phosphorus-32 (P 32)......................................................................................10 Platinum-191 (Pt 191) ...................................................................................100 Platinum-193m (Pt 193m) ............................................................................ 100 Platinum-193 (Pt 193) ...................................................................................100 Platinum-197m (Pt 197m) ............................................................................ 100 Platinum-197 (Pt 197) ...................................................................................100 Polonium-210 (Po 210) ..................................................................................0.1 Potassium-42 (K 42) .......................................................................................10 Potassium-43 (K 43) .......................................................................................10 Praseodymium-142 (Pr 142) ........................................................................ 100 Praseodymium-143 (Pr 143) ........................................................................ 100 Promethium-147 (Pm 147)..............................................................................10 Promethium-149 (Pm 149)..............................................................................10 Rhenium-186 (Re 186)..................................................................................100 Rhenium-188 (Re 188)..................................................................................100 Rhodium-103m (Rh 103m)........................................................................... 100 Rhodium-105 (Rh 105)..................................................................................100 Rubidium-81 (Rb 81).......................................................................................10 Rubidium-86 (Rb 86).......................................................................................10 Rubidium-87 (Rb 87).......................................................................................10 Ruthenium-97 (Ru 97)...................................................................................100 Ruthenium-103 (Ru 103).................................................................................10 Ruthenium-105 (Ru 105).................................................................................10 Ruthenium-106 (Ru 106)...................................................................................1 Samarium-151 (Sm 151).................................................................................10 Samarium-153 (Sm 153)............................................................................... 100 Scandium-46 (Sc 46) ......................................................................................10 Scandium-47 (Sc 47) ....................................................................................100 Scandium-48 (Sc 48) ......................................................................................10 Selenium-75 (Se 75)........................................................................................10 Silicon-31 (Si 31)...........................................................................................100 Silver-105 (Ag 105)..........................................................................................10 Silver-110m (Ag 110m) .....................................................................................1 Silver-111 (Ag 111)........................................................................................100 Sodium-22 (Na 22)..........................................................................................10 Sodium-24 (Na 24)..........................................................................................10 Strontium-85 (Sr 85)........................................................................................10 Strontium-89 (Sr 89)..........................................................................................1 Strontium-90 (Sr 90).......................................................................................0.1 Strontium-91 (Sr 91)........................................................................................10 Strontium-92 (Sr 92)........................................................................................10 Sulphur-35 (S 35)..........................................................................................100 Tantalum-182 (Ta 182)....................................................................................10 Technetium-96 (Tc 96)....................................................................................10 Technetium-97m (Tc 97m)............................................................................ 100 Technetium-97 (Tc 97)..................................................................................100 Technetium-99m (Tc 99m)............................................................................ 100 Technetium-99 (Tc 99)....................................................................................10 Tellurium-125m (Te 125m)..............................................................................10 Tellurium-127m (Te 127m)..............................................................................10 Tellurium-127 (Te 127)..................................................................................100 Tellurium-129m (Te 129m)..............................................................................10 Tellurium-129 (Te 129)..................................................................................100 Tellurium-131m (Te 131m)..............................................................................10 Tellurium-132 (Te 132)....................................................................................10 Terbium-160 (Tb 160) .....................................................................................10 Thallium-200 (Tl 200).....................................................................................100 Thallium-201 (Tl 201).....................................................................................100 Thallium-202 (Tl 202).....................................................................................100 Thallium-204 (Tl 204).......................................................................................10 Thulium-170 (Tm 170).....................................................................................10 Thulium-171 (Tm 171).....................................................................................10 Tin-113 (Sn 113)..............................................................................................10 Tin-125 (Sn 125)..............................................................................................10 Tungsten-181 (W 181) ....................................................................................10 Tungsten-185 (W 185) ....................................................................................10 Tungsten-187 (W 187) ..................................................................................100 Vanadium-48 (V 48).........................................................................................10 Xenon-131m (Xe 131m)............................................................................. 1,000 Xenon-133 (Xe 133)......................................................................................100 Xenon-135 (Xe 135)......................................................................................100 Ytterbium-175 (Yb 175)................................................................................. 100 Yttrium-87 (Y 87).............................................................................................10 Yttrium 88 (Y 88)..............................................................................................10 Yttrium-90 (Y 90).............................................................................................10 Yttrium-91 (Y 91).............................................................................................10 Yttrium-92 (Y 92)...........................................................................................100 Yttrium-93 (Y 93)...........................................................................................100 Zinc-65 (Zn 65) ...............................................................................................10 Zinc-69m (Zn 69m) .......................................................................................100 Zinc-69 (Zn 69) ..........................................................................................1,000 Zirconium-93 (Zr 93) .......................................................................................10 Zirconium-95 (Zr 95) .......................................................................................10 Zirconium-97 (Zr 97) .......................................................................................10 Any radioactive material not listed above other than alpha emitting radioactive material................................................ 0.1
To convert µCi to SI units kBq, multiply the above values by 37.
Zirconium-97 (10 µCi multiplied by 37 is equivalent to 370 kBq).
APPENDIX 3-C
LIMITS FOR BROAD LICENSES 180 NAC 3-013
Radioactive Material ...................... Col. I curies ................... Col. II curies
Antimony-122...................................................... 1.................................. 0.01 Antimony-124...................................................... 1.................................. 0.01 Antimony-125...................................................... 1.................................. 0.01 Arsenic-73......................................................... 10.................................... 0.1 Arsenic-74........................................................... 1.................................. 0.01 Arsenic-76........................................................... 1.................................. 0.01 Arsenic-77......................................................... 10.................................... 0.1 Barium-131 ...................................................... 10.................................... 0.1 Barium-140 ........................................................ 1.................................. 0.01 Beryllium-7....................................................... 10..................................... 0.1 Bismuth-210.................................................... 0.1................................. 0.001 Bromine-82 ...................................................... 10.................................... 0.1 Cadmium-109 .................................................... 1.................................. 0.01 Cadmium-115m ................................................. 1.................................. 0.01 Cadmium-115 .................................................. 10.................................... 0.1 Calcium-45......................................................... 1.................................. 0.01 Calcium-47....................................................... 10.................................... 0.1 Carbon-14...................................................... 100.................................... 1.0 Cerium-141...................................................... 10.................................... 0.1 Cerium-143...................................................... 10.................................... 0.1 Cerium-144..................................................... 0.1................................ 0.001 Cesium-131 .................................................. 100.................................... 1.0 Cesium-134m ............................................... 100.................................... 1.0 Cesium-134 ................................................... 0.1................................ 0.001 Cesium-135 ...................................................... 1.................................. 0.01 Cesium-136 .................................................... 10.................................... 0.1 Cesium-137 ................................................... 0.1................................ 0.001 Chlorine-36 ....................................................... 1.................................. 0.01 Chlorine-38 ................................................... 100.................................... 1.0 Chromium-51................................................. 100.................................... 1.0 Cobalt-57 ........................................................ 10.................................... 0.1 Cobalt-58m ................................................... 100.................................... 1.0 Cobalt-58 .......................................................... 1.................................. 0.01 Cobalt-60 ....................................................... 0.1................................ 0.001 Copper-64....................................................... 10..................................... 0.1 Dysprosium-165............................................ 100..................................... 1.0 Dysprosium-166.............................................. 10..................................... 0.1 Erbium-169 ..................................................... 10..................................... 0.1 Erbium-171 ..................................................... 10..................................... 0.1 Europium-152 (9.2h)....................................... 10...................................... 0.1 Europium-152 (13 y) ..................................... 0.1.................................. 0.001 Europium-154 ............................................... 0.1................................. 0.001 Europium-155 .................................................. 1................................... 0.01 Fluorine-18................................................... 100.................................... 1.0 Gadolinium-153................................................ 1.................................. 0.01 Gadolinium-159.............................................. 10.................................... 0.1 Gallium-72 ..................................................... 10.................................... 0.1 Germanium-71............................................. 100.................................... 1.0 Gold-198........................................................ 10.................................... 0.1 Gold-199........................................................ 10.................................... 0.1 Hafnium-181 ................................................... 1................................... 0.01 Holmium-166 ................................................ 10.................................... 0.1 Hydrogen-3................................................. 100.................................... 1.0 Indium-113m............................................... 100.................................... 1.0 Indium-114m................................................... 1.................................. 0.01 Indium-115m............................................... 100.................................... 1.0 Indium-115...................................................... 1.................................. 0.01 Iodine-125.................................................... 0.1................................ 0.001 Iodine-126.................................................... 0.1................................ 0.001 Iodine-129.................................................... 0.1................................ 0.001 Iodine-131.................................................... 0.1................................ 0.001 Iodine-132..................................................... 10.................................... 0.1 Iodine-133....................................................... 1.................................. 0.01 Iodine-134..................................................... 10.................................... 0.1 Iodine-135....................................................... 1.................................. 0.01 Iridium-192...................................................... 1.................................. 0.01 Iridium-194.................................................... 10.................................... 0.1 Iron-55 .......................................................... 10.................................... 0.1 Iron-59 ............................................................ 1….............................. 0.01 Krypton-85 .................................................. 100…................................ 1.0 Krypton-87 .................................................... 10................................... 0.1 Lanthanum-140............................................... 1.................................. 0.01 Lutetium-177................................................. 10.................................... 0.1 Manganese-52................................................ 1.................................. 0.01 Manganese-54................................................ 1.................................. 0.01 Manganese-56.............................................. 10.................................... 0.1 Mercury-197m............................................... 10.................................... 0.1 Mercury-197.................................................. 10.................................... 0.1 Mercury-203.................................................... 1.................................. 0.01 Molybdenum-99 ............................................ 10.................................... 0.1 Neodymium-147............................................ 10.................................... 0.1 Neodymium-149............................................ 10.................................... 0.1 Nickel-59....................................................... 10.................................... 0.1 Nickel-63......................................................... 1.................................. 0.01 Nickel-65....................................................... 10.................................... 0.1 Niobium-93m .................................................. 1.................................. 0.01 Niobium-95 ..................................................... 1.................................. 0.01 Niobium-97 ................................................. 100.................................... 1.0 Osmium-185 ................................................... 1.................................. 0.01 Osmium-191m ............................................ 100.................................... 1.0 Osmium-191 ................................................. 10.................................... 0.1 Osmium-193 ................................................. 10.................................... 0.1 Palladium-103............................................... 10.................................... 0.1 Palladium-109............................................... 10.................................... 0.1 Phosphorus-32................................................ 1.................................. 0.01 Platinum-191................................................. 10.................................... 0.1 Platinum-193m............................................. 100................................... 1.0 Platinum-193................................................. 10.................................... 0.1 Platinum-197m............................................ 100.................................... 1.0 Platinum-197................................................. 10.................................... 0.1 Polonium-210............................................. 0.01.............................. 0.0001 Potassium-42.................................................. 1.................................. 0.01 Praseodymium-142....................................... 10.................................... 0.1 Praseodymium-143....................................... 10.................................... 0.1 Promethium-147 ............................................. 1.................................. 0.01 Promethium-149 ........................................... 10.................................... 0.1 Radium-226 ............................................... 0.01.............................. 0.0001 Rhenium-186 ................................................ 10.................................... 0.1 Rhenium-188 ................................................ 10.................................... 0.1 Rhodium-103m ........................................ 1,000.................................. 10.0 Rhodium-105 ................................................ 10.................................... 0.1 Rubidium-86 ................................................... 1.................................. 0.01 Rubidium-87 ................................................... 1.................................. 0.01 Ruthenium-97 ............................................ 100.................................... 1.0 Ruthenium-103 ............................................... 1.................................. 0.01 Ruthenium-105 ............................................. 10.................................... 0.1 Ruthenium-106 ............................................ 0.1................................ 0.001 Samarium-151 ................................................ 1.................................. 0.01 Samarium-153 .............................................. 10.................................... 0.1 Scandium-46................................................... 1.................................. 0.01 Scandium-47................................................. 10.................................... 0.1 Scandium-48................................................... 1.................................. 0.01 Selenium-75.................................................... 1.................................. 0.01 Silicon-31...................................................... 10.................................... 0.1 Silver-105........................................................ 1.................................. 0.01 Silver-110m.................................................. 0.1................................ 0.001 Silver-111...................................................... 10.................................... 0.1 Sodium-22 .................................................. 0.1................................ 0.001 Sodium-24 ..................................................... 1.................................. 0.01 Strontium-85m ........................................ 1,000.................................. 10.0 Strontium-85 .................................................. 1.................................. 0.01 Strontium-89 .................................................. 1.................................. 0.01 Strontium-90 ............................................. 0.01.............................. 0.0001 Strontium-91 ................................................ 10.................................... 0.1 Strontium-92 ................................................ 10.................................... 0.1 Sulphur-35 ................................................... 10.................................... 0.1 Tantalum-182.................................................. 1.................................. 0.01 Technetium-96.............................................. 10.................................... 0.1 Technetium-97m........................................... 10.................................... 0.1 Technetium-97.............................................. 10.................................... 0.1 Technetium-99m......................................... 100.................................... 1.0 Technetium-99................................................ 1.................................. 0.01 Tellurium-125m............................................... 1.................................. 0.01 Tellurium-127m............................................... 1.................................. 0.01 Tellurium-127................................................ 10.................................... 0.1 Tellurium-129m............................................... 1.................................. 0.01 Tellurium-129.............................................. 100.................................... 1.0 Tellurium-131m............................................. 10.................................... 0.1 Tellurium-132.................................................. 1.................................. 0.01 Terbium-160 .................................................. 1.................................. 0.01 Thallium-200................................................. 10.................................... 0.1 Thallium-201................................................. 10.................................... 0.1 Thallium-202................................................. 10.................................... 0.1 Thallium-204................................................... 1.................................. 0.01 Thulium-170.................................................... 1.................................. 0.01 Thulium-171.................................................... 1.................................. 0.01 Tin-113 ........................................................... 1.................................. 0.01 Tin-125 ........................................................... 1.................................. 0.01 Tungsten-181.................................................. 1.................................. 0.01 Tungsten-185.................................................. 1.................................. 0.01 Tungsten-187................................................ 10.................................... 0.1 Vanadium-48 .................................................. 1.................................. 0.01 Xenon-131m ............................................1,000.................................. 10.0 Xenon-133 ................................................. 100.................................... 1.0 Xenon-135 ................................................. 100.................................... 1.0 Ytterbium-175 .............................................. 10.................................... 0.1 Yttrium-90 ...................................................... 1.................................. 0.01 Yttrium-91 ...................................................... 1.................................. 0.01 Yttrium-92 .................................................... 10.................................... 0.1 Yttrium-93 ...................................................... 1.................................. 0.01 Zinc-65............................................................ 1.................................. 0.01 Zinc-69m....................................................... 10.................................... 0.1 Zinc-69........................................................ 100.................................... 1.0 Zirconium-93................................................... 1.................................. 0.01 Zirconium-95................................................... 1.................................. 0.01 Zirconium-97................................................... 1.................................. 0.01
Any radioactive material other than source material, special nuclear material, or alpha emitting radioactive material not listed above............. 0.1.............................. 0.001
To convert curies (Ci) to SI units of GBq multiply the above values by 37
Zirconium-97 (Col. II) (0.01 Ci) multiplied by 37 is equivalent to 0.37 GBq
APPENDIX 3-D
Criteria Relating to Use of Financial Tests and Self-Guarantees for Providing Reasonable Assurance of Funds for Decommissioning
I. INTRODUCTION
An applicant or licensee may provide reasonable assurance of the availability of funds for decommissioning based on furnishing its own guarantee that funds will be available for decommissioning costs and on a demonstration that the company passes the financial test of Section II of this appendix. The terms of this self-guarantee are in Section III of this appendix. This appendix establishes criteria for passing the financial test for the self-guarantee and establishes the terms for obtaining a self-guarantee.
II. FINANCIAL TEST
A. To pass the financial test a company must meet all of the criteria set forth in this section. For purposes of applying the Appendix 3-D criteria, tangible net worth must be calculated to exclude all intangible assets and the net book value of the facility and site, and total net worth, which may include intangible assets, must be calculated to exclude the net book value and goodwill of the facility and site. These criteria include:
(1) Tangible net worth of at least $21 million, and total net worth at least 10 times the amount of decommissioning funds being assured by a self-guarantee for all decommissioning activities for which the company is responsible as self-guaranteeing licensee and as parent-guarantor for the total of all facilities or parts, or the current amount required if certification is used.
(2) Assets located in the United States amounting to at least 90% of total assets or at least 10 times the amount of decommissioning funds being assured by a self-guarantee, for all decommissioning activities for which the company is responsible as self-guaranteeing licensee and as parent-guarantor for the total of all facilities or parts, or the current amount required if certification is used.
(3) A current rating for its most recent uninsured, uncollateralized, and unencumbered bond issuance of AAA, AA, or A, including adjustments of + and –, as issued by Standard and Poor's, or Aaa, Aa, or A, including adjustments of 1, 2, or 3, as issued by Moody's.
B. To pass the financial test, a company must meet all of the following additional requirements:
(1) The company must have at least one class of equity securities registered under the Securities Exchange Act of 1934;
(2) The company's independent certified public accountant must have compared the data used by the company in the financial test, which is derived from the independently audited, year-end financial statements for the latest fiscal year, with the amounts in such financial statement. The accountant must evaluate the company's off-balance sheet transactions and provide an opinion on whether those transactions could materially adversely affect the company's ability to pay for decommissioning costs. The accountant must verify that a bond rating, if used to demonstrate passage of the financial test, meets the requirements of Section II, paragraph A of this appendix. In connection with the auditing procedure, the licensee must inform the Department within 90 days of any matters coming to the attention of the auditor that cause the auditor to believe that the data specified in the financial test should be adjusted and that the company no longer passes the test; and
(3) After the initial financial test, the company must annually pass the test and provide documentation of its continued eligibility to use the self-guarantee to the Department within 90 days after the close of each succeeding fiscal year.
C. If the company no longer meets the requirements of Section II.A of this appendix, the licensee must send immediate notice to the Department of its intent to establish alternate financial assurance as specified in the Department’s regulations within 120 days of such notice.
III. COMPANY SELF-GUARANTEE
The terms of a self-guarantee which an applicant or licensee furnishes must provide that:
A. The guarantee will remain in force unless the licensee sends notice of cancellation by certified mail to the Department. Cancellation may not occur, however during the 120 days beginning on the date of receipt of the notice of cancellation by the Department, as evidenced by the return receipt.
B. The licensee must provide alternative financial assurance as specified in the Department’s regulations within 90 days following receipt by the Department of a notice of cancellation of the guarantee.
C. The guarantee and financial test provisions must remain in effect until the Department has terminated the license or until another financial assurance method acceptable to the Department has been put in effect by the licensee.
D. The licensee will promptly forward to the Department and the licensee’s independent auditor all reports covering the latest fiscal year filed by the licensee with the Securities and Exchange Commission according to the requirements of Section 13 of the Securities and Exchange Act of 1934.
E.
(1) If, at any time, the licensee's most recent bond issuance ceases to be rated in any category of "A–" and above by Standard and Poor's or in any category of "A3" and above by Moody's, the licensee will notify the Department in writing within 20 days after publication of the change by the rating service.
(2) If the licensee's most recent bond issuance ceases to be rated in any category of A or above by both Standard and Poor's and Moody's, the licensee no longer meets the requirements of Section II.A of this appendix.
F. The applicant or licensee must provide to the Department a written guarantee, a written commitment by a corporate officer, which states that the licensee will fund and carry out the required decommissioning activities or, upon issuance of an order by the Department, the licensee will fund the standby trust in the amount guaranteed by the self-guarantee agreement.
G.
(1) A standby trust to protect public health and safety and the environment must be established for decommissioning costs before the self-guarantee agreement is submitted.
(2) The trustee and trust must be acceptable to the Department. 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. The Department has the right to change the trustee. An acceptable trust will meet the regulatory criteria established in these regulations that govern the issuance of the license for which the guarantor has accepted the obligation to pay for decommissioning costs.
H. The guarantor must agree that if the guarantor admits in writing its inability to pay its debts generally, or makes a general assignment for the benefit of creditors, or any proceeding is instituted by or against the guarantor seeking to adjudicate it as bankrupt or insolvent, or seeking dissolution, liquidation, winding-up, reorganization, arrangement, adjustment, protection, relief or composition of it or its debts under any law relating to bankruptcy, insolvency, or reorganization or relief of debtors, or seeking the entry of an order for relief or the appointment of a receiver, trustee, custodian, or other similar official for the guarantor or for any substantial part of its property, or the guarantor takes any action to authorize or effect any of the actions stated in this paragraph, then the Department may:
(1) Declare that the financial assurance guaranteed by the self-guarantee agreement is immediately due and payable to the standby trust set up to protect the public health and safety and the environment, without diligence, presentment, demand, protest or any other notice of any kind, all of which are expressly waived by guarantor; and
(2) Exercise any and all of its other rights under applicable law.
I. The guarantor must notify the Department, in writing, immediately following the occurrence of any event listed in paragraph H of this appendix, and must include a description of the event, including major creditors, the amounts involved, and the actions taken to assure that the amount of funds guaranteed by the self-guarantee agreement for decommissioning will be transferred to the standby trust as soon as possible.
APPENDIX 3-E
Quantities of Radioactive Materials Requiring Consideration of the Need for an Emergency Plan for Responding to a Release.
Radioactive material 1....... Release fraction ................ Quantity (curies)
Actinium-228..........................................0.001................................... 4,000 Americium-241.......................................0.001........................................... 2 Americium-242.......................................0.001........................................... 2 Americium-243.......................................0.001........................................... 2 Antimony-124...........................................0.01................................... 4,000 Antimony-126...........................................0.01................................... 6,000 Barium-133 .............................................0.01.................................. 10,000 Barium-140 .............................................0.01.................................. 30,000 Bismuth-207.............................................0.01.................................... 5,000 Bismuth-210.............................................0.01....................................... 600 Cadmium-109..........................................0.01.................................... 1,000 Cadmium-113..........................................0.01......................................... 80 Calcium-45..............................................0.01.................................. 20,000 Californium-252.......................................0.00............................. 19 (20 mg) Carbon-14 (Non CO)...............................0.01.................................. 50,000 Cerium-141 .............................................0.01.................................. 10,000 Cerium-144 .............................................0.01....................................... 300 Cesium-134.............................................0.01.................................... 2,000 Cesium-137.............................................0.01.................................... 3,000 Chlorine-36 ...............................................0.5....................................... 100 Chromium-51 ..........................................0.01................................ 300,000 Cobalt-60 ..............................................0.001.................................... 5,000 Copper-64................................................0.01................................ 200,000 Curium-242 ...........................................0.001......................................... 60 Curium-243...........................................0.001........................................... 3 Curium-244 ...........................................0.001...........................................4 Curium-245 ...........................................0.001...........................................2 Europium-152..........................................0.01....................................... 500 Europium-154..........................................0.01....................................... 400 Europium-155..........................................0.01.................................... 3,000 Germanium-68 ........................................0.01.................................... 2,000 Gadolinium-153........................................0.01.................................... 5,000 Gold-198 ..................................................0.01.................................. 30,000 Hafnium-172 ............................................0.01....................................... 400 Hafnium-181 ............................................0.01.................................... 7,000 Holmium-166m.........................................0.01....................................... 100 Hydrogen-3 ...............................................0.5.................................. 20,000 Iodine-125..................................................0.5......................................... 10 Iodine-131..................................................0.5......................................... 10 Indium-114m............................................0.01.................................... 1,000 Iridium-192.............................................0.001.................................. 40,000 Iron-55.....................................................0.01.................................. 40,000 Iron-59.....................................................0.01.................................... 7,000 Krypton-85 ................................................1.0............................. 6,000,000 Lead-210..................................................0.01........................................... 8 Manganese-56 ........................................0.01................................. 60,00 Mercury-203............................................0.01.................................. 10,000 Molybdenum-99 .....................................0.01.................................. 30,000 Neptunium-237......................................0.001........................................... 2 Nickel-63.................................................0.01.................................. 20,000 Niobium-94.............................................0.01....................................... 300 Phosphorus-32.........................................0.5....................................... 100 Phosphorus-33.........................................0.5.................................... 1,000 Polonium-210.........................................0.01......................................... 10 Potassium-42.........................................0.01.................................... 9,000 Promethium-145.....................................0.01.................................... 4,000 Promethium-147.....................................0.01.................................... 4,000 Radium-226 .........................................0.001....................................... 100 Ruthenium-106.......................................0.01....................................... 200 Samarium-151........................................0.01.................................... 4,000 Scandium-46..........................................0.01.................................... 3,000 Selenium-75............................................0.01.................................. 10,000 Silver-110m.............................................0.01.................................... 1,000 Sodium-22...............................................0.01.................................... 9,000 Sodium-24...............................................0.01.................................. 10,000 Strontium-89 ...........................................0.01.................................... 3,000 Strontium-90 ...........................................0.01......................................... 90 Sulfur-35 ...................................................0.5....................................... 900 Technetium-99 ........................................0.01.................................. 10,000 Technetium-99m .....................................0.01................................ 400,000 Tellurium-127m .......................................0.01.................................... 5,000 Tellurium-129m .......................................0.01.................................... 5,000 Terbium-160.............................................0.01.................................... 4,00 Thulium-170.............................................0.01.................................... 4,000 Tin-113.....................................................0.01.................................. 10,000 Tin-123.....................................................0.01.................................... 3,000 Tin-126.....................................................0.01.................................... 1,000 Titanium-44..............................................0.01....................................... 100 Vanadium-48............................................0.01.................................... 7,000 Xenon-133 .................................................1.0................................ 900,000 Yttrium-91 ................................................0.01.................................... 2,000 Zinc-65......................................................0.01.................................... 5,000 Zirconium-93.............................................0.01....................................... 400 Zirconium-95.............................................0.01.................................... 5,000 Any other beta-gamma emitter..................0.01.................................... 10,00 Mixed fission products..............................0.01.................................... 1,000 Mixed Corrosion products ........................0.01.................................. 10,000 Contaminated equipment beta-gamma .. 0.001................................. 10,000 Irradiated material, any form other than solid Noncombustible ........................................0.01.................................... 1,000 Irradiated material, solid noncombustible . 0.001............................... 10,000 Mixed radioactive waste, beta-gamma ......0.01................................... 1,000 Packaged mixed waste, beta-gamma2 ... 0.001................................. 10,000 Any other alpha emitter ............................0.001...........................................2 Contaminated equipment, alpha............. 0.0001........................................ 20 Packaged waste, alpha2 ....................... 0.0001......................................... 20 Combinations of radio-active materials listed above1........................................................----- ...................................... -----
1 For combinations of radioactive materials, consideration of the need for an emergency plan is required if the sum of the ratios of the quantity of each radioactive material authorized to the quantity listed for that material in 180 NAC 3, Appendix 003-E exceeds one.
2 Waste packaged in Type B containers does not require an emergency plan.
APPENDIX 3-F
Criteria Relating to Use of Financial Tests and Parent Company Guarantees for Providing Reasonable Assurance of Funds for Decommissioning
I. INTRODUCTION
An applicant or licensee may provide reasonable assurance of the availability of funds for decommissioning based on obtaining a parent company guarantee that funds will be available for decommissioning costs and on a demonstration that the parent company passes a financial test. This appendix establishes criteria for passing the financial test and for obtaining the parent company guarantee.
II. FINANCIAL TEST
A. To pass the financial test, the parent company must meet the criteria of either paragraph A.1 or A.2 of this section. For purposes of applying the Appendix 3-F criteria, tangible net worth must be calculated to exclude all intangible assets and the net book value of the facility and site, and total net worth, which may include intangible assets, must be calculated to exclude the net book value and goodwill of the facility and site.
- The parent company must have:
(i) Two of the following three ratios: A ratio of total liabilities to net worth less than 2.0; a ratio of the sum of net income plus depreciation, depletion, and amortization to total liabilities greater than 0.1; and a ratio of current assets to current liabilities greater than 1.5;
(ii) Net working capital and tangible net worth each at least six times the amount of decommissioning being issued by a parent company guarantee for the total of all facilities or parts, or prescribed amount if a certification is used;
(iii) Tangible net worth of at least $21 million; and
(iv) Assets located in the United States amounting to at least 90% of the total assets or at least six times the current decommissioning cost estimates for the total of all facilities or parts, or prescribed amount if a certification is used.
- The parent company must have:
(i) A current rating for its most recent uninsured, uncollateralized, and unencumbered bond issuance of AAA, AA, A, or BBB, including adjustments of + and –, as issued by Standard and Poor's or AAA, AA, A, or Baa, including adjustment of 1, 2, or 3, as issued by Moody's;
(ii) Net working capital and tangible net worth each at least six times the amount of decommissioning funds being assured by a parent company guarantee for the total of all facilities or parts, or prescribed amount if a certification is used;
(iii) Tangible net worth of at least $21 million; and
(iv) Assets located in the United States amounting to at least 90% of the total assets or at least six times the current decommissioning cost estimates for the total of all facilities or parts, or prescribed amount if a certification is used.
B. The parent company's independent certified public accountant must compare the data used by the parent company in the financial test, which is derived from the independently audited, yearend financial statements for the latest fiscal year, with the amounts in such financial statement. The accountant must evaluate the parent company's off-balance sheet transactions and provide an opinion on whether those transactions could materially adversely affect the parent company's ability to pay for decommissioning costs. The accountant must verify that a bond rating, if used to demonstrate passage of the financial test, meets the requirements of paragraph A of this section. In connection with the auditing procedure, the licensee must inform the Department within 90 days of any matters coming to the auditor's attention which cause the auditor to believe that the data specified in the financial test should be adjusted and that the company no longer passes the test.
C.
-
After the initial financial test, the parent company must annually pass the test and provide documentation of its continued eligibility to use the parent company guarantee to the Department within 90 days after the close of each succeeding fiscal year.
-
If the parent company no longer meets the requirements of paragraph A of this section, the licensee must send notice to the Department of intent to establish alternate financial assurance as specified in the Department's regulations. The notice must be sent by certified mail within 90 days after the end of the fiscal year for which the yearend financial data show that the parent company no longer meets the financial test requirements. The licensee must provide alternate financial assurance within 120 days after the end of such fiscal year.
III. PARENT COMPANY GUARANTEE
The terms of a parent company guarantee which an applicant or licensee obtains must provide that:
A. The parent company guarantee will remain in force unless the guarantor sends notice of cancellation by certified mail to the licensee and the Department. Cancellation may not occur, however, during the 120 days beginning on the date of receipt of the notice of cancellation by both the licensee and the Department, as evidenced by the return receipts.
B. If the licensee fails to provide alternate financial assurance as specified in the Department's regulations within 90 days after receipt by the licensee and Department of a notice of cancellation of the parent company guarantee from the guarantor, the guarantor will provide alternative financial assurance that meets to provision of the Department’s regulation in the name of the licensee.
C. The parent company guarantee and financial test provisions must remain in effect until the Department has terminated the license, accepted in writing the parent company’s alternate financial assurances, or accepted in writing the licensee’s financial assurances.
D. A standby trust to protect public health and safety and the environment must be established for decommissioning costs before the parent company guarantee agreement is submitted. The trustee and trust must be acceptable to the Department. An acceptable trustee includes an appropriate State or Federal Government agency or an entity which has the authority to act as a trustee, whose trust operations are regulated and examined by a Federal or State agency. The Department has the right to change the trustee. An acceptable trust will meet the regulatory criteria established in these regulations that govern the issuance of the license for which the guarantor has accepted the obligation to pay for decommissioning costs.
E. The guarantor must agree that it would be subject to Department orders to make payments under the guarantee agreement.
F. The guarantor must agree that if the guarantor admits in writing its inability to pay its debts generally, or makes a general assignment for the benefit of creditors, or any proceeding is instituted by or against the guarantor seeking to adjudicate it as bankrupt or insolvent, or seeking dissolution, liquidation, winding-up, reorganization, arrangement, adjustment, protection, relief or composition of it or its debts under any law relating to bankruptcy, insolvency, or reorganization or relief of debtors, or seeking the entry of an order for relief or the appointment of a receiver, trustee, custodian, or other similar official for the guarantor or for any substantial part of its property, or the guarantor takes any action to authorize or effect any of the actions stated in this paragraph, then the Department may:
-
Declare that the financial assurance guaranteed by the parent company guarantee agreement is immediately due and payable to the standby trust set up to protect the public health and safety and the environment, without diligence, presentment, demand, protest or any other notice of any kind, all of which are expressly waived by guarantor; and
-
Exercise any and all of its other rights under applicable law.
G.
- The guarantor must agree to notify the Department, in writing, immediately following the filing of a voluntary or involuntary petition for bankruptcy under any chapter of title 11, Bankruptcy, of the United States Code, or the occurrence of any other event listed in paragraph F of this Appendix, by or against:
(i) The guarantor;
(ii) The licensee;
(iii) An entity, as that term is defined in 11 U.S.C. 101(14), controlling the licensee or listing the license or licensee as property of the estate; or
(iv) An affiliate, as that term is defined in 11 U.S.C. 101(2), of the licensee.
- This notification must include:
(i) A description of the event, including major creditors, the amounts involved, and the actions taken to assure that the amount of funds guaranteed by the parent company guarantee for decommissioning will be transferred to the standby trust as soon as possible;
(ii) If a petition of bankruptcy was filed, the identity of the bankruptcy court in which the petition for bankruptcy was filed; and
(iii) The date of filing of any petitions
ATTACHMENT 1
Form NRH-5
ATTACHMENT 2
Form NRH-11
ATTACHMENT 3
Form NRH-17
ATTACHMENT 4
Form NRH-60
ATTACHMENT 5
Form NRH-653
ATTACHMENT 6
History
- Effective 2021-06-15
Chapter 4 Standards for Protection Against Radiation
Neb. Admin. Code tit. 180, ch. 4 Standards for Protection Against Radiation {#sec-180-nac-4 omnilex-key=us-ne-regs-official--title-180--180 NAC 4}
TITLE 180 CONTROL OF RADIATION
CHAPTER 4 STANDARDS FOR PROTECTION AGAINST RADIATION
Effective Date: 6/7/2021
001. SCOPE AND AUTHORITY . 180 Nebraska Administrative Code (NAC) 4 establishes standards for protection against ionizing radiation resulting from activities conducted according to licenses or registrations issued by the Department. The regulations are authorized by and implement the Nebraska Radiation Control Act, Nebraska Revised Statute (Neb. Rev. Stat.) §§ 71-3501 to 71-3520.
001.01 SOURCE CONTROL. The requirements of 180 NAC 4 are designed to control the receipt, possession, use, transfer, and disposal of sources of radiation by any licensee or registrant so the total dose to an individual, including doses resulting from all sources of radiation other than background radiation, does not exceed the standards for protection against radiation prescribed in 180 NAC 4. However, nothing in 180 NAC 4 will be construed as limiting actions that may be necessary to protect health and safety.
001.02 EXCEPTIONS. Except as specifically provided in other Chapters of Title 180, 180 NAC 4 applies to persons licensed or registered by the Department to receive, possess, use, transfer, or dispose of sources of radiation. The limits in 180 NAC 4 do not apply to doses due to background radiation, to exposure of patients to radiation for the purpose of medical diagnosis or therapy, to exposure from individuals administered radioactive material and released in accordance with 180 NAC 7-037 or to voluntary participation in medical research programs.
001.03 CODE OF FEDERAL REGULATIONS. 40 Code of Federal Regulations (CFR) as published on July 1, 2013 and 49 CFR as published October 1, 2013 and referred throughout this Chapter are herein incorporated by reference and available for viewing at the Nebraska Department of Health and Human Services, Radiological Health, 301 Centennial Mall South, 3rd Floor, Lincoln, Nebraska 68509.
001.04 INCORPORATION BY REFERENCE. National Council on Radiation Protection and Measurement (NRCP) 116, International Commission on Radiological Protection (ICRP) 23 and Compressed Gas Association Publication G7.1 as referred to in this Chapter are herein incorporated by reference and available for viewing at the Nebraska Department of Health and Human Services, Radiological Health, 301 Centennial Mall South, 3rd Floor, Lincoln, Nebraska 68509.
002. DEFINITIONS . The following definitions apply:
002.01 AIR-PURIFYING RESPIRATOR. An air-purifying respirator is a respirator with an air-purifying filter, cartridge, or canister that removes specific air contaminants by passing ambient air through the air-purifying element.
002.02 ANNUAL LIMIT ON INTAKE (ALI). The annual limit on intake (ALI) is the derived limit for the amount of radioactive material taken into the body of an adult worker by inhalation or ingestion in a year. Annual limit on intake (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 (Sv) (5 roentgen equivalent man (rem)) or a committed dose equivalent of 0.5 Sv (50 rem) to any individual organ or tissue. Annual limit on intake (ALI) values for intake by ingestion and by inhalation of selected radionuclides are given in Table I, Columns 1 and 2, of Appendix 4-B of 180 NAC 4.
002.03 ASSIGNED PROTECTION FACTOR (APF). The assigned protection factor (APF) is 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 assigned protection factor (APF).
002.04 ATMOSPHERE-SUPPLYING RESPIRATOR. An atmosphere-supplying respirator is a respirator that supplies the respirator user with breathing air from a source independent of the ambient atmosphere, and includes supplied-air respirators (SARs) and self-contained breathing apparatus (SCBA) units.
002.05 CLASS. Class is the 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 10 days, for Class W (Weeks) from 10 to 100 days, and for Class Y (Years) of greater than 100 days. For purposes of these regulations, "lung class" and "inhalation class" are equivalent terms.
002.06 DECLARED PREGNANT WOMAN. A declared pregnant woman is a woman who has voluntarily informed the licensee, 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.
002.07 DEMAND RESPIRATOR. A demand respirator is an atmosphere-supplying respirator that admits breathing air to the face piece only when a negative pressure is created inside the face piece by inhalation.
002.08 DERIVED AIR CONCENTRATION (DAC). The derived air concentration (DAC) is the concentration of a given radionuclide in air which, if breathed by the reference man for working year of 2,000 hours under conditions of light work, (inhalation rate 1.2 cubic meters of air per hour), results in an intake of one annual limit on intake (ALI). Derived air concentration (DAC) values are given in Table I, Column 3, of Appendix 4-B of 180 NAC 4.
002.09 DERIVED AIR CONCENTRATION-HOUR (DAC-HOUR). A derived air concentration-hour (DAC-hour is the product of the concentration of radioactive material in air, 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 2,000 derived air concentration (DAC)-hours to represent one annual limit on intake (ALI), equivalent to a committed effective dose equivalent of 0.05 Sv (5 rem).
002.10 DISPOSABLE RESPIRATOR. A disposable respirator is 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 (SCBA).
002.11 DOSE OR RADIATION DOSE. Dose or radiation dose is a generic term that means absorbed dose, dose equivalent, effective dose equivalent, committed dose equivalent, committed effective dose equivalent, or total effective dose equivalent, as defined in other paragraphs of this section.
002.12 DOSIMETRY PROCESSOR. A dosimetry processor is an individual or an organization that processes and evaluates individual monitoring devices in order to determine the radiation dose delivered to the monitoring devices.
002.13 FILTERING FACEPIECE. A filtering facepiece is 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. Dust mask is another term for filtering facepiece.
002.14 FIT FACTOR. The fit factor is the 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.
002.15 FIT TEST. A fit test is the use of a protocol to qualitatively or quantitatively evaluate the fit of a respirator on an individual.
002.16 HELMET. A helmet is a rigid respiratory inlet covering that also provides head protection against impact and penetration.
002.17 HOOD. A hood is a respiratory inlet covering that completely covers the head and neck and may also cover portions of the shoulders and torso.
002.19 INHALATION CLASS. Inhalation class has the same meaning as class.
002.20 LOOSE-FITTING FACEPIECE. A loose-fitting facepiece is a respiratory inlet covering that is designed to form a partial seal with the face.
002.21 LUNG CLASS. Lung class has the same meaning as class.
002.22 NEGATIVE PRESSURE RESPIRATOR. A negative pressure respirator is a respirator in which the air pressure inside the facepiece is negative during inhalation with respect to the ambient air pressure outside the respirator. A tight fitting respirator is another term for a negative pressure respirator.
002.23 NONSTOCHASTIC EFFECT. A nonstochastic effect is a health effect, the severity of which varies with the dose and for which a threshold is believed to exist. Radiation-induced cataract formation is a nonstochastic effect. For purposes of Title 180, a deterministic effect is an equivalent term.
002.24 PLANNED SPECIAL EXPOSURE. A planned special exposure is an infrequent exposure to radiation, separate from and in addition to the annual occupational dose limits.
002.25 POSITIVE PRESSURE RESPIRATOR. A positive pressure respirator is a respirator in which the pressure inside the respiratory inlet covering exceeds the ambient air pressure outside the respirator.
002.26 POWERED AIR-PURIFYING RESPIRATOR (PAPR). A powered air-purifying respirator (PAPR) is an air-purifying respirator that uses a blower to force the ambient air through air-purifying elements to the inlet covering.
002.27 PRESSURE DEMAND RESPIRATOR. A pressure demand respirator is a positive pressure atmosphere-supplying respirator that admits breathing air to the facepiece when the positive pressure is reduced inside the facepiece by inhalation.
002.28 QUALITATIVE FIT TEST (QLFT). A qualitative fit test (QLFT) is a pass or fail fit test to assess the adequacy of respirator fit that relies on the individual's response to the test agent.
002.29 QUANTITATIVE FIT TEST (QNFT). A quantitative fit test (QNFT) is an assessment of the adequacy of respirator fit by numerically measuring the amount of leakage into the respirator.
002.29 QUARTER. A quarter is the period of time equal to one-fourth of the year observed by the licensee or registrant, approximately 13 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.
002.30 REFERENCE MAN. Reference man is the hypothetical aggregation of human physical and physiological characteristics determined 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. A description of the reference man is contained in the International Commission on Radiological Protection Report, ICRP Publication 23, "Report of the Task Group on Reference Man."
002.31 RESPIRATORY PROTECTIVE EQUIPMENT. Respiratory protective equipment is an apparatus, such as a respirator, used to reduce an individual's intake of airborne radioactive materials.
002.32 SANITARY SEWERAGE. Sanitary sewerage is a system of public sewers for carrying off waste water and refuse, but excluding sewage treatment facilities, septic tanks, and leach fields owned or operated by the licensee.
002.33 SELF-CONTAINED BREATHING APPARATUS (SCBA). Self-contained breathing apparatus (SCBA) is an atmosphere-supplying respirator for which the breathing air source is designed to be carried by the user.
002.34 STOCHASTIC EFFECT. A stochastic effect is a health effect that occurs 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 stochastic effects.
002.35 SUPPLIED-AIR RESPIRATOR (SAR). A supplied-air respirator (SAR) is an atmosphere-supplying respirator for which the source of breathing air is not designed to be carried by the user. Airline respirator is another term for a supplied-air respirator.
002.36 TIGHT-FITTING FACEPIECE. A tight-fitting facepiece is a respiratory inlet covering that forms a complete seal with the face.
002.37 USER SEAL CHECK. A user seal check is 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. Fit check is another term for user seal check.
002.38 VERY HIGH RADIATION AREA. A very high radiation area is 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 5 Gy (500 rad) in 1 hour at 1 meter from a radiation source or 1 meter from any surface that the radiation penetrates. Note: For the very high doses received at high dose rates, the units of absorbed dose, gray and rad, are appropriate, rather than units of dose equivalent, sieverts and rem.
002.39 WEIGHTING FACTOR (WT). The weighting factor (WT) for an organ or tissue (T) means 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 WT are:
| ORGAN DOSE WEIGHTING FACTORS | | | --- | --- | | Organ or Tissue | | | | wT | | Gonads | 0.25 | | Breast | 0.15 | | Red Bone Marrow | 0.12 | | Lung | 0.12 | | Thyroid | 0.03 |
| Bone Surfaces | 0.03 | | --- | --- | | Remainder | 0.30a | | Whole Body | 1.00b |
a 0.30 results from 0.06 for each of 5 "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, wT = 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.
003. IMPLEMENTATION . Conditions on licenses are implemented as follows.
003.01 MORE RESTRICTIVE. Any existing license condition that is more restrictive than 180 NAC 4 remains in force until there is an amendment or renewal of the license.
003.02 EXEMPTIONS. If a license condition exempts a licensee from a provision of 180 NAC 4 in effect on or before May 30, 1994, it also exempts the licensee from the corresponding provision of 180 NAC 4.
003.03 PRIOR REGULATIONS. If a license condition cites provisions of 180 NAC 4 in effect prior to May 30, 1994, which do not correspond to any provisions of 180 NAC 4, the license condition remains in force until there is an amendment or renewal of the license that modifies or removes this condition.
004. RADIATION PROTECTION PROGRAMS . Each licensee or registrant must have and follow a radiation protection program as follows.
004.01 RADIATION PROTECTION PROGRAM COMPLIANCE. Each licensee or registrant must develop, document, and implement a radiation protection program sufficient to ensure compliance with the provisions of 180 NAC 4. See 180 NAC 4-047 for recordkeeping requirements relating to these programs.
004.02 AS LOW AS REASONABLY ACHIEVABLE (ALARA). The licensee or registrant must use, to the extent practical, procedures and engineering controls based upon sound radiation protection principles to achieve occupational doses and public doses that are as low as reasonably achievable (ALARA).
004.03 RADIATION PROTECTION PROGRAM REVIEW. The licensee or registrant must, at intervals not to exceed 12 months, review the radiation protection program content and implementation.
004.04 CONSTRAINT ON AIR EMISSIONS. To implement the as low as reasonably achievable (ALARA) requirements of 180 NAC 4-004.02 and despite of the requirements in 180 NAC 4-013, a constraint on air emissions of radioactive material to the environment, excluding radon-222 and its daughters must 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 mSv (10 mrem) per year from these emissions. If a licensee subject to this requirement exceeds this dose constraint, the licensee must report the exceedance as provided in 180 NAC 4-059 and promptly take appropriate corrective action to ensure against a recurrence.
005. OCCUPATIONAL DOSE LIMITS FOR ADULTS . Occupational dose limits for adults are as follows.
005.01 OCCUPATIONAL DOSE CONTROL. The licensee or registrant must control the occupational dose to individual adults, except for planned special exposures according to 180 NAC 4-010, to the following dose limits:
(A) An annual limit, which is the more limiting of:
(i) The total effective dose equivalent being equal to 0.05 Sv (5 rem); or (ii) 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 Sv (50 rem).
(B) 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:
(i) A lens dose equivalent of 0.15 Sv (15 rem), and (ii) A shallow dose equivalent of 0.5 Sv (50 rem) to the skin of the whole body or to the skin of any extremity.
005.02 DOSES RECEIVED IN EXCESS OF THE ANNUAL LIMITS. Doses received in excess of the annual limits, including doses received during accidents, emergencies, and planned special exposures, must be subtracted from the limits for planned special exposures that the individual may receive during the current year and during the individual's lifetime. See 180 NAC 4-010(E)(i) and (ii).
005.03 EXTERNAL EXPOSURE. Licensees and registrants must determine external exposure so that:
(A) 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 U.S. Nuclear Regulatory Commission (NRC). The assigned deep-dose equivalent must be for the part of the body receiving the highest exposure. The assigned shallow-dose equivalent must be the dose averaged over the contiguous 10 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. (B) If an individual is required to be monitored by 180 NAC 4-022, when a protective apron is worn while working with medical fluoroscopic equipment and monitoring is conducted as specified in 180 NAC 4-022.01(E), the effective dose equivalent for external radiation must be determined as follows:
(i) When only one individual monitoring device is used and it is located at the neck (collar) outside the protective apron, the reported deep dose equivalent must be the effective dose equivalent for external radiation; or (ii) When only one individual monitoring device is used and it is located at the neck (collar) outside the protective apron, and the reported dose exceeds 25% of the limit specified in 180 NAC 4-005.01, the reported deep dose equivalent value multiplied by 0.3 must be the effective dose equivalent for external radiation; or (iii) When individual monitoring devices are worn, both under the protective apron at the waist and outside the protective apron at the neck, the effective dose equivalent for external radiation must 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.
005.04 DERIVED AIR CONCENTRATION (DAC) AND ANNUAL LIMIT ON INTAKE (ALI) VALUES. Derived air concentration (DAC) and annual limit on intake (ALI) values are presented in Table I of Appendix 4-B of 180 NAC 4 and may be used to determine the individual's dose and to demonstrate compliance with the occupational dose limits. See 180 NAC 4-052.
005.05 SOLUBLE URANIUM INTAKE. In addition to the annual dose limits, the licensee must limit the soluble uranium intake by an individual to 10 milligrams in a week in consideration of chemical toxicity. See Appendix 4-B of 180 NAC 4.
005.06 DOSE REDUCTION. The licensee or registrant must 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.
006. COMPLIANCE WITH REQUIREMENTS FOR SUMMATION OF EXTERNAL AND INTERNAL DOSES . Requirements for addressing external and internal doses are as follows.
006.01 SUMMING EXTERNAL AND INTERNAL DOSES. If the licensee is required to monitor according to both 180 NAC 4-022.01 and 4-022.02, the licensee must demonstrate compliance with the dose limits by summing external and internal doses. If the licensee or registrant is required to monitor only according to 180 NAC 4-022.01 or only according to 180 NAC 4-022.02 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 according to 180 NAC 4-006.02 through 4-006.04. 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.
006.02 INTAKE BY INHALATION. 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, and one of the following, does not exceed unity:
(A) The sum of the fractions of the inhalation annual limit on intake (ALI) for each radionuclide; (B) The total number of derived air concentration-hours (DAC-hours) for all radionuclides divided by 2,000; 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, WT, and the committed dose equivalent, HT,50, per unit intake is greater than 10% of the maximum weighted value of HT,50 (WTHT,50) per unit intake for any organ or tissue.
006.03 INTAKE BY ORAL INGESTION. If the occupationally exposed individual also receives an intake of radionuclides by oral ingestion greater than 10% of the applicable oral annual limit on intake (ALI), the licensee or registrant must account for this intake and include it in demonstrating compliance with the limits.
006.04 INTAKE THROUGH WOUNDS OR ABSORPTION THROUGH SKIN. The licensee or registrant must 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 derived air concentration (DAC) for hydrogen-3 and does not need to be evaluated or accounted for according to 180 NAC 4-006.04.
007. DETERMINATION OF EXTERNAL DOSE FROM AIRBORNE RADIOACTIVE MATERIAL . Licensees must determine dose from airborne radioactive material as follows.
007.01 DEEP DOSE EQUIVALENT, LENS DOSE EQUIVALENT AND SHALLOW DOSE EQUIVALENT. Licensees must, when determining the dose from airborne radioactive material, include the contribution to the deep dose equivalent, lens dose equivalent, and shallow dose equivalent from external exposure to the radioactive cloud. See Appendix 4-B of 180 NAC 4.
007.02 RADIONUCLIDES OTHER THAN NOBLE GASES OR NONUNIFORM DISTRIBUTION. Airborne radioactivity measurements and derived air concentration (DAC) values must not be used 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 must be based upon measurements using instruments or individual monitoring devices.
008. DETERMINATION OF INTERNAL DOSE . Licensees must determine the internal dose as follows.
008.01 TIMELY MEASUREMENTS. For purposes of assessing dose used to determine compliance with occupational dose equivalent limits, the licensee must, when required under 180 NAC 4-022 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.
008.02 INHALATION CONCENTRATION. Unless respiratory protective equipment is used, as provided in 180 NAC 4-028 or the assessment of intake is based on bioassays, the licensee must assume that an individual inhales radioactive material at the airborne concentration in which the individual is present.
008.03 ADDITIONAL CONSIDERATIONS. When specific information on the physical and biochemical properties of the radionuclides taken into the body or the behavior or 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 must document that information in the individual's record; and (B) Upon prior approval of the Department, adjust the derived air concentration (DAC) or annual limit on intake (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. See Appendix 4-B of 180 NAC 4.
008.04 CLASS Y MATERIAL INTAKE ASSESSMENT. If the licensee chooses to assess intakes of Class Y material using the measurements given in 180 NAC 4-008.01(B) or (C), the licensee may delay the recording and reporting of the assessments for periods up to seven months, unless otherwise required by 180 NAC 4-058 or 4-059. This delay permits the licensee to make additional measurements basic to the assessments.
008.05 KNOWN NUCLIDES AND CONCENTRATION. If the identity and concentration of each radionuclide in a mixture are known, the fraction of the derived air concentration (DAC) applicable to the mixture for use in calculating derived air concentration (DAC)-hours must be either:
(A) The sum of the ratios of the concentration to the appropriate derived air concentration (DAC) value, D, W, or Y, from Appendix 4-B of 180 NAC 4 for each radionuclide in the mixture; or (B) The ratio of the total concentration for all radionuclides in the mixture to the most restrictive derived air concentration (DAC) value for any radionuclide in the mixture.
008.06 KNOWN NUCLIDES. 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 derived air concentration (DAC) for the mixture must be the most restrictive derived air concentration (DAC) of any radionuclide in the mixture.
008.07 MIXTURE OF NUCLIDES. When a mixture of radionuclides in air exists, a licensee may disregard certain radionuclides in the mixture if:
(A) The licensee uses the total activity of the mixture in demonstrating compliance with the dose limits in 180 NAC 4-005 and in complying with the monitoring requirements in 180 NAC 4-022; (B) The concentration of any radionuclide disregarded is less than 10% of its derived air concentration (DAC); and (C) The sum of these percentages for all of the radionuclides disregarded in the mixture does not exceed 30%.
008.08 DETERMINING COMMITTED EFFECTIVE DOSE EQUIVALENT. Committed effective dose equivalent must be determined as follows:
(A) In order to calculate the committed effective dose equivalent, the licensee may assume that the inhalation of one annual limit on intake (ALI), or an exposure of 2,000 derived air concentration (DAC)-hours, results in a committed effective dose equivalent of 0.05 Sv (5 rem) for radionuclides that have their annual limit on intake (ALI)s or derived air concentration (DAC)s based on the committed effective dose equivalent; and (B) For an annual limit on intake (ALI), and the associated derived air concentration (DAC) determined by the nonstochastic organ dose limit of 0.5 Sv (50 rem), the intake of radionuclides that would result in a committed effective dose equivalent of 0.05 Sv (5 rem), the stochastic annual limit on intake (ALI) is listed in parentheses in Table I of Appendix 4-B of 180 NAC 4. The licensee may, as a simplifying assumption, use the stochastic annual limit on intake (ALI) to determine committed effective dose equivalent. However, if the licensee uses the stochastic annual limit on intake (ALI), the licensee must also demonstrate that the limit in 180 NAC 4-005.01(A)(ii) is met.
009. DETERMINATION OF PRIOR OCCUPATIONAL DOSE . Prior occupational dose must be determined as follows.
009.01 PRIOR OCCUPATIONAL DOSE. For each individual who may enter the licensee's or registrant's restricted area and is likely to receive, in a year, an occupational dose requiring monitoring according to 180 NAC 4-022, the licensee or registrant must:
(A) Determine the occupational radiation dose received during the current year; and (B) Attempt to obtain the records of cumulative occupational radiation dose.
009.02 PRIOR PLANNED SPECIAL EXPOSURE AND DOSES IN EXCESS OF THE LIMITS. Prior to permitting an individual to participate in a planned special exposure, the licensee or registrant must 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.
009.03 RECORDS OF PRIOR OCCUPATIONAL DOSE. In complying with the requirements of 180 NAC 4-009.01, 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 statement 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 received during the current year; (B) Accept, as the record of cumulative radiation dose, an up-to-date Department Form NRH-1, 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; or (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, electronic media, or letter. The licensee or registrant must request a written verification of the dose data if the authenticity of the transmitted report cannot be established.
009.04 EXPOSURE HISTORY. The licensee or registrant must record the exposure history, as required by 180 NAC 4-009.01, on Department Form NRH-1, or other clear and legible record, including all of the information required on that form.
(A) The form or record must show each period in which the individual received occupational exposure to radiation or radioactive material and must be signed by the individual who received the exposure. For each period for which the licensee or registrant obtains reports, the licensee or registrant must use the dose shown in the report in preparing Department Form NRH-1 or equivalent. For any period in which the licensee or registrant does not obtain a report, the licensee or registrant must place a notation on Department Form NRH-1 indicating the periods of time for which data are not available. (B) Licensees or registrants are not required to partition historical dose between external dose equivalent(s) and internal committed dose equivalent(s). Further, occupational exposure histories obtained and recorded on Department Form NRH-1 before the May 30, 1994, might not have included effective dose equivalent, but may be used in the absence of specific information on the intake of radionuclides by the individual.
009.05 ASSUMPTIONS. 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 must assume:
(A) In establishing administrative controls under 180 NAC 4-005.06 for the current year, that the allowable dose limit for the individual is reduced by 12.5 mSv (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.
009.06 RECORDS RETENTION. The licensee or registrant must retain the records on Department Form NRH-1 or equivalent until the Department terminates each pertinent license or registration requiring this record. The licensee or registrant must retain records used in preparing Department Form NRH-1 or equivalent for three years after the record is made. This includes records required under the standards for protection against radiation in effect prior to May 30, 1994.
010. PLANNED SPECIAL EXPOSURES . A licensee or registrant may authorize an adult worker to receive doses in addition to and accounted for separately from the doses received under the limits specified in 180 NAC 4-005 provided that each of the following conditions is satisfied:
(A) The licensee or registrant authorizes a planned special exposure only in an exceptional situation when alternatives that might avoid the dose estimated to result from the planned special exposure are unavailable or impractical; (B) The licensee or registrant, and employer if the employer is not the licensee or registrant, specifically authorizes the planned special exposure, in writing, before the exposure occurs. (C) Before a planned special exposure, the licensee or registrant ensures that each individual involved is:
(i) Informed of the purpose of the planned operation; and (ii) 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 (iii) Instructed in the measures to be taken to keep the dose as low as reasonably achievable (ALARA) considering other risks that may be present;
(D) Prior to permitting an individual to participate in a planned special exposure, the licensee or registrant ascertains prior doses as required by 180 NAC 4-009.02 during the lifetime of the individual for each individual involved; (E) Subject to 180 NAC 4-005.02, the licensee or registrant must 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:
(i) The numerical values of any of the dose limits in 180 NAC 4-005.01 in any year; and (ii) Five times the annual dose limits in 180 NAC 4-005.01 during the individual's lifetime;
(F) The licensee or registrant maintains records of the conduct of a planned special exposure in accordance with 180 NAC 4-051 and submits a written report in accordance with 180 NAC 4-060; and (G) The licensee or registrant 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 30 days from the date of the planned special exposure. The dose from planned special exposures must not be considered in controlling future occupational dose of the individual according to 180 NAC 4-005.01 but must be included in evaluations required by 180 NAC 4-010.04 and 4-010.05.
011. OCCUPATIONAL DOSE LIMITS FOR MINORS . The annual occupational dose limits for minors are 10% of the annual occupational dose limits specified for adult workers in 180 NAC 4-005.
012. DOSE EQUIVALENT TO AN EMBRYO/FETUS . Licensees and registrants must control doses to embryo/fetus as follows.
012.01 DOSE LIMIT. The licensee or registrant must ensure that the dose equivalent to an embryo/ fetus during the entire pregnancy, due to occupational exposure of a declared pregnant woman, does not exceed 5 mSv (0.5 rem). See 180 NAC 4-052 for record keeping requirements.
012.02 UNIFORM EXPOSURE RATE. The licensee or registrant must make efforts to avoid substantial variation above a uniform monthly exposure rate to a declared pregnant woman so as to satisfy the limit in 180 NAC 4-012.01.
012.03 DOSE EQUIVALENT. The dose equivalent to an embryo/fetus is the sum of:
(A) The deep dose equivalent to the declared pregnant woman; and (B) The equivalent dose to the embryo/fetus resulting from radionuclides in the embryo/fetus and radionuclides in the declared pregnant woman.
012.04 REMAINDER OF PREGNANCY. If the dose equivalent to the embryo/fetus is found to have exceeded 5 mSv (0.5 rem), or is within 0.5 mSv (0.05 rem) of this dose, by the time the woman declares the pregnancy to the licensee, the licensee or registrant must be deemed to be in compliance with 180 NAC 4-012.01 if the additional dose to the embryo/fetus does not exceed 0.5 mSv (0.05 rem) during the remainder of the pregnancy.
013. DOSE LIMITS FOR INDIVIDUAL MEMBERS OF THE PUBLIC . Licensees and registrants must control doses to individual members of the public as follows.
013.01 DOSE LIMITS. Each licensee or registrant must conduct operations so that:
(A) The total effective dose equivalent to individual members of the public from the licensed or registered operation does not exceed 1 mSv (0.1 rem) in a year, exclusive of the dose contributions from background radiation, from any medical administration the individual has received, from exposure to individuals administered radioactive material and released in accordance with 180 NAC 7-037, from voluntary participation in medical research programs, and from the licensee's or registrant's disposal of radioactive material into sanitary sewerage in accordance with 180 NAC 4-04; and (B) The dose in any unrestricted area from external sources, exclusive of the dose contributions from patients administered radioactive material and released in accordance with 180 NAC 7-037, does not exceed 0.02 mSv (0.002 rem) in any one hour.
013.02 MEMBERS OF THE PUBLIC IN RESTRICTED AREAS. If the licensee or registrant permits members of the public to have access to restricted areas, the limits for members of the public continue to apply to those individuals.
013.03 VISITORS. Despite the requirements of 180 NAC 4-013.01(A), a licensee may permit visitors to an individual who cannot be released, under 180 NAC 7-037, to receive a radiation dose greater than 1 mSv (0.1 rem) if:
(A) The radiation dose received does not exceed 5 mSv (0.5 rem); and (B) The authorized user, as defined in 180 NAC 7, has determined before the visit that it is appropriate.
013.04 PRIOR AUTHORIZATION. 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 5 mSv (0.5 rem). This application must include the following information:
(A) Demonstration of the need for and the expected duration of operations in excess of the limit in 180 NAC 4-013.01; and (B) The licensee's or registrant's program to assess and control dose within the 5 mSv (0.5 rem) annual limit; and (C) The procedures to be followed to maintain the dose as low as reasonably achievable (ALARA).
013.05 ADDITIONAL REQUIREMENTS. In addition to the requirements of 180 NAC 4, a licensee or registrant subject to the provisions of the U.S. Environmental Protection Agency's generally applicable environmental radiation standards in 40 CFR 190 must comply with those standards.
013.06 ADDITIONAL RESTRICTIONS. In order to restrict the collective dose, licensees and registrants may be required to further restrict radiation levels in unrestricted areas or on the total quantity of radionuclides that may be released in effluents.
014. COMPLIANCE WITH DOSE LIMITS FOR INDIVIDUAL MEMBERS OF THE PUBLIC . Licensees and registrants must demonstrate compliance with dose limits for individual members of the public as follows.
014.01 SURVEYS. The licensee or registrant must make or cause to be made surveys of radiation levels in unrestricted areas and radioactive materials in effluents released to unrestricted areas to demonstrate compliance with the dose limits for individual members of the public in 180 NAC 4-013.
014.02 DEMONSTRATING COMPLIANCE. A licensee or registrant must show compliance with the annual dose limit in 180 NAC 4-013 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 Table II of Appendix 4-B of 180 NAC 4; and (ii) If an individual were continuously present in an unrestricted area, the dose from external sources would not exceed 0.02 mSv (0.002 rem) in an hour and 0.5 mSv (0.05 rem) in a year.
014.03 ADJUSTMENT OF EFFLUENT CONCENTRATION VALUES. Upon approval from the Department, the licensee or registrant may adjust the effluent concentration values in Appendix 4-B, Table II, of 180 NAC 4 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, and chemical form.
015. RADIOLOGICAL CRITERIA FOR LICENSE TERMINATION . The radiological criteria for termination of a license are as follows.
015.01 GENERAL PROVISIONS AND SCOPE. The criteria in 180 NAC 4 apply to the decommissioning of facilities licensed under 180 NAC 3. The criteria do not apply to uranium and thorium recovery facilities or to uranium solution extraction facilities.
015.02 LIMITATIONS. The criteria in 180 NAC 4 do not apply to sites which:
(A) Were decommissioned prior to May 27, 2000 in accordance criteria identified in the Site Decommissioning Management Plan Action Plan of April 16, 1992 (57 FR 13389); or (B) Previously submitted and received Department approval on a decommissioning plan that is compatible with the Site Decommissioning Management Plan Action Plan criteria.
015.03 ADDITIONAL CLEANUP. After a site has been decommissioned and the license terminated in accordance with the criteria in 180 NAC 4, a former licensee must conduct additional cleanup only if, based on new information, the Department determines that the criteria of 180 NAC 4 were not met and residual radioactivity remaining at the site could result in significant threat to public health and safety.
015.04 PEAK TOTAL EFFECTIVE DOSE EQUIVALENT. When calculating total effective dose equivalent (TEDE) to the average member of the critical group the license must determine the peak annual total effective dose equivalent (TEDE) dose expected within the first 1000 years after decommissioning.
016. RADIOLOGICAL CRITERIA FOR UNRESTRICTED USE . A site will be considered acceptable for unrestricted use if 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 mSv (25 mrem) 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 as low as reasonably achievable (ALARA) must take into account consideration of any detriments expected to potentially result from decontamination and waste disposal.
017. CRITERIA FOR LICENSE TERMINATION UNDER RESTRICTED CONDITIONS . The criteria for license termination under restricted conditions are as follows.
017.01 CRITERIA. A site will be considered acceptable for license termination under restricted conditions if:
(A) The licensee can demonstrate that further reductions in residual radioactivity necessary to comply with the provisions of 180 NAC 4-016 would result in net public or environmental harm or were not being made because the residual levels associated with restricted conditions are as low as reasonably achievable (ALARA). Determination of the levels which are as low as reasonably achievable (ALARA) must take into account consideration of any detriments, such as traffic accidents, expected to potentially result from decontamination and waste disposal; (B) The licensee has made provisions for legally enforceable institutional controls that provide reasonable assurance that the total effective dose equivalent (TEDE) from residual radioactivity distinguishable from background to the average member of the critical group will not exceed 0.25 mSv (25 mrem) per year; (C) The licensee has provided sufficient financial assurance 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. Acceptable financial assurance mechanisms are:
(i) Funds placed into an account segregated from the licensee’s assets and outside the licensee’s administrative control, and in which the adequacy of the trust funds is to be assessed based on an assumed annual one percent real rate of return on investment. (ii) A statement of intent in the case of Federal, State or local Government licensees, as described in 180 NAC 3-018.06, (D); or (iii) When a governmental entity is assuming custody and ownership of a site, an arrangement that is deemed acceptable by such governmental entity.
(D) The licensee has submitted a decommissioning plan to the Department indicating the licensee’s intent to decommission in accordance with 180 NAC 3-018.01, and specifying that the licensee intends to decommission by restricting use of the site. The licensee must document in the decommissioning plan 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.
(i) Licensees proposing to decommission by restricting use of the site must seek advice from such affected parties regarding the following matters concerning the proposed decommissioning:
(1) Whether provisions for institutional controls proposed by the licensee:
(a) Will provide reasonable assurance that the total effective dose equivalent (TEDE) from residual radioactivity distinguishable from background to the average member of the critical group will not exceed 25 0.25 mSv (25 mrem) total effective dose equivalent (TEDE) per year; (b) Will be enforceable; and (c) Will not impose undue burdens on the local community or other affected parties.
(2) Whether the licensee has provided sufficient financial assurance 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.
(ii) In seeking advice on the issues identified in 180 NAC 4-017.01, (D)(i), the licensee must provide for:
(1) Participation by representatives of a broad cross section of community interests who may be affected by the decommissioning; (2) An opportunity for a comprehensive, collective discussion on the issues by the participants represented; and (3) 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; and
(E) Residual radioactivity at the site has been reduced so that if the institutional controls were no longer in effect, there is reasonable assurance that the total effective dose equivalent (TEDE) from residual radioactivity distinguishable from background to the average member of the critical group is as low as reasonably achievable and would not exceed either;
(i) 1 mSv (100 mrem) per year; or (1 mSv) per year; or (ii) 5 mSv (500 mrem) per year provided the licensee;
(1) Demonstrates that further reductions in residual radioactivity necessary to comply with the 1 mSv/y (100 mrem/y) value of 180 NAC 4-017.01, (E)(i), are not technically achievable, would be prohibitively expensive, or would result in net public or environmental harm; (2) Makes provisions for durable institutional controls; (3) Provides sufficient financial assurance to enable a responsible government entity or independent third party, including a governmental custodian of a site both to carry out periodic rechecks of the site, no less frequently than every five years to assure that the institutional controls necessary to meet the criteria of 180 NAC 4-017.01, (B) and to assume and carry out responsibilities for any necessary control and, maintenance of those controls. Acceptable financial assurance mechanisms are those in 180 NAC 4-017.01, (C).
018. ALTERNATE CRITERIA FOR LICENSE TERMINATION . Alternate criteria for license termination are as follows.
018.01 CRITERIA. For the Department to consider terminating a license using alternate criteria greater than the dose criterion of 180 NAC 4-016, 4-017.01(B), and 4-017.01(D)(i)(1)(a), the licensee must:
(A) Provide 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 1 mSv per year (100 mrem per year) limit of 180 NAC 4-013.01(A) by submitting an analysis of possible sources of exposure; (B) Employ to the extent practical restrictions on site use according to the provisions of 180 NAC 4-017 in minimizing exposures at the site; (C) Reduce doses to as low as reasonably achievable (ALARA) levels, taking into consideration any detriments such as traffic accidents expected to potentially result from decontamination and waste disposal; (D) Have submitted a decommissioning plan to the Department indicating the licensee’s intent to decommission in accordance with 180 NAC 3-019.04 and specifying that the licensee proposes to decommission by use of alternate criteria. The licensee must document in the decommissioning plan how the advice of individuals and institutions in the community who may be affected by the decommissioning has been sought and addressed, as appropriate, following analysis of that advice. In seeking such advice, the licensee must provide for:
(i) Participation by representatives of a broad cross section of community interests who may be affected by the decommissioning; (ii) An opportunity for a comprehensive, collective discussion on the issues by the participants represented; and (iii) 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; and
(E) Have 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.
018.02 ALTERNATE CRITERIA. The use of alternate criteria to terminate a license requires the approval of the Department and will consider any comments provided by the Environmental Protection Agency and any public comments submitted according to 180 NAC 4-019.
019. PUBLIC NOTIFICATION AND PUBLIC PARTICIPATION . The process for public notification and participation in the Department’s consideration of license termination under restricted and alternate conditions is as follows.
019.01 COMMENTS. Upon the receipt of the decommissioning plan from the licensee, or a proposal by the licensee for release of a site according to 180 NAC 4-017 and 4-018, or whenever the Department deems such notice to be in the public interest, the Department may:
(A) Notify and solicit comments from:
(i) Local and State governments in the vicinity of the site and any Indian Nation or other indigenous people that have treaty or statutory rights that could be affected by the decommissioning; and (ii) The Environmental Protection Agency for cases where the licensee proposes to release a site according to 180 NAC 4-018.
019.02 PUBLICATION. A notice may be posted in local newspapers, letters to the State or local organizations, or other appropriate forum, that is readily accessible to individuals in the vicinity of the site, and comments may be solicited from affected parties.
020. MINIMIZATION OF CONTAMINATION . Contamination must be minimized as follows.
020.01 APPLICANTS. Applicants for licenses, other than renewals, must describe in the application how the facility design and the procedures for operation will minimize, to the extent practicable, contamination of the facility and the environment, facilitate eventual decommissioning, and minimize, to the extent practicable, the generation of radioactive waste.
020.02 LICENSEES. Licensees must, 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 180 NAC 4-004 and radiological criteria for license termination in 180 NAC 4-015 through 4-020.
021. SURVEYS AND MONITORING . Licensees and registrants must conduct surveys and monitor for radiation as follows.
021.01 AREA SURVEYS. Each licensee or registrant must make, or cause to be made, surveys of areas, including the subsurface, that:
(A) Are necessary for the licensee or registrant to comply with 180 NAC 4; and (B) Are necessary under the circumstances to evaluate:
(i) The magnitude and extent of radiation levels; and (ii) Concentrations or quantities of residual radioactivity; and (iii) The potential radiological hazards of the radiation levels and residual radioactivity detected.
021.02 SUBSURFACE RESIDUAL RADIOACTIVITY. Despite the requirements of 180 NAC 4-048.01, 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 those records must be retained in accordance with 180 NAC 3-018.07, as applicable.
021.03 SURVEY INSTRUMENT AND EQUIPMENT CALIBRATION. The licensee or registrant must ensure that instruments and equipment used for quantitative radiation measurements, including dose rate and effluent monitoring, are calibrated at intervals not to exceed 12 months for the radiation measured, except when a more frequent interval is specified in another applicable chapter or a license condition.
021.04 PERSONNEL DOSIMETERS. All personnel dosimeters, except for direct and indirect reading pocket ionization chambers and those dosimeters used to measure the dose to any extremity, that require processing to determine the radiation dose and that are used by licensees and registrants to comply with 180 NAC 4-005, with other applicable provisions of these regulations, or with conditions specified in a license or registration must be processed and evaluated by a dosimetry processor:
(A) Holding current personnel dosimetry accreditation from the National Voluntary Laboratory Accreditation Program (NVLAP) of the National Institute of Standards and Technology; and (B) Approved in this accreditation process for the type of radiation or radiations included in the National Voluntary Laboratory Accreditation Program (NVLAP) program that most closely approximates the type of radiation or radiations for which the individual wearing the dosimeter is monitored.
021.05 DECEPTIVE EXPOSURE OF AN INDIVIDUAL MONITORING DEVICE. The licensee or registrant must ensure that adequate precautions are taken to prevent a deceptive exposure of an individual monitoring device.
022. CONDITIONS REQUIRING INDIVIDUAL MONITORING OF EXTERNAL AND INTERNAL OCCUPATIONAL DOSE . Each licensee or registrant must monitor exposures to radiation and radioactive material at levels sufficient to demonstrate compliance with the occupational dose limits of 180 NAC 4 as follows.
022.01 OCCUPATIONAL EXPOSURE MONITORING. Each licensee or registrant must monitor occupational exposures to radiation from registered, licensed and unlicensed radiation sources under the control of the licensee or registrant and must supply and require the use of individual monitoring devices by:
(A) Adults likely to receive, in one year from sources external to the body, a dose in excess of 10% of the limits in 180 NAC 4-005.01; and (B) Minors likely to receive, in one year, from sources external to the body, a deep dose equivalent in excess of 1 mSv (0.1 rem), a lens dose equivalent in excess of 1.5 mSv (0.15 rem), or a shallow dose equivalent to the skin or to the extremities in excess of 5 mSv (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 1 mSv (0.1 rem). All of the occupational doses in 180 NAC 4-005 continue to be applicable to the declared pregnant worker as long as the embryo/fetus dose limit is not exceeded; (D) Individuals entering a high or very high radiation area; and (E) Individuals working with medical fluoroscopic equipment:
(i) An individual monitoring device used for the dose to an embryo/fetus of a declared pregnant woman, according to 180 NAC 4-012.01, must be located under the protective apron at the waist; (ii) An individual monitoring device used for lens dose equivalent must be located at the neck or collar, or an unshielded location closer to the eye, outside the protective apron; and (iii) When only one individual monitoring device is used to determine the effective dose equivalent for external radiation according to 180 NAC 4-005.03, it must be located at the neck or collar outside the protective apron. When a second individual monitoring device is used for the same purpose, it must be located under the protective apron at the waist. The second individual monitoring device is required for a declared pregnant woman.
022.02 OCCUPATIONAL INTAKE OF RADIOACTIVE MATERIAL. Each licensee or registrant must monitor, to determine compliance with 180 NAC 4-008, 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 10% of the applicable annual limit on intake (ALI) in Table I, Columns 1 and 2, of Appendix of 180 NAC 4; (B) Minors likely to receive, in one year, a committed effective dose equivalent in excess of 1 mSv (0.1 rem); and (C) Declared pregnant women likely to receive, during the entire pregnancy, a committed effective dose equivalent in excess of 1 mSv (0.1 rem).
023. CONTROL OF ACCESS TO HIGH RADIATION AREAS . The requirements for control of access to high radiation areas are as follows.
023.01 ACCESS POINTS. The licensee or registrant must ensure 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 1 mSv (0.1 rem) in one hour at 30 centimeters from the source of radiation from any surface that the radiation penetrates; (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 positive control over each individual entry.
023.02 CONTINUOUS DIRECT OR ELECTRONIC SURVEILLANCE. In place of the controls required by 180 NAC 4-023.01 for a high radiation area, the licensee or registrant may substitute continuous direct or electronic surveillance that is capable of preventing unauthorized entry.
023.03 APPLICATION FOR APPROVAL OF ALTERNATIVE METHODS. The licensee or registrant may apply to the Department for approval of alternative methods for controlling access to high radiation areas.
023.04 EGRESS. The licensee or registrant must establish the controls required by 180 NAC 4-023.01 and 4-023.03 in a way that does not prevent individuals from leaving a high radiation area.
023.05 RADIOACTIVE MATERIALS PACKAGED AND LABELED FOR TRANSPORT. 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 U.S. Department of Transportation provided that:
(A) The packages do not remain in the area longer than 3 days; and (B) The dose rate at 1 meter from the external surface of any package does not exceed 0.1 mSv (0.01 rem) per hour.
023.06 PATIENTS CONTAINING RADIOACTIVE MATERIAL. 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 180 NAC 4 and to operate within the as low as reasonably achievable (ALARA) provisions of the licensee's radiation protection program.
023.07 EXCEPTION. 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 180 NAC 4-023 if the registrant has met all the specific requirements for access and control specified applicable chapters of Title 180, 180 NAC 5 for industrial radiography, 180 NAC 6 for x-rays in the healing arts, or 180 NAC 9 for particle accelerators.
024. CONTROL OF ACCESS TO VERY HIGH RADIATION AREAS . The requirements for control of access to very high radiation areas are as follows.
024.01 UNAUTHORIZED OR INADVERTENT ACCESS. In addition to the requirements in 180 NAC 4-023, the licensee or registrant must institute measures to ensure that an individual is not able to gain unauthorized or inadvertent access to areas in which radiation levels could be encountered at 5 Gy (500 rad) or more in 1 hour at 1 meter from a source of radiation or any surface through which the radiation penetrates. This requirement does not apply to rooms or areas in which diagnostic x-ray systems are the only source of radiation, or to non-self-shielded irradiators.
024.02 EXCEPTION. 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 described in 180 NAC 4-024.01 if the registrant has met all the specific requirements for access and control specified in applicable chapters of Title 180, 180 NAC 5 for industrial radiography, 180 NAC 6 for x-rays in the healing arts, or 180 NAC 9 for particle accelerators.
025. CONTROL OF ACCESS TO VERY HIGH RADIATION AREAS—IRRADIATORS . The requirements for control of access to very high radiation areas at non-self-shielded irradiators are as follows.
025.01 NON-SELF-SHIELDED IRRADIATORS. 180 NAC 4-025 applies to licensees or registrants with sources of radiation in non-self-shielded irradiators. 180 NAC 4-025 does not apply to sources of radiation that are used in teletherapy, in industrial radiography, or in completely self-shielded irradiators in which the source of radiation is both stored and operated within the same shielding radiation barrier and, in the designed configuration of the irradiator, is always physically inaccessible to any individual and cannot create high levels of radiation in an area that is accessible to any individual.
025.02 AREA CONTROLS. Each area in which there may exist radiation levels in excess of 5 Gy (500 rad) in 1 hour at 1 meter from a source of radiation that is used to irradiate materials must meet the following requirements.
025.02(A) ENTRANCE OR ACCESS POINT. Each entrance or access point must be equipped with entry control devices that:
(i) Function automatically to prevent any individual from inadvertently entering a very high radiation area; (ii) Permit deliberate entry into the area only after a control device is actuated that causes the radiation level within the area, from the source of radiation, to be reduced below that at which it would be possible for an individual to receive a deep dose equivalent in excess of 1 mSv (0.1 rem) in 1 hour; and (iii) Prevent operation of the source of radiation if it would produce radiation levels in the area that could result in a deep dose equivalent to an individual in excess of 1 mSv (0.1 rem) in 1 hour.
025.02(B) ADDITIONAL CONTROL DEVICES. Be provided with additional control devices upon failure of the entry control devices to function as required by 180 NAC 4-025.02(A):
(i) The radiation level within the area, from the source of radiation, is reduced below that at which it would be possible for an individual to receive a deep dose equivalent in excess of 1 mSv (0.1 rem) in 1 hour; and (ii) Conspicuous visible and audible alarm signals are generated to make an individual attempting to enter the area aware of the hazard and at least one other authorized individual, who is physically present, familiar with the activity, and prepared to render or summon assistance, aware of the failure of the entry control devices.
025.02(C) FAILURE OR REMOVAL OF PHYSICAL RADIATION BARRIERS. The licensee or registrant must provide control devices so that, upon failure or removal of physical radiation barriers:
(i) The radiation level from the source of radiation is reduced below that at which it would be possible for an individual to receive a deep dose equivalent in excess of 1 mSv (0.1 rem) in 1 hour; and (ii) Conspicuous visible and audible alarm signals are generated to make potentially affected individuals aware of the hazard and the licensee or registrant or at least one other individual, who is familiar with the activity and prepared to render or summon assistance, aware of the failure or removal of the physical barrier.
025.02(D) PERMANENT STRUCTURAL COMPONENTS. Physical radiation barriers that comprise permanent structural components or walls that have no credible probability of failure or removal in ordinary circumstances need not meet the requirements of 180 NAC 4-025.02(C).
025.02(E) VISIBLE AND AUDIBLE ALARMS. Each area must be equipped with devices that will automatically generate conspicuous visible and audible alarm signals to alert personnel in the area before the source of radiation can be put into operation and in time for any individual in the area to operate a clearly identified control device, which must be installed in the area and which can prevent the source of radiation from being put into operation.
025.02(F) AREA CONTROLS. Each area must be controlled by use of such administrative procedures and such devices as are necessary to ensure that the area is cleared of personnel prior to each use of the source of radiation.
025.02(G) RADIATION MEASUREMENT. Each area must be checked by a radiation measurement to ensure that, prior to the first individual's entry into the area after any use of the source of radiation, the radiation level from the source of radiation in the area is below that at which it would be possible for an individual to receive a deep dose equivalent in excess of 1 mSv (0.1 rem) in 1 hour.
025.02(H) ENTRY CONTROL DEVICE TESTING. The entry control devices required in 180 NAC 4-025.02(A), must have been tested for proper functioning:
(i) Testing must be conducted prior to initial operation with the source of radiation on any day, unless operations were continued uninterrupted from the previous day; (ii) Testing must be conducted prior to resumption of operation of the source of radiation after any unintentional interruption; and (iii) The licensee or registrant must submit and adhere to a schedule for periodic tests of the entry control and warning systems.
025.02(I) FUNCTIONING CONTROL DEVICES. The licensee or registrant must not conduct operations, other than those necessary to place the source of radiation in safe condition or to effect repairs on controls, unless control devices are functioning properly.
025.02(J) ENTRY AND EXIT PORTALS. Entry and exit portals that are used in transporting materials to and from the irradiation area, and that are not intended for use by individuals, must be controlled by such devices and administrative procedures as are necessary to physically protect and warn against inadvertent entry by any individual through these portals.
025.03 ALTERNATIVE SAFETY MEASURES. Registrants or applicants for registrations for sources of radiation within the scope of 180 NAC 4-025.02 that will be used in a variety of positions or in locations that make it impracticable to comply with certain requirements of 180 NAC 4-025.02, may apply to the Department for approval of alternative safety measures. Alternative safety measures must provide personnel protection at least equivalent to those specified in 180 NAC 4-025.02. At least one of the alternative measures must include an entry-preventing interlock control based on a measurement of the radiation that ensures the absence of high radiation levels before an individual can gain access to the area where such sources of radiation are used.
025.04 ENTRY CONTROL DEVICES. The entry control devices required by 180 NAC 4-025.02 and 4-025.03 must be established in such a way that no individual will be prevented from leaving the area.
026. CONTROL OF CONCENTRATIONS OF RADIOACTIVE MATERIAL IN AIR . The licensee or registrant must use, to the extent practical, process or other engineering controls, containment, decontamination or ventilation to control the concentrations of radioactive material in air.
027. USE OF OTHER CONTROLS . The licensee may consider the following in limiting the concentrations of radioactive material in air.
027.01 INCREASED MONITORING AND LIMIT INTAKES. 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 or registrant must, consistent with maintaining the total effective dose equivalent as low as reasonably achievable (ALARA), increase monitoring and limit intakes by one or more of the following means:
(A) Control of access; (B) Limitation of exposure times; (C) Use of respiratory protection equipment; or (D) Other controls.
027.02 SAFETY FACTORS. If the licensee performs an as low as reasonably achievable (ALARA) analysis to determine whether or not respirators should be used, the licensee may consider safety factors other than radiological factors. The licensee may also consider the impact of respirator use on workers' industrial health and safety.
028. USE OF INDIVIDUAL RESPIRATORY PROTECTION EQUIPMENT . This section addresses the use of respiratory protection equipment.
028.01 RESPIRATORY PROTECTION EQUIPMENT. If the licensee assigns or permits the use of respiratory protection equipment to limit the intake of radioactive material, according to 180 NAC 4-027 the licensee must:
(A) Use only respiratory protection equipment that is tested and certified by the National Institute for Occupational Safety and Health (NIOSH), except as provided in 180 NAC 4-028.01(B); (B) Submit an application for authorized use if the licensee wishes to use equipment that has not been tested or certified by the National Institute for Occupational Safety and Health (NIOSH), or for which there is no schedule for testing or certification, except as provided in 180 NAC 4-028.01. The application must include evidence that the material and performance characteristics of the equipment are capable of providing the proposed degree of protection under anticipated conditions of use. This must be demonstrated either by licensee testing or on the basis of reliable test information. (C) Implement and maintain a respiratory protection program that includes:
(i) Air sampling sufficient to identify the potential hazard, permit proper equipment selection, and estimate doses; (ii) Surveys and bioassays, as necessary, to evaluate actual intakes; (iii) Testing of respirators for operability consisting of a user seal check for face sealing devices and functional check for each other immediately prior to each use; and (iv) Written procedures regarding:
(1) Monitoring, including air sampling and bioassays; (2) Supervision and training of respiratory users; (3) Fit testing; (4) Respiratory selection; (5) Breathing air quality; (6) Inventory and control; (7) Storage, issuance, maintenance, repair, testing, and quality assurance of respiratory protection equipment; (8) Recordkeeping; and (9) Limitations on periods of respirator use and relief from respirator use; and
(v) A determination by a physician that the individual user is medically fit to use the respiratory protection equipment:
(1) Before the initial fitting of a face sealing respiratory; (2) Before the first field use of non-face sealing respirators, and (3) Either every 12 months thereafter, or periodically at a frequency determined by a physician; and
(vi) Fit testing, with fit factor ≥10 times the assigned protection factor (APF) for negative pressure devices, and a fit factor ≥ 500 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; and
(D) 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; and (E) Consider limitations appropriate to the type and mode of use. When selecting respiratory devices the licensee must provide for vision correction, adequate communication, low temperature work environments, and the concurrent use of other safety or radiological protection equipment. The licensee must use equipment in such a way as not to interfere with the proper operation of the respirator; and (F) Have standby rescue persons 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 themself. The standby persons must be equipped with respiratory protection devices or other apparatus appropriate for the potential hazards. The standby rescue persons must observe or otherwise maintain continuous communication with the workers through visual, voice, signal line, telephone, radio, or other suitable means, and be immediately available 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 standby rescue persons must be immediately available to assist all users of this type of equipment and to provide effective emergency rescue if needed; and (G) Supply atmosphere-supplying respirators with respirable air of grade D quality or better as specified in the regulations of the Occupational Safety and Health Administration at 29 CFR 1910.134(i)(1)(ii)(2016). Grade D quality air criteria include:
(i) Oxygen content (v/v) of 19.5-23.5%; (ii) Hydrocarbon (condensed) content of 5 milligrams per cubic meter of air or less; (iii) Carbon monoxide (CO) content of 10 ppm or less; (iv) Carbon dioxide content of 1,000 ppm or less; and (v) Lack of noticeable odor; and
(H) Ensure that no objects, materials or substances, such as facial hair, or any conditions that interfere with the face--facepiece seal or valve function, and that are under the control of the respirator wearer, are present between the skin of the wearer's face and the sealing surface of a tight-fitting respirator facepiece; and (I) Initially assume the concentration of radioactive material in the air that is inhaled when respirators are worn to be the ambient concentration in air without respiratory protection, divided by the assigned protection factor when estimating the dose to individuals from intake of airborne radioactive materials. If the dose is later found to be greater than the estimated dose, the corrected value must be used. If the dose is later found to be less than the estimated dose, the corrected value may be used.
029. FURTHER RESTRICTIONS ON THE USE OF RESPIRATORY PROTECTION EQUIPMENT . Licensees must comply with restrictions imposed by the Department in addition to the provisions of 180 NAC 4-027, 4-028, and Appendix 4-A as follows.
029.01 AS LOW AS REASONABLY ACHIEVABLE (ALARA). Licensees must comply with further restrictions imposed by the Department to 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 as low as reasonably achievable (ALARA).
029.02 RELIANCE ON RESPIRATORY PROTECTION EQUIPMENT. Licensees must comply with any limits imposed by the Department on the extent to which a licensee may use respiratory protection equipment instead of process or other engineering controls.
030. APPLICATION FOR USE OF HIGHER ASSIGNED PROTECTION FACTORS . The licensee must obtain authorization from the Department before using assigned protection factors in excess of those specified in Appendix 4-A.
030.01 DESCRIPTION OF THE SITUATION. An application to use protection factors in excess of those specified in Appendix 4-A must describe the situation for which a need exists for higher protection factors.
030.02 CONDITIONS OF USE. An application to use protection factors in excess of those specified in Appendix 4-A must demonstrate that the respiratory protection equipment provides these higher protection factors under the proposed conditions of use.
031. SECURITY AND CONTROL OF LICENSED OR REGISTERED SOURCES OF RADIATION . Licensed or registered sources of radiation must be secured and controlled as follows.
031.01 UNAUTHORIZED REMOVAL OR ACCESS OF RADIOACTIVE MATERIAL. The licensee or registrant must secure licensed or registered radioactive material from unauthorized removal or access.
031.02 UNAUTHORIZED USE OF RADIOACTIVE MATERIAL. The licensee or registrant must maintain constant surveillance, use devices and administrative procedures to prevent unauthorized use of licensed or registered radioactive material that is in an unrestricted area and that is not in storage.
031.03 MOBILE AND PORTABLE RADIATION MACHINES. The registrant must secure mobile or portable radiation machines that are capable of producing a high radiation area as defined in 180 NAC 1 from unauthorized removal.
031.04 UNAUTHORIZED USE OF RADIATION MACHINES. The registrant must use devices or administrative procedures to prevent unauthorized use of registered radiation machines.
031.05 SECURITY REQUIREMENTS FOR PORTABLE GAUGES. Each portable gauge licensee must 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.
032. RESERVED .
033. CAUTION SIGNS . This section addresses caution signs and their appearance.
033.01 STANDARD RADIATION SYMBOL. Unless otherwise authorized by the Department, the symbol prescribed by 180 NAC 4-033 must use the colors magenta, or purple, or black on yellow background. The symbol prescribed is the three-bladed design as follows:
(A) Cross-hatched area is to be magenta, or purple, or black, and (B) The background is to be yellow.
033.02 EXCEPTION TO COLOR REQUIREMENTS FOR STANDARD RADIATION SYMBOL. Despite the requirements of 180 NAC 4-033.01, licensees or registrants are authorized to label sources, source holders, or device components containing sources of radiation that are subjected to high temperatures, with conspicuously etched or stamped radiation caution symbols and without a color requirement.
033.03 ADDITIONAL INFORMATION ON SIGNS AND LABELS. In addition to the contents of signs and labels prescribed in 180 NAC 4, the licensee or registrant must 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.
034. POSTING REQUIREMENTS . This section address posting requirements.
034.01 POSTING OF RADIATION AREAS. The licensee or registrant must post each radiation area with a conspicuous sign or signs bearing the radiation symbol and the words "CAUTION, RADIATION AREA."
034.02 POSTING OF HIGH RADIATION AREAS. The licensee or registrant must 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."
034.03 POSTING OF VERY HIGH RADIATION AREAS. The licensee or registrant must post each very high radiation area with a conspicuous sign or signs bearing the radiation symbol and words "GRAVE DANGER, VERY HIGH RADIATION AREA."
034.04 POSTING OF AIRBORNE RADIOACTIVITY AREAS. The licensee or registrant must 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."
034.05 POSTING OF AREAS OR ROOMS IN WHICH LICENSED OR REGISTERED MATERIAL IS USED OR STORED. The licensee or registrant must post each area or room in which there is used or stored an amount of licensed or registered material exceeding ten times the quantity of such material specified in Appendix 4-C of 180 NAC 4 with a conspicuous sign or signs bearing the radiation symbol and the words "CAUTION, RADIOACTIVE MATERIAL(S)" or "DANGER, RADIOACTIVE MATERIAL(S)."
035. EXCEPTIONS TO POSTING REQUIREMENTS . The exceptions to the posting requirements are as follows.
035.01 RADIATION FOR PERIODS OF LESS THAN EIGHT HOURS. A licensee or registrant is not required to post caution signs in areas or rooms containing sources of radiation for periods of less than eight hours, if each of the following conditions is met:
(A) The sources of radiation are constantly attended 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 180 NAC 4; and (B) The area or room is subject to the licensee's or registrant's control.
035.02 PATIENT ROOMS AND AREAS. Rooms or other areas in hospitals that are occupied by patients are not required to be posted with caution signs according to 180 NAC 4-034 provided that the patient could be released from licensee control according to 180 NAC 7-037.
035.03 SEALED SOURCE. 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 30 centimeters from the surface of the sealed source container or housing does not exceed 0.05 mSv (0.005 rem) per hour.
035.04 TELETHERAPY. Rooms in hospitals or clinics that are used for teletherapy are exempt from the requirement to post caution signs in accordance with 180 NAC 4-034 if:
(A) Access to the room is controlled in accordance with 180 NAC 7-071; and (B) 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 180 NAC 4-035.
036. LABELING CONTAINERS AND RADIATION MACHINES . The requirements for labeling containers and radiation machines are as follows.
036.01 RADIOACTIVE MATERIAL LABEL. The licensee or registrant must ensure that each container of licensed or registered material bears a durable, clearly visible label bearing the radiation symbol and the words "CAUTION, RADIOACTIVE MATERIAL" or "DANGER, RADIOACTIVE MATERIAL." The label must 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.
036.02 RADIOACTIVE MATERIAL LABEL REMOVAL. Each licensee or registrant must, prior to removal or disposal of empty uncontaminated containers to unrestricted areas, remove or deface the radioactive material label or otherwise clearly indicate that the container no longer contains radioactive materials.
036.03 RADIATION MACHINE LABEL. Each registrant must ensure that each radiation machine is labeled in a conspicuous manner which cautions individuals that radiation is produced when it is energized.
037. EXEMPTIONS TO LABELING REQUIREMENTS . A licensee or registrant is not required to label:
037.01 CONTAINERS HOLDING QUANTITIES LESS THAN APPENDIX 4-C. Containers holding licensed or registered material in quantities less than the quantities listed in Appendix 4-C of 180 NAC 4;
037.02 CONTAINERS HOLDING CONCENTRATIONS LESS THAN TABLE III OF APPENDIX 4-B. Containers holding licensed or registered material in concentrations less than those specified in Table III of Appendix B of 180 NAC 4;
037.03 CONTAINERS ATTENDED BY AN INDIVIDUAL. Containers attended by an individual who takes the precautions necessary to prevent the exposure of individuals in excess of the limits established by 180 NAC 4;
037.04 CONTAINERS IN TRANSPORT. Containers when they are in transport and packaged and labeled in accordance with the regulations of the U.S. Department of Transportation. Labeling of packages containing radioactive materials is required by the U.S. Department of Transportation if the amount and type of radioactive material exceeds the limits for an excepted quantity or article as defined and limited by U.S. Department of Transportation regulations 49 CFR 173.403(m) and (w) and 173.421-424;
037.05 LIMITED ACCESS CONTAINERS. 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 must be retained as long as the containers are in use for the purpose indicated on the record; or
037.06 INSTALLED MANUFACTURING OR PROCESS EQUIPMENT. Installed manufacturing or process equipment, such as piping and tanks.
038. PROCEDURES FOR RECEIVING AND OPENING PACKAGES . This section addresses the procedures for opening packages containing radioactive materials.
038.01 RECEIPT. Each licensee who expects to receive a package containing quantities of radioactive material in excess of a Type A quantity, as defined in 180 NAC 13-002 and Appendix A of 180 NAC 13, must make arrangements to receive:
(A) The package when the carrier offers it for delivery; or (B) Notification of the arrival of the package at the carrier's terminal and to take possession of the package expeditiously.
038.02 MONITORING. Each licensee must monitor:
(A) The external surfaces of a labeled package for radioactive contamination unless the package contains only radioactive material in the form of a gas or in special form as defined in 180 NAC 1-002. A labeled package is a package labeled with a Radioactive White I, Yellow II, or Yellow III label as specified in U.S. Department of Transportation regulations, 49 CFR 172.403 and 172.436-440; (B) 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, as defined in 180 NAC 13-002 and Appendix A to 180 NAC 13. A labeled package is a package labeled with a Radioactive White I, Yellow II, or Yellow III label as specified in U.S. Department of Transportation regulations, 49 CFR 172.403 and 172.436-440; and (C) All packages known to contain radioactive material for radioactive contamination and radiation levels if there is evidence of degradation of package integrity, such as packages that are crushed, wet, or damaged.
038.03 MONITORING. The licensee must perform the monitoring required by 180 NAC 4-038.02 as soon as practical after receipt of the package, but not later than three hours after the package is received at the licensee's or registrant's facility if it is received during the licensee's or registrant's normal working hours, or not later than three hours from the beginning of the next working day if it is received after working hours.
038.04 IMMEDIATE NOTIFICATION. The licensee must immediately notify the final delivery carrier and the Department by telephone and telegram, mailgram, or facsimile when:
(A) Removable radioactive surface contamination exceeds the limits of 180 NAC 13-015.09; or (B) External radiation levels exceed the limits of 180 NAC 13-015.10 and 13-015.11.
038.05 WRITTEN PROCEDURES. Each licensee must:
(A) Establish, maintain, and retain written procedures for safely opening packages in which radioactive material is received; and (B) Ensure that the procedures are followed and that due consideration is given to special instructions for the type of package being opened.
038.06 EXEMPTION. Licensees transferring special form sources in vehicles owned or operated by the licensee to and from a work site are exempt from the contamination monitoring requirements of 180 NAC 4-038.02, but are not exempt from the monitoring requirement in 180 NAC 4-038.02 for measuring radiation levels that ensures that the source is still properly lodged in its shield.
039. WASTE DISPOSAL GENERAL REQUIREMENTS .
039.01 DISPOSAL. A licensee must dispose of licensed material only:
(A) By transfer to an authorized recipient as provided in 180 NAC 4-044 or in 180 NAC 3, 12 or 19, or to the U.S. Department of Energy; or (B) By decay in storage in accordance with 180 NAC 4-039.03; or (C) By release in effluents within the limits in 180 NAC 4-013; or (D) As authorized according to 180 NAC 4-040 through 4-043 or 4-039.05 and 4-039.06.
039.02 RECEIVING WASTE. A person must be specifically licensed to receive waste containing licensed material from other persons for:
(A) Treatment prior to disposal; or (B) Treatment or disposal by incineration; or (C) Decay in storage; or (D) Management at a facility licensed according to 180 NAC 12; or (E) Storage until transferred to a storage or disposal facility authorized to receive the waste.
039.03 DECAY IN STORAGE. A licensee may hold radioactive material with a physical half-life of less than or equal to 120 days for decay-in-storage before disposal without regard to its radioactivity if the licensee:
(A) Holds radioactive material for decay a minimum of ten half-lives; (B) Monitors radioactive material at the container surface before disposal and determines that its radioactivity cannot be distinguished from the background radiation level with an appropriate radiation detection survey instrument set on its most sensitive scale and with no interposed shielding; (C) Removes or obliterates all radiation labels; except for materials that will be handled as biomedical waste after released; and (D) Separates and monitors each generator column individually with all radiation shielding removed to ensure that its contents have decayed to background radiation level before disposal.
039.04 DECAY IN STORAGE RECORDS. For radioactive material disposed in accordance with 180 NAC 4-039.03, the licensee must retain a record of each disposal in accordance with 180 NAC 4-054.03.
039.05 DISPOSAL AT A LICENSED LOW-LEVEL RADIOACTIVE WASTE FACILITY. Discrete sources of radium-226 and discrete sources of naturally occurring radioactive material may be disposed of at a facility licensed for land disposal of low-level radioactive waste, even though it is not defined as low-level radioactive waste. Therefore, any licensed radioactive material being disposed of at a facility, or transferred for ultimate disposal at a facility licensed for land disposal of low-level radioactive waste must meet the requirements of 180 NAC 4-044.02.
039.06 DISPOSAL AT SOLID OR HAZARDOUS WASTE FACILITY. A licensee may dispose of discrete sources of radium-226 and discrete sources of naturally occurring radioactive material, at a disposal facility authorized to dispose of such material in accordance with any Federal or State solid or hazardous waste law.
040. METHOD FOR OBTAINING APPROVAL OF PROPOSED DISPOSAL PROCEDURES . A licensee or applicant for a license may apply to the Department for approval of proposed procedures, not otherwise authorized in these regulations, to dispose of licensed material generated in the licensee's operations. Each application must include:
(A) A description of the waste containing licensed or registered 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; and (B) An analysis and evaluation of pertinent information on the nature of the environment; and (C) The nature and location of other potentially affected facilities; and (D) Analyses and procedures to ensure that doses are maintained as low as reasonably achievable (ALARA) and within the dose limits in 180 NAC 4.
041. DISPOSAL BY RELEASE INTO SANITARY SEWERAGE . This section addresses disposal of radioactive material by release into sanitary sewerage.
041.01 CONDITIONS FOR DISCHARGE OF LICENSED MATERIAL INTO SANITARY SEWAGE. A licensee may discharge licensed material into sanitary sewerage if each of the following conditions is satisfied:
(A) The material is readily soluble, or is readily dispersible biological material, in water; (B) The quantity of licensed 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 4-B of 180 NAC 4; (C) If more than one radionuclide is released, the following conditions must also be satisfied:
(i) The licensee must determine the fraction of the limit in Table III of Appendix 4-B of 180 NAC 4 represented by discharges into sanitary sewerage by dividing the actual monthly average concentration of each radionuclide released by the licensee or registrant into the sewer by the concentration of that radionuclide listed in Table III of Appendix 4-B of 180 NAC 4; and (ii) The sum of the fractions for each radionuclide required by 180 NAC 4-041.01, (C)(i) does not exceed unity; and
(D) The total quantity of licensed radioactive material that the licensee releases into the sanitary sewerage system in a year does not exceed 185 GBq (5 Ci) of hydrogen-3, 37 GBq (1 Ci) of carbon-14, and 37 GBq (1 Ci) of all other radioactive materials combined.
041.02 EXCRETA. Excreta from individuals undergoing medical diagnosis or therapy with radioactive material are not subject to the limitations contained in 180 NAC 4-039.01.
042. TREATMENT OR DISPOSAL BY INCENERATION . A licensee may treat or dispose of licensed material by incineration only in the amounts and forms specified in 180 NAC 4-043 or as specifically approved by the Department according to 180 NAC 4-040.
043. DISPOSAL OF SPECIFIC WASTES . This section addresses the disposal of specific wastes.
043.01 DISPOSAL AS NOT RADIOACTIVE. A licensee may dispose of the following licensed material as if it were not radioactive:
(A) 1.85 kBq (0.05 μCi), or less, of Hydrogen-3, Carbon-14 or Iodine-125 per gram of medium used for liquid scintillation counting; and (B) 1.85 kBq (0.05 μCi), or less, of Hydrogen-3, or Carbon-14 or Iodine-125 per gram of animal tissue, averaged over the weight of the entire animal.
043.02 DISPOSAL OF TISSUE. A licensee must not dispose of tissue according to 180 NAC 4-041.01, (B) in a manner that would permit its use either as food for humans or as animal feed.
043.03 RECORD MAINTENANCE. The licensee must maintain records in accordance within 180 NAC 4-054.
043.04 CURIE AND CONCENTRATION LIMITS. Any licensee may, upon Department approval of procedures required in 180 NAC 4-043.06, dispose of radioactive material included in Appendix 4-G of 180 NAC 4, provided that it does not exceed the concentration and total curie limits contained there. Any radioactive material included in Appendix 4-G of 180 NAC 4 may be disposed of at a city or county landfill facility authorized to receive the radioactive material.
043.05 SURVEYS AND LABEL REMOVAL. Each licensee who disposes of radioactive material described in 180 NAC 4-043.01 or 4-043.04 must:
(A) Make surveys adequate to assure that the limits of 180 NAC 4-043.01 or 4-043.04 are not exceeded; and (B) Remove or otherwise obliterate all labels, tags, or other markings which would indicate that the material or its contents is radioactive.
043.06 PROCEDURES. Prior to the initiation of disposals authorized by 180 NAC 4-043.04, a licensee must submit procedures to the Department for:
(A) The physical delivery of the material to the disposal site, the physical placing of the material in the disposal location and that the material is properly covered; (B) Surveys to be performed for compliance with 180 NAC 4-043.05(A); (C) Maintaining secure packaging during transportation to the site; (D) Maintaining records of disposals made under 180 NAC 4-043.04; and (E) Written authorization by the landfill operator agreeing to such disposal.
043.07 MAINTAINING RECORDS. Nothing in 180 NAC 4, however, relieves the licensee of maintaining records showing the receipt, transfer, and disposal of such radioactive material as specified according to 180 NAC 1-004.
043.08 OTHER REGULATIONS. Nothing in 180 NAC 4 relieves the licensee from complying with other applicable federal, state or local regulations governing any other toxic or hazardous property of these materials.
043.09 EXCEPTION. Radioactive material disposed of under 180 NAC 4 is not subject to the requirements of 180 NAC 13.
044. TRANSFER FOR DISPOSAL AND WASTE MANIFESTS . This section addresses the requirements for transfer for disposal and waste manifests.
044.01 WASTE CONTROL AND WASTE MANIFEST TRACKING SYSTEM. The requirements of 180 NAC 4 and Appendix 4-D of 180 NAC 4 are designed to:
(A) Control transfers of low-level radioactive waste by any waste generator, waste collector, or waste processor license, as defined in 180 NAC 4, who ships low-level waste either directly, or indirectly through a waste collector or waste processor, to a licensed low-level waste disposal facility; (B) Establish a manifest tracking system; and (C) Supplement existing requirements concerning transfers and recordkeeping for those wastes.
044.02 WASTE MANIFEST. Any licensee shipping radioactive waste intended for ultimate disposal at a licensed land disposal facility must:
(A) Be accompanied by a shipment manifest as specified in Section I of Appendix 4-D OF 180 NAC 4; and (B) Transfer this recorded manifest information to the intended consignee in accordance with Appendix 4-D of 180 NAC 4.
044.03 CERTIFICATION BY WASTE GENERATOR. Each shipment manifest must include a certification by waste generator as specified in Section II of Appendix 4-D of 180 NAC 4.
044.04 PERSONS INVOLVED IN THE TRANSFER. Each person involved in the transfer for disposal and disposal of waste, including the waste generator, waste collector, waste processor, and disposal facility operator, must comply with the requirements specified in Section III of Appendix 4-D of 180 NAC 4.
045. COMPLIANCE WITH ENVIRONMENTAL AND HEALTH PROTECTION REGULATIONS . Nothing in 180 NAC 4-039 through 4-044 relieves the licensee or registrant from complying with other applicable Federal, State, and local regulations governing any other toxic or hazardous properties of materials that may be disposed of according to 180 NAC 4-039 through 4-044.
046. GENERAL PROVISONS FOR RECORDS . This section addresses general provisions for records.
046.01 UNITS. Each licensee or registrant must use the International System of Units (SI) units becquerel, gray, sievert and coulomb per kilogram, or the special units curie, rad, rem, and roentgen, including multiples and subdivisions, and must clearly indicate the units of all quantities on records required by 180 NAC 4.
046.02 SHIPMENT MANIFESTS. Despite of the requirements of 180 NAC 4-046.01, when recording information on shipment manifests, as required in 180 NAC 4-044.02(A), information must be recorded in the International System of Units (SI) or in SI and units as specified in 180 NAC 4-046.01.
046.03 CLEAR DISTINCTION AMONG QUANTITIES. The licensee or registrant must make a clear distinction among the quantities entered on the records required by 180 NAC 4, including total effective dose equivalent, total organ dose equivalent, shallow dose equivalent, lens dose equivalent, deep dose equivalent, or committed effective dose equivalent.
047. RECORDS OF RADIATION PROTECTION PROGRAMS . This section addresses records of radiation protection programs.
047.01 RADIATION PROTECTION PROGRAM RECORDS. Each licensee or registrant must maintain records of the radiation protection program, including:
(A) The provisions of the program; and (B) Audits and other reviews of program content and implementation.
047.02 RECORD RETENTION. The licensee or registrant must retain the records required by 180 NAC 4-047.01(A) until the Department terminates each pertinent license or registration requiring the record. The licensee or registrant must retain the records required by 180 NAC 4-047.01(B) for three years after the record is made.
048. RECORDS OF SURVEYS . This section addresses records of surveys.
048.01 SURVEYS AND CALIBRATIONS. Each licensee or registrant must maintain records showing the results of surveys and calibrations required by 180 NAC 4-021 and 4-038.02. The licensee or registrant must retain these records for three years after the record is made.
048.02 RECORD RETENTION. The licensee or registrant must retain each of the following records until the Department terminates each pertinent license or registration requiring the record:
(A) 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. This includes those records of results of surveys to determine the dose from external sources and used, in the absence of or in combination with individual monitoring data, in the assessment of individual dose equivalents required under the standards for protection against radiation in effect prior to May 30, 1994; (B) Records of the results of measurements and calculations used to determine individual intakes of radioactive material and used in the assessment of internal dose. This includes those records of the results of measurements and calculations used to determine individual intakes of radioactive material and used in the assessment of internal dose required under the standards for protection against radiation in effect prior to May 30, 1994. (C) Records showing the results of air sampling, surveys, and bioassays required according to 180 NAC 4-028.01(C)(i). This includes those records showing the results of air sampling, surveys and bioassays required under the standards for protection against radiation in effect prior to May 30, 1994; and (D) Records of the results of measurements and calculations used to evaluate the release of radioactive effluents to the environment. This includes those records of the results of measurements and calculations used to evaluate the release of radioactive effluents to the environment required under the standards for protection against radiation in effect prior to May 30, 1994.
049. RECORDS OF TESTS FOR LEAKAGE OR CONTAMINATION OF SEALED SOURCES . Records of tests for leakage or contamination of sealed sources required by 180 NAC 1-011 must be kept in units of Becquerel or microcurie and maintained for inspection by the Department for five years after the records are made.
050. RECORDS OF PRIOR OCCUPATIONAL DOSE . For each individual who is likely to receive in a year, an occupational dose requiring monitoring according to 180 NAC 4-022 the licensee or registrant must retain records:
(A) Of prior occupational dose and exposure history as specified in 180 NAC 4-009 on Department Form NRH-1 or equivalent until the Department terminates each pertinent license or registration requiring this record; and (B) Used in preparing Department Form NRH-1 for three years after the record is made.
051. RECORDS OF PLANNED SPECIAL EXPOSURES . This section addresses records of planned special exposures.
051.01 RECORD MAINTENANCE. For each use of the provisions of 180 NAC 4-010 for planned special exposures, the licensee or registrant must maintain records that describe:
(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 as low as reasonably achievable (ALARA); (F) What individual and collective doses were expected to result; and (G) The doses actually received in the planned special exposure.
051.02 PLANNED SPECIAL EXPOSURE RECORD RETENTION. The licensee or registrant must retain the records until the Department terminates each pertinent license or registration requiring these records.
052. RECORDS OF INDIVIDUAL MONITORING RESULTS . This section addresses records of individual monitoring results.
052.01 RECORDKEEPING REQUIREMENT. Each licensee or registrant must maintain records of doses received by all individuals for whom monitoring was required according to 180 NAC 4-022 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 October 30, 1996 for 180 NAC 4 need not be changed. These records must 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 of radionuclides, see 180 NAC 4-006; (C) The committed effective dose equivalent assigned to the intake of radionuclides; (D) The specific information used to calculate the committed effective dose equivalent according to 180 NAC 4-008.03; (E) The total effective dose equivalent when required by 180 NAC 4-006; and (F) The total of the deep dose equivalent and the committed dose to the organ receiving the highest total dose.
052.02 RECORDKEEPING FREQUENCY. The licensee or registrant must make entries of the records specified in 180 NAC 4-052.01 at intervals not to exceed one year.
052.03 RECORDKEEPING FORMAT. The licensee or registrant must maintain the records specified in 180 NAC 4-052.01 on Department Form NRH-2, in accordance with the instructions for Department Form NRH-2, or in clear and legible records containing all the information required by Department Form NRH-2.
052.04 RECORD MAINTENANCE. The licensee or registrant must maintain the records of dose to an embryo/fetus with the records of dose to the declared pregnant woman. The declaration of pregnancy, including the estimated date of conception, must also be kept on file, but may be maintained separately from the dose records.
052.05 RECORD RETENTION. The licensee or registrant must retain each required form or record until the Department terminates each pertinent license or registration requiring the record.
053. RECORDS OF DOSE TO INDIVIDUAL MEMBERS OF THE PUBLIC . This section addresses records of dose to individual members of the public.
053.01 RECORD MAINTENANCE. Each licensee or registrant must maintain records sufficient to demonstrate compliance with the dose limit for individual members of the public. See 180 NAC 4-013.
053.02 RECORD RETENTION. The licensee or registrant must retain the records required by 180 NAC 4-053 until the Department terminates each pertinent license or registration requiring the record.
054. RECORDS OF WASTE DISPOSAL . This section addresses records of waste disposal.
054.01 PRIOR DISPOSALS. Each licensee must maintain records of the disposal of licensed materials made according to 180 NAC 4-040 through 4-043 and 180 NAC 12, and disposal by burial in soil, including burials authorized before August 22, 1982.
054.02 RECORD RETENTION. The licensee must retain the records required by 180 NAC 4-054.01 until the Department terminates each pertinent license requiring the record. Requirements for disposition of these records, prior to license termination, are located in 180 NAC 3-030 for activities licensed under 180 NAC 4. This includes records required under the standards for protection against radiation in effect prior to May 30, 1994.
054.03 DISPOSAL RECORDS. A licensee must maintain records of the disposal of licensed materials, as required by 180 NAC 4-039.03 for three years. The record must include the date of the disposal, the date on which the radioactive material was placed in storage, the specific 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.
055. RECORDS OF TESTING ENTRY CONTROL DEVICES FOR VERY HIGH RADIATION AREAS . This section addresses records of testing entry control devices for very high radiation areas.
055.01 RECORDS OF TESTS. Each licensee or registrant must maintain records of tests made according to 180 NAC 4-025.02(H), on entry control devices for very high radiation areas. These records must include the date, time, and results of each such test of function.
055.02 RECORD RETENTION. The licensee or registrant must retain the records required by 180 NAC 4-055.01 for three years after the record is made.
056. FORM OF RECORDS . Each record required by 180 NAC 4 must be legible throughout the specified retention period. The record must 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 or registrant must maintain adequate safeguards against tampering with and loss of records.
057. REPORTS OF STOLEN, LOST, OR MISSING LICENSED OR REGISTERED SOURCES OF RADIATION . This section addresses reports of stolen, lost or missing sources of radiation.
057.01 TELEPHONE REPORTS. Each licensee or registrant must report to the Department by telephone as follows:
(A) Immediately after its occurrence becomes known to the licensee or registrant, stolen, lost, or missing licensed radioactive material in an aggregate quantity equal to or greater than 1,000 times the quantity specified in Appendix 4-C of 180 NAC 4 under such circumstances that it appears to the licensee that an exposure could result to individuals in unrestricted areas; (B) Within 30 days after its occurrence becomes known to the licensee or registrant, lost, stolen, or missing licensed radioactive material in an aggregate quantity greater than 10 times the quantity specified in Appendix 4-C of 180 NAC 4 that is still missing; and (C) Immediately after its occurrence becomes known to the registrant, a stolen, lost, or missing radiation machine.
057.02 WRITTEN REPORTS. Each licensee or registrant required to make a report according to 180 NAC 4-057.01 must, within 30 days after making the telephone report, make a written report to the Department setting forth the following information:
(A) A description of the licensed or registered source of radiation involved, including, for radioactive material, the kind, quantity, and chemical and physical form; and, for radiation machines, the manufacturer, model and serial number, type and maximum energy of radiation emitted; (B) A description of the circumstances under which the loss or theft occurred; (C) A statement of disposition, or probable disposition, of the licensed or registered source of radiation involved; (D) Exposures of individuals to radiation, circumstances under which the exposures occurred, and the possible total effective dose equivalent to persons in unrestricted areas; (E) Actions that have been taken, or will be taken, to recover the source of radiation; and (F) 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.
057.03 ADDITIONAL SUBSTANTIVE INFORMATION. Subsequent to filing the written report, the licensee or registrant must also report additional substantive information on the loss or theft within 30 days after the licensee or registrant learns of such information.
057.04 NAMES OF INDIVIDUALS. The licensee or registrant must prepare any report filed with the Department according to 180 NAC 4-057 so that names of individuals who may have received exposure to radiation are stated in a separate and detachable portion of the report.
058. NOTIFICATION OF INCIDENTS . This section addresses notification requirements for incidents involving sources of radiation.
058.01 IMMEDIATE NOTIFICATION. In addition to other requirements for notification, each licensee or registrant must immediately report each event involving a source of radiation possessed by the licensee or registrant that may have caused or threatens to cause:
(A) An individual to receive:
(i) A total effective dose equivalent of 0.25 Sv (25 rem) or more; (ii) A lens dose equivalent of 0.75 Sv (75 rem) or more; or (iii) A shallow dose equivalent to the skin or extremities of 2.5 Gy (250 rad) or more; or
(B) The release of radioactive material, inside or outside of a restricted area, so that, had an individual been present for 24 hours, the individual could have received an intake five times the occupational annual limit on intake (ALI). This provision does not apply to locations where personnel are not normally stationed during routine operations, such as hot-cells or process enclosures.
058.02 TWENTY-FOUR HOUR NOTIFICATION. Each licensee or registrant must, within 24 hours of discovery of the event, report to the Department 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:
(A) An individual to receive, in a period of 24 hours:
(i) A total effective dose equivalent exceeding 0.05 Sv (5 rem); (ii) A lens dose equivalent exceeding 0.15 Sv (15 rem); or (iii) A shallow dose equivalent to the skin or extremities exceeding 0.5 Sv (50 rem); or
(B) The release of radioactive material, inside or outside of a restricted area, so that, had an individual been present for 24 hours, the individual could have received an intake in excess of one occupational annual limit on intake (ALI). This provision does not apply to locations where personnel are not normally stationed during routine operations, such as hot-cells or process enclosures.
058.03 NAMES OF INDIVIDUALS. The licensee or registrant must prepare each report filed with the Department according to 180 NAC 4-058 so that names of individuals who have received exposure to sources of radiation are stated in a separate and detachable portion of the report.
058.04 INITIAL CONTACT WITH THE DEPARTMENT. Licensees or registrants must make the reports required by 180 NAC 4-058.01 and 4-058.02 by initial contact by telephone to the Department and must confirm the initial contact by telegram, mailgram, or electronic media to the Department.
058.05 EXCEPTION. The provisions of 180 NAC 4-058 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 according to180 NAC 4-060.
059. REPORTS OF EXPOSURES, RADIATION LEVELS, AND CONCENTRATIONS OF RADIOACTIVE MATERIAL EXCEEDING THE CONSTRAINTS OR LIMITS . This section addresses report of exposures, radiation levels and concentrations of radioactive material exceeding the constraints or limits.
059.01 REPORTABLE EVENTS. In addition to the notification required by 180 NAC 4-058, each licensee or registrant must submit a written report within 30 days after learning of any of:
(A) Any incident for which notification is required by 180 NAC 4-058; or (B) Doses in excess of any of the following:
(i) The occupational dose limits for adults in 180 NAC 4-005; (ii) The occupational dose limits for a minor in 180 NAC 4-011; (iii) The limits for an embryo/fetus of a declared pregnant woman in 180 NAC 4-012; (iv) The limits for an individual member of the public in 180 NAC 4-013; (v) Any applicable limit in the license or registrant; or (vi) The as low as reasonably achievable (ALARA) constraints for air emissions established under 180 NAC 4-004.04; or
(C) Levels of radiation or concentrations of radioactive material in:
(i) A restricted area in excess of applicable limits in the license; or (ii) An unrestricted area in excess of 10 times the applicable limit in 180 NAC 4 or in the license, whether or not involving exposure of any individual in excess of the limits in 180 NAC 4-013; or
(D) Levels of radiation or releases of radioactive material in excess of U.S. Environmental Protection Agency's generally applicable environmental radiation standards in 40 CFR 190, or of license conditions related to those standards for licensees subject to the provisions.
059.02 CONTENTS OF REPORTS. Each report:
(A) Required by 180 NAC 4-059 must describe the extent of exposure of individuals to radiation and radioactive material, including, as appropriate:
(i) Estimates of each individual's dose; and (ii) The levels of radiation and concentrations of radioactive material involved; and (iii) The cause of the elevated exposures, dose rates, or concentrations; and (iv) Corrective steps taken or planned to ensure against a recurrence, including the schedule for achieving conformance with applicable limits, as low as reasonably achievable (ALARA) constraints, generally applicable environmental standards and associated license conditions; and
(B) Filed according to 180 NAC 4-059.01 must include for each individual exposed: the name, identifying number, and date of birth. With respect to the limit for the embryo fetus in 180 NAC 4-012, the identifiers should be those of the declared pregnant woman. The report must be prepared so that this information is stated in a separate and detachable portion of the report.
059.03 WRITTEN REPORTS OF EVENTS. All licensees or registrants who make reports according to 180 NAC 4-059.01 must submit the report in writing to the Department.
060. REPORTS OF PLANNED SPECIAL EXPOSURES . The licensee or registrant must submit a written report to the Department within 30 days following any planned special exposure conducted in accordance with 180 NAC 4-010, informing the Department that a planned special exposure was conducted and indicating the date the planned special exposure occurred and the information required by 180 NAC 4-051.
061. RESERVED .
062. REPORTS OF INDIVIDUAL MONITORING . This section addresses reports of individual monitoring.
062.01 APPLICIBILITY. 180 NAC 4 applies to each person:
(A) Licensed by the Department to possess or use sources of radiation for purposes of industrial radiography according to 180 NAC 3 or 180 NAC 5; (B) Licensed by the Department to receive radioactive waste from other persons for disposal according to 180 NAC 12; or (C) Licensed by the Department to possess or use at any time, for processing or manufacturing for distribution according to 180 NAC 3 or 180 NAC 7, radioactive material in quantities exceeding any one of the following quantities:
| | | Activity | | --- | --- | --- | | Radionuclide | Ci | GBq | | Cesium-137 | 1 | 37 | | Cobalt-60 | 1 | 37 | | Gold-198 | 100 | 3,700 | | Iodine-131 | 1 | 37 | | Iridium-192 | 10 | 370 | | Krypton-85 | 1,000 | 37,000 | | Promethium-147 | 10 | 370 | | Technetium-99m | 1,000 | 37,000 |
(D) Licensees required by a license condition, rule, regulation, or order according to 180 NAC 1-007 who are licensed to use radionuclides not specified in 180 NAC 4-062.01(C) in quantities sufficient to cause comparable radiation levels.
062.02 ANNUAL REPORT. Each licensee in a category listed in 180 NAC 4-062.01 must submit an annual report of the results of individual monitoring carried out by the licensee for each individual for whom monitoring was required by 180 NAC 4-022 during that year. The licensee may include additional data for individuals for whom monitoring was provided but not required. The licensee must use Department Form NRH-2 or electronic media containing all the information required by Department Form NRH-2.
062.03 ANNUAL REPORT DEADLINE. The licensee submit to the Department the report required by 180 NAC 4-060.02, covering the preceding year, on or before April 30 of each year.
063. NOTIFICATIONS AND REPORTS TO INDIVIDUALS . This section addresses notifications and reports to individuals.
063.01 REPORTS. Requirements for notification and reports to individuals of exposure to radiation or radioactive material are specified in 180 NAC 10-004.
063.02 DEPARTMENT NOTIFICATION. When a licensee or registrant is required, according to the provisions of 180 NAC 4-059, 4-060, and 4-062, to report to the Department any exposure of identified occupationally exposed individual, or an identified member of the public, to radiation or radioactive material, the licensee or registrant must also provide a copy of the report submitted to the Department to the individual. This report must be transmitted at a time no later than the transmittal to the Department.
064. REPORTS OF LEAKING OR CONTAMINATED SEALED SOURCES . The licensee must file a report within 5 days with the Department if the test for leakage or contamination required according to 180 NAC 1-011 indicates a sealed source is leaking or contaminated. The report must include the equipment involved, the test results and the corrective action taken.
065. VACATING PREMISES . Each specific licensee must, no less than 30 days before vacating or relinquishing possession or control of premises which may have been contaminated with radioactive material as a result of their activities, notify the Department in writing of intent to vacate. When deemed necessary by the Department, the licensee must decontaminate the premises in such a manner as the Department may specify.
066. REPORTS OF TRANSACTIONS INVOLVING NATIONALLY TRACKED SOURCES . Each licensee who manufactures, transfers, receives, disassembles, or disposes of a nationally tracked source (Refer to Appendix 4-H) must complete and submit a National Source Tracking Transaction Report as specified in 180 NAC 4-066.01 through 4-066.05 for each type of transaction.
066.01 MANUFACTURE. Each licensee who manufactures a nationally tracked source must complete and submit a National Source Tracking Transaction Report. The report must include the following information:
(A) The name, address, and license number of the reporting licensee; (B) The name of the individual preparing the report; (C) The manufacturer, model, and serial number of the source; (D) The radioactive material in the source; (E) The initial source strength in becquerels (curies) at the time of manufacture; and (F) The manufacture date of the source.
066.02 TRANSFER. Each licensee that transfers a nationally tracked source to another person must complete and submit a National Source Tracking Transaction Report. The report must include the following information:
(A) The name, address, and license number of the reporting licensee; (B) The name of the individual preparing the report; (C) The name and license number of the recipient facility and the shipping address; (D) The manufacturer, model, and serial number of the source or, if not available, other information to uniquely identify the source; (E) The radioactive material in the source; (F) The initial or current source strength in becquerels (curies); (G) The date for which the source strength is reported; (H) The shipping date; (I) The estimated arrival date; and (J) 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.
066.03 RECEIVE. Each licensee that receives a nationally tracked source must complete and submit a National Source Tracking Transaction Report. The report must include the following information:
(A) The name, address, and license number of the reporting licensee; (B) The name of the individual preparing the report; (C) The name, address, and license number of the person that provided the source; (D) The manufacturer, model, and serial number of the source or, if not available, other information to uniquely identify the source; (E) The radioactive material in the source; (F) The initial or current source strength in becquerels (curies); (G) The date for which the source strength is reported; (H) The date of receipt, and (I) For material received under a Uniform Low-Level Radioactive Waste Manifest, the waste manifest number and the container identification with the nationally tracked source.
066.04 DISASSEMBLE. Each licensee that disassembles a nationally tracked source must complete and submit a National Source Tracking Transaction Report. The report must include the following information:
(A) The name, address, and license number of the reporting licensee; (B) The name of the individual preparing the report; (C) The manufacturer, model, and serial number of the source or, if not available, other information to uniquely identify the source; (D) The radioactive material in the source; (E) The initial or current source strength in becquerels (curies); (F) The date for which the source strength is reported; (G) The disassemble date of the source.
066.05 DISPOSE. Each licensee who disposes of a nationally tracked source must complete and submit a National Source Tracking Transaction Report. The report must include the following information:
(A) The name, address, and license number of the reporting licensee; (B) The name of the individual preparing the report; (C) The waste manifest number; (D) The container identification with the nationally tracked source; (E) The date of disposal; and (F) The method of disposal.
066.06 SUBMISSION DEADLINE. The reports discussed in 180 NAC 4-066.01 through 4-066.05 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:
(A) The on-line National Source Tracking System; (B) Electronically using a computer readable format; (C) By facsimile; (D) By mail to the address on the National Source Tracking Transaction Report Form (NRC Form 748); or (E) By telephone with follow-up by facsimile or mail.
066.07 ERROR CORRECTION. Each licensee must correct any error in previously filed reports or file a new report for any missed transaction within 5 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 must 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 in 180 NAC 4-066.01 through 4-066.05. By January 31 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.
History
- Effective 2021-06-07
Chapter 4A Appendices: 4-a & 4-B
Neb. Admin. Code tit. 180, ch. 4A Appendices: 4-a & 4-B {#sec-180-nac-4a omnilex-key=us-ne-regs-official--title-180--180 NAC 4A}
APPENDIX 4-A
Effective Date: 6/7/2021
aThese assigned protection factors apply only in a respiratory protection program that meets the requirements of this Chapter. They are applicable only to airborne radiological hazards and may not be appropriate to circumstances when chemical or other respiratory hazards exist instead of, or in addition to, radioactive hazards. Selection and use of respirators for such circumstances must also comply with U.S. Department of Labor regulations. Radioactive contaminants for which the concentration values in Table 1, Column 3 of Appendix 4-B are based on internal dose due to inhalation may, in addition, present external exposure hazards at higher concentrations. Under these circumstances, limitations on occupancy may have to be governed by external dose limits. b Air purifying respirators with assigned protection factors (APF) <100 must be equipped with particulate filters that are at least 95% efficient. Air purifying respirators with assigned protection factors (APF) = 100 must be equipped with particulate filters that are at least 99% efficient. Air purifying respirators with assigned protection factors (APF) >100 must be equipped with particulate filters that are at least 99.97% efficient. c The licensee may apply to the Department for the use of an assigned protection factors (APF) greater than 1 for sorbent cartridges as protection against airborne radioactive gases and vapors, radioiodine. d Licensees may permit individuals to use this type of respirator who have not been medically screened or fit tested on the device provided that no credit be taken for their use in estimating intake or dose. It is also recognized that it is difficult to perform an effective positive or negative pressure pre-use user seal check on this type of device. All other respiratory protection program requirements listed in 180 NAC 4-028 apply. An assigned protection factor has not been assigned for these devices. However, an assigned protection factors (APF) equal to 10 may be used if the licensee can demonstrate a fit factor of at least 100 by use of a validated or evaluated, qualitative or quantitative fit test. e Under-chin type only. No distinction is made in this Appendix between elastomeric half-masks with replaceable cartridges and those designed with the filter medium as an integral part of the facepiece, disposable or reusable disposable. Both types are acceptable so long as the seal area of the latter contains some substantial type of seal-enhancing material such as rubber or plastic, the two or more suspension straps are adjustable, the filter medium is at least 95% efficient and all other requirements of 180 NAC 4 are met. f The assigned protection factors for gases and vapors are not applicable to radioactive contaminants that present an absorption or submersion hazard. For tritium oxide vapor, approximately one-third of the intake occurs by absorption through the skin so that an overall protection factor of 3 is appropriate when atmosphere-supplying respirators are used to protect against tritium oxide. Exposure to radioactive noble gases is not considered a significant respiratory hazard, and protective actions for these contaminants should be based on external, submersion, dose considerations. g No National Institute for Occupational Safety and Health (NIOSH) approval schedule is currently available for atmosphere supplying suits. This equipment may be used in an acceptable respiratory protection program as long as all the other minimum program requirements, with the exception of fit testing, are met as required by 180 NAC 4-028. h The licensee should implement institutional controls to assure that these devices are not used in areas immediately dangerous to life or health (IDLH). i This type of respirator may be used as an emergency device in unknown concentrations for protection against inhalation hazards. External radiation hazards and other limitations to permitted exposure such as skin absorption must be taken into account in these circumstances. This device may not be used by any individual who experiences perceptible outward leakage of breathing gas while wearing the device.
APPENDIX 4-B
ANNUAL LIMITS ON INTAKE (ALI) AND DERIVED AIR CONCENTRATIONS (DAC) OF RADIONUCLIDES FOR OCCUPATIONAL EXPOSURE; EFFLUENT CONCENTRATIONS; CONCENTRATIONS FOR RELEASE TO SANITARY SEWERAGE
Introduction
For each radionuclide, Table I indicates the chemical form which is to be used for selecting the appropriate annual limit on intake (ALI) or derived air concentration (DAC) value. The annual limit on intake annual limit on intake (ALI)s and derived air concentration (DAC)s for inhalation are given for an aerosol with an activity median aerodynamic diameter (AMAD) of 1 m, micron, and for three classes (D,W,Y) of radioactive material, which refer to their retention (approximately days, weeks or years) in the pulmonary region of the lung. This classification applies to a range of clearance half-times for D if less than 10 days, for W from 10 to 100 days, and for Y greater than 100 days. The class (D,W, or Y) given in the column headed "Class" applies only to the inhalation annual limit on intake (ALI)s and derived air concentration (DAC)s given in Table I, columns 2 and 3. Table II provides concentration limits for airborne and liquid effluents released to the general environment. Table III provides concentration limits for discharges to sanitary sewerage.
Note: The values in Tables I, II, and III are presented in the computer "E" notation. In this notation a value of 6E-02 represents a value of 6 x 10-2 or 0.06, 6E+2 represents 6 x 102 or 600, and 6E+0 represents 6 x 100 or 6.
Table I "Occupational Values"
Note that the columns in Table I of this appendix captioned "Oral Ingestion annual limit on intake (ALI)," "Inhalation annual limit on intake (ALI)," and " derived air concentration (DAC)" are applicable to occupational exposure to radioactive material.
The annual limit on intake (ALI)s in this appendix are the annual intakes of given radionuclide by "Reference Man" which would result in either (1) a committed effective dose equivalent of 0.05 Sv (5 rem), stochastic annual limit on intake (ALI), or (2) a committed dose equivalent of 0.5 Sv (50 rem) to an organ or tissue, non-stochastic annual limit on intake (ALI). The stochastic annual limit on intake (ALI)s were derived to result in a risk, due to irradiation of organs and tissues, comparable to the risk associated with deep dose equivalent to the whole body of 0.05 Sv (5 rem). The derivation includes multiplying the committed dose equivalent to an organ or tissue by a weighting factor, wT. This weighting factor is the proportion of the risk of stochastic effects resulting from irradiation of the organ or tissue, T, to the total risk of stochastic effects when the whole body is irradiated uniformly. The values of wT are listed under the definition of weighting factor in 180 NAC 4-02. The non-stochastic annual limit on intake (ALI)s were derived to avoid non- stochastic effects, such as prompt damage to tissue or reduction in organ function.
A value of wT = 0.06 is applicable to each of the five organs or tissues in the "remainder" category receiving the highest dose equivalents, and the dose equivalents of all other remaining tissues may be disregarded. The following portions of the gastrointestinal (GI) tract -- stomach, small intestine, upper large intestine, and lower large intestine -- are to be treated as four separate organs.
Note that the dose equivalents for an extremity, skin, and lens of the eye are not considered in computing the committed effective dose equivalent, but are subject to limits that must be met separately.
When an annual limit on intake (ALI) is defined by the stochastic dose limit, this value alone is given. When an annual limit on intake (ALI) is determined by the non-stochastic dose limit to an organ, the organ or tissue to which the limit applies is shown, and the annual limit on intake (ALI) for the stochastic limit is shown in parentheses. Abbreviated organ or tissue designations are used:
LLI wall = lower large intestine wall; St. wall = stomach wall; Blad wall = bladder wall; and Bone surf = bone surface.
The use of the annual limit on intake (ALI)s listed first, the more limiting of the stochastic and non-stochastic annual limit on intake (ALI)s, will ensure that non-stochastic effects are avoided and that the risk of stochastic effects is limited to an acceptably low value. If, in a particular situation involving a radionuclide for which the nonstochastic annual limit on intake (ALI) is limiting, use of that non-stochastic annual limit on intake (ALI) is considered unduly conservative, the licensee may use the stochastic annual limit on intake (ALI) to determine the committed effective dose equivalent. However, the licensee shall also ensure that the 0.5 Sv (50 rem) dose equivalent limit for any organ or tissue is not exceeded by the sum of the external deep dose equivalent plus the internal committed dose equivalent to that organ, not the effective dose. For the case where there is no external dose contribution, this would be demonstrated if the sum of the fractions of the nonstochastic annual limit on intake (ALI)s (ALIns) that contribute to the committed dose equivalent to the organ receiving the highest dose does not exceed unity, that is, Σ (intake (in μCi) of each radionuclide/ALIns) ≤ 1.0. If there is an external deep dose equivalent contribution of Hd, then this sum must be less than 1 - (Hd/50), instead of ≤1.0.
The derived air concentration (DAC) values are derived limits intended to control chronic occupational exposures. The relationship between the derived air concentration (DAC) and the annual limit on intake (ALI) is given by:
derived air concentration (DAC) = annual limit on intake (ALI) (in µCi)/(2000 hours per working year x 60 minutes/hour x
2 x 104 ml per minute) = [annual limit on intake (ALI)/2.4 x 109] µCi/ml,
where 2 x 104 ml is the volume of air breathed per minute at work by Reference Man under working conditions of light work.
The derived air concentration (DAC) values relate to one of two modes of exposure: either external submersion or the internal committed dose equivalents resulting from inhalation of radioactive materials. derived air concentration (DAC)s based upon submersion are for immersion in a semi-infinite cloud of uniform concentration and apply to each radionuclide separately.
The annual limit on intake (ALI) and derived air concentration (DAC) values include contributions to exposure by the single radionuclide named and any in-growth of daughter radionuclides produced in the body by decay of the parent. However, intakes that include both the parent and daughter radionuclides should be treated by the general method appropriate for mixtures.
The values of annual limit on intake (ALI) and derived air concentration (DAC) do not apply directly when the individual both ingests and inhales a radionuclide, when the individual is exposed to a mixture of radionuclides by either inhalation or ingestion or both, or when the individual is exposed to both internal and external irradiation. See 180 NAC 4-06. When an individual is exposed to radioactive materials which fall under several of the translocation classifications of the same radionuclide, such as, Class D, Class W, or Class Y, the exposure may be evaluated as if it were a mixture of different radionuclides.
It should be noted that the classification of a compound as Class D, W, or Y is based on the chemical form of the compound and does not take into account the radiological half-life of different radionuclides. For this reason, values are given for Class D, W, and Y compounds, even for very short-lived radionuclides.
Table II "Effluent Concentrations"
The columns in Table II of this appendix captioned "Effluents," "Air" and "Water" are applicable to the assessment and control of dose to the public, particularly in the implementation of the provisions of 180 NAC 4-014. The concentration values given in Columns 1 and 2 of Table II are equivalent to the radionuclide concentrations which, if inhaled or ingested continuously over the course of a year, would produce a total effective dose equivalent of 0.5 mSv (0.05 rem).
Consideration of non-stochastic limits has not been included in deriving the air and water effluent concentration limits because non-stochastic effects are presumed not to occur at or below the dose levels established for individual members of the public. For radionuclides, where the non-stochastic limit was governing in deriving the occupational derived air concentration (DAC), the stochastic annual limit on intake (ALI) was used in deriving the corresponding airborne effluent limit in Table II. For this reason, the derived air concentration (DAC) and airborne effluent limits are not always proportional as was the case in Appendix 1 180 NAC 4.
The air concentration values listed in Table II, Column 1 were derived by one of two methods. For those radionuclides for which the stochastic limit is governing, the occupational stochastic inhalation annual limit on intake (ALI) was divided by 2.4 x 109ml, relating the inhalation annual limit on intake (ALI) to the derived air concentration (DAC), as explained above, and then divided by a factor of 300. The factor of 300 includes the following components: a factor of 50 to relate the 0.05 Sv (5 rem) annual occupational dose limit to the 1 mSv (0.1 rem) limit for members of the public, a factor of 3 to adjust for the difference in exposure time and the inhalation rate for a worker and that for members of the public; and a factor of 2 to adjust the occupational values, derived for adults, so that they are applicable to other age groups.
For those radionuclides for which submersion, external dose, is limiting, the occupational derived air concentration (DAC) in Table I, Column 3 was divided by 219. The factor of 219 is composed of a factor of 50, as described above, and a factor of 4.38 relating occupational exposure for 2,000 hours per year to full- time exposure (8,760 hours per year). Note that an additional factor of 2 for age considerations is not warranted in the submersion case.
The water concentrations were derived by taking the most restrictive occupational stochastic oral ingestion annual limit on intake (ALI) and dividing by 7.3 x 107. The factor of 7.3 x 107 (ml) includes the following components: the factors of 50 and 2 described above and a factor of 7.3 x 105 (ml) which is the annual water intake of Reference Man.
Note 2 at the end of this appendix provides groupings of radionuclides which are applicable to unknown mixtures of radionuclides. These groupings, including occupational inhalation annual limit on intake (ALI)s and derived air concentration (DAC)s, air and water effluent concentrations and releases to sewer, require demonstrating that the most limiting radionuclides in successive classes are absent. The limit for the unknown mixture is defined when the presence of one of the listed radionuclides cannot be definitely excluded as being present either from knowledge of the radionuclide composition of the source or from actual measurements.
Table III "Releases to Sewers"
The monthly average concentrations for release to sanitary sewerage are applicable to the provisions in
004.40. The concentration values were derived by taking the most restrictive occupational stochastic oral ingestion annual limit on intake (ALI) and dividing by 7.3 x 106 (ml). The factor of 7.3 x 106 (ml) is composed of a factor of 7.3 x 105 (ml), the annual water intake by Reference Man, and a factor of 10, such that the concentrations, if the sewage released by the licensee were the only source of water ingested by a Reference Man during a year, would result in a committed effective dose equivalent of 0.5 mSv (0.5 rem).
History
- Effective 2021-06-07
Chapter 4B Appendices: 4-C Through 4-H
Neb. Admin. Code tit. 180, ch. 4B Appendices: 4-C Through 4-H {#sec-180-nac-4b omnilex-key=us-ne-regs-official--title-180--180 NAC 4B}
APPENDIX 4-C
Effective Date: 6/7/2021
QUANTITIES1 MATERIAL REQUIRING LABELING
*To convert mCi to kBq, multiply the mCi value by 37.
| Radionuclide | Quantity (µCi)* | Radionuclide | Quantity (µCi)* | | --- | --- | --- | --- | | Hydrogen-3 | 1,000 | Manganese-56 | 1,000 | | Beryllium-7 | 1,000 | Iron-52 | 100 | | Beryllium-10 | 1 | Iron-55 | 100 | | Carbon-11 | 1,000 | Iron-59 | 10 | | Carbon-14 | 100 | Iron-60 | 1 | | Fluorine-18 | 1,000 | Cobalt-55 | 100 | | Sodium-22 | 10 | Cobalt-56 | 10 | | Sodium-24 | 100 | Cobalt-57 | 100 | | Magnesium-28 | 100 | Cobalt-58m | 1,000 | | Aluminum-26 | 10 | Cobalt-58 | 100 | | Silicon-31 | 1,000 | Cobalt-60m | 1,000 | | Silicon-32 | 1 | Cobalt-60 | 1 | | Phosphorus-32 | 10 | Cobalt-61 | 1,000 | | Phosphorus-33 | 100 | Cobalt-62m | 1,000 | | Sulfur-35 | 100 | Nickel-56 | 100 | | Chlorine-36 | 10 | Nickel-57 | 100 | | Chlorine-38 | 1,000 | Nickel-59 | 100 | | Chlorine-39 | 1,000 | Nickel-63 | 100 | | Argon-39 | 1,000 | Nickel-65 | 1,000 | | Argon-41 | 1,000 | Nickel-66 | 10 | | Potassium-40 | 100 | Copper-60 | 1,000 | | Potassium-42 | 1,000 | Copper-61 | 1,000 | | Potassium-43 | 1,000 | Copper-64 | 1,000 | | Potassium-44 | 1,000 | Copper-67 | 1,000 | | Potassium-45 | 1,000 | Zinc-62 | 100 | | Calcium-41 | 100 | Zinc-63 | 1,000 | | Calcium-45 | 100 | Zinc-65 | 10 | | Calcium-47 | 100 | Zinc-69m | 100 | | Scandium-43 | 1,000 | Zinc-69 | 1,000 | | Scandium-44m | 100 | Zinc-71m | 1,000 | | Scandium-44 | 100 | Zinc-72 | 100 | | Scandium-46 | 10 | Gallium-65 | 1,000 | | Scandium-47 | 100 | Gallium-66 | 100 | | Scandium-48 | 100 | Gallium-67 | 1,000 | | Scandium-49 | 1,000 | Gallium-68 | 1,000 | | Titanium-44 | 1 | Gallium-70 | 1,000 | | Titanium-45 | 1,000 | Gallium-72 | 100 | | Vanadium-47 | 1,000 | Gallium-73 | 1,000 | | Vanadium-48 | 100 | Germanium-66 | 1,000 | | Vanadium-49 | 1,000 | Germanium-67 | 1,000 | | Chromium-48 | 1,000 | Germanium-68 | 10 | | Chromium-49 | 1,000 | Germanium-69 | 1,000 | | Chromium-51 | 1,000 | Germanium-71 | 1,000 | | Manganese-51 | 1,000 | Germanium-75 | 1,000 | | Manganese-52m | 1,000 | Germanium-77 | 1,000 | | Manganese-52 | 100 | Germanium-78 | 1,000 | | Manganese-53 | 1,000 | Arsenic-69 | 1,000 | | Manganese-54 | 100 | Arsenic-70 | 1,000 |
QUANTITIES1 MATERIAL REQUIRING LABELING
*To convert mCi to kBq, multiply the mCi value by 37.
| Radionuclide | Quantity (µCi)* | Radionuclide | Quantity (µCi)* | | --- | --- | --- | --- | | Arsenic-71 | 100 | Strontium-85m | 1,000 | | Arsenic-73 | 100 | Strontium-85 | 100 | | Arsenic-74 | 100 | Strontium-87m | 1,000 | | Arsenic-76 | 100 | Strontium-89 | 10 | | Arsenic-77 | 100 | Strontium-90 | 0.1 | | Arsenic-78 | 1,000 | Strontium-91 | 100 | | Selenium-70 | 1,000 | Strontium-92 | 100 | | Selenium-73m | 1,000 | Yttrium-86m | 1,000 | | Selenium-73 | 100 | Yttrium-86 | 100 | | Selenium-75 | 100 | Yttrium-87 | 100 | | Selenium-79 | 100 | Yttrium-88 | 10 | | Selenium-81m | 1,000 | Yttrium-90m | 1,000 | | Selenium-81 | 1,000 | Yttrium-90 | 10 | | Selenium-83 | 1,000 | Yttrium-91m | 1,000 | | Bromine-74m | 1,000 | Yttrium-91 | 10 | | Bromine-74 | 1,000 | Yttrium-92 | 100 | | Bromine-75 | 1,000 | Yttrium-93 | 100 | | Bromine-76 | 100 | Yttrium-94 | 1,000 | | Bromine-77 | 1,000 | Yttrium-95 | 1,000 | | Bromine-80m | 1,000 | Zirconium-86 | 100 | | Bromine-80 | 1,000 | Zirconium-88 | 10 | | Bromine-82 | 100 | Zirconium-89 | 10 | | Bromine-83 | 1,000 | Zirconium-93 | 1 | | Bromine-84 | 1,000 | Zirconium-95 | 10 | | Krypton-74 | 1,000 | Zirconium-97 | 100 | | Krypton-76 | 1,000 | Niobium-88 | 1,000 | | Krypton-77 | 1,000 | Niobium-89 (66 min) | 1,000 | | Krypton-79 | 1,000 | Niobium-89 (122 min) | 1,000 | | Krypton-81 | 1,000 | Niobium-90 | 100 | | Krypton-83m | 1,000 | Niobium-93m | 10 | | Krypton-85m | 1,000 | Niobium-94 | 1 | | Krypton-85 | 1,000 | Niobium-95m | 100 | | Krypton-87 | 1,000 | Niobium-95 | 100 | | Krypton-88 | 1,000 | Niobium-96 | 100 | | Rubidium-79 | 1,000 | Niobium-97 | 1,000 | | Rubidium-81m | 1,000 | Niobium-98 | 1,000 | | Rubidium-81 | 1,000 | Molybdenum-90 | 100 | | Rubidium-82m | 1,000 | Molybdenum-93m | 100 | | Rubidium-83 | 100 | Molybdenum-93 | 10 | | Rubidium-84 | 100 | Molybdenum-99 | 100 | | Rubidium-86 | 100 | Molybdenum-101 | 1,000 | | Rubidium-87 | 100 | Technetium-93m | 1,000 | | Rubidium-88 | 1,000 | Technetium-93 | 1,000 | | Rubidium-89 | 1,000 | Technetium-94m | 1,000 | | Strontium-80 | 100 | Technetium-94 | 1,000 | | Strontium-81 | 1,000 | Technetium-96m | 1,000 | | Strontium-83 | 100 | Technetium-96 | 100 | | Strontium-83 | 100 | Technetium-97m | 100 |
QUANTITIES1 MATERIAL REQUIRING LABELING
*To convert mCi to kBq, multiply the mCi value by 37.
| Radionuclide | Quantity (µCi)* | Radionuclide | Quantity (µCi)* | | --- | --- | --- | --- | | Technetium-97 | 1,000 | Indium-109 | 1,000 | | Technetium-98 | 10 | Indium-110 (69.1m) | 1,000 | | Technetium-99m | 1,000 | Indium-110 (4.9h) | 1,000 | | Technetium-99 | 100 | Indium-111 | 100 | | Technetium-101 | 1,000 | Indium-112 | 1,000 | | Technetium-104 | 1,000 | Indium-113m | 1,000 | | Ruthenium-94 | 1,000 | Indium-114m | 10 | | Ruthenium-97 | 1,000 | Indium-115m | 1,000 | | Ruthenium-103 | 100 | Indium-115 | 100 | | Ruthenium-105 | 1,000 | Indium-116m | 1,000 | | Ruthenium-106 | 1 | Indium-117m | 1,000 | | Rhodium-99m | 1,000 | Indium-117 | 1,000 | | Rhodium-99 | 100 | Indium-119m | 1,000 | | Rhodium-100 | 100 | Tin-110 | 100 | | Rhodium-101m | 1,000 | Tin-111 | 1,000 | | Rhodium-101 | 10 | Tin-113 | 100 | | Rhodium-102m | 10 | Tin-117m | 100 | | Rhodium-102 | 10 | Tin-119m | 100 | | Rhodium-103m | 1,000 | Tin-121m | 100 | | Rhodium-105 | 100 | Tin-121 | 1,000 | | Rhodium-106m | 1,000 | Tin-123m | 1,000 | | Rhodium-107 | 1,000 | Tin-123 10 | | | Palladium-100 | 100 | Tin-125 10 | | | Palladium-101 | 1,000 | Tin-126 10 | | | Palladium-103 | 100 | Tin-127 | 1,000 | | Palladium-107 | 10 | Tin-128 | 1,000 | | Palladium-109 | 100 | Antimony-115 | 1,000 | | Silver-102 | 1,000 | Antimony-116m | 1,000 | | Silver-103 | 1,000 | Antimony-116 | 1,000 | | Silver-104m | 1,000 | Antimony-117 | 1,000 | | Silver-104 | 1,000 | Antimony-118m | 1,000 | | Silver-105 | 100 | Antimony-119 | 1,000 | | Silver-106m | 100 | Antimony-120 (16min.) | 1,000 | | Silver-106 | 1,000 | Antimony-120 (5.76d) | 100 | | Silver-108m | 1 | Antimony-122 | 100 | | Silver-110m | 10 | Antimony-124m | 1,000 | | Silver-111 | 100 | Antimony-124 | 10 | | Silver-112 | 100 | Antimony-125 | 100 | | Silver-115 | 1,000 | Antimony-126m | 1,000 | | Cadmium-104 | 1,000 | Antimony-126 | 100 | | Cadmium-107 | 1,000 | Antimony-127 | 100 | | Cadmium-109 | 1 | Antimony-128 (10.4min.) | 1,000 | | Cadmium-113m | 0.1 | Antimony-128 (9.01h) | 100 | | Cadmium-113 | 100 | Antimony-129 | 100 | | Cadmium-115m | 10 | Antimony-130 | 1,000 | | Cadmium-115 | 100 | Antimony-131 | 1,000 | | Cadmium-117m | 1,000 | Tellurium-116 | 1,000 | | Cadmium-117 | 1,000 | Tellurium-121m | 10 |
QUANTITIES1 MATERIAL REQUIRING LABELING
*To convert mCi to kBq, multiply the mCi value by 37.
| Radionuclide | Quantity (µCi)* | Radionuclide | Quantity (µCi)* | | --- | --- | --- | --- | | Tellurium-121 | 100 | Cesium-132 | 100 | | Tellurium-123m | 10 | Cesium-134m | 1,000 | | Tellurium-123 | 100 | Cesium-134 | 10 | | Tellurium-125m | 10 | Cesium-135m | 1,000 | | Tellurium-127m | 10 | Cesium-135 | 100 | | Tellurium-127 | 1,000 | Cesium-136 | 10 | | Tellurium-129m | 10 | Cesium-137 | 10 | | Tellurium-129 | 1,000 | Cesium-138 | 1,000 | | Tellurium-131m | 10 | Barium-126 | 1,000 | | Tellurium-131 | 100 | Barium-128 | 100 | | Tellurium-132 | 10 | Barium-131m | 1,000 | | Tellurium-133m | 100 | Barium-131 | 100 | | Tellurium-133 | 1,000 | Barium-133m | 100 | | Tellurium-134 | 1,000 | Barium-133 | 100 | | Iodine-120m | 1,000 | Barium-135m | 100 | | Iodine-120 | 100 | Barium-139 | 1,000 | | Iodine-121 | 1,000 | Barium-140 | 100 | | Iodine-123 | 100 | Barium-141 | 1,000 | | Iodine-124 | 10 | Barium-142 | 1,000 | | Iodine-125 | 1 | Lanthanum-131 | 1,000 | | Iodine-126 | 1 | Lanthanum-132 | 100 | | Iodine-128 | 1,000 | Lanthanum-135 | 1,000 | | Iodine-129 | 1 | Lanthanum-137 | 10 | | Iodine-130 | 10 | Lanthanum-138 | 100 | | Iodine-131 | 1 | Lanthanum-140 | 100 | | Iodine-132m | 100 | Lanthanum-141 | 100 | | Iodine-132 | 100 | Lanthanum-142 | 1,000 | | Iodine-133 | 10 | Lanthanum-143 | 1,000 | | Iodine-134 | 1,000 | Cerium-134 | 100 | | Iodine-135 | 100 | Cerium-135 | 100 | | Xenon-120 | 1,000 | Cerium-137m | 100 | | Xenon-121 | 1,000 | Cerium-137 | 1,000 | | Xenon-122 | 1,000 | Cerium-139 | 100 | | Xenon-123 | 1,000 | Cerium-141 | 100 | | Xenon-125 | 1,000 | Cerium-143 | 100 | | Xenon-127 | 1,000 | Cerium-144 | 1 | | Xenon-129m | 1,000 | Praseodymium-136 | 1,000 | | Xenon-131m | 1,000 | Praseodymium-137 | 1,000 | | Xenon-133m | 1,000 | Praseodymium-138m | 1,000 | | Xenon-133 | 1,000 | Praseodymium-139 | 1,000 | | Xenon-135m | 1,000 | Praseodymium-142m | 1,000 | | Xenon-135 | 1,000 | Praseodymium-142 | 100 | | Xenon-138 | 1,000 | Praseodymium-143 | 100 | | Cesium-125 | 1,000 | Praseodymium-144 | 1,000 | | Cesium-127 | 1,000 | Praseodymium-145 | 100 | | Cesium-129 | 1,000 | Praseodymium-147 | 1,000 | | Cesium-130 | 1,000 | Neodymium-136 | 1,000 | | Cesium-131 | 1,000 | Neodymium-138 | 100 |
QUANTITIES1 MATERIAL REQUIRING LABELING
*To convert mCi to kBq, multiply the mCi value by 37.
| Radionuclide | Quantity (µCi)* | Radionuclide | Quantity (µCi)* | | --- | --- | --- | --- | | Neodymium-139m | 1,000 | Gadolinium-153 | 10 | | Neodymium-139 | 1,000 | Gadolinium-159 | 100 | | Neodymium-141 | 1,000 | Terbium-147 | 1,000 | | Neodymium-147 | 100 | Terbium-149 | 100 | | Neodymium-149 | 1,000 | Terbium-150 | 1,000 | | Neodymium-151 | 1,000 | Terbium-151 | 100 | | Promethium-141 | 1,000 | Terbium-153 | 1,000 | | Promethium-143 | 100 | Terbium-154 | 100 | | Promethium-144 | 10 | Terbium-155 | 1,000 | | Promethium-145 | 10 | Terbium-156m (5.0h) | 1,000 | | Promethium-146 | 1 | Terbium-156m (24.4h) | 1,000 | | Promethium-147 | 10 | Terbium-156 | 100 | | Promethium-148m | 10 | Terbium-157 | 10 | | Promethium-148 | 10 | Terbium-158 | 1 | | Promethium-149 | 100 | Terbium-160 | 10 | | Promethium-150 | 1,000 | Terbium-161 | 100 | | Promethium-151 | 100 | Dysprosium-155 | 1,000 | | Samarium-141m | 1,000 | Dysprosium-157 | 1,000 | | Samarium-141 | 1,000 | Dysprosium-159 | 100 | | Samarium-142 | 1,000 | Dysprosium-165 | 1,000 | | Samarium-145 | 100 | Dysprosium-166 | 100 | | Samarium-146 | 1 | Holmium-155 | 1,000 | | Samarium-147 | 100 | Holmium-157 | 1,000 | | Samarium-151 | 10 | Holmium-159 | 1,000 | | Samarium-153 | 100 | Holmium-161 | 1,000 | | Samarium-155 | 1,000 | Holmium-162m | 1,000 | | Samarium-156 | 1,000 | Holmium-162 | 1,000 | | Europium-145 | 100 | Holmium-164m | 1,000 | | Europium-146 | 100 | Holmium-164 | 1,000 | | Europium-147 | 100 | Holmium-166m | 1 | | Europium-148 | 10 | Holmium-166 | 100 | | Europium-149 | 100 | Holmium-167 | 1,000 | | Europium-150 (12.62h) | 100 | Erbium-161 | 1,000 | | Europium-150 (34.2y) | 1 | Erbium-165 | 1,000 | | Europium-152m | 100 | Erbium-169 | 100 | | Europium-152 | 1 | Erbium-171 | 100 | | Europium-154 | 1 | Erbium-172 | 100 | | Europium-155 | 10 | Thulium-162 | 1,000 | | Europium-156 | 100 | Thulium-166 | 100 | | Europium-157 | 100 | Thulium-167 | 100 | | Europium-158 | 1,000 | Thulium-170 | 10 | | Gadolinium-145 | 1,000 | Thulium-171 | 10 | | Gadolinium-146 | 10 | Thulium-172 | 100 | | Gadolinium-147 | 100 | Thulium-173 | 100 | | Gadolinium-148 | 0.001 | Thulium-175 | 1,000 | | Gadolinium-149 | 100 | Ytterbium-162 | 1,000 | | Gadolinium-151 | 10 | Ytterbium-166 | 100 | | Gadolinium-152 | 100 | Ytterbium-167 | 1,000 |
QUANTITIES1 MATERIAL REQUIRING LABELING
*To convert mCi to kBq, multiply the mCi value by 37.
| Radionuclide | Quantity (µCi)* | Radionuclide | Quantity (µCi)* | | --- | --- | --- | --- | | Ytterbium-169 | 100 | Tungsten-177 | 1,000 | | Ytterbium-175 | 100 | Tungsten-178 | 1,000 | | Ytterbium-177 | 1,000 | Tungsten-179 | 1,000 | | Ytterbium-178 | 1,000 | Tungsten-181 | 1,000 | | Lutetium-169 | 100 | Tungsten-185 | 100 | | Lutetium-170 | 100 | Tungsten-187 | 100 | | Lutetium-171 | 100 | Tungsten-188 | 10 | | Lutetium-172 | 100 | Rhenium-177 | 1,000 | | Lutetium-173 | 10 | Rhenium-178 | 1,000 | | Lutetium-174m | 10 | Rhenium-181 | 1,000 | | Lutetium-174 | 10 | Rhenium-182 (12.7h) | 1,000 | | Lutetium-176m | 1,000 | Rhenium-182 (64.0h) | 100 | | Lutetium-176 | 100 | Rhenium-184m | 10 | | Lutetium-177m | 10 | Rhenium-184 | 100 | | Lutetium-177 | 100 | Rhenium-186m | 10 | | Lutetium-178m | 1,000 | Rhenium-186 | 100 | | Lutetium-178 | 1,000 | Rhenium-187 | 1,000 | | Lutetium-179 | 1,000 | Rhenium-188m | 1,000 | | Hafnium-170 | 100 | Rhenium-188 | 100 | | Hafnium-172 | 1 | Rhenium-189 | 100 | | Hafnium-173 | 1,000 | Osmium-180 | 1,000 | | Hafnium-175 | 100 | Osmium-181 | 1,000 | | Hafnium-177m | 1,000 | Osmium-182 | 100 | | Hafnium-178m | 0.1 | Osmium-185 | 100 | | Hafnium-179m | 10 | Osmium-189m | 1,000 | | Hafnium-180m | 1,000 | Osmium-191m | 1,000 | | Hafnium-181 | 10 | Osmium-191 | 100 | | Hafnium-182m | 1,000 | Osmium-193 | 100 | | Hafnium-182 | 0.1 | Osmium-194 | 1 | | Hafnium-183 | 1,000 | Iridium-182 | 1,000 | | Hafnium-184 | 100 | Iridium-184 | 1,000 | | Tantalum-172 | 1,000 | Iridium-185 | 1,000 | | Tantalum-173 | 1,000 | Iridium-186 | 100 | | Tantalum-174 | 1,000 | Iridium-187 | 1,000 | | Tantalum-175 | 1,000 | Iridium-188 | 100 | | Tantalum-176 | 100 | Iridium-189 | 100 | | Tantalum-177 | 1,000 | Iridium-190m | 1,000 | | Tantalum-178 | 1,000 | Iridium-190 | 100 | | Tantalum-179 | 100 | Iridium-192 (73.8d) | 1 | | Tantalum-180m | 1,000 | Iridium-192m (1.4min.) | 10 | | Tantalum-180 | 100 | Iridium-194m | 10 | | Tantalum-182m | 1,000 | Iridium-194 | 100 | | Tantalum-182 | 10 | Iridium-195m | 1,000 | | Tantalum-183 | 100 | Iridium-195 | 1,000 | | Tantalum-184 | 100 | Platinum-186 | 1,000 | | Tantalum-185 | 1,000 | Platinum-188 | 100 | | Tantalum-186 | 1,000 | Platinum-189 | 1,000 | | Tungsten-176 | 1,000 | Platinum-191 | 100 |
QUANTITIES1 MATERIAL REQUIRING LABELING
*To convert mCi to kBq, multiply the mCi value by 37.
| Radionuclide | Quantity (µCi)* | Radionuclide | Quantity (µCi)* | | --- | --- | --- | --- | | Platinum-193m | 100 | Lead-212 | 1 | | Platinum-193 | 1,000 | Lead-214 | 100 | | Platinum-195m | 100 | Bismuth-200 | 1,000 | | Platinum-197m | 1,000 | Bismuth-201 | 1,000 | | Platinum-197 | 100 | Bismuth-202 | 1,000 | | Platinum-199 | 1,000 | Bismuth-203 | 100 | | Platinum-200 | 100 | Bismuth-205 | 100 | | Gold-193 | 1,000 | Bismuth-206 | 100 | | Gold-194 | 100 | Bismuth-207 | 10 | | Gold-195 | 10 | Bismuth-210m | 0.1 | | Gold-198m | 100 | Bismuth-210 | 1 | | Gold-198 | 100 | Bismuth-212 | 10 | | Gold-199 | 100 | Bismuth-213 | 10 | | Gold-200m | 100 | Bismuth-214 | 100 | | Gold-200 | 1,000 | Polonium-203 | 1,000 | | Gold-201 | 1,000 | Polonium-205 | 1,000 | | Mercury-193m | 100 | Polonium-207 | 1,000 | | Mercury-193 | 1,000 | Polonium-210 | 0.1 | | Mercury-194 | 1 | Astatine-207 | 100 | | Mercury-195m | 100 | Astatine-211 | 10 | | Mercury-195 | 1,000 | Radon-220 | 1 | | Mercury-197m | 100 | Radon-222 | 1 | | Mercury-197 | 1,000 | Francium-222 | 100 | | Mercury-199m | 1,000 | Francium-223 | 100 | | Mercury-203 | 100 | Radium-223 | 0.1 | | Thallium-194m | 1,000 | Radium-224 | 0.1 | | Thallium-194 | 1,000 | Radium-225 | 0.1 | | Thallium-195 | 1,000 | Radium-226 | 0.1 | | Thallium-197 | 1,000 | Radium-227 | 1,000 | | Thallium-198m | 1,000 | Radium-228 | 0.1 | | Thallium-198 | 1,000 | Actinium-224 | 1 | | Thallium-199 | 1,000 | Actinium-225 | 0.01 | | Thallium-200 | 1,000 | Actinium-226 | 0.1 | | Thallium-201 | 1,000 | Actinium-227 | 0.001 | | Thallium-202 | 100 | Actinium-228 | 1 | | Thallium-204 | 100 | Thorium-226 | 10 | | Lead-195m | 1,000 | Thorium-227 | 0.01 | | Lead-198 | 1,000 | Thorium-228 | 0.001 | | Lead-199 | 1,000 | Thorium-229 | 0.001 | | Lead-200 | 100 | Thorium-230 | 0.001 | | Lead-201 | 1,000 | Thorium-231 | 100 | | Lead-202m | 1,000 | Thorium-232 | 100 | | Lead-202 | 10 | Thorium-234 | 10 | | Lead-203 | 1,000 | Thorium-natural | 100 | | Lead-205 | 100 | Protactinium-227 | 10 | | Lead-209 | 1,000 | Protactinium-228 | 1 | | Lead-210 | 0.01 | Protactinium-230 | 0.1 | | Lead-211 | 100 | Protactinium-231 | 0.001 |
QUANTITIES1 MATERIAL REQUIRING LABELING
*To convert mCi to kBq, multiply the mCi value by 37.
| Radionuclide | Quantity (µCi)* | Radionuclide | Quantity (µCi)* | | --- | --- | --- | --- | | Protactinium-232 | 1 | Americium-246m | 1,000 | | Protactinium-233 | 100 | Americium-246 | 1,000 | | Protactinium-234 | 100 | Curium-238 | 100 | | Uranium-230 | 0.01 | Curium-240 | 0.1 | | Uranium-231 | 100 | Curium-241 | 1 | | Uranium-232 | 0.001 | Curium-242 | 0.01 | | Uranium-233 | 0.001 | Curium-243 | 0.001 | | Uranium-234 | 0.001 | Curium-244 | 0.001 | | Uranium-235 | 0.001 | Curium-245 | 0.001 | | Uranium-236 | 0.001 | Curium-246 | 0.001 | | Uranium-237 | 100 | Curium-247 | 0.001 | | Uranium-238 | 100 | Curium-248 | 0.001 | | Uranium-239 | 1,000 | Curium-249 | 1,000 | | Uranium-240 | 100 | Berkelium-245 | 100 | | Uranium-natural | 100 | Berkelium-246 | 100 | | Neptunium-232 | 100 | Berkelium-247 | 0.001 | | Neptunium-233 | 1,000 | Berkelium-249 | 0.1 | | Neptunium-234 | 100 | Berkelium-250 | 10 | | Neptunium-235 | 100 | Californium-244 | 100 | | Neptunium-236 (1.15x105y) | 0.001 | Californium-246 | 1 | | Neptunium-236 (22.5h) | 1 | Californium-248 | 0.01 | | Neptunium-237 | 0.001 | Californium-249 | 0.001 | | Neptunium-238 | 10 | Californium-250 | 0.001 | | Neptunium-239 | 100 | Californium-251 | 0.001 | | Neptunium-240 | 1,000 | Californium-252 | 0.001 | | Plutonium-234 | 10 | Californium-253 | 0.1 | | Plutonium-235 | 1,000 | Californium-254 | 0.001 | | Plutonium-236 | 0.001 | Any alpha emitting radionuclide not listed above or mixtures of alpha emitters of unknown composition | | | Plutonium-237 | 100 | | | | Plutonium-238 | 0.001 | | | | Plutonium-239 | 0.001 | 0.001 | | | Plutonium-240 | 0.001 | Einsteinium-250 | 100 | | Plutonium-241 | 0.01 | Einsteinium-251 | 100 | | Plutonium-242 | 0.001 | Einsteinium-253 | 0.1 | | Plutonium-243 | 1,000 | Einsteinium-254m | 1 | | Plutonium-244 | 0.001 | Einsteinium-254 | 0.01 | | Plutonium-245 | 100 | Fermium-252 | 1 | | Americium-237 | 1,000 | Fermium-253 | 1 | | Americium-238 | 100 | Fermium-254 | 10 | | Americium-239 | 1,000 | Fermium-255 | 1 | | Americium-240 | 100 | Fermium-257 | 0.01 | | Americium-241 | 0.001 | Mendelevium-257 | 10 | | Americium-242m | 0.001 | Mendelevium-258 | 0.01 | | Americium-242 | 10 | Any radionuclide other than alpha-emitting radionuclides not listed above, or mixtures of beta- emitters of unknown composition | | | Americium-243 | 0.001 | | | | Americium-244m | 100 | | | | Americium-244 | 10 | | | | Americium-245 | 1,000 | 0.01 | |
QUANTITIES1 MATERIAL REQUIRING LABELING
*To convert mCi to kBq, multiply the mCi value by 37.
| Radionuclide | Quantity (µCi)* | Radionuclide | Quantity (µCi)* | | --- | --- | --- | --- | | 1The quantities listed above were derived by taking 1/10th of the most restrictive annual limit on intake (ALI) listed in Table I, Columns 1 and 2, of Appendix 004-B to Section 004, rounding to the nearest factor of 10, and constraining the values listed between 37 Bq and 37 MBq (0.001 and 1,000 µCi). Values of 3.7 MBq (100 µCi) have been assigned for radionuclides having a radioactive half-life in excess of 109 years, except rhenium, 37 MBq (1,000 µCi), to take into account their low specific activity. | NOTE: For purposes of 180 NAC 4-34.05, 4-037.01 and 4-057.01 where there is involved a combination of radionuclides in known amounts, the limit for the combination should be derived as follows: determine, for each radionuclide in the combination, the ratio between the quantity present in the combination and the limit otherwise established for the specific radionuclide when not in combination. The sum of such ratios for all radionuclides in the combination may not exceed "1" or unity. | | |
APPENDIX 4-D
REQUIREMENTS FOR TRANSFERS OF LOW-LEVEL RADIOACTIVE WASTE INTENDED FOR DISPOSAL AT LICENSED DISPOSAL FACILITIES AND MANIFESTS
SECTION I - MANIFEST
A waste generator, collector, or processor who transports, or offers for transportation, low-level radioactive waste intended for ultimate disposal at a licensed low-level radioactive waste disposal facility must prepare a Manifest reflecting information requested on the following forms, U.S. Nuclear Regulatory Commission (U.S. NRC) U.S. NRC 540, (Uniform Low-Level Radioactive Waste Manifest (Shipping Paper) and U.S. Form NRC 541 (Uniform Low-Level Radioactive Waste Manifest (Container and Waste Description) and if necessary, on Agency Form NRC 542 (Uniform Low-Level Radioactive Waste Manifest (Manifest Index and Regional Compact Tabulation). U.S. NRC 540 and U.S. NRC 540A must be completed and must physically accompany the pertinent low-level radioactive waste shipment. Upon agreement between shipper and consignee, U.S. Forms U.S. NRC 541 and U.S. NRC 541A and U.S. NRC 542 and U.S. NRC 542A may be completed, transmitted, and stored in electronic media with the capability for producing legible, accurate, and complete records on the respective forms. Licensees are not required by the Agency to comply with the manifesting requirements of this section when they ship:
(a) Low-Level Waste for processing and expect its return (that is, for storage under their license) prior to disposal at a licensed land disposal facility;
(b) Low-Level Waste that is being returned to the licensee who is the “waste generator” or “generator,” as defined in this section; or
(c) Radioactively contaminated material to a “waste processor” that becomes the processor’s “residual waste”.
For guidance in completing these forms, refer to the instructions that accompany the forms. Copies of manifests required by this appendix may be legible carbon copies, photocopies, or computer printouts that reproduce the data in the format of the uniform manifest.
Forms U.S. NRC 540, U.S. NRC 541, U.S. NRC 541A and U.S. NRC 542 and U.S. NRC 542A and the accompanying instructions, in hard copy, may be obtained from:
Department of Health and Human Services Division of Public Health, Radiological Health 301 Centennial Mall South P.O. Box 95026 Lincoln, Nebraska 68509-5026
This appendix includes information requirements of the Department of Transportation, as codified in 49 CFR part 172. Information on hazardous, medical, or other waste, required to meet Environmental Protection Agency regulations, as codified in 40 CFR parts 259, 261 or elsewhere, is not addressed in this section, and must be provided on the required EPA forms. However, the required EPA forms must accompany the Uniform Low-Level Radioactive Waste Manifest required by this section.
As used in this appendix, the following definitions apply:
CHELATING AGENT. Chelating agent has the same meaning as that given in 180 NAC 1-002.
CHEMICAL DESCRIPTION. Chemical description is a description of the principal chemical characteristics of a low-level radioactive waste.
COMPUTER-READABLE MEDIUM. The Department’s computer can transfer the information from the medium into its memory is computer-readable medium.
CONSIGNEE. Consignee is the designated receiver of the shipment of low-level radioactive waste.
DECONTAMINATION FACILITY. A decontamination facility is a facility operating under an Agency, U.S. Nuclear Regulatory Commission or Agreement State or license whose principal purpose is decontamination of equipment or materials to accomplish recycle, reuse, or other waste management objectives, and, for purposes of this section, is not considered to be a consignee for low-level waste shipments.
DISPOSAL CONTAINER. A disposal container is a container principally used to confine low-level radioactive waste during disposal operations at a land disposal facility. See “high integrity container”. For some shipments the disposal container may be the transport package.
EPA IDENTIFICATION NUMBER. An EPA identification number is the number received by a transporter following application to the Administrator of the Environmental Protection Agency (EPA) as required by 40 CFR part 263.
GENERATOR. A generator is a licensee operating under a Department, U.S. Nuclear Regulatory Commission or Agreement State license who (1) is a waste generator as defined in this part, or (2) is the licensee to whom waste can be attributed within the context of the Low-Level Radioactive Waste Policy Amendments Act of 1985, waste generated as a result of decontamination or recycle activities.
HIGH INTEGRITY CONTAINER (HIC). A high integrity container (HIC) is a container commonly designed to meet the structural stability requirements of Appendix 4-E, section II 180 NAC 4, and to meet Department of Transportation requirements for a Type A package.
U.S. NRC FORMS 540, 540A, 541, 541A, 542, AND 542A. U. S. Nuclear Regulatory Commission (NRC) forms 540, 540A, 541, 542 and 542A are forms referenced in this appendix. Licensees need not use originals of these U.S. Nuclear Regulatory Commission (NRC) forms as long as any substitute forms are equivalent to the original document in respect to content, clarity, size, and location of information. Upon agreement between the shipper and consignee, U.S. Nuclear Regulatory Commission (NRC) forms 541, 541A, 542 and 542A may be completed, transmitted, and stored in electronic media. The electronic media must have the capability for producing legible, accurate, and complete records in the format of the uniform manifest.
PACKAGE. A package is an assembly of components necessary to ensure compliance with the packaging requirements of Department of Transportation (DOT) regulations, together with its radioactive contents, as presented for transport.
PHYSICAL DESCRIPTION. A physical description is the items called for on Form U.S. Nuclear Regulatory Commission (NRC) 541 to describe a low-level radioactive waste.
RESIDUAL WASTE. Residual waste is low-level radioactive waste resulting from processing or decontamination activities that cannot be easily separated into distinct batches attributable to specific waste generators. This waste is attributable to the processor or decontamination facility, as applicable.
SHIPPER. A shipper is a licensed entity, the waste generator, waste collector, or waste processor, who offers low-level radioactive waste for transportation, typically consigning this type of waste to a licensed waste collector, waste processor, or land disposal facility operator.
SHIPPING PAPER. U.S. Nuclear Regulatory Commission (NRC) 540 and, if required form U.S. Nuclear Regulatory Commission (NRC) 540A, which includes the information required by DOT in 49 CFR part 172.
SOURCE MATERIAL. Source material has the same meaning as that given in180 NAC 1-002.
SPECIAL NUCLEAR MATERIAL. Special nuclear material has the same meaning as that given in 180 NAC 1-002.
UNIFORM LOW-LEVEL RADIOACTIVE WASTE MANIFEST OR UNIFORM MANIFEST. Uniform low-level radioactive waste manifest or uniform manifest means the combination of U.S. Nuclear Regulatory Commission (NRC) Forms 540, 541, and if necessary, 542, and their respective continuation sheets as needed, or equivalent.
WASTE COLLECTOR. A waste collector is an entity, operating under a Department, U.S. Nuclear Regulatory Commission or Agreement State license, whose principal purpose is to collect and consolidate waste generated by others, and to transfer this waste, without processing or repackaging the collected waste, to another licensed waste collector, licensed waste processor, or licensed disposal facility.
WASTE DESCRIPTION. A waste description is the physical, chemical and radiological description of a low-level radioactive waste as called for on Form U.S. Nuclear Regulatory Commission (NRC) 541.
WASTE GENERATOR. A waste generator is an entity, operating under a Department, U.S. Nuclear Regulatory Commission or Agreement State license, who (1) possesses any material or component that contains radioactivity or is radioactively contaminated for which the licensee foresees no further use, and (2) transfers this material or component to a licensed disposal facility or to a licensed waste collector or processor for handling or treatment prior to disposal. A licensee performing processing or decontamination services may be a “waste generator” if the transfer of low-level radioactive waste from its facility is defined as “residual waste.”
WASTE PROCESSOR. A waste processor is an entity, operating under a Department, U.S. Nuclear Regulatory Commission or Agreement State license, whose principal purpose is to process, repackage, or otherwise treat low-level radioactive material or waste generated by others prior to eventual transfer of waste to a licensed low-level radioactive waste disposal facility.
WASTE TYPE. Waste type is a waste within a disposal container having a unique physical description that is, a specific waste descriptor code or description; or a waste absorbed on or solidified in a specifically defined media.
INFORMATION REQUIREMENTS
A. General Information
The shipper of the low-level radioactive waste must provide the following information on the uniform manifest:
- The name, facility address, and telephone number of the licensee shipping the waste;
- An explicit declaration indicting whether the shipper is acting as a waste generator, collector, processor, or a combination of these identifiers for purposes of the manifested shipment; and
- The name, address, and telephone number, or the name and Environmental Protection Agency (EPA) identification number for the carrier transporting the waste.
B. Shipment Information
The shipper of the radioactive waste must provide the following information regarding the waste shipment on the uniform manifest:
- The date of the waste shipment;
- The total number of packages/disposal containers;
- The total disposal volume and disposal weight in the shipment;
- The total radionuclide activity in the shipment.
- The activity of each of the radionuclides H-3, C-14, Tc-99, and I-129 contained in the shipment; and
- The total masses of U-233, U-235, and plutonium in the form of special nuclear material, and the total mass of uranium and thorium in the form of source material.
C. Disposal Container and Waste Information
The shipper of the radioactive waste must provide the following information on the uniform manifest regarding the waste and each disposal container of waste in the shipment:
- An alphabetic or numeric identification that uniquely identifies each disposal container in the shipment;
- A physical description of the disposal container, including the manufacturer and model of any high integrity container;
- The volume displaced by the disposal container;
- The gross weight of the disposal container, including the waste;
- For waste consigned to a disposal facility, the maximum radiation level at the surface of each disposal container;
- A physical and chemical description of the waste;
- The total weight percentage of chelating agent for any waste containing more than 0.1% chelating agent by weight, plus the identity of the principal chelating agent;
- The approximate volume of waste within a container;
- The sorbing or solidification media, if any, and the identity of the solidification media vendor and brand name;
- The identities and activities of individual radionuclides contained in each container, the masses of U-233, U-235, and plutonium in the form of special nuclear material, and the masses of uranium and thorium in the form of source material. For discrete waste types, activated materials, contaminated equipment, mechanical filters, sealed source/devices, and wastes in solidification or stabilization media, the identities and activities of individual radionuclides associated with a disposal container must be reported;
- The total radioactivity within each container; and
- For wastes consigned to a disposal facility, the classification of the waste pursuant to Appendix 4-E, Section I. Waste not meeting the structural stability requirements of Appendix 4-E, Section II(b) must be identified.
D. Uncontainerized Waste Information
The shipper of the radioactive waste must provide the following information on the uniform manifest regarding a waste shipment delivered without a disposal container:
- The approximate volume and weight of the waste;
- A physical and chemical description of the waste;
- The total weight percentage of chelating agent if the chelating agent exceeds 0.1% by weight, plus the identity of the principal chelating agent;
- For waste consigned to a disposal facility, the classification of the waste pursuant to Appendix 4-E, Section I of 180 NAC 4. Waste not meeting the structural stability requirements of Appendix 4-E, Section II(b) of 180 NAC 4 must be identified.
- The identities and activities of individual radionuclides contained in the waste, the masses of U-233, U-235, and plutonium in the form of special nuclear material, and the masses of uranium and thorium in the form of source material; and
- For wastes consigned to a disposal facility, the maximum radiation levels at the surface of the waste.
E. Multi-Generator Disposal Container Information
This section applies to disposal containers enclosing mixtures of waste originating from different generators. Licensees note that the origin of the low-level waste resulting from a processor’s activities may be attributable to one or more “generators”, including “waste generators”, as defined in this section. It also applies to mixtures of wastes shipped in an uncontainerized form, for which portions of the mixture within the shipment originate from different generators:
- For homogeneous mixtures of waste, such as incinerator ash, provide the waste description applicable to the mixture and the volume of the waste attributed to each generator.
- For heterogeneous mixtures of waste, such as the combined products from a large compactor, identify each generator contributing waste to the disposal container, and, for discrete waste types, activated materials, contaminated equipment, mechanical filters, sealed source or devices, and wastes in solidification or stabilization media, the identities and activities of individual radionuclides contained on these waste types within the disposal container. For each generator, provide the following:
(a) The volume of waste within the disposal container; (b) A physical and chemical description of the waste, including the solidification agent, if any; (c) The total weight percentage of chelating agents for any disposal container containing more than 0.1% chelating agent by weight, plus the identity of the principal chelating agent; (d) The sorbing or solidification media, if any, and the identity of the solidification media vendor and brand name if the media is claimed to meet stability requirements in Appendix 4-E, Section II(b) of 180 NAC 4; and (e) Radionuclide identities and activities contained in the waste, the masses of U-233, U- 235, and plutonium in the form of special nuclear material, and the masses of uranium and thorium in the form of source material if contained in the waste.
SECTION II - CERTIFICATION
An authorized representative of the waste generator, processor, or collector must certify by signing and dating the shipment manifest that the transported materials are properly classified, described, packaged, marked, and labeled and are in proper condition for transportation according to the applicable regulations of the Department of Transportation and the Department. A collector in signing the certification is certifying that nothing has been done to the collected waste which would invalidate the waste generator’s certification.
SECTION III - CONTROL AND TRACKING
A. Any licensee who transfers radioactive waste to a land disposal facility or a licensed waste collector must comply with the requirements in A.1 through 9 of this section. Any licensee who transfers waste to a licensed waste processor for waste treatment or repackaging of A.4 through 9 of this section. A licensee must:
- Prepare all wastes so that the waste is classified according to Appendix 4-E, Section I of 180 NAC 4 and meets waste characteristics requirements in Appendix 4-E, Section II of 180 NAC 4.
- Label each disposal container, or transport package if potential radiation hazards preclude labeling of the individual disposal container, of waste to identify whether it is Class A waste, Class B waste, Class C waste, or greater than Class C waste, as required by Appendix 4-E, Section I of 180 NAC 4.
- Conduct a quality assurance program to assure compliance with Appendix 4-E, Section I and Section II of 180 NAC 4. The program must include management evaluation of audits;
- Prepare the Department Uniform Low-Level Radioactive Waste Manifest as required by this appendix;
- Forward a copy or electronically transfer the Uniform Low-Level Radioactive Waste Manifest to the intended consignee so that either (i) receipt of the manifest precedes the low-level waste shipment or (ii) the manifest is delivered to the consignee with the waste at the time the waste is transferred to the consignee. Using both (i) and (ii) is also acceptable;
- Include forms U.S. Nuclear Regulatory Commission (NRC) 540 and U.S. Nuclear Regulatory Commission (NRC) 540A, if required, with the shipment regardless of the option in Paragraph A.5 of this section;
- Retain a copy of the manifest and documentation of acknowledgment of receipt as the record of transfer of licensed material as required by 180 NAC 3. This includes those manifests and documents required under the standards for protection against radiation in effect prior to May 30, 1994; and
- Retain a copy of or electronically store the Uniform Low-Level Radioactive Waste Manifest and documentation of acknowledgment of receipt as the record of transfer of licensed material as required by Appendix 4-D of 180 NAC 4.
- For any shipments or any part of a shipment for which acknowledgment of receipt has not been received within the times specified in this appendix, conduct an investigation in accordance with Paragraph E of this appendix.
B. Any waste collector licensee who handles only prepackaged waste must:
- Acknowledge receipt of the waste from the shipper within one week of receipt by returning a signed copy of form U.S. Nuclear Regulatory Commission (NRC) 540.
- Prepare a new manifest to reflect consolidated shipments that meet the requirements of this appendix. The waste collector must ensure that, for each container of waste in the shipment, the manifest identifies the generator of that container of waste;
- Forward a copy or electronically transfer the Uniform Low-Level Radioactive Waste Manifest to the intended consignee so that either: (i) Receipt of the manifest precedes the low-level waste shipment or (ii) the manifest is delivered to the consignee with the waste at the time the waste is transferred to the consignee. Using both (i) and (ii) is also acceptable;
- Include forms U.S. Nuclear Regulatory Commission (NRC) 540 and U.S. Nuclear Regulatory Commission (NRC) 540A, if required, with the shipment regardless of the option chosen in Paragraph B.3 of this section;
- Retain a copy of the manifest and documentation of acknowledgment of receipt as the record of transfer of licensed material as required by 180 NAC 3, and retain information from generator manifest until the license is terminated. This includes those manifests and documents of acknowledgment of receipt required under the standards for protection against radiation in effect prior to May 30, 1994;
- Retain a copy of or electronically store the Uniform Low-Level Radioactive Waste Manifest and documentation of acknowledgment of receipt;
- For any shipments or any part of a shipment for which acknowledgment of receipt has not been received within the times specified in this appendix, conduct an investigation in accordance with Paragraph E of this appendix; and
- Notify the shipper and the Department when any shipment, or part of a shipment, has not arrived within 60 days after receipt of an advance manifest, unless notified by the shipper that the shipment has been canceled.
C. Any licensed waste processor who treats or repackages waste must:
- Acknowledge receipt of the waste from the shipper within one week of receipt by returning a signed copy of Form U.S. Nuclear Regulatory Commission (NRC) 540;
- Prepare a new manifest that meets the requirements of this appendix. Preparation of the new manifest reflects that the processor is responsible for meeting these requirements. For each container of waste in the shipment, the manifest must identify the waste generators, the preprocessed waste volume, and other information as required in Section I.E. of this appendix;
- Prepare all wastes so that the waste is classified according to Appendix 4-D, Section I., paragraph E of 180 NAC 4 and meets the waste characteristics requirements in Appendix 4- E, Section II of 180 NAC 4;
- Label each package of waste to identify whether it is Class A waste, Class B waste, or Class C waste, in accordance with Appendix 4-E, Section I and Section III of 180 NAC 4;
- Conduct a quality assurance program to assure compliance with Appendix 4-E, Sections I and II, the program must include management evaluation of audits of 180 NAC 4;
- Forward a copy or electronically transfer the Uniform Low-Level Radioactive Waste Manifest to the intended consignee so that either: (i) receipt of the manifest precedes the low-level waste shipment or (ii) the manifest is delivered to the consignee with the waste at the time the waste is transferred to the consignee. Using both (i) and (ii) is also acceptable;
- Include forms U.S. Nuclear Regulatory Commission (NRC) 540 and U.S. Nuclear Regulatory Commission (NRC) 540A, if required, with the shipment regardless of the option chosen in Paragraph C.6 of this section;
- Retain copies of the original manifests and new manifests and documentation of acknowledgment of receipt as the record of transfer of licensed material as required by 180 NAC 3. This includes those manifests and documents of acknowledgment of receipt required under the standards for protection against radiation in effect prior to May 30, 1994; and
- Retain a copy of or electronically store the Uniform Low-Level Radioactive Waste Manifest and documentation of acknowledgment of receipt as the record of transfer of licensed material as required by 180 NAC 3;
- For any shipment or any part of a shipment for which acknowledgment of receipt has not been received within the times specified in this appendix, conduct an investigation in accordance with Paragraph E of this appendix; and
- Notify the shipper and the Department when any shipment, or any part of a shipment, has not arrived within 60 days after receipt of an advance manifest, unless notified by the shipper that the shipment has been canceled.
D. The land disposal facility operator must:
- Acknowledge receipt of the waste within one week of receipt by returning, as a minimum, a signed copy of Form U.S. NRC 540 to the shipper. The shipper to be notified is the licensee who last possessed the waste and transferred the waste to the operator. If any discrepancy exists between materials listed on the Uniform Low-Level Radioactive Waste Manifest and materials received, copies or electronic transfer of the affected forms must be returned indicating that discrepancy.
- Maintain copies of all completed manifests or equivalent documentation until the license is terminated. This includes those manifests or equivalent documents required under the standards for protection against radiation in effect prior to May 30, 1994.
- Notify the shipper and the Department when any shipment, or part of a shipment, has not arrived within 60 days after receipt of an advance manifest, unless notified by the shipper that the shipment has been canceled.
E. Any shipments or part of a shipment for which acknowledgment is not received within the times specified in this section must:
- Be investigated by the shipper if the shipper has not received notification or receipt within 20 days after transfer; and
- Be traced and reported. The investigation must include tracing the shipment and filing a report with the Department. Each licensee who conducts a trace investigation must file a written report with the Department within two weeks of completion of the investigation.
APPENDIX 4-E
CLASSIFICATION AND CHARACTERISTICS OF LOW-LEVEL RADIOACTIVE WASTE
I. Classification of Radioactive Waste for Land Disposal
- Considerations. 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, improved waste form, and deeper disposal 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.
- Classes of waste.
- 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 specified in Section II. (a). If Class A waste also meets the stability requirements specified in Section II. (b), it is not necessary to segregate the waste for disposal.
- 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 specified in Section II.
- 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 specified in Section II.
c) Classification determined by long-lived radionuclides. If the radioactive waste contains only radionuclides listed in Table I, classification must be determined as follows:
- If the concentration does not exceed 0.1 times the value in Table I, the waste is Class A.
- If the concentration exceeds 0.1 times the value in Table I, but does not exceed the value in Table I, the waste is Class C.
- If the concentration exceeds the value in Table I, the waste is not generally acceptable for near surface disposal.
- For wastes containing mixtures of radionuclides listed in Table I, the total concentration must be determined by the sum of fractions rule described in Section I. (g).
| Table I | | | | --- | --- | --- | | Radionuclide | Concentration | | | curie/cubic metera | nanocurie/gramb | | | C-14 | 8 | | | C-14 in activated metal | 80 | | | Ni-59 in activated metal | 220 | | | Nb-94 in activated metal | 0.2 | | | Tc-99 | 3 | | | I-129 | 0.08 | | | Alpha emitting transuranic radionuclides with half-life greater than five years | | 100 | | Pu-241 | | 3,500 | | Cm-242 | | 20,000 | | Ra-226 | | 100 | | aTo convert the Ci/m3 values to gigabecquerel (Gbq) per cubic meter, multiply the Ci/m3 value by 37. | | | | bTo convert the nCi/g values to becquerel (Bq) per gram, multiply the nCi/g value by 37. | | |
d) Classification determined by short-lived radionuclides. If the waste does not contain any of the radionuclides listed in Table I classification must be determined based on the concentrations shown in Table II. However, as specified in Section I. (f), if radioactive waste does not contain any nuclides listed in either Table I or II, it is Class A.
- If the concentration does not exceed the value in Column 1, the waste is Class A.
- If the concentration exceeds the value in Column 1 but does not exceed the value in Column 2, the waste is Class B.
- If the concentration exceeds the value in Column 2 but does not exceed the value in Column 3, the waste is Class C.
- If the concentration exceeds the value in Column 3, the waste is not generally acceptable for near-surface disposal.
- For wastes containing mixtures of the radionuclides listed in Table II, the total concentration must be determined by the sum of fractions rule described in Section I. (g).
| Table II | | | | | --- | --- | --- | --- | | | Concentration, curie/cubic meter* | | | | Radionuclide | Column 1 | Column 2 | Column 3 | | Total of all radionuclides with less than 5-year half-life | 700 | ----- | ----- | | H-3 | 40 | ----- | ----- | | Co-60 | 700 | ----- | ----- | | Ni-63 | 3.5 | 70 | 700 | | Ni-63 in activated metal | 35 | 700 | 7000 | | Sr-90 | 0.04 | 150 | 7000 | | Cs-137 | 1 | 44 | 4600 | | *To convert the Ci/m3 value to gigabecquerel (Gbq) per cubic meter, multiply the curies (Ci)/m3 value by 37. 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 radionuclides in Table II determine the waste to be Class C independent of these radionuclides. | | | |
e) Classification determined by both long- and short-lived radionuclides. If the radioactive waste contains a mixture of radionuclides, some of which are listed in Table I and some of which are listed in Table II, classification must be determined as follows:
- If the concentration of a radionuclide listed in Table I is less than 0.1 times the value listed in Table I, the class must be that determined by the concentration of radionuclides listed in Table II.
- If the concentration of a radionuclide listed in Table I exceeds 0.1 times the value listed in Table I, but does not exceed the value in Table I, the waste must be Class C, provided the concentration of radionuclides listed in Table II does not exceed the value shown in Column 3 of Table II.
- Classification of wastes with radionuclides other than those listed in Tables I and II. If the waste does not contain any radionuclides listed in either Table I or II, it is Class A.
- 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 1.0 if the waste class is to be determined by that column. Example: A waste contains Sr-90 in a concentration of 1.85 TBq/m3 (50 Ci/m3) and Cs-137 in a concentration of 814 GBq/m3 (22 Ci/m3). Since the concentrations both exceed the values in Column 1, Table II, they must be compared to Column 2 values. For Sr-90 fraction, 50/150 = 0.33., for Cs-137 fraction, 22/44 = 0.5; the sum of the fractions = 0.83. Since the sum is less than 1.0, the waste is Class B.
- Determination of concentrations in wastes. 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 becquerel (nanocurie) per gram.
II. Radioactive Waste Characteristics
a) The following are minimum requirements for all classes of waste and are intended to facilitate handling and provide protection of health and safety of personnel at the disposal site.
- Wastes must be packaged in conformance with the conditions of the license issued to the site operator to which the waste will be shipped. Where the conditions of the site license are more restrictive than the provisions of 180 NAC 4, the site license conditions shall govern.
- Wastes must not be packaged for disposal in cardboard or fiberboard boxes.
- Liquid waste must be packaged in sufficient absorbent material to absorb twice the volume of the liquid.
- Solid waste containing liquid must contain as little free-standing and non-corrosive liquid as is reasonably achievable, but in no case shall the liquid exceed 1% of the volume.
- 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.
- 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 Section II. (a)(8).
- Waste must not be pyrophoric. Pyrophoric materials contained in wastes must be treated, prepared, and packaged to be nonflammable.1
- Wastes in a gaseous form shall be packaged at an absolute pressure that does not exceed 1.5 atmospheres at 20µC. Total activity must not exceed 3.7 TBq (100 Ci) per container.
- Wastes containing hazardous, biological, pathogenic, or infectious material must be treated to reduce to the maximum extent practicable the potential hazard from the non- radiological materials.
b) The following requirements are intended to provide stability of the waste. Stability is intended to ensure that the waste does not 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.
- 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.
- Notwithstanding the provisions in Section II. (a)(3) and (4), liquid wastes, or wastes containing liquid, must be converted into a form that contains as little free-standing and non-corrosive liquid as is reasonably achievable, but in no case shall the liquid exceed 1% of the volume of the waste when the waste is in a disposal container designed to ensure stability, or 0.5% of the volume of the waste for waste processed to a stable form.
- Void spaces within the waste and between the waste and its package must be reduced to the extent practicable.
III. Labeling
Each package of waste must be clearly labeled to identify whether it is Class A, Class B, or Class C waste, in accordance with Section I.
APPENDIX 4-F
| QUANTITIES FOR USE WITH DECOMMISSIONING (To convert µCi to kBq, multiply the µCi value by 37.) | | | --- | --- | | Material | Microcurie | | Americium-241 | 0.01 | | Antimony-122 | 100 | | Antimony-124 | 10 | | Antimony-125 | 10 | | Arsenic-73 | 100 | | Arsenic-74 | 10 | | Arsenic-76 | 10 | | Arsenic-77 | 100 | | Barium-131 | 10 | | Barium-133 | 10 | | Barium-140 | 10 | | Bismuth-210 | 1 | | Bromine-82 | 10 | | Cadmium-109 | 10 | | Cadmium-115m | 10 | | Cadmium-115 | 100 | | Calcium-45 | 10 | | Calcium-47 | 10 | | Carbon-14 | 100 | | Cerium-141 | 100 | | Cerium-143 | 100 | | Cerium-144 | 1 | | Cesium-131 | 1,000 | | Cesium-134m | 100 | | Cesium-134 | 1 | | Cesium-135 | 10 | | Cesium-136 | 10 | | Cesium-137 | 10 | | Chlorine-36 | 10 | | Chlorine-38 | 10 | | Chromium-51 | 1,000 | | Cobalt-58m | 10 | | Cobalt-58 | 10 | | Cobalt-60 | 1 | | Copper-64 | 100 | | Dysprosium-165 | 10 | | Dysprosium-166 | 100 | | Erbium-169 | 100 | | Erbium-171 | 100 | | Europium-152 (9.2 h) | 100 | | Europium-152 (13 yr) | 1 | | Europium-154 | 1 | | Europium-155 | 10 | | Florine-18 | 1,000 | | Gadolinium-153 | 10 | | Gadolinium-159 | 100 | | Gallium-72 | 10 |
| QUANTITIES FOR USE WITH DECOMMISSIONING (To convert µCi to kBq, multiply the µCi value by 37.) | | | --- | --- | | Material | Microcurie | | Germanium-71 | 100 | | Gold-198 | 100 | | Gold-199 | 100 | | Hafnium-181 | 10 | | Holmium-166 | 100 | | Hydrogen-3 | 1,000 | | Indium-113m | 100 | | Indium-114m | 10 | | Indium-115m | 100 | | Indium-115 | 10 | | Iodine-125 | 1 | | Iodine-126 | 1 | | Iodine-129 | 0.1 | | Iodine-131 | 1 | | Iodine-132 | 10 | | Iodine-133 | 1 | | Iodine-134 | 10 | | Iodine-135 | 10 | | Iridium-192 | 10 | | Gold-198 | 100 | | Gold-199 | 100 | | Hafnium-181 | 10 | | Holmium-166 | 100 | | Hydrogen-3 | 1,000 | | Indium-113m | 100 | | Indium-114m | 10 | | Indium-115m | 100 | | Indium-115 | 10 | | Iodine-125 | 1 | | Iodine-126 | 1 | | Iodine-129 | 0.1 | | Iodine-131 | 1 | | Iodine-132 | 10 | | Iodine-133 | 1 | | Iodine-134 | 10 | | Iodine-135 | 10 | | Iridium-192 | 10 | | Iridium-194 | 100 | | Iron-55 | 100 | | Iron-59 | 10 | | Krypton-85 | 100 | | Krypton-87 | 10 | | Lanthanum-140 | 10 | | Lutetium-177 | 100 | | Manganese-52 | 10 | | Manganese-54 | 10 | | Manganese-56 | 10 | | Mercury-197m | 100 | | Mercury-197 | 100 |
| QUANTITIES FOR USE WITH DECOMMISSIONING (To convert µCi to kBq, multiply the µCi value by 37.) | | | --- | --- | | Material | Microcurie | | Mercury-203 | 10 | | Molybdenum-99 | 100 | | Neodymium-147 | 100 | | Neodymium-149 | 100 | | Nickel-59 | 100 | | Nickel-63 | 10 | | Nickel-65 | 100 | | Niobium-93m | 10 | | Niobium-95 | 10 | | Niobium-97 | 10 | | Osmium-185 | 10 | | Osmium-191m | 100 | | Osmium-191 | 100 | | Osmium-193 | 100 | | Palladium-103 | 100 | | Palladium-109 | 100 | | Phosphorus-32 | 10 | | Platinum-191 | 100 | | Platinum-193m | 100 | | Platinum-193 | 100 | | Platinum-197m | 100 | | Platinum-197 | 100 | | Plutonium-239 | 0.01 | | Polonium-210 | 0.1 | | Molybdenum-99 | 100 | | Neodymium-147 | 100 | | Neodymium-149 | 100 | | Nickel-59 | 100 | | Nickel-63 | 10 | | Nickel-65 | 100 | | Niobium-93m | 10 | | Niobium-95 | 10 | | Niobium-97 | 10 | | Osmium-185 | 10 | | Osmium-191m | 100 | | Osmium-191 | 100 | | Osmium-193 | 100 | | Palladium-103 | 100 | | Palladium-109 | 100 | | Phosphorus-32 | 10 | | Platinum-191 | 100 | | Platinum-193m | 100 | | Platinum-193 | 100 | | Platinum-197m | 100 | | Platinum-197 | 100 | | Plutonium-239 | 0.01 | | Polonium-210 | 0.1 | | Potassium-42 | 10 | | Praseodymium-142 | 100 |
| QUANTITIES FOR USE WITH DECOMMISSIONING (To convert µCi to kBq, multiply the µCi value by 37.) | | | --- | --- | | Material | Microcurie | | Praseodymium-143 | 100 | | Promethium-147 | 10 | | Promethium-149 | 10 | | Radium-226 | 0.01 | | Rhenium-186 | 100 | | Rhenium-188 | 100 | | Rhodium-103m | 100 | | Rhodium-105 | 100 | | Rubidium-86 | 10 | | Rubidium-87 | 10 | | Ruthenium-97 | 100 | | Ruthenium-103 | 10 | | Ruthenium-105 | 10 | | Ruthenium-106 | 1 | | Samarium-151 | 10 | | Samarium-153 | 100 | | Scandium-46 | 10 | | Scandium-47 | 100 | | Scandium-48 | 10 | | Selenium-75 | 10 | | Silicon-31 | 100 | | Silver-105 | 10 | | Silver-110m | 1 | | Silver-111 | 100 | | Sodium-22 | 1 | | Sodium-24 | 10 | | Strontium-85 | 10 | | Strontium-89 | 1 | | Strontium-90 | 0.1 | | Strontium-91 | 10 | | Strontium-92 | 10 | | Sulfur-35 | 100 | | Tantalum-182 | 10 | | Technetium-96 | 10 | | Technetium-97m | 100 | | Technetium-97 | 100 | | Technetium-99m | 100 | | Technetium-99 | 10 | | Tellurium-125m | 10 | | Tellurium-127m | 10 | | Tellurium-127 | 100 | | Tellurium-129m | 10 | | Tellurium-129 | 100 | | Tellurium-131m | 10 | | Tellurium-132 | 10 | | Terbium-160 | 10 | | Thallium-200 | 100 | | Thallium-201 | 100 | | Thallium-202 | 100 |
| QUANTITIES FOR USE WITH DECOMMISSIONING (To convert µCi to kBq, multiply the µCi value by 37.) | | | --- | --- | | Material | Microcurie | | Thallium-204 | 10 | | Thorium (natural)1 | 100 | | Thulium-170 | 10 | | Thulium-171 | | | Tin-113 | 10 | | Tin-125 | 10 | | Tungsten-181 | 10 | | Tungsten-185 | 10 | | Tungsten-187 | 100 | | Uranium (natural)2 | 100 | | Uranium-233 | 0.01 | | Uranium-234 | 0.01 | | Uranium-235 | 0.01 | | Vanadium-48 | 10 | | Xenon-131m | 1,000 | | Xenon-133 | 100 | | Xenon-135 | 100 | | Ytterbium-175 | 100 | | Yttrium-90 | 10 | | Yttrium-91 | 10 | | Yttrium-92 | 100 | | Yttrium-93 | 100 | | Zinc-65 | 10 | | Zinc-69m | 100 | | Zinc-69 | 1,000 | | Zirconium-93 | 10 | | Zirconium-95 | 10 | | Zirconium-97 | 10 | | Any alpha emitting radionuclide not listed above or mixtures of alpha emitters of unknown composition | 0.01 | | Any radionuclide other than alpha emitting Radionuclides, not listed above or mixtures of Beta emitters of unknown composition | 0.1 | | Where there is involved a combination of isotopes in known amounts, the limit for the combination should be derived as follows: Determine, for each isotope in the combination, the ratio between the quantity present in the combination and the limit otherwise established for the specific isotope when not in combination. The sum of such ratios for all the isotopes in the combination may not exceed "1" is unity. | |
1Based on alpha disintegration rate of Th-232, Th-230 and their daughter products.
2Based on alpha disintegration rate of U-238, U-234 and U-235.
APPENDIX 4-G
CONCENTRATION AND ACTIVITY LIMITS OF NUCLIDES FOR DISPOSAL IN A CITY OR COUNTY LANDFILL DISPOSAL FACILITY
(For use in 180 NAC 4-038)
| Nuclides | Concentration Limits (Ci/m3) | Annual Generator Disposal Limit (Ci/yr) | | --- | --- | --- | | F-18 | 3E-1 | 8 | | Si-31 | 1E-2 | 3E+3 | | Na-24 | 9E-4 | 2E-2 | | P-32 | 2 | 5E+1 | | P-33 | 10 | 3E+2 | | S-35 | 9 | 2E+2 | | Ar-41 | 3E-1 | 8 | | K-42 | 2E-2 | 5E-1 | | Ca-45 | 4 | 1E+2 | | Ca-47 | 2E-2 | 5E-1 | | Sc-46 | 2E-3 | 5E-2 | | Cr-51 | 6E-1 | 2E+1 | | Fe-59 | 5E-3 | 1E-1 | | Co-57 | 6E-2 | 2 | | Co-58 | 1E-2 | 3E-1 | | Zn-65 | 7E-3 | 2E-1 | | Ga-67 | 3E-1 | 8 | | Se-75 | 5E-2 | 1 | | Br-82 | 2E-3 | 5E-2 | | Rb-86 | 4E-2 | 1 | | Sr-85 | 2E-2 | 5E-1 | | Sr-89 | 8 | 2E+2 | | Y-90 | 4 | 1E+2 | | Y-91 | 4E-1 | 10 | | Zr-95 | 8E-3 | 2E-1 | | Nb-95 | 8E-3 | 2E-1 | | Mo-99 | 5E-2 | 1 | | Tc-99m | 1 | 3E+1 | | Rh-106 | 1 | 3E+1 | | Ag-110m | 2E-3 | 5E-2 | | Cd-115m | 2E-1 | 5 | | In-111 | 9E-2 | 2 | | In-113m | 9 | 2E+2 | | Sn-113 | 6E-2 | 2 | | Sn-119 | 2E+1 | 5E+2 | | Sb-124 | 2E-3 | 5E-2 |
CONCENTRATION AND ACTIVITY LIMITS OF NUCLIDES FOR DISPOSAL IN A CITY OR COUNTY LANDFILL DISPOSAL FACILITY
(For use in 180 NAC 4-038)
| Nuclides | Concentration Limits (Ci/m3) | Annual Generator Disposal Limit (Ci/yr) | | --- | --- | --- | | Te-129 | 2E-1 | 5 | | I-123 | 4E-1 | 1E+1 | | I-125 | 7E-1 | 2E+1 | | I-131 | 4E-2 | 1 | | I-133 | 2E-2 | 5E-1 | | Xe-127 | 8E-2 | 2 | | Xe-133 | 1 | 3E+1 | | Ba-140 | 2E-3 | 5E-2 | | La-140 | 2E-3 | 5E-2 | | Ce-141 | 4E-1 | 1E+1 | | Ce-144 | 1E-3 | 3E-2 | | Pr-143 | 6 | 2E+2 | | Nd-147 | 7E-2 | 2 | | Yb-169 | 6E-2 | 2 | | Ir-192 | 1E-2 | 3E-1 | | Au-198 | 3E-2 | 8E-1 | | Hg-197 | 8E-1 | 2E+1 | | TI-201 | 4E-1 | 1E+1 | | Hg-203 | 1E-1 | 3 |
In any case where there is a mixture in waste of more than one radionuclide, the limiting values for purposes of this Appendix must be determined as follows:
For each radionuclide in the mixture, calculate the ratio between the quantity present in the mixture and the limit established in Appendix 004-G for the specific radionuclide when not in a mixture. The sum of such ratios for all the radionuclides in the mixture may not exceed "1" or “unity".
Examples: If radionuclides a, b, and c are present in concentrations Ca, Cb, and Cc, and if the applicable concentrations are CLa, CLb, and CLc respectively, then the concentrations shall be limited so that the following relationship exists:
(Ca/CLa) + (Cb/CLb) + (Cc/CLc) < 1
If the total curies for radionuclides a, b, and c are represented Aa, Ab, and Ac, and the annual curie limit for each radionuclide is ALa, ALb, and ALc, then the generator is limited to the following:
(Aa /ALa) + (Ab/AL=) + (Ac/ALc) < 1
APPENDIX 4-H
NATIONALLY TRACKED SOURCE THRESHOLDS
The Terabecquerel (TBq) values are the regulatory standard. The curie (Ci) values specified are obtained by converting from the TBq value. The curie values are provided for practical usefulness only and are rounded after conversion.
| Radioactive material | Category 1 (TBq) | Category 1 (Ci) | Category 2 (TBq) | Category 2 (Ci) | | --- | --- | --- | --- | --- | | Actinium-227 | 20 | 540 | 0.2 | 5.4 | | Americium-241 | 60 | 1,600 | 0.6 | 16 | | Americium-241/Be | 60 | 1,600 | 0.6 | 16 | | Californium-252 | 20 | 540 | 0.2 | 5.4 | | Cobalt-60 | 30 | 810 | 0.3 | 8.1 | | Curium-244 | 50 | 1,400 | 0.5 | 14 | | Cesium-137 | 100 | 2,700 | 1.0 | 27 | | Gadolinium-153 | 1,000 | 27,000 | 10 | 270 | | Iridum-192 | 80 | 2,200 | 0.8 | 22 | | Plutonium-238 | 60 | 1,600 | 0.6 | 16 | | Plutonium-239/Be | 60 | 1,600 | 0.6 | 16 | | Polonium-210 | 60 | 1,600 | 0.6 | 16 | | Promethium-147 | 40,000 | 1,100,000 | 400 | 11,000 | | Radium-226 | 40 | 1,100 | 0.4 | 11 | | Selenium-75 | 200 | 5,400 | 2 | 54 | | Strontium-90 | 1,000 | 27,000 | 10 | 270 | | Thorium-228 | 20 | 540 | 0.2 | 5.4 | | Thorium-229 | 20 | 540 | 0.2 | 5.4 | | Thulium-170 | 20,000 | 540,000 | 200 | 5,400 | | Ytterbium-169 | 300 | 8,100 | 3 | 81 |
History
- Effective 2021-06-07
Chapter 5 Radiation Safety Requirements for Industrial Radiographic Operations Compatibility Chapter
Neb. Admin. Code tit. 180, ch. 5 Radiation Safety Requirements for Industrial Radiographic Operations Compatibility Chapter {#sec-180-nac-5 omnilex-key=us-ne-regs-official--title-180--180 NAC 5}
Effective Date: 6/14/2023
001. SCOPE AND AUTHORITY . 180 Nebraska Administrative Code (NAC) 5 prescribes requirements for the issuance of licenses or registrations for the industrial use of sources of radiation and radiation safety requirements for persons using these sources of radiation in industrial radiography. The regulations are authorized by and implement the Nebraska Radiation Control Act, Nebraska Revised Statute (Neb. Rev. Stat.) §§ 71-3501 to 71-3520.
001.01 GENERAL PROVISIONS. The provisions and requirements of 180 NAC 5 are in addition to, and not in substitution for, other requirements of Title 180. In particular, the general requirements and provisions of 180 NAC 1, 2, 3, 4, 10, 13, and 18 apply to applicants, licensees, and registrants subject to 180 NAC 5. 180 NAC 5 does not apply to medical uses of sources of radiation addressed in 180 NAC 6, 7 and 20.
001.02 NATIONAL BUREAU OF STANDARDS HANDBOOK. National Bureau of Standards Handbook 136 issued 1-1981 as referred to in this Chapter is herein incorporated by reference and available for viewing at the Nebraska Department of Health and Human Services, Division of Public Health, Office of Radiological Health, 301 Centennial Mall South, Lincoln, Nebraska 68509-5026.
002. DEFINITIONS . As used in 180 NAC 5, the following definitions apply:
002.01 ANNUAL REFRESHER SAFETY TRAINING. A review conducted or provided by the licensee or registrant for its employees on radiation safety aspects of industrial radiography. The review must include, as a minimum, any results of internal inspections, new procedures, or equipment, new or revised regulations, and accidents or errors that have been observed. The review must also provide opportunities for employees to ask safety questions.
002.02 ASSOCIATED EQUIPMENT. Equipment used in conjunction with a radiographic exposure device to make radiographic exposures that drives, guides, or comes in contact with the source. Associated equipment includes, but is not limited to the guide tube, control or drive cable, removable stop, and the “J” tube and collimator when used as an exposure head.
002.03 CAMERA. Has the same meaning as radiographic exposure device.
002.04 CERTIFYING ENTITY. An independent certifying organization meeting the requirements in Appendix A of 180 NAC 5 or a state regulatory program meeting the requirements in Appendix A, Parts II and III of 180 NAC 5.
002.05 COLLIMATOR. 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.
002.06 CONTROL CABLE. A cable connected to the source assembly and used to drive the source to and from the exposure location. A control cable is also known as a drive cable.
002.07 CONTROL DRIVE MECHANISM. A device that enables the source assembly to be moved into and out of the exposure device.
002.08 CONTROL TUBE. A protective sheath for guiding the control cable. The control tube connects the control drive mechanism to the radiographic exposure device.
002.09 DRIVE CABLE. Has the same meaning as control cable.
002.10 EXPOSURE HEAD. Device that locates the gamma radiography sealed source in the selected working position. An exposure head is also known as a source stop.
002.11 FIELD STATION. A facility where sources of radiation may be stored or used and from which equipment is dispatched.
002.12 GUIDE TUBE. A flexible or rigid tube or “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. A guide tube is also known as a projection sheath.
002.13 HANDS-ON EXPERIENCE. Experience in all of those areas considered to be directly involved in the radiography process that includes, but is not limited to taking radiographs, calibration of survey instruments, operational and performance testing of survey instruments and devices, film development, posting of radiation areas, transportation of radiography equipment, posting of records and radiation area surveillance, as applicable.
002.14 INDEPENDENT CERTIFYING ORGANIZATION. An organization that meets all the criteria of Appendix A to 180 NAC 5.
002.15 INDUSTRIAL RADIOGRAPHY. An examination of the structure of materials by nondestructive methods using sources of ionizing radiation to produce radiographic images. Also known as radiography.
002.16 PERMANENT RADIOGRAPHIC INSTALLATION. An enclosed shielded room, cell, or vault, not located at a temporary jobsite, where radiography is performed.
002.17 PIGTAIL. Has the same meaning as source assembly.
002.18 PRACTICAL EXAMINATION. A demonstration through application of the safety rules and principles in industrial radiography including use of all procedures and equipment to be used by radiographic personnel.
002.19 PROJECTOR. Has the same meaning as radiographic exposure device.
002.20 RADIATION SAFETY OFFICER FOR INDUSTRIAL RADIOGRAPHY. An individual with the responsibility for the overall radiation safety protection program on behalf of the licensee or registrant and who meets the requirements of 180 NAC 5-015.
002.21 RADIOGRAPHER. Any individual who performs or who, in attendance at the site where the sources of radiation are being used, personally supervises industrial radiographic operations and who is responsible to the licensee or registrant for assuring compliance with the requirements of the Department’s regulations and the conditions of the license or registration.
002.22 RADIOGRAPHER’S ASSISTANT. Any individual who under the direct supervision of a radiographer, uses radiographic exposure devices, sources of radiation, related handling tools, or radiation survey instruments in industrial radiography.
002.23 RADIOGRAPHER CERTIFICATION. Written approval received from a certifying entity stating that an individual has satisfactorily met the radiation safety, testing, and experience criteria in 180 NAC 15-016.
002.24 RADIOGRAPHIC EXPOSURE DEVICE. Any instrument containing a sealed source fastened or contained therein, where 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. A radiographic exposure device is also known as a camera or projector.
002.25 RADIOGRAPHIC OPERATIONS. All activities performed with a radiographic exposure device, or with a radiation machine. Activities include using, transporting, except by common or contract carriers, or storing a temporary job site, performing surveys to confirm the adequacy of boundaries, setting up equipment, and any activity inside restricted area boundaries. Transporting a radiation machine is not considered a radiographic operation.
002.26 RADIOGRAPHY. See Industrial radiography.
002.27 S-TUBE. A tube through which the radioactive source travels when inside a radiographic exposure device.
002.28 SEALED SOURCE. Has the same meaning as 180 NAC 1-002.
002.29 SHIELDED POSITION. A location within the radiographic exposure device, source changer or storage container that, by manufacturer's design, is the proper location for storage of the sealed source.
002.30 SOURCE ASSEMBLY. Consists of the sealed source and a connector that attaches the source to the control cable. The source assembly may include a ballstop to secure the source in the shielded position. Also known as a pigtail.
002.31 SOURCE CHANGER. A device designed and used for replacement of sealed sources in radiographic exposure devices. A source changer may also be used for transporting and storing sealed sources.
002.32 STORAGE AREA. Any location, facility, or vehicle that is used to store and secure a radiographic exposure device, a radiation machine, sealed source, or a storage container, when it is not used for radiographic operations. Storage areas are locked or have a physical barrier to prevent accidental exposure, tampering, or unauthorized removal of the device, machine, or container.
002.33 STORAGE CONTAINER. A device in which sealed sources or radiation machines are secured or stored.
002.34 TEMPORARY JOB SITE. A location where radiographic operations are performed and where sources of radiation may be stored other than the location(s) of use authorized on the license or registration.
002.35 UNDERWATER RADIOGRAPHY. Radiographic operations performed when the radiographic exposure device or radiation machine or related equipment, or both, are beneath the surface of the water.
003. EXEMPTIONS . Industrial uses of hand-held light intensified imaging devices are exempt from the requirements in 180 NAC 5 if the dose rate 18 inches from the source of radiation to any individual does not exceed 2 millirem per hour. Devices that exceed this limit must meet applicable requirements of 180 NAC 5 and applicable licensing or registration requirements of 180 NAC 2 or 180 NAC 3.
004. LICENSING AND REGISTRATION REQUIREMENTS FOR INDUSTRIAL RADIOGRAPHY OPERATIONS . In addition to paying the applicable fees specified 180 NAC 18, an application for specific license for the use of licensed material or a registration for use of radiation machines must include the following:
(A) The applicant satisfies the general requirements specified in 180 NAC 2 for radiation machine facilities or 180 NAC 3 for radioactive material, as applicable, and any special requirements contained in 180 NAC 5; (B) The applicant submits an adequate program for training radiographers and radiographer’s assistants that meets the requirements of 180 NAC 5-016; (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 180 NAC 5-017; (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 180 NAC 5-016.05; (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 submits the qualifications of the individual or individuals designated as the radiation safety officer as described in 180 NAC 5-015.01; (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 the test and the qualifications of the person or persons 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:
(i) Methods of collecting the samples; (ii) Qualifications of the individual who analyzes the samples; (iii) Instruments to be used; and (iv) Methods of analyzing the samples;
(I) If the applicant intends to perform calibrations of survey instruments and alarming ratemeters, the applicant must describe methods to be used and the experience of the person or persons who will perform the calibrations. All calibrations must be performed according to the procedures described and at the intervals prescribed in 180 NAC 5-008 and 180 NAC 5-019.07(D); (J) The applicant identifies and describes the location or locations of all field stations and permanent radiographic installations; (K) The applicant identifies the location or locations where all records required by Title 180 will be maintained; and (L) If an application includes underwater radiography, a description of:
(i) Radiation safety procedures and radiographer responsibilities unique to the performance of underwater radiography; (ii) Radiographic equipment and radiation safety equipment unique to underwater radiography; and (iii) Methods for gas-tight encapsulation of equipment.
005. PERFORMANCE REQUIREMENTS FOR INDUSTRIAL RADIOGRAPHY EQUIPMENT .
005.01 DESIGN STANDARDS. Each radiographic exposure device, source assembly or sealed source, and all associated equipment must meet the requirements specified in American National Standards Institute (ANSI), N432-1980 “Radiological Safety for the Design and Construction of Apparatus for Gamma Radiography,” published as National Bureau of Standards Handbook 136, issued January 1981.
005.02 ADDITIONAL REQUIREMENTS. In addition to the requirements specified in 180 NAC 5-005.01, the following requirements apply to radiographic exposure devices, source changers, source assemblies and sealed sources:
(A) The licensee must ensure that each radiographic exposure device has attached to it a durable, legible, clearly visible label bearing the:
(i) Chemical symbol and mass number of the radionuclide in the device; (ii) Activity and the date on which this activity was last measured; (iii) Model or product code and serial number of the sealed source; (iv) Name of the manufacturer of the sealed source; and (v) Licensee’s name, address, and telephone number;
(B) Radiographic exposure devices intended for use as Type B packages must meet the applicable transportation requirements of 180 NAC 13; and (C) 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.
005.03 ADDITIONAL REQUIREMENTS FOR COMPONENTS THAT ALLOW THE SOURCE TO BE MOVED OUT OF THE DEVICE. In addition to the requirements specified in 180 NAC 5-005.01 and 5-005.02, 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:
(A) 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; (B) 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; (C) 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; (D) 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”. The label may not interfere with the safe operation of the exposure device or associated equipment; (E) 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; (F) Guide tubes must be used when moving the source out of the device; (G) An exposure head or similar device designed to prevent the source of assembly from passing out of the end of the guide tube must be attached to the outermost end of the guide tube during the industrial radiography operations; (H) The guide tube exposure head connection must be able to withstand the tensile test for control units specified in American National Standards Institute (ANSI), N432-1980; and (I) Source changes 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.
005.04 EXCEPTION. As an exception to 180 NAC 5-005.01, equipment used in industrial radiographic operations need not comply with Section 8.9.2(c) of the Endurance Test in American National Standards Institute (ANSI), N432-1980, if the prototype equipment has been tested using a torque value representative of the torque that an individual using the radiography equipment can reasonably exert on the lever or crankshaft of the drive mechanism.
006. LIMITS ON EXTERNAL RADIATION LEVELS FROM STORAGE CONTAINERS AND SOURCE CHANGERS . The maximum exposure rate limits for storage containers and source changers are 2 millisieverts (200 mrem) per hour at any exterior surface, and 0.1 millisieverts (10 mrem) per hour at 1 meter from any exterior surface with the sealed source in the shielded position.
007. LOCKING OF SOURCES OF RADIATION, STORAGE CONTAINERS AND SOURCE CHANGERS .
007.01 RADIOGRAPHIC EXPOSURE DEVICE. 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 or its container, or both, must be kept locked, and if a keyed-lock, 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 180 NAC 5-021. In addition, during radiographic operations the sealed source assembly must be secured in a shielded position each time the source is returned to that position.
007.02 SEALED SOURCE STORAGE CONTAINER OR SOURCE CHANGER. 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 a keyed-lock, 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.
007.03 RADIATION MACHINE. The control panel of each radiation machine must be equipped with a lock that will prevent the unauthorized use of a x-ray system or the accidental production of radiation. The radiation machine must be kept locked and the key removed at all times except when under the direct visual surveillance of a radiographer or a radiographer’s assistant.
008. RADIATION SURVEY INSTRUMENTS .
008.01 INSTRUMENT PERFORMANCE REQUIREMENTS. The licensee or registrant must keep sufficient calibrated and operable radiation survey instruments at each location where sources of radiation are present to make the radiation surveys required by 180 NAC 4 and 180 NAC 5. Instrumentation required by 180 NAC 5 must be capable of measuring a range from 0.02 millisieverts (2 mrem) per hour through 0.01 sievert (1 rem) per hour.
008.02 CALIBRATION REQUIREMENTS. The licensee or registrant must have each radiation survey instrument required under 180 NAC 5-008.01 calibrated:
(A) At energies appropriate for use and at intervals not to exceed six months or after instrument servicing, except for battery changes; (B) 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 3 points between 0.02 and 10 millisieverts (2 and 1000 mrem) per hour; and (C) So that an accuracy within plus or minus 20% of the true radiation dose rate can be demonstrated at each point checked.
008.03 RECORDS. The licensee or registrant must maintain records of the results of the instrument calibrations as required by 180 NAC 5-025.
009. LEAK TESTING AND REPLACEMENT OF SEALED SOURCES .
009.01 SEALED SOURCE REPLACEMENT. 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 to do so by the Department, NRC, or another Agreement State.
009.02 OPENING REPAIR OR MODIFICATION. The opening, repair, or modification of any sealed source must be performed by persons specifically authorized to do so by the Department, NRC, or another Agreement State.
009.03 LEAK TESTING AND RECORDKEEPING REQUIREMENTS.
(A) Each licensee who uses a sealed source must have the source tested for leakage at intervals not to exceed six months. The leak testing of the sources must be performed using a method approved by the Department, NRC, or by another 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 185 becquerel (0.005 μCi) of radioactive material on the test sample and must be performed by a person specifically authorized by the Department, NRC, or another Agreement State to perform the analysis. (B) The licensee must maintain records of the leak tests as required by 180 NAC 5-026. (C) 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.
009.04 LEAKING SOURCES. Any test conducted pursuant to 180 NAC 5-009.02 and 180 NAC 5-009.03 that reveals the presence of 185 becquerel (0.005 μCi) or more of removable radioactive material must be considered evidence that the sealed source is leaking. The licensee must immediately withdraw the equipment involved from use and must have it decontaminated and repaired or disposed of as required by Department regulations. A report must be filed with the Department within five days of any test with results that exceed the threshold in 180 NAC 5-009.04, describing the equipment involved, the test results, and the corrective action taken.
009.05 DEPLETED URANIUM LEAK TESTING. Each exposure device using depleted uranium shielding and an S-tube configuration must be tested for depleted uranium contamination at intervals not to exceed 12 months. The analysis must be capable of detecting the presence of 185 becquerel (0.005 μCi) of radioactive material on the test sample and must be performed by a person specifically authorized by the Department, NRC, or another Agreement State to perform the analysis. Should such testing reveal the presence of 185 becquerel (0.005 μCi) or more of 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 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 not in use and in storage. Before using or transferring such a device, however, the device must be tested for depleted uranium contamination, if the interval of storage exceeds 12 months. A record of the depleted uranium leak-test must be made as required by 180 NAC 5-026.
010. QUARTERLY INVENTORY .
010.01 PHYSICAL INVENTORY. Each licensee or registrant must conduct a quarterly physical inventory to account for all sources of radiation, and for devices containing depleted uranium received and possessed under the license.
010.02 RECORDS. The licensee or registrant must maintain records of the quarterly inventory as required by 180 NAC 5-027.
011. INSPECTION AND MAINTENANCE .
011.01 VISUAL AND OPERABILITY CHECKS. The licensee or registrant must perform visual and operability checks on survey meters, radiation machines, radiographic exposure devices, transport and storage containers, associated equipment and source changers before each day’s use, or work shift, to ensure that:
(A) The equipment is in good working condition; (B) The sources are adequately shielded; and (C) Required labeling is present.
011.02 SURVEY INSTRUMENT OPERABILITY. Survey instrument operability must be performed using check sources or other appropriate means.
011.03 EQUIPMENT PROBLEMS. If equipment problems are found during visual and operability checks, the equipment must be removed from service until repaired.
011.04 INSPECTION AND ROUTINE MAINTENANCE. Each licensee or registrant must have written procedures for and perform inspection and routine maintenance of radiation machines, 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. If equipment problems are found, the equipment must be removed from service until repaired.
011.05 PACKAGE PROCEDURES. The licensee’s inspection and maintenance program must include procedures to assure that Type B packages are shipped and maintained as specified in the certificate of compliance or other approval.
011.06 RECORDS. Records of equipment problems and of any maintenance performed under 180 NAC 5-011 must be made as required by 180 NAC 5-029.
011.07 TRANSPORT CONTAINER INSPECTION AND MAINTENANCE PROGRAM. 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 180 NAC 5-011 or equivalent NRC or Agreement State requirement, is deemed to satisfy the requirements of 180 NAC 13-007 and 180 NAC 13-021.
012. PERMANENT RADIOGRAPHIC INSTALLATIONS .
012.01 ENTRANCE. Each entrance that is used for personnel access to the high radiation area in a permanent radiographic installation must have either:
(A) An entrance control of the type described in 180 NAC 4-023.01(A) that causes the radiation level upon entry into the area to be reduced; or (B) Both conspicuous visible and audible warning signals to warn of the presence of radiation. The visible sign must be actuated by radiation whenever the source is exposed or the machine is energized. The audible signal must be actuated when an attempt is made to enter the installation while the source is exposed or the machine is energized.
012.02 ALARM SYSTEM TEST. 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 as designated in 180 NAC 5-012.01(A) 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 7 calendar days. The facility may continue to be used during this seven day period, provided the licensee or registrant implements the continuous surveillance requirements of 180 NAC 5-021 and uses an alarming ratemeter. Test records for entrance controls and audible and visual alarms must be maintained as required by 180 NAC 5-030.
013. LABELING, STORAGE, AND TRANSPORTATION .
013.01 LABELING. The licensee may not use a source changer or a container to store radioactive 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, that is, magenta, purple or black on a yellow background, having a minimum diameter of 25 mm, and the wording:
CAUTION* RADIOACTIVE MATERIAL NOTIFY CIVIL AUTHORITIES (or “NAME OF COMPANY”) *______________ or “DANGER”
013.02 TRANSPORT OF RADIOACTIVE MATERIAL. The licensee may not transport radioactive material unless the material is packaged, and the package is labeled, marked, and accompanied with appropriate shipping papers as required by 180 NAC 13.
013.03 SECURE DEVICE. Radiographic exposure devices, source changers, storage containers, and radiation machines, must be physically secured to prevent tampering or removal by unauthorized personnel. The licensee must store radioactive material in a manner that will minimize danger from explosion or fire.
013.04 SECURE TRANSPORT PACKAGE. The licensee must lock and physically secure the transport package containing radioactive material in the transporting vehicle to prevent accidental loss, tampering, or unauthorized removal.
013.05 TRANSPORT VEHICLE. The licensee or registrant’s name must be prominently displayed with a durable, clearly visible label or labels on both sides of all vehicles used to transport radioactive material or radiation machines for temporary job site use.
014. INDUSTRIAL RADIOGRAPHIC OPERATIONS .
014.01 RADIOGRAPHIC PERSONNEL. 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 180 NAC 5-016.03. The additional qualified individual must 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.
014.02 PERMANENT RADIOGRAPHIC INSTALLATION. All radiographic operations must be conducted in a permanent radiographic installation unless otherwise specifically authorized by the Department.
014.03 COLLIMATORS. Except when physically impossible, collimators must be used in industrial radiographic operations that use radiographic exposure devices that allow the source to be moved out of the device.
014.04 LAY-BARGE, OFFSHORE PLATFORM AND UNDERWATER RADIOGRAPHY. A licensee or registrant may conduct lay-barge, offshore platform, or underwater radiography only if procedures have been approved by the Department, NRC, or by another Agreement State.
015. RADIATION SAFETY OFFICER FOR INDUSTRIAL RADIOGRAPHY . The radiation safety officer must ensure that radiation safety activities are being performed as specified in approved procedures and regulatory requirements in the daily operation of the licensee’s or registrant’s program.
015.01 QUALIFICATIONS, TRAINING AND EXPERIENCE. The minimum qualifications, training, and experience for radiation safety officers for industrial radiography are as follows:
(A) Completion of the training and testing requirements of 180 NAC 5-016.01; (B) 2000 hours of hands-on experience as a qualified radiographer in industrial radiographic operations; and (C) Formal training in the establishment and maintenance of a radiation safety protection program.
015.02 ALTERNATIVE TRAINING AND EXPERIENCE. The Department will consider alternatives when the radiation safety officer has appropriate training and 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.
015.03 DUTIES AND AUTHORITIES. The specific duties and authorities of the radiation safety officer include:
(A) Establishing and overseeing all operating, emergency, and as low as reasonably achievable procedures as required by 180 NAC 4 and reviewing them regularly to ensure that they conform to Department regulations and the license or registration conditions; (B) Overseeing and approving the training program for radiographic personnel to ensure that appropriate and effective radiation protection practices are taught; (C) Ensuring that required radiation surveys and leak tests are performed and documented as specified in the regulations, including any corrective measures when levels of radiation exceed established limits; (D) Ensuring that personnel monitoring devices are calibrated, if applicable, and used properly; that records are kept of the monitoring results; and that timely notifications are made as required by 180 NAC 4; and (E) Ensuring that operations are conducted safely and for implementing corrective actions including terminating operations.
016. TRAINING .
016.01 RADIOGRAPHER. The licensee or registrant may not permit any individual to act as a radiographer until the individual:
(A) Has received at least 40 hours of training in the subjects in 180 NAC 5-016.07, in addition to on-the-job training consisting of hands-on experience under the supervision of a radiographer and is certified through a radiographer certification program by a certifying entity according to the criteria specified in Appendix A of 180 NAC 5. The on-the-job training must include a minimum of two months (320 hours) of active participation in the performance of industrial radiography utilizing radioactive material or one month (160 hours) of active participation in the performance of industrial radiography utilizing radiation machines, or both. Individuals performing industrial radiography utilizing radioactive materials and radiation machines must complete both segments of the on-the-job training totaling three months (480 hours).
016.02 ADDITIONAL REQUIREMENTS. In addition, the licensee or registrant may not permit any individual to act as a radiographer until the individual has:
(A) Received copies and instruction in the requirements described in the regulations contained in 180 NAC 5, and applicable chapters of 180 NAC 4, 10, and 13, in the license or registration under which the radiographer will perform industrial radiography, and the licensee’s or registrant’s operating and emergency procedures; (B) Demonstrated an understanding of items in 180 NAC 5-016.02(A) by successful completion of a written or oral examination; (C) Received training in the use of the registrant’s radiation machines, or 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 (D) Demonstrated understanding of the use of the equipment described in 180 NAC 5-016.02(C) by successful completion of a practical examination.
016.03 RADIOGRAPHER’S ASSISTANT. The licensee or registrant may not permit any individual to act as a radiographer’s assistant until the individual has:
(A) Received copies of and instruction in the requirements described in the regulations contained in 180 NAC 5, and applicable 180 NAC 4, 10, and 13, in the license or registration under which the radiographer’s assistant will perform industrial radiography, and the licensee’s or registrant’s operating and emergency procedures; (B) Demonstrated an understanding of items 180 NAC 5-016.03(A) by successful completion of a written or oral examination; (C) Received training to use, under the personal supervision of a radiographer, the registrant’s radiation machines, or the licensee’s radiographic exposure devices and sealed sources, in the daily inspection of devices and associated equipment, and radiation survey instruments the assistant will use; and (D) Demonstrated understanding of the use of the equipment described in 180 NAC 5-016.03(C) by successful completion of a practical examination.
016.04 ANNUAL REFRESHER SAFETY TRAINING. The licensee or registrant must provide annual refresher safety training for each radiographer and radiographer’s assistant at intervals not to exceed 12 months.
016.05 JOB PERFORMANCE INSPECTION PROGRAM. Except as provided in 180 NAC 5-016.05(C), the radiation safety officer or designee must conduct an inspection program of the job performance of each radiographer and radiographer’s assistant to ensure that the Department’s regulations, license requirements, and the applicant’s operating and emergency procedures are followed.
(A) The inspection program must:
(i) 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 (ii) 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 180 NAC 5-016.02(C) and the radiographer’s assistant must demonstrate knowledge of the training requirements of 180 NAC 5-016.03(C) by a practical examination before these individuals can next participate in a radiographic operation;
(B) The Department must approve alternative methods in situations where the individual serves as both radiographer and radiation safety officer; and (C) In those operations where a single individual serves as both radiographer and radiation safety officer, and performs all radiography operations, an inspection program is not required.
016.06 TRAINING RECORDS. The licensee or registrant must maintain records of the above training to include certification documents, written, oral and practical examinations, refresher safety training and inspections of job performance required by 180 NAC 5-031.
016.07 TRAINING SUBJECT. The licensee or registrant must include the following subjects:
(A) Fundamentals of radiation safety including:
(i) Characteristics of gamma and x-radiation; (ii) Units of radiation dose and quantity of radioactivity; (iii) Hazards of exposure to radiation; (iv) Levels of radiation from sources of radiation; and (v) Methods of controlling radiation dose (time, distance, and shielding);
(B) Radiation detection instruments including:
(i) Use, operation, calibration, and limitations of radiation survey instruments; (ii) Survey techniques; and (iii) Use of personnel monitoring equipment;
(C) Equipment to be used including:
(i) Operation and control of radiographic exposure equipment, remote handling equipment, and storage containers, including pictures or models of source assemblies (pigtails); (ii) Operation and control of radiation machines; (iii) Storage, control, and disposal of sources of radiation; and (iv) Inspection and maintenance of equipment;
(D) The requirements of pertinent state and federal regulations; and
(E) Case histories of accidents in radiography.
016.08 RADIOGRAPHER CERTIFICATION RECORDS. Records of radiographer certification maintained as required by 180 NAC 5-031 are to provide documentation of certification requirements specified in180 NAC 5-016.01.
017. OPERATING AND EMERGENCY PROCEDURES .
017.01 CONTENT. Operating and emergency procedures must include, as a minimum, instructions in the following:
(A) Appropriate handling and use of sources of radiation so that no person is likely to be exposed to radiation doses in excess of the limits established in 180 NAC 4; (B) Methods and occasions for conducting radiation surveys; (C) Methods of posting and controlling access to radiographic areas; (D) Methods and occasions for locking and securing sources of radiation; (E) Personnel monitoring and the use of personnel monitoring equipment; (F) Transporting equipment to field locations, including packing of radiographic exposure devices and storage containers in the vehicles, placarding of vehicles when needed, and control of the equipment during transportation as described in 180 NAC 13; (G) The inspection, maintenance, and operability checks of radiographic exposure devices, radiation machines, survey instruments, alarming ratemeters, transport containers, and storage containers; (H) Steps that must be taken immediately by radiography personnel in the event a pocket dosimeter is found to be off-scale or an alarming ratemeter alarms unexpectedly; (I) The procedure for identifying and reporting defects and noncompliance, as required by 180 NAC 5-037; (J) The procedure for notifying proper persons in the event of an accident or incident; (K) Minimizing exposure of persons in the event of an accident or incident, including a source disconnect, a transport accident, or loss of a source of radiation; (L) Source recovery procedure if licensee will perform source recoveries; and (M) Maintenance of records.
017.02 MAINTENANCE. The licensee or registrant must maintain copies of current operating and emergency procedures as required by 180 NAC 5-032 and 180 NAC 5-036.
018. SUPERVISION OF RADIOGRAPHERS’ ASSISTANTS . The radiographer’s assistant must be under the personal supervision of a radiographer when using sources of radiation or conducting radiation surveys required by 180 NAC 5-020 (B) to determine that the sealed source has returned to the shielded position or the radiation machine is off after an exposure. The personal supervision must include:
(A) The radiographer’s physical presence at the site where the sources of radiation 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 180 NAC 5-018.
019. PERSONNEL MONITORING .
019.01 DIRECT READING DOSIMETER, ALARMING RATE METER AND PERSONNEL DOSIMETER. The licensee or registrant 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 alarming ratemeter, and a personnel dosimeter. At permanent radiography installations where other appropriate alarming or warning devices are in routine use, the use of an alarming ratemeter is not required.
(A) Pocket dosimeters must have a range from zero to 2 millisieverts (200 mrem) and must be recharged at the start of each shift. Electronic personal dosimeters may only be used in place of ion-chamber pocket dosimeters. (B) Each personnel dosimeter must be assigned to and worn by only one individual; (C) 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.
019.02 BEGINNING AND END OF SHIFT. 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 as required by 180 NAC 5-033.
019.03 RESPONSE TO RADIATION CHECK. Pocket dosimeters, or electronic personal dosimeters, must be checked at periods not to exceed 12 months for correct response to radiation, and records must be maintained as required by 180 NAC 5-033. Acceptable dosimeters must read within plus or minus 20% of the true radiation exposure.
019.04 PERSONNEL DOSIMETER PROCESSING. If an individual’s pocket chamber is found to be off-scale, or if the individual’s electronic personal dosimeter reads greater than 2 millisieverts (200 mrem), and the possibility of radiation exposure cannot be ruled out as the cause, the individual’s personnel dosimeter must be sent for processing and evaluation within 24 hours. For personnel dosimeters that do not require processing, evaluation of the dosimeter must be started within 24 hours. In addition, the individual may not resume work associated with licensed material use until a determination of the individual’s radiation dose 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 as required by 180 NAC 5-033.
019.05 LOST OR DAMAGED PERSONNEL DOSIMETER. If the personnel dosimeter that is required by 180 NAC 5-019 is lost or damaged, the worker must cease work immediately until a replacement personnel dosimeter meeting the requirements of 180 NAC 5-019 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 as required by 180 NAC 5-033.
019.06 RECORD RETENTION. Dosimetry results must be retained as required by 180 NAC 5-033.
019.07 ALARMING RATEMETER. Each alarming ratemeter must:
(A) Be checked to ensure that the alarm functions properly before using at the start of each shift; (B) Be set to give an alarm signal at a preset dose rate of 5 millisieverts per hour (500 mrem/hr); with an accuracy of plus or minus 20% of the true radiation dose rate; (C) Require special means to change the preset alarm function; and (D) Be calibrated at periods not to exceed 12 months for correct response to radiation. The licensee must maintain records of alarming ratemeter calibrations as required by 180 NAC 5-033.
020. RADIATION SURVEYS . The licensee or registrant must:
(A) Conduct all surveys with a calibrated and operable radiation survey instrument that meets the requirements of 180 NAC 5-008; (B) Conduct a survey of the radiographic exposure device and guide tube after each exposure when approaching the device or the guide tube. The survey must determine that a sealed source has returned to its shielded position before exchanging films, repositioning the exposure head, or dismantling equipment. Radiation machines must be surveyed after each exposure to determine that the machine is off; (C) Conduct a survey of the radiographic exposure device whenever the source is exchanged and whenever a radiographic exposure devices is placed in a storage area as defined in 180 NAC 5-002, to ensure that the sealed source is in its shielded position; and (D) Maintain records as required by 180 NAC 5-034.
021. SURVEILLANCE . During each radiographic operation, the radiographer must ensure continuous direct visual surveillance of the operation to protect against unauthorized entry into a radiation area or a high radiation area, as defined in 180 NAC 1 except at permanent radiographic installations where all entryways are locked and the requirements of 180 NAC 5-012 are met.
022. POSTING . All areas where industrial radiography is being performed must be conspicuously posted as required by 180 NAC 4-034. The exceptions listed in 180 NAC 4-035 do not apply to industrial radiographic operations.
023. RECORDS FOR INDUSTRIAL RADIOGRAPHY . Each licensee or registrant must maintain a copy of its license or registration, documents incorporated by reference, and amendments to each of these items until superseded by new documents approved by the Department, or until the Department terminates the license or registration.
024. RECORDS OF RECEIPT AND TRANSFER OF SOURCES OF RADIATION . Each licensee or registrant must maintain records showing the receipts and transfers of sealed sources, devices for using depleted uranium for shielding, and radiation machines, and retain each record for three years after it is made. Records must include:
(A) The date; (B) Name of individual making the record; (C) Radionuclide; (D) Number of becquerels or curies, or mass of depleted uranium in each device; and (E) Manufacturer, model, and serial number of each source of radiation or device, or both, as appropriate.
025. RECORDS OF RADIATION SURVEY INSTRUMENTS . Each licensee or registrant must maintain records of the calibrations of its radiation survey instruments that are required under 180 NAC 5-008 and retain each record for three years after it is made.
026. RECORDS OF LEAK TESTING OF SEALED SOURCES AND DEVICES CONTAINING DEPLETED URANIUM . Each licensee must maintain records of leak test results for sealed sources and for devices containing depleted uranium. The results must be stated in units of becquerels or microcuries. The licensee must retain each record for three years after it is made or until the source in storage is removed.
027. RECORDS OF QUARTERLY INVENTORY . Each licensee or registrant must maintain records of the quarterly inventory of sources of radiation, including devices containing depleted uranium as required by 180 NAC 5-010, and retain each record for three years from the date of inventory. The record must include the date of the inventory and the information required by 180 NAC 5-024(B) through (E).
028. UTILIZATION LOGS . Each licensee or registrant must maintain utilization logs and retain the logs for three years after the log is made. The log for each source of radiation must include:
(A) A description, including the make, model, and serial number of the radiation machine or the radiographic exposure device, transport, or storage container in which the sealed source is located; (B) The identity and signature of the radiographer to whom assigned; (C) The location and dates of use, including the dates removed and returned to storage; and (D) For permanent radiographic installations, the dates each radiation machine is energized.
029. RECORDS OF INSPECTION AND MAINTENANCE OF RADIATION MACHINES, RADIOGRAPHIC EXPOSURE DEVICES, TRANSPORT, AND STORAGE CONTAINERS, ASSOCIATED EQUIPMENT, SOURCE CHANGERS, AND SURVEY INSTRUMENTS . Each licensee or registrant must maintain records specified in 180 NAC 5-011 of equipment problems found in daily checks and quarterly inspections of radiation machines, 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:
(A) The check or inspection date; (B) Name of inspector; (C) Equipment involved; (D) Any problems found; and (E) Any repair or maintenance performed.
030. RECORDS OF ALARM SYSTEM AND ENTRANCE CONTROL CHECKS AT PERMANENT RADIOGRAPHIC INSTALLATIONS . Each licensee or registrant must maintain records of alarm systems and entrance control device tests required by 180 NAC 5-012 and retain each record for three years after the record is made.
031. RECORDS OF TRAINING AND CERTIFICATION . Each licensee or registrant must maintain the following records for three years after the record was made:
(A) 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, names of individuals conducting and receiving the oral and practical examinations, and a list of items tested and the results of the oral and practical examinations; and (B) 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 non-compliance observed by the radiation safety officer or designee.
032. COPIES OF OPERATING AND EMERGENCY PROCEDURES . Each licensee or registrant must maintain a copy of current operating and emergency procedures until the Department terminates the license or registration. Superseded material must be retained for three years after the change is made.
033. RECORDS OF PERSONNEL MONITORING . Each licensee or registrant must maintain the following exposure records specified in 180 NAC 5-019:
(A) Direct reading dosimeter readings and yearly operability checks required by 180 NAC 5-019.02 and 5-019.03 for three years after the record is made; (B) Records of alarming ratemeter calibrations three years after the record is made; (C) Personnel dosimeter results until the Department terminates the license or registration; and (D) Records of estimates of exposures as a result of off-scale personal direct reading dosimeters, or loss of damaged personnel dosimeters until the Department terminates the license or registration.
034. RECORDS OF RADIATION SURVEYS . Each licensee must maintain a record of each exposure device survey conducted before the device is placed in storage as specified in 180 NAC 5-020(C). Each record must be maintained for three years after the record is made.
035. FORM OF RECORDS . Each record required by 180 NAC 5 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 of 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 or registrant must maintain adequate safeguards against tampering with and the loss of records.
036. LOCATION OF DOCUMENTS AND RECORDS . Each licensee or registrant must maintain copies of records required by 180 NAC 5 and other applicable chapters of Title 180 at the location or locations specified in the application.
036.01 ADDITIONAL REQUIREMENTS. Each licensee or registrant must also maintain current copies of the following documents and records sufficient to demonstrate compliance at each applicable field station and each temporary jobsite:
(A) The license or registration authorizing the use of sources of radiation; (B) A copy of 180 NAC 1, 4, 5, and 10; (C) Utilization logs for each source of radiation dispatched from the location as required by 180 NAC 5-028; (D) Records of equipment problems identified in daily checks of equipment as required by 180 NAC 5-029; (E) Records of alarm system and entrance control checks required by 180 NAC 5-030, if applicable; (F) Records of dosimeter readings as required by 180 NAC 5-033; (G) Operating and emergency procedures required by 180 NAC 5-032; (H) Evidence of the latest calibrations and of radiation survey instruments in use at the site, as required by 180 NAC 5-025; (I) Evidence of the latest calibrations of alarming ratemeters and operability checks of dosimeters as required by 180 NAC 5-033; (J) Survey records as required by 180 NAC 5-034 and 180 NAC 4-049 as applicable, for the period of operation at that site; (K) The shipping papers for the transportation of radioactive materials required by 180 NAC 013; and (L) When operating under reciprocity pursuant to 180 NAC 3 or registration pursuant to 180 NAC 2, a copy of the applicable state license or registration, or NRC license authorizing the use of sources of radiation.
037. NOTIFICATIONS .
037.01 WRITTEN REPORT. In addition to the reporting requirements specified in 180 NAC 3-026 and 180 NAC 4, each licensee or registrant must provide a written report to the Department within 30 days of the occurrence of any of the following incidents involving radiographic equipment:
(A) Unintentional disconnection of the source assembly from the control cable; (B) Inability to retract the source assembly to its fully shielded position and secure it in this position; (C) Failure of any component, which is critical to safe operation of the device, to properly perform its intended function; or (D) An indicator on a radiation machine fails to show that radiation is being produced, an exposure switch fails to terminate production of radiation when turned to the off position, or a safety interlock fails to terminate x-ray production.
037.02 WRITTEN REPORT CONTENT. The licensee or registrant must include the following information in each report submitted under 180 NAC 5-037.01, and in each report of overexposure submitted under 180 NAC 4-060 which involves failure of safety components of radiography equipment:
(A) Description of the equipment problem; (B) Cause of each incident, if known; (C) Name of the manufacturer and model number of equipment involved in the incident; (D) Place, date, and time of the incident; (E) Actions taken to establish normal operations; (F) Corrective actions taken or planned to prevent recurrence; and (G) Names and qualifications of personnel involved in the incident.
037.03 LIMITATIONS. Any licensee or registrant conducting radiographic operations or storing sources of radiation at any location not listed on the license or registration for a period in excess of 180 days in a calendar year, must notify the Department prior to exceeding the 180 days.
038. RECIPROCITY . Licensees requesting reciprocal recognition of a license must meet the requirements of 180 NAC 3-028.
038.01 INDIVIDUAL RADIOGRAPHER CERTIFICATION. Applicants requesting reciprocal recognition of an individual radiographer certification must ensure that:
(A) The individual holds a valid certification in the appropriate category issued by a certifying entity, as defined in 180 NAC 5-002; (B) The requirements and procedures of the certifying entity issuing the certification affords the same or comparable certification standards as those afforded by 180 NAC 5-016.01; (C) The applicant presents the certification to the Department prior to the entry into the state; and (D) No escalated enforcement action is pending with the NRC or in any other state.
038.02 EXPIRATION OF CERTIFICATION. Certified individuals who are granted reciprocity by the Department must maintain the certification upon which the reciprocal recognition was granted, or prior to the expiration of such certification, must met the requirements of 180 NAC 5-016.01.
039. SPECIFIC REQUIREMENTS FOR RADIOGRAPHIC PERSONNEL PERFORMING INDUSTRIAL RADIOGRAPHY .
039.01 JOB SITE REQUIREMENTS. At a job site, the following must be supplied by the licensee or registrant:
(A) At least one operable, calibrated survey instrument for each exposure device or radiation machine in use; (B) A current whole body personnel dosimeter for each person performing radiographic operations; (C) An operable, calibrated pocket dosimeter with a range of zero to 200 milliroentgens for each person performing radiographic operations; (D) An operable, calibrated, alarming ratemeter for each person performing radiographic operations using a radiographic exposure device; and (E) The appropriate barrier ropes and signs.
039.02 IDENTIFICATION CARD. Each radiographer at a job site must have on their person a valid certification identification card issued by a certifying entity.
039.03 LIMITATIONS. Industrial radiographic operations must not be performed if any of the items in 180 NAC 5-039.01 and 5-039.02 are not available at the job site or are inoperable.
APPENDIX A
I. REQUIREMENTS FOR AN INDEPENDENT CERTIFYING ORGANIZATION. An independent certifying organization must:
(A) Be an organization such as a society or association, whose members participate in, or have an interest in, the field of industrial radiography;
(B) Make its membership available to the general public nationwide. Membership must not be restricted because of race, color, religion, sex, age, national origin, or disability;
(C) Have a certification program open to nonmembers, as well as members;
(D) Be an incorporated, nationally recognized organization that is involved in setting national standards of practice within its field of expertise;
(E) Have an adequate staff, a viable system for financing its operations, and a policy and decision-making review board;
(F) Have a set of written organizational by-laws and policies that provide adequate assurance of lack of conflict of interest and a system for monitoring and enforcing those by-laws and policies;
(G) Have a committee, whose members can carry out their responsibilities impartially, to review and approve the certification guidelines and procedures, and to advise the organization’s staff in implementing the certification program;
(H) Have a committee, whose members can carry out their responsibilities impartially, to review complaints against certified individuals and to determine appropriate sanctions;
(I) Have written procedures describing all aspects of its certification program, maintain records of the current status of each individual’s certification and the administration of its certification program;
(J) Have procedures to ensure that certified individuals are provided due process with respect to the administration of its certification program, including the process of becoming certified and any sanctions imposed against certified individuals;
(K) Have procedures for proctoring examinations, including qualifications for proctors. These procedures must ensure that the individuals proctoring each examination are not employed by the same company or corporation (or a wholly-owned subsidiary of such company or corporation) as any of the examinees;
(L) Exchange information about certified individuals with the U.S. Nuclear Regulatory Commission (NRC) and other independent certifying organizations and Agreement States and allow periodic review of its certification program and related records; and
(M) Provide a description to the NRC of its procedures for choosing examination sites and for providing an appropriate examination environment.
II. REQUIREMENTS FOR CERTIFICATION PROGRAMS. All certification programs must:
(A) Require applicants for certification to:
(i) Receive training in the topics set forth in 180 NAC 5-016.07 or equivalent Agreement State or NRC regulations, and
(ii) Satisfactorily complete a written examination covering these topics;
(B) Require applicants for certification to provide documentation that demonstrates that the applicant has:
(i) Received training in the topics set forth in 180 NAC 5-016.07 or equivalent Agreement State or NRC regulations; (ii) Satisfactorily completed a minimum period of on-the-job training as specified in180 NAC 5-016.01; and (iii) Received verification by an Agreement State licensee or registrant or an NRC licensee that the applicant has demonstrated the capability of independently working as a radiographer;
(C) Include procedures to ensure that all examination questions are protected from disclosure;
(D) Include procedures for denying an application and revoking, suspending, and reinstating a certification;
(E) Provide a certification period of not less than three years nor more than five years;
(F) Include procedures for renewing certifications and, if the procedures allow renewals without examination, require evidence of recent full-time employment and annual refresher training; and
(G) Provide a timely response to inquiries, by telephone or letter, from members of the public, about an individual’s certification status.
III. REQUIREMENTS FOR WRITTEN EXAMINATIONS. All examinations must:
(A) Be designed to test an individual’s knowledge and understanding of the topics listed in 180 NAC 5-016.07 or equivalent Agreement State or NRC requirements;
(B) Be written in multiple-choice format; and
(C) Have test items drawn from a question bank containing psychometrically valid questions based on the material in 180 NAC 5-016.07.
History
- Effective 2023-06-14
Chapter 6 Diagnostic X-Rays in the Healing Arts
Neb. Admin. Code tit. 180, ch. 6 Diagnostic X-Rays in the Healing Arts {#sec-180-nac-6 omnilex-key=us-ne-regs-official--title-180--180 NAC 6}
Effective Date: 11/4/2020
001. SCOPE AND AUTHORITY . This chapter establishes requirements for the use of diagnostic x-ray equipment and imaging systems by or under the supervision of an individual authorized by and licensed according to State statutes to engage in the healing arts, dental healing arts, or veterinary medicine. The regulations are authorized by and implement the Nebraska Radiation Control Act, Nebraska Revised Statute (Neb. Rev. Stat.) §§ 71-3501 to 71-3520. The requirements of this chapter are in addition to, and not in substitution for, other applicable provisions of 180 NAC 1, 2, 4, 9, 10, 15, 18, and 20.
001.01 PART 21 CODE OF FEDERAL REGULATIONS. Part 21 Code of Federal Regulations (CFR) as published on April 1, 2017 and referred throughout this Chapter are incorporated by reference and available for viewing at the Department of Health and Human Services, Division of Public Health, Radiological Health, 301 Centennial Mall South, 3rd Floor, Lincoln, Nebraska 68509.
002. DEFINITIONS . The following definitions apply:
002.01 AIR KERMA RATE (AKR). Air kerma rate (AKR) has the same meaning as set out in 21 CFR §1020.30(b).
002.02 ALUMINUM EQUIVALENT. Aluminum equivalent has the same meaning as set out in 21 CFR §1020.30(b).
002.03 AUTOMATIC EXPOSURE CONTROL (AEC). Automatic exposure control (AEC) has the same meaning as set out in 21 CFR §1020.30(b).
002.04 BARRIER. See “Protective barrier”.
002.05 BEAM-LIMITING DEVICE. Beam-limiting device has the same meaning as set out in 21 CFR §1020.30(b).
002.06 BONE DENSITOMETRY SYSTEMS. A bone densitometry system is a medical device which uses electronically-produced ionizing radiation to determine the density of bone structures of human patients.
002.07 C-ARM FLUOROSCOPIC SYSTEM. C-arm fluoroscopic system has the same meaning as set out in 21 CFR §1020.30(b).
002.08 CASSETTE HOLDER. Cassette holder has the same meaning as set out in 21 CFR §1020.30(b).
002.09 COEFFICIENT OF VARIATION OR "C". Coefficient of variation or “C” has the same meaning as set out in 21 CFR §1020.30(b).
002.10 COMPUTED TOMOGRAPHY. Computed tomography has the same meaning as set out in 21 CFR §1020.30(b).
002.11 CONE BEAM COMPUTED TOMOGRAPHY (CBCT). Cone beam computed tomography (CBCT) is a volumetric imaging modality. Volumetric data are acquired using two dimensional digital detector arrays, and a cone-shaped x-ray beam that rotates around the patient. Reconstruction algorithms can be used to generate images of any desired plane.
002.12 CONTINUOUS PRESSURE SWITCH. A continuous pressure switch is a switch constructed so that a circuit closing contact can be maintained only by continuous pressure on the switch by the operator.
002.13 CONTROL PANEL. Control panel has the same meaning as set out in 21 CFR §1020.30(b).
002.14 COOLING CURVE. Cooling curve has the same meaning as set out in 21 CFR §1020.30(b).
002.15 DENTAL RADIATION GENERATING EQUIPMENT. Dental radiation generating equipment is equipment specifically used for making dental radiographs of the human teeth or tissues or the oral cavity. Dental radiographic equipment does not include dental tomography, dental computed tomography, cone beam dental computed tomography, dental fluoroscopic equipment, or rotating anode tube radiation generating equipment.
002.16 DIAGNOSTIC X-RAY SYSTEM. Diagnostic x-ray system has the same meaning as set out in 21 CFR §1020.30(b).
002.17 EQUIPMENT. See "X-ray equipment".
002.18 EXPOSURE (X). Exposure or “X” has the same meaning as set out in 21 CFR §1020.30(b).
002.19 FACILITY. A facility is the location at which one or more radiation generating devices or sources of radiation are installed or located within one building, vehicle, or under one roof and are under the same administrative control.
002.20 FILTER. A filter is material placed in the useful beam to preferentially absorb selected radiations.
002.21 FLUOROSCOPY. Fluoroscopy has the same meaning as set out in 21 CFR §1020.30(b).
002.22 GENERAL PURPOSE RADIOGRAPHIC X-RAY SYSTEM. General purpose x-ray system has the same meaning as set out in 21 CFR §1020.30(b).
002.23 GONAD SHIELD. A gonad shield is a protective barrier for the testes or ovaries.
002.24 HAND HELD X-RAY EQUIPMENT. Hand held x-ray equipment is equipment that is designed to be hand-held during operation.
002.25 HEALING ARTS SCREENING. A healing arts screening is the testing of human beings using x-ray machines for the detection or evaluation of health indications when such tests are not specifically and individually ordered by a licensed practitioner of the healing arts legally authorized to prescribe x-ray tests for the purpose of diagnosis or treatment.
002.26 IMAGE INTENSIFIER. Image intensifier has the same meaning as set out in 21 CFR §1020.30(b).
002.27 IMAGE RECEPTOR. Image receptor has the same meaning as set out in 21 CFR §1020.30(b).
002.28 INTERIM INSPECTION. An interim inspection is an examination by the Department of information submitted by the registrant on a form provided by the Department.
002.29 INTERPRETATIVE FLUOROSCOPIC PROCEDURES. See Neb. Rev. Stat. §38-1904.
002.30 IRRADIATION. Irradiation is the exposure of matter to ionizing radiation.
002.31 KERMA. Kerma has the same meaning as set out in 21 CFR §1020.30(b).
002.32 KILOVOLTS PEAK (KVP). See "Peak tube potential".
002.33 LEAD EQUIVALENT. Lead equivalent is the thickness of lead affording the same attenuation, under specified conditions, as the material in question.
002.34 MOBILE X-RAY EQUIPMENT. See “X-ray equipment”.
002.35 NON-IMAGE-INTENSIFIED FLUOROSCOPY. Non-image-intensified fluoroscopy has the same meaning as set out in 21 CFR §1020.30(b).
002.36 PATIENT. A patient is an individual subjected to healing arts examination, diagnosis, or treatment.
002.37 PEAK TUBE POTENTIAL. Peak tube potential has the same meaning as set out in 21 CFR §1020.30(b).
002.38 PHANTOM. A phantom is a volume of material behaving in a manner similar to tissue with respect to the attenuation and scattering of radiation. This requires that both the atomic number, Z, and the density of the material be similar to that of tissue.
002.39 PORTABLE X-RAY EQUIPMENT. See “X-ray equipment”.
002.40 POSITION INDICATING DEVICE (PID). A position indicating device (PID) is a device on dental x-ray equipment used to indicate the beam position and to establish a definite source-surface of the skin distance. It may or may not incorporate, or serve as, a beam-limiting device.
002.41 PRIMARY PROTECTIVE BARRIER. Primary protective barrier has the same meaning as set out in 21 CFR §1020.30(b).
002.42 PROTECTIVE APRON. A protective apron is an apron made of radiation absorbing materials used to reduce radiation exposure.
002.43 PROTECTIVE GLOVE. A protective glove is a glove made of radiation absorbing materials used to reduce radiation exposure.
002.44 QUALIFIED EXPERT. A qualified expert is an individual who meets the requirements of 180 NAC 15-004.03.
002.45 RADIATION THERAPY SIMULATION SYSTEM. Radiation therapy simulation system has the same meaning as set out in 21 CFR §1020.30(b).
002.46 RADIOGRAPH. A radiograph is an image receptor on which the image is created directly or indirectly by an x-ray pattern and results in a permanent record.
002.47 RADIOGRAPHY. Radiography has the same meaning as 21 CFR §1020.30(b).
002.48 RADIOLOGICAL MEDICAL PHYSICIST. A radiological medical physicist is an individual who meets the requirements of 180 NAC 15-004.01.
002.49 RADIOLOGICAL HEALTH PHYSICIST. A radiological health physicist is an individual who meets the requirements of 180 NAC 15-004.02.
002.50 RATING. Rating has the same meaning as set out in 21 CFR §1020.30(b).
002.51 RECORDING. Recording has the same meaning as set out in 21 CFR §1020.30(b).
002.52 SCAN. Scan has the same meaning as set out in 21 CFR §1020.30(b).
002.53 SCAN TIME. Scan time has the same meaning as set out in 21 CFR §1020.30(b).
002.54 SCATTERED RADIATION. Scattered radiation is radiation that during passage through matter has been deviated in direction.
002.55 SHUTTER. A shutter is a device attached to the tube housing assembly which can intercept the entire cross sectional area of the useful beam and has a lead equivalency not less than that of the tube housing assembly.
002.56 SOURCE. Source has the same meaning as set out in 21 CFR §1020.30(b).
002.57 SOURCE-IMAGE RECEPTOR DISTANCE (SID). Source-image receptor distance (SID) has the same meaning as set out in 21 CFR §1020.30(b).
002.58 SOURCE-SKIN DISTANCE (SSD). Source-skin distance has the same meaning as set out in 21 CFR §1020.30(b).
002.59 SPOT CHECK. A spot check procedure is a procedure which is performed to assure that a previous calibration continues to be valid.
002.60 STATIONARY X-RAY EQUIPMENT. See “X-ray equipment”.
002.61 STRAY RADIATION. Stray radiation is the sum of leakage and scattered radiation.
002.62 TECHNIQUE FACTORS. Technique factors has the same meaning as set out in 21 CFR §1020.30(b).
002.63 TOMOGRAM. Tomogram has the same meaning as set out in 21 CFR §1020.30(b).
002.64 TOMOGRAPHIC PLANE. Tomographic plane has the same meaning as set out in 21 CFR §1020.33(b)(18).
002.65 TRACEABLE TO A NATIONAL STANDARD. Traceable to a national standard means a quantity or a measurement has been compared to a national standard directly or indirectly through one or more intermediate steps and that all comparisons have been documented.
002.66 TUBE. Tube has the same meaning as set out in 21 CFR §1020.30(b).
002.67 TUBE HOUSING ASSEMBLY. Tube housing assembly has the same meaning as set out in 21 CFR §1020.30(b).
002.68 TUBE RATING CHART. Tube rating chart has the same meaning as set out in 21 CFR §1020.30(b).
002.69 USEFUL BEAM. Useful beam has the same meaning as set out in 21 CFR §1020.30(b).
002.70 X-RAY CONTROL. X-ray control has the same meaning as set out in 21 CFR §1020.30(b).
002.71 X-RAY EXPOSURE CONTROL. X-ray exposure control is a device, switch, button or other similar means that an operator initiates or terminates the radiation exposure. The x-ray exposure control may include other associated equipment.
002.72 X-RAY EQUIPMENT. X-ray equipment has the same meaning as set out in 21 CFR §1020.30(b).
002.73 X-RAY FIELD. X-ray field has the same meaning as set out in 21 CFR §1020.30(b).
002.74 X-RAY SYSTEM. X-ray system has the same meaning as set out in 21 CFR §1020.30(b).
002.75 X-RAY TUBE. X-ray tube has the same meaning as set out in 21 CFR §1020.30(b).
003. ADMINISTRATIVE CONTROLS . The registrant is responsible for directing the operation of the x-ray system or systems under the registrant’s administrative control. The registrant or registrant’s agent must assure that requirements of 180 NAC 6-003 are met in the operation of the x-ray system or systems.
003.01 HEALING ARTS USES OF X-RAY EQUIPMENT. The use of x-ray equipment for the intentional exposure of individuals for diagnosis or treatment must be by or under the supervision of one licensed to practice the healing arts in Nebraska.
003.02 VETERINARY USES OF X-RAY EQUIPMENT. The use of x-ray equipment in the practice of veterinary medicine must be by or under the supervision of an individual licensed to practice veterinary medicine in the State of Nebraska.
003.03 DENTAL USES OF X-RAY EQUIPMENT. The use of x-ray equipment for the exposure of individuals for dental diagnosis or treatment must be by or under the supervision of one licensed to practice dentistry in Nebraska.
003.04 X-RAY SYSTEM REQUIREMENTS. An x-ray system which does not meet the requirements of Title 180 must not be operated for diagnostic purposes.
003.05 OPERATOR REQUIREMENTS. Registrants must only allow individuals to operate:
(A) X-ray systems under the direction of healing arts practitioners who meet the requirements as specified in Neb. Stat. Rev. §§ 38-1901 to 1920, Medical Radiography Practice Act; and (B) Dental x-ray systems who meet the requirements as specified in Neb. Rev. Stat. § 38-1131 to practice as dental hygienists, or Neb. Rev. Stat. § 38-1135 to practice as dental assistants.
003.06 TECHNIQUE CHART. A technique chart must be provided in the vicinity of the diagnostic x-ray system's control panel.
003.06(A) DIAGNOSTIC X-RAY EQUIPMENT. Except for dental radiation generating systems, a technique chart must include the following information for all examinations performed with that system:
(i) Patient's body part and anatomical size, or body part thickness, or age, for pediatrics; (ii) Technique factors; (iii) Type and focal distance of the grid to be used, if any; (iv) Source to image receptor distance (SID) to be used; (v) Type and location of placement of gonad shielding to be used; and (vi) Type and size of the film or film-screen combination to be used.
003.06(B) DENTAL RADIATION GENERATING EQUIPMENT. Registrants using dental radiation generating equipment must have a technique chart displayed in the vicinity of the x-ray machine’s control panel.
003.07 WRITTEN SAFETY PROCEDURES. The registrant must create and make available to x-ray operators written safety procedures, to include patient holding and any restriction of the operating technique required for the safe operation of the particular x-ray system. The operator must be able to demonstrate familiarity with these procedures.
003.08 INDIVIDUALS PRESENT DURING A RADIOGRAPHIC EXPOSURE. Except for patients who cannot be moved out of the room only the staff, ancillary personnel, or other persons required for the medical procedure or training may be in the room during the radiographic exposure. Other than the patient being examined:
(A) Each individual must be positioned so that no part of the body will be struck by the useful beam unless protected by not less than 0.5 millimeter lead equivalent; (B) The x-ray operator, other staff, ancillary personnel, and other persons required for the medical procedure must be protected from the direct scatter radiation by protective aprons or whole body protective barriers of not less than 0.25 millimeter lead equivalent; and (C) Human patients who cannot be removed from the room must be protected from the direct scatter radiation by whole body protective barriers of not less than 0.25 millimeter lead equivalent or must be positioned so the nearest portion of the body is at least 2 meters from both the tube head and the nearest edge of the image receptor.
003.09 GONAD SHIELDING. Except for cases where gonad shielding would interfere with the diagnostic procedure, gonad shielding of not less than 0.5 millimeter lead equivalent must be used for human patients that have not passed the reproductive age during radiographic procedures where the gonads are in the useful beam.
003.10 EXPOSURE TO THE USEFUL BEAM. Individuals must not be exposed to the useful beam except for healing arts purposes unless the exposure has been specifically and individually ordered by a licensed practitioner of the healing arts. This provision prohibits deliberate exposure for the following purposes:
(A) Exposure to an individual for training, demonstration, or other non-healing-arts purposes; and (B) Exposure to an individual for the purpose of healing arts screening except as authorized by 180 NAC 6-003.14.
003.11 EXPOSURE FOR RESEARCH PURPOSES. Radiation exposure to an individual for research is prohibited, except when the research has been approved by an institutional review board and is conducted under federal regulations for the protection of human subjects in research under 45 CFR §46 (October 1, 2016 edition).
003.12 AUXILIARY SUPPORT. Auxiliary support must be used when a patient or film must be provided with supplemental support during a radiation exposure. The following requirements apply:
(A) When a patient or image receptor must be held in position during radiography, mechanical supporting or restraining devices must be used except in individual cases where the registrant has determined the devices used for holding are contraindicated. The written safety procedures, required by 180 NAC 6-003.07, must list projections where holding devices cannot be utilized; (B) The human holder must be instructed in personal radiation safety and protected as required by 180 NAC 6-003.08; (C) An individual must not be used routinely to hold film or patients; (D) Written safety procedures, as required by 180 NAC 6-003.07, must indicate the requirements for selecting a holder and the procedure the holder must follow; (E) In those cases where the patient must hold the film, except during intraoral examinations, any portion of the body other than the area of clinical interest struck by the useful beam must be protected by not less than 0.5 millimeter lead equivalent material; and (F) Each registrant must have leaded protective aprons and protective gloves available in sufficient numbers to provide protection to all personnel who are involved with x-ray operations and who are not shielded.
003.13 PROCEDURES AND EQUIPMENT. Procedures and equipment designed to minimize patient and personnel exposure while providing the needed diagnostic information must be utilized. The following requirements apply:
(A) The speed of film or screen and film combinations must be the fastest speed consistent with the diagnostic objective of the examinations. Film cassettes without intensifying screens must not be used for any routine diagnostic radiological imaging, with the exception of veterinary radiography; (B) The radiation exposure to the patient must be the minimum exposure required to produce images of good diagnostic quality; (C) Portable or mobile x-ray equipment must be used only for examinations where it is not feasible to transfer the patient or patients to a stationary x-ray installation; (D) X-ray systems subject to this chapter must not be used in procedures where the source to patient distance is less than 30 centimeters, except for veterinary systems; and (E) If grids are used between the patient and the image receptor to decrease scatter to the film and improve contrast, the grid must be positioned properly and, if the grid is of the focused type, be the proper focal distance for the source to image distance (SID) being used.
003.14 HEALING ARTS SCREENING. An individual requesting to conduct a healing arts screening must submit information about the healing arts screening on a form provided by the Department. If any information submitted to the Department becomes invalid or outdated, the Department must be notified immediately.
003.15 X-RAY ROOM DOORS. Doors that are an integral part of room shielding must be closed during x-ray procedures and must be posted "Close door during x-ray procedures" or words having a similar intent.
003.16 INFORMATION AND MAINTENANCE RECORDS FOR X-RAY SYSTEMS. The registrant must maintain the following records on each x-ray system for inspection by the Department:
(A) The model and serial numbers of all certifiable components, and user’s manuals for those components; (B) The records of surveys, calibrations, maintenance, and modifications performed; (C) The tube rating charts and cooling curves; and (D) A copy of all correspondence with the Department regarding each x-ray system.
003.17 X-RAY UTILIZATION LOG. Except for registrants using only dental radiation generating equipment, registrants must maintain an x-ray log or chart containing the patient's identification, the type of examinations, the dates the examinations were performed, and the x-ray equipment operator’s name.
003.18 SCALE DRAWING. Except for registrants using only dental radiation generating equipment or bone densitometers, a scale drawing must be available of the room where a stationary x-ray system is located. The drawing must indicate the use of areas adjacent to the room and an estimation of the extent of occupancy by an individual in those areas. The drawing must include:
(A) The results of a survey for radiation levels present at the operator's position and at pertinent points outside the room at specified test conditions; or (B) The type and thickness of materials, or lead equivalency, of each protective barrier.
003.19 PLAN REVIEW. Except for registrants using only dental radiation generating equipment or bone densitometers, the following requirements apply:
(A) The floor plans and equipment arrangement of all new installations, modifications of existing installations, or any analysis of operating conditions that indicates an individual may receive a dose in excess of the limits prescribed in 180 NAC 4-005, 4-011 or 4-013, must be submitted within 30 days to an individual meeting the requirements of 180 NAC 2-005.04(C) for review and comment; and (B) All permanent protective barriers must be constructed so the requirements of 180 NAC 4-005, 4-011, and 4-013 will be met.
003.20 X-RAY FILM PROCESSING. A registrant using radiographic film must have equipment for handling and processing radiographic film.
003.20(A) MANUALLY DEVELOPED FILM. The following requirements apply to film that is developed manually:
(i) Processing tanks must be constructed of mechanically rigid, corrosion resistant material; and (ii) The temperature of solutions in the tanks must be maintained within the range of 60º Fahrenheit to 80º Fahrenheit (16º Celsius to 27º Celsius). Film must be developed according to the time-temperature relationships recommended by the film manufacturer, or, in the absence of those recommendations, with the following time chart:
| Time-Temperature Chart | | | | --- | --- | --- | | Thermometer Reading (Degrees) | Minimum Developing Time (Minutes) | | | ºCelsius | ºFahrenheit | | | 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 | 3.5 | | 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 must be used that indicate the actual temperature of the developer and signal the passage of a preset time appropriate to the developing time required. (iv) The specified developer temperature and development time must be posted in the darkroom.
003.20(B) AUTOMATIC FILM PROCESSING. Films must be developed according to the time-temperature relationships recommended by the film manufacturer; in the absence of those recommendations, the film must be developed using the following chart:
| Developer Temperature (Degrees) | Minimum Immersion Time (Seconds) | | | --- | --- | --- | | ºCelsius | ºFahrenheit | | | 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 | | 39.5 | 85 | 30 | | Immersion time only, no crossover time included. | | |
003.20(C) FILM PROCESSING REQUIREMENTS. Processing deviations and the reason for the deviation from the requirements of 180 NAC 6-003.20 must be documented by the registrant.
003.20(D) DARKROOM REQUIREMENTS. Registrants must maintain a light-tight darkroom, as applicable, use proper safelights and safeguards, and evaluate darkroom integrity and daylight loading systems for film fog every six months and after a change that may impact film fog.
(i) Each darkroom, other than those used for dental, podiatric and veterinary purposes, must use proper safelights so that any film type exposed in a cassette to x-radiation sufficient to produce an optical density from 1 to 2 when processed must not suffer an increase in density greater than 0.1 when exposed in the darkroom for 2 minutes with all safelights on. If used, daylight film handling boxes must prevent fogging of the film.
003.20(E) FILM. Film must be stored in a cool, dry place and must be protected from exposure to stray radiation. Film in open packages must be stored in a light tight container.
003.20(F) FILM CASSETTES. Film cassettes and intensifying screens must be inspected periodically and must be cleaned and replaced as necessary to assure radiographs of good diagnostic quality.
003.20(G) OUTDATED FILM. Outdated x-ray film must not be used for diagnostic radiographs, except when the film has been stored according to the manufacturer's recommendations and a sample of the film passes a sensitometric test for normal ranges of base plus fog and speed.
003.20(H) FILM DEVELOPING SOLUTIONS. Film developing solutions must be prepared according to the directions given by the manufacturer and must be maintained in strength by replenishment or renewal, so full development is accomplished within the time specified by the manufacturer.
003.20(I) PASS BOXES. Pass boxes must be constructed to exclude light from the darkroom when cassettes are placed in or removed from the boxes. Pass Boxes must have adequate shielding from stray radiation to prevent exposure of undeveloped film.
003.20(J) ALTERNATIVE PROCESSING SYSTEMS. The use of daylight processing systems, laser processors, self-processing film systems, or other alternative processing systems will follow manufacturer’s recommendations for image processing.
004. GENERAL REQUIREMENTS FOR ALL DIAGNOSTIC AND INTERVENTIONAL X-RAY SYSTEMS . In addition to other requirements of 180 NAC 6-004, all diagnostic and interventional x-ray systems must meet the specifications of 21 CFR §1020.30.
004.01 FILTRATION CONTROL. X-ray systems that have variable kilovolt peak (kVp) and variable filtration for the useful beam must have a device to link the kilovolt peak (kVp) selector with the filter or filters and must prevent an exposure unless the minimum amount of filtration required in 21 CFR §1020.30(m) is in the useful beam for the kVp that has been selected.
004.02 BEAM LIMITATION. The useful beam must be limited to the area of clinical interest.
004.03 MULTIPLE TUBES. When two or more radiographic tubes are controlled by one exposure switch, the tube or tubes which have been selected must be clearly indicated prior to initiation of the exposure. This indication must be on the x-ray control panel and at or near the tube housing assembly that has been selected.
004.04 MECHANICAL SUPPORT OF TUBE HEAD. The tube housing assembly supports must be adjusted so that the tube housing assembly will remain stable during the exposure except when the tube housing movement is a designed function of the x-ray system.
004.05 MAINTAINING COMPLIANCE. Diagnostic x-ray systems and their associated components used on humans and certified under the Federal X-ray Equipment Performance Standard, 21 CFR Part 1020, must be maintained in compliance with applicable requirements of that standard.
004.06 LOCKS. All position locking, holding, and centering devices on x-ray systems components and systems must function as intended.
004.07 EQUIPMENT PERFORMANCE EVALUATION. For all radiation generating equipment, except bone densitometry, veterinary, computed tomography (CT), and cone beam computed tomography (CBCT) the registrant must perform, or cause to be performed, tests necessary to insure the proper function of equipment. These tests must be performed every three years. For dental radiation generating equipment, these tests must be performed every five years. The evaluation must include the following measures.
004.07(A) TIMER. The accuracy of the timer must meet the manufacturer’s specifications. If the manufacturer’s specifications are not obtainable, the timer accuracy must be within plus or minus 10% of the indicated time with testing performed at 0.5 second.
004.07(B) EXPOSURE REPRODUCIBILITY. When all technique factors are held constant, including control panel selections associated with automatic exposure control systems, the coefficient of variation of exposure for both manual and automatic exposure control systems will not exceed 0.05. This requirement applies to clinically used techniques.
004.07(C) KILOVOLT PEAK (kVp). The kilovolt peak (kVp) must meet the manufacturer’s specifications. If the manufacturer’s specifications are not obtainable, the indicated kilovolt peak must be accurate to within plus or minus 10% of the indicated setting or settings. For dental radiation generating equipment, with fewer than three fixed kilovolt peak (kVp) settings, the machine must be checked at those settings.
004.07(D) TUBE STABILITY. The x-ray tube must remain physically stable during exposures. When tubes are designed to move during exposure, the registrant will assure proper and free movement of the radiation generating equipment.
004.07(E) COLLIMATION. Field limitation must meet the requirements of 21 CFR §1020.32(b) for fluoroscopic systems, 21 CFR §1020.31(d) for radiographic systems, 21 CFR §1020.31(f)(1), for dental intraoral equipment, or 21 CFR §1020.31(f)(4) for dental extraoral equipment.
004.07(F) CORRECTION OR REPAIR. Any items not meeting the specifications of the tests must be corrected or repaired. Correction or repair must begin within 30 days following the check and must be performed according to a plan developed by the registrant. Correction or repair must be completed 90 days from discovery unless authorized by the Department.
004.07(G) IN-AIR EXPOSURE. A measurement of the in-air exposure or exposures at a technique factor or factors for an average adult thickness for the most common procedure or procedures performed.
004.07(H) DOSIMETRY SYSTEM. The measurement of the radiation output of an x-ray system must be performed with a calibrated dosimetry system. The calibration of that system must be traceable to a national standard. The dosimetry system must have been calibrated within the preceding two years. During the calendar year the dosimetry system is not calibrated, an intercomparison to a system calibrated within the previous 12 months must be performed.
005. FLUOROSCOPIC X-RAY SYSTEMS . Fluoroscopic x-ray systems must meet the machine performance standards of 21 CFR §1020.32. Use of non-image intensified fluoroscopic equipment is prohibited. The provisions of this chapter apply to equipment for fluoroscopic imaging or for recording images from the fluoroscopic image receptor, except computed tomography (CT) x-ray systems manufactured on or after November 29, 1984.
005.01 PERIODIC MEASUREMENT OF AIR KERMA RATE (AKR). A periodic measurement of air kerma rate (AKR) must be performed as follows.
005.01(A) MEASUREMENTS OF AIR KERMA RATE (AKR). Measurements must be made for both typical and maximum values of the air kerma rate (AKR), materials may be placed in the useful beam to protect the imaging system when performing the periodic measurements.
005.01(A)(i) Measurements must be made annually or after any maintenance of the system which might affect the air kerma rate (AKR).
005.01(A)(ii) For units manufactured before June 10, 2006, results of the measurements must be posted where a fluoroscopist may have access to those results while using the fluoroscope.
005.01(B) RECORDS OF MEASUREMENTS OF AIR KERMA RATE (AKR).The measurement results may be stated in roentgens per minute (R/min) or milliGray per minute (mGy/min). The results must include the technique factors used to determining the results, the name of the individual that performed the measurements, and the date the measurements were performed.
005.01(C) CONDITIONS OF PERIODIC MEASUREMENT OF TYPICAL AIR KERMA RATE (AKR). The following conditions apply to the periodic measurement of the typical Air Kerma Rate (AKR):
(i) The measurement must be made under the conditions that satisfy the requirements of 21 CFR §1020.32(d)(3); (ii) Fluoroscopic systems that do not incorporate automatic exposure rate control (AERC) must use a milliamperage (mA) and kilovolt peak (kVp) typical of clinical use of the fluoroscopic system; and (iii) Fluoroscopic systems that incorporate automatic exposure rate control (AERC) must have sufficient material placed in the useful beam to produce a milliamperage (mA) and kilovolt peak (kVp) typical of the clinical use of the fluoroscopic system.
005.01(D) CONDITIONS OF PERIODIC MEASUREMENT OF MAXIMUM AIR KERMA RATE (AKR). The following conditions apply to the periodic measurement of the maximum air kerma rate (AKR):
(i) The measurement must be made under the conditions that satisfy the requirements of 21 CFR §1020.32(d)(3); (ii) Fluoroscopic systems that do not incorporate automatic exposure rate control (AERC) must be adjusted to those settings which give the maximum air kerma rate (AKR); and (iii) Fluoroscopic systems that incorporate automatic exposure rate control (AERC) must have sufficient material placed in the useful beam to produce the maximum air kerma rate (AKR) of the system.
005.02 CONTROL OF SCATTERED RADIATION. The following requirements apply to controlling the scatter of radiation.
005.02(A) FLUOROSCOPIC TABLE DESIGNS. Fluoroscopic table designs, when combined with the procedures performed at the registrant’s facility, must ensure that no unprotected part of any staff or ancillary individual's body is exposed to unattenuated scattered radiation that originates from under the table. The attenuation provided must be not less than 0.25 millimeter lead equivalent.
005.02(B) EQUIPMENT CONFIGURATION. Equipment configuration, when combined with procedures performed at the registrant’s facility, must ensure that no portion of any staff or ancillary individual's body, except the extremities, is exposed to the unattenuated scattered radiation that originates from above the tabletop unless:
(i) That individual is 120 centimeters from the center of the useful beam; or (ii) The radiation has passed through not less than 0.25 millimeter lead equivalent material including, but not limited to, drapes, bucky-slot cover panel, or self-supporting curtains. This requirement is in addition to any lead equivalency provided by the protective apron specified in 180 NAC 003.08.
005.02(C) EXEMPTIONS TO THE USE OF PROTECTIVE BARRIERS. When a sterile field will not permit the use of the normal protective barriers or drapes, the shielding required by 180 NAC 6-005.02(B) must be maintained to the degree possible under the clinical conditions.
005.03 FLUOROSCOPIC RADIATION THERAPY SIMULATION SYSTEMS. Fluoroscopic radiation therapy simulation systems are exempt from the requirements of 180 NAC 6-005.01. In addition, these systems are exempt from the requirements of 21 CFR §1020.32(a) provided these systems are designed and used in a manner that no individual other than the patient is in the x-ray room during the time the system is producing x-rays.
005.04 EQUIPMENT OPERATION. The following requirements apply to the operation of fluoroscopic equipment.
005.04(A) Images formed by the use of fluoroscopic x-ray systems must be under the direction of and interpreted by a licensed practitioner of the healing arts.
005.04(B) Only a licensed practitioner may perform interpretative fluoroscopic procedures.
005.04(C) Fluoroscopy must not be used as a positioning tool for general purpose radiographic examinations.
005.04(D) Operators must be competent in the standard operating procedures of the unit in use.
005.04(E) Registrants must maintain a record of the cumulative fluoroscopic exposure time used and the number of fluorographic images recorded for each examination. This record must include patient identification, type and date of examination, the fluoroscopic system used, and operator's name.
006. REQUIREMENTS FOR RADIOGRAPHIC SYSTEMS OTHER THAN FLUOROSCOPIC, BONE DENSITOMETRY, VETERINARIAN, OR COMPUTED TOMOGRAPHY (CT) X-RAY SYSTEMS . In addition to the requirements of 180 NAC 6-006, radiographic systems other than fluoroscopic, bone densitometry, veterinarian, or computed tomography (CT), must meet the specifications of 21 CFR §1020.31.
006.01 INITIATION AND INDICATION OF RADIATION EXPOSURE. The following apply to the initiation and indication of radiation exposure.
006.01(A) EXPOSURE INITIATION. Means must be provided to initiate the radiation exposure by a deliberate action on the part of the operator. In addition, it must not be possible to initiate an exposure when the timer is set to a “zero” or ”off” position if either position is provided.
006.01(B) EXPOSURE INDICATION. Means must be provided for visual indication, observable at or from the operator’s protected position, whenever x-rays are produced. In addition, a signal audible to the operator must indicate that the exposure has terminated.
006.01(C) OPERATOR PROTECTION. Initiation of the production of x-rays must occur in an area that protects the operator from radiation exposure.
006.01(C)(i) STATIONARY X-RAY SYSTEMS. Stationary x-ray systems must have the x-ray control, including the exposure switch, permanently mounted in a protected area so that the operator must remain in that protected area during the entire exposure.
006.01(C)(ii) DENTAL X-RAY SYSTEMS. The x-ray control for dental x-ray systems must be positioned so the operator must stand at least six feet from the useful beam or behind a protective barrier, except when using units designed to be hand-held.
006.01(D) EXPOSURE CONTROL LOCATION. The x-ray exposure control must be placed so the operator can maintain verbal, aural, and visual contact with the patient while making any exposure.
006.02 TUBE STANDS FOR PORTABLE X-RAY SYSTEMS. A tube stand or other mechanical support must be used for portable x-ray systems so the x-ray tube housing assembly is not hand-held during exposures.
007. VETERINARY MEDICINE RADIOGRAPHIC INSTALLATIONS . This section applies to registrants using x-ray generating equipment in veterinary medicine.
007.01 VETERINARY MEDICINE EQUIPMENT REQUIREMENTS. Radiation generating equipment used in veterinary medicine must meet the following requirements:
(A) The protective tube housing must be constructed to meet the specifications of 21 CFR §1020.30(k); (B) Diaphragms or cones must be provided for collimating the useful beam to the area of clinical interest and must provide the same degree of protection as is required of the tube housing; (C) The total filtration permanently in the useful beam must not be less than 0.5 millimeters aluminum equivalent for machines operating up to 50 kilovolt peak (kVp), 1.5 millimeters aluminum equivalent for machines operating between 50 and 70 kilovolt (kVp), and 2.5 millimeters aluminum equivalent for machines operating above 70 kilovolt peak (kVp); (D) A device must be provided to terminate the exposure after a preset time or exposure; and (E) A continuous pressure type of exposure switch must be provided, with an electrical cord of adequate length, so the operator can stand out of the useful beam and at least 6 feet (1.83 meters) from the animal during all x-ray exposures.
007.02 OPERATING PROCEDURES. The following requirements apply to the operation of x-ray generating equipment used in veterinary medicine.
007.02(A) The operator must be protected from the direct scatter radiation by a whole body protective barrier of 0.25 millimeter lead equivalent or must be positioned so the nearest portion of the body is at least 2 meters from the tube head and the nearest edge of the image receptor.
007.02(B) When an animal must be held in position during radiography, mechanical supporting or restraining devices should be used. If the animal must be held by an individual, the individual must be protected with appropriate shielding devices, and be positioned so no part of the body will be struck by the useful beam.
007.03 VETERINARY ASSISTANT OR VETERINARY TECHNICIAN TRAINING REQUIREMENTS. Veterinary assistants and veterinary technicians must meet the following requirements prior to operating x-ray generating equipment:
(A) Eight hours of classroom instruction in the fundamentals of radiation safety, radiographic equipment, state regulations, and operating and emergency procedures; or (B) Be a graduate of an accredited veterinarian technician’s program.
008. COMPUTED TOMOGRAPHY (CT) AND CONE BEAM COMPUTED TOMOGRAPHY (CBCT) SYSTEMS . This section applies to registrants using computed tomography (CT) systems and cone beam computed tomography (CBCT) systems.
008.01 DEFINITIONS. In addition to the definitions provided in 180 NAC 1-002 and 180 NAC 6-002, the following definitions apply to 180 NAC 6-008.
008.01(A) CONTRAST SCALE. Contrast scale has the same meaning as 21 CFR §1020.33(b).
008.01(B) COMPUTED TOMOGRAPHY (CT) CONDITIONS OF OPERATION. Computed tomography (CT) conditions of operation are all selectable parameters governing the operation of a computed tomography (CT) system including, but not limited to, nominal tomographic section thickness, filtration, and the technique factors as defined in this chapter.
008.01(C) COMPUTED TOMOGRAPHY (CT) NUMBER. Computed tomography (CT) number has the same meaning as set out in 21 CFR §1020.33(b).
008.01(D) NOISE. Noise has the same meaning as set out in 21 CFR §1020.33(b).
008.01(E) NOMINAL TOMOGRAPHIC SECTION THICKNESS. Nominal tomographic section thickness has the same meaning as set out in 21 CFR §1020.33(b).
008.01(F) REFERENCE PLANE. Reference plane is a plane which is displaced from and parallel to the tomographic plane.
008.01(G) SCAN. Scan is 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.
008.01(H) SCAN INCREMENT. Scan increment has the same meaning as set out in 21 CFR §1020.33(b).
008.01(I) SCAN SEQUENCE. Scan sequence has the same meaning as set out in 21 CFR §1020.33(b).
008.01(J) TOMOGRAPHIC PLANE. Tomographic plane has the same meaning as set out in 21 CFR §1020.33(b).
008.01(K) TOMOGRAPHIC SECTION. Tomographic section has the same meaning as set out in 21 CFR §1020.33(b).
008.02 COMPUTED TOMOGRAPHY (CT) AND CONE BEAM COMPUTED TOMOGRAPHY (CBCT) EQUIPMENT REQUIREMENTS. Computed tomography (CT) and cone beam computed tomography (CBCT) equipment must meet the following requirements, except for fluoroscopic systems capable of performing cone beam computed tomography (CBCT).
008.02(A) TERMINATION OF EXPOSURE. The timer must meet the specifications of 21 CFR §1020.33(f)(2).
008.02(B) TOMOGRAPHIC PLANE INDICATION AND ALIGNMENT. Tomographic plane indication and alignment must meet the specifications of 21 CFR §1020.33(g).
008.02(C) BEAM-ON AND SHUTTER STATUS INDICATORS AND CONTROL SWITCHES. Visual indication of x-ray production and shutter status must meet the specifications of 21 CFR §1020.33(h). Each emergency button or switch must be clearly labeled as to its function.
008.02(D) INDICATION OF CONDITIONS OF OPERATION. Visual indication of the conditions of operation to be used during a scan or scan sequence must meet the specifications of 21 CFR §1020.33(f).
008.02(E) SCAN INCREMENT ACCURACY. The accuracy of scanning increments must meet the specifications of 21 CFR §1020.33(i).
008.02(F) MEAN AND STANDARD DEVIATION. The method used to calculate the mean and standard deviation must meet the specifications of 21 CFR §1020.33(j).
008.03 FACILITY DESIGN REQUIREMENTS. Registrants using computed tomography (CT) equipment must meet facility design specifications.
008.03(A) AURAL COMMUNICATION. There must be two-way aural communication between the patient and the operator at the control panel.
008.03(B) VIEWING SYSTEMS. Viewing systems must include the following:
(i) Windows, mirrors, closed-circuit television, or an equivalent must be provided to permit continuous observation of the patient during irradiation and must be located so the operator can observe the patient from the control panel; and (ii) When the primary viewing system is by electronic means, an alternate viewing system, which may be electronic, must be available for use in the event of failure of the primary viewing system.
008.04 PLAN REVIEWS, CALIBRATIONS, SPOT CHECKS, AND OPERATING PROCEDURES. Plan reviews, calibration, spot checks and operating procedures for computed tomography (CT) and cone beam computed tomography (CBCT) systems must meet the following requirements.
008.04(A) PLAN REVIEWS. For computed tomography (CT) and cone beam computed tomography (CBCT) x-ray systems, the plan review required by 180 NAC 6-003.19 must be performed by, or under the direction of, a radiological medical physicist or radiological health physicist meeting the requirements of 180 NAC 2-005.04(C)(ii). In addition, radiation surveys must be performed after any change in the registrant’s facility or equipment that might cause an individual to receive a dose in excess of the limits prescribed in 180 NAC 4-005, 4-011 or 4-013.
008.04(B) PLAN REVIEW RESULTS. The registrant must obtain a written report of the results of the plan review from the radiological medical physicist or radiological health physicist. A copy of the report must be maintained for inspection by the Department.
008.04(C) RADIATION CALIBRATIONS OF COMPUTED TOMOGRAPHY (CT) AND CONE BEAM COMPUTED TOMOGRAPHY (CBCT) SYSTEMS. The calibration of radiation output of computed tomography (CT) or cone beam computed tomography (CBCT) system must be performed by, or under the direction of, a radiological medical physicist or radiological health physicist meeting the requirements of 180 NAC 2-005.04(C)(ii) who is physically present at the registrant’s facility during the calibration. Calibration procedures must be in writing.
008.04(C)(i) FREQUENCY OF CALIBRATION. The calibration of a computed tomography (CT) or cone beam computed tomography (CBCT) system must be performed after initial installation, prior to the first use on a patient, and at intervals specified by a radiological medical physicist or radiological health physicist, not to exceed two years. Additionally, a calibration must be performed by a radiological medical physicist or radiological health physicist within 30 days after any change or replacement of components that, in the opinion of the radiological medical physicist or radiological health physicist, could cause a change in the radiation output. Calibration of a computed tomography (CT) system must include the spot-checks specified in 180 NAC 6-008.05(A)(ii). Calibration of a cone beam computed tomography (CBCT) system must include the quality control checks specified in 180 NAC 6-008.07(C).
008.04(C)(ii) DOSIMETRY SYSTEM. The measurement of the radiation output of a computed tomography (CT) or cone beam computed tomography (CBCT) system must be performed with a calibrated dosimetry system. The calibration of that system must be traceable to a national standard. The dosimetry system must have been calibrated within the preceding two years.
008.04(C)(iii) DOSIMETRY PHANTOMS. Computed tomography (CT) dosimetry phantom or phantoms must be used to ensure the computed tomography (CT) system meets the specifications of 21 CFR §1020.33(b)(6).
008.04(C)(iv) HEAD, BODY, OR WHOLE-BODY SCANS. A computed tomography (CT) system must be calibrated for each type of head, body, or whole-body scan or scans performed at the registrant’s facility to ensure that the system meets the specifications of 21 CFR §1020.33(c)(2).
008.04(C)(v) RECORDS OF COMPUTED TOMOGRAPHY (CT) CALIBRATIONS AND CONE BEAM COMPUTED TOMOGRAPHY (CBCT). Records of calibrations performed must be maintained for inspection by the Department.
008.05 SPOT CHECKS OF COMPUTED TOMOGRAPHY (CT) EQUIPMENT. Spot-check procedures must be in writing and must be developed by a radiological medical physicist or radiological health physicist.
008.05(A) SPOT-CHECK PROCEDURES. Spot-check procedures must include the following:
(i) Use of a computed tomography (CT) phantom or phantoms that meets the requirements of 21 CFR §1020.33(d)(1); (ii) A check of the contrast scale, noise, nominal tomographic section thickness, spatial resolution of the system for low and high contrast objects, and a measurement of the mean computed tomography (CT) number of water or a reference material; and (iii) Acquisition of images must be obtained with the computed tomography (CT) phantom or phantoms using the same processing mode and computed tomography (CT) conditions of operation used to perform calibrations required by this chapter.
008.05(B) FREQUENCY OF SPOT-CHECKS. All spot checks must be performed at the frequency and under system conditions specified by a radiological medical physicist or radiological health physicist.
008.05(C) SPOT-CHECK RECORDS. Records of the spot-checks performed must be maintained for inspection by the Department.
008.06 OPERATING PROCEDURES FOR COMPUTED TOMOGRAPHY (CT) SYSTEMS. Registrants must develop written operating procedures for computed tomography (CT) systems as follows.
008.06(A) OPERATION OF THE COMPUTED TOMOGRAPHY (CT) SYSTEM. The system must only be operated by an individual who has been specifically trained in its operation and meets the requirements of 180 NAC 6-003.05.
008.06(B) INFORMATION ON OPERATION AND CALIBRATION. Information must be available in the operator control area regarding the operation and calibration of the system. The information must include:
(i) Dates of the latest calibration and spot-checks and the location where the results of those tests may be found; (ii) Instructions on the use of the computed tomography (CT) phantom or phantoms including a schedule of spot-checks appropriate for the system, allowable variations for the indicated parameters, and the results of the most recent spot-checks performed on the system; (iii) The distance in millimeters between the tomographic plane and the reference plane if a reference plane is utilized; and (iv) A current technique chart available at the control panel which specifies, for each routine examination, the computed tomography (CT) conditions of operation and the number of scans for each examination.
008.06(C) OPERATING PARAMETERS. If the calibration or spot-check of the computed tomography (CT) system identifies that a system operating parameter has exceeded a tolerance established by the radiological medical physicist or radiological health physicist, use of the system on patients must be limited to those permitted by written instructions of the radiological medical physicist or radiological health physicist.
008.07 CONE BEAM COMPUTED TOMOGRAPHY (CBCT) SYSTEMS. In addition to other requirements of this chapter, this section applies to registrants using with cone beam computed tomography (CBCT) systems.
008.07(A) OPERATION OF THE CONE BEAM COMPUTED TOMOGRAPHY (CBCT) SYSTEM. The cone beam computed tomography (CBCT) system must only be operated by an individual who has been specifically trained in its operation and meets the requirements of 180 NAC 6-003.05.
008.07(B) BEAM ALIGNMENT. The x-ray field in the plane of the image receptor must not exceed beyond the edge of the image receptor by more than two percent of the source-to-image distance (SID) when the axis of the x-ray beam is perpendicular to the plane of the image receptor. In addition, the center of the x-ray field must be aligned with the center of the image receptor to within 2 percent of the source-to-image distance (SID).
008.07(C) QUALITY CONTROL. The registrant must follow the quality control recommendations of the manufacturer. If manufacturer recommendations are not obtainable, the registrant must perform quality control on the cone beam computed tomography (CBCT) system that has been developed by a radiological medical physicist or radiological health physicist.
008.07(D) INFORMATION FOR THE CONE BEAM COMPUTED TOMOGRAPHY (CBCT) OPERATOR. The following information must be readily available to the operator of the cone beam computed tomography (CBCT) system:
(i) Instructions on performing quality control on the cone beam computed tomography (CBCT) system; (ii) The time interval for performing quality control on the cone beam computed tomography (CBCT) system; (iii) The allowable uses of the cone beam computed tomography (CBCT) system if a quality control check identifies a system operating parameter has exceeded a tolerance established by the manufacturer. If tolerances from the manufacturer are not obtainable, a radiological medical physicist or radiological health physicist must establish the tolerances and the cone beam computed tomography (CBCT) system must be limited to those uses allowed by the radiological medical physicist or radiological health physicist; and (iv) The results of the most recent quality control completed on the cone beam computed tomography (CBCT) system.
009. DENTAL REGISTRANTS . In addition to other requirements of this chapter, this section applies to registrants using dental radiation generating equipment.
009.01 EXEMPTION FROM INDIVIDUAL MONITORING. Individual monitoring is not required for personnel operating only dental radiation generating equipment for dental diagnostic purposes.
009.02 TUBE HOUSING. The tube housing and position indicating device (PID) must not be hand-held during an exposure, except for units designed to be hand-held.
009.03 TUBE HOUSING SUPPORT. The tube housing support must be constructed and adjusted so that the tube housing will not drift from its set position during an exposure.
009.04 X-RAY CONTROL. Each x-ray system must have a control that allows the operator to terminate the exposure at any time, except for exposures of 0.5 second or less. The exposure switch will be of the continuous pressure type.
009.05 SOURCE-TO-SKIN DISTANCE (SSD). X-ray systems designed for use with an intraoral image receptor must be provided with means to limit the source-to-skin distance (SSD) to meet the requirements of 21 CFR §1020.31(i).
009.06 KVP LIMITATIONS. Dental x-ray radiation generating equipment with a fixed kilovolt peak (kVp) of less than 50 kilovolt peak (kVp) must not be used to make diagnostic dental radiographs of humans.
009.07 DENTAL INTERIM INSPECTIONS. This subsection addresses interim inspections of dental registrants.
009.07(A) INTERIM INSPECTIONS. For interim inspections of dental radiation generating equipment, each registrant must:
(i) Respond to a request from the Department for an interim inspection; (ii) Complete the Interim Inspection Form NRH-6. Form NRH-6 is set out as Attachment 1 to this chapter; and (iii) Return the completed interim inspection form with documentation of the most recent equipment performance evaluation or evaluations performed according to 180 NAC 6-004.07 by the deadline indicated in the inspection notice.
010. HAND-HELD DENTAL AND VETERINARY EQUIPMENT . In addition to the requirements of this chapter, hand-held dental and veterinary equipment must meet these requirements.
010.01 BACKSCATTER SHIELD. Hand-held dental and veterinary equipment must be equipped with a backscatter shield of at least 0.25 millimeter (mm) lead equivalent and be at least 15.2 centimeters (cm) in diameter. The shield must be positioned as close as practical to the distal end of the position indicating device (PID).
010.02 MANUFACTURER TRAINING. Individuals operating hand-held dental and veterinary equipment must complete training as specified by the manufacturer.
010.03 MANUFACTURER PROTOCOLS. Registrants with hand-held dental and veterinary equipment must follow manufacturer protocols for the safe operation of the equipment.
010.04 UNAUTHORIZED REMOVAL OR USE. The registrant must secure hand-held dental and veterinary equipment from unauthorized removal or use.
010.05 EXPOSURE PREVENTION. Hand-held dental or veterinary equipment must be kept in a mode that prevents an exposure when the device is not being used.
History
- Effective 2020-11-04
Chapter 7 Medical Use of Radioactive Material
Neb. Admin. Code tit. 180, ch. 7 Medical Use of Radioactive Material {#sec-180-nac-7 omnilex-key=us-ne-regs-official--title-180--180 NAC 7}
Effective Date: 6/14/2023
001. SCOPE AND AUTHORITY . 180 Nebraska Administrative Code (NAC) 7 establishes requirements and provisions for the production, preparation, compounding and use of radionuclides in the healing arts and for issuance of licenses authorizing these activities. These requirements and provisions provide for the radiation safety of workers, the general public, patients, and human research subjects. The requirements and provisions of 180 NAC 7 are in addition to, and not in substitution for, others in 180. The requirements and provisions of 180 NAC 1, 3, 4, 10, 13, 15, and 18 apply to applicants and licensees subject to 180 NAC 7 unless specifically exempted. The regulations are authorized by and implement the Nebraska Radiation Control Act, Nebraska Revised Statute (Neb. Rev. Stat.) §§ 71-3501 to 71-3520.
002. DEFINITIONS . As used in 180 NAC 7, the following definitions apply to this chapter:
002.01 ACCREDITED INSTITUTION. A teaching facility for nuclear medicine technology or radiation therapy technology whose standards are accepted by the United States Department of Education.
002.02 ADDRESS OF USE. The address of the building or buildings identified on the license and where radioactive material may be produced, prepared, received, used, or stored.
002.03 AREA OF USE. The portion of an address of use set aside for the purpose of receiving, using, or storing radioactive material.
002.04 ASSOCIATE RADIATION SAFETY OFFICER (ARSO). An individual who:
(A) Meets the requirements in 180 NAC 7-022 and 7-027; and (B) Is currently identified as an ARSO for the types of use of radioactive material for which the individual has been assigned duties and tasks by the RSO on:
(i) A specific medical use license issued by the Department, the U.S. Nuclear Regulatory Commission (NRC), or an Agreement State; or (ii) A medical use permit issued by an U.S. Nuclear Regulatory Commission (NRC) master material licensee.
002.05 AUTHORIZED MEDICAL PHYSICIST. An individual who:
(A) Meets the requirements in 180 NAC 7-023(A) and 7-027; or (B) Is identified as an authorized medical physicist or teletherapy physicist on a specific license or equivalent permit issued by the Department, NRC or Agreement State; or (C) Is identified as an authorized medical physicist on a permit issued by a Department, NRC, or Agreement State specific medical use license of broad scope authorized to permit the use of radioactive material.
002.06 AUTHORIZED NUCLEAR PHARMACIST. A pharmacist who:
(A) Meets the requirements of 180 NAC 7-024.01 and 7-027; or (B) Is identified as an authorized nuclear pharmacist on a specific license or equivalent permit that authorizes medical use, the practice of nuclear pharmacy, commercial nuclear pharmacy or the manufacture and distribution of radiopharmaceuticals issued by the Department, NRC or Agreement State; or (C) Is identified as an authorized nuclear pharmacist on a permit issued by the Department, NRC or Agreement State specific medical use license of broad scope authorized to permit the use of radioactive material.
002.07 AUTHORIZED USER. A physician, dentist, or podiatrist who:
(A) Meets the requirements in 180 NAC 7-027 and 7-043(A), 7-047.01, 7-052.(A), 7-053.(A), 7-054.(A), 7-063.(A), 7-066.(A) or 7-084.(A); or (B) Is identified as an authorized user on a specific license or equivalent permit issued by the Department, NRC or Agreement State; or (C) Is identified as an authorized user on a permit issued by an Department, NRC or Agreement State specific license of broad scope authorized to permit the medical use of radioactive material.
002.08 BRACHYTHERAPY. A method of radiation therapy where plated, embedded, activated, or sealed sources are utilized to deliver a radiation dose at a distance of up to a few centimeters, by surface, intracavitary, intraluminal, or interstitial application.
002.09 BRACHYTHERAPY SOURCE. A radioactive source or a manufacturer-assembled source train or a combination of these sources designed to deliver a therapeutic dose within a distance of a few centimeters.
002.10 CLIENT’S ADDRESS. The address of use or a temporary job site for the purpose of providing mobile medical service according to 180 NAC 7-038.
002.11 DEDICATED CHECK SOURCE. A radioactive source used to assure the consistent response of a radiation detection or measurement device over several months or years.
002.12 DIAGNOSTIC CLINICAL PROCEDURES MANUAL. A collection of written procedures that describes each method, and other instructions and precautions, by which the licensee performs diagnostic clinical procedures; where each diagnostic clinical procedure has been approved by the authorized user and includes the radiopharmaceutical, dosage, and route of administration, or in the case of sealed sources for diagnosis, the procedure.
002.13 HIGH DOSE-RATE (HDR) REMOTE AFTERLOADER. A device that remotely delivers a dose rate in excess of 12 gray (1200 rads) per hour at the treatment site.
002.14 LOW DOSE-RATE (LDR) REMOTE AFTERLOADER. A device that remotely delivers a dose rate of less than or equal to 2 gray (200 rads) per hour at the treatment site.
002.15 MANAGEMENT. The individual having the authority to manage, direct, or administer the licensee’s activities, or that persons’ designee or designees.
002.16 MANUAL BRACHYTHERAPY. A type of therapy where the brachytherapy sources are manually applied or inserted.
002.17 MEDICAL INSTITUTION. An organization where several medical disciplines are practiced.
002.18 MEDICAL USE. The intentional internal or external administration of radioactive material, or radiation from radioactive material to patients or human research subjects under the supervision of an authorized user.
002.19 MEDIUM DOSE-RATE (MDR) REMOTE AFTERLOADER. A brachytherapy device that remotely delivers a dose rate of greater than 2 gray (200 rads) per hour, but less than 12 gray (1200 rads) per hour at the point or surface where the dose is prescribed.
002.20 MISADMINISTRATION. An event that meets the criteria in 180 NAC 7-115.
002.21 MOBILE MEDICINE SERVICE. The transportation of radioactive material or its medical use at the client’s address.
002.22 NUCLEAR MEDICINE TECHNOLOGIST. An individual who meets the requirements of 180 NAC 7-025.01 and is under the supervision of an authorized user, to prepare or administer radioactive drugs to patients or human research subjects, or perform in vivo or in vitro measurements for medical purposes.
002.23 NUCLEAR MEDICINE TECHNOLOGY. The science and art of in vivo or in vitro detection and measurement of radioactivity and the administration of radioactive drugs to patients or human research subjects for diagnostic and therapeutic purposes.
002.24 OPHTHALMIC PHYSICIST. An individual who:
(A) Meets the requirements in 180 NAC 7-060.05 and 180 NAC 7-027; and (B) Is identified as an ophthalmic physicist on a:
(i) Specific medical use license issued by the Department, NRC or an Agreement State; (ii) Permit issued by a Department, NRC or Agreement State broad scope medical use licensee; (iii) Medical use permit issued by a NRC master material licensee; or (iv) Permit issued by a NRC master material licensee broad scope medical use permittee.
002.25 OUTPUT. 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.
002.26 PATIENT INTERVENTION. Actions by the patient or human research subject, whether intentional or unintentional, dislodging or removing treatment devices or prematurely terminating the administration.
002.27 PRECEPTOR. An individual who provides, directs, or verifies training and experience required for an individual to become an authorized user, authorized medical physicist, authorized nuclear pharmacist, nuclear medicine technologist, radiation therapy technologist, RSO, or ARSO.
002.28 PRESCRIBED DOSAGE. A specified activity or range of activity of radioactive drug as documented:
(A) In a written directive as specified in 180 NAC 7-019; or (B) According to the directions of the authorized user for procedures performed per 180 NAC 7-041, 7-044 and 7-048.
002.29 PRESCRIBED DOSE. A prescribed dose means for:
(A) Gamma stereotactic radiosurgery, the total dose as documented in the written directive; (B) Teletherapy, the total dose and dose per fraction as documented in the written directive; (C) Manual brachytherapy, either the total source strength and exposure time or the total dose as documented in the written directive; or (D) Remote brachytherapy afterloaders, the total dose and dose per fraction as documented in the written directive.
002.30 PULSED DOSE-RATE (PDR) REMOTE AFTERLOADER. A special type of remote afterloading device that uses a single source capable of delivering dose rates in the “high dose-rate” range, but is:
(A) Approximately one-tenth of the activity of typical HDR remote afterloader sources; and (B) Used to simulate the radiobiology of a LDR treatment by inserting the source for a given fraction of each hour.
002.31 RADIATION SAFETY OFFICER (RSO). An individual who:
(A) Meets the requirements in 180 NAC 7-022(A) and 7-026; (B) Is identified as RSO on an NRC or Agreement State license or other equivalent permit or license recognized by the Department for similar types and uses of radioactive material.
002.32 RADIATION THERAPIST. An individual who meets the requirements of 180 NAC 7-025.02 and is under the supervision of an authorized user to perform procedures and apply radiation emitted from sealed radioactive sources to human beings for therapeutic purposes.
002.33 RADIATION THERAPY TECHNOLOGY. The science and art of applying radiation emitted from sealed radioactive sources to patients or human research subjects for therapeutic purposes.
002.34 RADIOACTIVE DRUG. Any chemical compound containing radioactive material that may be used on or administered to patients or human research subjects as an aid in the diagnosis, treatment, or prevention of disease or other abnormal condition.
002.35 SEALED SOURCE AND DEVICE REGISTRY. A national registry that contains all the registration certificates maintained by the NRC that summarize the radiation safety information for the sealed sources and devices and describe the licensing and use conditions approved for the product.
002.36 STEREOTACTIC RADIOSURGERY. The use of external radiation in conjunction with a stereotactic guidance device to precisely deliver a dose to a treatment site.
002.37 STRUCTURED EDUCATION PROGRAM. An educational program designed to impart particular knowledge and practical education through interrelated studies and supervised training.
002.38 TELETHERAPY. A method of radiation therapy where collimated gamma rays are delivered at a distance from the patient or human research subject.
002.39 TEMPORARY JOB SITE. A location where mobile medical services are conducted other than any location of use authorized on the license.
002.40 THERAPEUTIC DOSAGE. A radiation dosage of unsealed radioactive material intended to deliver a radiation dose to a patient or human research subject for palliative or curative treatment.
002.41 THERAPEUTIC DOSE. A radiation dose delivered from a source containing radioactive material to a patient or human research subject for palliative or curative treatment.
002.42 TREATMENT SITE. An anatomical description of the tissue intended to receive a radiation dose, as described in a written directive.
002.43 TYPE OF USE. The use of radioactive material as specified in 180 NAC 7-041, 7-044, 7-048, 7-055, 7-065, 7-067 or 7-085.
002.44 UNIT DOSAGE. A dosage that is:
(A) Obtained or prepared according to the regulations for uses described in 180 NAC 7-041, 7-044, or 7-048; and (B) To be administered as a single dosage to patient or human research subject without any further manipulation of the dosage after it is initially prepared.
002.45 WRITTEN DIRECTIVE. An authorized user’s written order for the administration of a radioactive material or radiation from radioactive material to a specific patient or human research subject, as specified in 180 NAC 7-019.
003. MAINTENANCE OF RECORDS . Each record required by 180 NAC 7 must be an original, electronic, microform, or reproduced copy, authenticated by authorized personnel, and capable of producing legible, accurate, and complete records, throughout the retention period specified by Title 180. Records, letters, drawings, specifications, must include all pertinent information, stamps, initials, and signatures. The licensee must maintain adequate safeguards against tampering with and loss of records.
004. PROVISIONS FOR RESEARCH INVOLVING HUMAN SUBJECTS . Requirements for research involving human subjects are as follows:
(A) Research must be conducted, funded, supported, or regulated by a Federal agency that has implemented the Federal Policy for the Protection of Human Subjects. Otherwise, a licensee may apply for and receive approval of a specific amendment to its Department license before conducting such research. Both types of licensees must, at a minimum, obtain prior informed consent from the human subjects and obtain prior review and approval of the research activities by an “Institutional Review Board” according to the meaning of these terms as defined and described in the Federal Policy for the Protection of Human Subjects; (B) Research involving human subjects authorized in 180 NAC 7-004 will be conducted using radioactive material authorized for medical use in the license; and (C) Nothing in 180 NAC 7-004 relieves the licensee from complying with the requirements in 180 NAC 7.
005. U.S. FOOD AND DRUG ADMINISTRATION (FDA), FEDERAL AND STATE REQUIREMENTS . Nothing in 180 NAC 7 relieves the licensee from complying with applicable U.S. Food and Drug Administration (FDA), Federal, and State requirements governing radioactive drugs or devices.
006. IMPLEMENTATION .
006.01 EFFECTIVE DATES. A licensee must implement the provisions in 180 NAC 7, with the exception of requirements listed in 180 NAC 7-006.02.
006.02 GOVERNING REQUIREMENTS. When a requirement of 180 NAC 7 differs from the requirement in an existing license condition, the requirement in 180 NAC 7 will govern.
006.03 EXISTING LICENSE CONDITIONS. Any existing license condition not affected by a requirement in 180 NAC 7 remains in effect until there is a license amendment or license renewal.
006.04 EXEMPT LICENSE CONDITIONS. If a license condition exempted a licensee from a provision of 180 NAC 7, it will continue to exempt a licensee from the corresponding provision in 180 NAC 7.
006.05 DELETED CITATIONS. If a license condition cites deleted provisions in 180 NAC 7, then the license condition remains in effect until there is a license amendment or renewal that modifies or removes the license condition.
006.06 COMPLIANCE. Licensees must continue to comply with any license condition that requires it to implement procedures required by 180 NAC 7-070, 7-076, 7-077 and 7-078 until there is a license amendment or renewal that modifies the license condition.
007. LICENSE REQUIRED . A person may manufacture, produce, prepare, acquire, receive, possess, use, or transfer radioactive material for medical use according to a specific license issued by the Department, NRC, or an Agreement State, or as allowed by 180 NAC 7-007. An individual may:
(A) Receive, possess, use, or transfer radioactive material according to 180 NAC 7 under the supervision of an authorized user as provided in 180 NAC 7-018, unless prohibited by license condition; or (B) Prepare unsealed radioactive material for medical use according to the regulations in 180 NAC 7 under the supervision of an authorized nuclear pharmacist or authorized user as provided in 180 NAC 7-018, unless prohibited by license condition.
008. APPLICATION FOR LICENSE, AMENDMENT, OR RENEWAL .
008.01 SIGNATURE. An application for a license, amendment, or renewal must be signed by the applicant’s or licensee’s management.
008.02 LICENSE APPLICATION. An application for a new license or license renewal for medical use of radioactive material as described in 180 NAC 7-041, 7-044, 7-048, 7-055, 7-065, 7-067 and 7-085 must be made by submitting an original Form NRH-7 “Application for Radioactive Material License - Medical” provided by the Department.
008.03 LICENSE AMENDMENT. A request for a license amendment must be submitted as an original in letter format.
008.04 SUPPLEMENTAL INFORMATION. In addition to the requirements of 180 NAC 7-008.02 and 7-008.03, an application for a license or amendment for medical use of radioactive material as described in 180 NAC 7-085 must also include information regarding any radiation safety aspects of the medical use of the material not addressed in 180 NAC 7-001 through 7-040, as well as any specific information on:
(A) Radiation safety precautions and instructions; (B) Training and experience of proposed users; (C) Methodology for measurement of dosages or doses to be administered to patients or human research subjects; and (D) Calibration, maintenance, and repair of instruments and equipment necessary for radiation safety.
008.05 REQUEST FOR ADDITIONAL INFORMATION. An applicant or licensee must also provide any other information requested by the Department in its review of the application.
008.06 TYPE A SPECIFIC LICENSE OF BROAD SCOPE. An applicant that satisfies the requirements specified in 180 NAC 3-013.02 may apply for a Type A specific license of broad scope.
009. MOBILE MEDICAL SERVICE ADMINISTRATIVE REQUIREMENTS .
009.01 LICENSURE. The mobile medical service must be licensed if the service receives, uses, or possesses radioactive material. The client of the mobile medical service must be licensed if the client receives or possesses radioactive material to be used by a mobile medical service.
009.02 LETTERS OF AUTHORITY AND RESPONSIBILITY. Mobile medical service licensees must obtain a letter signed by the management of each location where services are rendered that authorizes use of radioactive material at the client’s address of use and clearly outlines the authority and responsibility of the client and the mobile medical service. If the client is licensed, the letters must document procedures for notification, receipt, storage, and documentation of transfer of radioactive material delivered to the client’s address for use by the mobile medical service.
009.03 DELIVERY OF RADIOACTIVE MATERIAL DIRECTLY TO THE CLIENT. A mobile medical service must not have radioactive material delivered directly from the manufacturer or 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.
009.04 INFORM AUTHORIZED USER. A mobile medical service must inform the authorized user identified in 180 NAC 7-018.03 at each client’s address of use prior to the radioactive material being administered.
009.05 LETTER RETENTION. A licensee providing mobile medical services must retain the letter required in 180 NAC 7-009.02 according to 180 NAC 7-097.
009.06 DOCUMENT MAINTENANCE. A mobile medical service licensee must, at a minimum, maintain the following documents on each mobile unit:
(A) The current operating and emergency procedures; (B) Copy of the license; (C) Copies of the letter required by 180 NAC 7-009.02; (D) Current calibration records for each survey instrument, diagnostic equipment, and dose calibration systems in use; (E) Quality control tests and records of quality control required by 180 NAC 7-028; and (F) Survey records covering uses associated with the mobile unit during, at a minimum, the preceding 30 calendar days.
009.07 RECORDS. A mobile medical service licensee must maintain all records required by 180 NAC 4 and 7 at a location within the Department’s jurisdiction that is:
(A) A single address of use:
(i) Identified as the records retention location; and (ii) Staffed at all reasonable hours by individual or individuals authorized to provide the Department with access for purposes of inspection; or
(B) On the mobile unit:
(i) Identified in the license; and (ii) Whose current client’s address schedule and location is reported to the Department.
010. LICENSE AMENDMENTS . A licensee must apply for and receive a license amendment before:
(A) Receiving, preparing, or using radioactive material for a type of use permitted under 180 NAC 7-007, but not authorized on the licensee’s current license issued under 180 NAC 7; (B) Permitting anyone to work as an authorized user, authorized nuclear pharmacist, authorized medical physicist, or an ophthalmic physicist under the license, other than an individual who is:
(i) An authorized user, who meets the requirements in 180 NAC 7-027 and 7-043(A), 7-047.01, 7-051(A), 7-052(A), 7-053(A), 7-063(A), 7-066(A), and 7-084(A); (ii) An authorized nuclear pharmacist, who meets the requirements in 180 NAC 7-024 and 7-027; (iii) An authorized medical physicist, an individual who meets the requirements in 180 NAC 7-027 and 7-023(A) and 7-023(C); (iv) Identified as an authorized user, authorized nuclear pharmacist or authorized medical physicist, or an ophthalmic physicist;
(1) On an NRC or Agreement State or other equivalennnnt permit or license recognized by the Department that authorizes the use of radioactive material in medical use or in the practice of nuclear pharmacy, respectively; or (2) On a permit by an NRC or Agreement State specific license of broad scope that authorizes the use of radioactive material in medical use or in the practice of nuclear pharmacy, respectively;
(C) Changing an RSO or ARSO, other than as provided in 180 NAC 7-015.05; (D) Receiving radioactive material in excess of the amount or in a different physical or chemical form, than is authorized on the license; (E) Adding to or changing the areas of use identified in the application or on the license; (F) Changing the address or addresses of use identified in the application or on the license; (G) Changing statements, representations, and procedures that are incorporated into the license; and (H) Releasing licensed facilities for unrestricted use.
011. NOTIFICATIONS .
011.01 DOCUMENTATION. A licensee must provide to the Department a copy of the board certification, the NRC or Agreement State license, the permit issued by an NRC master material licensee, the permit issued by an NRC or Agreement State licensee of a broad scope, or the permit issued by an NRC master material license broad scope permittee, or documentation that only accelerator-produced radioactive materials, discrete sources of radium-226, or both, were used for medical use 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 NRC and for each individual no later than thirty days after the date the licensee permits the individual to work as an authorized user, an authorized nuclear pharmacist, authorized medical physicist, or an ophthalmic physicist according to 180 NAC 7-010, (B). For individuals permitted to work under 180 NAC 7-010, (B) items within the same thirty day time frame, the licensee must also provide as appropriate, verification of completion of:
(A) Any additional case experience required in 180 NAC 7-051(B)(i)(2)(f) for an authorized user under 180 NAC 7-048; (B) Any additional training required in 180 NAC 7-084(C) for an authorized user under 180 NAC 7-067; and (C) Any additional training required in 180 NAC 7-023(C) for an authorized medical physicist.
011.02 NOTIFICATION. A licensee must notify the Department, in writing, no later than thirty days after:
(A) An authorized user, an authorized nuclear pharmacist, RSO, ophthalmic physicist, or an authorized medical physicist permanently discontinues performance of duties under the license or has a name change; (B) The licensee’s mailing address changes; or (C) The licensee’s name changes, but the name change does not constitute a transfer of control of the license as described in 180 NAC 3-017.02.
011.03 DOCUMENT MAILING ADDRESS. The licensee must send the documents required in 180 NAC 7-011 to the appropriate address identified in 180 NAC 1-012.
012. TYPE A SPECIFIC LICENSE OF BROAD SCOPE EXEMPTIONS . A licensee possessing a Type A specific license of broad scope for medical use issued under 180 NAC 3-013 is exempt from the provisions of:
(A) 180 NAC 7-008.04 regarding the need to file an amendment to the license for medical use of radioactive material as described in 180 NAC 7-085; (B) 180 NAC 7-010.02 regarding the need to file an amendment before permitting anyone to work as an authorized user, authorized nuclear pharmacist, or authorized medical physicist under the license; (C) 180 NAC 7-010.05 regarding additions to or changes in the areas of use at the addresses specified in the license; (D) 180 NAC 7-011.01 regarding notification to the Department for new authorized users, authorized nuclear pharmacists, ophthalmic physicists, and authorized medical physicists; and (E) 180 NAC 7-021, (A) regarding supplier for sealed sources.
013. LICENSE APPLICATION . The applicant for a license for:
(A) Medical use of radioactive material must:
(i) File NRH-7 “Application for Radioactive Material License – Medical” according to instructions in 180 NAC 7-008; (ii) Pay any applicable fee as provided in 180 NAC 18; (iii) Meet the requirements of 180 NAC 3; and (iv) Establish that they are equipped and committed to observe the safety standards established by the Department in Title 180 for the protection of public health and safety.
(B) Mobile medical service must:
(i) Meet the requirements in 180 NAC 7-013, (A); and (ii) Demonstrate individuals to whom radioactive drugs or radiation from implants containing radioactive material will be administered may be released following treatment according to 180 NAC 7-037.
014. SPECIFIC EXEMPTIONS . The Department may, upon application or upon its own initiative, grant such exemptions from the requirements of 180 NAC 7 as allowed by Neb. Rev. Stat. § 71-3507.
015. RADIATION PROTECTION PROGRAM .
015.01 NOTICE TO WORKERS. The licensee’s program must include notice to workers of the program's existence and workers responsibility to help keep dose equivalents As Low As Reasonably Achievable (ALARA), a review of the summaries of the types and amounts of radioactive material used, occupational doses, changes in radiation safety measures, and continuing education and training for all personnel who work with or in the vicinity of radioactive material. The purpose of the review is to ensure licensees make every reasonable effort to maintain individual and collective occupational doses ALARA.
015.02 ALARA PROGRAM WRITTEN DESCRIPTION RETENTION. The licensee must retain a current written description of the ALARA program for the duration of the license. The written description must include:
(A) A commitment by management to keep occupational doses as low as reasonably achievable; (B) A requirement that the RSO brief management once each year on the radiation safety program; and (C) Personnel exposure investigational levels that, when exceeded, will initiate a prompt investigation by the RSO of the cause of the exposure and a consideration of possible actions taken to reduce the probability of recurrence.
015.03 WRITTEN APPROVAL. In addition to the radiation protection program requirements of 180 NAC 4-004, before submitting to the Department, a licensee’s management must approve in writing any requests for a license application, renewal, or amendment for:
(A) Any individual before allowing that individual to work as an authorized user, authorized nuclear pharmacist, or authorized medical physicist; and (B) Radiation protection program changes that do not require a license amendment and are permitted under 180 NAC 7-016.
015.04 RSO APPOINTMENT. A licensee’s management must appoint an RSO, who agrees, in writing, to be responsible for implementing the radiation protection program. The licensee, through the RSO, must ensure radiation safety activities are being performed according to licensee-approved procedures and regulatory requirements. A licensee’s management may appoint, in writing, one or more ARSOs to support the RSO. The RSO, with written agreement of the licensee’s management, must assign the specific duties and tasks to each ARSO. These duties and tasks are restricted to the types of use for which the ARSO is listed on a license. The radiation safety officer may delegate duties and tasks to the ARSO but must not delegate the authority or responsibilities for implementing the radiation protection program.
015.05 TEMPORARY RADIATION SAFETY OFFICER. For up to 60 days each year, a licensee may permit an authorized user or an individual qualified to be an RSO to function as a temporary RSO and perform the functions of a radiation safety officer, as provided in 180 NAC 7-015.07, provided the licensee takes the actions required in 180 NAC 7-015.02, 7-015.06, 7-015.07 and 7-015.010. A licensee may simultaneously appoint more than one temporary RSO, if needed, to ensure the licensee has a temporary RSO that satisfies the requirements to be an RSO for each of the different uses of radioactive material permitted by the license.
015.06 AUTHORITY, DUTIES AND RESPONSIBILITIES. A licensee must establish in writing the authority, duties, and responsibilities of the RSO.
015.07 PROVISIONS. A licensee must provide the RSO sufficient authority, organizational freedom, time, resources and management prerogative to:
(A) Identify radiation safety problems; (B) Initiate, recommend, or provide corrective actions; (C) Stop unsafe operations; and (D) Verify implementation of corrective actions.
015.08 RADIATION SAFETY COMMITTEE. Licensees authorized for two or more different types of use under 180 NAC 7-048, 7-055, 7-067 and 7-085, or one or more types of units under 180 NAC 7-067, must 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 RSO, a representative of the nursing service, and a representative of management who is neither an authorized user nor an RSO, and may include other members the licensee deems appropriate.
015.09 RADIATION SAFETY COMMITTEE MEETINGS. A licensee’s radiation safety committee must meet as necessary, but at intervals not to exceed six months. The licensee must maintain minutes of each meeting according to 180 NAC 7-086.
015.10 RECORD OF ACTIONS. A licensee must retain a record of actions taken under 180 NAC 7-015.01, 7-015.02 and 7-015.05 according to 180 NAC 7-086.
016. RADIATION PROTECTION PROGRAM CHANGES .
016.01 REVISION LIMITATIONS. A licensee may revise its radiation protection program without Department approval if:
(A) The revision does not require a license amendment under 180 NAC 7-010; (B) The revision is in compliance with the regulations and the license; (C) The revision has been reviewed and approved by the RSO, licensee management and licensee’s Radiation Safety Committee, if applicable; and (D) The affected individuals are instructed on the revised program before changes are implemented.
016.02 RECORDS. A licensee must retain a record of each change according to 180 NAC 7-087.
017. DUTIES OF AUTHORIZED USER AND AUTHORIZED MEDICAL PHYSICIST .
017.01 AUTHORIZED USER. Only authorized users for the type of radioactive material used:
(A) Prescribe the radiopharmaceutical dosage or dose to be administered through the issuance of a written directive or reference to the diagnostic clinical procedures manual; (B) Direct, as specified in 180 NAC 7-018 and 7-019, or in license conditions, the administration of radioactive material for medical use to patients or human research subjects; (C) Prepare and administer, or supervise the preparation and administration of radioactive material for medical use, according to 180 NAC 7-007 and 7-018; and (D) Perform the final interpretation of the results of tests, studies, or treatments.
017.02 AUTHORIZED MEDICAL PHYSICIST. Only authorized medical physicists may perform, as applicable:
(A) Full calibration measurement as described in 180 NAC 7-073, 7-074, and 7-075; and (B) Radiation surveys as described in 180 NAC 7-080.
018. SUPERVISION .
018.01 TRAINING, INSTRUCTIONS AND AUDITS. A licensee permitting the receipt, possession, use, or transfer of radioactive material by an individual under the supervision of an authorized user as allowed by 180 NAC 7-007(A), must:
(A) In addition to the requirements of 180 NAC 10-003, instruct the supervised individual in the licensee’s written radiation protection procedures, written directive procedures, regulations of 180 NAC 7, and the license conditions with respect to the use of radioactive material; (B) Require the supervised individual to follow the instructions of the supervising authorized user for medical uses of radioactive material, written radiation protection procedures, written directive procedures, regulations of 180 NAC 7, and license conditions with respect to the medical use of radioactive material; (C) Require that only those individuals specifically trained, and designated by the authorized user, be permitted to administer radionuclides or radiation to patients or human research subjects; and (D) Require the authorized user to audit the performance of each supervised individual initially and at least annually. The audit must include verification that the supervised individual is meeting the requirements of 180 NAC 7-018.01(B) and physical observation of the individual performing the duties the authorized user has delegated to them.
018.02 PREPARATION OF RADIOACTIVE MATERIAL FOR MEDICAL USE. A licensee permitting 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 180 NAC 7-007(B), must:
(A) Train and instruct the supervised individual in the preparation of radioactive material for medical use, as appropriate to that individual’s involvement with radioactive material; and (B) 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, the written radiation protection procedures, the regulations of 180 NAC 7, and license conditions.
018.03 IMMEDIATE AVAILABILITY. Unless physical presence as described in other sections of 180 NAC 7 is required, a licensee who permits supervised activities under 180 NAC 7-018.01 and 7-018.02 must require an authorized user to be immediately available, by telephone within ten minutes, to communicate with the supervised individual.
018.04 RESPONSIBILITY. A licensee that permits supervised activities under 180 NAC 7-018.01 and 7-018.02 is responsible for the acts and omissions of the supervised individual.
019. WRITTEN DIRECTIVES .
019.01 DATE AND SIGNATURE. A written directive must be dated and signed by an authorized user prior to administration of I-131 sodium iodide greater than 1.11 megabecquerels (MBq) (30 microcuries (μCi)), any therapeutic dosage of unsealed radioactive material or any therapeutic dose of radiation from radioactive material.
(A) 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, provided that the information contained in the oral directive is documented as soon as possible in writing in the patient's record and a written directive is prepared within 48 hours of the oral directive.
019.02 REQUIRED INFORMATION. The written directive must contain the patient or human research subject's name and the following information:
(A) For any administration of dosage of radioactive drug containing radioactive material: the radioactive drug containing radioactive material, dosage, and the route of administration; (B) For gamma stereotactic radiosurgery: the total dose, treatment site, and number of target coordinate settings per treatment for each anatomically distinct treatment site; (C) For teletherapy: the total dose, dose per fraction, number of fractions, and treatment site; (D) For HDR remote afterloading brachytherapy: the radionuclide, treatment site, dose per fraction, number of fractions, and total dose; (E) For permanent implant brachytherapy:
(i) Before implantation: The treatment site, the radionuclide, and the total source strength; and (ii) 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 date; or
(F) For all other brachytherapy, including low, medium, and pulsed dose rate remote afterloaders:
(i) Before implantation: treatment site, the radionuclide, and dose; and (ii) After implantation but prior to completion of the procedure: the radioisotope, treatment site, number of sources, and total source strength and exposure time, or the total dose; and the date.
019.03 WRITTEN REVISIONS. A written revision to an existing written directive may be made provided that the revision is dated and signed by an authorized user prior to the administration of the dosage of radioactive drug containing unsealed radioactive material, the brachytherapy dose, the gamma stereotactic radiosurgery dose, the teletherapy dose, or the next fractional dose.
(A) 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 and a revised written directive is signed by the authorized user within 48 hours of the oral revision.
019.04 RETENTION. The licensee must retain a copy of the written directive according to 180 NAC 7-088.
020. PROCEDURES FOR ADMINISTRATIONS REQUIRING A WRITTEN DIRECTIVE .
020.01 WRITTEN PROCEDURES. For any administration requiring a written directive, the licensee must develop, implement, and maintain written procedures to provide high confidence that:
(A) The patient’s or human research subject’s identity is verified before each administration; and (B) Each administration is according to the written directive.
020.02 VERIFICATION. The procedures required by 180 NAC 7-020.01 must, at a minimum, address the following items that are applicable to the licensee’s use of radioactive material:
(A) Verifying the identity of the patient or human research subject; (B) Verifying that the specific details of the administration is according to the treatment plan, if applicable, and the written directive; (C) Checking both manual and computer-generated dose calculations; (D) Verifying that any computer-generated dose calculations are correctly transferred into the consoles of therapeutic medical units authorized by 180 NAC 7-067 or 7-085; (E) Determining if a misadministration, as defined in 180 NAC 7-115, has occurred; and (F) 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.
021. SUPPLIERS OF SEALED SOURCES OR DEVICES FOR MEDICAL USE . A licensee may only use:
(A) Sealed sources or devices initially manufactured, labeled, packaged, and distributed according to a license issued according to 180 NAC 3 or the equivalent regulations of the NRC or another Agreement State. (B) Teletherapy sources manufactured and distributed according to a license issued according to 180 NAC 3, or the equivalent regulations of the NRC or another Agreement State.
022. TRAINING FOR RADIATION SAFETY OFFICER OR ASSOCIATE RADIATION SAFETY OFFICER . Other than provided in 180 NAC 7-026, the licensee must require an individual fulfilling the responsibilities of the RSO or an individual assigned duties and tasks as ARSO as provided in 180 NAC 7-015 to meet the following requirements:
(A) The individual must be certified by a specialty board whose certification process has been recognized by the Department, an Agreement State or the NRC and who meets the requirements in 180 NAC 7-022(D). The names of board certifications that have been recognized by the NRC or an Agreement State are posted on the NRC’s Medical Uses Licensee Toolkit website. To have its certification process recognized, a specialty board must require all candidates for certification to:
(i) For bachelor’s or graduate degrees:
(1) 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 20 college credits in physical science; (2) Have five or more years of professional experience in health physics, graduate training may be substituted for no more than two years of the required experience, including at least three years in applied health physics; and (3) 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
(ii) For master’s and doctor’s degrees:
(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 or supervised experience in medical physics:
(a) Under the supervision of a medical physicist who is certified in medical physicist by a specialty board recognized by the Department, an Agreement State, or the NRC; or (b) In clinical nuclear medicine facilities providing diagnostic or therapeutic services under the direction of physicians who meet the requirements for authorized users in 180 NAC 7-026, 7-047 or 7-051; and
(iii) 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) The individual must:
(i) Have completed a structured educational program consisting of both:
(1) 200 hours of classroom and laboratory training in the following areas:
(a) Radiation physics and instrumentation; (b) Radiation protection; (c) Mathematics pertaining to the use and measurement of radioactivity; (d) Radiation biology; and (e) Radiation dosimetry; and
(2) One year of full-time radiation safety experience under the supervision of the individual identified as the RSO on an NRC or an Agreement State license or permit issued by an NRC master material licensee that authorizes similar type or types of use or uses of radioactive material. An ARSO may provide supervision for those areas for which the ARSO is authorized on an NRC or an Agreement State license or permit issued by an NRC master material licensee. The full-time radiation safety experience must involve the following:
(a) Shipping, receiving, and performing related radiation surveys; (b) Using and performing checks for proper operation of instruments used to determine the activity of dosages, survey meters, and instruments used to measure radionuclides; (c) Securing and controlling radioactive material; (d) Using administrative controls to avoid mistakes in the administration of radioactive material; (e) Using procedures to prevent or minimize radioactive contamination and using proper decontamination procedures; (f) Using emergency procedures to control radioactive material; (g) Disposing of radioactive material; and
(ii) Obtain a written attestation, signed by a preceptor RSO or ARSO, who has experience with the radiation safety aspects of similar types of use of radioactive material for which the individual is seeking approval as an RSO or as an ARSO. The written attestation must state that the individual has satisfactorily completed the requirements in 180 NAC 7-022(B)(i) and 180 NAC 7-022 (D), and is able to independently fulfill the radiation safety related duties as a radiation safety officer or as an associate radiation safety officer for medical use license; or
(C) The individual must:
(i) Be a medical physicist certified by a specialty board whose certification process has been recognized by the Department, the NRC or an Agreement State in 180 NAC 7-023(A) 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 RSO or an ARSO, and who meets the requirement in 180 NAC 7-022(D); or (ii) Be an authorized user, authorized medical physicist, or authorized nuclear pharmacist identified on the Department, the NRC or an Agreement State license, a permit issued by NRC master material licensee, a permit issued by the NRC or an Agreement State licensee of broad scope, or a permit issued by the NRC 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 RSO or ARSO, and meets the requirements in 180 NAC 7-022(D); or (iii) Have 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 RSO and the authorized user on the same new medical use license or new medical use permit issued by a Commission master material licensee. The individual must also meet the requirements in 180 NAC 7-022(D); and
(D) An individual who 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 supervised by a RSO, an ARSO, authorized medical physicist, authorized nuclear pharmacist, or authorized user as appropriate, who is authorized for the type or types of use for which the licensee is seeking approval.
023. TRAINING FOR AN AUTHORIZED MEDICAL PHYSICIST . Other than provided in 180 NAC 7-026 the licensee must require the authorized medical physicist to be:
(A) An individual who is certified by a specialty board whose certification process has been recognized by the Department, the NRC or an Agreement State and who meets the requirements of 180 NAC 7-023(C). The names of board certifications that have been recognized by an Agreement State or the NRC are posted on the NRC’s Medical Uses Licensee Toolkit website. To have its certification process recognized, a specialty board must require all candidates for certification to:
(i) 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; (ii) Have two years of full-time practical training or supervision experience in medical physics:
(1) 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 section by the Department, an Agreement State, or the NRC; or
(2) In a clinical radiation facility providing high energy, external beam therapy (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 180 NAC 7-026, 7-063 or 7-084; and
(iii) Pass an examination, administered by diplomates of the specialty board, which 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) An individual who:
(i) 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 types or types 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, photons and electrons with energies greater than or equal to one million electron volts, and brachytherapy services and must include:
(1) Performing sealed source leak tests and inventories; (2) Performing decay corrections; (3) Performing full calibration and periodic spot checks of external beam treatment units, stereotactic radiosurgery units, and remote afterloading units as applicable; and (4) Conducting radiation surveys around external beam treatment units, stereotactic radiosurgery units, and remote afterloading units as applicable; and
(ii) Has obtained written attestation that the individual has satisfactorily completed the requirements in 180 NAC 7-023.02(B)(i) and 180 NAC 7-023(C), 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 180 NAC 7-023, 7-026 or equivalent NRC 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; and
(C) Has training for the type or types of use for which authorization is sought that includes hands-on device operation, safety procedures, clinical use, and 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 or types of use for which the individual is seeking authorization.
024. TRAINING FOR AN AUTHORIZED NUCLEAR PHARMACIST . The licensee must require the authorized nuclear pharmacist to be a pharmacist who:
(A) Is certified by a specialty board whose certification process has been recognized by an Agreement State or the NRC. The names of the board certifications that have been recognized by an Agreement State or the NRC are posted on the NRC Medical Uses Licensee Toolkit website. To have its certification process recognized, a specialty board must require all candidates for certification to:
(i) Have graduated from a pharmacy program accredited by the Accreditation Council for Pharmacy Education, previously named the American Council on Pharmaceutical Education, or have passed the Foreign Pharmacy Graduate Examination Committee examination; (ii) Hold a current, active license to practice pharmacy; (iii) Provide evidence of having acquired at least 4,000 hours of training or experience, or both in nuclear pharmacy practice. Academic training may be substituted for no more than 2,000 hours of the required training and experience; and (iv) Pass an examination in nuclear pharmacy administered by diplomates of the specialty board, which 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 completed all of the following requirements:
(i) 700 hours in a structured educational program consisting of both:
(1) 200 hours of classroom and laboratory training in the following areas:
(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) Supervised practical experience in nuclear pharmacy involving:
(a) Shipping, receiving, and performing related radiation surveys; (b) 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; (c) Calculating, assaying, and safely preparing dosages for patients or human research subjects; (d) Using administrative controls to avoid misadministrations in the administration of radioactive material; and (e) Using procedures to prevent or minimize radioactive contamination and using proper decontamination procedures; and
(ii) Has obtained written attestation, signed by a preceptor authorized nuclear pharmacist, that the individual has satisfactorily completed the requirements of 180 NAC 7-024(B) and is able to independently fulfill the radiation safety-related duties as an authorized nuclear pharmacist.
025. TRAINING AND TECHNICAL REQUIREMENT FOR NUCLEAR MEDICINE TECHNOLOGISTS AND RADIATION THERAPISTS .
025.01 NUCLEAR MEDICINE TECHNOLOGY. The licensee must require an individual performing nuclear medicine technology under the supervision of an authorized user to be an individual who:
(A) Is certified in:
(i) Nuclear Medicine by the Nuclear Medicine Technology Certification Board; or (ii) Nuclear Medicine by the American Registry of Radiologic Technologists (ARRT) with competency in Nuclear Medicine;
(B) Is board eligible to take the Nuclear Medicine Technology Certification Board or the ARRT with competency in Nuclear Medicine examination; (C) Has successfully completed a training program in nuclear medicine which has resulted in certificate, associate degree, or baccalaureate degree in a nuclear medicine technology program from an accredited institution; or (D) Has training and experience in basic radionuclide handling techniques applicable to the medical use of unsealed radioactive material that includes:
(i) 200 hours of classroom and laboratory training in the following areas:
(1) Radiation Physics and instrumentation; (2) Radiation protection; (3) Mathematics pertaining to the use and measurement of radioactivity; (4) Chemistry of radioactive material for medical use; (5) Radiation biology; and (6) Imaging Technology;
(ii) Work experience, under the supervision of an authorized user involving:
(1) Ordering, receiving, and unpacking radioactive materials safely and performing the related radiation surveys; (2) Quality Control checking of instruments used to determine the activity of dosages and performing checks for proper operation of survey meters; (3) Calculating, measuring, and safely preparing patient or human research subject dosages; (4) Using administrative controls to prevent a misadministration involving the use of unsealed radioactive material; and (5) Using procedures to contain spilled radioactive material safely and using proper decontamination procedures;
(iii) Supervised clinical experience under the supervision of an authorized user that includes:
(1) Reviewing the case histories of individuals to determine their suitability for radioisotope diagnosis, limitations, or contraindications; (2) Identifying radiopharmaceuticals for clinical procedures and calculating and measuring the dosages; (3) Administering dosages to individuals and using syringe radiation shields; and (4) Acquiring and manipulating diagnostic data; and
(iv) Has obtained written certification, signed by a preceptor authorized user the individual has satisfactorily completed the requirements of 180 NAC 7-025.01(D)(i) and (ii) and has achieved a level of radiation safety competency sufficient to independently function as a nuclear medicine technologist.
025.02 RADIATION THERAPY. The licensee must require a radiation therapist using radioactive materials under the supervision of an authorized user to be an individual who:
(A) Is certified in Radiation Therapy by the ARRT; (B) Be eligible to take the ARRT examination in Radiation Therapy; (C) Has successfully completed a training program in radiation therapy which has resulted in a certificate, associate degree, or baccalaureate degree in a radiologic technology program that complies with the requirements of the Joint Review Committee on Education in Radiologic Technology, "Standards for Accredited Educational Program in Radiologic Sciences – Effective January 1, 2002”, Joint Review Committee on Education in Radiologic Technology, January 1996; Revised 2001. This document is available for viewing at the Department of Health and Human Services, Office of Radiological Health, 301 Centennial Mall South, Lincoln, Nebraska 68509; or (D) Has completed 200 hours of training and experience in basic radionuclide handling techniques applicable to the medical use of radioactive material that includes:
(i) 200 hours of classroom and laboratory training in the following areas:
(1) Radiation physics and instrumentation; (2) Radiation protection; (3) Mathematics pertaining to the use and measurement of radioactivity; and (4) Radiation biology; and
(ii) Work experience, under the supervision of an authorized user involving:
(1) Ordering, receiving, and unpacking radioactive materials safely and performing the related radiation surveys; (2) Assisting the authorized user in simulating the patient for treatment; (3) Preparing the patient for treatment; (4) Implementing treatment plans as prescribed by the authorized user; (5) Providing written documentation of treatment setup and patient treatments; (6) Quality control checks to determine that devices used to deliver the radiation doses are in compliance with institutional standards and performing checks for proper operation of survey meters; (7) Preparing or assisting in the preparation of sources, and implantation and removal of sealed sources; (8) Delivering doses to patients or human research subjects under the supervision of the authorized user; (9) Maintaining running inventories of radioactive material on hand; (10) Using administrative controls to prevent a misadministration involving the use of radioactive material; and, (11) Properly implementing emergency procedures; and
(iii) Has obtained written certification, signed by a preceptor authorized user that the individual has satisfactorily completed the requirements of 180 NAC 7-025.02 (D)(i) and (D)(ii) and has achieved a level of radiation safety competency sufficient to independently function as a radiation therapist.
025.03 RECORDS. The licensee must maintain records of the above training as specified in 180 NAC 7-100.
026. PROVISIONS FOR EXPERIENCED RADIATION SAFETY OFFICER, TELETHERAPY OR MEDICAL PHYSICIST, AUTHORIZED MEDICAL PHYSICIST, AUTHORIZED USER, NUCLEAR PHARMACIST AND AUTHORIZED NUCLEAR PHARMACIST .
026.01 LICENSE OR PERMIT. An individual identified on an NRC or Agreement State license or a permit issued by an NRC or Agreement State broad scope licensee or master material license permit or by a master material license permittee of broad scope as an RSO, a teletherapy or medical physicist, an authorized medical physicist, a nuclear pharmacist or an authorized nuclear pharmacist on or before the effective date of these regulations need not comply with the training requirements of 180 NAC 7-022 through 7-024, respectively, other than RSOs and authorized medical physicists identified in this paragraph must meet the training requirements in 180 NAC 7-022(D) or 7-023(C) as appropriate, for any material or uses for which they were not authorized prior to this date.
026.02 CERTIFICATION. 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 180 NAC 7-022 to be identified as a radiation safety officer or as an associate on an NRC or an Agreement State license or NRC master material license permit for those materials and uses that these individuals performed on or before October 24, 2005.
026.03 PRIOR CERTIFICATION. Any individual certified by the American Board of Radiology in therapeutic radiological physics, Roentgen ray and gamma ray physics, x-ray 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 180 NAC 7-023, for those materials and uses that these individuals performed on or before October 24, 2005.
026.04 IDENTIFIED AS AN AUTHORIZED USER. Physicians, dentists, or podiatrists identified as authorized users for the medical use of radioactive material on a license issued by the NRC, an Agreement State or the Department, a permit issued by an NRC master material licensee, a permit issued by an NRC, an Agreement State, or the Department broad scope licensee, or on a permit issued by an NRC master material license broad scope permittee before the effective date of these regulations, who perform only those medical uses for which they were authorized on or before that date need not comply with the training requirements 180 NAC 7-041 through 7-084.
026.05 NOT IDENTIFIED AS AN AUTHORIZED USER. Physicians, dentists, or podiatrists not identified as authorized users for the medical use of radioactive material on a license issued by the NRC or an Agreement State, a permit issued by an NRC master material licensee, a permit issued by an NRC or an Agreement State broad scope licensee, or a permit issued by an NRC master material broad scope license on or before October 24, 2005, need not comply with the training requirements for those materials and uses that these individuals performed on or before October 24, 2005, as follows:
(A) For uses authorized under 180 NAC 7-041 or 7-044 or oral administration of sodium iodide I–131 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 xRadiology; 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 180 NAC 7-048, 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 180 NAC 7-055 or 7-067, 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 180 NAC 7-065, 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.
026.06 PRECEPTORS AND SUPERVISORS. Individuals who need not comply with training requirements as described in 180 NAC 7-026 may serve as preceptors for, and supervisors of, applicants seeking authorization on Department licenses for the same uses for which these individuals are authorized.
027. RECENTNESS OF TRAINING . The training and experience specified in 180 NAC 7 must have been obtained within seven years preceding the date of license application or the individual must have had related continuing education and experience since the required training and experience was completed.
028. QUALITY CONTROL OF DIAGNOSTIC EQUIPMENT . Each licensee must establish written quality control procedures for all diagnostic equipment used for radionuclide studies. As a minimum, quality control procedures and frequencies must be those recommended by equipment manufacturers or procedures, which have been approved by the Department. The licensee must conduct quality control procedures according to written procedures.
029. POSSESSION, USE, AND CALIBRATION OF INSTRUMENTS USED TO MEASURE THE ACTIVITY OF UNSEALED RADIOACTIVE MATERIAL . To perform direct measurements according to 180 NAC 7-031, a licensee must:
(A) Possess and use instrumentation to measure the activity of unsealed radioactive material before administration to each patient or human research subject; (B) Calibrate the instrumentation according to nationally recognized standards or the manufacturer’s instructions. The calibrations must, at minimum and as appropriate to demonstrate proper operation of the instrument, test for:
(i) Constancy; (ii) Linearity; (iii) Accuracy; and (iv) Geometry dependence; and
(C) Retain a record of each instrument test required by 180 NAC 7-029 according to 180 NAC 7-091.
030. CALIBRATION OF SURVEY INSTRUMENTS .
030.01 REQUIREMENTS. A licensee must calibrate the survey instruments used to show compliance with 180 NAC 7 and 180 NAC 4 before first use, annually, and following any repair that affects the calibration. A licensee must:
(A) Calibrate all required scale readings up to 10 mSv (1000 mrem) per hour with a radiation source; (B) Have each radiation survey instrument calibrated:
(i) At energies appropriate for use and at annual intervals or after servicing instrument, other than battery changes; (ii) 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 and each decade, and at two points of at least one decade; and for digital instruments, at three points between 0.02 and 10 mSv (2 and 1,000 mrem) per hour; and (iii) For dose rate instruments, so that an accuracy within plus or minus twenty percent of the true radiation dose rate can be demonstrated at each point checked; and
(C) Conspicuously note on the instrument the date of calibration.
030.02 TOLERANCE. The licensee may not use survey instruments if the difference between the indicated exposure rate and the calculated exposure rate is more than twenty percent.
030.03 SURVEY INSTRUMENT CHECK. A licensee must check each survey instrument for consistent response with a dedicated check source before each use. The licensee is not required to keep records of these checks.
030.04 RECORDS. A licensee must maintain a record of each survey instrument calibration according to 180 NAC 7-092.
031. DETERMINATION OF DOSAGES OF UNSEALED RADIOACTIVE MATERIAL FOR MEDICAL USE .
031.01 DOSAGE ACTIVITY. A licensee must determine and record the activity of each dosage prior to medical use.
031.02 UNIT DOSAGE DETERMINATION. For unit dosages, this determination must be made by:
(A) Direct measurement of radioactivity; or (B) A decay calculation, based on the activity or activity concentration determined by:
(i) A manufacturer or preparer licensed according to 180 NAC 3-014.10 or equivalent NRC or Agreement State requirements; (ii) A Department, NRC, or Agreement State licensee for use in research according to a Radioactive Drug Research Committee-approved protocol or an Investigation New Drug (IND) protocol accepted by the FDA; or (iii) A positron emission tomography (PET) radioactive drug producer licensed in 180 NAC 3-010.11 or equivalent NRC or Agreement State requirements.
031.034 OTHER THAN UNIT DOSAGE. For other than unit dosages, this determination must be made by:
(A) Direct measurement of radioactivity; (B) Combination of measurement of radioactivity and mathematical calculations; or (C) Combination of volumetric measurements and mathematical calculations, based on the measurement made by:
(i) A manufacturer or preparer licensed according to 180 NAC 3-014.10 or equivalent provision of the NRC or Agreement State; or (ii) A PET radioactive drug producer licensed in 180 NAC 3-010.11 or equivalent NRC or Agreement State requirements.
031.04 DOSAGE RANGE. 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 percent.
031.05 RECORD RETENTION. A licensee must retain a record of the dosage determination required by 180 NAC 7 according to 180 NAC 7-093.
032. AUTHORIZATION FOR CALIBRATION, TRANSMISSION AND REFERENCE SOURCES . Any person authorized by 180 NAC 7-007 for medical use of radioactive material may receive, possess, and use the following radioactive material for check, calibration, and reference use:
(A) Sealed sources manufactured and distributed, or redistributed by persons specifically licensed according to 180 NAC 3 or equivalent provisions of the NRC, or Agreement State and that do not exceed 1.11 GBq (30 mCi) each; (B) Any radioactive material with a half-life of 120 days or less in individual amounts not to exceed 555 MBq (15 mCi); (C) Any radioactive material with a half-life greater than 120 days in individual amounts not to exceed the smaller of:
(i) 7.4 MBq (200 μCi); or (ii) 1000 times the quantities in Appendix B of 180 NAC 3; or
(D) Technetium-99m in amounts as needed.
033. REQUIREMENTS FOR POSSESSION OF SEALED SOURCES AND BRACHYTHERAPY SOURCES .
033.01 RADIATION SAFETY AND HANDLING INSTRUCTIONS. A licensee in possession of any sealed source or brachytherapy source must follow the radiation safety and handling instructions supplied by the manufacturer, or equivalent instructions approved by the Department.
033.02 LEAK TESTING. A licensee in possession of a sealed source must:
(A) Test the source for leakage according to 180 NAC 1-011; and (B) Test the source for leakage at intervals not to exceed six months or at intervals approved by the Department, another Agreement State, or the NRC in the Sealed Source and Device Registry.
033.03 REMOVABLE CONTAMINATION FINDING. If a leak test reveals the presence of 185 Bq (0.005 μCi) or more of removable contamination, the licensee must:
(A) Immediately withdraw the sealed source from use and store, dispose, or cause it to be repaired according to the requirements of 180 NAC 1-011.06 and 180 NAC 4; and (B) File a report within five days of the leak test according to 180 NAC 7-118.
033.04 PHYSICAL INVENTORY. A licensee in possession of a sealed source or brachytherapy source, other than gamma stereotactic radiosurgery sources, must conduct a semi-annual physical inventory of all such sources. The licensee must retain each inventory record according to 180 NAC 7-094.
034. LABELING OF VIALS AND SYRINGES . Each syringe and vial containing 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.
035. VIAL AND SYRINGE SHIELDS .
035.01 VIALS CONTAINING RADIOACTIVE DRUGS. A licensee must require each individual preparing or handling a vial containing a radioactive drug to keep the vial in a vial shield.
035.02 SYRINGES CONTAINING RADIOACTIVE MATERIAL. A licensee must:
(A) Keep syringes containing radioactive material to be administered in a shield; and (B) Require each individual who prepares or administers radioactive drugs to use a syringe shield unless the use of the shield is contraindicated for that patient or human research subject.
036. SURVEYS FOR AMBIENT RADIATION DOSE RATE AND CONTAMINATION . A licensee must:
(A) Survey with a radiation detection survey instrument:
(i) At the end of each day of use all areas where radioactive drugs are routinely prepared for use or administered; and (ii) At least once each week all areas where radioactive drugs or radioactive wastes are stored;
(B) Conduct the surveys required by 180 NAC 7-036 (A) so as to be able to measure dose rates as low as 1 μSv (0.1 mrem) per hour;
(C) Establish dose rate action levels for the surveys required by 180 NAC 7-036 (A) and must require that the individual performing the survey to immediately notify the radiation safety officer if a dose rate exceeds the action level;
(D) Survey for removable contamination:
(i) Once each day of use all areas where generators and bulk radioactive drugs are prepared for use or administered, and (ii) Once each week where unsealed radioactive materials are prepared for use or administered and where unsealed radioactive materials are stored;
(E) Conduct the surveys required by 180 NAC 7-036 (D) so as to be able to detect contamination on each wipe sample of 33.3 Bq (2000 dpm);
(F) Establish removable contamination action levels for the surveys required by 180 NAC 7-036 (D) and must require that the individual performing the survey to immediately notify the radiation safety officer if contamination exceeds the action level; and
(G) Retain a record of each survey according to 180 NAC 7-095.
037. RELEASE OF INDIVIDUALS CONTAINING RADIOACTIVE DRUGS OR IMPLANTS .
037.01 TOTAL EFFECTIVE DOSE EQUIVALENT TO ANOTHER INDIVIDUAL. A licensee may authorize the release from its control of any individual who has been administered unsealed radioactive drugs 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 5 mSv (0.5 rem). NRC’s - NUREG-1556, Vol.9 “Consolidated Guidance About Materials Licenses: Program-Specific Guidance About Medical Licenses,” describes methods for calculating doses to other individuals and contains tables of activities not likely to cause doses exceeding 5 mSv (0.5 rem).
037.02 ORAL AND WRITTEN INSTRUCTIONS. For patients administered radioactive material for which a written directive is required, a licensee must provide the released individual, or individual’s parent or guardian with oral and written instructions on actions recommended to maintain doses to other individuals ALARA if the total effective dose equivalent to any other individual is likely to exceed 1 mSv (0.1 rem). If the dose to a breast-feeding infant or child could exceed 1 mSv (0.1 rem) assuming there were no interruption of breast-feeding, the instructions must also include:
(A) Guidance on the interruption or discontinuation of breast-feeding; and (B) Information on the potential consequences, if any, of failure to follow the guidance.
037.03 APPROVAL FOR PATIENT RELEASE. Release of the patient must be approved by an individual listed as an authorized user on the Department license or an approved individual who is operating directly under the supervision of an authorized user approved for the type of radioactive material use for which the patient being released has received.
037.04 RECORD OF BASIS FOR RELEASE. The licensee must maintain a record of the basis for authorizing the release of an individual according to 180 NAC 7-096.
037.05 RECORD OF INSTRUCTIONS PROVIDED TO BREASTFEEDING FEMALES. The licensee must maintain a record of instructions provided to a breast-feeding female according to 180 NAC 7-096.
037.06 NOTIFICATION. The licensee must notify the Department according to 180 NAC 7-119:
(A) When they are aware a patient containing radioactive material and who was released according to 180 NAC 7-037 dies; and, (B) If it is possible that any individual could receive exposures in excess of 5 mSv (500 mrem) as a result of the deceased’s body.
038. MOBILE MEDICINE SERVICE TECHNICAL REQUIREMENTS . A licensee providing mobile nuclear medicine services must:
(A) Transport to each address of use only syringes or vials containing prepared drugs or radioactive materials intended for reconstitution of radioactive drug kits; (B) Bring into each location of use all radioactive material to be used and, before leaving, remove all unused radioactive material and associated radioactive waste; (C) Secure or keep under constant surveillance and immediate control all radioactive material when in transit or at an address of use; (D) Check instruments used to measure the activity of unsealed radioactive material for proper function before medical use at each address of use or on each day of use, whichever is more frequent. At a minimum, the check for proper function must include a constancy check; (E) Check survey instruments for consistent response with a dedicated check source before use at each client's address; (F) Prior to leaving a client's address of use, perform area surveys and survey for removable contamination in all areas of use to ensure compliance with the requirements in 180 NAC 4; (G) Use radioactive gases only in areas of use and under conditions which have been evaluated and approved by the Department for compliance with airborne release standards; and (H) Retain a record of each survey required by 180 NAC 7-038, (F) according to 180 NAC 7-097.
039. STORAGE AND CONTROL OF VOLATILES AND GASES .
039.01 VOLATILE RADIOACTIVE MATERIAL AND RADIOACTIVE GASES. A licensee must store volatile radioactive material and radioactive gases in a radiation shield and container.
039.02 MULTI-DOSE CONTAINER. A licensee must store and use a multi-dose container in a properly functioning fume hood.
039.03 AIRBORNE CONCENTRATIONS. A licensee who administers radioactive aerosols or gases must do so with a system that will keep airborne concentrations within the limits prescribed in 180 NAC 4.
039.04 VENTILATION. The system must either be directly vented to the atmosphere through an air exhaust or provide for collection and decay or disposal of the aerosol or gas in a shielded container.
039.05 COLLECTION SYSTEM OPERATIONS CHECK. A licensee must check the operation of collection systems monthly and measure the ventilation rates in areas of use at intervals not to exceed six months. Records of these checks and measurements must be maintained for three years.
039.06 NEGATIVE PRESSURE ROOMS. A licensee must only administer radioactive gases in rooms that are at negative pressure compared to surrounding rooms.
039.07 TIME AFTER RELEASE CALCULATION. Before receiving, using, or storing a radioactive gas, the licensee must calculate the amount of time needed after a release to reduce the concentration in the area of use to the occupational limit listed in 180 NAC 4, Appendix 4-B. The calculation must be:
(A) Based on the highest activity of gas handled in a single container, the air volume of the room, and the measured available air exhaust rate; (B) Posted at the area of use and require that, in the case of a gas spill, individuals evacuate the room until the posted time has elapsed; and (C) Recorded and retained for the duration of the license.
040. DECAY-IN-STORAGE . See 180 NAC 4-039.03 for decay-in-storage requirements.
041. USE OF UNSEALED RADIOACTIVE MATERIAL FOR UPTAKE, DILUTION, AND EXCRETION STUDIES FOR WHICH A WRITTEN DIRECTIVE IS NOT REQUIRED . A licensee may use any unsealed radioactive material, in quantities that do not require a written directive, prepared for medical use involving measurements of uptake, dilution, or excretion that is:
(A) Obtained from:
(i) A manufacturer or preparer licensed according to 180 NAC 3-014.10 or equivalent NRC or Agreement State requirements; or (ii) A PET radioactive drug producer licensed under 180 NAC 3-010.11 or equivalent NRC or Agreement State requirements; or
(B) Excluding production of PET radionuclides, prepared by:
(i) An authorized nuclear pharmacist; (ii) A physician who is an authorized user and who meets the requirements specified in 180 NAC 7-047 or 7-051 and 7-047.03(A)(ii)(7); or (iii) An individual under the supervision, as specified in 180 NAC 7-018, of the authorized nuclear pharmacist in 180 NAC 7-041(B(i) or the physician who is authorized user in 180 NAC 7-041(Bii).
(C) Obtained from and prepared by an NRC or Agreement State licensee for use in research according to a Radioactive Drug Research Committee-approved protocol or an Investigational New Drug (IND) protocol accepted by the FDA. (D) Prepared by the licensee according to a Radioactive Drug Research Committee-approved application or an Investigational New Drug (IND) protocol accepted by the FDA for use in research.
042. POSSESSION OF SURVEY INSTRUMENT . A licensee authorized to use radioactive material for uptake, dilution, and excretion studies must possess a portable radiation detection survey instrument capable of detecting dose rates over the range of 1 μSv (0.1 mrems) per hour to 1000 μSv (100 mrems) per hour. The instrument must be operable and calibrated according to 180 NAC 7-030.
043. TRAINING FOR UPTAKE, DILUTION, AND EXCRETION STUDIES . Other than as provided in 180 NAC 7-026, the licensee must require an authorized user of unsealed radioactive material for the uses authorized in 180 NAC 7-041 to be a physician who:
(A) Is certified by a medical specialty board whose certification process has been recognized by the Department, NRC, or an Agreement State. The names of board certifications that have been recognized by the NRC or an Agreement State are posted on the NRC’s Medical Uses Licensee Toolkit website. To have its certification process recognized, a specialty board must require all candidates for certification to:
(i) Complete 60 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 as described in 180 NAC 7-043(C)(i) and (ii); and (ii) 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 180 NAC 7-047 or 7-051 or equivalent NRC or Agreement State requirements; or
(C) Has completed 60 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:
(i) Classroom and laboratory training in the following areas:
(1) Radiation physics and instrumentation; (2) Radiation protection; (3) Mathematics pertaining to the use and measurement of radioactivity; (4) Chemistry of radioactive material for medical use; and (5) Radiation biology;
(ii) Work experience, under the supervision of an authorized user who meets the requirements in 180 NAC 7-026, 7-043, 7-047 or 7-051 or equivalent NRC or Agreement State requirements, involving:
(1) Ordering, receiving, and unpacking radioactive materials safely and performing the related radiation surveys; (2) Performing quality control procedures on instruments used to determine the activity of dosages and performing checks for proper operation of survey meters; (3) Calculating, measuring, and safely preparing patient or human research subject dosages; (4) Using administrative controls to prevent a misadministration involving the use of unsealed radioactive material; (5) Using procedures to contain spilled radioactive material safely and using proper decontamination procedures; and (6) Administering dosages of radioactive drugs to patients or human research subjects; and
(iii) Has obtained written attestation that the individual has satisfactorily completed the requirement in 180 NAC 7-043(C) and is able to independently fulfill the radiation safety-related duties as an authorized user for the medical uses authorized under 180 NAC 7-041. The attestation must be obtained from either:
(1) A preceptor authorized user who meets the requirements in 180 NAC 7-026, 7-043, 7-047, or 7-051, or equivalent NRC or Agreement State requirements; or (2) 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 180 NAC 7-026, 7-043, 7-047, or 7-051, or equivalent NRC 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 or 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 180 NAC 7-043(C) of this section.
044. USE OF UNSEALED RADIOACTIVE MATERIAL FOR IMAGING AND LOCALIZATION STUDIES FOR WHICH A WRITTEN DIRECTIVE IS NOT REQUIRED . A licensee may use, for imaging and localization studies, any radioactive material prepared for medical use, in quantities that do not require a written directive as described in 180 NAC 7-019 that is:
(A) Obtained from:
(i) A manufacturer or preparer licensed according to 180 NAC 3-014.10 or equivalent NRC or Agreement State; or (ii) A PET radioactive drug producer licensed according to 180 NAC 3-010.11 or equivalent NRC or Agreement State; or
(B) Excluding production of PET radionuclides, prepared by:
(i) An authorized nuclear pharmacist; (ii) A physician who is an authorized user and who meets the requirements specified in 180 NAC 7-047, or 7-051 and 7-047.03(A)(ii)(7); or (iii) An individual under the supervision, as specified in 180 NAC 7-018, of the authorized nuclear pharmacist in paragraph 180 NAC 7-044(B)(i) or the physician who is an authorized user in paragraph 180 NAC 7-044(B)(ii); or
(C) Obtained from and prepared by an NRC or Agreement State licensee for use in research according to a Radioactive Drug Research Committee approved protocol or an Investigational New Drug (IND) protocol accepted by the FDA; or (D) Prepared by the licensee for use in research according to a Radioactive Drug Research Committee-approved application or an Investigational New Drug (IND) protocol accepted by the FDA.
045. RADIONUCLIDE CONTAMINANTS .
045.01 LIMITS. A licensee must not administer to humans a radioactive drug containing:
(A) More than 0.15 kBq of molybdenum-99 per MBq of technetium-99m (0.15 μCi of molybdenum-99 per mCi of technetium-99m); (B) More than 0.02 kBq of strontium-82 per MBq of rubidium-82 chloride injection (0.02 μCi of strontium-82 per mCi of rubidium-82 chloride injection); or (C) More than 0.02 kBq of strontium-85 per MBq of rubidium-82 chloride injection (0.02 μCi of strontium-85 per mCi of rubidium-82 chloride injection).
045.02 CONCENTRATION MEASUREMENT IN RADIOACTIVE DRUG PREPARATION. To demonstrate compliance with 180 NAC 7-045, the licensee preparing radioactive drugs from radionuclide generators must:
(A) Measure the concentration of radionuclide contaminant in each eluate after receipt of a molybdenum-99/technetium-99m generator; or (B) Measure the concentration of radionuclide contaminant in each eluate or extract, as appropriate for other generator systems.
045.03 STRONTIUM-82/RUBIDIUM-82 GENERATORS. A licensee that uses strontium-82/rubidium-82 generator for preparing a rubidium-82 radiopharmaceutical must, before the first patient use of the day, measure the concentration of radionuclides strontium-82 and strontium-85 to demonstrate compliance with 180 NAC 7-045.01.
045.04 RECORDS. A licensee who must measure radionuclide concentration must retain a record of each measurement according to 180 NAC 7-099.
045.05 REPORTING REQUIREMENT. A licensee must report according to 180 NAC 7-120 each occurrence of a concentration exceeding the limits specified in 180 NAC 7-045.01.
046. POSSESSION OF SURVEY INSTRUMENTS . A licensee authorized to use radioactive material for imaging and localization studies must possess a portable radiation detection survey instrument capable of detecting dose rates over the range of 1 μSv (0.1 mrem) per hour to 500 μSv (50 mrem) per hour. If generators, Mo99/Tc99m or Sr82/Rb82, are utilized, a portable radiation measurement survey instrument capable of measuring dose rates over the range 10 μSv (1 mrem) per hour to 10 mSv (1000 mrem) per hour. The instruments must be operable and calibrated according to 180 NAC 7-030.
047. TRAINING FOR IMAGING AND LOCALIZATION STUDIES . Other than provided in 180 NAC 7-026, the licensee must require an authorized user of unsealed radioactive material for the uses authorized in 180 NAC 7-044 to be a physician who:
047.01 CERTIFICATION. Is certified by a medical specialty board whose certification process has been recognized by an Agreement State or the NRC. The names of board certification that have been recognized by the Department, an Agreement State or the NRC are posted on the NRC’s Medical Uses Licensee Toolkit website. To have its certification process recognized, a specialty board must require all candidates for certification to:
(A) Complete 700 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 as described in 180 NAC 7-047.03(A)(i) through (A)(ii)(7); and (B) Pass an examination, administered by diplomates of the specialty board, which assesses knowledge and competence in radiation safety, radionuclide handling, and quality control; or
047.02 AUTHORIZED USER. Is an authorized user in 180 NAC 7-051 and meets the requirements in 180 NAC 7-047.03(A)(ii)(7) or equivalent NRC or Agreement State requirements; or
047.03 TRAINING AND EXPERIENCE. The physician has:
(A) Completed 700 hours of training and experience, including a minimum of 80 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:
(i) Classroom and laboratory training in the following areas:
(1) Radiation physics and instrumentation; (2) Radiation protection; (3) Mathematics pertaining to the use and measurement of radioactivity; (4) Chemistry of radioactive material for medical use; and (5) Radiation biology; and
(ii) Work experience, under the supervision of an authorized user, who meets the requirements in 180 NAC 7-026, 7-047, or 7-051 and 7-047.03(A)(ii)(7) or equivalent NRC or Agreement State requirements. An authorized nuclear pharmacist who meets the requirements in 180 NAC 7-024 or 7-026 may provide the supervised work experience for 180 NAC 7-047.03(A)(ii)(7) of this section. Work experience must involve:
(1) Ordering, receiving, and unpacking radioactive materials safely and performing the related radiation surveys; (2) Performing quality control procedures on instruments used to determine the activity of dosages and performing checks for proper operation of survey meters; (3) Calculating, measuring, and safely preparing patient or human research subject dosages; (4) Using administrative controls to prevent a misadministration involving the use of unsealed radioactive material; (5) Using procedures to contain spilled radioactive material safely and using proper decontamination procedures; (6) Administering dosages of radioactive drugs to patients or human research subjects; and (7) Eluting generator systems appropriate for preparation of radioactive drugs for imaging and localization studies, measuring and testing the eluate for radionuclide purity, and processing the eluate with reagent kits to prepare labeled radioactive drugs; and
(B) Obtained written attestation, that the individual has satisfactorily completed the requirements in 180 NAC 7-047.03(A) and is able to independently fulfill the radiation safety-related duties as an authorized user for the medical uses authorized under 180 NAC 7-041 and 7-044. The attestation must be obtained from either:
(i) A preceptor authorized user who meets the requirements in 180 NAC 7-026, 7-047, or 7-051 and 7-047.03(A)(ii)(7), or equivalent NRC or Agreement State requirements; or (ii) 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 180 NAC 7-026, 7-047, or 7-051 and 7-047.03(A)(ii)(7), or equivalent NRC 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 or 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 180 NAC 7-47.03(A) of this section.
048. USE OF UNSEALED RADIOACTIVE MATERIAL FOR WHICH A WRITTEN DIRECTIVE IS REQUIRED . A licensee may use any unsealed radioactive material identified in 180 NAC 7-051 (B)(i)(2)(f) prepared for medical use and for which a written directive is required that is:
(A) Obtained from:
(i) A manufacturer or preparer licensed in 180 NAC 3-014.10; or equivalent NRC or Agreement State; or (ii) A PET radioactive drug producer licensed according to 180 NAC 3-010.11 or equivalent NRC or Agreement State; or
(B) Excluding production of PET radionuclides, prepared by:
(i) An authorized nuclear pharmacist, a physician who is an authorized user and who meets the requirements specified in 180 NAC 7-047 or 7-051; (ii) An individual under the supervision of either as specified in 180 NAC 7-018; or (iii) An individual under the supervision, as specified in 180 NAC 7-018, of the authorized nuclear pharmacist in 7-048(B)(i) or the physician who is authorized in 7-048(B)(ii); or
(C) Obtained from and prepared by the Department, NRC or Agreement State licensee according to a Radioactive Drug Research Committee’s approval protocol or an Investigational New Drug protocol accepted by the FDA for use in research; or (D) Prepared by the licensee for use in research according to an approved application or an Investigational New Drug protocol accepted by the FDA for use in research.
049. SAFETY INSTRUCTION AND SAFETY PRECAUTIONS .
049.01 ADDITIONAL SAFETY REQUIREMENTS. In addition to the requirements of 180 NAC 10-003:
(A) A licensee must provide radiation safety instruction, initially and at least annually, to all personnel caring for patients or human research subjects who cannot be released according to 180 NAC 7-037. The instruction must be appropriate to the personnel’s assigned duties and include:
(i) Patient or human research subject control; (ii) Visitor control, to include:
(1) Routine visitation to hospitalized individuals according to 180 NAC 4-013.01(A); and (2) Visitation authorized according to 180 NAC 4-013.03;
(iii) Contamination control; (iv) Waste control; and (v) Notification of the RSO or their designee and the authorized user if the patient or the human research subject has a medical emergency or dies; and
(B) A licensee must retain a record of individuals receiving instruction required by 180 NAC 7-101.
049.02 SAFETY PRECAUTIONS. Safety precautions must be followed as specified below.
(A) For each patient or human research subject who cannot be released under 180 NAC 7-037, a licensee must:
(i) Quarter the patient or the human research subject either in:
(1) A private room with a private sanitary facility; or (2) 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 180 NAC 7-037;
(ii) Visibly post the patient’s or the human research subject’s door with a "Caution: Radioactive Materials" sign and 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; and
(iii) Either:
(1) Monitor material and items removed from the patient’s or the human research subject’s room to determine 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 (2) Handle such material and items as radioactive waste; and
(B) The RSO, or their designee, and the authorized user must be notified immediately if the hospitalized patient dies or has a medical emergency. The licensee must also notify the Department according to 180 NAC 7-119 if it is possible any individual could receive exposures in excess of 180 NAC 4-013 as a result of the deceased’s body; and (C) Measure the thyroid burden of each individual who helped prepare or administer a liquid dosage of iodine-131 or in all cases where the patients vomits or the capsule is compromised. The measurement must be done within three days after administering the dosage and retain for the period required by 180 NAC 4-052 a record of each thyroid burden measurement, date of measurement, the name of the individual whose thyroid burden was measured, and the initials of the individual who made the measurements.
050. POSSESSION OF SURVEY INSTRUMENTS . A licensee authorized to use radioactive material for which a written directive is required must possess a portable radiation detection survey instrument capable of detecting dose rates over the range of 1 μSv (0.1 mrem) per hour to 1,000 μSv (100 mrems) per hour, and a portable radiation measurement survey instrument capable of measuring dose rates over the range of 10 μSv (1 mrem) per hour to 10 mSv (1000 mrems) per hour. The instruments must be operable and calibrated according to 180 NAC 7-030.
051. TRAINING FOR USE OF UNSEALED RADIOACTIVE MATERIAL FOR WHICH A WRITTEN DIRECTIVE IS REQUIRED . Other than as provided in 180 NAC 7-026, the licensee must require an authorized user of unsealed radioactive material for the uses authorized under 180 NAC 7-048 to be a physician who:
(A) Is certified by a medical specialty board whose certification process has been recognized by the Department, an Agreement State, or the NRC who meets the requirements in 180 NAC 7-051(B)(i)(2)(f) and 7-051(B)(ii). Specialty Boards whose certification process has been recognized by an Agreement State or the NRC are posted on the NRC’s Medical Uses Licensee Toolkit website. To be recognized, a specialty board must require all candidates for certification to:
(i) 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 700 hours of training and experience as described in 180 NAC 7-051(B)(i)(1) through 7-051(B)(i)(2)(e). Eligible training programs must be approved by the Residency Review Committee of the Accreditation Council for Graduate Medical Education or Royal College of Physicians and Surgeons of Canada or the Council on Postdoctoral Training of the American Osteopathic Association; and (ii) 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) The physician has:
(i) Completed 700 hours of training and experience, including a minimum of 200 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:
(1) Classroom and laboratory training in the following areas:
(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) Work experience, under the supervision of an authorized user who meets the requirements in 180 NAC 7-026, 7-051, or equivalent NRC or Agreement State requirements. A supervising authorized user, who meets the requirements in 180 NAC 7-051(B), must also have experience in administering dosages in the same dosage category or categories, 180 NAC 7-051(B)(i)(2)(f), 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 misadministration 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 of radioactive drugs to patients or human research subjects in each of the following categories. Radioactive drugs containing radionuclides in categories not included in this paragraph are regulated under 180 NAC 7-085. 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:
(i) Oral administration of less than or equal to 1.22 GBq (33 mCi) of sodium iodide I-131, for which a written directive is required; (ii) Oral administration of greater than 1.22 GBq (33 mCi) of sodium iodide I-131. Experience with at least three cases in 180 NAC 7-051(B)(i)(2)(f)(ii) also satisfies the requirement in 180 NAC 7-051(B)(i)(2)(f)(i); and (iii) Parenteral administration of any radioactive drug that contains a radionuclide primarily used for its electron emission, beta radiation characteristics, alpha radiation characteristics, or photon energy of less than 150 keV, for which a written directive is required; and
(ii) Obtained written attestation that the individual has satisfactorily completed the requirements in 180 NAC 7-051(B) and is able to independently fulfill the radiation safety-related duties as an authorized user for the medical uses authorized under 180 NAC 7-048 for which the individual is requesting authorized user status. The attestation must be obtained from either:
(1) A preceptor authorized user who meets the requirements in 180 NAC 7-026 or 7-051, or equivalent NRC 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 (2) 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 180 NAC 7-026 or 7-051, or equivalent NRC 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 or 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 180 NAC 7-051 (B).
052. TRAINING FOR THE ORAL ADMINISTRATION OF SODIUM IODIDE I-131 IN QUANTITIES LESS THAN OR EQUAL TO 1.22 GIGABECQUERELS (33 MILLICURIES) FOR WHICH A WRITTEN DIRECTIVE IS REQUIRED . Other than as provided in 180 NAC 7-026, the licensee must require an authorized user for the oral administration of sodium iodide I-131 in quantities less than or equal to 1.22 GBq (33 mCi), for which a directive is required, to be a physician who:
(A) Is certified by a medical specialty board whose certification process includes all of the requirements in 180 NAC 7-052(C)(i) and (ii) and whose certification has been recognized by the Department, an Agreement State or the NRC. The names of board certifications that have been recognized by an Agreement State or the NRC are posted on the NRC’s Medical Uses Licensee Toolkit website; or (B) Is an authorized user under 180 NAC 7-051(A), 7-051(B) for uses listed in 180 NAC 7-051(B)(i)(2)(f)(i) or (ii), 180 NAC 7-053, or equivalent NRC or Agreement State requirements; or (C) The physician has:
(i) Successfully completed 80 hours of classroom and laboratory training, applicable to the medical use of sodium iodide I-131 for procedures requiring a written directive. The training must include:
(1) Radiation physics and instrumentation; (2)Radiation protection; (3)Mathematics pertaining to the use and measurement of radioactivity; (4)Chemistry of radioactive material for medical use; and (5)Radiation biology;
(ii) Work experience, under the supervision of an authorized user who meets the requirements in 180 NAC 7-026, 7-051, 7-052, 7-053, or equivalent NRC or Agreement State requirements. A supervising authorized user who meets the requirements in 180 NAC 7-051(B), must have experience in administering dosages as specified in 180 NAC 7-051(B)(i)(2)(f)(i) or (ii) The work experience must involve:
(1) Ordering, receiving, and unpacking radioactive materials safely and performing the related radiation surveys; (2) Performing quality control procedures on instruments used to determine the activity of dosages and performing check for proper operation of survey meters; (3) Calculating, measuring, and safely preparing patient or human research subject dosages; (4) Using administrative controls to prevent a misadministration involving the use of radioactive material; (5) Using procedures to contain spilled radioactive material safely and using proper decontamination procedures; and (6) 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 GBq (33 mCi) of sodium iodide I-131; and
(iii) Obtained written attestation that the individual has satisfactorily completed the requirements in 180 NAC 7-052(C)(i) and (ii) and is able to independently fulfill the radiation safety-related duties as an authorized user for oral administration of less than or equal to 1.22 gigabecquerels (33 millicuries) of sodium iodide I–131 for medical uses authorized under 180 NAC 7-048. The attestation must be obtained from either:
(1) A preceptor authorized user who meets the requirements in 180 NAC 7-026, 7-051, 7-052, 7-053, or equivalent NRC or Agreement State requirements, and has experience in administering dosages as specified in 180 NAC 7-051(B)(i)(2)(f)(i) or (i); or (2) 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 180 NAC 7-026, 7-051, 7-052, 7-053, or equivalent NRC or Agreement State requirements, has experience in administering dosages as specified in 180 NAC 7-051(B)(i)(2)(f)(i) or (i), 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 or 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 180 NAC 7-052(C).
053. TRAINING FOR THE ORAL ADMINISTRATION OF SODIUM IODIDE 1-131 IN QUANTITIES GREATER THAN 1.22 GIGABECQUERELS (33 MILLICURIES) FOR WHICH A WRITTEN DIRECTIVE IS REQUIRED . Other than as provided in 180 NAC 7-026, the licensee must require an authorized user for the oral administration of sodium iodide 1-131 in quantities greater than 1.22 GBq (33 mCi), to be a physician who:
(A) Is certified by a medical specialty board whose certification process includes all of the requirements in 180 NAC 7-053(C)(i) and (ii) and whose certification has been recognized the Department, an Agreement State, or the NRC. The name of board certifications that have been recognized by an Agreement State or the NRC are posted on the NRC’s Medical Uses Licensee Toolkit website; or (B) Is an authorized user under 180 NAC 7-051, for uses listed in 180 NAC 7-051 (B)(i)(2)(f)(ii), or equivalent Agreement State, or NRC requirements; or (C) The physician has:
(i) Successfully completed 80 hours of classroom and laboratory training, applicable to the medical use of sodium iodide I-131 for procedures requiring a written directive; the training must include:
(1) Radiation physics and instrumentation; (2) Radiation protection; (3) Mathematics pertaining to the use and measurement of radioactivity; (4) Chemistry of radioactive material for medical use; and (5) Radiation biology;
(ii) Work experience, under the supervision of an authorized user who meets the requirements in 180 NAC 7-026, 7-051, 7-053, or equivalent NRC or Agreement State requirements. A supervising authorized user, who meets the requirements in 180 NAC 7-051(B), must have experience in administering dosages as specified in 180 NAC 7-051(B)(i)(2)(f)(ii). Work experience must involve:
(1) Ordering, receiving, and unpacking radioactive materials safely and performing the related radiation surveys; (2) Performing quality control procedures on instruments used to determine the activity of dosages and performing checks for proper operation of survey meters; (3) Calculating, measuring, and safely preparing patient or human research subject dosages; (4) Using administrative controls to prevent a misadministration event involving the use of radioactive material; (5) Using procedures to contain spilled radioactive material safely and using proper decontamination procedures; and (6) Administering dosages to patients or human research subjects, that includes at least three cases involving the oral administration of greater than 1.22 GBq (33 mCi) of sodium iodide I-131; and
(iii) Obtained written attestation that the individual has satisfactorily completed the requirements in paragraphs 180 NAC 7-053(C)(i) and (ii), and is able to independently fulfill the radiation safety-related duties as an authorized user for oral administration of greater than 1.22 gigabecquerels (33 millicuries) of sodium iodide I–131 for medical uses authorized under 180 NAC 7-048. The attestation must be obtained from either:
(1) A preceptor authorized user who meets the requirements in 7-026, 7-051, 7-053, equivalent NRC or Agreement State requirements, and has experience in administering dosages as specified in 7-051(B)(i)(2)(f)(ii); or (2) 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 7-026, 7-051, 7-053, equivalent NRC or Agreement State requirements, has experience in administering dosages as specified in 7-051(B)(i)(2)(f)(ii), 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 or 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 7-053(C)(i) and (i).
054. TRAINING FOR THE PARENTERAL ADMINISTRATION OF UNSEALED RADIOACTIVE MATERIAL REQUIRING A WRITTEN DIRECTIVE .
054.01 AUTHORIZED USER. Other than as provided in 180 NAC 7-026, the licensee must require an authorized user for the parenteral administration requiring a written directive, to be a physician who:
(A) Is an authorized user under 180 NAC 7-051 for uses listed in 7-051(B)(i)(2)(f)(iii), or equivalent Agreement State or NRC requirements; (B) Is an authorized user under 180 NAC 7-063 or 7-084, or equivalent Agreement State or NRC requirements and who meets the requirements in 180 NAC 7-054.02; or (C) Is certified by a medical specialty board whose certification process has been recognized by the Department, the NRC or an Agreement State under 180 NAC 7-063 or 7-084; and who meets the requirements in 180 NAC 7-054.02.
054.02 TRAINING AND SUPERVISED WORK EXPERIENCE. The physician has:
(A) Successfully completed eighty hours of classroom and laboratory training, applicable to parenteral administrations listed in 7-051(B)(i)(2)(f)(iii). The training must include:
(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;
(B) Work experience, under the supervision of an authorized user who meets the requirements in 180 NAC 7-026, 7-051 or 7-054, or equivalent NRC or Agreement State requirements, in the parenteral administrations listed in 7-051(B)(i)(2)(f)(iii). A supervising authorized user who meets the requirements in 180 NAC 7-051, 7-054, or equivalent NRC 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:
(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 misadministration 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 to patients or human research subjects, that include at least three cases of the parenteral administrations as specified in 180 NAC 7-051(B)(i)(2)(f)(iii); and
(C) Obtained written attestation that the individual has satisfactorily completed the requirements in 180 NAC 7-054.02(A) and (B), 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:
(i) A preceptor authorized user who meets the requirements in 180 NAC 7-026, 7-051, or 7-054, or equivalent NRC or Agreement State requirements. A preceptor authorized user who meets the requirements in 180 NAC 7-051, or 7-054, or equivalent Agreement State requirements, must have experience in administering dosages in the same category or categories as the individual requesting authorized user status; or (ii) 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 180 NAC 7-026, 7-051, or 7-054, or equivalent NRC 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 or 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 180 NAC 7-54.02 (A) and (B).
055. USE OF SOURCES FOR MANUAL BRACHYTHERAPY . A licensee must use only brachytherapy sources:
(A) Approved in the Sealed Source and Device Registry for manual brachytherapy medical use. The manual brachytherapy sources may be used for manual brachytherapy uses not explicitly listed in the Sealed Source and Device Registry, but must be used according to 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 according to an active Investigational Device Exemption (IDE) application accepted by the FDA, provided the requirements of 180 NAC 7-021, (A) are met.
056. SURVEYS AFTER SOURCE IMPLANT AND REMOVAL . The licensee must:
(A) Immediately after implanting sources in a patient or a human research subject, make a survey to locate and account for all sources that have not been implanted; (B) Immediately after removing the last temporary implant source from a patient or a human research subject, 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; and (C) Retain a record of the surveys according to 180 NAC 7-102.
057. BRACHYTHERAPY SOURCES INVENTORY . The licensee must:
(A) Maintain accountability at all times for all brachytherapy sources in storage or use. (B) Promptly after removing sources from a patient or a human research subject, return brachytherapy sources to a secure storage area. (C) Maintain a record of the brachytherapy source accountability according to 180 NAC 7-103.
058. SAFETY INSTRUCTION . In addition to the requirements of 180 NAC 10-003, the licensee must:
(A) Provide radiation safety instruction, initially and at least annually, to personnel caring for a patient or human research subjects that are undergoing implant therapy and cannot be released under 180 NAC 7-037. The instruction must be commensurate with the duties of the personnel and must include the following:
(i) Size and appearance of the brachytherapy sources; (ii) Safe handling and shielding instructions; (iii) Patient or human research subject control; (iv) Visitor control, including both:
(1) Routine visitation of hospitalized individual according to 180 NAC 4-013.01; and (2) Visitation authorized according to 180 NAC 4-013.01; and
(v) Notification of the RSO or their designee, and authorized user if the patient or the human research subject dies or has a medical emergency. The licensee must also notify the Department according to 180 NAC 7-119 if it is possible that any individual could receive exposures in excess of 5 mSv (500 mrem) as a result of the deceased’s body; and
(B) Retain a record of individuals receiving instruction required by 180 NAC 7-101.
059. SAFETY PRECAUTIONS FOR PATIENTS OR HUMAN RESEARCH SUBJECTS RECEIVING BRACHYTHERAPY .
059.01 PATIENT OR HUMAN RESEARCH SUBJECT RECEIVING BRACHYTHERAPY THAT CANNOT BE RELEASED. For each patient or human research subject that is receiving brachytherapy that cannot be released according to 180 NAC 7-037 a licensee must:
(A) Not quarter the patient or the human research subject in the same room as an individual who is not receiving radiation therapy; and (B) Visibly post the patient’s or human research subject’s door with a "Caution: Radioactive Materials" sign; and note on the door or 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.
059.02 RADIOLOGICAL EMERGENCY RESPONSE EQUIPMENT. A licensee must have radiological emergency response equipment available near each treatment room to respond to a source that inadvertently becomes:
(A) Dislodged from the patient; and (B) Lodged within the patient following removal of the source applicators.
059.03 NOTIFICATION OF MEDICAL EMERGENCY OR DEATH. The RSO, or their designee, and authorized user must be notified immediately if the hospitalized patient or human research subject has a medical emergency or dies.
060. CALIBRATION MEASUREMENTS OF BRACHYTHERAPY SOURCES .
060.01 USE PARAMETERS. Before the first medical use of a brachytherapy source a licensee must:
(A) Determine the source output or activity using a dosimetry system that meets the requirements of 180 NAC 7-072.01; (B) Determine source positioning accuracy within applicators; and (C) Use published protocols currently accepted by nationally recognized bodies to meet the requirements of 180 NAC 7-060.01(A) and (B).
060.02 SOURCE MANUFACTURER OR CALIBRATION LABORATORY. A licensee may use measurements provided by the source manufacturer or by a calibration laboratory accredited by the American Association of Physicists in Medicine that are made according to 180 NAC 7-060.01.
060.03 PHYSICAL DECAY CORRECTION. A licensee must mathematically correct the outputs or activities determined in 180 NAC 7-060.01 for physical decay at intervals consistent with one percent physical decay.
060.04 PERFORM OR REVIEW OF CALCULATION MEASUREMENTS. An authorized medical physicist must perform or review the calculation measurements made according to 180 NAC 7-060.01, 7-060.02, or 7-060.03.
060.05 STRONTIUM-90 SOURCES FOR OPHTHALMIC TREATMENTS. Requirements for licensees using strontium-90 sources for ophthalmic treatments are as follows:
(A) Licensees who use strontium-90 for ophthalmic treatments must ensure certain activities specified in 180 NAC 7-060.05 (B) are performed by either:
(i) An authorized medical physicist; or (ii) An individual who:
(1) Is identified as an ophthalmic physicist on a specific medical use license issued by the Department, NRC, or an Agreement State; permit issued by a Department, NRC, or Agreement State broad scope medical use licensee; medical use permit issued by an NRC master material licensee; or permit issued by a NRC master material licensee broad scope medical use permittee; (2) 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; (3) 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; (4) Has documented training in:
(a) The creation, modification, and completion of written directives; and (b) Procedures for administrations requiring a written directive; and
(5) Is performing the calibration measurements of brachytherapy sources as detailed in 180 NAC 7-060;
(B) The individuals identified in 180 NAC 060.05 (A) must:
(i) 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 180 NAC 7-060; and (ii) Assist the licensee in developing, implementing, and maintaining written procedures to provide high confidence that the administration is according to the written directive. These procedures must include the frequencies that the individual meeting the requirements in 180 NAC 7-060.05 (A) will observe treatments, review the treatment methodology, calculate treatment time for the prescribed dose, and review records to verify that the administrations were according to the written directives; and
(C) Licensees must retain a record of the activity of each strontium-90 source according to 180 NAC 7-105.
060.06 RECORDS. A licensee must retain a record of each calibration according to 180 NAC 7-104.
061. THERAPY-RELATED COMPUTER SYSTEMS . The licensee must perform acceptance testing on the treatment planning system of therapy-related computer systems according to 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.
062. POSSESSION OF SURVEY INSTRUMENT . A licensee authorized to use manual brachytherapy sources must possess a portable radiation detection survey instrument capable of detecting dose rates over the range of 1 μSv (0.1 mrem) per hour to 1,000 μSv (100 mrems) per hour, and a portable radiation measurement survey instrument capable of measuring dose rates over the range of 10 μSv (1 mrem) per hour to 10 mSv (1000 mrems) per hour. The instruments must be operable and calibrated according to 180 NAC 7-030.
063. TRAINING FOR USE OF MANUAL BRACHYTHERAPY SOURCES . Other than as provided in 180 NAC 7-026, the licensee must require an authorized user of a manual brachytherapy source for the uses authorized under 180 NAC 7-055 to be a physician who:
(A) Is certified by a medical specialty board whose certification process has been recognized by the Department, an Agreement State or the NRC. The names of board certifications that have been recognized by an Agreement State or the NRC are posted on the NRC’s Medical Uses Licensee Toolkit website. To have its certification process recognized, a specialty board must require all candidates for certification to:
(i) 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 Royal College of Physicians and Surgeons of Canada or the Council on Postdoctoral Training of the American Osteopathic Association; and (ii) 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 manual brachytherapy; or
(B) The physician has:
(i) Completed a structured educational program in basic radionuclide handling techniques applicable to the use of manual brachytherapy sources that includes:
(1) 200 hours of classroom and laboratory training in the following areas:
(a) Radiation physics and instrumentation; (b) Radiation protection; (c) Mathematics pertaining to the use and measurement of radioactivity; and (d) Radiation biology; and
(2) 500 hours of work experience, under the supervision of an authorized user who meets the requirements in 180 NAC 7-026, 7-063 or equivalent NRC or Agreement State requirements at a medical facility authorized to use radioactive materials under 180 NAC 7-055, involving:
(a) Ordering, receiving, and unpacking radioactive materials safely and performing the related radiation surveys; (b) Checking survey meters for proper operation; (c) Preparing, implanting, and removing brachytherapy sources; (d) Maintaining running inventories of material on hand; (e) Using administrative controls to prevent a misadministration involving the use of radioactive material; and (f) Using emergency procedures to control radioactive material; and
(ii) Completed three years of supervised clinical experience in radiation oncology, under an authorized user who meets the requirements in 180 NAC 7-026, 7-063 or equivalent NRC or Agreement State requirements, as a 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 180 NAC 7-063(B)(i)(2); and (iii) Obtained written attestation that the individual has satisfactorily completed the requirements in 180 NAC 7-063(B)(i) and (ii) 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 180 NAC 7-055. The attestation must be obtained from either:
(1) A preceptor authorized user who meets the requirements in 180 NAC 7-026, 7-063, or equivalent NRC or Agreement State requirements; or (2) 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 180 NAC 7-026, 7-063, or equivalent NRC 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 or 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 180 NAC 7-063(B)(i) and (ii).
064. TRAINING FOR OPHTHALMIC USE OF STRONTIUM-90 . Other than as provided in 180 NAC 7-026, the licensee must require the authorized user of strontium-90 for ophthalmic uses authorized under 180 NAC 7-055 to be:
(A) A physician who is an authorized user under 180 NAC 7-063 or equivalent NRC or Agreement State requirements; or (B) A physician that has:
(i) Completed 24 hours of classroom and laboratory training applicable to the medical use of strontium-90 for ophthalmic radiotherapy. 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
(ii) 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:
(1) Examination of each individual to be treated; (2) Calculation of the dose to be administered; (3) Administration of the dose; and (4) Follow up and review of each individual's case history; and
(iii) Obtained written attestation, signed by a preceptor authorized user who meets the requirements in 180 NAC 7-026, 7-063, 7-064 or equivalent NRC or Agreement State requirements, that the individual has satisfactorily completed the requirements in 180 NAC 7-064(B) and is able to independently fulfill the radiation safety-related duties as an authorized user of strontium-90 for ophthalmic use.
065. USE OF SEALED SOURCES FOR DIAGNOSIS .
065.01 SEALED SOURCES NOT IN MEDICAL DEVICES. 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 according to the radiation safety conditions and limitations described in the Sealed Source and Device Registry.
065.02 MEDICAL DEVICES CONTAINING SEALED SOURCES. 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 according to the radiation safety conditions and limitations described in the Sealed Source and Device Registry.
065.03 SEALED SOURCES AND DEVICES USED IN RESEARCH. Sealed sources and devices for diagnostic medical uses may be used in research according to an active Investigational Device Exemption (IDE) application accepted by the FDA provided the requirements of 180 NAC 7-021(A) are met.
066. TRAINING FOR USE OF SEALED SOURCES FOR DIAGNOSIS . Other than as provided in 180 NAC 7-026, the licensee must require the authorized user of a diagnostic sealed source or a device authorized under 180 NAC 7-065 to be a physician, dentist, or podiatrist who:
(A) Is certified by a specialty board whose certification process includes all of the requirements in 180 NAC 7-066.03 and 7-066.04 whose certification has been recognized by an Agreement State or the NRC. The names of board certifications that have been recognized by an Agreement State or the NRC are posted on the NRC’s Medical Uses Licensee Toolkit website; or (B) Is an authorized user for uses listed in 180 NAC 7-044, or equivalent NRC 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:
(i) Radiation physics and instrumentation; (ii) Radiation protection; (iii) Mathematics pertaining to the use and measurement of radioactivity; and (iv) Radiation biology; and
(D) Has completed training in the use of the device for the uses requested.
067. USE OF A SEALED SOURCE IN A REMOTE AFTERLOADER UNIT, TELETHERAPY UNIT, OR GAMMA STEREOTACTIC RADIOSURGERY UNIT .
067.01 APPROVED SEALED SOURCE. A licensee must only use sealed sources:
(A) As approved and as provided for in the NRC Sealed Source and Device Registry; or (B) In research according to an active Investigational Device Exemption application accepted by the FDA provided the requirements of 180 NAC 7-021(A) are met.
067.02 APPROVED DEVICES. A licensee must only use devices:
(A) 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 according to radiation safety conditions and limitations described in the Sealed Source and Device Registry; or (B) In research according to an active Investigational Device Exemption application accepted by the FDA provided the requirements of 180 NAC 7-021(A) are met.
068. SURVEYS OF PATIENTS AND HUMAN RESEARCH SUBJECTS TREATED WITH A REMOTE AFTERLOADER UNIT .
068.01 CONFIRMATION OF SOURCE REMOVAL. Before releasing a patient or a human research subject from licensee control, a licensee must make a survey of the patient or the human research subject and the remote afterloader unit with a portable radiation detection survey instrument to confirm that the source or sources has been removed from the patient or human research subject and returned to the shielded position.
068.02 RECORDS. A licensee must retain a record of surveys according to 180 NAC 7-102.
069. INSTALLATION, MAINTENANCE, ADJUSTMENT, AND REPAIR .
069.01 CONFIRMATION OF SOURCE REMOVAL. Only a person specifically licensed by the NRC or an Agreement State may install, maintain, adjust, or repair a remote afterloader unit, teletherapy unit, or gamma stereotactic radiosurgery unit that involves work on the source or sources shielding, the source or sources driving unit, or other electronic or mechanical component that could expose the source or sources, reduce the shielding around the source or sources, or compromise the radiation safety of the unit or the source or sources.
069.02 LICENSE REQUIRED. Other than LDR remote afterloader units, only a person specifically licensed by the Department, the NRC or an Agreement State may install, replace, relocate, or remove a sealed source or source contained in other remote afterloader units, teletherapy units, or gamma stereotactic radiosurgery units.
069.03 LDR REMOTE AFTERLOADER UNIT. For a LDR remote afterloader unit, only a person specifically licensed by the Department, the NRC, an Agreement State or an authorized medical physicist may install, replace, relocate, or remove a sealed source or sources contained in the unit.
069.04 RECORDS. A licensee must retain a record of the installation, maintenance, adjustment, and repair of remote afterloader units, teletherapy units, and gamma stereotactic radiosurgery units according to 180 NAC 7-106.
070. SAFETY PROCEDURES AND INSTRUCTIONS FOR REMOTE AFTERLOADER UNITS, TELETHERAPHY UNITS, AND GAMMA STEREOTACTIC RADIOSURGERY UNITS .
070.01 SAFETY AND WRITTEN PROCEDURES. A licensee must:
(A) Secure the unit, the console, the console keys, and the treatment room when not in use or unattended; (B) Permit only individuals approved by the authorized user, RSO, or authorized medical physicist to be present in the treatment room during treatment with the source or sources; (C) Prevent dual operation of more than one radiation producing device in a treatment room if applicable; and (D) Develop, implement, and maintain written procedures for responding to an abnormal situation when the operator is unable to place the source or sources 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:
(i) Instructions for responding to equipment failures and the names of the individuals responsible for implementing corrective actions; (ii) The process for restricting access to and posting of the treatment area to minimize the risk of inadvertent exposure; and (iii) The names and telephone numbers of the authorized users, the authorized medical physicist, and the RSO to be contacted if the unit or console operates abnormally.
070.02 PROCEDURE LOCATION. A copy of the procedures required by 180 NAC 7-070.01(D) must be physically located at the unit console.
070.03 INSTRUCTION POSTING. A licensee must post instructions at the unit console to inform the operator of:
(A) The location of the procedures required by 180 NAC 7-70.01(D); and (B) The names and telephone numbers of the authorized users, the authorized medical physicist, and the RSO to be contacted if the unit or console operates abnormally.
070.04 INSTRUCTION FREQUENCY. A licensee must:
(A) 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; and (B) 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 must include:
(i) The procedures identified in 180 NAC 7-070.01(D); and (ii) The operating procedures for the unit.
070.05 PARTICIPATION IN DRILLS AND EMERGENCY PROCEDURES. A licensee must ensure that operators, authorized medical physicists, and authorized users participate in drills of the emergency procedures, initially and at least annually.
070.06 RECORDS. A licensee must retain a record of individuals receiving instruction required by 180 NAC 7-070.04, according to 180 NAC 7-101.
071. SAFETY PRECAUTIONS FOR REMOTE AFTERLOADER UNITS, TELETHERAPY UNITS, AND GAMMA STEREOTACTIC RADIOSURGERY UNITS .
071.01 CONTROLLED ACCESS. A licensee must control access to the treatment room by a door at each entrance.
071.02 ELECTRICAL INTERLOCK SYSTEM. A licensee must equip each entrance to the treatment room with an electrical interlock system that will:
(A) Prevent the operator from initiating the treatment cycle unless each treatment room entrance door is closed; (B) Cause the source or sources to be shielded promptly when an entrance door is opened; and (C) Prevent the source or sources from being exposed following an interlock interruption until all treatment room entrance doors are closed and the source or sources on-off control is reset at the console.
071.03 AMBIENT RADIATION LEVELS. A licensee must require any individual entering the treatment room to assure, through the use of appropriate radiation monitors, that radiation levels have returned to ambient levels.
071.04 VIEWING AND INTERCOM SYSTEM. Other than low-dose remote afterloader units, a licensee must 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.
071.05 EXPEDITIOUS REMOVAL. For licensed activities where sources are placed within the patient's or human research subject's body, a licensee may only conduct treatments which allow for expeditious removal of a decoupled or jammed source.
071.06 ADDITIONAL REQUIREMENTS. In addition to the requirements specified in 180 NAC 7-071.01 through 7-071.05, a licensee must:
(A) For LDR, MDR and PDR remote afterloader units, require:
(i) 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 (ii) 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 or applicators in the event of an emergency involving the unit, to be immediately available during continuation of all patient treatments involving the unit;
(B) For HDR remote afterloader units, require:
(i) An authorized user and an authorized medical physicist to be physically present during the initiation of all patient treatments involving the unit; and (ii) 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;
(C) 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; and
(D) Notify the RSO, or their designee, and an authorized user as soon as possible if the patient or human research subject has a medical emergency and immediately if the patient dies.
071.07 RADIOLOGICAL EMERGENCY RESPONSE EQUIPMENT. A licensee must have applicable radiological emergency response equipment available near each treatment room to respond to a source that inadvertently:
(A) Remains in the unshielded position; or (B) Lodges within the patient following completion of the treatment.
072. DOSIMETRY EQUIPMENT .
072.01 CALIBRATED DOSIMETRY SYSTEM. Other than LDR remote afterloader sources where the source output or activity is determined by the manufacturer, a licensee must have a calibrated dosimetry system available for use. To satisfy this requirement, one of the following conditions must be met.
(A) 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 (B) The system must have been calibrated within the previous four years. Within 18 to 30 months after that calibration, the system must have been intercompared with another dosimetry system that was calibrated within the past 24 months by the National Institute of Standards and Technology (NIST) or by a calibration laboratory accredited by the American Association of Physicists in Medicine (AAPM). The results of the intercomparison must have indicated that the calibration factor of the licensee's system had not changed by more than 2%. 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 must 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.
072.02 SPOT-CHECK SYSTEM. The licensee must have available for use a dosimetry system for spot-check output measurements, if applicable. To satisfy this requirement, the system may be compared with a system calibrated according to 180 NAC 7-072.01. 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 180 NAC 7-072.01.
072.03 RECORDS. The licensee must retain a record of each calibration, intercomparison, and comparison according to 180 NAC 7-107.
073. FULL CALIBRATION MEASUREMENTS ON TELETHERAPY UNITS .
073.01 FREQUENCY. A licensee authorized to use a teletherapy unit for medical use must perform full calibration measurements on each teletherapy unit:
(A) Before the first medical use of the unit; (B) Before medical use under the following conditions:
(i) Whenever spot-check measurements indicate that the output differs by more than 5% from the output obtained at the last full calibration corrected mathematically for radioactive decay; (ii) Following replacement of the source or following reinstallation of the teletherapy unit in a new location; and (iii) 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
(C) At intervals not exceeding one year.
073.02 DETERMINANTS. To satisfy the requirement of 180 NAC 7-073.01, full calibration measurements must include determination of:
(A) The output within plus or minus 3% for the range of field sizes and for the distance or range of distances used for medical use; (B) The coincidence of the radiation field and the field indicated by the light beam localizing device; (C) The uniformity of the radiation field and its dependence on the orientation of the useful beam; (D) Timer accuracy, and linearity over the range of use; (E) “On-off" error; and (F) The accuracy of all distance measuring and localization devices in medical use.
073.03 DOSIMETRY SYSTEM USAGE. A licensee must use the dosimetry system described in 180 NAC 7-072.01 to measure the output for one set of exposure conditions. The remaining radiation measurements required by 7-073.02(A) may then be made using a dosimetry system that indicates relative dose rates.
073.04 PROTOCOLS. A licensee must make full calibration measurements required by 180 NAC 7-073.01 according to published protocols accepted by nationally recognized bodies.
073.05 MATHEMATICAL CORRECTION OF OUTPUTS. A licensee must mathematically correct the outputs determined in 180 NAC 7-073.02, (A), for physical decay for intervals not exceeding one month for cobalt-60, six months for cesium-137, or at intervals consistent with 1% decay for all other nuclides.
073.06 CALIBRATION MEASUREMENT AND DECAY CORRECTIONS. Full calibration measurements required by 180 NAC 7-073.01 and physical decay corrections required by 180 NAC 7-073.05 must be performed by an authorized medical physicist.
073.07 RECORDS. A licensee must maintain a record of each calibration according to 180 NAC 7-108.
074. FULL CALIBRATION MEASUREMENTS ON REMOTE AFTERLOADER UNITS .
074.01 FREQUENCY. A licensee authorized to use a remote afterloader unit for medical use must perform full calibration measurements on each unit:
(A) Before the first medical use of the unit; (B) Before medical use under the following conditions:
(i) Following replacement of the source or following reinstallation of the unit in a new location outside the facility; and (ii) Following any repair of the unit that includes removal of the source or major repair of the components associated with the source exposure assembly;
(C) At intervals not exceeding one calendar quarter for HDR, MDR, and PDR remote afterloader units with sources whose half-life exceeds 75 days; and (D) At intervals not exceeding one year for LDR remote afterloader units.
074.02 DETERMINANTS. To satisfy the requirement of 7-074.01, full calibration measurements must include, as applicable, determination of:
(A) The output within ± 5%; (B) Source positioning accuracy to within ±1 millimeter; (C) Source retraction with backup battery upon power failure; (D) Length of the source transfer tubes; (E) Timer accuracy and linearity over the typical range of use; (F) Length of the applicators; and (G) Function of the source transfer tubes, applicators, and transfer tube-applicator interfaces.
074.03 VERIFICATION OF INVENTORY AND SOURCE ARRANGEMENT. In addition to the requirements for full calibration for LDR remote afterloader units in 180 NAC 7-074.02, a licensee must perform an autoradiograph of the source or sources to verify inventory and source or sources arrangement at intervals not exceeding one calendar quarter.
074.04 USE OF DOSIMETRY SYSTEM. A licensee must use the dosimetry system described in 180 NAC 7-072.01 to measure the output.
074.05 PROTOCOLS. A licensee must make full calibration measurements required by 180 NAC 7-074.01 according to published protocols accepted by nationally recognized bodies.
074.06 SOURCE MANUFACTURER MEASUREMENTS. For LDR remote afterloader units, a licensee may use measurements provided by the source manufacturer that are made according to180 NAC 7-074.01 through 7-074.05.
074.07 ONE PERCENT PHYSICAL DECAY. A licensee must mathematically correct the outputs determined in 180 NAC 7-074.02(A) for physical decay at intervals consistent with one percent physical decay.
074.08 FULL CALIBRATION MEASUREMENTS AND PHYSICAL DECAY CORRECTIONS. Full calibration measurements required by 180 NAC 7-074.01 and physical decay corrections required by 180 NAC 7-074.07 must be performed by the authorized medical physicist.
074.09 RECORDS. A licensee must retain a record of each calibration according to 180 NAC 7-108.
075. FULL CALIBRATION MEASUREMENTS ON GAMMA STEREOTACTIC RADIOSURGERY UNITS .
075.01 FREQUENCY. A licensee authorized to use a gamma stereotactic radiosurgery unit for medical use must perform full calibration measurements on each unit:
(A) Before the first medical use of the unit; (B) Before medical use under the following conditions:
(i) Whenever spot-check measurements indicate that the output differs by plus or minus 5% from the output obtained at the last full calibration corrected mathematically for radioactive decay; (ii) Following replacement of the sources or following reinstallation of the gamma stereotactic radiosurgery unit in a new location; and (iii) 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
(C) 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.
075.02 DETERMINANTS. To satisfy the requirement of 180 NAC 7-075.01, full calibration measurements must include determination of:
(A) The output within ±3%; (B) Relative helmet factors to verify that the helmet material provides the required shielding to the patient; (C) Isocenter coincidence to confirm the centering accuracy of the radiation beam relative to the alignment helmet openings; (D) Timer accuracy and linearity over the range of use; (E) On-off error; (F) Trunnion centricity to determine the rotational center of the source relative to the alignment helmet openings; (G) Treatment table retraction mechanism, using backup battery power or hydraulic backups with the unit off; (H) Helmet microswitches to determine if the switches terminate the radiation beam; (I) Emergency timing circuits; and (J) Stereotactic frames, localizing devices and trunnions.
075.03 DOSIMETRY SYSTEM. A licensee must use the dosimetry system described in 180 NAC 7-072.01 to measure the output for one set of exposure conditions. The remaining radiation measurements required in paragraph 180 NAC 7-075.02(A) may be made using a dosimetry system that indicates relative dose rates.
075.04 CALIBRATION MEASUREMENT PROTOCOLS. A licensee must make full calibration measurements required by 180 NAC 7-075.01 according to published protocols accepted by nationally recognized bodies.
075.05 MATHEMATICAL CORRECTION OF OUTPUTS. A licensee must mathematically correct the outputs determined in 180 NAC 7-075.02(A) at intervals not exceeding one month for cobalt-60 and at intervals consistent with one percent physical decay for all other radionuclides.
075.06 AUTHORIZED MEDICAL PHYSICIST. Full calibration measurements required by 180 NAC 7-075.01 and physical decay corrections required by 180 NAC 7-075.05 must be performed by the authorized medical physicist.
075.07 RECORDS. A licensee must retain a record of each calibration according to 180 NAC 7-108.
076. PERIODIC SPOT-CHECKS FOR TELETHERAPY UNITS .
076.01 DETERMINANTS. A licensee authorized to use teletherapy units for medical use must perform output spot-checks on each teletherapy unit once in each calendar month that include determination of:
(A) Timer accuracy, and timer linearity over the range of use; (B) On-off error; (C) The coincidence of the radiation field and the field indicated by the light beam localizing device; (D) The accuracy of all distance measuring and localization devices used for medical use; (E) The output for one typical set of operating conditions measured with the dosimetry system described in 180 NAC 7-072.02; and (F) The difference between the measurement made in 180 NAC 7-076.01(E) and the anticipated output, expressed as a percentage of the anticipated output or the value obtained at last full calibration corrected mathematically for physical decay.
076.02 MEASUREMENTS. A licensee must perform measurements required by 180 NAC 7-076.01 according to written procedures established by the authorized medical physicist. The authorized medical physicist need not actually perform the spot-check measurements.
076.03 RESULTS. A licensee must have the authorized medical physicist review and sign the results of each spot-check within 15 days. The authorized medical physicist must notify the licensee within 10 days in writing of the results of each spot-check.
076.04 SAFETY SPOT-CHECKS. A licensee authorized to use a teletherapy unit for medical use must perform safety spot-checks of each teletherapy facility once in each calendar month and after each source installation to assure proper operation of:
(A) Electrical interlocks at each teletherapy room entrance; (B) 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; (C) Source exposure indicator lights on the teletherapy unit, on the control console, and in the facility; (D) Viewing and intercom systems; (E) Treatment room doors from inside and outside the treatment room; and (F) Electrically assisted treatment room doors with the teletherapy unit electrical power turned off.
076.05 SYSTEM MALFUNCTION. If the results of the checks required in 180 NAC 7-076.02 and 7-076.04 indicate the malfunction of any system, a licensee must lock the control console in the off position and not use the unit other than as necessary to repair, replace, or check the malfunctioning system.
076.06 RECORDS. A licensee must retain a record of each spot-check required by 180 NAC 7-076.01 and 7-076.04 and according to 180 NAC 7-109.
077. PERIODIC SPOT-CHECKS FOR REMOTE AFTERLOADER UNITS .
077.01 SPOT-CHECK FREQUENCY. A licensee authorized to use a remote afterloader unit for medical use must perform spot-checks of each remote afterloader facility and on each unit:
(A) At the beginning of each day of use of a HDR, MDR, or PDR remote afterloader unit; (B) Prior to each patient treatment with a LDR remote afterloader unit; and (C) After each source installation.
077.02 WRITTEN PROCEDURES. The licensee must have the authorized medical physicist establish written procedures for performing the spot-checks required in 180 NAC 7-077.01. The authorized medical physicist need not actually perform the spot-check measurements.
077.03 RESULTS. A licensee must have the authorized medical physicist review and sign the results of each spot-check within fifteen days. The authorized medical physicist must notify the licensee within ten days in writing of the results of each spot-check.
077.04 ASSURANCE OF PROPER OPERATION. To satisfy the requirements of 180 NAC 7-077.01, spot-checks must, at a minimum, assure proper operation of:
(A) Electrical interlocks at each remote afterloader unit room entrance; (B) Source exposure indicator lights on the remote afterloader unit, on the control console, and in the facility; (C) Viewing and intercom systems in each HDR, MDR, and PDR remote afterloader facility; (D) Radiological emergency response equipment; (E) Radiation monitors used to indicate the source position; (F) Timer accuracy; (G) Clock, date and time, in the unit's computer; and (H) Decayed source or sources activity in the unit's computer.
077.05 SYSTEM MALFUNCTION. If the results of the checks required in 180 NAC 7-077.04 indicate the malfunction of any system, a licensee must lock the control console in the off position and not use the unit other than as necessary to repair, replace, or check the malfunctioning system.
077.06 RECORDS. A licensee must retain a record of each check required by 180 NAC 7-077.04 according to 180 NAC 7-110.
078. PERIODIC SPOT-CHECKS FOR GAMMA STEREOTACTIC RADIOSURGERY UNITS .
078.01 FREQUENCY. A licensee authorized to use a gamma stereotactic radiosurgery unit for medical use must perform spot-checks of each gamma stereotactic radiosurgery facility and on each unit:
(A) Monthly; (B) Before the first use of the unit on a given day; and (C) After each source installation.
078.02 WRITTEN PROCEDURES. The licensee must have the authorized medical physicist:
(A) Establish written procedures for performing the spot-checks required in 180 NAC 7-078.01; and (B) Review and sign the results of each spot-check required by 180 NAC 7-078.01 within fifteen days of the check. The authorized medical physicist need not actually perform the spot-check measurements. The authorized medical physicist must notify the licensee within ten days in writing of the results of the spot check.
078.03 MINIMUM REQUIREMENTS. To satisfy the requirements of 180 NAC 7-078.01(A), spot-checks must, at a minimum:
(A) Assure proper operation of:
(i) Treatment table retraction mechanism, using backup battery power or hydraulic backups with the unit off; (ii) Helmet microswitches; (iii) Emergency timing circuits; and (iv) Stereotactic frames, localizing devices, and trunnions; and
(B) Determine:
(i) The output for one typical set of operating conditions measured with the dosimetry system described in 180 NAC 7-072.02; (ii) The difference between the measurement made in 180 NAC 7-078.03(B)(i) and the anticipated output, expressed as a percentage of the anticipated output, or the value obtained at last full calibration corrected mathematically for physical decay; (iii) Source output against computer calculation; (iv) Timer accuracy and linearity over the range of use; (v) On-off error; and (vi) Trunnion centricity.
078.04 ASSURANCE OF PROPER OPERATION. To satisfy the requirements of 180 NAC 7-078.01(B) and (C), spot-checks must assure proper operation of:
(A) Electrical interlocks at each gamma stereotactic radiosurgery room entrance; (B) Source exposure indicator lights on the gamma stereotactic radiosurgery unit, on the control console, and in the facility; (C) Viewing and intercom systems; (D) Timer termination; (E) Radiation monitors used to indicate room exposures; and (F) Emergency off buttons.
078.05 REPAIRS. A licensee must arrange for the repair of any system identified in 180 NAC 7-078.03 that is not operating properly.
078.06 SYSTEM MALFUNCTION. If the results of the checks required in 180 NAC 7-078.04 indicate the malfunction of any system, a licensee must lock the control console in the off position and not use the unit unless necessary to repair, replace, or check the malfunctioning system.
078.07 RECORDS. A licensee must retain a record of each check required by 180 NAC 7-078.03 and 7-078.04 and according to 180 NAC 7-111.
079. ADDITIONAL TECHNICAL REQUIREMENTS FOR MOBILE REMOTE AFTERLOADER UNITS .
079.01 BEFORE MEDICAL USE. A licensee providing mobile remote afterloader service must:
(A) Check survey instruments for consistent response before medical use at each address of use or on each day of use, whichever is more frequent; and (B) Account for all sources before departure from a client's address of use.
079.02 AT EACH ADDRESS OF USE. In addition to the periodic spot-checks required by 180 NAC 7-077 a licensee authorized to use mobile afterloaders for medical use must 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:
(A) Electrical interlocks on treatment area access points; (B) Source exposure indicator lights on the remote afterloader unit, on the control console, and in the facility; (C) Viewing and intercom systems; (D) Applicators, source transfer tubes, and transfer tube-applicator interfaces; (E) Radiation monitors used to indicate room exposures; (F) Source positioning accuracy; and (G) Radiation monitors used to indicate whether the source has returned to a safe shielded position.
079.03 SIMULATED CYCLE OF TREATMENT. In addition to the requirements for checks 180 NAC 7-079.02, a licensee must ensure overall proper operation of the remote afterloader unit by conducting a simulated cycle of treatment before use at each address of use.
079.04 SYSTEM MALFUNCTION. If the results of the checks required in 180 NAC 7-079.02 indicate the malfunction of any system, a licensee must lock the control console in the off position and not use the unit unless necessary to repair, replace, or check the malfunctioning system.
079.05 RECORDS. A licensee must retain a record of each check required by 180 NAC 7-079.02 according to 180 NAC 7-112.
080. RADIATION SURVEYS .
080.01 RESULTS. In addition to the survey requirement in 180 NAC 4-021, a person licensed to possess or a use remote afterloader, teletherapy or gamma stereotactic radiosurgery unit must perform surveys of the device and ensure the results of the surveys from the surface of the main source safe, with the sources in the shielded position, do not exceed the maximum and average radiation levels listed in the Sealed Source and Device Registry.
080.02 SURVEY AFTER REPAIR. The licensee must perform the survey required by 180 NAC 7-080.01 upon installation of a new source and following repairs to the source or sources shielding, the source or sources driving unit, or other electronic or mechanical component that could expose the source, reduce the shielding around the source or sources, or compromise the radiation safety of the unit or the source or sources.
080.03 RECORDS. A licensee must retain a record of the radiation surveys required by 180 NAC 7-080.01 according to 180 NAC 7-113.
081. FULL-INSPECTION SERVICING FOR TELETHERAPY AND GAMMA STEREOTACTIC RADIOSURGERY UNITS .
081.01 FREQUENCY. A licensee must 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 must not to exceed five years for each teletherapy unit and must not exceed seven years for each gamma stereotactic radiosurgery unit.
081.02 SPECIFICALLY LICENSED PERSONS. This inspection and servicing must only be performed by persons specifically licensed to do so by the Department, the NRC, or an Agreement State.
081.03 RECORDS. A licensee must maintain a record of the inspection and servicing according to 180 NAC 7-114.
082. THERAPY-RELATED COMPUTER SYSTEMS . The licensee must perform acceptance testing on the treatment planning system according to 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 radioactive 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.
083. POSSESSION OF SURVEY INSTRUMENTS . A licensee authorized to use radioactive material in remote afterloader units, teletherapy units, and gamma stereotactic radiosurgery units must possess a portable radiation detection survey instrument capable of detecting dose rates over the range of 1 μSv (0.1 mrem) per hour to 1,000 μSv (100 mrems) per hour, and a portable radiation measurement survey instrument capable of measuring dose rates over the range of 10 μSv(1 mrem) per hour to 10 mSv (1000 mrems) per hour. The instruments must be operable and calibrated according to 180 NAC 7-030.
084. TRAINING FOR USE OF REMOTE AFTERLOADER UNITS, TELETHERAPY UNITS, AND GAMMA STEREOTACTIC RADIOSURGERY UNITS . Other than as provided in 180 NAC 7-026, the licensee must require an authorized user of a sealed source for a use authorized under 180 NAC 7-067 to be a physician who:
(A) Is certified by a medical specialty board whose certification process has been recognized by the Department, an Agreement State or the NRC and who meets the requirements of 180 NAC 7-084(C). The names of board certifications that have been recognized the Department, an Agreement State or the NRC are posted on the NRC’s Medical Uses Licensee Toolkit website. To be recognized, a specialty board must require all candidates for certification to:
(i) 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 Royal College of Physicians and Surgeons of Canada or the Council on Postdoctoral Training of the American Osteopathic Association; and (ii) 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) The physician has:
(i) Completed a structured educational program in basic radionuclide techniques applicable to the use of a sealed source in a therapeutic medical unit that includes:
(1) 200 hours of classroom and laboratory training in the following areas:
(a) Radiation physics and instrumentation; (b) Radiation protection; (c) Mathematics pertaining to the use and measurement of radioactivity; and (d) Radiation biology; and
(2) 500 hours of work experience, under the supervision of an authorized user who meets the requirements in 180 NAC 7-026, 7-084 or equivalent NRC or Agreement State requirements at a medical facility that is authorized to use radioactive materials in 180 NAC 7-067, involving:
(a) Reviewing full calibration measurements and periodic spot-checks; (b) Preparing treatment plans and calculating treatment doses and times; (c) Using administrative controls to prevent a misadministration involving the use of radioactive material; (d) Implementing emergency procedures to be followed in the event of the abnormal operation of the medical unit or console; (e) Checking and using survey meters; and (f) electing the proper dose and how it is to be administered;
(ii) Completed three years of supervised clinical experience in radiation therapy, under an authorized user who meets the requirements in 180 NAC 7-026, 7-084, or equivalent Agreement State or NRC 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 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 180 NAC 7-084(B)(i)(2); and (iii) Obtained written attestation that the individual has satisfactorily completed the requirements in 180 NAC 7-084(B)(i) and (ii) and 7-087.03; 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:
(1) A preceptor authorized user who meets the requirements in 180 NAC 7-026, 7-084, or equivalent NRC or Agreement State requirements, for the type or types of therapeutic medical unit for which the individual is requesting authorized user status; or (2) 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 180 NAC 7-026, 7-084, or equivalent NRC or Agreement State requirements, for the type or types 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 or 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 180 NAC 7-084(B)(i) and (ii); and
(C) Has received training in device operation, safety procedures, and clinical use of the type or types 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 or types of use for which the individual is seeking authorization.
085. OTHER MEDICAL USES OF RADIOACTIVE MATERIAL OR RADIATION FROM RADIOACTIVE MATERIAL . A licensee may use radioactive material or radiation sources approved for medical use which is not specifically addressed in 180 NAC 7 provided that the applicant or licensee has:
(A) Submitted the information required by 180 NAC 7-008.02 through 7-008.04; and (B) Received written approval from the NRC or Agreement State in a license and uses the material according to the regulations and specific conditions the NRC or Agreement State considers necessary for the medical use of the material.
086. RECORDS OF AUTHORITY AND RESPONSIBILITIES FOR RADIATION PROTECTION PROGRAMS . A licensee must:
(A) Retain a record of actions taken by the licensee’s management according to 180 NAC 7-015.02 and 7-015.03 for five years. The record must include a summary of the actions taken and a signature of licensee management. (B) Retain a current copy of the authorities, duties and responsibilities of the RSO as required by 180 NAC 7-015.06, and a signed copy of the RSOs agreement to be responsible for implementing the radiation safety program, as required by 180 NAC 7-015.04. The record must include the signature of the radiation safety officer and licensee management. (C) For each ARSO appointed under 180 NAC 7-015.04 the licensee must retain, for 5 years after the ARSO is removed from the license, a copy of the written document appointing the ARSO signed by the licensee's management. (D) Maintain minutes of each Radiation Safety Committee meeting held according to 180 NAC 7-015.09. Minutes must include:
(i) The date of the meeting; (ii) Members present; (iii) Members absent; and (iv) Summary of deliberations and discussions.
087. RECORDS OF RADIATION PROTECTION PROGRAM CHANGES . A licensee must retain a record of each radiation protection program made according to 180 NAC 7-016.01 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.
088. RECORDS OF WRITTEN DIRECTIVES . A licensee must retain a copy of each written directive as required by 180 NAC 7-019 for three years.
089. RECORDS OF MISADMINISTRATION . A licensee must retain a record of misadministration reported according to 180 NAC 7-115 for three years. The record must contain:
(A) The licensee’s name; (B) Name of the individual involved; (C) Identification number or if no other identification number is available, the social security number of the individual who is the subject of the misadministration; (D) A brief description of the event; (E) Why it occurred; (F) The effect, if any, on the individual; (G) The actions if any taken, or planned, to prevent recurrence; and (H) Whether the licensee notified the individual, or the individual’s responsible relative or guardian; and, if not, whether such failure to notify was based on guidance from the referring physician.
090. RECORDS OF A DOSE TO AN EMBRYO OR FETUS OR A NURSING CHILD . A licensee must retain a record of a dose to an embryo or fetus or a nursing child reported according to 180 NAC 7-117 for three years. The record must contain:
(A) The licensee’s name; (B) Name of all the individuals involved; (C) Identification number or if no other identification number is available, the social security number of the pregnant individual or nursing child who is the subject of the event; (D) A brief description of the event; (E) Why it occurred; (F) The effect, if any, on the embryo or fetus or nursing child; (G) The actions, if any, taken or planned, to prevent recurrence; and (H) Whether the licensee notified the pregnant individual or mother, or the mother’s or child’s responsible relative or guardian, and, if not, whether such failure to notify was based on guidance from the referring physician.
091. RECORDS OF CALIBRATION OF INSTRUMENTS USED TO MEASURE THE ACTIVITY OF UNSEALED RADIOACTIVE MATERIAL . A licensee must maintain a record of instrument calibrations required by 180 NAC 7-029 for three years. The records must include:
(A) The model and serial number of the instrument; (B) Calibration date; (C) Calibration results; and (D) Name of the individual who performed the calibration.
092. RECORDS OF RADIATION SURVEY INSTRUMENT CALIBRATIONS . A licensee must maintain a record of radiation survey instrument calibration required by 180 NAC 7-030 for three years. The record must include the items listed in 180 NAC 7-091 (A) through (D).
093. RECORDS OF DOSAGES OF UNSEALED RADIOACTIVE MATERIAL FOR MEDICAL USE . A licensee must maintain a record of dosage determinations required by 180 NAC 7-031 for three years. The record must contain the:
(A) The radioactive drug; (B) Patient’s or human research subject’s name, or identification number if one has been assigned; (C) Prescribed dosage, the determined dosage, or a notation that the total activity is less than 1.1 MBq (30 μCi); (D) Date and time of the dosage determination; and (E) Name of the individual who determined the dosage.
094. RECORDS OF INVENTORY OF SEALED SOURCES AND BRACHYTHERAPY SOURCES . A licensee must retain a record of the semi-annual physical inventory of sealed sources and brachytherapy sources required by 180 NAC 7-033.04 for three years. The inventory records must include:
(A) The model number of each source; (B) Serial number if one has been assigned; (C) Identity of each source radionuclide and its nominal activity; (D) Location of each source; and (E) Name of the individual who performed the test.
095. RECORDS OF SURVEYS FOR AMBIENT RADIATION EXPOSURE RATE AND CONTAMINATION . A licensee must retain a record of each survey required by 180 NAC 7–036 for three years. The record must include:
(A) The survey date; (B) Survey results; (C) Specific survey instrument used; and (D) Name of the individual who performed the survey.
096. RECORDS OF THE RELEASE OF INDIVIDUALS CONTAINING RADIOACTIVE DRUGS OR IMPLANTS CONTAINING RADIOACTIVE MATERIAL . Each applicable record in this section must be maintained for three years after the date of the release of the individual. A licensee must retain a record:
(A) Of the basis for authorizing the release of an individual according to 180 NAC 7-037, if the total effective dose equivalent is calculated by:
(i) Using the retained activity rather than the activity administered; (ii) Using an occupancy factor less than 0.25 at 1 meter; (iii) Using the biological or effective half-life; or (iv) Considering the shielding by tissue; and
(B) That instructions required by 180 NAC 7-037.02 were provided to a breast-feeding woman if the radiation dose to the infant or child from continued breast-feeding could result in a total effective dose equivalent exceeding 1 mSv (0.1 rem).
097. RECORDS OF ADMINISTRATIVE AND TECHNICAL REQUIREMENTS THAT APPLY TO THE PROVISION OF MOBILE SERVICES . A licensee must retain:
(A) A copy of each letter that permits the use of radioactive material at a client's address, as required by 180 NAC 7-009.02, for three years after the last provision of service; and (B) The record of each survey required by 180 NAC 7-038(F), 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.
098. RECORDS OF DECAY-IN-STORAGE . Records of decay-in-storage are to be retained as stated in 180 NAC 4-054.02.
099. RECORDS OF RADIONUCLIDE PURITY . A licensee must maintain a record of the radionuclide contaminant concentration tests required by 180 NAC 7-045.02 for three years. The record must include, for each measured elution of radionuclide used to prepare a radioactive drug:
(A) The ratio of the measures expressed as kilobecquerel of contaminant per megabecquerel of desired radionuclide (microcuries/millicurie), or microgram of contaminant per megabecquerel of desired radionuclide (microgram/millicurie); (B) Time and date of the measurement; and (C) Name of the individual who made the measurement.
100. RECORDS OF TRAINING . A licensee must maintain records of training required by 180 NAC 7-025 for three years after the last date an individual was authorized to act as a nuclear medicine technologist or radiation therapist at the licensee’s facility.
101. RECORDS OF SAFETY INSTRUCTION AND TRAINING . A licensee must maintain a record of safety instructions required by 180 NAC 7-049, 7-058 and 7-070 for three years. The record must include:
(A) A list of topics covered; (B) The date of instruction; (C) Names of attendees; and (C) Names of individuals who provided the instruction.
102. RECORDS OF SURVEYS OF PATIENTS AND HUMAN RESEARCH SUBJECTS . A licensee must maintain a record of the surveys required by 180 NAC 7-056 and 7-068 for three years. Each record must include the items listed in 180 NAC 7-095 (A) through (D).
103. RECORDS OF BRACHYTHERAPY SOURCE INVENTORY . A licensee must maintain a record of brachytherapy source accountability required by 180 NAC 7-057 for three years. The record must include:
(A) For temporary implants:
(i) 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 (ii) 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; and
(B) For permanent implants:
(i) 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; (ii) 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 (iii) The number and activity of sources permanently implanted in the patient or human research subject.
104. RECORDS OF CALIBRATION MEASUREMENTS OF BRACHYTHERAPY SOURCES . A licensee must maintain a record of the calibrations of brachytherapy sources required by 180 NAC 7-060 for three years after the last use of the source. The record must include:
(A) The date of the calibration; (B) The manufacturer's name, model number, and serial number for the source and the instruments used to calibrate the source; (C) The source output or activity; (D) The source positioning accuracy within the applicators; and (E) The signature of the authorized medical physicist.
105. RECORDS OF DECAY OF STRONTIUM-90 SOURCES FOR OPHTHALMIC TREATMENTS . A licensee must maintain a record of the activity of a strontium-90 source required by 180 NAC 7-060 for the life of the source. The record must include:
(A) The date and initial activity of the source as determined under 180 NAC 7-060; and (B) For each decay calculation, the date and the source activity as determined under 180 NAC 7-060.
106. RECORDS OF INSTALLATION, MAINTENANCE, ADJUSTMENT, AND REPAIR . A licensee must retain a record of the installation, maintenance, adjustment, and repair of remote afterloader units, teletherapy units, and gamma stereotactic radiosurgery units as required by 180 NAC 7-069 for three years. For each installation, maintenance, adjustment and repair, the record must include:
(A) The date; (B) Description of the service; and (C) Names of the individuals who performed the work.
107. RECORDS OF DOSIMETRY EQUIPMENT . A licensee must retain a record of the calibration, intercomparison, and comparisons of its dosimetry equipment done according to 180 NAC 7-072 for the duration of the license. For each calibration, intercomparison, or comparison, the record must include:
(A) The date; (B) The manufacturer's name, model numbers and serial numbers of the instruments that were calibrated, intercompared, or compared as required by 180 NAC 7-072.01 and 7-072.02; (C) The correction factor that was determined from the calibration or comparison or the apparent correction factor that was determined from an intercomparison; and (D) The names of the individuals who performed the calibration, intercomparison, or comparison.
108. RECORDS OF TELETHERAPY, REMOTE AFTERLOADER, AND GAMMA STEREOTACTIC RADIOSURGERY FULL CALIBRATIONS . A licensee must maintain a record of the teletherapy unit, remote afterloader unit, and gamma stereotactic radiosurgery unit full calibrations required by 180 NAC 7-073 through 7-075 for three years. The record must include:
(A) The date of the calibration; (B) The manufacturer's name, model number, and serial number of the teletherapy, remote afterloader, and gamma stereotactic radiosurgery unit or units, the source or sources, and the instruments used to calibrate the unit or units; (C) The results and an assessment of the full calibrations; (D) The results of the autoradiograph required for LDR remote afterloader units; and (E) The signature of the authorized medical physicist who performed the full calibration.
109. RECORDS OF PERIODIC SPOT-CHECKS FOR TELETHERAPY UNITS . A licensee must retain a record of each periodic spot-check for teletherapy units required by 180 NAC 7-076 for three years. The record must include:
(A) The date of the spot-check; (B) 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; (C) An assessment of timer linearity and constancy; (D) The calculated on-off error; (E) A determination of the coincidence of the radiation field and the field indicated by the light beam localizing device; (F) The determined accuracy of each distance measuring and localization device; (G) The difference between the anticipated output and the measured output; (H) 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 (I) 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.
110. RECORDS OF PERIODIC SPOT-CHECKS FOR REMOTE AFTERLOADER UNITS . A licensee must retain a record of each spot-check for remote afterloader units required by 180 NAC 7-077 for three years. The record must include, as applicable:
(A) The date of the spot-check; (B) The manufacturer's name, model number, and serial number for the remote afterloader unit and source; (C) An assessment of timer accuracy; (D) 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 (E) 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.
111. RECORDS OF PERIODIC SPOT-CHECKS FOR GAMMA STEREOTACTIC RADIOSURGERY UNITS . A licensee must retain a record of each spot-check for gamma stereotactic radiosurgery units required by 180 NAC 7-078 for three years. The record must include:
(A) The date of the spot-check; (B) 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; (C) An assessment of timer linearity and accuracy; (D) The calculated on-off error; (E) A determination of trunnion centricity; (F) The difference between the anticipated output and the measured output; (G) An assessment of source output against computer calculations; (H) 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 (I) 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.
112. RECORDS OF ADDITIONAL TECHNICAL REQUIREMENTS FOR MOBILE REMOTE AFTERLOADER UNITS . A licensee must retain a record of each check for mobile remote afterloader units required by 180 NAC 7-079 for three years. The record must include:
(A) The date of the check; (B) The manufacturer's name, model number, and serial number of the remote afterloader unit; (C) Notations accounting for all sources before the licensee departs from a facility; (D) 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 (E) The signature of the individual who performed the check.
113. RECORDS OF SURVEYS OF THERAPEUTIC TREATMENT UNITS . A licensee must maintain a record of radiation surveys of treatment units made according to 180 NAC 7-080 for the duration of use of the unit. The record must include:
(A) The date of the measurements; (B) The manufacturer's name, model number and serial number of the treatment unit, source, and instrument used to measure radiation levels; (C) Each dose rate measured around the source while the unit is in the off position and the average of all measurements; and (D) The signature of the individual who performed the test.
114. RECORDS OF FIVE YEAR INSPECTIONS FOR TELETHERAPY AND GAMMA STEREOTACTIC RADIOSURGERY UNITS . A licensee must maintain a record of the five year inspections for teletherapy and gamma stereotactic radiosurgery units required by 180 NAC 7-081 for the duration of use of the unit. The record must contain:
(A) The inspector's radioactive materials license number; (B) The inspection date; (C) The manufacturer's name and model number and serial number of both the treatment unit and source; (D) A list of components inspected and serviced, and the type of service; and (E) The signature of the inspector.
115. REPORT AND NOTIFICATION OF MISADMINISTRATION .
115.01 MISADMINISTRATION REPORTING. A licensee must report any event as a misadministration, other than events that result from patient intervention, where:
(A) The administration of radioactive material or radiation from radioactive material, except permanent implant brachytherapy, results in:
(i) A dose that differs from the prescribed dose or dose that would have resulted from the prescribed dosage by more than 0.05 Sv (5 rem) effective dose equivalent, 0.5 Sv (50 rem) to an organ or tissue, or 0.5 Sv (50 rem) shallow dose equivalent to the skin; and either
(1) The total dose delivered differs from the prescribed dose by twenty percent or more; (2) The total dosage delivered differs from the prescribed dosage by twenty percent or more or falls outside the prescribed dosage range; or (3) The fractionated dose delivered differs from the prescribed dose, for a single fraction, by fifty percent or more;
(ii) A dose that exceeds 0.05 Sv (5 rem) effective dose equivalent, 0.5 Sv (50 rem) to an organ or tissue, or 0.5 Sv (50 rem) shallow dose equivalent to the skin from any of the following:
(1) An administration of a wrong radioactive drug containing radioactive material or the wrong radionuclide for a brachytherapy procedure; (2) An administration of a radioactive drug containing radioactive material by the wrong route of administration; (3) An administration of a dose or dosage to the wrong individual or human research subject; (4) An administration of a dose or dosage delivered by the wrong mode of treatment; or (5) A leaking sealed source; or
(iii) A dose to the skin or an organ or tissue other than the treatment site that exceeds by:
(1) 0.5 Sv (50 rem) or more the expected dose to that site from the procedure if the administration had been given according to the written directive prepared or revised before administration; and (2) Fifty percent or more the expected dose to that site from the procedure if the administration had been given according to the written directive prepared or revised before administration.
(B) 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, which results in:
(i) The total source strength administered differing by twenty percent or more from the total source strength documented in the post-implantation portion of the written directive; (ii) The total source strength administered outside of the treatment site exceeding twenty percent of the total source strength documented in the post-implantation portion of the written directive; or (iii) An administration that includes any of the following:
(1) The wrong radionuclide; (2) The wrong individual or human research subject; (3) Sealed source or sources implanted directly into a location discontiguous from the treatment site, as documented in the post-implantation portion of the written directive; or (4) A leaking sealed source resulting in a dose that exceeds 0.5 Sv (50 rem) to an organ or tissue.
115.02 REPORTING. A licensee must 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.
115.03 DEPARTMENT NOTIFICATION. The licensee must notify the Department by telephone, no later than the next business day after the discovery of a misadministration.
115.04 REPORT REQUIREMENTS. The licensee must submit a written report to the Department within 15 days after discovery of the misadministration.
(A) The written report must include:
(i) The licensee's name; (ii) The name of the prescribing physician; (iii) A brief description of the event; (iv) Why the event occurred; (v) The effect, if any, on the individual or individuals who received the administration; (vi) What actions, if any, have been taken or are planned to prevent recurrence; and (vii) Certification that the licensee notified the individual, or the individual's responsible relative or guardian, and if not, why not; and
(B) The report cannot contain the individual's name or any other information that could lead to identification of the individual.
115.05 REFERRING PHYSICIAN NOTIFICATION. The licensee must provide notification of the misadministration to the referring physician and also notify the individual who is the subject of the misadministration no later than 24 hours after its discovery, unless the referring physician personally informs the licensee either that they will inform the individual or that, based on medical judgment, telling the individual would be harmful. 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 24 hours, the licensee must make the appropriate notifications 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 misadministration, because of any delay in notification. To meet the requirements of 180 NAC 7-115.05, the notification of the individual who is the subject of the misadministration may be made instead to that individual's responsible relative or guardian. If a verbal notification is made, the licensee must inform the individual, or appropriate responsible relative or guardian that a written description of the event can be obtained from the licensee upon request. The licensee must provide such a written description if requested.
115.06 RIGHTS AND DUTIES. Aside from the notification requirement, nothing in 180 NAC 7-115 affects any rights or duties of licensees and physicians in relation to each other, to individuals affected by the misadministration, or to that individual's responsible relatives or guardians.
115.07 RECORDS. A licensee must retain a record of a misadministration according to 180 NAC 7-089. A copy of the record required under 180 NAC 7-089 must be provided to the referring physician if other than the licensee, within 15 days after discovery of the misadministration.
116. RECORDS OF SUPERVISION AUDITS . A licensee must maintain a record of audits required by 180 NAC 7-018.01(D) for three years. The record must include a list of items audited, the date of the audit, the name of the supervised individual, and the name and signature of the authorized user conducting the audit.
117. REPORT AND NOTIFICATION OF A DOSE TO AN EMBRYO OR FETUS OR A NURSING CHILD .
117.01 DOSE TO EMBRYO OR FETUS. A licensee must report any dose to an embryo or fetus that is greater than 5 mSv (500 mrem) 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 or fetus was specifically approved, in advance, by the authorized user.
117.02 DOSE TO A NURSING CHILD. A licensee must report any dose to a nursing child that was not specifically approved, in advance, by the authorized user; that is a result of an administration of radioactive material to a breast-feeding individual that:
(A) Is greater than 5 mSv (500 mrem) total effective dose equivalent; or (B) Has resulted in unintended permanent functional damage to an organ or a physiological system of the child, as determined by a physician.
117.03 TELEPHONE NOTIFICATION. The licensee must notify by telephone the Department no later than the next calendar day after discovery of a dose to the embryo or fetus or nursing child that requires a report in 180 NAC 7-117.01 or 7-117.02.
117.04 WRITTEN REPORT REQUIREMENTS. The licensee must submit a written report to the Department within 15 days after discovery of a dose to the embryo or fetus or nursing child that requires a report in 180 NAC 7-117.01 or 7-117.02.
(A) The written report must include:
(i) The licensee's name; (ii) The name of the prescribing physician; (iii) A brief description of the event; (iv) Why the event occurred; (v) The effect, if any, on the embryo or fetus or the nursing child; (vi) What actions, if any, have been taken or are planned to prevent recurrence; and (vii) Certification that the licensee notified the pregnant individual or mother, or the mother's or child's responsible relative or guardian, and if not, why not; and
(B) The report cannot contain the individual's or child's name or any other information that could lead to identification of the individual or child.
117.05 NOTIFICATIONS. The licensee must 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 24 hours after discovery of an event that would require reporting in 180 NAC 7-117.01 and 7-117.02, unless the referring physician personally informs the licensee either that they will inform the mother or that, based on medical judgment, telling the mother would be harmful. 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 24 hours, the licensee must make the appropriate notifications as soon as possible thereafter. The licensee may not delay any appropriate medical care for the embryo or 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 180 NAC 7-117.05, the notification may be made to the mothers or child's responsible relative or guardian instead of the mother. If a verbal notification is made, the licensee must inform the mother, or the mothers or child's responsible relative or guardian that a written description of the event can be obtained from the licensee upon request. The licensee must provide such a written description if requested.
117.06 RECORDS. A licensee must retain a record of a dose to an embryo or fetus or a nursing child according to 180 NAC 7-090. A copy of the record required under 180 NAC 7-090 must be provided to the referring physician, if other than the licensee, within 15 days after the discovery of the event.
118. REPORTS OF LEAKING SOURCES . A licensee must file a report within 5 days if a leak test required by 180 NAC 7-033 reveals the presence of 185 Bq ( 0.005 μCi) or more of removable contamination. 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.
119. NOTIFICATION OF DECEASED PATIENT OR HUMAN RESEARCH SUBJECTS CONTAINING RADIOACTIVE MATERIA L. The licensee must:
(A) Notify the Department by telephone immediately upon discovery that a patient or human research subject containing radioactive material has died, and it is possible that any individual could receive exposures in excess of 180 NAC 4-013 as a result of the deceased’s body; and
(B) Submit a written report to the Department within 30 days after discovery that the patient or human research subject referenced in 180 NAC 7-119(A) has died. The written report must include:
(i) The licensee’s name; (ii) The date of death; (iii) The radionuclide, chemical and physical form, and calculated activity at time of death; and (iv) The names or titles and address or addresses of known individuals who might have received exposures exceeding 5 mSv (500 mrem).
120. REPORT AND NOTIFICATION FOR AN ELUATE EXCEEDING PERMISSIBLE MOLYBDENUM-99, STRONTIUM-82, AND STRONTIUM-85 CONCENTRATIONS . The licensee must:
(A) Notify the Department and the distributor of the generator by telephone within seven calendar days after discovery that an eluate exceeded the permissible concentration listed in 180 NAC 7-045.01 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; and (B) 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 180 NAC 7-120(A).
History
- Effective 2023-06-14
Chapter 8 Radiation Safety Requirements for Non-Healing Arts Radiation Generating Devices
Neb. Admin. Code tit. 180, ch. 8 Radiation Safety Requirements for Non-Healing Arts Radiation Generating Devices {#sec-180-nac-8 omnilex-key=us-ne-regs-official--title-180--180 NAC 8}
Effective Date: 6/26/2021
001. SCOPE AND AUTHORITY . This chapter provides special requirements for radiation generating devices. The regulations are authorized by and implement the Radiation Control Act, Nebraska Revised Statute (Neb. Rev. Stat.) §§ 71-3501 to 71-3520. For purposes of this section, non-healing arts x-ray equipment include, but are not limited to, open and closed analytical x-ray equipment, x-ray gauges, cabinet x-ray radiography, security screening units, quality control application devices, ion implantation devices, electron beam welders, non-human use x-ray fluoroscopy, x-ray bomb detection, and x-ray irradiators. The requirements of this chapter are in addition to, and not in substitution for applicable requirements in 180 Nebraska Administrative Code (NAC) 1, 2, 4, 10, 15, and 18.
002. DEFINITIONS . The following definitions apply:
002.01 ACCESSIBLE SURFACE. An accessible surface is a surface that is external or outside of the enclosure or housing provided by the manufacturer. This includes the high-voltage generator, doors, access panels, latches, control knobs, and other permanently mounted hardware and including the plane across the exterior edge of any opening.
002.02 BAGGAGE UNIT. A baggage unit has the same meaning as stated in "Security Screening Unit".
002.03 BEAM PORT. The beam port is the opening on the x-ray apparatus designed to emit a primary beam. This does not include openings on baggage units
002.04 BOMB DETECTION RADIOGRAPHIC EQUIPMENT. Bomb detection radiographic equipment is equipment used solely for the purpose of remotely detecting explosive devices. This definition does not include hand held x-ray bomb detection equipment for the purposes of this chapter.
002.05 CABINET RADIOGRAPHY. Cabinet radiography is industrial radiography using radiation machines not subject to Food and Drug Administration (FDA) performance standards for cabinet x-ray systems, in an enclosed, interlocked cabinet in which the portion of a material being irradiated is contained, and where:
(A) The radiation machine will not operate unless all openings are closed with interlocks activated; (B) The cabinet is shielded so that every location on the exterior meets the conditions for an unrestricted area as defined in 180 NAC 4 of these regulations; and (C) The cabinet is constructed or arranged to exclude the entrance of any part of the body of an individual during irradiation.
002.06 CABINET X-RAY SYSTEM. Cabinet x-ray system has the same meaning as set out in Part 21 Code of Federal Regulations (CFR), 21 CFR §1020.40
002.07 CERTIFIED CABINET X-RAY SYSTEM. A certified cabinet x-ray system is a radiation generating device certified by the manufacturer according to 21 CFR §1010.2 as being manufactured and assembled according to the provisions of applicable federal radiation safety performance standards 21 CFR §1010 and 21 CFR §1020.40.
002.08 CERTIFIABLE CABINET X-RAY SYSTEM. A certifiable cabinet x-ray system is an existing uncertified radiation generating device that has been modified to meet the certification requirements specified in 21 CFR §1020.40.
002.09 CLOSED-BEAM X-RAY EQUIPMENT. Closed-beam x-ray equipment is a system where the beam path cannot be entered by any part of the body during normal operation.
002.10 COLLIMATOR. A collimator is a device for restricting the useful radiation in one or more directions.
002.11 CONTROL PANEL. A control panel is a device containing means for regulation and activation of radiation generating equipment or for the preselection and indication of operating factors.
002.12 FAIL-SAFE CHARACTERISTICS DESIGN. A fail-safe characteristics design is a design feature of a unit which causes beam port shutters to close, or otherwise prevents emergence of the primary beam, upon the failure of safety or warning devices.
002.13 HAND HELD X-RAY SYSTEM. A hand held x-ray system is a portable instrument that is designed to operate when held in the hand.
002.14 INDUSTRIAL RADIOGRAPHY. Industrial radiography is an examination of the structure of materials by nondestructive methods utilizing ionizing radiation to make radiographic images.
002.15 INTERLOCK. An interlock is a device or engineered system that prohibits access to an area of radiation hazard either by preventing entry or by automatically removing the hazard.
002.16 LEAKAGE RADIATION. Leakage radiation is all radiation coming from within the source housing, except the useful beam.
002.17 LOCAL COMPONENTS. Local components are part of a radiation generating device x-ray system and includes areas that are struck by x-rays including the radiation source housing, beam port and shutter assemblies, collimators, sample holders, cameras, goniometers, detectors and shielding, but do not include power supplies, transformers, amplifiers, readout devices, and control panels.
002.18 NORMAL OPERATING PROCEDURES. Normal operating procedures are step-by-step instructions necessary to accomplish the analysis. These procedures must include sample insertion and manipulation, equipment alignment, routine maintenance by the registrant, and data recording procedures which are related to radiation safety.
002.19 OPEN-BEAM CONFIGURATION. An open-beam configuration is a x-ray system where an individual could place some part of their body in the primary beam path during operation.
002.20 PRIMARY BEAM. The primary beam is ionizing radiation coming directly from the radiation source through a beam port into the volume defined by the collimation system.
002.21 RADIATION GENERATING DEVICE (RGD). A radiation generating device is any system, device, subsystem, or component of, which may generate x-rays or particle radiation between 5 kiloelectron volt (keV) and 1 megaelectronvolt (MeV), and is not intended for healing arts use for humans or animals. Radiation generating devices (RGD) are classified in the following ways:
(A) A mobile radiation generating device is mounted on a permanent base with wheels or casters for moving while completely assembled; (B) A portable radiation generating device is designed to be hand-carried; (C) A stationary radiation generating device is installed or placed in a fixed location; or (D) A transportable radiation generating device is installed in a vehicle or may be readily disassembled for transport or use in a vehicle.
002.22 RADIATION SOURCE OR X-RAY TUBE HOUSING. The radiation source or x-ray tube housing is the portion of an x-ray system that contains the x-ray tube or secondary target. Often the housing contains radiation shielding material or inherently provides shielding.
002.23 SAFETY DEVICE. A safety device is a device, interlock, or system that prevents the entry of any portion of an individual’s body into the primary x-ray beam path or that causes the beam to be shut off upon entry into its path.
002.24 SCATTERED RADIATION. Scattered radiation is radiation that has been deviated in direction, energy by passing through matter, or both.
002.25 SECURITY SCREENING UNIT. A security screening unit is a non-human use x-ray system with accessible openings designed for the detection of weapons or bombs, or contraband concealed in baggage, mail, packages, or other commodities or structures.
002.26 SHIELDED ROOM. A shielded room is a room housing a radiation generating device where, when the radiation generating device is set at maximum techniques, the exterior room environs meets the unrestricted area limits of 0.02 milliSievert (2 millirem) in any one hour and 1 milliSievert (100 millirem) in a year at 30 centimeters from the barrier. A shielded room does not include radiation generating equipment meeting the definition of cabinet x-ray systems.
002.27 SHUTTER. A shutter is a moveable device used to block the useful or primary beam emitted from an x-ray tube assembly.
002.28 SOURCE. A source is a point of origin of the radiation.
002.29 WARNING DEVICE. A warning device is a visible or audible signal that warns individuals of a potential radiation hazard.
002.30 X-RAY GENERATOR. A x-ray generator is a portion of an x-ray system that provides accelerating high voltage and current for the x-ray tube.
003. DEVICE SAFETY REQUIREMENTS . Radiation generating devices must meet the requirements of this section.
003.01 WARNING DEVICES. Warning devices must be labeled so their purpose is easily identified. On equipment installed after June 27, 1983, warning devices must have fail-safe characteristics.
003.01(A) WARNING LIGHT LOCATION. An easily visible warning light labeled with the words "X-RAY ON", or words having a similar intent, must be located near any switch that energizes an x-ray tube and must be illuminated only when the tube is energized.
003.02 PORTS. Unused ports on radiation source housings must be secured in the closed position in a way that will prevent unintended opening.
003.03 LABELING. All radiation generating devices must be labeled with a readily visible sign or signs bearing the radiation symbol and the words:
(A) "CAUTION RADIATION - THIS EQUIPMENT PRODUCES RADIATION WHEN ENERGIZED", or words having a similar intent, near any switch that energizes an x-ray tube. (B) For radiation generating devices with designed openings, for object entries, the following must be posted at or near each opening: “CAUTION – X-RAY HAZARD: DO NOT INSERT ANY PART OF THE BODY WHEN SYSTEM IS ENERGIZED”, or words having similar intent. (C) “"CAUTION - HIGH INTENSITY X-RAY BEAM", or words having a similar intent, if applicable, on the x-ray source housing.
003.04 RADIATION SOURCE HOUSING. Each radiation source housing must be subject to the following requirements:
(A) Each x-ray tube housing must be equipped with an interlock that shuts off the tube if it is removed from the radiation source housing or if the housing is disassembled. (B) Each port cover or each x-ray tube housing must be constructed so that, with all shutters closed, the radiation measured at a distance of 5 centimeters (cm) from its surface is not capable of producing a dose in excess of 0.025 milliSievert (2.5 millirem) in one hour. This limit must be met at any specified tube rating.
003.05 GENERATOR CABINET. Each x-ray generator must be supplied with a protective cabinet which limits leakage radiation measured at a distance of 5 cm from its surface so it is not capable of producing a dose in excess of 2.5 microSievert (0.25 millirem) in one hour.
004. AREA REQUIREMENTS . Areas where radiation generating devices are located must meet the requirements of this section.
004.01 RADIATION LEVELS. The local components of radiation generating devices must be located and arranged, and include sufficient shielding or access control, so that radiation levels in any area surrounding the local component group cannot result in a dose to an individual present in that area in excess of the dose limits given in 180 NAC 4-013. For systems utilizing x-ray tubes, these levels must be met at any specified tube rating.
004.02 SURVEYS. Facilities with radiation generating devices must have surveys completed as required by 180 NAC 4-021. The surveys must be sufficient to show compliance with 180 NAC 8-004.01 and must be performed:
(i) Upon installation of the equipment and at least once every 12 months thereafter; (ii) Following any change in the initial arrangement, number, or type of local components in the system; (iii) Following any maintenance requiring the disassembly or removal of a local component in the system; (iv) During the performance of maintenance and alignment procedures if the procedures require the presence of a primary x-ray beam when any local component in the system is disassembled or removed; (v) After bypass of a safety device or interlock; (vi) Any time a visual inspection of the local components in the system reveals an abnormal condition; and (vii) Whenever personnel monitoring devices show a significant increase over the previous monitoring period or the readings are approaching the limits specified in 180 NAC 4-005.
004.02(A) DEMONSTRATION OF COMPLIANCE. Radiation survey measurements will not be required if a registrant can demonstrate compliance to the satisfaction of the Department with subsection 004.01 in some other manner.
004.03 POSTING. Each area or room containing radiation generating devices must be clearly posted with a sign or signs bearing the radiation symbol and the words "CAUTION X-RAY EQUIPMENT", or words having a similar intent, according to 180 NAC 4-033.
005. OPERATING REQUIREMENTS . This section addresses the operating requirements of radiation generating devices.
005.01 PROCEDURES. Normal operating procedures must be written and available to all operators of radiation generating devices. No individual will be allowed to operate radiation generating devices in any manner other than that specified in the procedures unless the individual has obtained written approval of the radiation safety officer.
005.02 BYPASSING. No individual must bypass a safety device, interlock, or remove shielding unless the individual has obtained the approval of the radiation safety officer. The approval must be for a specified period of time. When a safety device or interlock has been bypassed, a visible sign bearing the words "SAFETY DEVICE NOT WORKING", or words having a similar intent, must be placed on the radiation source housing and at the control switch.
005.03 CONTROL PANEL. The radiation generating device can only be activated from a control panel. All indicators and controls that control the primary beam must be identifiable and visible through the use of labels, symbols, software displays, or the equivalent.
005.04 INTERLOCKS. An interlock must not be used to de-activate the x-ray tube or radiation generating device, except in an emergency or during testing of the interlock system. All interlocks must be of a fail-safe design.
005.05 MULTIPLE SOURCES. If more than one x-ray tube assembly or assemblies or focal spot can be operated sequentially or simultaneously from a control panel, visual indicators must identify which tube assembly or assemblies or focal spot has been selected. The selectors must be able to identify their function.
005.06 REPAIR OR MODIFICATION OF X-RAY TUBE SYSTEMS. Except as specified in subsection 005.02, no operation involving removal of covers, shielding materials, tube housing, modifications to shutters, collimators, or beam stops must be performed without determining that the tube is off and will remain off until safe conditions have been restored. The main switch, rather than interlocks, must be used for routine shutdown in preparation for repairs.
006. TESTING OF SAFETY DEVICES . This section addresses the testing of safety devices for radiation generating devices.
006.01 TESTING INTERVALS. Tests of all safety devices, including but not limited to, interlocks, shutters, warning lights, and required emergency shut-off switches, must be conducted at intervals recommended by the manufacturer but not to exceed 12 months.
006.02 SAFETY DEVICE FAILURE. If any safety device fails during testing, the radiation generating device must be removed from service until the safety device failure is corrected or temporary administrative controls are established and approved in writing by the radiation safety officer.
006.03 RECORDS. Records of safety device tests, check dates, findings, and corrective actions must be available for inspection and maintained for 5 years.
006.04 SAFETY DEVICE TESTING. If testing of a safety device cannot be performed due to manufacturer design, the registrant must document that the safety device will not be tested and specifically why the safety device cannot be tested.
007. PERSONNEL REQUIREMENTS . This section addresses personnel requirements to operate radiation generating devices, except registrants using only cabinet x-ray systems.
007.01 INSTRUCTION. No individual is allowed to operate or maintain radiation generating devices unless the individual has received four hours of instruction in and demonstrated competence in the following:
(A) Identification of radiation hazards associated with the use of the equipment; (B) Significance of the various radiation warning and safety devices and interlocks incorporated into the equipment, or the reasons they have not been installed on certain pieces of equipment and extra precautions required in those cases; (C) Appropriate operating procedures for the equipment; (D) Recognition of symptoms of an acute localized exposure; (E) Appropriate procedures for reporting an actual or suspected exposure; (F) Radiation protection appropriate for the hazards of the radiation generating device; and (G) Performing surveys where applicable.
007.02 PERSONNEL MONITORING. This subsection addresses personnel monitoring requirements for operators of radiation generating devices.
007.02(A) EXTREMITY DOSIMETRY DEVICES. Extremity dosimetry devices must be provided to and used by:
(i) Radiation generating device workers using systems having an open-beam configuration and not equipped with a safety device; and (ii) Personnel maintaining radiation generating devices if the maintenance procedures require the presence of a primary x-ray beam when any local component in the x-ray system is disassembled or removed.
007.02(B) REPORTED DOSE VALUES. Reported dose values must not be used for the purpose of determining compliance with 180 NAC 4-005 unless evaluated by a qualified expert as specified in 180 NAC 15-004.03.
008. ADDITIONAL REQUIREMENTS FOR CLOSED-BEAM RADIATION GENERATING DEVICES . In addition to the requirements of section 003 through 007, the following requirements apply to all closed-beam radiation generating devices:
008.01 SYSTEM ENCLOSURE. The radiation source, sample or object, detector, and analyzing crystal, if used, must be enclosed in a chamber or coupled chambers that cannot be entered by any part of the body during normal operation.
008.02 RADIATION EMISSION LIMIT. The radiation emission for all closed beam radiation generating devices must not exceed a dose rate of 0.005 milliSievert (0.5 millirem) in one hour at five centimeters outside any accessible surface.
008.03 SECURITY SCREENING UNITS. Security screening units must be provided with means to ensure operator presence at the control area in a position which allows surveillance of the openings and doors during generation of x-radiation.
(A) During an exposure or preset succession of exposures of one-half second or greater duration, the means provided must enable the operator to terminate the exposure or preset succession of exposures at any time. (B) During an exposure or preset succession of exposures of less than one-half second duration, the means provided may allow completion of the exposure in progress but must enable the operator to prevent additional exposures.
009. ADDITIONAL REQUIREMENTS FOR OPEN-BEAM RADIATION GENERATING DEVICES . In addition to the requirements in section 003 through 007, the following requirements apply to all open-beam radiation generating devices not otherwise addressed in this chapter.
009.01 SAFETY DEVICE. Safety devices must meet the following requirements:
(A) The registrant must document their justification of the use of open-beam instead of closed-beam x-ray systems; (B) If the registrant uses an open-beam system, the registrant must consider a safety device which prevents the entry of any portion of the operator’s body into the path of the primary beam or which causes the primary beam to be shut off upon entry into its path; (C) If the registrant’s use of the open-beam radiation generating device does not permit the use of a safety device to prevent direct body exposure, the registrant must maintain a written record of the various safety devices that have been evaluated and reasons for why these devices cannot be used. These records must be available onsite for inspection; (D) In place of the safety device described in subsection 009.01(B) above, the registrant must use alternative methods to minimize the possibility of unnecessary exposure. The registrant must maintain documentation describing the alternative methods. This documentation must be available for inspection as long as these methods are employed, plus an additional three years; and (E) The safety device requirement may be met for portable open-beam radiation generating devices that are manufactured to be used hand held, or potentially used as hand held, without safety devices, by complying with all the requirements in section 009 prior to use.
009.02 X-RAY ON STATUS. Open-beam radiation generating devices must be provided with a visible and active indication of:
(i) X-ray tube "on-off" status located near the radiation source housing. The warning lights as required by subsection 003.01(A) can meet this requirement if the warning lights are visible by anyone near the primary beam; (ii) Shutter "open-closed" status located at the control panel and near each beam port on the radiation source housing, if the primary beam is controlled with a shutter. The shutter status device must be clearly labeled as to the meaning of the device status. The status light at the control panel can meet the requirement for the status light at the beam port if the status light at the control panel is visible by anyone near the primary beam.
009.02(A) The x-ray tube “on-off” status indicator and the shutter “open-closed” status indicators must be of a fail-safe design.
009.03 SHUTTERS. On open-beam configurations installed after June 27, 1983, each port on the radiation source housing must be equipped with a shutter that cannot be opened unless a collimator or a coupling has been connected to the port.
009.04 PRIMARY BEAM ATTENUATION. In cases where the primary x-ray beam is not intercepted by the detector device under all conditions of operation, protective measures must be provided to avoid exposure to any individual from the transmitted primary x-ray beam.
009.05 OPERATOR ATTENDANCE. The operator must be in immediate attendance at all times when the equipment is in operation except when the area is locked or the equipment is secured to protect against unauthorized or accidental entry.
009.06 CONTROL OF ACCESS. If the radiation generating device is not in a restricted area and is capable of creating a radiation area or a high radiation area, the operator must be able to control access to the radiation generating device at all times during operation and meet the following requirements:
(A) Radiation areas must be clearly identified. The radiation source must be within a visible perimeter that meets the posting requirements of 180 NAC 4-034.01. The operator must ensure that no one is inside or enters the radiation area during operation of the radiation generating device; (B) High radiation areas must be clearly identified. The radiation source must be within a visible perimeter that meets the posting requirements of 180 NAC 4-034. The operator must ensure that no one is inside or enters the high radiation area during operation of the radiation generating device; (C) The operator must perform a visual check of the controlled area to ensure it is free of all unauthorized personnel immediately prior to activating the radiation source; (D) Surveillance of the exposure area must be maintained during operation, either visually or by other reliable means to ensure that no individual enters the area; (E) During the initial exposure, the radiation levels must be measured around the perimeter of the controlled area. The perimeter must be adjusted accordingly to meet the access control requirement for radiation areas or high radiation areas; and (F) The survey around the perimeter must be made for each new operating condition and the perimeter adjusted accordingly. The area of operation must be monitored periodically if radiation levels are variable.
010. ADDITIONAL REQUIREMENTS FOR OPEN-BEAM, HAND HELD RADIATION GENERATING DEVICES . In addition to the requirements in section 003 through 007 and 009, the following requirements apply to open-beam, hand held radiation generating devices.
010.01 PROCEDURES. All registrants possessing open-beam, hand held radiation generating devices must have available for review to the Department operating policies and procedures that contain measures to ensure that:
(A) The operator will not hold the sample during operation of the radiation generating device and that no part of the operator’s body will approach or be exposed to the primary beam; (B) The operator will not aim the primary beam at themselves or at any individual during operation of the radiation generating device; and (C) Operator radiation exposure is as low as reasonably achievable (ALARA).
011. SHIELDED ROOM RADIATION GENERATING DEVICES. Radiation generating devices in a shielded room must meet the requirements of section 003 through 007 and the following:
011.01 POSTING. All entrances to the room containing the radiation generating device must be posted “CAUTION – HIGH RADIATION AREA”, or “GRAVE DANGER – VERY HIGH RADIATION AREA”, as required by 180 NAC 4.
011.02 ENTRANCE INTERLOCKS. All entrances into the shielded room must be provided with interlocks. After an interlock has been interrupted, broken, or tripped, x-rays must only be produced again from the control panel. Interlocks must not be used to shut off the x-ray equipment except in an emergency or during testing.
011.03 ENTRANCE WARNING DEVICES. All entrances into the shielded room must be provided with a clearly visible warning device that operates only when radiation is being produced. The warning device must be labeled in accordance with subsection 003.01.
011.04 ROOM WARNING LIGHTS. The interior of the shielded room must be provided with flashing or rotating warning lights that only operate when radiation is being produced. These lights must be positioned so they can be observed from any position or orientation in the room. The lights must be posted indicating the meaning of the warning signal and instructions on what to do when the lights are operating; the posting must be legible, clearly visible, and accessible to view.
011.05 AUDIBLE ROOM WARNING DEVICE. An audible warning signal in the room must be activated and give individuals enough time to leave the room prior to the first initiation of radiation after the closing of any opening that can admit personnel. The registrant must post the meaning of the warning signal and instructions on what to do when the signal is operating; the posting must be legible, clearly visible, and accessible to view.
011.06 EMERGENCY SHUT-OFF. If dose rates exceed the High Radiation Area limits, an emergency shut off switch must be accessible to individuals in the high radiation areas. The switch and it’s mode of operation must be identified by a clearly visible sign posted adjacent to the switch. The emergency shut-off switch must include a manual reset that must be reset at the switch before x-rays can be produced again from the control panel. After an emergency shut-off switch has been activated, x-rays must only be produced again from the control panel.
011.07 SEPARATE ELECTRICAL SYSTEMS. The interlock system and the emergency shut-off system must be separate electrical or mechanical systems.
011.08 ENTRY INTO THE SHIELDED ROOM. After each exposure and before entry of any personnel, the control panel must indicate that the radiation generating device is no longer producing radiation. If the control panel does not indicate that the radiation generating device is not producing radiation, a survey must be performed upon entry to the shielded room to ensure that the radiation generating device is no longer producing radiation.
011.09 PERSONNEL MONITORING. All personnel associated with the x-ray equipment must be provided with personnel monitoring devices that must be calibrated for the x-ray energies being utilized. Records of personnel exposure must be maintained.
011.10 TRAINING. The registrant must not allow any individual to operate a radiation generating device in a shielded room until that individual has received a copy of, instruction in, and demonstrated an understanding of, operating and emergency procedures for the unit and competence in its use. Records must be maintained of all operator training.
011.11 CONTROL PANEL SECURITY. The equipment control panel must be provided with a locking device to prevent unauthorized use. The locking device must, when locked, prevent the production of radiation by the equipment.
011.12 MALFUNCTIONS. If a safety or warning device malfunctions, the control panel must be locked in the “off” position. The control panel must not be used, except as necessary for repair or replacement of the malfunctioning safety or warning device, until the safety or warning device is functioning properly.
012. RADIATION GENERATING DEVICES FOR BOMB DETECTION . In addition to the general requirements in section 003 through 007 the following requirements in this section apply to bomb detection radiation generating devices.
012.01 CONTROL PANEL SECURITY. When not in use, each bomb detection radiation generating device must be locked to prevent unauthorized use.
012.02 AREA CONTROL. The registrant must provide security to prevent entry by individuals from any point when the machine is energized during training.
History
- Effective 2021-06-26
Chapter 9 Radiation Safety Requirements for Non Human Use Particle Accelerators
Neb. Admin. Code tit. 180, ch. 9 Radiation Safety Requirements for Non Human Use Particle Accelerators {#sec-180-nac-9 omnilex-key=us-ne-regs-official--title-180--180 NAC 9}
Effective Date: 6/26/2021
001. SCOPE AND AUTHORITY . This chapter establishes procedures for the registration and use of particle accelerators for nonhuman use. Title 180 is authorized by and implement the Nebraska Radiation Control Act, Nebraska Revised Statute (Neb. Rev. Stat.) §§ 71-3501 to 71-3520. In addition to the requirements of this chapter, all registrants are subject to the requirements of 180 Nebraska Administrative Code (NAC) 1, 2, 4, 10, 15, and 18. Registrants whose operations result in the production of radioactive material must also meet the requirements of 180 NAC 3.
002. REGISTRATION REQUIREMENTS . Any person intending to receive, possess, use, transfer, own, or acquire a particle accelerator must have a registration which permits that activity.
003. GENERAL REQUIREMENTS . In addition to the requirements of 180 NAC 2 a registrant must:
(A) Appoint a radiation safety officer; (B) Establish a radiation safety committee to approve, in advance, proposals for use of a particle accelerator. The radiation safety committee, consisting of at least three members, must oversee the use of the particle accelerator, and review the registrant's radiation safety program. Membership of the committee must include at least an authorized user, a representative of the registrant's management, and the Radiation Safety Officer; (C) Have proposed or existing equipment, facilities, and operating and emergency procedures adequate to protect health and minimize danger to public health and safety or property as required by 180 NAC 9-004 through 009; (D) Be qualified by training and experience to use the accelerator in question for the purpose requested as specified in this chapter, 180 NAC 4, and 180 NAC 10 in a manner as to minimize danger to public health and safety or property; (E) Ensure operation of the particle accelerator will not be harmful to the health and safety of the public; and (F) Ensure that the applicant, or the applicant's staff, or both, has training and experience in the use of particle accelerators as specified in 180 NAC 15-010.
004. OPERATOR QUALIFICATIONS . A person intending to operate an accelerator must meet the training requirements of 180 NAC 15-010.
005. OPERATING REQUIREMENTS . This section addresses requirements for operation of particle accelerators.
005.01 OPERATOR REQUIREMENTS. No registrant may permit any individual to act as an operator of a particle accelerator until the individual has:
(A) Been instructed in and demonstrated an understanding of radiation safety; (B) Received copies of, instruction in, and demonstrated an understanding of the requirements of this chapter and the applicable requirements of 180 NAC 4 and 180 NAC 10, pertinent registration conditions, and the registrant's operating and emergency procedures; and (C) Demonstrated competence to use the particle accelerator, related equipment, and survey instruments which will be used.
005.02 RADIATION SAFETY COMMITTEE. The radiation safety committee or the radiation safety officer must have the authority to terminate the operations at a particle accelerator facility if the action is necessary to minimize danger to public health and safety or property.
006. SHIELDING AND SAFETY DESIGN REQUIREMENTS . Particle accelerator facilities must meet shielding and design requirements as specified below.
006.01 DESIGN AND SURVEY. A radiological health physicist as specified in 180 NAC 15-004.02 must be consulted in the design of a particle accelerator installation and must perform a radiation survey when the accelerator is first capable of producing radiation. A copy of the survey results must be available to the Department for review.
006.02 PRIMARY AND SECONDARY BARRIERS. Each particle accelerator installation must be provided with primary and secondary barriers as are necessary to be in compliance with 180 NAC 4-005 and 013.
007. PARTICLE ACCELERATOR CONTROLS AND INTERLOCK SYSTEMS . Particle accelerator control and interlocks must meet the following requirements.
007.01 CONTROL CONSOLE. Instrumentation, readouts and controls on the particle accelerator control console must be clearly identified and easily discernible.
007.02 ENTRANCE. Each entrance into a target room or other high radiation area must be provided with a safety interlock(s) that shuts down the machine under conditions of barrier penetration.
007.03 MANUAL RESET. When a safety interlock system has been tripped, it must only be possible to resume operation of the accelerator by manually resetting controls at the position where the safety interlock has been tripped, and lastly at the main control console.
007.04 INDEPENDENT CIRCUIT. Each safety interlock must be on a circuit which must allow its operation independently of all other safety interlocks.
007.05 DESIGN. All safety interlocks must be designed so that any defect or component failure in the safety interlock system prevents operation of the accelerator.
007.06 CUTOFF SWITCH. A scram button or other emergency power cutoff switch must be located and easily identifiable in all high radiation areas. The cutoff switch must include a manual reset so that the accelerator cannot be restarted from the accelerator control console without resetting the cutoff switch.
008. WARNING DEVICES . Particle accelerators must be equipped with warning devices as required below.
008.01 LOCATION. Each location designated as a high radiation area, and each entrance to that location, must be equipped with easily observable warning lights that operate when, and only when, radiation is being produced.
008.02 AUDIBLE WARNING DEVICE. Each high radiation area must have an audible warning device which must be activated for 15 seconds prior to the possible creation of a high radiation area. The warning device must be clearly discernible in all high radiation areas and all radiation areas.
008.03 BARRIERS. Barriers, temporary or otherwise, and pathways leading to high radiation areas must be identified as required by 180 NAC 4-033.
009. SAFETY SYSTEMS . The safety systems described below must be in place.
009.01 UNAUTHORIZED USE. When not in operation, a particle accelerator must be secured to prevent unauthorized use.
009.02 SAFETY INTERLOCK SYSTEM. The safety interlock system must not be used to turn off the accelerator beam except in an emergency.
009.03 SAFETY AND WARNING DEVICES. All safety and warning devices, including interlocks, must be checked for proper operation at intervals not to exceed six months. Results of these checks must be maintained at the accelerator facility for inspection by the Department.
009.04 ELECTRICAL CIRCUIT DIAGRAMS. Electrical circuit diagrams of the accelerator and the associated interlock system must be kept current and maintained for inspection by the Department and must be available to the operator at each accelerator facility.
009.05 SAFETY INTERLOCK BYPASS. If it is necessary to intentionally bypass a safety interlock, the action must be:
(A) Authorized by the radiation safety committee, radiation safety officer, or both; (B) Recorded in a permanent log and a notice posted at the accelerator control console, and; (C) Terminated as soon as possible.
009.06 OPERATING AND EMERGENCY PROCEDURES. A copy of the current operating and emergency procedures must be maintained at the accelerator control panel.
010. RADIATION MONITORING REQUIREMENTS . Radiation must be monitored as described below.
010.01 MONITORING EQUIPMENT. There must be available at each particle accelerator facility appropriate portable monitoring equipment that is operable and has been appropriately calibrated for the radiation being produced at the facility. The equipment must be tested for proper operation daily and calibrated at intervals not to exceed one year and after each servicing and repair.
010.02 RADIATION PROTECTION SURVEY. A radiation protection survey must be performed and documented by a radiological health physicist as set out in 180 NAC 15-004.02 when changes have been made in shielding, operation, equipment, or occupancy of adjacent areas.
010.03 RADIATION LEVELS. Radiation levels in all high radiation areas must be continuously monitored. The monitoring devices must be electronically independent of the accelerator control and safety interlock systems and capable of providing a readout at the control panel.
010.04 AREA MONITORS. All area monitors must be calibrated at intervals not to exceed one year and after each servicing and repair.
010.05 PERIODIC AIR SURVEYS. Whenever applicable, periodic surveys must be made to determine the amount of airborne particulate radioactivity present.
010.06 PERIODIC SMEAR SURVEYS. Whenever applicable, periodic smear surveys must be made to determine the degree of contamination.
010.07 WRITTEN PROCEDURES FOR SURVEYS. All surveys must be made following the written procedures established by a radiological health physicist as set out in 15-004.02 or by the radiation safety officer.
010.08 RECORDS. Records of all radiation protection surveys, calibration and instrumentation tests must be maintained at the accelerator facility for inspection by the Department.
011. VENTILATION SYSTEMS . Ventilation systems must control airborne radioactive material.
011.01 AIRBORNE RADIOACTIVE MATERIAL. Ventilation systems must be provided to ensure that personnel entering any area where airborne radioactivity may be produced will not be exposed to airborne radioactive material in excess of the limits specified in 180 NAC 4, Appendix 4-B, Table l.
011.02 RELEASES. A registrant, as required by 180 NAC 4-014, must not vent, release or otherwise discharge airborne radioactive material to an unrestricted area which exceed the limits specified in 180 NAC 4, Appendix 4-B, Table II, except as authorized in 180 NAC 4-014 or 040. For purposes of 180 NAC 9-011, concentrations may be averaged over a period of not greater than one year. Every reasonable effort should be made to maintain releases of radioactive material to unrestricted areas as far below these limits as is reasonably achievable.
History
- Effective 2021-06-26
Chapter 10 Notices, Instructions and Reports to Workers: Inspections
Neb. Admin. Code tit. 180, ch. 10 Notices, Instructions and Reports to Workers: Inspections {#sec-180-nac-10 omnilex-key=us-ne-regs-official--title-180--180 NAC 10}
Effective Date: 6/26/2021
001. SCOPE AND AUTHORITY . This chapter establishes requirements for notices, instructions and reports by licensees or registrants to individuals engaged in activities under a license or registration and options available to individuals in connection with Department inspections of licensees or registrants to determine compliance with the provisions of the Act and regulations, orders and licenses issued regarding radiological working conditions. These regulations are authorized and implemented by the Nebraska Radiation Control Act, Nebraska Revised Statute (Neb. Rev. Stat.) §§ 71-3501 to 71-3520. These regulations apply to all persons who receive, possess, use, own or transfer sources of radiation licensed or registered with the Department according to 180 Nebraska Administrative Code (NAC) 2, 3, 5, 6, 7, 8, 9, 11, 14, 19, and 20.
002. POSTING OF NOTICES TO WORKERS . This section addresses documents that must be posted.
002.01 REQUIRED POSTINGS. Each licensee or registrant must post current copies of the following documents:
(A) The regulations in 180 NAC 4 and 10; (B) The license, certificate of registration, conditions or documents incorporated into the license by reference and amendments; (C) The operating procedures applicable to activities under the license or registration; and (D) Any notice of violation involving radiological working conditions, proposed imposition of civil penalty, or order issued and any response from the licensee or registrant.
002.02 ALTERNATIVE POSTINGS. If posting a document specified in subsection 002.01 (A), (B) or (C) is not practicable, the licensee or registrant may post a notice which describes the document and states where it may be examined.
002.03 NOTICE TO EMPLOYEES. Form NRH-3, "Notice to Employees" must be posted by each licensee or registrant wherever individuals work in or frequent any portion of a restricted area. Form NRH-3 is set out in Attachment 1 this chapter.
002.04 NOTICE OF VIOLATION. Department documents posted according to subsection 002.01 (D), must be posted within two working days after receipt of the documents from the Department; the licensee's or registrant's response, if any, must be posted within two working days after dispatch from the licensee or registrant. The documents must remain posted for a minimum of five working days or until action correcting the violation has been completed, whichever is later.
002.05 POSTING LOCATIONS. Documents, notices or forms posted according to 180 NAC 9-002 must appear in a sufficient number of places to permit individuals engaged in work under the license or registration to observe them on the way to or from any particular work location to which the document applies, must be conspicuous, and must be replaced if defaced or altered.
003. INSTRUCTIONS TO WORKERS . This section addresses instructions that must be provided to workers.
003.01 OCCUPATIONAL DOSE. All individuals who in the course of employment are likely to receive in a year an occupational dose in excess of 100 millirem (mrem) or 1 millisievert (mSv) must be:
(A) Kept informed of the storage, transfer, or use of radiation or radioactive material; (B) Instructed in the health protection problems associated with exposure to radiation or radioactive material, precautions or procedures to minimize exposure, and in the purposes and functions of protective devices employed; (C) Instructed in, and required to observe, to the extent within the worker's control, the applicable provisions of these regulations and licenses for the protection of personnel from exposures to radiation or radioactive material; (D) Instructed of their responsibility to report promptly to the licensee or registrant any condition which may lead to, constitute, or cause a violation of the Act, these regulations, and licenses or unnecessary exposure to radiation or radioactive material; (E) Instructed 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) Advised as to the radiation exposure reports which workers must be furnished according to 180 NAC 10-004.
003.02 INSTRUCTIONS TO WORKERS. In determining individuals subject to the requirements of 180 NAC 10-003.01, licensees or registrants must consider assigned activities during normal and abnormal situations involving exposure to radiation or radioactive material which can reasonably be expected to occur during the life of a licensee or registrant facility. These instructions must be commensurate with potential radiological health protection problems present in the work place and performed annually.
003.03 RECORDS. Records of the instructions to workers required by 180 NAC 10- 003 must be maintained by the licensee and registrant until reviewed by the Department.
004. NOTIFICATIONS AND REPORTS TO INDIVIDUALS . This section addresses reports and notifications.
004.01 REPORT CONTENT. 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 must be reported to the individual as specified in this section. The information reported must include data and results obtained according to these regulations, orders, or license conditions, as shown in records maintained by the licensee or registrant according to 180 NAC 4-052. Each notification and report must:
(A) Be in writing; (B) Include the name of the licensee or registrant, the name of the individual, and the individual's identification number; (C) Include the individual's exposure information; and (D) Contain the following statement:
"This report is furnished to you under the provisions of 180 NAC 10. You should preserve this report for further reference."
004.02 ANNUAL EXPOSURE REPORT. Each licensee or registrant must make dose information available to workers as shown in records maintained by the licensee or registrant under 180 NAC 4-052. The licensee or registrant must provide an annual report to each individual monitored under 180 NAC 4-022 of the dose received in that monitoring year if:
(A) The individual’s occupational dose exceeds 1 mSv (100 mrem) TEDE or 1 mSv (100 mrem) to any individual organ or issue; or (B) The individual requests their annual dose report.
004.03 FORMER WORKERS. Licensees and registrants must provide a written report of a former worker’s exposure to sources of radiation:
(A) At the request of a worker formerly engaged in activities controlled by the licensee or registrant. The report must include the dose record for each year the worker was required to be monitored according to 180 NAC 4-022; and (B) Within 30 days from the request date, or within 30 days after the dose of the individual has been determined by the licensee or registrant, whichever is later. The report must cover the period of time the worker's activities involved exposure to sources of radiation and must include the dates and locations of work under the license or registration in which the worker participated during this period.
004.04 INTERNAL DEPOSITION. Each licensee or registrant must furnish to each worker a report of the worker's results of any measurements, analyses and calculations of radioactive material deposited or retained in the body. The report must be furnished to the worker within 30 days of the determination by the licensee or registrant.
004.05 INCIDENT REPORTS. When a licensee or registrant is required according to 180 NAC 4-058, 4-059, or 4-060 to report to the Department any exposure of an individual to sources of radiation, the licensee or the registrant must provide the individual a written report on the exposure data included in the report to the Department. These reports must be transmitted at a time not later than the transmittal to the Department.
004.06 TERMINATING EMPLOYMENT. At the request of a worker who is terminating employment with the licensee or registrant in work involving exposure to radiation or radioactive material, during the current year, each licensee or registrant must 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 year. 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.
005. PRESENCE OF REPRESENTATIVES OF LICENSEES OR REGISTRANTS AND WORKERS DURING INSPECTION . This section addresses staff presence during an inspection.
005.01 INSPECTIONS. Each licensee or registrant must afford to the Department at all reasonable times opportunity to inspect materials, machines, activities, facilities, premises, and records according to these regulations.
005.02 CONSULTATION. During an inspection, Department inspectors may consult privately with workers as specified in 180 NAC 10-006. The licensee or registrant may accompany Department inspectors during other phases of an inspection.
005.03 WORKER’S REPRESENTATIVE. If an individual has been authorized by the workers to represent them during Department inspections, the licensee or registrant must notify the inspectors of the authorization and must give the workers' representative an opportunity to accompany the inspectors during the inspection of physical working conditions.
005.04 WORKER’S REPRESENTATIVE INSTRUCTIONS. Each workers' representative must be routinely engaged in work under control of the licensee or registrant and must have received instructions as specified in section 003.
005.05 ACCOMPANIMENT. 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 workers' representative at a time may accompany the inspectors.
005.06 CONSULTANT. With the approval of the licensee or registrant and the workers' representative, an individual who is not routinely engaged in work under control of the licensee or registrant serving as a consultant to the licensee or registrant or to the workers' representative must be afforded the opportunity to accompany Department inspectors during the inspection of physical working conditions.
005.07 LIMITATIONS. Notwithstanding the other provisions of 180 NAC 10-005, Department inspectors are authorized to refuse to permit accompaniment by any individual who deliberately interferes with a fair and orderly inspection. With regard to any area containing proprietary information, the workers' representative for that area must be an individual previously authorized by the licensee or registrant to enter that area.
006. CONSULTATION WITH WORKERS DURING INSPECTIONS . The Department may consult privately with workers during inspections.
006.01 PRIVATE CONSULTATION. Department inspectors may consult privately with workers concerning occupational radiation protection and other matters related to applicable provisions of these regulations and licenses that the inspectors deem necessary for the conduct of an effective and thorough inspection.
006.02 WORKER CONCERNS. During an inspection, any worker may bring privately to the attention of the inspectors, either orally or in writing, any past or present condition which the worker believes contributed to or caused any violation of the Act, these regulations, license condition, or any unnecessary exposure of an individual to sources of radiation under the licensee's or registrant's control. Any notice in writing must comply with the requirements of subsection 007.01.
006.03 INSTRUCTIONS. 180 NAC 10-006.02 must not be interpreted as authorization to disregard instructions according to 180 NAC 10-003.
007. REQUESTS BY WORKERS FOR INSPECTIONS . This section addresses requests for inspection by workers.
007.01 WRITTEN REQUEST FOR INSPECTION. Any worker or representative of workers who believes that a violation of the Act, these regulations or license conditions exists or has occurred in work under a license or registration to radiological working conditions in which the worker is engaged, may request an inspection by giving notice of the alleged violation to the Department. Any notice must be in writing, must set the specific grounds for the notice, and must be signed by the worker or representative of the workers. Upon the request of the worker giving the notice, the individual’s name and the name of individuals referred to in the notice will not appear in the copy or on any record published, released, or made available by the Department, except for good cause shown.
007.02 INSPECTION CONTENT. An inspection resulting from a request made under 180 NAC 10-007.01 is not limited to matters referred to in the request.
007.03 WORKER PROTECTION. A licensee, registrant, contractor or subcontractor of a licensee or registrant must not discharge or in any manner discriminate against any worker because the worker has filed a complaint, instituted or caused to be instituted any proceeding under these regulations or has testified or is about to testify in any proceeding or because of the exercise by a worker on behalf of themselves or others of any option afforded by 180 NAC 10.
History
- Effective 2021-06-26
Chapter 11 Requirements for Radon and Radon Progeny Measurement and Mitigation Services
Neb. Admin. Code tit. 180, ch. 11 Requirements for Radon and Radon Progeny Measurement and Mitigation Services {#sec-180-nac-11 omnilex-key=us-ne-regs-official--title-180--180 NAC 11}
Effective Date: 9/20/2023
001. SCOPE AND AUTHORITY . This chapter provides for the licensure of radon measurement specialists, radon measurement businesses, radon mitigation specialists, and radon mitigation businesses. The regulations are authorized by and implement the Radiation Control Act, the Uniform Credentialing Act and the Administrative Procedure Act. In addition to the requirements of this chapter, all licensees are subject to 180 NAC 1, 4, and 10.
002. DEFINITIONS . Definitions set out in the Nebraska Radiation Control Act, the Uniform Credentialing Act, the Radon Resistant New Construction Act, American National Standards Institute - American Association of Radon Scientists and Technologists Protocols for Measuring Radon and Radon Decay Products in Homes (MAH-2019), American National Standards Institute - American Association of Radon Scientists and Technologists Soil Gas Mitigation Standards for Existing Homes (SGM-SF-2017), American National Standards Institute - American Association of Radon Scientists and Technologists Protocol for Conducting Measurements of Radon and Radon Decay Products in Multifamily, School, Commercial and Mixed-Use Buildings (MA-MFLB 2023), American National Standards Institute - American Association of Radon Scientists and Technologists Soil Gas Mitigation Standards for existing Multifamily, School, Commercial and Mixed-Use Buildings (SGM-MFLB 2023), and the following apply to this chapter. Copies of all documents, guidelines, and similar items referenced in this chapter are available for viewing at the Nebraska Radon Program, Department of Health and Human Services, 301 Centennial Mall South, Lincoln, Nebraska 68509-5026.
002.01 ATTEST AND ATTESTATION. A declaration that all statements on the application are true and complete.
002.02 COMPLETE APPLICATION. An application that contains all of the information requested on the application, with attestation to its truth and completeness, and that is submitted with the required fees and documentation.
002.03 RADON MEASUREMENT BUSINESS. A person, including a laboratory, who analyzes or tests for and measures radon or radon progeny concentrations and which employs one or more radon measurement specialist.
002.04 RADON MEASUREMENT SPECIALIST. A person who performs radon or radon progeny measurements for a radon measurement business; or provides professional advice on radon or radon progeny measurements, health risks, radon-related exposure, or other radon-related activities.
002.05 RADON MITIGATION BUSINESS. A person who designs or installs systems in existing buildings to mitigate radon or radon progeny and which employs one or more radon mitigation specialist.
002.06 RADON MITIGATION SPECIALIST. A person who designs mitigation systems, or an individual who performs and evaluates diagnostic tests to determine appropriate radon or radon progeny mitigation
002.07 RADON RESISTANT NEW CONSTRUCTION (RRNC). The established standards and techniques for control of radon by using a passive new construction system, as defined in Nebraska Revised Statute (Neb. Rev. Stat.) § 76-3503.
002.08 RELEVANT POST-SECONDARY EDUCATION. A curriculum in architecture, engineering, building construction, physical sciences, or related disciplines. One year of post-secondary education consists of a minimum of 24 semester hours, of which at least ten hours must be in the above subject areas, or 36 quarter hours, of which at least 15 hours must be in the above subject areas.
002.09 RELEVANT WORK EXPERIENCE. The design, construction and renovation of buildings, or associated heating, ventilation, and air conditioning systems.
003. GENERAL PROVISIONS . The following general provisions must be met.
003.01 LICENSE REQUIRED. No person may provide services for the measurement or mitigation of radon in the State of Nebraska unless such person has been licensed as provided in 180 NAC 11.
003.01(A) EXEMPTIONS. The requirement to have a license does not apply to:
(i) Individuals measuring or mitigating the premises in which they reside. (ii) Federal, state, county and local health departments and their employees who provide professional advice on radon measurement or mitigation activities or perform radon screening services without charge to the recipient of the service in the course of their assigned duties. (iii) An individual, business entity or government entity acting in compliance with the requirements of Neb. Rev. Stat. § 76-3506.
004. OPERATING REQUIREMENTS . Licensees under this chapter must meet the requirements of this section.
004.01 LICENSED INDIVIDUAL.
004.01(A) ACTIVITIES. Conduct activities as permitted in the approved license and in accordance with provisions of the Radiation Control Act, all sections of these regulations, and all other related municipal, county, state, and federal laws and regulations.
004.01(B) CONTINUING EDUCATION. Complete continuing education requirements specified in this chapter.
004.01(C) AUDIT COMPLIANCE. Allow authorized representatives of the Department to have access to the licensee’s facilities, offices and files for inspection and examination of radon-related records and test procedures. The licensee must also allow authorized representatives of the Department to accompany the licensee while performing any radon measurement or mitigation activities for the purpose of inspecting these activities. Failure to cooperate with an audit or inspection is grounds for disciplinary action.
004.01(D) RADON MEASUREMENT SPECIALIST. In addition to following the operating requirements in 004.01(A)-(C), a radon measurement specialist is responsible for:
(i) Conducting all radon testing on behalf of the radon measurement business. This includes the initial placement and final retrieval of all measurement devices, along with verification of measurement results:
(1) Testing of single-family residences must be conducted according to the requirements described in American National Standards Institute - American Association of Radon Scientists and Technologists Protocol for Conducting Measurements of Radon and Radon Decay Products in Homes (MAH-2019) incorporated herein by this reference. (2) Testing of multifamily, school, commercial, and mixed-use buildings must comply with the requirements described in American National Standards Institute - American Association of Radon Scientists and Technologists Protocol for Conducting Measurements of Radon and Radon Decay Products in Multifamily, School, Commercial and Mixed-Use Buildings (MA-MFLB 2023) incorporated herein by this reference. Measurement Specialists conducting testing in multifamily, school, commercial and mixed-use buildings larger than 2,000 square feet must have completed a training course from an approved training provider for radon measurements in multifamily, school, commercial, and mixed-use buildings. (3) EXCEPTIONS. The following is an exception to the requirements described in American National Standards Institute - American Association of Radon Scientists and Technologists Protocol for Conducting Measurements of Radon and Radon Decay Products in Homes (MAH-2019) and American National Standards Institute - American Association of Radon Scientists and Technologists Protocol for Conducting Measurements of Radon and Radon Decay Products in Multifamily, School, Commercial and Mixed-Use Buildings (MA-MFLB 2023):
(a) A signed homeowner noninterference agreement is not required.
(ii) Ensuring that all radon measurement devices are approved by the National Radon Proficiency Program (NRPP), the National Radon Safety Board (NRSB), or a national proficiency program approved by the Department; (iii) Ensuring that all radon measurement devices are calibrated annually. Calibration must be conducted by either the manufacturer, or a chamber approved by the National Radon Proficiency Program (NRPP), the National Radon Safety Board (NRSB), or a national proficiency program approved by the Department; (iv) Directing measurement activities for the licensed business to include directing the submission of reports to the Department containing the information specified in 180 NAC 11; (v) Informing clients of radon levels in accordance with the provisions of 180 NAC 11; (vi) Following quality assurance and quality control measures, and adhering to an approved quality assurance plan, as specified in 180 NAC 11; and (vii) Evaluating operating procedures and ensuring compliance with state and federal regulations.
004.01(E) RADON MITIGATION SPECIALIST. In addition to following the operating requirements in 004.01(A)-(C), a radon mitigation specialist is responsible for:
(i) Directing mitigation activities for the licensed business to include directing the submission of reports to the Department containing the information specified in 180 NAC 11; (ii) Evaluating operating procedures and ensuring compliance with state and federal regulations; (iii) Supervising radon mitigation installations, assuring systems are installed according to 180 NAC 11-009 MITIGATION SYSTEM INSTALLATION REQUIREMENTS, and adhering to information submitted to the Department as required in 180 NAC 11; and (iv) Evaluating diagnostic tests of a building and designing mitigation systems to be in compliance with 180 NAC 11-009 Mitigation System Installation Requirements.
004.02 RADON MEASUREMENT BUSINESS. A radon measurement business must meet the requirements in this section.
004.02(A) ACTIVITIES. Ensure that all employed or contracted Radon Measurement professionals conduct activities as described in the approved license and as required by provisions of the Radiation Control Act, this chapter, and all other related municipal, county, state, and federal laws and regulations.
004.02(B) REQUIRED STAFF. Maintain on staff or retain as a consultant a radon measurement specialist. If a radon measurement business loses its radon measurement specialist, the radon measurement business must notify the Department in writing within five business days. The radon measurement business must not conduct measurements without a radon measurement specialist.
004.02(C) RECORDS. Maintain the following records for six years:
(i) Records of all radon tests performed, including client name, test date, address, and test results; (ii) Records of instrument calibrations and other quality control samples; (iii) Records of completing continuing education courses specified in this chapter; and (iv) Copies of licenses for radon measurement specialists employed or used as consultants.
004.02(D) CHANGES. Submit any changes in the information provided in the original or renewal application, including changes in licensed personnel or to the quality assurance documents as an amendment request to the Department for approval prior to implementation of such change.
004.02(E) DEVICE APPROVAL. Ensure that all radon measurement devices are approved by the National Radon Proficiency Program (NRPP), the National Radon Safety Board (NRSB), or a national proficiency program approved by the Department.
004.02(F) LICENSE NOT TRANSFERABLE. Each measurement business license issued is nontransferable.
004.03 RADON MITIGATION BUSINESS. A radon mitigation business must meet the requirements of this section.
004.03(A) ACTIVITIES. Ensure that all employed or contracted radon mitigation professionals conduct activities as described in the approved license and as required by provisions of the Radiation Control Act, this chapter, and all other related municipal, county, state, and federal laws and regulations.
004.03(B) REQUIRED STAFF. Maintain on staff or retain as a consultant a radon mitigation specialist. If a radon mitigation business loses its radon mitigation specialist, the radon mitigation business must notify the Department in writing within five business days. The radon mitigation business must not conduct mitigations without a radon mitigation specialist.
004.03(C) RECORDS. Maintain the following records for six years:
(i) Records of all mitigation work performed, including client name, address, a description of each mitigation system and materials installed, copies of building and electrical permits, pre-mitigation and post-mitigation measurements including method of measurement and all pertinent dates. (ii) Records of mitigation plans developed and signed by a radon mitigation specialist. (iii) Records of all instrument calibrations, contracts, and warranties on equipment installed. (iv) Records of completing continuing education courses specified in this chapter. (v) Records of employee exposure to radon during employment. (vi) Copies of the licenses for radon mitigation specialists employed or used as consultants.
004.03(D) CHANGES. Submit any changes in the information provided in the original or renewal application, including changes in licensed personnel or the quality assurance documents, as an amendment request to the Department for approval prior to implementation of such change.
004.03(E) LICENSE NOT TRANSFERABLE. Each mitigation business license issued is nontransferable.
005. INITIAL QUALIFICATIONS FOR AN INDIVIDUAL LICENSE .
005.01 RADON MEASUREMENT SPECIALIST. To receive a license to perform radon measurement, an individual must submit a complete application meet all statutory requirements, and the following:
005.01(A) EDUCATION. Within two years prior to application, the individual must have successfully completed a training course and passed an examination on radon measurements approved by the Department under the requirements specified in 180 NAC 11 and furnish proof of successful completion.
005.01(B) EXAMINATION. The individual must achieve or exceed the minimum passing score on the national examination provided by the National Radon Proficiency Program (NRPP) or the National Radon Safety Board (NRSB).
005.02 RADON MITIGATION SPECIALIST. To receive a license to perform radon mitigation, an individual must submit a complete application meet all statutory requirements, and the following:
005.02(A) EDUCATION. Within two years prior to application, the individual must have successfully completed a training course and passed an examination on radon mitigation approved by the Department under the requirements specified in 180 NAC 11 and furnish proof of successful completion.
005.02(B) EXPERIENCE. The applicant must possess any combination of two years of relevant post-secondary education or relevant work experience as defined in this chapter.
005.02(C) EXAMINATION. The individual must achieve or exceed the minimum passing score on the national examination provided by the National Radon Proficiency Program (NRPP) or the National Radon Safety Board (NRSB).
005.03 RECIPROCITY. A person who has a valid license or certification from a state which licenses or certifies persons who measure or mitigate radon in a certification or licensing program with requirements determined by the Department as comparable with the provisions of this chapter may be licensed by the Department upon submission of a complete application, and a copy of the certification or license from the other state.
005.04 WITHDRAWN APPLICATIONS. A request to withdraw an application will be granted:
(A) When the application is incomplete; or (B) When the request for withdrawal is received within five business days of the receipt of a complete application. The fee will be returned to the applicant except for a $25 administrative fee.
006. INITIAL LICENSE FOR A BUSINESS . The following applies for an initial license for a business.
006.01 RADON MEASUREMENT BUSINESS. To apply for a radon measurement business license, the applicant must submit a complete application.
006.02 RADON MITIGATION BUSINESS. To apply for a radon mitigation business license, the applicant must submit a complete application.
006.03 RADON LABORATORIES. To apply for a business license to operate as a radon laboratory, the applicant must submit a complete Measurement Business application, at least one completed measurement specialist application form as specified in this chapter or verification of an existing Nebraska radon measurement specialist license, and meet the requirements as set out in this chapter for a Radon Measurement Business license.
007. APPROVED RADON TRAINING COURSES . To be approved as a radon training course, the course must meet the following requirements:
007.01 APPROVAL OF RADON MEASUREMENT TRAINING COURSES. To be approved as a radon measurement training course, a course must meet and maintain approval by the National Radon Proficiency Program (NRPP) or National Radon Safety Board (NRSB) as an entry level or initial radon measurement course and must meet for a minimum of 16 hours or apply for approval as an alternative measurement course.
007.01(A) COURSE PROVIDER. The course provider must submit a complete application provided by the Department, documentation of current approval from the National Radon Proficiency Program (NRPP) or the National Radon Safety Board (NRSB) for the level of the course, a copy of the certificate to be issued to individuals upon completion of the course.
007.01(B) ALTERNATIVE MEASUREMENT COURSE. To apply for approval as an alternative measurement course, a course provider must submit a complete application provided by the Department and meet the following requirements:
(i) DOCUMENTATION. Submit documentation that the course will meet for a minimum of 16 hours with instruction on the following topics:
(1) radioactivity, radon, and radon’s health effects; (2) radon entry and behavior; (3) radon measurement devices, techniques, and protocols; (4) quality assurance and quality control; (5) worker health and safety; (6) measuring radon in water; and (7) an overview of radon mitigation techniques.
(ii) EVALUATION. Submit documentation that course participants had the opportunity to evaluate the course instructor(s) and materials.
(iii) CERTIFICATE. Submit a copy of the certificate issued upon completion of the course.
007.02 APPROVAL OF RADON MITIGATION COURSES. To be approved as a radon mitigation training course, a course must meet and maintain approval by the National Radon Proficiency Program (NRPP) or National Radon Safety Board (NRSB) as an entry level or initial radon mitigation course and must meet for a minimum of 20 hours or apply for approval as an alternative mitigation course.
007.02(A) COURSE PROVIDER. The course provider must submit a complete application provided by the Department, documentation showing approval from the NRPP or NRSB as an entry level or initial radon mitigation course, and a copy of the certificate to be issued upon completion of the course.
007.02(B) ALTERNATIVE MITIGATION COURSE. To apply for approval as an alternative mitigation course, a course provider must submit a complete application provided by the Department and meet the following requirements:
(i) DOCUMENTATION. Submit documentation that the course will meet for a minimum of 20 hours with instruction on the following topics:
(1) radon mitigation system design, diagnostics, and installation; (2) radon in water mitigation; and (3) radon-resistant new construction.
(ii) EVALUATION. Submit documentation that course participants had the opportunity to evaluate the course instructor(s) and materials.
(iii) CERTIFICATE. Submit a copy of the certificate issued upon completion of the course.
008. CONTINUING COMPETENCY . Each person holding an active license within the state must, on or before the date of expiration of the license, comply with the continuing competency requirements for their profession, unless the requirements are waived in accordance with 180 NAC 11. Each licensed individual is responsible for maintaining certificates or records of continuing competency activities.
008.01 REQUIREMENTS FOR CONTINUING COMPETENCY. To maintain a license, an individual must meet the following requirements.
008.01(A) CONTINUING EDUCATION. Complete at least six hours of radon courses, seminars, or meetings offered or approved by the Department by the expiration date of the license.
008.01(B) INSTRUCTORS. Instructors of radon-related courses or seminars may apply to the Department for continuing education credit, which will be determined by the Department. To receive continuing education credit for instruction, the person requesting credit must submit the following information:
(i) Name, address, and telephone number of the instructor; (ii) Biography or credentials of instructor; (iii) Type of course, frequency of course offerings, total hours of supervised instruction, and an agenda outlining the hours of instruction, describing the subject matter to be included; and (iv) A copy of the certificate issued upon completion of the course.
008.01(C) VALIDITY. Continuing education credit will only be valid for the licensing period in which it was received. Credit will not be granted for attendance of a duplicate course during the licensing period.
008.01(D) EXEMPTION. If an individual holds a measurement license and a mitigation license, a minimum of eleven total hours of continuing education must be completed by the expiration date of the licenses.
008.01(E) MILITARY WAIVERS. The Department may waive continuing competency requirements if a licensee has served in the regular armed forces of the U.S. during part of the credentialing period immediately preceding the renewal date.
008.02 APPROVAL OF CONTINUING COMPETENCY COURSES. The requirements for approval of continuing competency courses are as follows:
008.02(A) DEPARTMENT COURSES. A course, workshop, or seminar about radon offered or sponsored by the Department will be accepted for the number of credits listed by the Department.
008.02(B) NATIONAL RADON PROFICIENCY PROGRAM OR NATIONAL RADON SAFETY BOARD COURSES. A course, workshop, or seminar about radon offered or approved by the National Radon Proficiency Program or the National Radon Safety Board will be accepted for the number of credits listed by the respective organization.
008.02(C) OTHER COURSES. A course, workshop, or seminar about radon, not meeting the requirements of 180 NAC 11-008.02 (A) or (B), that is attended or taught by the licensee may be accepted as one hour of continuing education per hour of instruction and must apply for credit by submitting the following:
(i) Name, address, and telephone number of applicant; (ii) Biography or credentials of instructor; (iii) Type of course, frequency of course offerings, total hours of supervised instruction, and an agenda outlining the hours of instruction, describing the subject matter to be included; and (iv) A copy of the certificate issued upon completion of the course.
009. MITIGATION SYSTEM INSTALLATION REQUIREMENTS . Radon mitigation systems must meet the following installation requirements:
009.01 RESPONSIBILITY FOR COMPLIANCE. Radon mitigation specialists are responsible for all radon mitigation systems installed by their firm or its subcontractors to ensure compliance with the requirements of 180 NAC 11.
009.02 SINGLE FAMILY RESIDENCES. All installations of radon mitigation systems in single-family residences must be conducted according to the requirements described in American National Standards Institute - American Association of Radon Scientists and Technologists Soil Gas Mitigation Standards for Existing Homes (SGM-SF 2017) incorporated herein by this reference.
009.03 MULTIFAMILY, SCHOOL, COMMERCIAL, AND MIXED-USE BUILDINGS. All installations of radon mitigation systems in multifamily, school, commercial, and mixed-use buildings must be conducted according to the requirements described in American National Standards Institute - American Association of Radon Scientists and Technologists Soil Gas Mitigation Standards for existing Multifamily, School, Commercial and Mixed-Use Buildings (SGM-MFLB 2023) incorporated herein by this reference. Mitigation Specialists supervising the installation of radon mitigation systems in multifamily, school, commercial, and mixed-use buildings must have completed a training course from an approved training provider for radon mitigation in multifamily, school, commercial, and mixed-use buildings.
009.04 EXCEPTIONS. The following are exceptions to the requirements described in American National Standards Institute - American Association of Radon Scientists and Technologists Soil Gas Mitigation Standards for Existing Homes (SGM-SF 2017), and American National Standards Institute - American Association of Radon Scientists and Technologists Soil Gas Mitigation Standards for existing Multifamily, School, Commercial and Mixed-Use Buildings (SGM-MFLB 2023):
(A) INFORMATION PACKAGE. For single family residences, where references to the required information package allow for the informational package to be otherwise provided to the Client, it must instead be securely attached to the system in a visible location or installed in the livable space, as prescribed. (B) ACTIVE NOTIFICATION MONITORS. No active notification monitors are required. (C) INSULATION. No insulation for duct piping or fans is required.
009.05 CONVERSION OF A PASSIVE RADON MITIGATION SYSTEM TO AN ACTIVE RADON MITIGATION SYSTEM. In order to convert a passive radon mitigation system to an active radon mitigation system, a person must:
(A) By the 15th day of each month, submit a report of all conversions completed during the previous month. This data is to be entered in the Department’s online reporting system. Mitigation reports must include all of the information requested in the required fields on the online reporting form; (B) By the 15th day of each month, submit to the Department the mitigation fee per installation for all of the conversions completed during the previous month in accordance with 180 NAC 11 014.03; (C) Label each radon mitigation system in accordance with 180 NAC 11 009.05(A), 009.05(D), and in accordance with Section 10.1 Radon Documentation Essential Information from American National Standards Institute - American Association of Radon Scientists and Technologists Soil Gas Mitigation Standards for Existing Homes (SGM-SF 2017); (D) Follow electrical requirements in accordance with 180 NAC 11 009.07; (E) Install a system monitor in accordance with the following requirements:
(i) All active mitigations systems must include a mechanism to monitor system performance and warn of system failure. The mechanism must be simple to read or interpret and be located where it is easily seen or heard by building occupants and protected from damage or destruction; and (ii) Mechanical radon mitigation system monitors, such as manometer type pressure gauges, must be clearly marked to indicate the range or zone of pressure readings that existed when the system was initially activated; and
(F) Install each radon vent fan in accordance with the following requirements:
(i) Fans used in radon mitigation systems must be designed specifically for radon removal applications and must be designed or otherwise sealed to reduce the potential for leakage of soil gas from the fan housing; (ii) Fans must be sized to provide the pressure difference and air flow characteristics necessary to achieve the radon reduction goals established for the specific mitigation project; (iii) Fans must not be installed:
(1) Below grade; (2) In the conditioned (heated or cooled) space of a building; or (3) In any basement, crawlspace, or other interior location directly beneath the conditioned spaces of a building;
(iv) Acceptable locations for fans include attics not suitable for occupancy (including attics over living spaces and garages) and garages that are not beneath conditioned spaces; (v) Fans must be installed vertically plumb and level with the outlet pointing up to avoid condensation buildup in the fan housing. Fans must be installed in vertical runs of the vent pipe; (vi) Fans must be mounted and secured in a manner that minimizes transfer of vibration to the structural framing of the building; and (vii) To facilitate maintenance and future replacement, fans must be installed in the vent pipe using removable couplings or flexible connections that can be tightly secured to both the fan and the vent pipe.
009.06 ADDITIONAL ELECTRICAL REQUIREMENTS. All electrical work must comply with current Electrical Code as adopted by the State Electrical Division. The following requirements apply to all installations that require the use of electricity.
009.06(A) RATING. If the rated electricity requirements of a radon mitigation system fan exceed 50% of the circuit capacity into which it will be connected, or if the total connected load on the circuit, including the radon vent fan, exceeds 80% of the circuit's rated capacity, a separate, dedicated circuit must be installed to power the fan.
009.06(B) CIRCUIT BREAKER. The circuit breakers controlling the circuits on which the radon vent fan operates must be labeled "Radon Reduction System."
009.06(C) FANS WITH PLUGGED CORDS. Fans with plugged cords must be installed in accordance with the following requirements:
(i) All electrical wiring and electrical components must:
(1) Be labeled “Radon Fan” every 10 feet, if they are 10 feet or longer. (2) If longer than 6 feet, be fastened to a permanent building component at least every 3 feet with cable staples, cable ties, cable clips, or other fasteners that adequately secure the material. (3) Be firmly secured in place and supported by the building structure such that they are not damaged by normal building use. (4) Not be fastened to other electrical wiring, conduit, or plumbing components.
(ii) Exposed wiring and live parts operating at 50 volts or more shall be guarded against electrical shock from accidental contact by means of enclosure or by elevation of 8 feet or more above the floor. Converter boxes must only be secured to non-combustible building material. (iii) Plugged receptacle outlet connections located within habitable space or garages shall be provided a safety cover that inhibits accidental disconnection. Upon completion of installation and maintenance services, safety covers shall be locked or clasped. This safety cover shall be labeled “Radon Fan- Do Not Unplug”. For outlet connections not located within habitable space or garages, the outlet shall be labeled “Radon Fan- Do Not Unplug”. (iv) No plugged disconnects are permitted outdoors. (v) Any plugged cord used to supply power to a 110-volt radon vent fan must be no longer than six feet in total length. (vi) No plugged flexible cord may penetrate a wall or be concealed within a wall.
009.07 NOTIFICATION TO DEPARTMENT. Before installing a radon mitigation system, radon mitigation businesses must submit to the Department via email at DHHS.HealthHazardsIndoorAir@nebraska.gov, a notification of each upcoming installation, including business name, installation site address, date, and time of scheduled installation. Within 24 hours of installing a radon mitigation system, radon mitigation businesses must submit to the Department via email at DHHS.HealthHazardsIndoorAir@nebraska.gov, a copy of the system design.
009.08 LIMITATIONS. The following limitations apply to this Act.
009.08(A) DISCREPANCIES. Where discrepancies exist between provisions of 180 NAC 11 and local codes or regulations, such as local plumbing, heating and cooling or electrical codes, the stricter code will apply unless there is an adverse impact on the radon reduction function for which the system was originally designed, as determined by the Department. Where conflicts exist between the provisions of this chapter and the documents referenced in this chapter the specific provision of this chapter governs.
009.08(B) PRIOR INSTALLATION. The requirements specified in this chapter will not apply to radon mitigation systems installed prior to April 6, 2003. If a mitigation specialist finds that a radon mitigation system does not comply with current standards, the specialist must recommend in writing to the client that the system be upgraded or altered to meet current standards. The licensee must obtain prior approval from the client before implementing any of the licensee’s written recommendations.
010. REPORTING REQUIREMENTS . Licensees must make reports to the Department and to clients.
010.01 MONTHLY REPORT REQUIRED BY RADON MEASUREMENT BUSINESSES. A radon measurement business or laboratory must submit to the Department, by the 15th day of each month, the results of all radon measurements performed in the State of Nebraska during the previous month. The absence of radon measurements must be reported by the 15th day of each month. Measurement reports must include all of the information in the required fields on the online reporting form.
010.02 WRITTEN REPORTS TO CLIENTS. Radon measurement businesses and radon mitigation businesses must report test results for radon in writing to the client as required in American National Standards Institute - American Association of Radon Scientists and Technologists Protocols for Measuring Radon and Radon Decay Products in Homes (MAH-2019), or American National Standards Institute - American Association of Radon Scientists and Technologists Protocol for Conducting Measurements of Radon and Radon Decay Products in Multifamily, School, Commercial and Mixed-Use Buildings (MA-MFLB 2023), as applicable.
010.03 NOTIFICATION REQUIREMENTS FOR RADON MEASUREMENT BUSINESSES. Radon measurement businesses must notify the client by telephone and in writing within two business days of any measurement with results equal to or greater than 100 pCi/l or 0.5 working levels (WL) and advise the client to contact the Department at 1-800-334-9491 or at other telephone numbers provided by the Department. The results of this measurement must also be provided to the Department by phone and mailed to Nebraska Radon Program, PO Box 95026, Lincoln, NE 68509-5026 or emailed to DHHS.HealthHazardsIndoorAir@Nebraska.gov within the same two-business day period.
010.04 MONTHLY REPORT REQUIRED BY RADON MITIGATION BUSINESS. By the 15th day of each month, radon mitigation businesses must submit a report on all mitigation work completed during the previous month, and the mitigation fee per installation. The absence of mitigation work must be reported by the 15th day of each month. Mitigation reports must include all of the information in the required fields on the online reporting form.
011. LICENSE RENEWAL . An individual or business wishing to renew a radon measurement or mitigation license must file a complete application for renewal provided by the Department prior to the expiration date of the license. Individuals must demonstrate compliance with continuing competency requirements of this chapter. All radon measurement or mitigation licenses issued by the Department will expire on March 31 of each odd-numbered year, unless renewed as provided below. No radon measurement or mitigation activity may be conducted after the expiration of the term of the license.
012. DISCIPLINARY ACTIONS . Licensees may be subject to discipline.
012.01 UNPROFESSIONAL CONDUCT. Unprofessional conduct includes but is not limited to the acts set out in Neb. Rev. Stat. § 38-179 and the following:
(A) Failure to exercise technical competence based on the profession for which the individual is licensed; (B) Refusal to cooperate or failure to furnish requested information during a licensing or discipline investigation or inspection by the Department; or (C) Refusing to provide professional service to a person because of such person’s race, creed, color, sex, religion, marital status, familial status, ancestry, or national origin.
012.02 VOLUNTARY SURRENDER. The voluntary surrender of a license may be unrelated to disciplinary matters or may be done to resolve a pending disciplinary matter, in lieu of disciplinary action, or in response to a notice of disciplinary action.
013. REINSTATEMENT . This section applies to businesses previously licensed in Nebraska which seek the authority to return to practice. Businesses may apply for reinstatement as follows:
(A) A business license which has expired, been placed on inactive status, voluntarily surrendered for an indefinite period of time, or suspended or limited for disciplinary reasons, may apply for reinstatement at any time. (B) A business license which has been voluntarily surrendered for a definite period of time may apply for reinstatement after that period of time has elapsed.
014. FEES . Fees are nonrefundable, except as provided by law.
014.01 INDIVIDUAL LICENSES. Initial and renewal fees for individual licenses are:
(A) Radon Measurement Specialist $46.00 (annually) (B) Radon Mitigation Specialist $46.00 (annually)
014.02 BUSINESS LICENSES. Initial and renewal fees for business licenses are:
(A) Radon Measurement Business $100.00 (annually) (B) Radon Mitigation Business $250.00 (annually)
014.03 MITIGATION SYSTEM INSTALLATION. The fee is:
(A) Mitigation System $50.00 (per installation). (B) For fee calculation purposes, one mitigation system installation is considered to be the installation of an interconnected system that contains one or more fans installed on a single riser, one or more suction points, and one or more exhausts. Systems with single or multiple fans installed on separate risers and installed in separate locations, each riser constitutes a separate installation.
014.04 PRORATED FEE SCHEDULE. Fees may be prorated according to a schedule.
014.04(A) When a Specialist license will expire within 180 days after its initial issuance date and the initial licensing fee is $25 or more, the Department will collect $25 or one-fourth of the initial licensing fee, whichever is greater, for the initial license, and the license will be valid until the next subsequent renewal date. Fees below are for a license issued for a two year period.
Year One (odd-numbered year)
| Jan | Feb | March | April | May | June | July | August | Sept | Oct | Nov | Dec | | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | | $25 | $25 | $25 | $92 | $92 | $92 | $92 | $92 | $92 | $92 | $92 | $92 |
Year Two (even-numbered year)
| Jan | Feb | March | April | May | June | July | August | Sept | Oct | Nov | Dec | | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | | $92 | $92 | $92 | $92 | $92 | $92 | $92 | $92 | $92 | $25 | $25 | $25 |
014.04(B) When a Radon Measurement Business license will expire within 180 days after its initial issuance date, the Department will collect a fee of $50. Fees below are for a license issued for a two year period.
Year One (odd-numbered year)
| Jan | Feb | March | April | May | June | July | August | Sept | Oct | Nov | Dec | | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | | $50 | $50 | $50 | $200 | $200 | $200 | $200 | $200 | $200 | $200 | $200 | $200 |
Year Two (even-numbered year)
| Jan | Feb | March | April | May | June | July | August | Sept | Oct | Nov | Dec | | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | | $200 | $200 | $200 | $200 | $200 | $200 | $200 | $200 | $200 | $50 | $50 | $50 |
014.04(C) When a Radon Mitigation Business license will expire within 180 days after its initial issuance date, the Department will collect a fee of $125.00. Fees below are for a license issued for a two year period.
Year One (odd-numbered year)
| Jan | Feb | March | April | May | June | July | August | Sept | Oct | Nov | Dec | | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | | $125 | $125 | $125 | $500 | $500 | $500 | $500 | $500 | $500 | $500 | $500 | $500 |
Year Two (even-numbered year)
| Jan | Feb | March | April | May | June | July | August | Sept | Oct | Nov | Dec | | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | | $500 | $500 | $500 | $500 | $500 | $500 | $500 | $500 | $500 | $125 | $125 | $125 |
014.05 OTHER FEES. Fees charged to businesses for other services are:
014.05(A) CERTIFICATION OF LICENSE. The fee is $25 for certifying the issuance of a license. The certification includes information regarding the basis on which a license was issued, the date of issuance, whether disciplinary action has been taken against the license, and the current status of the license.
014.05(B) VERIFICATION. The fee is $5 for verification of a license. The verification includes written confirmation as to whether a license was valid.
014.05(C) DUPLICATE LICENSE. The fee is $10 for a duplicate of original license document or reissued license.
014.05(D) ADMINISTRATIVE. An administrative fee of $25 will be retained by the Department for a denied license or a withdrawn application.
014.05(E) REINSTATEMENT. For a reinstated license the fee is $35 in addition to the renewal fee specified in 180 NAC 11-014.
These amended rules and regulations replace Title 180 NAC 11 Requirements for Radon and Radon Progeny Measurement and Mitigation Services, effective July 5, 2015.
History
- Effective 2023-09-20
Chapter 13 Transportation of Radioactive Material
Neb. Admin. Code tit. 180, ch. 13 Transportation of Radioactive Material {#sec-180-nac-13 omnilex-key=us-ne-regs-official--title-180--180 NAC 13}
Effective Date:11/2/2022
001. SCOPE AND AUTHORITY . The regulations in this Chapter establish requirements for packaging, preparation for shipment, and transportation of radioactive material. The regulations are authorized by and implement the Nebraska Radiation Control Act, Nebraska Revised Statute (Neb. Rev. Stat.) §§ 71-3501 to 71-3520. 10 Code of Federal Regulations (CFR) as published on January 1, 2006, and 49 CFR as published October 1, 2006, and referred throughout this chapter are incorporated by reference and available for viewing at the Department of Health and Human Services, Office of Radiological Health, 301 Centennial Mall South, Lincoln, Nebraska 68509-5026. The regulations in 180 Nebraska Administrative Code (NAC) 13 apply to any licensee authorized by specific or general license issued by this Department to receive, possess, use, or transfer licensed material, if the licensee delivers that material to a carrier for transport, transport the material outside the site of usage as specified in the Department’s license, or transport that material on public highways. No provision of 180 NAC 13 authorizes possession of licensed material.
002. DEFINITIONS . As used in 180 NAC 13, the following definitions apply:
002.01 CERTIFICATE HOLDER. A person who has been issued a certificate of compliance or other package approval by the U.S. Nuclear Regulatory Commission (NRC).
002.02 CERTIFICATE OF COMPLIANCE (COC). A certificate issued by the NRC under 10 CFR 71 Subpart D which approves the design of a package for the transportation of radioactive material.
002.03 CLOSE REFLECTION BY WATER. Immediate contact by water of sufficient thickness for maximum neutron reflection.
002.04 CLOSED TRANSPORT VEHICLE. 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 either temporary or permanent but must limit access from top, sides, and ends. In the case of packaged materials, it may be of the "see-through" type.
002.05 CONSIGNMENT. The shipment of a package, groups of packages, or load of radioactive material offered by a shipper for transport.
002.06 CONTAMINATION. The presence of a radioactive substance on a surface in quantities in excess of 0.4 becquerel (Bq)/cm2 (1x10-5 microcurie (µCi)/cm2) for beta and gamma emitters and low toxicity alpha emitters, or 0.04 Bq/cm2 (1x10-6 µCi/cm2) for all other alpha emitters.
(A) Fixed contamination means contamination that cannot be removed from a surface during normal conditions of transport. (B) Non-fixed contamination means contamination that can be removed from a surface during normal conditions of transport.
002.07 CONTAINMENT SYSTEM. The assembly of packaging components intended to retain the radioactive material during transport.
002.08 CONVEYANCE. Conveyance means any of the following:
(A) For transport by public highway or rail any transport vehicle or large freight container; (B) For transport by water any vessel, or any hold, compartment, or defined deck area of a vessel including any transport vehicle on board; and (C) For transport by aircraft any aircraft.
002.09 CRITICALITY SAFETY INDEX (CSI). 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 180 NAC 13-011 and 13-012, and 10 CFR 71.59. 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.
002.10 DEUTERIUM. For the purposes of 180 NAC 13-004.04 and 13-011, deuterium and any deuterium compounds, including heavy water, where the ratio of deuterium atoms to hydrogen atoms exceeds 1:5000.
002.11 DOT. DOT means the U.S. Department of Transportation.
002.12 EXCLUSIVE USE. The sole use of a conveyance by a single consignor for which all initial, intermediate, and final loading and unloading are carried out according to the direction of the consignor or consignee. The consignor and the carrier must ensure any loading or unloading 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.
002.13 FISSILE MATERIAL. Plutonium-239, plutonium-241, uranium-233, uranium-235, or any combination of these radionuclides is fissile material. 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. Department jurisdiction extends only to "special nuclear material in quantities not sufficient to form a critical mass" as defined in 180 NAC 1-002. Exclusions from fissile material control are provided in 180 NAC 13-004.04.
002.14 GRAPHITE. For the purposes of 180 NAC 13-004.04 and 13-011, graphite means graphite with a boron equivalent content less than 5 parts per million and density greater than 1.5 grams per cubic centimeter.
002.15 HIGHWAY ROUTE CONTROLLED QUANTITY. The quantity within a single package that exceeds:
(A) 3,000 times the A1 value of the radionuclides as specified in 49 CFR 173.435 for special form Class 7 (radioactive) material; (B) 3,000 times the A2 value of the radionuclides as specified in 49 CFR 173.435 for normal form Class 7 (radioactive) material; or (C) 1,000 TBq (27,000 curie (Ci)), whichever is least.
002.16 LOW SPECIFIC ACTIVITY (LSA) MATERIAL. Radioactive material with limited specific activity which is nonfissile or is excepted under 180 NAC 13-004.04, 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 material must be in one of three groups:
002.16(A) LSA-I. The following criteria applies:
(i) Uranium and thorium ores, concentrates of uranium and thorium ores, and other ores containing naturally occurring radioactive radionuclides 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 where the activity is distributed throughout and the estimated average specific activity does not exceed 30 times the value for exempt material activity concentration determined according to Appendix 13-A.
002.16(B) LSA-II. The following criteria applies:
(i) Water with tritium concentration up to 0.8 TBq/liter (20.0 Ci/liter); or (ii) Other radioactive material in which the activity is distributed throughout, and the average specific activity does not exceed 10-4 A2/g for solids and gases, and 10-5 A2/g for liquids.
002.16 (C) LSA-III SOLIDS. Solids excluding powders, that satisfy the requirements of 10 CFR 71.77 where:
(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; and (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 leaching, when placed in water for 7 days, would not exceed 0.1 A2; and (iii) The estimated average specific activity of the solid, excluding any shielding material, does not exceed 2 E-3 A2/g.
002.17 LOW TOXICITY ALPHA EMITTERS. 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 10 days.
002.18 NATURAL THORIUM. Thorium with the naturally occurring distribution of thorium isotopes, essentially 100 weight percent thorium-232.
002.19 NORMAL FORM RADIOACTIVE MATERIAL. Radioactive material which has not been demonstrated to qualify as “special form radioactive material” as defined 180 NAC 1-002.
002.20 OPTIMUM INTERSPERSED HYDROGENOUS MODERATION. The presence of hydrogenous material between packages to such an extent the maximum nuclear reactivity results.
002.21 PACKAGE. 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 DOT regulations in 49 CFR 173. (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 NRC as B(U) unless the package has a maximum normal operating pressure or more than 700 Kilopascal Pressure Unit (kPa) (100 lb/in2) gauge or pressure relief device that would allow the release of radioactive material to the environment under the tests specified in 10 CFR Part 71.73 (hypothetical accident conditions), where 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 DOT regulations, 49 CFR 173. A Type B package approved before September 6, 1983, was designated only as Type B. Limitations on its use are specified 10 CFR 71.19.
002.22 PACKAGING. The assembly of components necessary to ensure compliance with the packaging requirements of 180 NAC 13. 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.
002.23 SPECIFIC ACTIVITY OF A RADIONUCLIDE. The radioactivity of a radionuclide per unit mass of that nuclide. The specific activity of a material where the radionuclide is essentially uniformly distributed is the radioactivity per unit mass of the material.
002.24 SURFACE CONTAMINATED OBJECT. A solid object not itself classed as radioactive material, but has radioactive material distributed on any of its surfaces. A Surface Contaminated Object must be in one of two groups with surface activity not exceeding the following limits:
002.24(A) SURFACE CONTAMINATED OBJECT-I. A solid object on which:
(i) The non-fixed contamination on the accessible surface averaged over 300 cm2 (or the area of the surface if less than 300 cm2) does not exceed 4 Bq/cm2 (10-4 µCi/cm2) for beta and gamma and low toxicity alpha emitters, or 0.4 Bq/cm2 (10-5 µCi/cm2) for all other alpha emitters; (ii) The fixed contamination on the accessible surface averaged over 300 cm2, or the area of the surface if less than 300 cm2, does not exceed 4E+4 Bq/cm2 (1.0 µCi/cm2) for beta and gamma and low toxicity alpha emitters, or 4E+3 Bq /cm2 (0.1 µCi/cm2) for all other alpha emitters; and (iii) The non-fixed contamination plus the fixed contamination on the inaccessible surface averaged over 300 cm2 (or the area of the surface if less than 300 cm2) does not exceed 4E+4 Bq/cm2 (1.0 µCi /cm2) for beta and gamma and low toxicity alpha emitters, or 4E+3 Bq /cm2 (0.1 µCi/cm2) for all other alpha emitters.
002.24(B) SURFACE CONTAMINATED OBJECT-II. A solid object on which the limits for Surface Contaminated Object-I are exceeded and on which:
(i) The non fixed contamination on the accessible surface averaged over 300 cm2 (or the area of the surface if less than 300 cm2) does not exceed 400 Bq/cm2 (10-2 µCi/cm2) or beta and gamma and low toxicity alpha emitters or 40 Bq/cm2 (10-3 µCi/cm2) for all other alpha emitters; (ii) The fixed contamination on the accessible surface averaged over 300 cm2 (or the area of the surface if less than 300 cm2) does not exceed 8E+5 Bq/cm2 (20 µCi/cm2) for beta and gamma and low toxicity alpha emitters, or 8E+4 Bq/cm2 (2 µCi/cm2) for all other alpha emitters; (iii) The non fixed contamination plus the fixed contamination on the inaccessible surface averaged over 300 cm2 (or the area of the surface if less than 300 cm2) does not exceed 8E+5 Bq/cm2 (20 µCi/cm2) for beta and gamma and low toxicity alpha emitters, or 8E+4 Bq/cm2 (2 µCi/cm2) for all other alpha emitters.
002.25 TRANSPORT INDEX. 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 at 1 meter (3.3 feet) from the external surface of the package by 100, equivalent to the maximum radiation level in millirem (mrem) per hour at 1 meter (3.3 feet).
002.26 TYPE A QUANTITY. 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 Appendix 13-A, Table A-1, or may be determined by procedures described in Appendix 13-A.
002.27 TYPE B QUANTITY. A quantity of radioactive material greater than a Type A quantity.
002.28 UNIRRADIATED URANIUM. Uranium containing not more than 2 x 103 Bq of plutonium per gram of uranium-235, not more than 9 x 106 Bq of fission products per gram of uranium-235, and not more than 5 x 10-3 g of uranium-236 per gram of uranium-235.
002.29 URANIUM - NATURAL, DEPLETED, ENRICHED. Natural uranium, depleted uranium and enriched uranium are:
002.29(A) NATURAL URANIUM. Uranium, which may be chemically separated, with the naturally occurring distribution of uranium isotopes, approximately 0.711 weight percent uranium-235, and the remainder by weight essentially uranium-238.
002.29(B) DEPLETED URANIUM. Uranium containing less uranium-235 than the naturally occurring distribution of uranium isotopes.
002.29(C) ENRICHED URANIUM. Uranium containing more uranium-235 than the naturally occurring distribution of uranium isotopes.
003. REQUIREMENT FOR LICENSE . Except as authorized in a general or specific license issued by the Department, or as exempted in 180 NAC 13-004, no licensee may:
(A) Deliver radioactive material to a carrier for transport; or (B) Transport radioactive material.
004. EXEMPTIONS .
004.01 COMMON AND CONTRACT CARRIERS. Common and contract carriers, freight forwarders, and warehouse workers which are subject to the requirements of the DOT in 49 CFR 170 through 189 or the U.S. Postal Service in the Postal Service Domestic Mail Manual, incorporated by reference, at 39 CFR 111.1 (1997) and set out as Attachment 1 of this chapter, are exempt from the requirements of this section to the extent they transport or store radioactive material in the regular course of their carriage for others or storage incident previously mentioned. Common and contract carriers who are not subject to the requirements of the DOT or U.S. Postal Service are subject to 180 NAC 13-003 and other applicable requirements of these regulations.
004.02 PHYSICIANS. Any physician licensed by the State of Nebraska to dispense drugs in the practice of medicine is exempt from 180 NAC 13-003 with respect to transport by the physician of radioactive material for use in the practice of medicine. However, any physician operating under this exemption must be licensed under 180 NAC 7 or equivalent NRC or Agreement State regulations.
004.03 LOW-LEVEL MATERIALS. Any licensee is exempt from the requirements of 180 NAC 13 with respect to shipment or carriage of the following low-level materials:
(A) Natural material and ores containing naturally occurring radionuclides 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 10 times the values specified in Appendix 13-A, Table A-2 or Table A-3; (B) Materials for which the activity concentration is not greater than the activity concentration values specified in Appendix 13-A, Table A-2 or Table A-3 or for which the consignment activity is not greater than the limit for an exempt consignment found in Appendix 13-A, Table A-2 or Table A-3; and (C) 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 180 NAC 13-002.
004.04 CLASSIFICATION AS FISSILE MATERIAL. Fissile material meeting the requirements of at least one of the items of 180 NAC 13-004.04(A) through (F) are exempt from classification as fissile material and from the fissile material package standards of 10 CFR 71.55 and 71.59, but are subject to all other requirements of 180 NAC 13, except as listed below:
(A) Individual package containing 2 grams or less fissile material; (B) Individual or bulk packaging containing 15 grams or less of fissile material provided the package has at least 200 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) Packages containing:
(i) Low concentrations of solid fissile material commingled with solid nonfissile material, provided that:
(1) There is at least 2000 grams of solid nonfissile material for every gram of fissile material; and (2) There is no more than 180 grams of fissile material distributed within 360 kg of contiguous nonfissile material; and
(ii) 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 1% by weight, and with total plutonium and uranium-233 content of up to 1% of the mass of uranium-235, provided that the mass of any beryllium, graphite, and hydrogenous material enriched in deuterium constitutes less than 5% 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 2% by mass, with a total plutonium and uranium-233 content not exceeding 0.002% of the mass of uranium, and with a minimum nitrogen to uranium atomic ratio (N/U) of 2. The material must be contained in at least a DOT Type A package; and (F) Packages containing, individually, a total plutonium mass of not more than 1000 grams, of which not more than 20% by mass may consist of plutonium-239, plutonium-241, or any combination of these radionuclides.
005. TRANSPORTATION OF LICENSED MATERIAL .
005.01 DOT COMPLIANCE. Each licensee who transports licensed material outside of the site of usage, as specified in the Department license, or where transport is on public highways, or who delivers licensed material to a carrier for transport, must comply with the applicable requirements of the DOT regulation in 49 CFR part 107, 171 through 180 and 390 through 397 appropriate to mode of transport. The licensee must:
(A) Comply with applicable DOT regulations in the following areas:
(i) PACKAGING. 49 CFR Part 173: Subparts A, B and I; (ii) MARKING AND LABELING. 49 CFR Part 172: Subpart D, §§ 172.400 through 172.407, §§ 172.436 through 172.441, of Subpart E; (iii) PLACARDING. 49 CFR Part 172: Subpart F, especially §§ 172.500 through 172.519, 172.556, and Appendices B and C; (iv) ACCIDENT REPORTING. 49 CFR Part 171: §§ 171.15 and 171.16; (v) SHIPPING PAPERS AND EMERGENCY INFORMATION. 49 CFR Part 172: Subparts C and G; (vi) HAZARDOUS MATERIAL EMPLOYEE TRAINING. 49 CFR Part 172: Subpart H; (vii) HAZARDOUS MATERIAL SHIPPER AND CARRIER REGISTRATION. 49 CFR Part 107: Subpart G; and (viii) SECURITY PLANS. 49 CFR Part 172; Subpart I.
(B) Comply with applicable DOT regulations pertaining to the following modes of transportation:
(i) RAIL. 49 CFR Part 174: Subparts A through D and K; (ii) AIR. 49 CFR Part 175; (iii) VESSEL. 49 CFR Part 176: Subparts A through F and M; and (iv) PUBLIC HIGHWAY. 49 CFR Part 177 and Parts 390 through 397; and
(C) Assure any special instructions needed to safely open the package are sent to or have been made available to the consignee according to 180 NAC 4-038.
005.02 CODE OF FEDERAL REGULATIONS COMPLIANCE. If DOT regulations are not applicable to a shipment of licensed material, the licensee must conform to the standards and requirements of 49 CFR Parts 107, 171 through 180 and 390 through 397 appropriate to the mode of transport to the same extent as if the shipment was subject to the 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 Department.
006. GENERAL LICENSES FOR CARRIERS .
006.01 COMMON OR CONTRACT CARRIERS. A general license is issued to any common or contract carrier not exempt under 180 NAC 13-004 to receive, possess, transport, and store radioactive material in the regular course of their carriage for others or storage incident previously mentioned, provided the transportation and storage is according to the applicable requirements, appropriate to the mode of transport, of the DOT to the extent that such requirements relate to the loading and storage of packages, placarding of the transporting vehicle, and incident reporting.
006.02 PRIVATE CARRIERS. A general license is issued to any private carrier to transport radioactive material, provided the transportation is according to the applicable requirements, appropriate to the mode of transport, of the DOT to the extent that such requirements relate to the loading and storage of packages, placarding of the transporting vehicle, and incident reporting. Notification of incidents must be filed with, or made to, the Department as prescribed in 49 CFR, regardless of and in addition to notification made to DOT or other agencies.
006.03 EXEMPTIONS. Persons who transport radioactive material according to the general licenses in 180 NAC 13-006.01 or 13-006.02 are exempt from the requirements of 180 NAC 4 and 10 to the extent that they transport radioactive material.
007. GENERAL LICENSE: APPROVED PACKAGES .
007.01 GENERAL LICENSE ISSUANCE. A general license is issued to any licensee of the Department to transport, or to deliver to a carrier for transport, licensed material in a package for which a license, or other approval has been issued by the NRC.
007.02 QUALITY ASSURANCE PROGRAM. This general license applies only to a licensee who has a quality assurance program approved by the Department as satisfying the provisions of 180 NAC 13-021.
007.03 APPLICABILITY. This general license applies only to a licensee who:
(A) Has a copy of the specific license, or other approval by the NRC of the package and has 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; (B) Complies with the terms and conditions of the license, certificate, or other approval by the NRC, as applicable, the requirements of 180 NAC 13, and 10 CFR Part 71, Subpart G, 71.91(a)(5) and (7), 71.91(b), 71.93, and 71.95(b)(c) and (d); and 10 CFR Part 71, Subpart H, 71.101(c)(2) and (d), (e) and (f), 71.103(d), (e) and (f), 71.105(a) and (b), and 71.107 through 71.125. (C) Submits 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 CFR 71.1(a), the licensee's name and license number and the package identification number specified in the package approval.
007.04 PACKAGE APPROVAL. The general license in 180 NAC 13-007.01 applies only when the package approval authorizes use of the package under this general license.
007.05 TYPE B OR FISSILE MATERIAL PACKAGE. For a Type B or fissile material package, the design of which was approved before April 1, 1996 the general license is subject to the additional restrictions of 10 CFR 71.19.
008. RESERVED .
009. RESERVED .
010. GENERAL LICENSE: USE OF FOREIGN APPROVED PACKAGE .
010.01 GENERAL LICENSE ISSUANCE. A general license is issued to any licensee of the Department 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 which has been revalidated by the DOT as meeting the applicable requirements of 49 CFR 171.23.
010.02 QUALITY ASSURANCE PROGRAM. Except as otherwise provided in this section, the general license applies only to a licensee who has a quality assurance program approved by the Department as satisfying the applicable provisions of 10 CFR 71, subpart H.
010.03 FOREIGN SHIPMENTS. This general license applies only to shipments made to or from locations outside the United States.
010.04 APPLICABILITY. Each general licensee in this section must:
(A) 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 (B) Comply with the terms and conditions of the certificate and revalidation, and with applicable requirements of 180 NAC 13.
011. GENERAL LICENSE: FISSILE MATERIAL .
011.01 GENERAL LICENSE ISSUANCE. A general license is issued to any licensee to transport fissile material, or to deliver fissile material to a carrier for transport, if the material is shipped according to 180 NAC 13-011. The fissile material need not be contained in a package which meets the standards of 10 CFR 71 subparts E and F; however, the material must be contained in a Type A package that meets the DOT requirements of 49 CFR 173.417(a).
011.02 QUALITY ASSURANCE PROGRAM. The general license applies only to a licensee who has a quality assurance program approved by the Department.
011.03 PACKAGE CONTENTS. The general license applies only when a package’s contents contain less than:
(A) A Type A quantity of fissile material; and (B) 500 total grams of beryllium, graphite, or hydrogenous material enriched in deuterium.
011.04 CSI LABELING. The general license applies only to packages containing fissile material labeled with a CSI which:
(A) Has been determined according to 180 NAC 13-011.05; (B) Has a value less than or equal to 10; and (C) For a shipment of multiple packages containing fissile material, the sum of the CSIs must be less than or equal to 50 for shipment on a nonexclusive use conveyance, and less than or equal to 100 for shipment on an exclusive use conveyance.
011.05 CRITICALITY SAFETY INDEX (CSI) DETERMINATION. This section addresses how to determine the CSI of fissile material.
(A) The value for the CSI must be greater than or equal to the number calculated by the following equation:
The calculated CSI must be rounded up to the first decimal place; (B) Values of X, Y, and Z used in the CSI equation must be taken from Table 13-1 or Table 13-2, as appropriate; (C) If Table 13-2 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 (D) Table 13-1 values for X, Y, and Z must be used to determine the CSI if:
(i) Uranium-233 is present in the package; (ii) The mass of the plutonium exceeds 1% of the mass of uranium-235; (iii) The uranium is of unknown uranium-235 enrichment or greater than 24 weight percent enrichment; or (iv) Substances having a moderating effectiveness, that is, an average hydrogen density greater than H2O, certain hydrocarbon oils or plastics, are present in any form, except as polyethylene used for packing or wrapping.
TABLE 13-1
Mass Limits for General License Packages Containing Mixed Quantities of Fissile Material or Uranium-235 of Unknown Enrichment per 180 NAC 13-011.05.
| 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 H2Oa (grams) | | --- | --- | --- | | 235U (X) | 60 | 38 | | 233U (Y) | 43 | 27 | | 239 Pu or 241 Pu (Z) | 37 | 24 |
aWhen mixtures of moderating substances are present, the lower mass limits must be used if more than 15% of the moderating substance has an average hydrogen density greater than H2O.
TABLE 13-2
Mass Limits for General License Packages Containing Uranium-235 of Known Enrichment per 180 NAC 13-011.
| Uranium enrichment in weight percent of uranium-235 not exceeding | Fissile material mass of uranium-235 U(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 |
012. GENERAL LICENSE: PLUTONIUM-BERYLLIUM SPECIAL FORM MATERIAL .
012.01 GENERAL LICENSE ISSUANCE. A general license is issued to any licensee to transport fissile material, or to deliver 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 according to this subsection. This material need not be contained in a package which meets the standards of 10 CFR 71 subpart E and F; however, the material must be contained in a Type A package that meets the DOT requirements of 40 CFR 173.417(a).
012.02 PACKAGE CONTENTS. This general license applies only when a package’s contents contain less than:
(A) A Type A quantity of radioactive material; and (B) 1000 g of plutonium, provided that: plutonium-239, plutonium-241, or any combination of these radionuclides, constitutes less than 240g of the total quantity of plutonium in the package.
012.03 QUALITY ASSURANCE PROGRAM. The general license applies only to a licensee who has a quality assurance program approved by the Department.
012.04 CSI LABELING. The general license applies only to packages labeled with a CSI which:
(A) Has been determined per 180 NAC 13-012.05; (B) Has a value less than or equal to 100; and (C) For a shipment of multiple packages containing Pu-Be sealed sources, the sum of the CSI must be less than or equal to 50 for shipment on a nonexclusive use conveyance and less than or equal to 100 for shipment on an exclusive use conveyance.
012.05 CSI DETERMINATION. This section addresses how to determine the CSI of plutonium-beryllium special form material.
(A) The value for the CSI must be greater than or equal to the number calculated by the following equation:
(B) The calculated CSI must be rounded up to the first decimal place.
013. ASSUMPTIONS AS TO UNKNOWN PROPERTIES . 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 must package the fissile material as if the unknown properties have credible values that will cause the maximum neutron multiplication.
014. PRELIMINARY DETERMINATIONS . Before the first use of any packaging for the shipment of licensed material the licensee must find out whether the determinations in 10 CFR 71.85 (a) – (c) have been made.
015. ROUTINE DETERMINATIONS . Before each shipment of licensed material, the licensee must ensure the package with its contents satisfies the applicable requirements of 180 NAC 13-015 and the license.
015.01 PROPER PACKAGING. The package is proper for the contents to be shipped.
015.02 UNIMPAIRED PHYSICAL CONDITION. The package is in unimpaired physical condition except for superficial defects such as marks or dents.
015.03 CLOSURE DEVICES. Each closure device of the packaging, including any required gasket, is properly installed and secured and free of defects.
015.04 LIQUIDS. Any system for containing liquid is adequately sealed and has adequate space or other specified provision for expansion of the liquid.
015.05 PRESSURE RELIEF DEVICES. Any pressure relief device is operable and set according to written procedures.
015.06 LOADING AND CLOSURE. The package has been loaded and closed according to written procedures.
015.07 MODERATORS AND NEUTRON ABSORBERS. For fissile material, any moderator or neutron absorber, if required, is present and in proper condition.
015.08 PACKAGE STRUCTURE REQUIREMENTS. 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 design requirements specified in 10 CFR 71.45.
015.09 PACKAGE EXTERNAL SURFACE LEVELS OF REMOVABLE RADIOACTIVE CONTAMINATION. The level of removable radioactive contamination on the external surfaces of each package offered for shipment is as low as reasonably achievable. The level of removable radioactive contamination may be determined by wiping an area of 300 cm2 of the surface concerned with an absorbent material, using moderate pressure, and measuring the activity on the wiping material. Sufficient measurements must be taken in the most appropriate locations to yield a representative assessment of the removable contamination levels. Except as provided in 180 NAC 13-015.09(A), the amount of radioactivity measured on any single wiping material, when averaged over the surface wiped, must not exceed the limits given in TABLE 13-3 of 180 NAC 13-015 at any time during transport. Other methods of assessment of equal or greater efficiency may be used. When other methods are used, the detection efficiency of the method used must be taken into account and in no case may the removable contamination on the external surfaces of the package exceed 10 times the limits listed in TABLE 13-3.
(A) In the case of packages transported as exclusive use shipments by rail or highway only, the removable radioactive contamination at any time during transport must not exceed 10 times the levels prescribed in 180 NAC 13-015.09. The levels at the beginning of transport must not exceed the levels in 180 NAC 13-015.09.
015.10 EXTERNAL RADIATION LEVELS AROUND THE PACKAGE AND AROUND THE VEHICLE. External radiation levels around the package and around the vehicle, if applicable, will not exceed 2 mSv/h (200 mrem/hr) at any point on the external surface of the package at any time during transportation. The transport index must not exceed 10.
015.11 EXCLUSIVE USE SHIPMENT. For a package transported in exclusive use by rail, highway or water:
(A) Radiation levels external to the package may exceed the limits specified in 180 NAC 13-015.09 but must not exceed any of the following:
(i) 2 mSv/h (200 mrem/hr) on the accessible external surface of the package unless the following conditions are met, in which case the limit is 10 mSv/h (1000 mrem/hr);
(1) The shipment is made in a closed transport vehicle; (2) Provisions are made to secure the package so its position within the vehicle remains fixed during transportation; and (3) There are no loading or unloading operations between the beginning and end of the transportation.
(ii) 2 mSv/h (200 mrem/hr) at any point on the outer surface of the vehicle, including the top and underside of the vehicle, or, in the case of a flatbed 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; (iii) 0.1 mSv/h (10 mrem/hr) at any point 2 meters from the vertical planes represented by the outer lateral surfaces of the vehicle, or, in the case of a flatbed style vehicle, at any point 2 meters from the vertical planes projected from the outer edges of the vehicle; and (iv)0.02 mSv/h (2 mrem/hr) in any normally occupied positions of the vehicle, except this provision does not apply to private motor carriers when persons occupying these positions are provided with special health supervision, personnel radiation exposure monitoring devices, and training according to 180 NAC 10-003; and
(B) The shipper must provide specific written instructions to the carrier for maintenance of the exclusive use shipment controls. The instructions must be:
(i) Included with the shipping paper information; and (ii) 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 member of the general public.
015.12 ACCESSIBLE PACKAGE SURFACE TEMPERATURES. A package must be prepared for transport so that in still air at 100 degrees Fahrenheit (38 degrees Celsius) and in the shade, no accessible surface of a package would have a temperature exceeding 122 degrees Fahrenheit (50 degrees Celsius) in a nonexclusive use shipment or 185 degrees Fahrenheit (85 degrees Celsius) in an exclusive use shipment. Accessible package surface temperatures must not exceed these limits at any time during transportation.
015.13 CONTINUOUS VENTILATION. A package may not incorporate a feature intended to allow continuous venting during transport.
TABLE 13-3
Removable External Radioactive Contamination Wipe Limits
| Contaminant | Maximum Permissible Limits | | | | --- | --- | --- | --- | | | Bq /cm2 | µCi /cm2 | dpm /cm2 | | Beta and gamma emitters and low toxicity alpha emitters | 0.4 | 1.0 E-5 | 22 | | All other alpha emitting radionuclides | 0.04 | 1.0 E-6 | 2.2 |
016. AIR TRANSPORT OF PLUTONIUM .
016.01 ADDITIONAL REQUIREMENTS. Despite the provisions of any general licenses and despite any exemptions stated directly in this Section or included indirectly by citation of the DOT regulations, as may be applicable, the licensee must assure that plutonium in any form is not transported by air, or delivered to a carrier for air transport, unless the plutonium is:
(A) Contained in a medical device designed for individual human application; (B) Contained in a material where the specific activity is less than or equal to the activity concentration values for plutonium specified in Appendix 13-A, Table A-2, where the radioactivity is essentially uniformly distributed; (C) Shipped in a single package containing no more than an A2 quantity of plutonium in any isotope or form and is shipped according to 180 NAC 13-005; or (D) Shipped in a package specifically authorized for the shipment of plutonium by air in the COC for that package issued by the NRC
016.02 INTERPRETATION OF REQUIREMENTS. Nothing in 180 NAC 13-016.01 is to be interpreted as removing or diminishing the requirements of 10 CFR 73.24.
016.03 DOT COMPLIANCE. For a shipment of plutonium by air which is subject to 180 NAC 13-016.01(D), the licensee must, through special arrangement with the carrier, require compliance with 49 CFR 175.704, the DOT regulations applicable to the air transport of plutonium.
017. OPENING INSTRUCTIONS . Before delivery of a package to a carrier for transport, the licensee must ensure 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 according to 180 NAC 4-038.
018. SHIPMENT RECORDS .
018.01 RECORD REQUIREMENTS. Each licensee must maintain for a period of three years after shipment a record of each shipment of licensed material not exempt under 180 NAC 13-004.03, showing, where applicable:
(A) Identification of the packaging by model number and serial number; (B) Verification the packaging, as shipped, has no significant defects; (C) Volume and identification of coolant; (D) Type and quantity of licensed material in each package, and the total quantity of each shipment; (E) Date of the shipment; (F) Name and address of the transferee; (G) Address to which the shipment was made; and (H) Results of the determinations required by 180 NAC 13-015 and by the conditions of the package approval.
018.02 RECORD AVAILABILITY. The licensee must make available for inspection, upon reasonable notice, all records required by these regulations. Records are only valid if stamped, initialed, or signed and dated by authorized personnel, or otherwise authenticated.
018.03 RECORD MAINTENANCE. The licensee must maintain sufficient written records to furnish evidence of the quality of packaging. The records to be maintained include results of the determinations required by 10 CFR 71.85 (a) – (c); 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 3 years after the life of the packaging to which they apply.
019. REPORTS . The licensee must report to the Department within 30 days:
(A) Any instance where there is significant reduction in the effectiveness of any packaging during use; (B) Details of any defects with safety significance in the packaging after first use, with the means employed to repair the defects and prevent their recurrence; or (C) Instances where the conditions of approval in the COC were not observed in making a shipment.
020. ADVANCE NOTIFICATION OF TRANSPORT OF NUCLEAR WASTE .
020.01 REQUIREMENTS. As specified in 180 NAC 13-020.02, 13-20.03 and 13-020.04, each licensee must provide advance notification to:
(A) The governor of a State, or the governor's designee, of the shipment of licensed material, within 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. (B) The Tribal official of participating Tribes referenced in 180 NAC 13-020.03, or the official's designee, of the shipment of licensed material, within or across the boundary of the 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.
020.02 CONDITIONS. Advance notification is also required in 180 NAC 13 for the shipment of licensed material, other than irradiated fuel, meeting the following three conditions:
(A) The nuclear waste is required to be in Type B packaging for transportation; (B) The nuclear waste is being transported into, within, or through, a state enroute to a disposal facility or to a collection point for transport to a disposal facility; and (C) The quantity of licensed material in a single package exceeds:
(i) 3000 times the A1 value of the radionuclides as specified in Appendix 13-A, Table I for special form radioactive material; (ii) 3000 times the A2 value of the radionuclides as specified in Appendix 13-A, Table I for normal form radioactive material; or (iii) 1000 TBq (27,000 Ci).
020.03 REQUIRED INFORMATION. Each advance notification required by 180 NAC 13-020.01 must contain the following information:
(A) The name, address, and telephone number of the shipper, carrier, and receiver of the shipment; (B) Description of the nuclear waste contained in the shipment as required by 49 CFR 172.202 and 172.203(d); (C) Point of origin of the shipment and the seven day period during which departure of the shipment is estimated to occur; (D) The seven day period during which arrival of the shipment at state boundaries or Tribal reservation boundaries is estimated to occur; (E) Destination of the shipment, and the seven day period during which arrival of the shipment is estimated to occur; and (F) Point of contact with a telephone number for current shipment information.
020.04 SUBMISSION PROCEDURES. The notification required by 180 NAC 13-020.01 must:
(A) Be made in writing to:
(i) The office of each appropriate governor, or governor's designee; (ii) The office of each appropriate Tribal official or Tribal official’s designee and (iii) To the U.S. Nuclear Regulatory Director, Division of Nuclear Security, Office of Nuclear Security and Incident Response;
(B) Be postmarked at least seven days before the beginning of the seven day period during which departure of the shipment is estimated to occur if delivered by mail. (C) Reach the office of the governor, or governor's designee, or the Tribal official or Tribal official’s designee at least four days before the beginning of the seven day period which departure of the shipment is estimated to occur, if the notification is delivered by any other means than mail.
(i) 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 NRC Web site at: https://scp.nrc.gov/special/designee.pdf. (ii) 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 Materials Safety, Security, State, and Tribal Programs, Office of Nuclear Material Safety and Safeguards, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001. (iii) The licensee must retain a copy of the notification as a record for 3 years.
020.05 REVISION NOTICE. 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, according to 180 NAC 13-020, will not be met, must 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 must maintain a record of the name of the individual contacted for three years.
020.06 CANCELLATION NOTICE. Each licensee who cancels an irradiated reactor fuel or nuclear waste shipment for which advance notification has been sent must:
(A) Send a cancellation notice to the governor of each State or to the governor’s designee previously notified, each Tribal official or to the Tribal official’s designee previously notified, and the Director, Office of Nuclear Security and Incident Response; (B) State in the notice that it is a cancellation and identify the advance notification being canceled; and (C) Retain a copy of the notice for three years.
021. QUALITY ASSURANCE REQUIREMENTS . This section 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 section, "quality assurance" includes all 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 section.
021.01 PROGRAM ESTABLISHMENT. Unless otherwise authorized by the Department, each licensee must establish, maintain, and execute a quality assurance program satisfying each of the applicable criteria of 10 CFR 71.101 through 71.137 and satisfying any specific provisions applicable to the licensee's activities including procurement of packaging. The licensee must execute the applicable criteria in a graded approach to an extent that is equivalent with the quality assurance requirement's importance to safety.
021.02 PROGRAM APPROVAL. Before the use of any package for the shipment of licensed material subject to this section, each licensee must obtain Departmental approval of its quality assurance program. Each licensee must file a description of its quality assurance program, including a discussion of which requirements of this section are applicable and how they will be satisfied, by submitting the description to: ATTN: Nebraska Department of Health and Human Services, Office of Radiological Health, 301 Centennial Mall South, P.O. Box 95026, Lincoln, NE 68509-5026
021.03 MATERIAL AND COMPONENT IDENTIFICATION. The licensee must identify the material and components to be covered by the quality assurance program.
021.04 PROCEDURES. Each licensee must document the quality assurance program by written procedures or instructions and must carry out the program according to those procedures throughout the period during which packaging is used.
021.05 WRITTEN RECORDS. The licensee must maintain sufficient written records to demonstrate compliance with the quality assurance program. Records of quality assurance pertaining to the use of a package for shipment of radioactive material must be maintained for a period of three years after shipment.
021.06 RADIOGRAPHY CONTAINERS. The licensee must maintain a program for transport container inspection and maintenance limited to radiographic exposure devices, source changer, or packages transporting these devices and meeting the requirements of 180 NAC 5-011 or equivalent Agreement State or NRC requirements.
021.07 DELEGATION. The licensee must 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 must retain responsibility for the program. The licensee must clearly establish and delineate, in writing, the authority and duties of persons and organizations performing activities affecting the safety-related functions of structures, systems, and components. These activities include performing the functions associated with attaining quality objectives and the quality assurance functions. While the term licensee is used in these criteria, the requirements are applicable to whatever design, fabrication, assembly, and testing of the package is accomplished with respect to a package before the time a package approval is issued.
021.08 FUNCTIONS. The quality assurance functions are:
(A) Assuring an appropriate quality assurance program is established and effectively executed; and (B) Verifying, by procedures such as checking, auditing, and inspection, that activities affecting the safety-related functions have been performed correctly.
021.09 AUTHORITY AND ORGANIZATIONAL FREEDOM. The persons and organizations performing quality assurance functions must have sufficient authority and organizational freedom to:
(A) Identify quality problems; (B) Initiate, recommend, or provide solutions; and (C) Verify implementation of solutions.
021.10 HANDLING, STORAGE, AND SHIPPING CONTROL. The licensee must establish measures to control, according to instructions, the handling, storage, shipping, cleaning, and preservation of materials and equipment to be used in packaging to prevent damage or deterioration. When necessary for particular products, special protective environments, such as inert gas atmosphere, and specific moisture content and temperature levels must be specified and provided.
021.11 INSPECTION, TEST, AND OPERATING STATUS. The licensee must:
(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 packaging. 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; and (B) Establish measures to identify the operating status of components of the packaging, such as tagging valves and switches, to prevent inadvertent operation.
021.12 NONCONFORMING MATERIALS, PARTS, OR COMPONENTS. The licensee must establish measures to control materials, parts, or components that do not conform to the licensee’s requirements to prevent their inadvertent use or installation. These measures must include, as appropriate, procedures for identification, documentation, segregation, disposition, and notification to affected organization. Nonconforming items must be reviewed and accepted, rejected, repaired, or reworked according to documented procedures.
021.13 CORRECTIVE ACTIONS. The licensee must establish measures to assure conditions adverse to quality, such as deficiencies, deviations, defective material and equipment, and nonconformances, are prompt identified and corrected. In the case of significant condition adverse to quality, the measures must assure the cause of the condition is determined and corrective action taken to preclude repetition. Identification of the significant condition adverse to quality, cause of the condition, and corrective action taken must be documented and reported to appropriate levels of management.
021.14 RECORDS. The licensee must maintain sufficient written records to describe the activities affecting quality. These records must include changes to the quality assurance program as required by 180 NAC 13-022. The records must include the instruction, procedures, and drawings to prescribe quality assurance activities and must include closely related specifications such as required qualification of personnel, procedures, and equipment. The records must include the instructions or procedures, which establish a records retention program consistent with applicable regulations and designates factors such as duration, location, and assigned responsibility. The licensee must retain these records for three years beyond the date which the licensee last engage in the activity for which the quality assurance program was developed. If any portion of the written procedures or instruction is superseded, the licensee must retain the superseded material for three years after it is superseded.
021.15 AUDITS. The licensee must carry out 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 according to 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.
021.16 COMPLEXITY AND PROPOSED USE OF THE PACKAGE AND ITS COMPONENTS. The licensee must 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:
(A) The impact of malfunction or failure of the item to 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.
021.17 INDOCTRINATION AND TRAINING. The licensee must provide for indoctrination and training of personnel performing activities affecting quality, as necessary to assure suitable proficiency is achieved and maintained. The licensee must review the status and adequacy of the quality assurance program at established intervals. Management of other organizations participating in the quality assurance program must review regularly the status and adequacy of that part of the quality assurance program they are executing.
022. CHANGES TO QUALITY ASSURANCE PROGRAM .
022.01 SUBMISSION AND IMPLEMENTATION. Each quality assurance program approval holder must:
(A) Submit a description of a proposed change to its Department-approved quality assurance program that will reduce commitments in the program description as approved by the Department. The description must identify:
(i) The change; (ii) Reason for the change; and (iii) Basis for concluding the revised program incorporating the change continues to satisfy the applicable requirements of 180 NAC 13-021; and
(B) Not implement the change before receiving Department approval.
022.02 PREVIOUSLY APPROVED QUALITY ASSURANCE PROGRAM. Each quality assurance program approval holder may change a previously approved quality assurance program without prior Department approval, if the change does not reduce the commitments in the quality assurance program previously approved by the Department. Changes to the quality assurance program that do not reduce the commitments must be submitted to the Department every 24 months. In addition to quality assurance program changes involving administrative improvements and clarifications, spelling corrections, and nonsubstantive changes to punctuation or editorial items, the following changes are not considered reductions in commitment:
(A) Use of a quality assurance standard approved by the Department that is more recent than the quality assurance standard in the licensee’s current quality assurance program at the time of the change; (B) Use of generic organizational position titles that clearly denote the position function, supplemented as necessary by descriptive text, rather than specific titles, provided there is no substantive change to either the functions of the position or reporting responsibilities; (C) Use of generic organizational charts to indicate functional relationships, authorities, and responsibilities, or alternatively, the use of descriptive text, provided there is no substantive change to the functional relationships, authorities, or responsibilities; (D) 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 (E) Organizational revisions that ensure 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.
022.03 RECORDS. Each quality assurance program approval holder must maintain records of quality assurance program changes.
APPENDIX 13-A
DETERMINATION OF A1 AND A2
I. Values of A1 and A2 for individual radionuclides, which are the bases for many activity limits elsewhere in these regulations, are given in Table A-1. The curie (Ci) values specified are obtained by converting from the Terabecquerel (TBq) value. The curie values are expressed to three significant figures to assure the difference in the TBq and Ci quantities is one tenth of one percent or less. Where values of A1 or A2 are unlimited, it is for radiation control purposes only. For nuclear criticality safety, some materials are subject to controls placed on fissile material.
II.
- For individual radionuclides whose identities are known, but which are not listed in Table A-1, the A1 and A2 values contained in Appendix 13-A, Table A-3 may be used. Otherwise the licensee must obtain prior Department approval of the A1 and A2 values for radionuclides not listed in Table A-1, before shipping the material.
- For individual radionuclides whose identities are known, but which are not listed in Table A-2, the exempt material activity concentration and exempt consignment activity values contained in Appendix 13-A, Table A-3 may be used. Otherwise, the licensee must obtain prior Department approval of the exempt material activity concentration and exempt consignment activity values for radionuclides not listed in Table A-2, before shipping the material.
- The licensee must submit requests for prior approval, described under paragraphs II.a. and II.b. of this Appendix, to the Department, according to 180 NAC 1-012.
III. In the calculations of A1 and A2 for a radionuclide not in Table A-1, a single radioactive decay chain, where radionuclides are present in their naturally occurring proportions, and where no daughter radionuclide has a half-life either longer than 10 days, or longer than that of the parent radionuclide, must be considered as a single radionuclide, and the activity to be taken into account, and the A1 and A2 value to be applied must be those corresponding to the parent nuclide of that chain. In the case of radioactive decay chains where any daughter radionuclide has a half-life either longer than 10 days, or greater than that of the parent radionuclide, the parent and those daughter radionuclides must be considered as mixtures of different nuclides.
IV. For mixtures of radionuclides whose identities and respective activities are known, the following conditions apply:
a. For special form radioactive material, the maximum quantity transported in a Type A package is as follows:
Where B(i) is the activity of radionuclide i in special form, and A1(i) is the A1 value for radionuclide i.
b. For normal form radioactive material, the maximum quantity transported in a Type A package is a follows:
where B(i) is the activity of radionuclide i in normal form, and A2(i) is the A2 value for radionuclide i.
c. If the package contains both special and normal form radioactive material, the activity that may be transported in a Type A package is as follows:
where B(i) is the activity of radionuclide i as special form radioactive material, A1 (i) is the A1 value for radionuclide i, C(j) is the activity of radionuclide j as normal form radioactive material, and A2 (j) is the A2 value for radionuclide j.
d. Alternatively, the A1 value for mixtures of special form material may be determined as follows:
where f(i) is the fraction of activity for radionuclide i in the mixture, and A2(i) is the appropriate A1 value for radionuclide i.
e. Alternatively, the A2 value for mixtures of normal form material may be determined as follows:
Where f(i) is the fraction of activity of radionuclide i in the mixture, and A2(i) is the appropriate A2 value for radionuclide i.
f. The exempt activity concentration for mixtures of nuclides may be determined as follows:
Where f(i) is the fraction of activity concentration of radionuclide i in the mixture, and A is the activity concentration for exempt material containing radionuclide i.
g. The activity limit for an exempt consignment for mixtures of radionuclides may be determined as follows:
Where f(i) is the fraction of activity of radionuclide i in the mixture, and A(i) is the activity limit for exempt consignments for radionuclide i.
V.
- When the identity of each radionuclide is known, but the individual activities of some of the radionuclides are not known, the radionuclides may be grouped and the lowest A1 or A2 value, as appropriate, for the radionuclides in each group may be used in applying the formulas in paragraph IV. Groups may be based on the total alpha activity and the total beta, gamma activity when these are known, using the lowest A1 or A2 values for the alpha emitters and beta, gamma emitters.
- When the identity of each radionuclide is known but the individual activities of some of the radionuclides are not known, the radionuclides may be grouped and the lowest [A] (activity concentration for exempt material) or A (activity limit for exempt consignment) value, as appropriate, for the radionuclides in each group may be used in applying the formulas in paragraph IV of this appendix. Groups may be based on the total alpha activity and the total beta, gamma activity when these are known, using the lowest [A] or A values for the alpha emitters and beta, gamma emitters, respectively.
ATTACHMENT 1
39 CFR Part 111, §111.1
History
- Effective 2022-11-02
Chapter 14 Radiation Safety Requirements for Well Logging and Subsurface Tracer Studies
Neb. Admin. Code tit. 180, ch. 14 Radiation Safety Requirements for Well Logging and Subsurface Tracer Studies {#sec-180-nac-14 omnilex-key=us-ne-regs-official--title-180--180 NAC 14}
Effective Date: 6/14/2023
001. SCOPE AND AUTHORITY . This chapter establishes radiation safety requirements for persons using sources of radiation in well logging and subsurface tracer operations. This chapter applies to all licensees who use radioactive material including sealed sources, radioactive tracers, radioactive markers, and uranium sinker bars in well logging in a single well. These regulations are authorized by and implement the Nebraska Radiation Control Act, Nebraska Revised Statute (Neb. Rev. Stat.) §§ 71-3501 to 71-3520. The provisions and requirements of this chapter are in addition to, and not in substitution for, other requirements of these regulations. The provisions of 180 Nebraska Administrative Code (NAC) 1, 2, 3, 4, 10, 13, 15 and 18 apply to applicants and licensees subject to this chapter.
001.01 40 CODE OF FEDERAL REGULATIONS (CFR). 40 CFR were published July 1, 2002 and are referred throughout this chapter and incorporated by reference and available for viewing at the Department of Health and Human Services, Office of Radiological Health, 301 Centennial Mall South, Lincoln, Nebraska 68509.
001.02 AMERICAN NATIONAL STANDARD INSTITUTE (ANSI) N43.6 AND UNITED STATES OF AMERICA STANDARD INSTITUTE (USASI) N 5.10-1968. ANSI N43.6 and USASI N 5.10-1968 are referred to throughout this chapter and incorporated by reference and available for viewing at the Department of Health and Human Services, Office of Radiological Health, 301 Centennial Mall South, Lincoln, Nebraska 68509.
002. DEFINITIONS . The following definitions apply to this chapter:
002.01 ENERGY COMPENSATION SOURCE (ECS). A small sealed source, with an activity not exceeding 3.7 megabecquerels (MBq) or 100 microcuries (μCi), used within a logging tool, or other tool components, to provide a reference standard to maintain the tool’s calibration when in use.
002.02 FIELD STATION. A facility where radioactive sources may be stored or used and from which equipment is dispatched to temporary jobsites.
002.03 FRESH WATER AQUIFER. A geologic formation capable of yielding fresh water to a well or spring, except those aquifers exempted according to 40 CFR 122.35.
002.04 INJECTION TOOL. A device used for controlled subsurface injection of radioactive tracer material.
002.05 IRRETRIEVABLE WELL LOGGING SOURCE. Any sealed source containing radioactive 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.
002.06 LOGGING ASSISTANT. 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 performs surveys required by 180 NAC 14-020.
002.07 LOGGING SUPERVISOR. An individual who uses radioactive material or provides personal supervision in the use of radioactive material at a temporary jobsite and is responsible to the licensee for assuring compliance with the regulation requirements and conditions of the license.
002.08 LOGGING TOOL. A device used subsurface to perform well logging.
002.09 PERSONAL SUPERVISION. Guidance and instruction by a logging supervisor, who is physically present at a temporary jobsite, in personal contact with logging assistants, and can give immediate assistance.
002.10 RADIOACTIVE MARKER. Radioactive material used for depth determination or direction orientation. This includes radioactive collar markers and radioactive iron nails.
002.11 SAFETY REVIEW. A periodic review provided by the licensee for its employees on radiation safety aspects of well logging. The review may include results of internal inspections, new procedures or equipment, accidents or errors that have been observed, and opportunities for employees to ask safety questions.
002.12 SOURCE HOLDER. A housing or assembly into which a sealed source is placed to facilitate the handling and use of the source in well logging.
002.13 SUBSURFACE TRACER STUDY. The release of unsealed radioactive material or a substance labeled with radioactive 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.
002.14 SURFACE CASING FOR PROTECTING FRESH WATER AQUIFERS. A pipe or tube used as a lining in a well to isolate fresh water aquifers from the well.
002.15 TEMPORARY JOBSITE. A place where radioactive materials are present for the purpose of performing well logging or subsurface tracer studies.
002.16 TRITIUM NEUTRON GENERATOR TARGET SOURCE. A tritium source used within a neutron generator tube to produce neutrons for use in well logging applications.
002.17 URANIUM SINKER BAR. A weight containing depleted uranium used to pull a logging tool toward the bottom of a well.
002.18 WELL. A drilled hole for the purpose of oil, gas, mineral, groundwater, or geological exploration where well logging may be performed.
002.19 WELL LOGGING. All operations involving the lowering and raising of measuring devices or tools which contain radioactive material or are used to detect radioactive 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.
003. SPECIFIC LICENSES FOR WELL LOGGING . An applicant for a specific license for the use of licensed material in well logging must:
(A) Satisfy the general requirements specified in 180 NAC 3-011 for radioactive material, 180 NAC 3-015 for source material and any special requirements contained in 180 NAC 14; (B) Develop a program for training logging supervisors and assistants and submit a description of this program which specifies:
(i) Initial training; (ii) On-the-job training; (iii) Annual safety reviews provided by the licensee; (iv) Means the applicant will use to demonstrate the logging supervisor's knowledge and understanding of and ability to comply with the Department's regulations and licensing requirements and the applicant's operating and emergency procedures; and (v) 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;
(C) Submit written operating and emergency procedures as described in 180 NAC 14-018 or an outline or summary of the procedures that includes the important radiation safety aspects of the procedures;
(D) Establish and submit its program for annual inspections of the job performance of each logging supervisor to ensure the Department's regulations, 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;
(E) 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; and
(F) If an applicant wants to perform leak testing of sealed sources, the applicant must 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 must establish procedures to be followed and submit a description of these procedures. The description must include the:
(i) Instruments to be used; (ii) Methods of performing the analysis; and (iii) Pertinent experience of the person who will analyze the wipe samples.
004. AGREEMENT WITH WELL OWNER OR OPERATOR . 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.
004.01 WRITTEN AGREEMENT. The agreement must identify who will meet the following requirements:
(A) If a sealed source becomes lodged in the well, reasonable recovery efforts will be made; (B) A person may not attempt to recover a sealed source in a manner which, in the licensee's opinion, could result in its rupture; (C) Radiation monitoring required in 180 NAC 14-021.01 will be performed; (D) If the environment, any equipment, or personnel are contaminated with radioactive material, they must be decontaminated before release from the site or release for unrestricted use; and (E) If the sealed source is classified as irretrievable after reasonable efforts at recovery have been expended, the following requirements must be implemented within 30 days:
(i) Each irretrievable source must be immobilized and sealed in place with a cement plug; (ii) A means to prevent inadvertent intrusion on the source, unless the source is not accessible to any subsequent drilling operations; and (iii) 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 17 centimeters (7 inches) square and 3 millimeters (1/8 inch) thick. The plaque must contain:
(1) The word "Caution"; (2) The radiation symbol. The color requirement in 180 NAC 4-033.01 need not be met; (3) The date the source was abandoned; (4) The name of the well owner or well operator as appropriate; (5) The well name and well identification number or numbers or other designation; (6) An identification of the sealed source or sources by radionuclide and quantity; (7) The depth of the source and depth to the top of the plug; and (8) An appropriate warning with similar wording as "DO NOT RE-ENTER THIS WELL".
(iv) If a radioactive source is classified as irretrievably lost in any well or test hole, the licensee must, within 15 days, file with the Register of Deeds of the County where the well or test hole is located, a map of the location, including the legal description where the source was irretrievably lost, and a statement identifying the type and quantity of the radioactive source. Certified copies of the filing must be submitted to the Department within 30 days of the filing.
004.02 AGREEMENT RETENTION. The licensee must retain a copy of the agreement for three years after completion of the well logging operation.
004.03 DRILLING SAFETY ZONE. If a radioactive source is irretrievably lost in a fresh water aquifer or down a liquefied petroleum products storage cavity, the establishment of a drilling safety zone, based upon review of the geology and hydrology of the site, must be sought from the Department. All wells and storage cavities in the drilling safety zone must be abandoned and no fluids may be removed except upon approval by the Department. In addition of the notice requirements in 180 NAC 14-004.01(E), within 15 days after receipt of notice of the establishment of a drilling safety zone by the Department, the licensee must prepare a map of the drilling safety zone indicating the type and quantity of radioactive source, and the map must be filed with the Register of Deeds of any County located within the drilling safety zone. Certified copies of the filing must be submitted to the Department within 30 days after the filing.
004.04 EXCEPTION. An 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 must still otherwise meet the requirements in 180 NAC 14-004.01 (A) through (E).
005. LABELS, SECURITY AND TRANSPORTATION PRECAUTIONS .
005.01 LABELS. Licensees must not:
(A) Use a source, source holder, or logging tool that contains radioactive material unless the smallest component transported as a separate piece of equipment with the radioactive material inside bears a durable, legible, and clearly visible marking or label. The marking or label must contain the radiation symbol specified in 180 NAC 4-033.01, without the conventional color requirements, and the wording:
CAUTION or DANGER RADIOACTIVE MATERIAL
(B) Use a container to store radioactive 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 180 NAC 4-033.01 and the wording:
CAUTION or DANGER RADIOACTIVE MATERIAL NOTIFY CIVIL AUTHORITIES or NAME OF COMPANY
(C) Transport radioactive material unless the material is packaged, labeled, marked, and accompanied with appropriate shipping papers according to 180 NAC 13.
005.02 SECURITY, STORAGE AND TRANSPORTATION. Licensees must:
(A) Store each source containing radioactive material in a storage container or transportation package. The container or package must be locked and physically secured to prevent tampering or removal of radioactive material from storage by unauthorized personnel. The licensee must store radioactive material in a manner that will minimize danger from explosion or fire; (B) Lock and physically secure the transport package containing radioactive material in the transporting vehicle to prevent accidental loss, tampering, or unauthorized removal of the radioactive material from the vehicle.
006. RADIATION SURVEY INSTRUMENTS . The licensee must:
(A) Keep a calibrated and operable radiation survey instrument capable of detecting beta and gamma radiation at each field station and temporary jobsite to make the radiation surveys required by this chapter and 180 NAC 4. To satisfy this requirement, the radiation survey instrument must be capable of measuring 0.001 millisievert (mSv) (0.1 millirem (mrem)) per hour through at least 0.5 mSv (50 mrem) per hour; (B) Have available additional calibrated and operable radiation survey instruments sensitive enough to detect 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 quickly from a second party; (C) Ensure each radiation survey instrument required under 180 NAC 14-006.01 is calibrated:
(i) At intervals not to exceed six months and after instrument servicing; (ii) At two points located approximately 1/3 and 2/3 of full scale on each scale for linear scale instruments; at midrange of each decade and at two points of at least one decade for logarithmic scale instruments; and at approximate points for digital instruments; (iii) So an accuracy within plus or minus 20% of the calibration standard can be demonstrated on each scale; and (iv) At energies and radiation levels appropriate for use; and
(D) Retain calibration records for a period of three years after the date of calibration for inspection by the Department.
007. LEAK TESTING OF SEALED SOURCES . Each licensee using sealed sources of radioactive material must have the sources tested for leakage. Records of test results must be kept in units of microcuries and maintained for inspection by the Department.
007.01 METHODS. The wipe of a sealed source must be performed using a leak test kit or method approved by the Department, the U.S. Nuclear Regulatory Commission (NRC), or another Agreement State. The wipe sample must be taken from the nearest accessible point to the sealed source where contamination might accumulate. The sample must be analyzed for radioactive contamination. The analysis must be capable of detecting the presence of 185 becquerel (Bq) (0.005 μCi) of radioactive material on the test sample and must be performed by a person approved by the Department, NRC, or another Agreement State to perform the analysis.
007.02 FREQUENCY. Leak testing must be performed at the following intervals:
(A) Each sealed source except an 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; and (B) Each ECS not exempt from testing according to 180 NAC 14-007.04 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.
007.03 DECONTAMINATION, REPORTING OF LEAKING SOURCES. Licensees must remove leaking sources from service and report to the Department as follows.
(A) If the test conducted according to 180 NAC 14-007 reveals the presence of 185 Bq (0.005 μCi) or more of removable radioactive material, the licensee must remove the sealed source from service immediately and have it decontaminated, repaired, or disposed of by the Department, NRC, or another Agreement State licensee authorized to perform these functions. The licensee must check the equipment associated with the leaking source for radioactive contamination and, if contaminated, have it decontaminated or disposed of by the Department, the NRC, or another Agreement State licensee authorized to perform these functions; and (B) The licensee must submit a report to the Department within five days of receiving the test results. The report must describe the equipment involved in the leak test, test results, any contamination which resulted from the leaking source, and corrective actions taken up to the time the report is made.
007.04 EXEMPTIONS. The following sealed sources are exempt from the periodic leak test requirements in 180 NAC 14-007:
(A) Hydrogen-3 (tritium) sources; (B) Sources containing radioactive material with a half-life of 30 days or less; (C) Sealed sources containing radioactive material in gaseous form; (D) Sources of beta or gamma emitting radioactive material with an activity of 3.7 MBq (100 μCi) or less; and (E) Sources of alpha or neutron emitting radioactive material with an activity of 0.37 MBq (10 μCi) or less.
008. PHYSICAL INVENTORY . Each licensee must conduct quarterly physical inventory to account for all radioactive material received and possessed under the license. The licensee must retain records of the inventory for three years from the date of the inventory for inspection by the Department. The inventory must indicate the quantity and kind of radioactive material, the location of the radioactive 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.
009. RECORDS OF MATERIAL USE . Each licensee must maintain and make available for inspection by the Department records for each use of radioactive material and retain the records for three years from the date of the recorded event. The records must show:
(A) The make, model number, and a serial number or description of each sealed source used; (B) In the case of unsealed radioactive 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; (C) The identity of the logging supervisor who is responsible for the radioactive material and the identity of logging assistants present; and (D) The location and date of use of the radioactive material.
010. DESIGN, PERFORMANCE CRITERIA FOR SEALED SOURCES .
010.01 SEALED SOURCE USE. A licensee may use a sealed source for use in well logging application if the sealed source:
(A) Is doubly encapsulated; (B) Contains radioactive material whose chemical and physical forms are as insoluble and nondispersible as practical; and (C) Meets the requirements in 180 NAC 14-010.02, 010.03, or 010.04.
010.02 SEALED SOURCES MANUFACTURED ON OR BEFORE JULY 14, 1989. 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 Radioactive Sources”, or the requirements in 180 NAC 14-010.03 and 010.04.
010.03 SEALED SOURCES MANUFACTURED AFTER JULY 14, 1989. 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.”
010.04 ADDITIONAL REQUIREMENTS FOR SEALED SOURCES MANUFACTURED AFTER JULY 14, 1989. For a sealed source manufactured after July 14, 1989, a licensee may use the sealed source for use in well logging applications, if:
(A) The sealed source’s prototype has been tested and found to maintain its integrity after each of the following tests:
(i) Temperature. The test source must be held at -40°Celsius (-40°Fahrenheit) for 20 minutes, 600°Celsius (1112°Fahrenheit) for 1 hour, and then be subject to a thermal shock test with a temperature drop from 600°Celsius (1112°Fahrenheit) to 20°Celsius (68°Fahrenheit) within 15 seconds (ii) Impact test. A 5 kilogram steel hammer, 2.5 centimeters in diameter, must be dropped from a height of 1 meter onto the test source. (iii) Vibration test. The test source must be subject to a vibration from 25 hertz to 500 hertz at 5 G amplitude for 30 minutes. (iv) Puncture test. A 1 gram hammer and pin, 0+.3 centimeters pin diameter, must be dropped from a height of 1 meter onto the test source. (v) Pressure test. The test source must be subjected to an external pressure of 1.695E+7 pascals (24,600 pounds per square inch absolute).
010.05 EXEMPTIONS. The requirements in 180 NAC 14-010.01 through 14-010.04 do not apply to sealed sources that contain radioactive material in gaseous form.
010.06 ENERGY COMPENSATION SOURCE EXEMPTIONS. The requirements in 180 NAC 14-010.01, 010.02, 010.03 and 010.04 do not apply to ECS. ECSs must be registered with the NRC under 10 CFR 32.210 or with an Agreement State.
011. INSPECTION, MAINTENANCE, AND OPENING OF A SOURCE OR SOURCE HOLDER . Licensees must inspect and maintain sealed sources. Records made must be retained for three years after any defects are found.
011.01 VISUAL INSPECTION PRIOR TO USE. Each licensee must visually check source holders, logging tools, and source handling tools for defects before each use to ensure the equipment is in good working condition and 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.
011.02 VISUAL INSPECTION AND ROUTINE MAINTENANCE PROGRAM. Each licensee must conduct, at intervals not to exceed six months, a program of visual inspection and routine maintenance of source holders, logging tools, injection tools, source handling tools, storage containers, transport containers, and uranium sinker bars to ensure the required labeling is legible and 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.
011.03 SEALED SOURCE REMOVAL PROCEDURES. Removal of a sealed source from a source holder or logging tool, and maintenance on sealed sources or holders where sealed sources are contained may not be performed by the licensee unless a written procedure according to 180 NAC 14-018 has been developed by the licensee and approved by the Department based upon compliance with 180 NAC 4 and 10.
011.04 STUCK SEALED SOURCE. If a sealed source is stuck in the source holder, the licensee may not perform any operation on the source holder, such as drilling, cutting, or chiseling, unless the licensee is specifically approved by the Department; approval is based upon training and experience of the licensee and upon compliance with 180 NAC 4 and 10.
011.05 OPENING OF SEALED SOURCES. The opening, repair, or modification of any sealed source must be performed by persons specifically approved by the Department, NRC, or an Agreement State.
012. SUBSURFACE TRACER STUDIES . Licensees performing subsurface tracer studies must:
(A) Require all personnel handling radioactive tracer material to use protective gloves and, if required by the licensee, other protective clothing and equipment; (B) Take precautions to avoid ingestion or inhalation of radioactive tracer material and to avoid contamination of field stations and temporary jobsites; and (C) Not knowingly inject radioactive material into fresh water aquifers.
013. URANIUM SINKER BARS . The licensee may use a uranium sinker bar in well logging applications only if it is legibly impressed with the words "CAUTION - RADIOACTIVE - DEPLETED URANIUM" and "NOTIFY CIVIL AUTHORITIES (or COMPANY NAME) IF FOUND".
014. SEALED SOURCE USE . Sealed source use in wells must meet the following requirements:
(A) No sealed source may be used in any well unless the well is cased according to the rules and regulations of the Nebraska Oil and Gas Conservation Commission Title 267 Chapter 3, 012.01 through 012.03 and 012.09 and Chapter 4, 006.01B, except as according to 180 NAC 14-014.02; and (B) 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 Department, NRC, or another Agreement State.
015. ENERGY COMPENSATION SOURCE . The licensee may use an ECS contained within a logging tool, or other tool components, only if the ECS contains quantities of licensed material not exceeding 3.7 MBq (100 μCi):
(A) Well logging applications with a surface casing for protecting fresh water aquifers, use of the ECS is only subject to the requirements of 180 NAC 14-007, 008, and 009. (B) Well logging applications without the surface casing for protecting fresh water aquifers, use of the ECS is only subject to the requirements of 180 NAC 14-004, 007, 008, 009, 014, and 027.
016. TRITIUM NEUTRON GENERATOR TARGET SOURCE . Use of a tritium neutron generator target source containing quantities:
(A) Not exceeding 1,110 GBq (30 curies) and in a well with a surface casing to protect fresh water aquifers, is subject to the requirements of this chapter except 180 NAC 14-004, 010 and 027; or (B) Exceeding 1,110 GBq (30 curies) or in a well without a surface casing to protect fresh water aquifers, is subject to the requirements of this chapter except 180 NAC 14-010.
017. TRAINING . The following requirements apply to well logging personnel:
017.01 RADIATION SAFETY OFFICER. A radiation safety officer must:
(A) Have a college degree at the bachelor level, or equivalent training and experience in the physical or biological sciences or in engineering; (B) Be qualified as well logger or have six weeks on-the-job training under an authorized user; and (C) Have forty hours of formal instruction in:
(i) Principles and practices of radiation protection; (ii) Radioactivity measurements standardization and monitoring techniques and instruments; (iii) Mathematics and calculations basic to the use of and measurement of radioactivity; (iv) Biological effects of radiation; and (v) Operating and emergency procedures and federal and state radiation control regulations.
017.02 SUPERVISOR. A logging supervisor must have:
(A) Completed forty hours of formal training in the subjects outlined in 180 NAC 14-017.06; (B) Received copies of and instruction in:
(i) 180 NAC 4, 10, and 14; (ii) The license under which the logging supervisor will perform well logging; and (iii) The licensee's operating and emergency procedures required by 180 NAC 14-019;
(C) Completed six weeks of on-the-job training under a logging supervisor and demonstrated competence in the use of radioactive materials, remote handling tools, and radiation survey instruments by a field evaluation; and (D) Demonstrated understanding of the requirements in 180 NAC 14-017.02(A) and (B) by successfully completing a written test.
017.03 ASSISTANT. A logging assistant must have:
(A) Received instruction in applicable parts of 180 NAC 4, and 10; (B) Received copies and instruction in the licensee's operating and emergency procedures required by 180 NAC 14-018; (C) Demonstrated understanding of the materials listed in 180 NAC 14-017.03(A) and (B) by successfully completing a written or oral test; and (D) Received instruction in the use of radioactive materials, remote handling tools, and radiation survey instruments, as appropriate for the logging assistant's intended job responsibilities.
017.04 SAFETY REVIEW. The licensee must provide safety reviews for logging supervisors and logging assistants at least once during each calendar year.
017.05 RECORDS. The licensee must 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 for three years following the termination of employment. Records of annual safety reviews must list the topics discussed and be retained for three years.
017.06 TRAINING SUBJECTS. The following topics must be included in the training required by 180 NAC 14-017.02:
(A) Fundamentals of radiation safety including:
(i) Characteristics of radiation; (ii) Units of radiation dose and quantity of radioactivity; (iii) Hazards of exposure to radiation; (iv) Levels of radiation from radioactive material; (v) Methods of controlling radiation dose (time, distance, and shielding); and (vi) Radiation safety practices, including prevention of contamination, and methods of decontamination; and
(B) Radiation detection instruments including:
(i) Use, operation, calibration, and limitations of radiation survey instruments; (ii) Survey techniques; and (iii) Use of personnel monitoring equipment; and
(C) Equipment to be used including:
(i) Operation of equipment, including source handling equipment and remote handling tools; (ii) Storage, control, and disposal of radioactive material; and (iii) Maintenance of equipment; and
(D) Requirements of pertinent regulations; and (E) Case histories of well logging accidents.
018. OPERATING AND EMERGENCY PROCEDURES . Each licensee must develop and follow written operating and emergency procedures that cover:
(A) Handling and use of radioactive materials including the use of sealed sources in wells without surface casing for protecting fresh water aquifers, if appropriate; (B) 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 180 NAC 14-020.02 through 020.05. (D) Minimizing personnel exposure including exposures from inhalation and ingestion of radioactive tracer materials; (E) Methods and occasions for locking and securing stored radioactive materials; (F) Personnel monitoring and the use of personnel monitoring equipment; (G) Transportation of sources of radiation to field stations or temporary jobsites, packaging of sources of radiation for transport in vehicles, placarding of vehicles when needed, and physically securing sources of radiation in transport vehicles during transportation to prevent accidental loss, tampering or unauthorized removal; (H) Picking up, receiving, and opening packages containing radioactive materials, according to 180 NAC 4-038; (I) For tracer use, decontamination of the environment, equipment, and personnel; (J) Maintenance of records generated by logging personnel at temporary jobsites; (K) 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 180 NAC 14-011; (L) Actions to be taken if a sealed source is lodged in a well; (M) Notifying proper persons in the event of an accident; and (N) Actions to be taken if a sealed source is ruptured including actions to prevent the spread of contamination, minimize inhalation and ingestion of radioactive materials, and obtain suitable radiation survey instruments as required by 180 NAC 14-006(B).
019. PERSONNEL MONITORING .
019.01 DOSIMETER REQUIREMENTS. 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 to and worn by only one individual. 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.
019.02 BIOASSAY SERVICES. The licensee must provide bioassay services to individuals using radioactive materials in subsurface tracer studies if required by the license.
019.03 RECORD RETENTION. The licensee must retain personnel dosimeters records required by 180 NAC 14-019.01 and bioassay results for inspection until the Department authorizes disposition.
020. RADIATION SURVEYS . The licensee must make radiation surveys, including but not limited to the surveys required in 180 NAC 14-020.01 through 020.04, of each area where radioactive materials are used and stored. Survey results required in this section must be recorded and include the survey date, name of the individual making the survey, identification of the survey instrument used, and location of the survey. The licensee must retain survey records for inspection by the Department for three years after they are made.
020.01 VEHICLE SURVEYS. Before transporting radioactive materials, the licensee must 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 radioactive materials.
020.02 LOGGING TOOL. If the sealed source assembly is removed from the logging tool before departure from the temporary jobsite, the licensee must confirm the logging tool is free of contamination by energizing the logging tool detector or by using a survey meter.
020.03 CONTAMINATION SURVEY. If the licensee has reason to believe that, as a result of any operation involving a sealed source, the encapsulation of sealed source could be damaged by the operation, the licensee must conduct a radiation survey, including a contamination survey, during and after the operation.
020.04 JOBSITE SURVEY. The licensee must make a radiation survey at the temporary jobsite before and after each subsurface tracer study to confirm the absence of contamination.
021. RADIOACTIVE CONTAMINATION CONTROL .
021.01 EMERGENCY PROCEDURES. If the licensee detects evidence a sealed source has ruptured or radioactive materials have caused contamination, the licensee must immediately initiate the emergency procedures required by 180 NAC 14-018.
021.02 DECONTAMINATION. If contamination results from the use of radioactive material in well logging, the licensee must decontaminate all work areas, equipment, and unrestricted areas.
021.03 MONITOR CIRCULATING FLUIDS. During efforts to recover a sealed source lodged in the well, the licensee must continuously monitor, with an appropriate radiation detection instrument or a logging tool with a radiation detector, circulating fluids from the well, if any, to check for contamination resulting from damage to the sealed source.
022. HANDLING TOOLS . The licensee must provide and require the use of tools that will assure remote handling of sealed sources other than low-activity calibration sources.
023. PARTICLE ACCELERATORS . No licensee or registrant may permit above-ground testing of particle accelerators designed for use in well logging, which results in the production of radiation, except in areas or facilities controlled or shielded so the appropriate requirements of 180 NAC 4-005 and 4-013 are met.
024. SECURITY .
024.01 PHYSICAL PRESENCE. A logging supervisor must be physically present at a temporary jobsite whenever radioactive materials are being handled or are not stored and locked in a vehicle or storage place. The logging supervisor may leave the jobsite in order to obtain assistance if a source becomes lodged in a well.
024.02 DIRECT SURVEILLANCE. 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 must maintain direct surveillance of the operation to prevent unauthorized entry into a restricted area, as defined 180 NAC 1-002.
025. DOCUMENTS AND RECORDS REQUIRED AT FIELD STATIONS . Each licensee must maintain the following documents and records at the field station:
(A) A copy of 180 NAC 4, 10, and 14; (B) The license authorizing the use of radioactive material; (C) Operating and emergency procedures required by 180 NAC 14-018; (D) Records of radiation survey instrument calibrations required by 180 NAC 14-006; (E) Records of leak tests required by 180 NAC 14-007; (F) Physical inventory records required by 180 NAC 14-008; (G) Utilization records required by 180 NAC 14-009; (H) Records of inspection and maintenance required by 180 NAC 14-011; (I) Training records required by 180 NAC 14-017; and (J) Survey records required by 180 NAC 14-020.
026. DOCUMENTS AND RECORDS REQUIRED AT TEMPORARY JOBSITES . Each licensee conducting operations at a temporary jobsite must maintain the following documents and records at the temporary jobsite until the well logging operation is completed:
(A) Operating and emergency procedures required by 180 NAC 14-018; (B) Evidence of latest calibration of the radiation survey instruments in use at the site required by 180 NAC 14-006; (C) Latest survey records required by 180 NAC 14-020.02, 020.03 and 020.05; (D) Shipping papers for the transportation of radioactive materials required by 180 NAC 13-005; and (E) When operating under reciprocity according to 180 NAC 3-028, a copy of the NRC or Agreement State license authorizing use of radioactive materials.
027. NOTIFICATION OF INCIDENTS AND LOST SOURCES; ABANDONMENT PROCEDURES FOR IRRETRIEVABLE SOURCES . Licensees must:
(A) Immediately notify the Department by telephone and subsequently, within 30 days, by confirmatory letter if the licensee knows or has reason to believe a sealed source has been ruptured. The letter must designate the well or other location, describe the magnitude and extent of the escape of radioactive materials, assess the consequences of the rupture, and explain efforts planned or being taken to mitigate these consequences; (B) Notify the Department of the theft or loss of radioactive materials, radiation overexposures, excessive levels and concentrations of radiation, and certain other accidents as required by 180 NAC 4-057, 4-058, 4-059, and 180 NAC 3-026; (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:
(i) Notify the appropriate Department by telephone of the circumstances that resulted in the inability to retrieve the source and
(1) Obtain Department approval to implement abandonment procedures; or (2) That the licensee implemented abandonment before receiving Department approval because the licensee believed there was an immediate threat to public health and safety; and
(ii) Advise the well owner or operator, as appropriate, of the abandonment procedures under 180 NAC 14-004.01 and 004.03; and (iii) Ensure either abandonment procedures are implemented within 30 days after the sealed source was classified as irretrievable or request an extension of time if unable to complete the abandonment procedures; and
(D) Within 30 days after a sealed source has been classified as irretrievable, make a report in writing to the Department the following information:
(i) Date of occurrence; (ii) Description of the irretrievable well logging source involved including the radionuclide and its quantity, chemical, and physical form; (iii) Surface location and identification of the well; (iv) Results of efforts to immobilize and seal the source in place; (v) Brief description of the attempted recovery effort; (vi) Depth of the source; (vii) Depth of the top of the cement plug; (viii) Depth of the well; (ix) The immediate threat to public health and safety justification for implementing abandonment if prior to Department approval was not obtained according to this section; and (x) Any other information, such as a warning statement, contained on the permanent identification plaque.
History
- Effective 2023-06-14
Chapter 15 Training and Experience Requirements for Use of Radiation Sources
Neb. Admin. Code tit. 180, ch. 15 Training and Experience Requirements for Use of Radiation Sources {#sec-180-nac-15 omnilex-key=us-ne-regs-official--title-180--180 NAC 15}
TITLE 180 CONTROL OF RADIATION
CHAPTER 15 TRAINING AND EXPERIENCE REQUIREMENTS FOR USE OF RADIATION SOURCES
Effective Date: 11/25/2020
001. SCOPE AND AUTHORITY . This chapter establishes the training and experience requirements of personnel utilizing or servicing sources of radiation addressed in 180 Nebraska Administrative Code (NAC) 2, 3, 5, 6, 8, 9, 12 and 20. It establishes the criteria which courses of instruction must possess prior to being approved by the Department. Title 180 is authorized by and implements the Nebraska Radiation Control Act, Nebraska Revised Statute (Neb. Rev. Stat.) §§ 71-3501 to 71-3520.
002. DEFINITIONS . The following definitions apply to 180 NAC 15.
002.01 EXPERIENCE. Active participation in events or activities, leading to accumulation of knowledge is experience.
002.02 FORMAL TRAINING. Training or education, including either didactic or clinical practicum or both, which has a specified objective, planned activities for students, and suitable methods for measuring student attainment, and which is offered, sponsored, or approved by an organization or institution which is able to meet or enforce these criteria is formal training.
003. RECENTNESS OF TRAINING . The training and experience specified in 180 NAC 15 must have been obtained within the seven years preceding the date of application or the individual must have related continuing education and experience since the required training and experience was completed.
004. MINIMUM QUALIFICATIONS . This section addresses the qualifications for a radiological medical physicist, a radiological health physicist, and a qualified expert.
004.01 RADIOLOGICAL MEDICAL PHYSICIST. A radiological medical physicist must:
(A) Be certified by the American Board of Radiology in therapeutic radiological physics, roentgen ray and gamma ray physics, x-ray and radium physics; or radiological physics; or the American Board of Medical Physics in radiation oncology physics or the Canadian College of Medical Physics. Certification must be in the specialty the individual will be clinically practicing; or (B) Have a master's or doctor's degree in physics, medical physics, other physical science, engineering, applied mathematics, nuclear physics, biophysics, radiological physics, or health physics 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 a radiological medical physicist that meets the requirements of 180 NAC 15-004.01(A) at a medical institution. Full time training and full time work experience must be in the specialty the individual will be clinically practicing.
004.02 RADIOLOGICAL HEALTH PHYSICIST. A radiological health physicist must:
(A) Be certified by the American Board of Health Physics or the American Board of Radiology in therapeutic radiological physics, roentgen ray and gamma ray physics, x-ray and radium physics, or radiological physics, diagnostic radiologic physics; or the American Board of Medical Physics, or the Canadian College of Medical Physics; (B) Have a master's or a doctor's degree in a physical or natural science or equivalent, biophysics, radiological physics or health physics, plus one year of full time experience in radiation protection and measurements; or (C) Have a bachelor's degree in a physical or natural science or equivalent, plus three years of full time training and experience in radiation protection and measurements and a written statement from a radiological health physicist as defined in 180 NAC 15-004.02(A) or (B) that two years of training and experience in radiation protection and measurements, including knowledge and training in the field of radiation shielding, have been obtained under their supervision.
004.03 QUALIFIED EXPERT. A qualified expert must have:
(A) A bachelor's degree in a physical or natural science, and one year of experience in radiation protection and measurements; or (B) A certificate or associate degree from an accredited radiological technology school and one year of experience in radiation protection and measurements.
005. TRAINING AND EXPERIENCE REQUIREMENTS FOR PERSONNEL FOR INSTITUTIONAL BROAD SCOPE TYPE LICENSE A, B, AND C LISTED IN 180 NAC 3-013 . This section addresses the training and experience requirements of personnel using radioactive material under a broad scope license.
005.01 RADIATION SAFETY OFFICER. A radiation safety officer must have:
(A) A college degree at the bachelor level, in physical or biological sciences or in engineering plus four years work experience in health physics, radiological health or another field equivalent to the above fields; or (B) A master's degree or equivalent graduate coursework in health physics or radiological health with two years of work experience in health physics or radiological health.
005.02 AUTHORIZED USER. An authorized user must have:
(A) A college degree at the bachelor level, or equivalent training or experience in the physical or biological sciences or in engineering; (B) 40 hours of formal instruction in:
(i) Radiation physics and instrumentation; (ii) Radiation protection; (iii) Mathematics pertaining to the use and measurement of radioactivity; and (iv) Biological effects of radiation; and
(C) One-hundred and sixty hours experience in the safe handling of radioactive material.
006. PERSONNEL TRAINING AND EXPERIENCE REQUIREMENTS FOR LICENSEES IN AN EDUCATIONAL INSTITUTION OTHER THAN BROAD SCOPE LICENSES . This section addresses training and experience requirements for personnel using radioactive material at an educational institution that has a license other than broad scope license.
006.01 RADIATION SAFETY OFFICER, AUTHORIZED USER, OR BOTH. A radiation safety officer, authorized user, or both must:
(A) Have a college degree at the bachelor level, or equivalent training and experience in the physical or biological sciences or in engineering; (B) Have 40 hours of formal instruction in:
(i) Radiation physics and instrumentation; (ii) Radiation protection; (iii) Mathematics pertaining to the use and measurement of radioactivity; and (iv) Biological effects of radiation; and
(C) Demonstrate an understanding of institution radiation safety policy and procedures and applicable parts of Title 180 or its equivalent.
007. TRAINING AND EXPERIENCE REQUIREMENTS FOR LABORATORY AND INDUSTRIAL USE OF RADIOACTIVE MATERIAL PERSONNEL . Personnel using radioactive material under laboratory or industrial licenses must meet the following requirements.
007.01 MILLICURIE QUANTITIES. For use of millicurie quantities, the radiation safety officer, authorized user, or both must:
(A) Have a college degree at the bachelor level, or equivalent training and experience in the physical or biological sciences or in engineering; (B) Have 40 hours of formal instruction in:
(i) Radiation physics and instrumentation; (ii) Radiation protection; (iii) Mathematics pertaining to the use and measurement of radioactivity; and (iv) Biological effects of radiation; and
(C) Demonstrate an understanding of operating and emergency procedures and applicable parts of Title 180 or its equivalent.
007.02 MICROCURIE QUANTITIES. For use of microcurie quantities, the radiation safety officer, authorized user, or both must:
(A) Have 40 hours of formal instruction in:
(i) Radiation physics and instrumentation; (ii) Radiation protection; (iii) Mathematics pertaining to the use and measurement of radioactivity; and (iv) Biological effects of radiation; and
(B) Demonstrate an understanding of operating and emergency procedures and applicable part of Title 180 or its equivalent.
008. PERSONNEL TRAINING AND EXPERIENCE REQUIREMENTS FOR LICENSES TO MANUFACTURE OR INTRODUCTION OF RADIOACTIVE MATERIAL INTO MANUFACTURED PRODUCTS AND DEVICES SPECIFIED IN 180 NAC 3-014.05, 3-014.06, 3-014.09, and 3-014.12 and 3-014.13 . Licensees that manufacture or introduce radioactive material into products and devices must have personnel that meet the following education and training requirements.
008.01 RADIATION SAFETY OFFICER, AUTHORIZED USER, OR BOTH. The radiation safety officer, authorized user, or both must:
(A) Have a college degree at the bachelor level, or equivalent training and experience in the physical or biological sciences or in engineering; (B) Have 40 hours of formal instruction in:
(i) Radiation physics and instrumentation; (ii) Radiation protection; (iii) Mathematics pertaining to the use and measurement of radioactivity; and (iv) Biological effects of radiation; and
(C) Demonstrate an understanding of operating and emergency procedures and these regulations or their equivalent.
009. PERSONNEL TRAINING AND EXPERIENCE REQUIREMENTS FOR LICENSES TO MANUFACTURE AND INTRODUCE RADIOACTIVE MATERIAL INTO RADIOPHARMACEUTICALS AS SPECIFIED IN 180 NAC 3-014.08 . Licensees that manufacture and introduce radioactive materials into radiopharmaceuticals must have personnel that meet the following training and experience requirements.
009.01 RADIATION SAFETY OFFICER, AUTHORIZED USER, OR BOTH. The radiation safety officer, authorized user, or both must:
(A) Be a registered pharmacist; (B) Have 200 hours of basic radioisotope handling techniques, including:
(i) Radiation physics and instrumentation; (ii) Radiation protection; (iii) Mathematics pertaining to the use and measurement of radioactivity; (iv) Biological effects of radiation; and (v) Radiopharmaceutical chemistry; and
(C) Have three-hundred hours experience as a radiopharmaceutical chemist.
010. TRAINING AND EXPERIENCE REQUIREMENTS FOR PARTICLE ACCELERATORS PERSONNEL - NON HUMAN USE . Licensees that operate particle accelerators for non human use must have personnel that meet the following requirements.
010.01 RADIATION SAFETY OFFICER, SUPERVISOR, OR BOTH. The radiation safety officer, supervisor, or both must have a bachelor of science degree plus one year experience in the use and operation of particle accelerators that includes forty hours of instruction as specified for particle accelerator operators in 180 NAC 15-010.02.
010.02 PARTICLE ACCELERATOR OPERATORS. Particle accelerator operators must:
(A) Have 40 hours of instruction in the fundamentals of radiation to include:
(i) Characteristics of radiation; (ii) Units of radiation dose; (iii) Biological effects of radiation; and (iv) Levels of radiation from particle accelerators;
(B) Be instructed in the methods used to prevent radiation exposure at the specific facility to be operated, including:
(i) Shielding; (ii) Interlock system; (iii) Safety rules; and (iv) Radiation monitoring equipment;
(C) Have one month of full time or equivalent on-the-job training under direct supervision. This training must be completed before assuming operational responsibility; (D) Have instruction on the use and care of personnel monitoring equipment employed at the facility; (E) Be familiar with the location and use of all operating controls; (F) Be familiar with the requirements of pertinent regulations in this title; and (G) Be familiar with the registrant's written operating and emergency procedures.
011. TRAINING AND EXPERIENCE FOR SELF-SHIELDED IRRADIATORS . Licensees that operate self-shielded irradiators must have authorized users that meet the following requirements.
011.01 AUTHORIZED USER. An authorized user must:
(A) Have eight hours of formal instruction in:
(i) Radiation physics and instrumentation; (ii) Radiation protection; (iii) Mathematics pertaining to the use and measurement of radiation; and (iv) Biological effects of radiation; and
(B) Demonstrate an understanding of operating and emergency procedures and these regulations or their equivalent.
012. TRAINING AND EXPERIENCE REQUIREMENTS FOR INDUSTRIAL GAUGE PERSONNEL . Industrial gauge personnel must meet the following requirements.
012.01 RADIATION SAFETY OFFICER, AUTHORIZED USER, OR BOTH. The radiation safety officer or authorized user, or both must demonstrate competency in use, maintenance, and transfer of devices by satisfactorily completing an eight hour course provided by the manufacturer of the device or any Department accepted course.
013. TRAINING AND EXPERIENCE REQUIREMENTS FOR GAS CHROMATOGRAPH PERSONNEL . Gas chromatograph personnel must meet the following requirements.EFFECTIVE
013.01 RADIATION SAFETY OFFICER, AUTHORIZED USER, OR BOTH. The radiation safety officer or authorized user, or both, must receive and be competent in using operating procedures and manufacturer's instructions.
014. TRAINING AND EXPERIENCE REQUIREMENTS FOR INSTALLATION AND SERVICING OF RADIATION GENERATING EQUIPMENT AND ASSOCIATED RADIATION GENERATING EQUIPMENT AS SUPPLIED BY THE EMPLOYER . Personnel servicing radiation generating equipment must meet the following requirements.
014.01 INSTALLATION AND SERVICING PERSONNEL. A person performing installation or servicing of radiation generating equipment must have:
(A) Formal training in radiation machine assembly, installation, or repair, or an associate’s degree in biomedical equipment repair. (B) Six months of supervised on-the-job training on the assembly or repair, or both, of the types of equipment to be serviced.
History
- Effective 2020-11-25
Chapter 18 Fees for Certificates of Registration, Radioactive Material(s) Licenses, Environmental Surveillance, Emergency Response and Other Regulatory Services
Neb. Admin. Code tit. 180, ch. 18 Fees for Certificates of Registration, Radioactive Material(s) Licenses, Environmental Surveillance, Emergency Response and Other Regulatory Services {#sec-180-nac-18 omnilex-key=us-ne-regs-official--title-180--180 NAC 18}
Effective Date: 6/14/2023
001. SCOPE AND AUTHORITY . This chapter establishes the fees for licensing, registration, environmental surveillance and implementation, emergency planning, emergency response and implementation, and other regulatory services and provide for their payment. The regulations are authorized by and implement the Nebraska Radiation Control Act, Nebraska Revised Statute (Neb. Rev. Stat.) §§ 71-3501 to 71-3520.
001.01 Unless specifically provided otherwise, the rules and requirements in this chapter apply to any person who is:
(A) An applicant for, or holder of:
(i) A radioactive material license pursuant to 180 Nebraska Administrative Code (NAC); (ii) A certificate of registration for radiation machines, facilities, or services issued pursuant to 180 NAC 2; or (iii) A general license.
(B) The holder of a fixed nuclear facility construction permit or operating license issued by the U.S. Nuclear Regulatory Commission (NRC) pursuant to 10 CFR Part 50; (C) The operator of any other fixed nuclear facility under a license issued by the NRC Pursuant to 10 CFR Parts 30, 31, 32, 33, 34, 35, 36, 39, 40, or 70; (D) The operator of any other nuclear facility; or (E) The operator of any facility that during the course of operation results in the release of radioactive material to the environment.
002. DEFINITIONS . As used in 180 NAC 18, the following definitions apply:
002.01 CARRIER. A person who transports passengers or property in commerce by rail car, aircraft, motor vehicle or vessel.
002.02 EMERGENCY PLANNING, EMERGENCY RESPONSE AND IMPLEMENTATION. The development and application of those capabilities necessary to protect the public and the environment from the effects of an accidental or uncontrolled exposure dose or release of radioactive materials, including the equipping, training and periodic retraining of emergency response personnel.
002.03 ENVIRONMENTAL SURVEILLANCE AND IMPLEMENTATION. The development and application of those capabilities necessary to assess the radiological impact of activities conducted by licensees and registrants on public health and safety and the environment.
002.04 FACILITY. Any facility other than that defined in this subsection.
002.05 FIXED NUCLEAR FACILITY. A fixed nuclear facility includes:
(A) Any nuclear reactor at a single site;
(B) Any facility designed or used for the assembly or disassembly of nuclear weapons; and
(C) Any other facility using or possessing source material, special nuclear material, by product material, or any other radioactive material for which the Department conducts off-site environmental surveillance to protect the public health and safety or the environment.
003. EXEMPTIONS .
003.01 No fee will be required for the Department of Health and Human Services, Office of Radiological Health.
004. PAYMENT OF FEES .
004.01 APPLICATION FEES. Each application for a license or certificate of registration for which a fee is prescribed will be accompanied by a non-refundable fee:
(A) An application for a certificate of registration must be accompanied by the total fee for all applicable categories; (B) Applications for new materials licenses, applications to reinstate expired, terminated or inactive licenses and applications for amendments to licenses that would place the license in a higher fee category or add a new fee category must be accompanied by the prescribed application fee for each category; (C) No application will be accepted for filing or processing prior to full fee payment, as specified, and the application will be returned to the applicant; and (D) All application fees will be charged regardless of the Department's disposition of the application or a withdrawal of the application.
004.02 ANNUAL FEES FOR LICENSES AND CERTIFICATES OF REGISTRATION. The following applies to annual fees for licenses and certificates of registration:
(A) A non-refundable fee as specified in 180 NAC 18-005 or 18-008 must be paid in full each year on or before the last day of the license or certificate of registration expiration anniversary month; (B) In the case of a single license which authorizes more than one category of use, an annual fee must be paid for each category applicable to the license; (C) In the case of a registration for radiation generating equipment, an annual fee must be paid for each machine at a facility; (D) In the case of services for radiation generating equipment which authorizes more than one category, annual fees must be paid for each category applicable to the registration; and (E) An application for an amendment to a license or certificate of registration which results in a change to a category with a higher annual fee will result in a fee being charged equal to the prorated difference between the fee for the current category and the one to which the amended license or certificate will escalate.
(i) The prorated costs will be based on monthly intervals and will be charged from the first day of the month the amendment is effective until the end of the current billing period; (ii) The Department will bill the licensee or registrant for the prorated portion of the applicable annual fee; and (iii) The replacement of part or parts for an existing radiation machine will not result in an additional fee.
004.03 RECIPROCITY FEES. The applicable annual fee must accompany each application for:
(A) Reciprocal recognition of an out-of-state radioactive materials license under 180 NAC 3-028; and (B) Recognition of an out-of-state registration under 180 NAC 2-012, provided that no such fee has been submitted within 12 months of the date of commencement of the proposed activity.
004.04 ENVIRONMENTAL SURVEILLANCE FEES. This fee will recover the expenses arising from environmental surveillance and implementation activities:
(A) Each holder of a fixed nuclear facility construction permit or operating license, or an operator of any other fixed nuclear facility, or any other facility as defined in 180 NAC 18-002 must submit the fee according to 180 NAC 18-009 for services received; and (B) Payment must be made within 60 days following the invoice date.
004.05 EMERGENCY PLANNING, EMERGENCY RESPONSE AND IMPLEMENTATION FEES. This fee will recover expenses that arise from emergency planning, response, and implementation activities:
(A) Each holder of a fixed nuclear facility construction permit or operating license, or an operator of any other fixed nuclear facility, or any other facility as defined in 180 NAC 18-002 must submit the fee, according to 180 NAC 18-010, for services received. (B) Payment must be made within 90 days following the invoice date.
004.06 METHOD OF PAYMENT. Fee payments must be made payable to the “Nebraska Department of Health and Human Services.”
Send to: Department of Health and Human Services, Radiological Health 301 Centennial Mall South P.O. Box 95026 Lincoln, Nebraska 68509-5026 or online at www.dhhs.ne.gov/rad
005. FEE SCHEDULE FOR RADIOACTIVE MATERIAL LICENSES .
005.01 FEE SCHEDULE.
| | LICENSE TYPE | ANNUAL FEE | NEW LICENSE APPLICATION - ONE TIME FEE | | --- | --- | --- | --- | | 1. | Reserved | | | | 2. | Reserved | | | | 3. | Manufacturing or Processing of Radioactive Material | $6,500 | $3,900 | | 4. | Industrial Radiography | $6,500 | $3,900 | | 5. | Broad License - Educational, Medical, or Both | $18,000 | $3,900 | | 6. | Irradiator, Unshielded During Irradiation | $11,500 | $3,900 | | 7. | Nuclear Pharmacy | $7,200 | $3,900 | | 8. | License for Distributor to distribute to persons generally licensed, or persons specifically licensed. | $5,500 | $3,900 | | 9. | Commercial collection and laundry of items contaminated with radioactive, source or special nuclear material. | $18,500 | $3,900 | | 10. | Manufacturer and distribution of encapsulated radioactive material, byproduct, source, or special nuclear material in a device that uses decay heat as a source of power. | $6,500 | $3,900 | | 11. | Well Logging | $2,500 | $3,000 | | 12. | Irradiator, Self-Shielded | $2,600 | $3,000 | | 13. | Mobile Scanning | $3,900 | $3,000 | | 14. | Nuclear Medicine/Brachytherapy. There is only one fee for any license type 14. | $3,900 | $3,000 | | a. | 7-041 Use of Unsealed Radioactive Material for Uptake, Dilution, and Excretion Studies for Which a Written Directive is Not Required | | | | b. | 180 NAC 7-044 Use of Unsealed Radioactive Material for Imaging and Localization Studies for Which a Written Directive is Not Required | | | | c. | 180 NAC 7-048 Use of Unsealed Radioactive Material for Which a Written Directive is Required | | | | d. | 180 NAC 7-055 Use of Sources for Manual Brachytherapy | | | | e. | 180 NAC 7-065 Use of Sealed Sources for Diagnosis | | | | f. | 180 NAC 7-085 Other Medical Uses of Radioactive Material or Radiation from Radioactive Material | | | | g. | High Dose Rate Remote After Loader (HDR) | | | | 15. | 180 NAC 7-067 Use of a Sealed Source in Teletherapy Units, and Gamma Stereotactic Radiosurgery Units | $6,000 | $3,000 | | 16. | Research and Development - Human Use | $6,200 | $3,000 | | 17. | Processing or manufacture and distribution of radiopharmaceuticals by other than a nuclear pharmacy | $4,200 | $3,000 | | 18. | Possession and use of radioactive materials, Ra-226, in luminous paint or products containing such paint | $2,000 | $3,000 | | 19. | Reserved | | | | 20. | Research and Development - Non-Human Use | $3,800 | $1,600 | | 21. | Educational - Instructional Only | $1,500 | $1,600 |
| | LICENSE TYPE | ANNUAL FEE | NEW LICENSE APPLICATION - ONE TIME FEE | | --- | --- | --- | --- | | 22. | Industrial Gauge | $1,500 | $1,600 | | 23. | Emergency Management - Civil Defense | $1,100 | $1,600 | | 24. | Services - Leak Testing, Instrument Calibration, Gauge Installations or Maintenance | $4,300 | $1,600 | | 25. | Gas Chromatograph Detector | $1,500 | $1,600 | | 26. | Other Specific License – Not Requiring A Decommissioning Funding Plan or Financial Assurance For Decommissioning | $1,200 | $1,600 | | a. | If license involves use of radioactive material at temporary job sites, additional fee: | | $200 | | b. | If license involves use of radioactive material in other than sealed source form, additional fee: | | $150 | | 27. | Additional permanent sites or mobile coaches where radioactive material is stored or used under same license 50% of applicable fee for each additional site or mobile coach. | | NA | | 28. | General License | $140 | NA | | 29. | Reciprocity | | | | a. | Industrial Radiography | $2,900 | NA | | b. | Well Logging | $1,200 | NA | | c. | Mobile Scanning | $1,700 | NA | | d. | Industrial Gauge | $750 | NA | | e. | Services | $750 | NA | | f. | Gas Chromatograph Detector | $750 | NA | | g. | Waste Disposal Including Waste Receipt and Packaging – Broker | $1,200 | NA | | 30. | Review of a device, product, or sealed source containing radioactive, byproduct, source or special nuclear material for which no prior review has been performed. Each device, product or sealed source will be considered an individual review. | | Full Cost | | 31. | Reserved | | | | 32. | Department-Approved Training Courses | | $650 | | 33. | Receipt of Prepackaged Waste | $4,000 | $3,500 | | 34. | Packaging Waste | $5,000 | $3,500 | | 35. | Special Projects or Complex Licenses Not Identified Above | Full Cost | Full Cost |
005.02 DEVICE, PRODUCT, OR SEALED SOURCE CONTAINING RADIOACTIVE, BYPRODUCT, SOURCE OR SPECIAL NUCLEAR MATERIAL REVIEW. The review of a device, product, or sealed source containing radioactive, byproduct, source or special nuclear material for which no prior review has been performed is a one-time fee which must be submitted upon the initial review request. Each and any modifications to the device product or sealed source would require a new review and the full cost of review fee must be paid.
005.03 TRAINING COURSE REVIEW. The fees for course approvals applies to all training courses regardless of who is offering such courses. There is a one-time fee for course review which is valid as long as the original course remains unchanged. Courses qualifying for deemed status will not be subject to a fee.
006. RESERVED .
007. RESERVED .
008. SCHEDULE OF ANNUAL FEES FOR CERTIFICATES OF REGISTRATION FOR RADIATION GENERATING EQUIPMENT AND SERVICES FOR RADIATION GENERATING EQUIPMENT .
008.01 RADIATION GENERATING EQUIPMENT.
| | MACHINE CATEGORY | FEE PER UNIT | | --- | --- | --- | | 1. | Healing Arts Diagnostic - General | $70 | | 2. | Healing Arts Diagnostic - Dental | $55 | | 3. | Healing Arts Therapy | | | a. | Superficial | $400 | | b. | X-ray Deep Therapy | $400 | | c. | Accelerator – Therapy | $400 | | d. | Veterinary Therapy | $400 | | e. | Other – Therapy | $400 | | 4. | Non-Healing Arts – Radiation Machines | | | a. | Accelerators | $400 | | b. | Radiographic Cabinet X-ray | $100 | | c. | Analytical X-ray | $100 | | d. | Airport Baggage X-ray | $100 | | e. | Spectroscopy/Spectrography X-ray | $100 | | f. | Particle Size Analyzer X-ray | $100 | | g. | Package X-ray | $100 | | h. | Industrial Gauge X-ray | $150 | | i. | Fluoroscopy X-ray Industrial | $250 | | j. | X-ray Fluorescence | $100 | | k. | X-ray Diffraction | $100 | | l. | Electron Beam Welding | $250 | | m. | Industrial Radiography, In-Plant Only | $500 | | n. | Industrial Radiography Temporary Job Site | $500 | | o. | Ion Implantation Device | $100 | | p. | Other Non-Healing Arts | $200 | | q. | Irradiator | $500 | | 5. | Other | | | a. | Other | $450 | | b. | Registration of Out-of-State radiation equipment brought into Nebraska for temporary use | Annual Fee of Applicable Category |
008.02 RADIATION GENERATING EQUIPMENT SERVICES.
| | SERVICE CATEGORY | ANNUAL FEE | | --- | --- | --- | | (A) | Installation/Service | $100 | | (B) | Calibration | $100 | | (C) | Reviews/Consultations | $100 | | (D) | Demonstration | $100 | | (E) | Sales | $100 | | (F) | Other | $100 |
009. ENVIRONMENTAL SURVEILLANCE FEES . Whenever the Department conducts environmental surveillance the full cost of the service will be charged.
010. EMERGENCY RESPONSE FEES . Whenever the Department provides emergency response capability a fee will be charged equal to the cost, to include personnel, equipment and supplies.
011. NUCLEAR POWER PLANT FEES . The fees for nuclear power plants are as provided in Nebraska Radiation Control Act, Neb. Stat. Rev. §§ 71-3505 (1) (g) – 71-3505 (2).
History
- Effective 2023-06-14
Chapter 19 Licenses and Radiation Safety Requirements for Irradiators
Neb. Admin. Code tit. 180, ch. 19 Licenses and Radiation Safety Requirements for Irradiators {#sec-180-nac-19 omnilex-key=us-ne-regs-official--title-180--180 NAC 19}
TITLE 180 CONTROL OF RADIATION
CHAPTER 19 LICENSES AND RADIATION SAFETY REQUIREMENTS FOR IRRADIATORS
Effective Date: 6/14/2023
001. SCOPE AND AUTHORITY . The regulations are authorized by and implement the Nebraska Radiation Control Act, Nebraska Revised Statute (Neb. Rev. Stat.) §§ 71-3501 to 71-3520. 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. 180 Nebraska Administrative Code (NAC) 19 also contains radiation safety requirements for operating irradiators. The requirements of this chapter are in addition to other requirements of Title 180. In particular, the provisions of 180 NAC 1, 3, 4, 10, 13 and 18 apply to applications and licenses subject to this chapter.
001.01 OTHER REQUIREMENTS. 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.
001.02 APPLICABILITY. This chapter applies to panoramic irradiators that have either dry or wet storage of the radioactive sealed sources and to underwater irradiators where both the source and product being irradiated are under water. Irradiators whose dose rates exceed 5 grays (500 rads) per hour at 1 meter from the radioactive sealed sources in air or in water, as applicable for the irradiator type, are covered by this chapter.
001.03 EXCEPTIONS. This chapter does 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, radiography, the irradiation of materials for nondestructive testing purposes, gauging, or open-field, agricultural irradiations.
001.04 CONCRETE STANDARD. American Concrete Institute Standard ACI 318-89 “Building Code Requirements for Reinforced Concrete,” Chapter 21 “Special Provisions for Seismic Design” as referred to in this Chapter is incorporated by reference and available for viewing at the Nebraska Department of Health and Human Services, Office of Radiological Health, 301 Centennial Mall South, Lincoln, Nebraska 68509-5026.
002. DEFINITIONS . The following definitions apply:
002.01 ANNUALLY. Annually is 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.
002.02 CONSTRUCTION. The construction of any portion of a permanent irradiator structure on a site. Construction does not include engineering and design work, site purchase, site surveys or soil testing, site preparation, site evacuation, construction of warehouse or auxiliary structures, and other similar tasks.
002.03 DOUBLY ENCAPSULATED SEALED SOURCE. A sealed source where the radioactive material is sealed within a capsule and that capsule is sealed within another capsule.
002.04 IRRADIATOR. A facility that uses radioactive sealed sources for irradiation of objects or materials and where radiation dose rates exceeding 5 grays (500 rads) per hour exist at 1 meter from sealed radioactive sources in air or water, as applicable for the irradiator type. The term does not include irradiators where both the sealed source and area subject to irradiation are contained within a device and not accessible to personnel.
002.05 IRRADIATOR OPERATOR. An individual who has successfully completed the training and testing described in 180 NAC 19-018 and is authorized by the terms of the license to operate the irradiator without a supervisor present.
002.06 PANORAMIC DRY-SOURCE-STORAGE IRRADIATOR. An irradiator where irradiations occur in air in areas potentially accessible to personnel and where sources are stored in shields made of solid materials. The term includes beam-type dry-source-storage irradiators where only a narrow beam of radiation is produced for performing irradiations.
002.07 PANORAMIC IRRADIATOR. An irradiator where the irradiations are done in air in areas potentially accessible to personnel. The term includes beam-type irradiators.
002.08 PANORAMIC WET-SOURCE STORAGE IRRADIATOR. An irradiator where irradiations occur in air in areas potentially accessible to personnel and where sources are stored under water in a storage pool.
002.09 POOL IRRADIATOR. Any irradiator where sources are stored or used in a pool of water including panoramic wet-source-storage irradiators and underwater irradiators.
002.10 PRODUCT CONVEYOR SYSTEM. A system for moving the product to be irradiated to, from, and within the area where irradiation takes place.
002.11 RADIATION ROOM. A shielded room where irradiations take place. Underwater irradiators do not have radiation rooms.
002.12 RADIATION SAFETY OFFICER. An individual with responsibility for the overall radiation safety program at the facility.
002.13 SEALED SOURCE. Any radioactive material used as a source of radiation and encased in a capsule designed to prevent leakage or escape of radioactive material.
002.14 SEISMIC AREA. Any area where the probability of a horizontal acceleration in rock of more than 0.3 times the acceleration of gravity in 250 years is greater than 10%, as designated by the U.S. Geological Survey.
002.15 UNDERWATER IRRADIATOR. An irradiator where 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.
003. SPECIFIC LICENSE APPLICATION . Each application for a license, must be accompanied by the fee set in 180 NAC 18-005.
004. SPECIFIC LICENSES FOR IRRADIATORS . The applicant must satisfy the general requirements specified in 180 NAC 3-011, (A) through (D) and the requirements contained in this chapter.
004.01 TRAINING. The application must describe the training provided to irradiator operators including:
(A) Classroom training; (B) On-the-job or simulator training; (C) Safety reviews; (D) Means employed by the applicant to test each operator's understanding of the Department's regulations and licensing requirements and irradiator operating and emergency procedures; and (E) Minimum training and experience of personnel who may provide training.
004.02 OPERATING AND EMERGENCY PROCEDURES. The application must include an outline of the written operating and emergency procedures listed in 180 NAC 19-019 that describes the radiation safety aspects of the procedures.
004.03 ORGANIZATIONAL STRUCTURE. The application must:
(A) 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; (B) Specify who, within the management structure, has authority to stop unsafe operations; and (C) Describe training and experience required for the position of radiation safety officer.
004.04 ACCESS CONTROL SYSTEMS. The application must include a description of the access control systems required by 180 NAC 19-008, radiation monitors required by 180 NAC 19-011, method of detecting leaking sources required by 180 NAC 19-022 including the sensitivity of the method, and a diagram of the facility showing the locations of all required interlocks and radiation monitors.
004.05 LEAK TEST PROCEDURES. If the applicant intends to perform leak testing of dry-source-storage sealed sources, the applicant must establish procedures for leak testing and submit a description of these procedures. The description must include the:
(A) Instruments to be used; (B) Methods of performing the analysis; and (C) Pertinent experience of the individual who analyzes the samples.
004.06 LOADING AND UNLOADING. If licensee personnel are to load or unload sources, the applicant must 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 of its facility, loading or unloading must be done by an organization specifically authorized by the Department, U.S. Nuclear Regulatory Commission (NRC) or an Agreement State to load or unload irradiator sources.
004.07 INSPECTION AND MAINTENANCE CHECKING. The applicant must describe the inspection and maintenance checks including the frequency of the checks required by 180 NAC 19-023.
005. START OF CONSTRUCTION . The applicant may not begin construction of a new irradiator before the submission of both a license application for the irradiator and the fee required by 180 NAC 18-005 to the Department. Any activities undertaken before the issuance of a license are entirely at the risk of the applicant and have no bearing on the issuance of license with respect to any statutory requirements or rules, regulations, and orders issued under of the Nebraska Radiation Control Act, as amended.
006. EXEMPTION APPLICATION . In addition to the exemption in 180 NAC 1-003.01, any application for a license or license amendment authorizing use of teletherapy-type unit for irradiation of materials or objects may include proposed alternatives for the requirements of this chapter. The applicant must provide adequate rationale for the proposed alternatives and demonstrate they are likely to provide an adequate level of safety for workers and the public.
007. PERFORMANCE CRITERIA FOR SEALED SOURCES .
007.01 INSTALLATION DATE. Sealed sources installed after October 30, 1996 must:
(A) Have a certificate of registration issued under the U. S. Nuclear Regulatory Commission (NRC) or an Agreement State for evaluation of radiation safety information about its product. (B) Be doubly encapsulated; (C) Use radioactive material that is as nondispersible as practical and as insoluble as practical if the source is used in a wet-source-storage or wet-source-change irradiator; (D) 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 sources are for use in irradiator pools; and (E) Have been leak tested and found leak-free after each test described in 180 NAC 19-007.02 through 19-007.07 in prototype testing of the sealed source.
007.02 TEMPERATURE. The test source must be held at -40° celsius for 20 minutes, 600° celsius for one hour, and then be subjected to a thermal shock test with a temperature drop from 600° celsius to 20° celsius within 15 seconds.
007.03 PRESSURE. The test source must be twice subjected for at least five minutes to an external absolute pressure of two million newtons per square meter.
007.04 IMPACT. A 2-kilogram steel weight, 2.5 centimeters in diameter, must be dropped from a height of 1 meter onto the test source.
007.05 VIBRATION. The test source must be subjected three times for ten minutes each to vibrations sweeping from 25 hertz to 500 hertz with a peak amplitude of five times the acceleration of gravity. In addition, each test source must be vibrated for 30 minutes at each resonant frequency found.
007.06 PUNCTURE. A 50-gram weight and pin, 0.3-centimeter pin diameter, must be dropped from a height of one meter onto the test source.
007.07 BEND. If the length of the source is more than 15 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.
008. ACCESS CONTROL .
008.01 PHYSICAL BARRIER. 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.
008.02 BACKUP ACCESS CONTROL. In addition, 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 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 must be trained on how to respond to the alarm and prepared to promptly render or summon assistance.
008.03 RADIATION MONITOR. 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 180 NAC 19-008.02. The monitor may be located in the entrance, normally referred to as the maze, but not in the direct radiation beam.
008.04 ALARM. 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 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.
008.05 IN-ROOM SOURCE CONTROL. 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.
008.06 SOURCE MOVEMENT CONTROL. 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.
008.07 SIGNAGE. 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 by 180 NAC 4-034.05. Panoramic irradiators must comply with the posting requirements of 180 NAC 4-034.03; however, the sign may be removed, covered, or otherwise made inoperative when the sources are fully shielded.
008.08 INTERLOCKS. 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.
008.09 PERSONNEL ACCESS BARRIER. 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.
009. SHIELDING .
009.01 OCCUPIED AREAS. The radiation dose rate in areas normally occupied during operation of a panoramic irradiator may not exceed 0.02 millisievert (2 millirems) per hour at any location 30 centimeters or more from the wall of the room when the sources are exposed. The dose rate must be averaged over any area not to exceed 100 square centimeters having no linear dimension greater than 20 centimeters. Areas where the radiation dose rate exceeds 0.02 millisievert (2 millirems) per hour must be locked, roped off, or posted.
009.02 POOL DOSE RATE. The radiation dose at 30 centimeters over the edge of the pool of a pool irradiator may not exceed 0.02 millisievert (2 millirems) per hour when the sources are in the fully shielded position.
009.03 DRY-SOURCE SHIELD. The radiation dose rate at 1 meter from the shield of a dry-source storage panoramic irradiator when the source is shielded may not exceed 0.02 millisievert (2 millirems) per hour and at 5 centimeters from the shield may not exceed 0.2 millisievert (20 millirems) per hour.
010. FIRE PROTECTION . The radiation room at a panoramic irradiator must have heat and smoke detectors and be equipped with a fire extinguishing system.
010.01 HEAT AND SMOKE DETECTORS. The detectors must activate an audible alarm capable of alerting a person who is prepared to summon assistance promptly. The sources must automatically become fully shielded if a fire is detected.
010.02 FIRE EXTINGUISHING SYSTEM. The system must be capable of extinguishing a fire without the entry of personnel into the room and have a shut-off valve to control flooding into unrestricted areas.
011. RADIATION MONITORS .
011.01 PRODUCT EXIT. Irradiators with automatic product conveyor systems must have a radiation monitor with an audible alarm located to detect loose radioactive sources 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 where the product moves within an enclosed stationary tube are exempt from the requirements of 180 NAC 19-011.01.
011.02 POOL. Underwater irradiators 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.
012. CONTROL OF SOURCE MOVEMENT .
012.01 KEY. 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 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 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.
012.02 POSITION DETECTOR. The console of a panoramic irradiator must have a source position indicator that indicates when the sources are in the fully shielded position, in transit, and exposed.
012.03 CONTROL CONSOLE. The control console of a panoramic irradiator must have a control that promptly returns the sources to the shielded position.
012.04 CONTROL MARKING. Each control for a panoramic irradiator must be clearly marked as to its function.
013. IRRADIATOR POOLS .
013.01 SPECIFICATIONS. For licenses initially issued after October 30, 1996, irradiators pools must either:
(A) Have a water-tight stainless steel liner or a liner metallurgically compatible with other components in the pools; or (B) Be constructed so there is a low likelihood of substantial leakage and have a surface designed to facilitate decontamination. In either case, the licensee must have a method to safely store the sources during repairs of the pool.
013.02 WATER OUTLETS. For licenses initially issued after October 30, 1996, 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 with intakes more than 0.5 meter below the normal low water level and could act as siphons must have siphon breakers to prevent the siphoning of pool water.
013.03 REPLENISHMENT. A means must be provided to replenish water losses from the pool.
013.04 VISIBLE INDICATOR. 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.
013.05 WATER PURITY. Irradiator pools must be equipped with a purification system designed to be capable of maintaining the water during normal operation at a conductivity of 20 microsiemens (ohms) per centimeter or less and with a clarity so the sources can be seen clearly.
013.06 PHYSICAL BARRIER. 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.
013.07 TOOLS. 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 (2 millirems) per hour.
014. SOURCE RACK PROTECTION . If the product to be irradiated moves on a product conveyor system, the source rack and 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.
015. POWER FAILURES . Systems must function properly in the event of a power failure.
015.01 POWER LOSS. If electrical power at a panoramic irradiator is lost for longer than ten seconds, the sources must automatically return to the shielded position.
015.02 LOCK. The lock on the door of the radiation room of a panoramic irradiator may not be deactivated by a power failure.
015.03 SURVEY METER. 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.
016. DESIGN REQUIREMENTS . Irradiators whose construction begins after October 30, 1996, must meet the design requirements of this section.
016.01 SHIELDING. For panoramic irradiators, the licensee must 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 180 NAC 19-009. If the irradiator will use more than 2 x1017 becquerels (5 million curies) of activity, the licensee must evaluate the effects of heating of the shielding walls by the irradiator sources.
016.02 FOUNDATIONS. For panoramic irradiators, the licensee must design the foundation, with consideration given to soil characteristics, to ensure it is adequate to support the weight of the facility shield walls.
16.03 POOL INTEGRITY. For pool irradiators, the licensee must design the pool to assure it is leak resistant, strong enough to bear the weight of the pool water and shipping casks, a dropped cask would not fall on sealed sources, all outlets or pipes meet the requirements of 180 NAC 19-013.02, and metal components are metallurgically compatible with other components in the pool.
016.04 WATER HANDLING SYSTEM. For pool irradiators, the licensee must verify the design of the water purification system is adequate to meet the requirements of 180 NAC 19-013.05. The system must be designed so water leaking from the system does not drain to unrestricted areas without being monitored.
016.05 RADIATION MONITORS. For all irradiators, the licensee must evaluate the location and sensitivity of the monitor to detect sources carried by the product conveyor system as required by 180 NAC 19-011.01. The licensee must verify the product conveyor is designed to stop before a source on the product conveyor would cause a radiation overexposure to any person. For pool irradiators, if the licensee uses radiation monitors to detect contamination under 180 NAC 19-022.02, the licensee must verify the design of radiation monitoring systems to detect pool contamination includes sensitive detectors located close to where contamination is likely to concentrate.
016.06 SOURCE RACK. For pool irradiators, the licensee must verify 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. For panoramic irradiators, the licensee must determine source rack drops due to loss of power will not damage the source rack and source rack drops due to failure of cables, or alternate means of support, will not cause loss of integrity of sealed sources. For panoramic irradiators, the licensee, must review the design of the mechanism that moves the sources to assure 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.
016.07 ACCESS CONTROL. For panoramic irradiators, the licensee must verify from the design and logic diagram that the access control system will meet the requirements of 180 NAC 19-008.
016.08 FIRE PROTECTION. For panoramic irradiators, the licensee must verify the number, location, and spacing of the smoke and heat detectors are appropriate to detect fires and the detectors are protected from mechanical and radiation damage. The licensee must verify the design of the fire extinguishing system provides the necessary discharge patterns, densities, and flow characteristics for complete coverage of the radiation room and the system is protected from mechanical and radiation damage.
016.09 SOURCE RETURN. For panoramic irradiators, the licensee must verify the source rack will automatically return to the fully shielded position if offsite power is lost for more than 10 seconds.
016.10 SEISMIC. For panoramic irradiators to be built in seismic areas, the licensee must 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," or local building codes, if current.
016.11 WIRING. For panoramic irradiators, the licensee must verify electrical wiring and electrical equipment in the radiation room are selected to minimize failures due to prolonged exposure to radiation.
017. CONSTRUCTION MONITORING AND ACCEPTANCE TESTING . The requirements of this section must be met for irradiators whose construction begins after October 30, 1996. The requirements must be met before loading sources.
017.01 SHIELDING. For panoramic irradiators, the licensee must monitor the construction of the shielding to verify the construction meets design specifications and generally accepted building code requirement for reinforced concrete.
017.02 FOUNDATIONS. For panoramic irradiators, the licensee must monitor the construction of the foundations to verify their construction meets design specifications.
017.03 POOL INTEGRITY. For pool irradiators, the licensee must verify the pool meets design specifications and must test the integrity of the pool. The licensee must verify outlets and pipes meet the requirements of 180 NAC 19-013.02.
017.04 WATER HANDLING SYSTEM. For pool irradiators, the licensee must verify the water purification system, conductivity meter, and water level indicators operate properly.
017.05 RADIATION MONITORS. For all irradiators, the licensee must verify the proper operation of the monitor to detect sources carried on the product conveyor system and the related alarms and interlocks required by 180 NAC 19-011.01. For pool irradiators, the licensee must verify the proper operation of the radiation monitors and the related alarm if used to meet 19-022.02. For underwater irradiators, the licensee must verify the proper operation of the over-the-pool monitors, alarms, and interlocks required by 19-011.02.
017.06 SOURCE RACK. For panoramic irradiators, the licensee must test the movement of the source racks for proper operation before source loading; testing must include source rack lowering due to simulated loss of power. For all irradiators with product conveyor systems, the licensee must observe and test the operation of the conveyor system to assure the requirements in 180 NAC 19-014 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.
017.07 ACCESS CONTROL. For panoramic irradiators, the licensee must test the completed access control system to assure it functions as designed and all alarms, controls, and interlocks work properly.
017.08 FIRE PROTECTION. For panoramic irradiators, the licensee must 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. The licensee must test the operability of the fire extinguishing systems.
017.09 SOURCE RETURN. For panoramic irradiators, the licensee must demonstrate the source racks can be returned to their fully shielded positions without offsite power.
017.10 COMPUTER SYSTEMS. For panoramic irradiators that use a computer system to control the access control system, the licensee must verify the access control system will operate properly if offsite power is lost and must verify 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.
017.11 WIRING. For panoramic irradiators, the licensee must verify the electrical wiring and electrical equipment that were installed meet the design specifications.
018. TRAINING .
018.01 INSTRUCTION AND TRAINING. Before an individual is permitted to operate an irradiator without a supervisor present, the individual must:
(A) Receive instruction in:
(i) 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 a 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; (ii) Requirements of 180 NAC 10 and this chapter that are relevant to the irradiator; (iii) Operation of the irradiator; (iv) Those operating and emergency procedures listed in 180 NAC 19-019 that the individual is responsible for performing; and (v) Case histories of accidents or problems involving irradiators;
(B) 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) Have received on-the-job training or simulator training in the use of the irradiator as described in the license application; and (D) Demonstrate the ability to perform those portions of the operating and emergency procedures the individual is to perform.
018.02 SAFETY REVIEW. The licensee must conduct safety reviews for irradiator operators at least annually. The licensee must give each operator a brief written test on the information. Each safety review must include, to the extent appropriate, each of the following:
(A) Changes in operating and emergency procedures since the last review, if any; (B) Changes in regulations and license conditions since the last review, if any; (C) Reports on recent accidents, mistakes, or problems that have occurred at irradiators, if any; (D) Relevant results of inspections of operator safety performance; (E) Relevant results of the facility's inspection and maintenance checks; and (F) A drill to practice an emergency or abnormal event procedure.
018.03 SAFETY PERFORMANCE. The licensee must evaluate the safety performance of each irradiator operator at least annually to ensure regulations, license conditions, and operating and emergency procedures are followed. The licensee must discuss the results of the evaluation with the operator and must instruct the operator on how to correct any mistakes or deficiencies observed.
018.04 UNESCORTED ACCESS. Individuals that 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, must be instructed and tested in any precautions they should take to avoid radiation exposure, any procedures or parts of procedures listed in 180 NAC 19-019 that they are expected to perform or comply with, and their proper response to alarms required in this chapter. Tests may be oral.
018.05 ALARM RESPONSE. Individuals who must be prepared to respond to alarms required by 180 NAC 19-008.02, 19-008.09, 19-010.01, 19-011.01, 19-011.02 and 19-022.02 must be trained and tested on how to respond. Each individual must be retested at least once a year. Tests may be oral.
019. OPERATING AND EMERGENCY PROCEDURES .
019.01 OPERATING PROCEDURES. The licensee must have and follow written operating procedures for:
(A) Irradiator operation, including entering and leaving the radiation room; (B) Personnel dosimeter use; (C) Surveying the shielding of panoramic irradiators; (D) Monitoring pool water for contamination while the water is in the pool and before release of pool water to unrestricted areas; (E) Leak testing of sources; (F) Inspection and maintenance checks required by 180 NAC 19-023; (G) Loading, unloading, and repositioning sources, if the operations will be performed by the licensee; and (H) Inspection of movable shielding required by 180 NAC 19-008.08, if applicable.
019.02 EMERGENCY PROCEDURES. The licensee must have and follow emergency or abnormal event procedures, appropriate for the irradiator type, for:
(A) Sources stuck in the unshielded position; (B) Personnel overexposures; (C) A radiation alarm from the product exit portal monitor or pool monitor; (D) Detection of leaking sources, pool contamination, or alarm caused by contamination of pool water; (E) A low or high water level indicator, an abnormal water loss, or leakage from the source storage pool; (F) Prolonged loss of electrical power; (G) A fire alarm or explosion in the radiation room; (H) An alarm indicating unauthorized entry into the radiation room, area around pool, or another alarmed area; (I) Natural phenomena, including an earthquake, a tornado, flooding, or other phenomena as appropriate for the geographical location of the facility; and (J) Automatic conveyor system jams.
019.03 REVISIONS. The licensee may revise operating and emergency procedures without Department approval only if all of the following conditions are met:
(A) Revisions do not reduce the safety of the facility; (B) Revisions are consistent with the outline or summary of procedures submitted with the license application; (C) Revisions have been reviewed and approved by the radiation safety officer; and (D) Users or operators are instructed and tested on the revised procedures before they are put into use.
020. PERSONNEL MONITORING .
020.01 IRRADIATOR OPERATORS. Irradiator operators must wear a personnel dosimeter while operating a panoramic irradiator or while in the area around the pool of an underwater irradiator. The personnel dosimeter 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.
020.02 OTHER INDIVIDUALS. Other individuals who enter the radiation room of a panoramic irradiator must 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 180 NAC 9-020, a check of their response to radiation must be done at least annually. Acceptable dosimeters must read within ± 30% of the true radiation dose.
021. RADIATION SURVEYS .
021.01 OUTSIDE OF SHIELDING. 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 of 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 modifications to the radiation room shielding or structure that might increase dose rates.
021.02 MODIFICATIONS. If the radiation levels specified in 180 NAC 19-009 are exceeded, the facility must be modified to comply with the requirements in this chapter.
021.03 CALIBRATION. Portable radiation survey meters must be calibrated at least annually to an accuracy of ± 20% 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.
021.04 WATER. 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 180 NAC 4, Table 2, Column 2 or Table 3 of Appendix 4-B, "Annual Limits on Intake (ALIs) and Derived Air Concentrations (DACs) of Radionuclides for Occupational Exposure; Effluent Concentrations; Concentrations for Release to Sewerage."
021.05 RESINS. 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.
022. DETECTION OF LEAKING SOURCES .
022.01 DRY-SOURCE STORAGE. 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 Department, NRC 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 200 becquerels (0.005 microcurie) of radioactive material and must be performed by a person approved by the Department, NRC or an Agreement State to perform the test.
022.02 POOL IRRADIATORS. 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 contamination check is done by analysis of a sample of pool water, the results of the analysis must be available within 24 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.
022.03 LEAKING SOURCE. If a leaking source is detected, the licensee must arrange to remove the leaking source from service and have it decontaminated, repaired, or disposed of by the Department, NRC or an Agreement State licensee authorized to perform these functions. The licensee must 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 must 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 product are found, the licensee must arrange to have them decontaminated or disposed of by the Department, NRC or an Agreement State licensee authorized to perform these functions. If a pool is contaminated, the licensee must arrange to clean the pool until the contamination levels do not exceed the appropriate concentration in 180 NAC 4, Table 2, Column 2. Appendix 4-B. See 180 NAC 3-026 for reporting requirements.
023. INSPECTION AND MAINTENANCE . Licensees must perform inspection and maintenance checks of the irradiator and components. Malfunctions and defects found must be repaired promptly.
023.01 CHECKS. Inspection and maintenance checks must include, as a minimum, each of the following at the frequency specified in the license or license application:
(A) Operability of each aspect of the access control system required by 180 NAC 19-008. (B) Functioning of the source position indicator required by 180 NAC 19-012.02. (C) Operability of the radiation monitor for radioactive contamination in pool water required by 180 NAC 19-022.02 using a radiation check source, if applicable. (D) Operability of the over-pool radiation monitor at underwater irradiators as required by 180 NAC 19-011.02. (E) Operability of the product exit monitor required by 180 NAC 19-011.01. (F) Operability of the emergency source return control required by 180 NAC 19-012.03. (G) Leak-tightness of systems through which pool water circulates by visual inspection. (H) Operability of the heat and smoke detectors and extinguisher system required by 180 NAC 19-010, but without turning extinguishers on. (I) Operability of the means of pool water replenishment required by 180 NAC 19-013.03. (J) Operability of the indicators of high and low pool water levels required by 180 NAC 19-013.04. (K) Operability of the intrusion alarm required by 180 NAC 19-008.09, if applicable. (L) Functioning and wear of the systems, mechanisms, and cables used to raise and lower sources. (M) Condition of the barrier to prevent products from hitting the sources or source mechanism as required by 180 NAC 19-014. (N) Amount of water added to the pool to determine if the pool is leaking. (O) Electrical wiring on required safety systems for radiation damage. (P) Pool water conductivity measurements and analysis as required by 180 NAC 19-024.02.
024. POOL WATER PURITY .
024.01 PURIFICATION SYSTEM. Pool water purification system must be run sufficiently to maintain the conductivity of the pool water below 20 microsiemens per centimeter under normal circumstances. If pool water conductivity rises above 20 microsiemens per centimeter, the licensee must take prompt actions to lower the pool water conductivity and must take corrective actions to prevent future recurrences.
024.02 CONDUCTIVITY. The licensee must measure the pool water conductivity frequently enough, but no less than weekly, to assure that the conductivity remains below 20 microsiemens per centimeter. Conductivity meters must be calibrated at least annually.
025. ATTENDANCE DURING OPERATION . Irradiators must be attended during operation.
025.01 PRODUCT MOVEMENT. 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, must be present onsite whenever:
(A) The irradiator is operated using an automatic product conveyor system; and (B) The product is moved into or out of the radiation room when the irradiator is operated in a batch mode.
025.02 STATIC IRRADIATIONS. At a panoramic irradiator at which static irradiations involving no movement of the product are occurring, a person who has received the training on how to respond to alarms described in 180 NAC 19-018.07 must be onsite.
025.03 UNDERWATER IRRADIATOR. 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 180 NAC 19-018.04 and 19-018.05. Static irradiations may be performed without a person present at the facility.
026. ENTERING AND LEAVING THE IRRADIATOR ROOM .
026.01 ENTERING. Upon first entering the radiation room of a panoramic irradiator after an irradiation, the irradiator operator must use a survey meter to determine that the source has returned to its fully shielded position. The operator must check the functioning of the survey meter with a radiation check source before entry.
026.02 EXITING. Before exiting from and locking the door to the radiation room of a panoramic irradiator before a planned irradiation, the irradiator operator must:
(A) Visually inspect the entire radiation room to verify no one else is in it; and (B) 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.
026.03 ENTERING DURING POWER FAILURE. 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 180 NAC 19-011.02 is operating with backup power.
027. IRRADIATION OF EXPLOSIVE OR FLAMMABLE MATERIALS .
027.01 EXPLOSIVE MATERIAL. Irradiation of explosive material is prohibited unless the licensee has received prior written authorization from the Department. Authorization will not be granted unless the licensee can demonstrate detonation of the explosive would not rupture the sealed sources, injure personnel, damage safety systems, or cause radiation overexposures of personnel.
027.02 FLAMMABLE MATERIAL. Irradiation of more than small quantities of flammable material, meaning a flash point below 140° Fahrenheit, is prohibited in panoramic irradiators unless the licensee has received prior written authorization from the Department. 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.
028. RECORDS AND RETENTION OF RECORDS . The licensee must 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 license amendments until superseded by new documents or until the Department terminates the license for documents that have not been superseded; (B) Each individual's training, tests, and safety reviews provided to meet the requirements of 180 NAC 19-018.01 through 19-018.02, 19-018.04 and 19-018.05 until three years after the individual terminates work; (C) Annual evaluations of the safety performance of irradiator operators required by 180 NAC 19-018.03 for three years after the evaluation; (D) A copy of the current operating and emergency procedures required by 180 NAC 19-019 until superseded or the Department terminates the license. Records of the radiation safety officer's review and approval of changes in procedures as required by 19-019.03 (C) retained for three years from the date of the change; (E) Personnel dosimeters evaluations required by 180 NAC 19-020 must be retained until the Department terminates the license; (F) Radiation surveys required by 180 NAC 19-021 for three years from the date of the survey; (G) Radiation survey meter calibrations required by 180 NAC 19-021 and pool water conductivity meter calibrations required by 19-024.02 until three years from the date of calibration; (H) Leak test results required by 180 NAC 19-022.01 and contamination check results required by 19-022.02 for three years from the date of each test; checks required by 180 NAC 19-023 for three years. (I) 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; (J) Receipt, transfer and disposal, of all licensed sealed sources as required by 180 NAC 3-025 and 3-030; (K) Design checks required by 180 NAC 19-016 and construction control checks as required by 19-017 until the license is terminated. Records must be signed and dated. The title or qualification of the person signing must be included; and (L) Records related to decommissioning of the irradiator as required by 180 NAC 3-018.07.
029. REPORTS .
029.01 EVENTS. In addition to the reporting requirements in other parts of Department regulations, the licensee must report the following events if not reported under other parts of Department regulations:
(A) Source stuck in an unshielded position. (B) Any fire or explosion in a radiation room. (C) Damage to the source racks. (D) Failure of the cable or drive mechanism used to move the source racks. (E) Inoperability of the access control system. (F) Detection of radiation source by the product exit monitor. (G) Detection of radioactive contamination attributable to licensed radioactive material. (H) Structural damage to the pool liner or walls. (I) Abnormal water loss or leakage from the source storage pool. (J) Pool water conductivity exceeding 100 microsiemens (ohms) per centimeter.
029.02 TELEPHONE REPORT. The report must include a telephone report within 24 hours as described in180 NAC 3-026.03 (A) and a written report within 30 days as described in 180 NAC 3-026.03 (B).
History
- Effective 2023-06-14
Chapter 20 Therapeutic Radiation Machines for Human Use
Neb. Admin. Code tit. 180, ch. 20 Therapeutic Radiation Machines for Human Use {#sec-180-nac-20 omnilex-key=us-ne-regs-official--title-180--180 NAC 20}
Effective Date: 11/21/2020
001. SCOPE AND AUTHORITY . This chapter provides special requirements for registrants using therapeutic radiation machines. The regulations are authorized by and implement the Nebraska Radiation Control Act, Nebraska Revised Statute (Neb. Rev. Stat.) §§ 71-3501 to 71-3520. The requirements of this 180 NAC 20 are in addition to, and not in substitution for applicable requirements in 180 NAC 1, 2, 3, 4, 6, 10, 15, and 18.
002. DEFINITIONS . The following definitions apply to this chapter.
002.01 ABSORBED DOSE RATE. Absorbed dose rate is the absorbed dose per unit time, for machines with timers, or dose monitor unit per unit time for linear accelerators.
002.02 AIR KERMA (K). Air kerma (K) is the kinetic energy released in air by ionizing radiation. Kerma is determined as the quotient of dE, where dE is the sum of the initial kinetic energies of all ionizing particles liberated by uncharged ionizing particles in air of mass dM. The International System of Units (SI) unit of air kerma is joule per kilogram and the special name for the unit of kerma is the gray (Gy).
002.03 BARRIER. Barrier has the same meaning as stated in protective barrier.
002.04 BEAM AXIS. Beam axis is the axis of rotation of the beam limiting device.
002.05 BEAM-LIMITING DEVICE. Beam-limiting device is a field defining collimator, integral to the therapeutic radiation machine, which provides a means to restrict the dimension of the useful beam.
002.06 BEAM MONITORING SYSTEM. Beam monitoring system is a system designed and installed in the radiation head to detect and measure the radiation present in the useful beam.
002.07 BEAM SCATTERING FOIL. Beam scattering foil is 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.
002.08 BENT BEAM LINEAR ACCELERATOR. Bent beam linear accelerator is a linear accelerator geometry in which the accelerated electron beam must change direction by passing through a bending magnet.
002.09 CHANGEABLE FILTERS. Changeable filters are any filter, exclusive of inherent filtration, which can be removed from the useful beam through any electronic, mechanical, or physical process.
002.10 CONTACT THERAPY SYSTEM. Contact therapy system is a therapeutic machine with a short target to skin distance (TSD), usually less than 5 centimeters.
002.11 CONVENTIONAL SIMULATOR. Conventional simulator is any x-ray system designed to reproduce the geometric conditions of the radiation therapy equipment.
002.12 DETECTOR. Detector has the same meaning as radiation detector.
002.13 DOSE MONITOR UNIT (DMU). Dose monitor unit (DMU) means the unit response from the beam monitoring system from which the absorbed dose can be calculated.
002.14 ELECTRONIC BRACHYTHERAPY. Electronic brachytherapy is the 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.
002.15 ELECTRONIC BRACHYTHERAPY DEVICE. Electronic brachytherapy device is a system used to produce and deliver therapeutic radiation including the x-ray tube, the control mechanism, the cooling system, and the power source.
002.16 ELECTRONIC BRACHYTHERAPY SOURCE. Electronic brachytherapy source is an x-ray tube component used in an electronic brachytherapy device.
002.17 EXTERNAL BEAM RADIATION THERAPY. External beam radiation therapy is a therapeutic irradiation in which the source of radiation is at a distance from the body.
002.18 FIELD-FLATTENING FILTER. Field-flattening filter is a filter used to homogenize the absorbed dose rate over the radiation field.
002.19 FILTER. Filter is material placed in the useful beam to change beam quality in therapeutic radiation machines subject to 180 NAC 20-006.
002.20 GANTRY. Gantry is part of a radiation therapy system supporting and allowing movements of the radiation head about a center of rotation.
002.21 HALF-VALUE LAYER (HVL). Half-value layer (HVL) is 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-half of the value measured without the material at the same point.
002.22 INTERLOCK. Interlock is a device preventing the start or continued operation of equipment unless certain predetermined conditions prevail.
002.23 INTERRUPTION OF IRRADIATION. Interruption of irradiation is the stopping of irradiation with the possibility of continuing irradiation without resetting of operating conditions at the control panel.
002.24 IRRADIATION. Irradiation is the exposure of a living being or matter to ionizing radiation.
002.25 ISOCENTER. Isocenter is the center of the sphere through which the useful beam axis passes while the gantry moves through its full range of motions.
002.26 KILOVOLT (kV) OR KILOELECTRON VOLT (keV). Kilovolt (kV) or kiloelectron volt (keV) is the energy equal to that acquired by a particle with one electron charge in passing through a potential difference of one thousand volts in a vacuum. The current convention is to use kilovolts (kV) for photons and kiloelectron volt (keV) for electrons.
002.27 LEAD EQUIVALENT. Lead equivalent is the thickness of the material in question affording the same attenuation, under specified conditions, as lead.
002.28 LEAKAGE RADIATION. Leakage radiation is radiation emanating from the radiation therapy system except for the useful beam.
002.29 LIGHT FIELD. Light field is the area illuminated by light, simulating the radiation field.
002.30 MA. The term mA is milliampere (mA).
002.31 MEGAVOLT (MV) OR MEGAELECTRON VOLT (MEV). Megavolt (MV) or megaelectron volt (MeV) is 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. The current convention is to use megavolt (MV) for photons and megaelectron volt (MeV) for electrons.
002.32 MISADMINISTRATION. Misadministration is an event that meets the criteria in 180 NAC 20-005.02.
002.33 MOBILE ELECTRONIC BRACHYTHERAPY SERVICE. Mobile electronic brachytherapy service is the transportation of an electronic brachytherapy device to provide electronic brachytherapy at an address that is not the address of record.
002.34 MONITOR UNIT (MU). Monitor unit (MU) has the same meaning as dose monitor unit.
002.35 MOVING BEAM RADIATION THERAPY. Moving beam radiation therapy is radiation therapy with any planned displacement of radiation field or patient relative to each other, or with any planned change of absorbed dose distribution. Includes arc, skip, conformal, intensity modulation, and rotational therapy.
002.36 NOMINAL TREATMENT DISTANCE. Nominal treatment distance is:
(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; or (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 must be that specified by the manufacturer.
002.37 PATIENT. Patient is an individual subjected to machine produced external beam radiation for the purposes of medical therapy.
002.38 PEAK TUBE POTENTIAL. Peak tube potential is the maximum value of the potential difference across the x-ray tube during an exposure.
002.39 PERIODIC QUALITY ASSURANCE CHECK. Periodic quality assurance check is a procedure which is performed to ensure that a previous calibration continues to be valid.
002.40 PHANTOM. Phantom is an object behaving in essentially the same manner as tissue, with respect to the absorption or scattering of the ionizing radiation in question.
002.41 PRESCRIBED DOSE. Prescribed dose is the total dose and dose per fraction as documented in the written directive. The prescribed dose is an estimation from measured data from a specified therapeutic machine 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.
002.42 PRIMARY DOSE MONITORING SYSTEM. Primary dose monitoring system is the 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.
002.43 PROTECTIVE BARRIER. Protective barrier is a barrier of radiation absorbing material or materials used to reduce radiation exposure. The types of protective barriers are as follows:
002.43(A) PRIMARY PROTECTIVE BARRIER. Primary protective barrier is the material, excluding filters, placed in the useful beam.
002.43(B) SECONDARY PROTECTIVE BARRIER. Secondary protective barrier is the material which attenuates stray radiation.
002.44 RADIATION DETECTOR. Radiation detector is 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.
002.45 RADIATION FIELD. Radiation field has the same meaning as stated in useful beam.
002.46 RADIATION HEAD. Radiation head is the structure from which the useful beam emerges.
002.47 RADIOLOGICAL MEDICAL PHYSICIST. Radiological medical physicist is an individual qualified according to 180 NAC 15-004.01.
002.48 REDUNDANT BEAM MONITORING SYSTEM. Redundant beam monitoring system is a combination of two independent dose monitoring systems in which each system is designed to terminate irradiation according to a pre-selected number of dose monitor units.
002.49 SCATTERED RADIATION. Scattered radiation is an ionizing radiation emitted by interaction of ionizing radiation with matter, the interaction being accompanied by a change in direction of the radiation. Scattered primary radiation means that scattered radiation which has been deviated in direction only by materials irradiated by the useful beam.
002.50 SECONDARY DOSE MONITORING SYSTEM. Secondary dose monitoring system is a system which will terminate irradiation in the event of failure of the primary dose monitoring system.
002.51 SHADOW TRAY. Shadow tray is a device attached to the radiation head to support auxiliary beam blocking material.
002.52 SHUTTER. Shutter is a device attached to the tube housing assembly which can totally intercept the useful beam and which has a lead equivalency not less than that of the tube housing assembly.
002.53 SIMULATOR OR RADIATION THERAPY SIMULATION SYSTEM. Simulator or radiation therapy simulation system is 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. See conventional simulator and virtual simulator.
002.54 SOURCE. Source is the region or material from which the radiation emanates.
002.55 SOURCE SKIN DISTANCE (SSD). The source skin distance (SSD) has the same meaning as target skin distance.
002.56 STATIONARY BEAM RADIATION THERAPY. Stationary beam radiation therapy is radiation therapy without displacement of one or more mechanical axes relative to the patient during irradiation.
002.57 STRAY RADIATION. Stray radiation equals the sum of leakage and scattered radiation.
002.58 TARGET. Target is 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.
002.59 TARGET SKIN DISTANCE (TSD). Target skin distance (TSD) is the distance measured along the beam axis from the center of the front surface of the x-ray target or electron virtual source to the surface of the irradiated object or patient.
002.60 TENTH VALUE LAYER (TVL). Tenth value layer (TVL) is 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.
002.61 TERMINATION OF IRRADIATION. Termination of radiation is the stopping of irradiation in a fashion which will not permit continuance of irradiation without the resetting of operating conditions at the control panel.
002.62 THERAPEUTIC RADIATION MACHINE. Therapeutic radiation machine is an x-ray or electron producing equipment designed and used for external beam radiation therapy. For the purpose of these regulations, therapeutic radiation machine includes, but is not limited to devices used to administer used to administer electronic brachytherapy.
002.63 TUBE. Tube is an x-ray tube, unless otherwise specified.
002.64 TUBE HOUSING ASSEMBLY. Tube housing assembly is the tube housing with tube installed. It includes high voltage or filament transformers and other appropriate elements when such are contained within the tube housing.
002.65 USEFUL BEAM. Useful beam is 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 therapeutic radiation machine to produce radiation.
002.66 VIRTUAL SIMULATOR. Virtual simulator is 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 computed tomography (CT) or other imaging modalities.
002.67 VIRTUAL SOURCE. Virtual source is a point from which radiation appears to originate.
002.68 WEDGE FILTER. Wedge filter is a filter which effects continuous change in transmission over all or a part of the useful beam.
002.69 WRITTEN DIRECTIVE. Written directive is an order in writing for the administration of radiation to a specific patient or human research subject, as specified in 180 NAC 20-005.01(A).
002.70 X-RAY TUBE. X-ray tube is any electron tube which is designed to be used primarily for the production of x-rays.
003. GENERAL ADMINISTRATIVE REQUIREMENTS FOR REGISTRANTS OF THERAPEUTIC RADIATION MACHINES . The general administrative requirements for registrants using therapeutic radiation machines are as follows.
003.01 ADMINISTRATIVE CONTROLS. The registrant must be responsible for directing the operation of the therapeutic radiation machines that have been registered with the Department. The registrant or the registrant's agent must ensure that the requirements of this chapter are met in the operation of the therapeutic radiation machine or machines.
003.02 PROHIBITION. A therapeutic radiation machine that does not meet the provisions of these regulations cannot be used for irradiation of patients.
003.03 TRAINING FOR EXTERNAL BEAM RADIATION THERAPY USERS. The registrant of any therapeutic radiation machine subject to 180 NAC 20-006 or 20-007 must require the user to be a physician who is licensed in the State of Nebraska and who:
(1) Is certified in:
(i) Radiology, combined diagnostic and therapeutic radiology program, therapeutic radiology or radiation oncology, by the American Board of Radiology; (ii) Radiation oncology by the American Osteopathic Board of Radiology; (iii) Radiology, with specialization in radiotherapy, as a British "Fellow of the Faculty of Radiology" or "Fellow of the Royal College of Radiology"; or (iv) Therapeutic radiology by the Canadian Royal College of Physicians and Surgeons; or
(2) Is in the active practice of therapeutic radiology, and has completed 200 hours of instruction in basic radiation techniques applicable to the use of an external beam radiation therapy unit, 500 hours of supervised work experience, and a minimum of three years of supervised clinical experience.
(i) To satisfy the requirement for instruction, the classroom and laboratory training must include:
(a) Radiation physics and instrumentation; (b) Radiation protection; (c) Mathematics pertaining to the use and measurement of ionization radiation; and (d) Radiation biology; and
(ii) To satisfy the requirement for supervised work experience, training must be under the supervision of an individual meeting the requirements of 180 NAC 20-003.03 and must include:
(a) Review of the full calibration measurements and periodic quality assurance checks; (b) Evaluation of prepared treatment plans and calculation of treatment times and patient treatment settings; (c) Using administrative controls to prevent misadministrations; and (d) Implementing emergency procedures to be followed in the event of the abnormal operation of an external beam radiation therapy unit or console; and
(iii) To satisfy the requirement for a period of supervised clinical experience, training must include one year in a formal training program approved by the Residency Review Committee for Radiology of the Accreditation Council for Graduate Medical Education or the Committee on Postdoctoral Training of the American Osteopathic Association and an additional two years of clinical experience in therapeutic radiology under the supervision of an individual meeting the requirements of 180 NAC 20-003.03. The supervised clinical experience must include:
(a) Examining individuals 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 external beam radiation therapy doses and collaborating with the user in the review of patients' progress and consideration of the need to modify originally prescribed doses or treatment plans, or both as warranted by patients' reaction to radiation; and (d) Post administration follow up and review of case histories.
003.03(A) TRAINING DOCUMENTATION. The names and training of all current users of therapeutic radiation machines must be kept on file at the facility. Information on former users of therapeutic radiation machines must be maintained for at least two years beyond the last date they were authorized as a user of the therapeutic radiation machine at that facility.
003.04 TRAINING FOR RADIOLOGICAL MEDICAL PHYSICIST. The registrant for any therapeutic radiation machine subject to 20 NAC 20-006 or 20-007 must require the individual to meet the training requirements of 180 NAC 15-004.01.
003.05 QUALIFICATIONS OF OPERATORS. Individuals who will be operating therapeutic radiation machines for medical use must meet the following requirements.
(A) Individuals who will be operating a therapeutic radiation machine for medical use must be American Registry of Radiologic Technologists (ARRT) Registered Radiation Therapy Technologists. Individuals who are not American Registry of Radiologic Technologists (ARRT) Registered Radiation Therapy Technologists must submit evidence that they have satisfactorily completed a radiation therapy technologist training program that complies with the requirements of the Joint Review Committee on Education in Radiologic Technology, "Standards for Accredited Educational Program in Radiologic Sciences – Effective January 1, 2002”, Joint Review Committee on Education in Radiologic Technology, January 1996; Revised 2001. This document is available for viewing at the Department of Health and Human Services, Division of Public Health, Office of Radiological Health, 301 Centennial Mall South, 3rd Floor, Lincoln, Nebraska 68509. (B) The names and training of all personnel currently operating a therapeutic radiation machine must be kept on file at the facility. Information on former operators must be retained for at least two (2) years beyond the last date they were authorized to operate a therapeutic radiation machine at that facility.
003.06 WRITTEN SAFETY PROCEDURES. Written safety procedures and rules must be developed by a radiological medical physicist and must be available in the control area of a therapeutic radiation machine. The written safety procedures must include any restrictions required for the safe operation of the each therapeutic radiation machine. The operator must be able to demonstrate familiarity with these procedures.
003.07 LIMITATIONS. Individuals must not be exposed to the useful beam except for medical therapy purposes and unless the exposure has been ordered in writing by a licensed practitioner of the healing arts. This provision prohibits deliberate exposure of an individual for training, demonstration, or other non-healing arts purposes.
003.08 COMPLIANCE WITH QUALITY MANAGEMENT PROGRAM. All individuals associated with the operation of a therapeutic radiation machine must be instructed in and comply with the provisions of the registrant's quality management program. In addition to the requirements of this chapter, these individuals are also subject to the requirements of 180 NAC 4-005, 4-009 and 4-021.
003.09 INFORMATION AND MAINTENANCE RECORD AND ASSOCIATED INFORMATION. The registrant must maintain the following information in a separate file or package for each therapeutic radiation machine for inspection by the Department:
(A) A report of acceptance testing; (B) The records of all surveys, calibrations, and periodic quality assurance checks of the therapeutic radiation machine required by this chapter, to include the name or names of the individual or individuals who performed the activities; (C) The records of maintenance or modifications, or both, performed on the therapeutic radiation machine, to include the name or names of the individual or individuals who performed the services; and (D) A signature of person authorizing the return of therapeutic radiation machine to clinical use after service, repair, or upgrade.
003.10 RECORDS RETENTION. All records required by this chapter must be retained until disposal is authorized by the Department, unless another retention period is authorized in this chapter. All required records must be retained in an active file from the time of generation, until at least the next Department inspection. Any required record generated prior to the last Department inspection may be microfilmed or otherwise archived as long as a complete copy of the record can be retrieved until the Department authorizes final disposal.
004. GENERAL TECHNICAL REQUIREMENTS FOR REGISTRANTS OF THERAPEUTIC RADIATION MACHINES . The general technical requirements for registrants using therapeutic radiation machines are as follows.
004.01 PROTECTION SURVEYS. Radiation protection surveys must be conducted as follows.
004.01(A) RADIATION SURVEY INSTRUMENT. The registrant must ensure that radiation protection surveys of all new facilities, and existing facilities not previously surveyed, are performed with an operable radiation measurement survey instrument calibrated according to 180 NAC 20-008. The radiation protection survey must be performed by, or under the direction of, a radiological medical physicist. The radiological medical physicist must verify, with the therapeutic radiation machine in a "BEAM-ON" condition, with the largest clinically available treatment field and with and without a scattering phantom in the useful beam of radiation:
(i) Radiation levels in restricted areas are not likely to cause personnel exposures in excess of the limits specified in 180 NAC 4-005.01; and (ii) Radiation levels in unrestricted areas do not exceed the limits specified in 180 NAC 4-013.01 and 180 NAC 4-013.02.
004.01(B) ADDITIONAL REQUIREMENTS. In addition to the requirements of 180 NAC 20-004.01(A), a radiation protection survey must also be performed prior to any subsequent medical use and:
(i) After making any change in the treatment room shielding; (ii) After making any change in the location of the therapeutic radiation machine within the treatment room; (iii) After relocating the therapeutic radiation machine; or (iv) Before using the therapeutic radiation machine in a manner that could result in increased radiation levels in areas outside the external beam radiation therapy treatment room.
004.01(C) VIOLATIONS. The survey record must indicate all instances where the registrant, in the opinion of the radiological medical physicist, is in violation of applicable regulations. The survey record must also include:
(i) The date of the measurements; (ii) The reason the survey is required; (iii) The manufacturer's name; (iv) The model number and serial number of the therapeutic radiation machine; (v) The instrument or instruments used to measure radiation levels; (vi) A plan of the areas surrounding the treatment room that were surveyed; (vii) The measured dose rate at several points in each area expressed in microsieverts or millirems per hour; (viii) The calculated maximum level of radiation over a period of one week for each restricted and unrestricted area; and (ix) The signature of the individual responsible for conducting the survey.
004.01(D) PROHIBITION OF USE. If the results of the surveys required by 180 NAC 20-004.01(A) or (B) indicate any radiation levels in excess of the respective limit specified in 180 NAC 20-004.01(A), the registrant must lock the control in the "OFF" position and not use the unit:
(i) Except as may be necessary to repair, replace, or test the therapeutic radiation machine, the therapeutic radiation machine shielding, or the treatment room shielding; or (ii) Until the registrant has received a specific exemption from the Department.
004.02 MODIFICATION OF RADIATION THERAPY UNIT OR ROOM BEFORE BEGINNING A TREATMENT PROGRAM. If the survey required by 180 NAC 20-004.01 indicates that an individual in an unrestricted area may be exposed to levels of radiation greater than those permitted by 180 NAC 4-013.01 and 4-013.02, before beginning the treatment program the registrant must:
(A) Either equip the unit with beam direction interlocks or add additional radiation shielding to ensure compliance with 180 NAC 4-013.01 and 4-013.02; (B) Perform the survey required by 180 NAC 20-004.01 again; and (C) Include in the report required by 180 NAC 20-004.04 the results of the initial survey, a description of the modification made to comply with 180 NAC 20-004.01(A), and the results of the second survey; or (D) Request and receive a registration amendment under 180 NAC 4-013.04 that authorizes radiation levels in unrestricted areas greater than those permitted by 180 NAC 4-013.01 and 4-013.02.
004.03 DOSIMETRY EQUIPMENT. The requirements for use of dosimetry equipment are as follows.
004.03(A) CALIBRATED DOSIMETRY SYSTEM. The registrant must have a calibrated dosimetry system available for use. The system must 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 must have been performed within the previous 24 months and after any servicing that may have affected system calibration. The dosimetry system must have been calibrated at an energy or energy range appropriate for the radiation being measured.
004.03(B) QUALITY ASSURANCE CHECK MEASUREMENTS. The registrant must have available for use a dosimetry system for quality assurance check measurements. To meet this requirement, the system may be compared with a system that has been calibrated according to 180 NAC 20-004.03(A). This comparison must have been performed within the previous 12 months and after any servicing that may have affected the system calibration. The quality assurance check system may be the same system used to meet the requirement in 180 NAC 20-004.03(A).
004.03(C) RECORDS. The registrant must maintain a record of each dosimetry system calibration, intercomparison, and comparison for the duration of the registration. For each calibration, intercomparison, or comparison, the record must include:
(i) The date; (ii) The model numbers and serial numbers of the instruments that were calibrated, inter-compared, or compared as required by 180 NAC 20-004.03(A) and (B); the correction factors that were determined; (iii) The names of the individuals who performed the calibration, intercomparison, or comparison; and (iv) Evidence that the intercomparison was performed by, or under the direct supervision and in the physical presence of, a radiological medical physicist.
005. QUALITY MANAGEMENT PROGRAM . Each registrant or applicant subject to 180 NAC 20-006 or 20-007 must develop, implement, and maintain a quality management program to ensure that radiation will be administered as directed by the user.
005.01 SCOPE AND APPLICABILITY. The quality management program must address, as a minimum, the following specific objectives.
005.01(A) WRITTEN DIRECTIVES. A written directive must:
(i) Be dated and signed by a user 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 writing in the patient’s record and a revised written directive is signed by a user within 48 hours of the oral revision; (ii) 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 the number of fractions; (iii) Be dated and signed by a user prior to the administration of the external beam dose or the next fractional dose for a written revision to an existing written directive; and (iv) Be retained by the registrant for three years.
005.01(B) PROCEDURES FOR ADMINISTRATION. The registrant must develop, implement, and maintain written procedures to ensure that:
(i) Prior to the administration of each course of radiation treatments, the patient’s or human research subject’s identity is verified, by more than one method, as the individual named in the written directive; (ii) Each administration is in according to the written directive; (iii) Therapeutic radiation machine final plans of treatment and related calculations are in according to the respective written directives by:
(1) Checking both manual and computer generated dose calculations to verify they are correct and in according to the written directive; and (2) Verifying that any computer-generated calculations are correctly transferred into the consoles of authorized therapeutic medical units;
(iv) Any unintended deviation from the written directive is identified and evaluated, and appropriate action is taken; and (v) The registrant retains a copy of the procedures for administration for the duration of the registration.
005.02 REPORTS AND NOTIFICATIONS OF MISADMINISTRATIONS. The requirements for reports and notifications of misadministrations are as follows.
005.02(A) EVENTS RESULTING FROM PATIENT OR HUMAN RESEARCH SUBJECT INTERVENTION. A registrant must report any event resulting from intervention of a patient or human research subject in which the administration of therapeutic radiation machine radiation results, or will result in, unintended permanent functional damage to an organ or a physiological system as determined by a physician.
005.02(B) OTHER EVENTS. Other than events that result from intervention by a patient or human research subject, a registrant must report any event in which the administration of an external beam radiation dose:
(i) Involves the wrong patient, wrong treatment modality, or wrong treatment site; (ii) Causes the calculated weekly administered dose to differ from the weekly prescribed dose by more than 30 percent; or (iii) Causes the calculated total administered dose to differ from the total prescribed dose by more than 20 percent.
005.02(C) TELEPHONE NOTIFICATION. The registrant must notify the Department by telephone no later than the next business day after the discovery of a misadministration.
005.02(D) WRITTEN REPORT. The registrant must submit a written report to the Department within 30 days after the discovery of a misadministration. The written report must include:
(i) The registrant’s name; (ii) The name of the prescribing physician; (iii) A brief description of the event; (iv) Why the event occurred; (v) The effect, if any, on the individual or individuals who received the administration; (vi) Actions, if any, that have been taken, or are planned to prevent recurrence; and (vii) Certification that the registrant notified the individual, or the individual’s responsible relative or guardian, and if not, why notification was not made.
005.02(E) IDENTIFICATION OF THE INDIVIDUAL PROHIBITED IN REPORT. The report must not contain the individual’s name or any other information that could lead to the identification of the individual.
005.02(F) NOTIFICATION TO THE REFERRING PHYSICIAN AND INDIVIDUAL. The registrant must provide notification of the event to the referring physician and also notify the individual who is the subject of the misadministration no later than 24 hours after its discovery, unless the referring physician personally informs the registrant that they will inform the individual or, based on their medical judgment, telling the individual would be harmful. The registrant 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 24 hours, the registrant must make the appropriate notifications as soon as possible after that. The registrant must not delay any appropriate medical care for the individual, including any necessary remedial care as a result of the misadministration, because of any delay in notification. To meet the requirements of 180 NAC 20-005.02(E), the notification of the individual who is the subject of the misadministration may be made to that individual’s responsible relative or guardian. If a verbal notification is made, the registrant must inform the individual, or responsible relative or guardian that a written description of the event can be obtained from the registrant upon request. The registrant must provide such a written description if requested.
005.02(G) RIGHTS AND DUTIES. Aside from the notification requirement, nothing in this subsection affects any rights or duties of registrants and physicians in relation to each other, to individuals affected by the misadministration, or to that individual’s responsible relative or guardians.
005.02(H) COPY OF RECORD TO REFERRING PHYSICIAN. The registrant must retain a record of misadministration according to 180 NAC 20-005.03. A copy of the required record must be provided to the referring physician, if other than the registrant, within 15 days after discovery of the misadministration.
005.03 RECORDS OF MISADMINISTRATIONS. A registrant must retain a record of misadministration reported according to 180 NAC 20-005.02 for three years.
006. THERAPEUTIC RADIATION MACHINES OF LESS THAN 500 KILOVOLTS (kV) . The requirements for therapeutic radiation machines of less than 500 kilovolts (kV) are as follows.
006.01 LEAKAGE RADIATION. When the x-ray tube is operated at its maximum rated tube current for the maximum kilovolts (kV), the leakage air kerma rate must not exceed the value specified at the distance specified for that classification of therapeutic radiation machine as follows.
006.01(A) 0-50 KILOVOLT (KV) SYSTEMS. The leakage air kerma rate measured at any position 5 centimeters from the tube housing assembly must not exceed 1 milligray (mGy) or 100 millirad (mrad) in any one hour.
006.01(B) GREATER THAN 50 AND LESS THAN 500 KILOVOLT (KV) SYSTEMS. The leakage air kerma rate measured at a distance of 1 meter from the target in any direction must not exceed 1 centigray (cGy) or 1 rad in any 1 hour. This air kerma rate measurement may be averaged over areas no larger than 100 square centimeters. In addition, the air kerma rate at a distance of 5 centimeters from the surface of the tube housing assembly must not exceed 30 centigray (cGy) or 30 rad per hour.
006.01(C) DETERMINATION OF LEAKAGE RADIATION. For each therapeutic radiation machine, the registrant must determine, or obtain from the manufacturer, the leakage radiation existing at the positions specified in 180 NAC 20-006.01(A) and 20-006.01(B) for the specified operating conditions. Records on leakage radiation measurements must be maintained at the installation for inspection by the Department.
006.02 PERMANENT BEAM LIMITING DEVICES. Permanent diaphragms or cones used for limiting the useful beam must provide at least the same degree of attenuation as required for the tube housing assembly.
006.03 ADJUSTABLE OR REMOVABLE BEAM LIMITING DEVICES. Adjustable or removable beam limiting devices must:
(A) Not transmit more than 5 percent of the useful beam for the most penetrating beam used for all adjustable or removable beam limiting devices, diaphragms, cones or blocks; and (B) Indicate the position and shape of the radiation field by a light beam when adjustable beam limiting devices are used.
006.04 FILTER SYSTEM. The filter system must be marked so that:
(A) Filters cannot be accidentally displaced at any possible tube orientation; (B) An interlock system prevents irradiation if the proper filter is not in place for equipment installed after July 11, 2009; (C) The air kerma rate escaping from the filter slot does not exceed 1 centigray (cGy) or 1 rad per hour at 1 meter under any operating conditions; and (D) Each filter is marked regarding its material of construction and its thickness.
006.05 TUBE IMMOBILIZATION. The x-ray tube and housing must be immobilized as follows.
006.05(A) X-RAY TUBE. The x-ray tube must be mounted so it cannot accidentally turn or slide with respect to the housing aperture.
006.05(B) TUBE HOUSING ASSEMBLY. The tube housing assembly must be capable of being immobilized for stationary portal treatments.
006.06 SOURCE MARKING. The tube housing assembly must be marked so that it is possible to determine the location of the source to within 5 millimeters. That marking must be readily accessible for use during calibration procedures.
006.07 BEAM BLOCK. Contact therapy tube housing assemblies must have a removable shield of material, equivalent in attenuation to 0.5 millimeters of lead at 100 kilovolts (kV) that can be positioned over the entire useful beam exit port during periods when the beam is not in use.
006.08 TIMER. A suitable irradiation control device must be provided to terminate the irradiation after a pre-set time interval. The timer must:
(A) Be provided at the treatment control panel. The timer must have a display and must have a preset time selector and an elapsed time or time remaining indicator; (B) 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 must be necessary to reset the elapsed time indicator; (C) The timer must terminate irradiation when a pre-selected time has elapsed, if any dose monitoring system present has not previously terminated irradiation; (D) Permit accurate pre-setting and determination of exposure times as short as 1 second; (E) Not permit an exposure if the timer is set at zero; (F) Not activate until the shutter is opened when irradiation is controlled by a shutter mechanism unless calibration includes a timer error correction to compensate for mechanical lag; and (G) Be accurate to within 1 percent of the selected value or 1 second, whichever is greater.
006.09 CONTROL PANEL FUNCTIONS. The control panel, in addition to the displays required by other provisions in 180 NAC 20-006, must have:
(A) An indication of whether electrical power is available at the control panel and if activation of the x-ray tube is possible; (B) An indication of whether x-rays are being produced; (C) A means for indicating x-ray tube potential and current; (D) A means for terminating an exposure at any time; (E) A locking device which will prevent unauthorized use of the therapeutic radiation machine; and (F) A positive display of specific filter or filters in the beam for therapeutic radiation machines installed after July 11, 2009.
006.10 MULTIPLE TUBES. When a control panel can energize more than one x-ray tube:
(A) It must be possible to activate only one x-ray tube at any time; (B) There must be an indication at the control panel identifying which x-ray tube is activated; and (C) There must be an indication at the tube housing assembly when that tube is energized.
006.11 TARGET TO SKIN DISTANCE (TSD). There must be a means of determining the central axis target to skin distance (TSD) to within 1 centimeter and to reproduce this measurement to within 2 millimeters from then on.
006.12 SHUTTERS. Unless it is possible to bring the x-ray output to the prescribed exposure parameters within 5 seconds after the x-ray "ON" switch is energized, the beam must be attenuated by a shutter having a lead equivalency not less than that of the tube housing assembly. In addition, after the unit is at operating parameters, the shutter must be controlled by the operator from the control panel. An indication of shutter position must appear at the control panel.
006.13 LOW FILTRATION X-RAY TUBES. Each therapeutic radiation machine equipped with a beryllium or other low filtration window must have the tube housing assembly clearly labeled and must 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.
006.14 FACILITY DESIGN REQUIREMENTS FOR THERAPEUTIC RADIATION MACHINES CAPABLE OF OPERATING IN THE RANGE 50 KILOVOLTS (KV) TO 500 KILOVOLTS (KV). In addition to shielding adequate to meet requirements of 180 NAC 20-009, the treatment room must meet the following design requirements.
006.14(A) AURAL COMMUNICATION. Provision must be made for continuous two way aural communication between the patient and the operator at the control panel.
006.14(B) VIEWING SYSTEMS. Provision must be made to permit continuous observation of the patient during irradiation. The viewing system must be located so the operator can observe the patient from the control panel. The therapeutic radiation machine must not be used for patient irradiation unless at least one viewing system is operational.
006.15 ADDITIONAL REQUIREMENTS. Treatment rooms that contain a therapeutic radiation machine capable of operating above 150 kilovolts (kV) must meet the following additional requirements.
006.15(A) FIXED PROTECTIVE BARRIERS. All protective barriers must be fixed except for entrance doors or beam interceptors.
006.15(B) CONTROL PANEL. The control panel must be located outside the treatment room or in a totally enclosed booth, which has a ceiling, inside the room.
006.15(C) INTERLOCKS. Interlocks must be provided so all entrance doors, including doors to any interior booths, must be closed before treatment can be initiated or continued. If the radiation beam is interrupted by any door opening, it must not be possible to restore the machine to operation without closing the door and reinitiating irradiation by manual action at the control panel.
006.15(D) DOOR. When any door referred to in 180 NAC 20-006.15, item (C) is opened while the x-ray tube is activated, the air kerma rate at a distance of 1 meter from the source must be reduced to less than 1 milligray (mGy) or 100 millirad (mrad) per hour.
006.16 FULL CALIBRATION MEASUREMENTS. Full calibration measurements must be performed as follows.
006.16(A) FREQUENCY. Full calibration of a therapeutic radiation machine subject to 180 NAC 20-006 must be performed by, or under the direct supervision of, a radiological medical physicist:
(i) Before the first medical use following installation or reinstallation of the therapeutic radiation machine; (ii) At intervals not exceeding one year; and (iii) Before medical use under the following conditions:
(1) Whenever quality assurance check measurements indicate that the radiation output differs by more than 5 percent from the value obtained at the last full calibration and the difference cannot be reconciled; and (2) Following any component replacement, major repair, or modification of components that could significantly affect the characteristics of the radiation beam.
(iv) Apart from the requirements of 180 NAC 20-006.16(A)(iii):
(1) Full calibration of therapeutic radiation machines with multi energy capabilities is required only for those modes or energies that are not within their acceptable range; and (2) If the repair, replacement or modification does not affect all energies, full calibration must 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 compared to the criteria in 180 NAC 20-006.16(A), item (iii)(1).
006.16(B) REQUIRED MEASUREMENTS. To satisfy the requirement of 180 NAC 20-006.16(A), full calibration must include all measurements recommended for annual calibration by the National Council on Radiation Protection and Measurements (NCRP) Report 69, “Dosimetry of X-ray and Gamma Ray Beams for Radiation Therapy in the Energy Range 10 keV to 50 MeV” (1981). This document is available for viewing at the Department of Health and Human Services, Division of Public Health, Office of Radiological Health, 301 Centennial Mall South, 3rd Floor, Lincoln, Nebraska 68509.
006.16(C) CALIBRATION RECORDS. The registrant must maintain a record of each calibration for the duration of the registration. The record must include:
(i) The date of the calibration; (ii) The manufacturer's name; (iii) Model number and serial number for the therapeutic radiation machine if applicable; (iv) The model numbers and serial numbers of the instruments used to calibrate the therapeutic radiation machine; and (v) The signature of the radiological medical physicist responsible for performing the calibration.
006.17 PERIODIC QUALITY ASSURANCE CHECKS. The requirements for periodic quality assurance checks are as follows.
006.17(A) APPLICABILITY. Periodic quality assurance checks must be performed on therapeutic radiation machines subject to 180 NAC 20-006 that are capable of operation at greater than or equal to 50 kilovolts (kV).
006.17(B) QUALITY ASSURANCE CHECK CONTENT. To satisfy the requirements of 180 NAC 20-006.17(A), quality assurance checks must meet the following requirements:
(i) Quality assurance checks must be performed according to written procedures established by the radiological medical physicist; and (ii) The quality assurance check procedures must specify the frequency the tests or measurements are to be performed. The quality assurance check procedures must specify that the quality assurance check will be performed during the calibration specified in 180 NAC 20-006.16(A). The acceptable tolerance for each parameter measured in the quality assurance check, when compared to the value for that parameter established in the calibration specified in 180 NAC 20-006.16(A), must be specified.
006.17(C) PARAMETER EXCEEDING TOLERANCE. The cause for a parameter exceeding a tolerance set by the radiological medical physicist must be investigated and corrected before the system is used for patient irradiation.
006.17(D) CHANGE IN OPERATING CHARACTERISTICS. Whenever a quality assurance check indicates a significant change in the operating characteristics of a system, as specified in the radiological medical physicist's quality assurance check procedures, the system must be recalibrated as required in 180 NAC 20-006.16(A).
006.17(E) DOSIMETRY SYSTEM. The registrant must use the dosimetry system described in 180 NAC 20-004.03(B), to make the quality assurance check required in 180 NAC 20-006.17(B).
006.17(F) RADIOLOGICAL MEDICAL PHYSICIST REVIEW. The registrant must have the radiological medical physicist review and sign the results of each radiation output quality assurance check within 1 month of the date that the check was performed.
006.17(G) REQUIRED INTERVALS. The registrant must ensure that quality assurance checks of therapeutic radiation machines subject to 180 NAC 20-006 are performed at intervals not to exceed 1 month.
006.17(H) PROHIBITION. Despite the requirements of 180 NAC 20-006.17(F) and (G), the registrant must ensure that no therapeutic radiation machine is used to administer radiation to humans unless the quality assurance checks required by 180 NAC 20-006.17(F) and (G) have been performed within the 30 day period immediately prior to that administration.
006.17(I) PROPER OPERATION. To satisfy the requirement of 180 NAC 20-006.17(B), safety quality assurance checks must ensure proper operation of:
(i) Electrical interlocks at each external beam radiation therapy room entrance; (ii) The "BEAM-ON" and termination switches; (iii) Beam condition indicator lights on the access door or doors, control console, and in the radiation therapy room; (iv) Viewing systems; and (v) If applicable, electrically operated treatment room doors from inside and outside the treatment room.
006.17(J) RECORD MAINTENANCE. The registrant must maintain a record of each quality assurance check required by 180 NAC 20-006.17(A) and (G) for three years. The record must include:
(i) The date of the quality assurance check; (ii) The manufacturer's name, model number, and serial number of the therapeutic radiation machine; (iii) The manufacture’s name, model number and serial number for the instrument or instruments used to measure the radiation output of the therapeutic radiation machine; and (iv) The signature of the individual who performed the periodic quality assurance check.
006.18 OPERATING PROCEDURES. The requirements for operation procedures are as follows.
006.18(A) PROHIBITION. The therapeutic radiation machine must not be used for irradiation of patients unless the requirements of 180 NAC 20-006.16 and 20-006.17 have been met.
006.18(B) SECURED IF UNATTENDED. Therapeutic radiation machines must not be left unattended unless secured according to 180 NAC 20-006.09, item (E).
006.18(C) MECHANICAL SUPPORT OR RESTRAINT. When a patient must be held in position for radiation therapy, mechanical supporting or restraining devices must be used.
006.18(D) HOLDER PROTECTION. The tube housing assembly must 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 50 kilovolts (kV). In those cases, the holder must wear protective gloves and a protective apron of not less than 0.5 millimeters lead equivalency at 100 kilovolts (kV).
006.18(E) OPERATING AND EMERGENCY PROCEDURES. A copy of the current operating and emergency procedures must be maintained at the therapeutic radiation machine control console.
006.18(F) INDIVIDUALS OTHER THAN THE PATIENT. No individual other than the patient must be in the treatment room during exposures from therapeutic radiation machines operating above 150 kilovolts (kV). At energies less than or equal to 150 kilovolts (kV), any individual, other than the patient, in the treatment room must be protected by a barrier sufficient to meet the requirements of 180 NAC 4-005.
007. THERAPEUTIC RADIATION MACHINES – PHOTON THERAPY SYSTEMS 500 KILOVOLTS (KV) AND ABOVE AND ELECTRON THERAPY SYSTEMS 500 KILOELECTRON VOLTS (keV) and ABOVE . The requirements for therapeutic radiation machines – photon therapy systems kilovolts (kV) and above and electron therapy systems 500 kiloelectron volts (keV) and above are as follows.
007.01 LEAKAGE RADIATION OUTSIDE THE MAXIMUM USEFUL BEAM IN PHOTON AND ELECTRON MODES. The requirements governing leakage radiation outside the maximum useful beam in photon and electron modes are as follows.
007.01(A) ABSORBED DOSE. 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 2 meters which is perpendicular to and centered on the central axis of the useful beam at the nominal treatment distance, must not exceed a maximum of 0.2 percent and an average of 0.1 percent of the absorbed dose on the central axis of the beam at the nominal treatment distance. Measurements must be averaged over an area not exceeding 100 square centimeters at a minimum of 16 points uniformly distributed in the plane.
007.01(B) LEAKAGE RADIATION. Except for the area defined in 180 NAC 20-007.01(A), the absorbed dose due to leakage radiation, excluding neutrons, at 1 meter from the electron path between the electron source and the target or electron window must not exceed 0.5 percent of the absorbed dose on the central axis of the beam at the nominal treatment distance. Measurements must be averaged over an area not exceeding 100 square centimeters.
007.01(C) NEUTRON ABSORBED DOSE. For equipment manufactured after July 11, 2009, the neutron absorbed dose outside the useful beam must not exceed manufacturer’s specifications.
007.01(D) LEAKAGE RADIATION MEASUREMENTS. For each therapeutic radiation machine, the registrant must determine, or obtain from the manufacturer, the leakage radiation existing at the positions specified in 180 NAC 20-007.01(A) through (C) for the specified operating conditions. Records on leakage radiation measurements must be maintained for inspection by the Department.
007.02 LEAKAGE RADIATION THROUGH BEAM LIMITING DEVICES. The requirements governing leakage radiation through beam limiting devices are as follows.
007.02(A) PHOTON RADIATION. All adjustable or interchangeable beam limiting devices must attenuate the useful beam so that at the nominal treatment distance, the maximum absorbed dose anywhere in the area shielded by the beam limiting device or devices must not exceed 2 percent of the maximum absorbed dose on the central axis of the useful beam measured in a 100 square centimeters radiation field, or maximum available field size if less than 100 square centimeters.
007.02(B) ELECTRON RADIATION. All adjustable or interchangeable electron applicators must 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, so that the absorbed dose in a plane perpendicular to the central axis of the useful beam at the nominal treatment distance must not exceed:
(i) A maximum of 2 percent and average of 0.5 percent of the absorbed dose on the central axis of the useful beam at the nominal treatment distance. This limit must apply beyond a line 7 centimeters outside the periphery of the useful beam; and (ii) A maximum of 10 percent of the absorbed dose on the central axis of the useful beam at the nominal treatment distance. This limit must apply beyond a line 2 centimeters outside the periphery of the useful beam.
007.03 MEASUREMENT OF LEAKAGE RADIATION. The requirements for measurement of leakage radiation are as follows.
007.03(A) PHOTON RADIATION. Measurements of leakage radiation through the beam limiting devices must be made with the beam limiting devices closed and any residual aperture blocked by a minimum of two tenth value layers of suitable absorbing material. In the case of overlapping beam limiting devices, the leakage radiation through each set must be measured independently at the depth of maximum dose. Measurements must be made, using a radiation detector, of an area not exceeding 10 square centimeters.
007.03(B) ELECTRON RADIATION. Measurements of leakage radiation through the electron applicators must be made with the electron beam directed into the air and using a radiation detector of an area up to, but not exceeding, one square centimeter suitably protected against radiation that has been scattered from material beyond the radiation detector. Measurements must be made using one centimeter of water equivalent build up material.
007.04 FILTERS AND WEDGES. The requirements governing filters and wedges are as follows.
007.04(A) WEDGE FILTERS. Each wedge filter that is removable from the system must be clearly marked with an identification number. For removable wedge filters, the nominal wedge angle must appear on the wedge, or wedge tray if permanently mounted to the tray. If the wedge or wedge tray is significantly damaged, the wedge transmission factor must be redetermined.
007.04(B) ABSORBED DOSE. If the absorbed dose rate information required by 180 NAC 20-007.01 relates exclusively to operation with a field flattening filter or beam scattering foil in place, such foil or filter must be removable only by the use of tools.
007.04(C) WEDGE FILTERS, INTERCHANGEABLE FIELD FLATTENING FILTERS, OR INTERCHANGEABLE BEAM SCATTERING FOILS. For equipment installed after July 11, 2009 that utilizes wedge filters, interchangeable field flattening filters, or interchangeable beam scattering foils, the following apply:
(i) Irradiation must not be possible until a selection of a filter, or a selection to use "no filter", has been made at the treatment control panel, either manually or automatically; (ii) An interlock system must be provided to prevent irradiation if the filter selected is not in the correct position; (iii) A display must be provided at the treatment control panel showing the wedge filter or filters, interchangeable field flattening filter or filters, or interchangeable beam scattering foil or foils in use; and (iv) An interlock must 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 at the treatment control panel.
007.05 STRAY RADIATION IN THE USEFUL BEAM. For equipment installed after July 11, 2009, the registrant must determine during acceptance testing, or obtain from the manufacturer, data sufficient to ensure that 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 do not exceed manufacturer’s specifications.
007.06 BEAM MONITORS. All therapeutic radiation machines subject to 180 NAC 20-007 must be provided with redundant beam monitoring systems. The sensors for these systems must be fixed in the useful beam during treatment to indicate the dose monitor unit rate.
007.06(A) INDEPENDENTLY POWERED INTEGRATING DOSE METERS. Equipment installed after July 11, 2009 must be provided with at least two independently powered integrating dose meters. Alternatively, common elements may be used if the production of radiation is terminated upon failure of any common element.
007.06(B) RADIATION DETECTOR. Equipment installed on or before July 11, 2009, must be provided with at least one radiation detector. This detector must be incorporated into a useful beam monitoring system;
007.06(C) DETECTOR AND SYSTEM. The detector and the system into which that detector is incorporated must meet the following requirements:
(i) Each detector must be removable only with tools and, if movable, must be interlocked to prevent incorrect positioning; (ii) Each detector must form part of a beam monitoring system from whose readings in dose monitor units the absorbed dose at a reference point can be calculated; (iii) Each beam monitoring system must be capable of independently monitoring, interrupting, and terminating irradiation; (iv) For equipment installed after July 11, 2009, the design of the beam monitoring systems must ensure that the:
(1) Malfunctioning of one system must not affect the correct functioning of the other system or systems; and (2) Failure of either system must terminate irradiation or prevent the initiation of radiation; and
(v) Each beam monitoring system must have a legible display at the treatment control panel. For equipment installed after July 11, 2009, each display must:
(1) Maintain a reading until intentionally reset; (2) Have only one scale and no electrical or mechanical scale multiplying factors; (3) Utilize a design so that increasing dose is displayed by increasing numbers; and (4) In the event of power failure, the beam monitoring information required in 180 NAC 20-007.06(C)(v)(3) displayed at the control panel at the time of failure must be retrievable in at least one system for a 20 minute period of time.
007.07 BEAM SYMMETRY. The requirements for beam symmetry are as follows.
007.07(A) AUXILIARY DEVICES. Bent beam linear accelerators with a beam flattening filter or filters subject to 180 NAC 20-007 must be provided with an auxiliary device or devices to monitor beam symmetry.
007.07(B) DETECTION OF ASYMMETRY. The device or devices referenced in 180 NAC 20-007.07(A) must be able to detect field asymmetry greater than 10 percent.
007.07(C) TERMINATE IRRADIATION. The device or devices referenced in 180 NAC 20-007.07(A) must be configured to terminate irradiation if the specifications in 180 NAC 20-007.07(B) cannot be maintained.
007.08 SELECTION AND DISPLAY OF DOSE MONITOR UNITS. The requirements for selection and display of dose monitor units are as follows.
007.08(A) SELECTION OF DOSE MONITORING UNITS. Irradiation must not be possible until a new selection of a number of dose monitor units has been made at the treatment control panel.
007.08(B) DISPLAY OF DOSE MONITORING UNITS. The pre-selected number of dose monitor units must be displayed at the treatment control panel until reset manually for the next irradiation.
007.08(C) RESETTING OF DOSIMETER DISPLAY. After termination of irradiation, it must be necessary to reset the dosimeter display before subsequent treatment can be initiated.
007.08(D) RESET OF PRE-SELECTED DOSE MONITOR UNITS. For equipment installed after July 11, 2009 after termination of irradiation, it must be necessary for the operator to reset the pre-selected dose monitor units before irradiation can be initiated.
007.09 AIR KERMA RATE OR ABSORBED DOSE RATE. For equipment installed after July 11, 2009, a system must be provided from where the readings of the air kerma rate or absorbed dose rate at a reference point can be calculated. The radiation detectors specified in 180 NAC 20-007.06 may form part of this system. In addition:
(A) The dose monitor unit rate must be displayed at the treatment control panel; (B) If the 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 must be provided which terminates irradiation when the air kerma rate or absorbed dose rate exceeds a value twice the specified maximum. A record of the dose rate that the irradiation will be terminated must be maintained by the registrant; (C) If the equipment can deliver, under any fault condition or conditions, 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 must 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 4 gray (Gy) or 400 rad; and (D) For each therapeutic radiation machine the registrant must determine, or obtain from the manufacturer, the maximum value or values specified in 180 NAC 20-007.09(B) and (C), for the specified operating conditions. Records of these maximum value or values must be maintained for inspection by the Department.
007.10 TERMINATION OF IRRADIATION BY THE BEAM MONITORING SYSTEM OR SYSTEMS DURING STATIONARY BEAM RADIATION THERAPY. The requirements for termination of irradiation by the beam monitoring system or systems during stationary beam radiation therapy are as follows.
007.10(A) PRE-SELECTED NUMBER OF DOSE MONITOR UNITS. Each primary system must terminate irradiation when the pre-selected number of dose monitor units has been detected by the system.
007.10(B) SECONDARY DOSE MONITORING SYSTEM. If the original design of the equipment included a secondary dose monitoring system, that system must be capable of terminating irradiation when not more than 15 percent or 40 dose monitor units above the pre-selected number of dose monitor units set at the control panel has been detected by the secondary dose monitoring system.
007.10(C) CONTROL PANEL INDICATION. For equipment installed after July 11, 2009, an indicator on the control panel must show which monitoring system has terminated irradiation.
007.11 TERMINATION OF IRRADIATION. It must 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.
007.12 INTERRUPTION OF IRRADIATION. If a therapeutic radiation machine has an interrupt mode, it must be possible to interrupt irradiation and equipment movements at any time from the treatment control panel. Following an interruption it must 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 must be automatically terminated.
007.13 TIMER. A suitable irradiation control device must be provided to terminate the irradiation after a pre-set time interval as follows:
(A) A timer must be provided which has a display at the treatment control panel. The timer must have a pre-set time selector and an elapsed time indicator; (B) The timer must 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 must be necessary to reset the elapsed time indicator; and (C) The timer must terminate irradiation when a pre-selected time has elapsed, if the dose monitoring systems have not previously terminated irradiation.
007.14 SELECTION OF RADIATION TYPE. Equipment capable of both x-ray therapy and electron therapy must meet the following additional requirements:
(A) Irradiation must not be possible until a selection of radiation type, x-rays or electrons, has been made at the treatment control panel; (B) The radiation type selected must be displayed at the treatment control panel before and during irradiation; (C) An interlock system must be provided to ensure that the equipment can principally emit only the radiation type that has been selected; (D) An interlock system must be provided to prevent irradiation with x-rays, except to obtain an image, when electron applicators are fitted; (E) An interlock system must be provided to prevent irradiation with electrons when accessories specific for x-ray therapy are fitted; and (F) An interlock system must be provided to prevent irradiation if any selected operations carried out in the treatment room do not agree with the selected operations carried out at the treatment control panel.
007.15 SELECTION OF ENERGY. Equipment capable of generating radiation beams of different energies must meet the following requirements:
(A) Irradiation must not be possible until a selection of energy has been made at the treatment control panel; (B) The nominal energy value selected must be displayed at the treatment control panel until reset manually for the next irradiation. After termination of irradiation, it must be necessary to reset the nominal energy value selected before subsequent treatment can be initiated; and (C) Irradiation must not be possible until the appropriate flattening filter or scattering foil for the selected energy is in its proper location.
007.16 SELECTION OF STATIONARY BEAM RADIATION THERAPY OR MOVING BEAM RADIATION THERAPY. Therapeutic radiation machines capable of both stationary beam radiation therapy and moving beam radiation therapy must meet the following requirements:
(A) Irradiation must not be possible until a selection of stationary beam radiation therapy or moving beam radiation therapy has been made at the treatment control panel; (B) The mode of operation must be displayed at the treatment control panel; (C) An interlock system must be provided to ensure that the equipment can operate only in the mode that has been selected; (D) An interlock system must be provided to prevent irradiation if any selected parameter in the treatment room does not agree with the selected parameter at the treatment control panel; (E) Moving beam radiation therapy must be controlled to obtain the selected relationships between incremental dose monitor units and incremental movement. For equipment installed after July 11, 2009:
(i) An interlock system must be provided to terminate irradiation if the number of dose monitor units delivered in any 10 degrees of rotation or 1 centimeter of linear motion differs by more than 20 percent from the selected value; (ii) Where the angle terminates the irradiation in moving beam radiation therapy, the dose monitor units delivered must differ by less than 5 percent from the dose monitor unit value selected; (iii) An interlock must be provided to prevent motion of more than 5 degrees or 1 centimeter beyond the selected limits during moving beam radiation therapy; (iv) An interlock must be provided to require that a selection of direction be made at the treatment control panel in all units that are capable of both clockwise and counter clockwise moving beam radiation therapy; and (v) Moving beam radiation therapy must be controlled with both primary position sensors and secondary position sensors to obtain the selected relationships between incremental dose monitor units and incremental movement;
(F) Where the beam monitor system terminates the irradiation in moving beam radiation therapy, the termination of irradiation must be as required by 180 NAC 20-007.10; and (G) For equipment installed after July 11, 2009, an interlock system must be provided to terminate irradiation if movement:
(i) Occurs during stationary beam radiation therapy; or (ii) Does not start or stop during moving beam radiation therapy unless such stoppage is a pre-planned function.
007.17 FACILITY DESIGN REQUIREMENTS FOR THERAPEUTIC RADIATION MACHINES OPERATING ABOVE 500 kilovolts (kV). In addition to shielding adequate to meet the requirements of 180 NAC 20-009, the facility design must include the following:
(A) All protective barriers must be fixed, except for access doors to the treatment room or movable beam interceptors; (B) In addition to other requirements specified in this chapter, the control panel must also:
(i) Be located outside the treatment room; (ii) Provide an indication of whether electrical power is available at the control panel and if activation of the radiation is possible; (iii) Provide an indication of whether radiation is being produced; and (iv) Include an access control or locking device that will prevent unauthorized use of the therapeutic radiation machine;
(C) Windows, mirrors, closed circuit television, or an equivalent viewing system must be provided to permit continuous observation of the patient following positioning and during irradiation and must be located so the operator may observe the patient from the treatment control panel. The therapeutic radiation machine must not be used for patient irradiation unless at least one viewing system is operational; (D) Provision must be made for continuous two way aural communication between the patient and the operator at the control panel. The therapeutic radiation machine must not be used for irradiation of patients unless continuous two way aural communication is possible; (E) Treatment room entrances must be provided with warning lights in a readily observable position near the outside of all access doors that indicate when the useful beam is "ON" and when it is "OFF"; (F) Interlocks must be provided so all access controls are activated before treatment can be initiated or continued. If the radiation beam is interrupted by any access control, it must not be possible to restore the machine to operation without resetting the access control and reinitiating irradiation by manual action at the control panel; (G) If the shielding material in any protective barrier requires the presence of a beam interceptor to ensure compliance with 180 NAC 4-013.01 and 4-013.02, interlocks must 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 or barriers; (H) At least one emergency power cutoff switch must be located in the radiation therapy room and must terminate all equipment electrical power including radiation and mechanical motion. This switch is in addition to the termination switch required by 180 NAC 20-007.11. All emergency power cutoff switches must include a manual reset so that the therapeutic radiation machine cannot be restarted from the unit's control console without resetting the emergency cutoff switch; (I) All safety interlocks must be designed so that any defect or component failure in the safety interlock system prevents or terminates operation of the therapeutic radiation machine; and (J) Surveys for residual activity must be conducted on all therapeutic radiation machines capable of generating photon and electron energies above 10 megavolts (MV) prior to machining, removing, or working on therapeutic radiation machine components which may have become activated due to photo-neutron production.
007.18 RADIOLOGICAL MEDICAL PHYSICIST SUPPORT. The requirements for radiological medical physicist support are as follows.
007.18(A) RADIOLOGICAL MEDICAL PHYSICIST RESPONSIBILITIES. The services of a radiological medical physicist is required for registrants using therapeutic radiation machines with energies of 500 kilovolts (kV) and above. The radiological medical physicist must be responsible for:
(i) Full calibration or calibrations required by 180 NAC 20-007.20 and protection surveys required by 180 NAC 20-004.01; (ii) Supervision and review of dosimetry; (iii) Beam data acquisition and transfer for computerized dosimetry, and supervision of its use; (iv) Quality assurance, including quality assurance check review required by 180 NAC 20-007.21(E); (v) Consultation with the user in treatment planning, as needed; and (vi) Performing calculations and assessments regarding misadministrations.
007.18(B) RADIOLOGICAL MEDICAL PHYSICIST CONTACT INFORMATION. If the radiological medical physicist is not a full time employee of the registrant, the operating procedures required by 180 NAC 20-007.19(F) must also specifically address how the radiological medical physicist is to be contacted for problems or emergencies, as well as the specific actions, if any, to be taken until the radiological medical physicist can be contacted.
007.19 OPERATING PROCEDURES. The requirements for operating procedures are as follows.
007.19(A) INDIVIDUALS OTHER THAN THE PATIENT. No individual, other than the patient, must be in the treatment room during treatment or during any irradiation for testing or calibration purposes.
007.19(B) PROHIBITION. Therapeutic radiation machines must not be made available for medical use unless the requirements of 180 NAC 20-004.01, 20-007.20 and 20-007.21 have been met.
007.19(C) SECURED IF UNATTENDED. Therapeutic radiation machines, when not in operation, must be secured to prevent unauthorized use.
007.19(D) RADIATION FIELD POSITION AND SHAPE INDICATION. When adjustable beam limiting devices are used, the position and shape of the radiation field must be indicated by a light field.
007.19(E) MECHANICAL SUPPORT OR RESTRAINING DEVICES. If a patient must be held in position during treatment, mechanical supporting or restraining devices must be used; and
007.19(F) OPERATING AND EMERGENCY PROCEDURES. A copy of the current operating and emergency procedures must be maintained at the therapeutic radiation machine control console.
007.20 ACCEPTANCE TESTING, COMMISSIONING, AND FULL CALIBRATION MEASUREMENTS. The requirements for acceptance testing, commissioning, and full calibration measurements are as follows.
007.20(A) PERFORMANCE. Acceptance testing, commissioning, and full calibration of a therapeutic radiation machine subject to 180 NAC 20-007 must be performed by, or under the supervision of, a radiological medical physicist.
007.20(B) INSTALLATION OR REINSTALLATION. Acceptance testing and commissioning must be performed according to "AAPM Code of Practice for Radiotherapy Accelerators: Report of AAPM Radiation Therapy Task Group 45" and manufacturers specifications, and must be conducted before the first medical use following installation or reinstallation of the therapeutic radiation machine. This document is available for viewing at the Department of Health and Human Services, Division of Public Health, Office of Radiological Health, 301 Centennial Mall South, 3rd Floor, Lincoln, Nebraska 68509.
007.20(C) FULL CALIBRATION MEASUREMENTS. Full calibration must include measurement of all applicable parameters required by Table II of "Comprehensive QA for Radiation Oncology: Report of AAPM Radiation Therapy: AAPM Report No. 46," prepared by Committee Task Group 40 and must be performed according to "AAPM Code of Practice for Radiotherapy Accelerators: AAPM Report No. 47" prepared by Radiation Therapy Task Group 45. These documents are available for viewing at the Department of Health and Human Services, Division of Public Health, Office of Radiological Health, 301 Centennial Mall South, 3rd Floor, Lincoln, Nebraska 68509. Although it may not be necessary to complete all elements of a full calibration at the same time, all applicable parameters, for all energies, must be completed at intervals not exceeding twelve calendar months, unless a more frequent interval is required in Table II.
007.20(D) FREQUENCY. The radiological medical physicist must perform all elements of a full calibration necessary to determine that all parameters are within acceptable limits:
(i) Whenever quality assurance check measurements indicate that the radiation output differs by more than 5 percent from the value obtained at the last full calibration and the difference cannot be reconciled. Therapeutic radiation machines with multi energy or multi-mode capabilities must require measurements for only those modes or energies that are not within their acceptable range; and (ii) Following any component replacement, major repair, or modification of components that could significantly affect the characteristics of the radiation beam. If the repair, replacement or modification does not affect all modes or energies, measurements must be performed on the effected mode or energy that is in most frequent clinical use at the facility. The remaining energies or modes may be validated with quality assurance check procedures against the criteria in 180 NAC 20-007.20(D)(i).
007.20(E) CALIBRATION RECORDS. The registrant must maintain a record of each calibration in an auditable form for the duration of the registration. The record must include:
(i) The date of the calibration; (ii) The manufacturer's name, model number, and serial number for the therapeutic radiation machine; (iii) The model numbers and serial numbers of the instruments used to calibrate the therapeutic radiation machine; and (iv) The signature of the radiological medical physicist responsible for performing the calibration.
007.21 PERIODIC QUALITY ASSURANCE CHECKS. The requirements for periodic quality assurance checks are as follows.
007.21(A) PERIODIC QUALITY ASSURANCE CHECKS INTERVALS. Periodic quality assurance checks must be performed on all therapeutic radiation machines subject to 180 NAC 20-007 at intervals not to exceed those specified in "Comprehensive QA for Radiation Oncology: AAPM Report No. 46,” prepared by AAPM Radiation Therapy Committee Task Group 40; or other procedure.
007.21(B) QUALITY ASSURANCE CHECK CONTENTS. To satisfy the requirement of 180 NAC 20-007.21(A), quality assurance checks must include a determination of central axis radiation output and a representative sampling of periodic quality assurance checks contained in "Comprehensive QA for Radiation Oncology: AAPM Report No. 46” prepared by Radiation Therapy Committee Task Group 40. The registrant may use an alternative protocol that has been submitted to the Department for approval. Representative sampling must include all applicable referenced periodic quality assurance checks in an interval not to exceed 12 consecutive calendar months.
007.21(C) DOSIMETRY SYSTEM. The registrant must use a dosimetry system that has been intercompared within the previous 12 months with the dosimetry systems described in 180 NAC 20-004.03(A) to make the periodic quality assurance checks required in 180 NAC 20-007.21(B).
007.21(D) WRITTEN PROCEDURES. The registrant must perform periodic quality assurance checks required by 180 NAC 20-007.21(A) according to written procedures established by the radiological medical physicist;
007.21(E) REVIEW OF RESULTS. The registrant must review the results of each periodic radiation output check according to the following procedures:
(i) The user and radiological medical physicist must be immediately notified if any parameter is not within its acceptable tolerance. The therapeutic radiation machine must not be made available for subsequent medical use until the radiological medical physicist has determined that all parameters are within their acceptable tolerances; (ii) If all quality assurance check parameters appear to be within their acceptable range, the quality assurance check must be reviewed and signed by either the user or radiological medical physicist within 3 treatment days; and (iii) The radiological medical physicist must review and sign the results of each radiation output quality assurance check at intervals not to exceed one month.
007.21(F) QUALITY ASSURANCE CHECK FREQUENCY. Therapeutic radiation machines subject to 180 NAC 20-007 must have applicable safety quality assurance checks listed in "Comprehensive QA for Radiation Oncology: AAPM Report No. 46” prepared by AAPM Radiation Therapy Committee Task Group 40. The registrant may use an alternative protocol that has been submitted to the Department for approval. The checks must be performed at intervals not to exceed 1 week.
007.21(G) PROPER OPERATION. To satisfy the requirement of 180 NAC 20-007.21(F), safety quality assurance checks must ensure proper operation of:
(i) Electrical interlocks at each external beam radiation therapy room entrance; (ii) Proper operation of the "BEAM-ON", interrupt and termination switches; (iii) Beam condition indicator lights on the access doors, control console, and in the radiation therapy room; (iv) Viewing systems; and (v) Electrically operated treatment room door or doors from inside and outside the treatment room.
007.21(H) PROMPTLY REPAIR. The registrant must promptly repair any system identified in 180 NAC 20-007.21(G) that is not operating properly.
007.21(I) QUALITY ASSURANCE CHECK RECORDS. The registrant must maintain a record of each quality assurance check required by 180 NAC 20-007.021(A) and (G) for three years. The record must include:
(i) The date of the quality assurance check; (ii) The manufacturer's name, model number, and serial number of the therapeutic radiation machine; (iii) The manufacturer's name, model number, and serial number for the instrument or instruments used to measure the radiation output of the therapeutic radiation machine; and (iv) The signature of the individual who performed the periodic quality assurance check.
007.21(J) QUALITY ASSURANCE CHECKS FOR INTENSITY MODULATED RADIATION THERAPY (IMRT) SYSTEMS. Quality assurance checks for intensity modulated radiation therapy (IMRT) systems must:
(i) Include commissioning and testing of the treatment planning and delivery systems, routine quality assurance of the delivery system, and patient-specific validation of treatment plans; (ii) Be performed according to "Guidance document on delivery, treatment planning, and clinical implementation of IMRT: Report of the IMRT subcommittee of the AAPM radiation therapy committee: AAPM Report No. 82”. This document is available for viewing at the Department of Health and Human Services, Division of Public Health, Office of Radiological Health, 301 Centennial Mall South, 3rd Floor, Lincoln, Nebraska 68509; and (iii) Be performed according to the manufacturer’s specifications.
008. CALIBRATION OF RADIATION SURVEY INSTRUMENTS . The requirements for calibration of survey instruments are as follows.
008.01 CALIBRATION FREQUENCY. The registrant must ensure that the survey instruments used to show compliance with this chapter have been calibrated before first use, at intervals not to exceed 12 months, and following repair.
008.02 CALIBRATION METHOD. To satisfy the requirements of 180 NAC 20-008.01, the registrant must:
(A) Calibrate all required scale readings up to 10 milliSievert (mSv) or 1000 millirem (mrem) per hour with an appropriate radiation source that is traceable to the National Institute of Standards and Technology (NIST); and (B) Calibrate at least two points on each scale to be calibrated. These points should be at approximately 1/3 and 2/3 of full-scale.
008.03 PERFORMANCE. To satisfy the requirements of 180 NAC 20-008.02, the registrant must:
(A) Consider a point as calibrated if the indicated dose rate differs from the calculated dose rate by not more than 10 percent; and (B) Consider a point as calibrated if the indicated dose rate differs from the calculated dose rate by not more than 20 percent if a correction factor or graph is conspicuously attached to the instrument.
008.04 RADIATION SURVEY INSTRUMENT CALIBRATION RECORDS. The registrant must retain a record of each calibration required in 180 NAC 20-008.01 for three years. The record must include:
(A) A description of the calibration procedure; and (B) A description of the source used, the certified dose rates from the source, the rates indicated by the instrument being calibrated, the correction factors deduced from the calibration data, the signature of the individual who performed the calibration, and the date of calibration.
008.05 CALIBRATION SERVICES. The registrant may obtain the services of individuals licensed by the Department, the U. S. Nuclear Regulatory Commission, an Agreement State, or a Licensing State to perform calibrations of survey instruments. Records of calibrations that contain information required by 180 NAC 20-008.04 must be maintained by the registrant.
009. SHIELDING AND SAFETY DESIGN REQUIREMENTS . The design requirements for shielding and safety are as follows.
009.01 PRIMARY AND SECONDARY BARRIERS. Each therapeutic radiation machine subject to this chapter must be provided with primary or secondary barriers as necessary to ensure compliance with 180 NAC 4-005 and 4-013.
009.02 NEW INSTALLATION. Facility design information for all new installations of a therapeutic radiation machine or installations of a therapeutic radiation machine of higher energy into a room not previously approved for that energy, must be submitted for Department approval prior to actual installation of the therapeutic radiation machine. The minimum facility design information that must be submitted is contained in Appendix 20-A.
010. QUALITY ASSURANCE FOR RADIATION THERAPY SIMULATION SYSTEMS . The quality assurance requirements for radiation therapy simulation systems are as follows.
010.01 ACCEPTANCE TESTING AND PERIODIC VERIFICATION OF PERFORMANCE. Quality assurance for a conventional or virtual simulator must include acceptance testing and periodic verification of system performance.
010.02 METHOD. Quality assurance for radiation therapy simulation systems must be performed according to "Comprehensive QA for Radiation Oncology: Report of AAPM Radiation Therapy Committee Task Group No. 40: AAPM Report No. 46” for a conventional simulator.
010.02(A) VIRTUAL SIMULATOR. For radiation therapy virtual simulator’s, quality assurance must be performed according to “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”. This document is available for viewing at the Department of Health and Human Services, Division of Public Health, Office of Radiological Health, 301 Centennial Mall South, 3rd Floor, Lincoln, Nebraska 68509.
011. ELECTRONIC BRACHYTHERAPY . This section addresses electronic brachytherapy.
011.01 APPLICABILITY. Electronic brachytherapy devices are subject to the requirements of 180 NAC 20-011, and are exempt for the requirements of 180 NAC 20-006.
011.01(A) PROHIBITION. An electronic brachytherapy device that does not meet the requirements of 180 NAC 20-011 must not be used for irradiation of patients.
011.01(B) APPROVAL FOR USE. An electronic brachytherapy device must only be utilized for human use applications specifically approved by the U.S. Food and Drug Administration (FDA) unless participating in a research study approved by the registrant’s Institutional Review Board (IRB).
011.02 POSSESSION OF SURVEY INSTRUMENTS. Each location authorized to use an electronic brachytherapy device according to 180 NAC 20-011 must possess appropriately calibrated portable monitoring equipment. As a minimum, the equipment must include a portable radiation measurement survey instrument capable of measuring dose rates over the range 10 microSievert (μSv) or 1 millirem (mrem) per hour to 10 milliSievert (mSv) or 1000 millirem (mrem) per hour. The survey instrument or instruments must be operable and calibrated in according to 180 NAC 20-008 for the applicable electronic brachytherapy source energy.
011.03 FACILITY DESIGN REQUIREMENTS FOR ELECTRONIC BRACHYTHERAPY DEVICES. In addition to shielding adequate to meet requirements of 180 NAC 20-009, the treatment room must meet the following design requirements.
011.03(A) SIMULTANEOUS OPERATION. If applicable, provision must be made to prevent simultaneous operation of more than one therapeutic radiation machine in a treatment room.
011.03(B) ENTRANCE. Access to the treatment room must be controlled by a door at each entrance.
011.03(C) CONTINUOUS AURAL COMMUNICATION AND VISUAL OBSERVATION. Each treatment room must have provisions to permit continuous aural communication and visual observation of the patient from the treatment control panel during irradiation. The electronic brachytherapy device must not be used for patient irradiation unless the patient can be observed.
011.03(D) SHIELDING FOR DEVICES OPERATING BELOW 50 KILOVOLTS (KV). For electronic brachytherapy devices capable of operating below 50 kilovolts (kV), radiation shielding for the staff in the treatment room must be available, either as a portable shield or as localized shielded material around the treatment site.
011.03(E) SHIELDING FOR DEVICES OPERATING ABOVE 150 KILOVOLTS (KV). For electronic brachytherapy devices capable of operating at greater than 150 kilovolts (kV):
(i) The control panel must be located outside the treatment room; and (ii) Electrical interlocks must be provided for all door or doors to the treatment room that must:
(1) Prevent the operator from initiating the treatment cycle unless each treatment room entrance door is closed; (2) Cause the source to be shielded when an entrance door is opened; and (3) 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.
011.04 ELECTRICAL SAFETY FOR ELECTRONIC BRACHYTHERAPY DEVICES. The requirements for electrical safety for electronic brachytherapy devices are as follows.
011.04(A) ELECTRICAL AND MAGNETIC INTERFERENCE. The high voltage transformer must be electrically isolated to prevent electrical and magnetic interference with the surrounding environment and ancillary equipment.
011.04(B) PROTECTIVE HOUSING. The high voltage transformer must be isolated from personnel, 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.
011.04(C) SAFETY LABELS. The high voltage transformer must have appropriate safety labels warning personnel of potential electrical shock or heat related injuries.
011.05 CONTROL PANEL FUNCTIONS. In addition to the displays required by other provisions of 180 NAC 20-011, the control panel must:
(A) Provide an indication of whether electrical power is available at the control panel and if activation of the electronic brachytherapy source is possible; (B) Provide an indication of whether x-rays are being produced; and (C) Provide a means for indicating electronic brachytherapy source potential and current;
(i) Provide the means for terminating an exposure at any time; and (ii) Include an access control or locking device that will prevent unauthorized use of the electronic brachytherapy device.
011.06 TIMER. A suitable irradiation control device or timer must be provided to terminate the irradiation after a pre-set time interval or integrated charge on a dosimeter-based monitor.
011.06(A) TIMER INDICATIONS. A timer must be provided at the treatment control panel. The timer must indicate the planned setting and the time elapsed or remaining.
011.06(B) PREVENT EXPOSURE IF SET AT ZERO. The timer must not permit an exposure if set at zero.
011.06(C) CUMULATIVE DEVICE. The timer must 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 must be necessary to reset the elapsed time indicator.
011.06(D) IRRADIATION TERMINATION. The timer must terminate irradiation when a pre-selected time has elapsed, if any dose monitoring system has not previously terminated irradiation.
011.06(E) SHORT TIMER SETTING. The timer must permit setting of exposure times as short as 0.1 second.
011.06(F) TIMER ACCURACY. The timer must be accurate to within one percent of the selected value or 0.1 second, whichever is greater.
011.07 RADIOLOGICAL MEDICAL PHYSICIST SUPPORT. The services of a radiological medical physicist is required for registrants using electronic brachytherapy devices.
011.07(A) RADIOLOGICAL MEDICAL PHYSICIST RESPONSIBILITIES. The radiological medical physicist is responsible for:
(i) Evaluation of the output from the electronic brachytherapy source; (ii) Generation of the necessary dosimetric information; (iii) Supervision and review of treatment calculations prior to initial treatment of any treatment site; (iv) Establishing the periodic and day-of-use quality assurance checks and reviewing the data from those checks as required in 20-011.10; (v) Consultation with the user in treatment planning, as needed; and (vi) Performing calculations and assessments regarding patient treatments that may constitute a misadministration.
011.07(B) RADIOLOGICAL MEDICAL PHYSICIST CONTACT INFORMATION. If the radiological medical physicist is not a full-time employee of the registrant, the operating procedures required by 20-011.08 must also specifically address how the radiological medical physicist is to be contacted for problems or emergencies, as well as the specific actions, if any, to be taken until the radiological medical physicist can be contacted.
011.08 OPERATING PROCEDURES. The requirements for operating procedures are as follows.
011.08(A) INDIVIDUALS PRESENT IN THE TREATMENT ROOM. Only individuals approved by the user or radiological medical physicist may be present in the treatment room during treatment.
011.08(B) PROHIBITION. Electronic brachytherapy devices must not be made available for medical use unless the requirements of 180 NAC 20-004.01, 20-011.09 and 20-010.10 have been met.
011.08(C) SECURE WHEN UNATTENDED. The electronic brachytherapy device must be inoperable, either by hardware or password, when unattended by qualified staff or service personnel.
011.08(D) MONITOR TO PREVENT UNSHIELDED EXPOSURE. During operation, the electronic brachytherapy device operator must 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.
011.08(E) MECHANICAL SUPPORTING OR RESTRAINING DEVICES. If a patient must be held in position during treatment, mechanical supporting or restraining devices must be used.
011.08(F) WRITTEN PROCEDURES. Written procedures must be developed, implemented, and maintained for responding to an abnormal situation. These procedures must include:
(i) Instructions for responding to equipment failures and the names of the individuals responsible for implementing corrective actions; and (ii) The names and telephone numbers of the users and the radiological medical physicist to be contacted if the device or console operates abnormally.
011.08(G) PHYSICAL LOCATION OF OPERATING AND EMERGENCY PROCEDURES. A copy of the current operating and emergency procedures must be physically located at the electronic brachytherapy device control console. If the control console is integral to the electronic brachytherapy device, the required procedures must be kept where the operator is located during electronic brachytherapy device operation.
011.08(H) CONTACT INFORMATION. Instructions must be posted at the electronic brachytherapy device control console to inform the operator of the names and telephone numbers of the users and radiological medical physicist to be contacted if the device or console operates abnormally.
011.09 SAFETY PRECAUTIONS FOR ELECTRONIC BRACHYTHERAPY DEVICES. The safety precautions for electronic brachytherapy devices are as follows.
011.09(A) MONITORING. A radiological medical physicist must determine which persons in the treatment room require monitoring when the beam is energized.
011.09(B) PHYSICALLY PRESENT DURING INITIATION OF TREATMENTS. A user and a radiological medical physicist must be physically present during the initiation of all patient treatments involving the electronic brachytherapy device.
011.09(C) PHYSICALLY PRESENT DURING CONTINUATION OF TREATMENTS. A radiological medical physicist and either a user, a physician, or electronic brachytherapy device operator, under the supervision of a user, who has been trained in the operation and emergency response for the electronic brachytherapy device, must be physically present during continuation of all patient treatments involving the electronic brachytherapy device.
011.09(D) USE OF A RADIATION SURVEY METER. When shielding is required by 180 NAC 20-011.03D the electronic brachytherapy device operator must use a survey meter to verify proper placement of the shielding immediately upon initiation of treatment. Alternatively, a radiological medical physicist must designate shield locations sufficient to meet the requirements of 180 NAC 4-005 for any individual, other than the patient, in the treatment room.
011.09(E) PERSONNEL SHIELDING. All personnel in the treatment room are required to remain behind shielding during treatment. A radiological medical physicist must approve any deviation from this requirement and must designate alternative radiation safety protocols, compatible with patient safety, to provide an equivalent degree of protection.
011.10 ELECTRONIC BRACHYTHERAPY SOURCE CALIBRATION MEASUREMENTS. The requirements for electronic brachytherapy source calibration measurements are as follows.
011.10(A) PERFORMANCE OF ELECTRONIC BRACHYTHERAPY SOURCE OUTPUT CALIBRATION. Calibration of the electronic brachytherapy source output for an electronic brachytherapy device subject to 180 NAC 20-011 must be performed by, or under the direct supervision of, a radiological medical physicist.
011.10(B) CALIBRATION FREQUENCY. Calibration of the electronic brachytherapy source output must be made for each electronic brachytherapy source, after any repair affecting the x-ray beam generation, and when indicated by the electronic brachytherapy source quality assurance checks.
011.10(C) DOSIMETRY SYSTEM. Calibration of the electronic brachytherapy source output must utilize a dosimetry system described in 180 NAC 20-004.03(A).
011.10(D) ELECTRONIC BRACHYTHERAPY SOURCE OUTPUT CALIBRATION. Calibration of the electronic brachytherapy source output must include, as applicable, determination of:
(i) The output within two percent of the expected value, if applicable, or determination of the output if there is no expected value; (ii) Timer accuracy and linearity over the typical range of use; (iii) Proper operation of back-up exposure control devices; (iv) Evaluation that the relative dose distribution about the source is within five percent of that expected; and (v) Source positioning accuracy to within one millimeter within the applicator;
011.10(E) CALIBRATION PROTOCOL. Calibration of the x-ray source output required by 180 NAC 20-010.09(A) through (F) must be those in current published recommendations from a recognized national professional association with expertise in electronic brachytherapy. The manufacturer’s calibration protocol must be followed.
011.10(F) CALIBRATION RECORDS. The registrant must maintain a record of each calibration in an auditable form for the duration of the registration. The record must include:
(i) The date of the calibration; (ii) The manufacturer's name, model number, and serial number for the electronic brachytherapy device and a unique identifier for its electronic brachytherapy source; (iii) The model numbers and serial numbers of the instrument or instruments used to calibrate the electronic brachytherapy device; and (iv) The name and signature of the radiological medical physicist responsible for performing the calibration.
011.11 PERIODIC AND DAY-OF-USE QUALITY ASSURANCE CHECKS FOR ELECTRONIC BRACHYTHERAPY DEVICES. Periodic and day-of-use quality assurance checks for electronic brachytherapy devices are as follows.
011.11(A) QUALITY ASSURANCE CHECK FREQUENCY. Quality assurance checks must be performed on each electronic brachytherapy device subject to 180 NAC 20-011:
(i) At the beginning of each day-of-use; (ii) Each time the device is moved to a new room or site. A site includes each day-of-use at each operating location for a self-contained electronic brachytherapy unit transported in a van or trailer; and (iii) After each x-ray tube installation.
011.11(B) PROCEDURES FOR PERIODIC QUALITY ASSURANCE CHECKS. The registrant must perform periodic quality assurance checks required by 180 NAC 20-011.11(A) in procedures established by the radiological medical physicist.
011.11(C) QUALITY ASSURANCE CHECK CONTENT. To satisfy the requirements of 180 NAC 20-011.11(A), radiation output quality assurance checks must include, at a minimum:
(i) Verification that output of the electronic brachytherapy source falls within three percent of expected values, as appropriate for the device, as determined by:
(1) Output as a function of time, or (2) Output as a function of setting on a monitor chamber.
(ii) Verification of the consistency of the dose distribution to within three percent of that found during calibration required by 180 NAC 20-011.10; and (iii) Validation of the operation of positioning methods to ensure that the treatment dose exposes the intended location within one millimeter.
011.11(D) DOSIMETRY SYSTEM. The registrant must use a dosimetry system that has been intercompared within the previous twelve months with the dosimetry system described in 180 NAC 20-004.03(A) to make the quality assurance checks required in 180 NAC 20-011.11(C).
011.11(E) REVIEW OF QUALITY ASSURANCE CHECK RESULTS. The registrant must review the results of each radiation output quality assurance check according to the following procedures:
(i) A user and radiological medical physicist must be immediately notified if any parameter is not within its acceptable tolerance. The electronic brachytherapy device must not be made available for subsequent medical use until the radiological medical physicist has determined that all parameters are within their acceptable tolerances; (ii) If all radiation output quality assurance check parameters appear to be within their acceptable range, the quality assurance check must be reviewed and signed by either the user or radiological medical physicist within two days; and (iii) The radiological medical physicist must review and sign the results of each radiation output quality assurance check at intervals not to exceed thirty days.
011.11(F) SAFETY DEVICE QUALITY ASSURANCE CHECKS. To satisfy the requirements of 180 NAC 20-011.11(A), safety device quality assurance checks must, at a minimum, assure:
(i) Proper operation of radiation exposure indicator lights on the electronic brachytherapy device and on the control console; (ii) Proper operation of viewing and intercom systems in each electronic brachytherapy facility, if applicable; (iii) Proper operation of radiation monitors, if applicable; (iv) The integrity of all cables, catheters or parts of the device that carry high voltages; and (v) Connecting guide tubes, transfer tubes, transfer-tube-applicator interfaces, and treatment spacers are free from any defects that interfere with proper operation.
011.11(G) SAFETY DEVICE QUALITY ASSURANCE CHECK RESULTS. If the results of the safety device quality assurance checks required in 180 NAC 20-011.11(F) indicate the malfunction of any system, a registrant must 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.
011.11(H) QUALITY ASSURANCE CHECK PROTOCOL. Quality assurance checks required by 20-011.11(A) through (F) must be those in current published recommendations from a recognized national professional association with expertise in electronic brachytherapy, or the manufacturer’s quality assurance check protocol.
011.11(I) RECORD MAINTENANCE. The registrant must maintain a record of each quality assurance check required by 180 NAC 20-011.11(C) and 20-011.11(F) in an auditable form for three years and must include:
(i) The date of the quality assurance check; (ii) The manufacturer's name, model number, and serial number for the electronic brachytherapy device;
(1) The name and signature of the individual who performed the periodic quality assurance check; and (2) The name and signature of the radiological medical physicist who reviewed the quality assurance check; and
(iii) For radiation output quality assurance checks required by 180 NAC 20-011.11(C) the record must also include:
(1) The unique identifier for the electronic brachytherapy source and the manufacturer's name; and (2) The model number and serial number for the instrument or instruments used to measure the radiation output of the electronic brachytherapy device.
011.12 THERAPY-RELATED COMPUTER SYSTEMS. The registrant must perform acceptance testing on the treatment planning system of electronic brachytherapy related computer systems according to 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 must be followed.
011.12(A) ACCEPTANCE TESTING. Acceptance testing must be performed by, or under the direct supervision of, radiological medical physicist. At a minimum, the acceptance testing must include, as applicable, verification of:
(i) The source-specific input parameters required by the dose calculation algorithm; (ii) The accuracy of dose, dwell time, and treatment time calculations at representative points; (iii) The accuracy of isodose plots and graphic displays; (iv) The accuracy of the software used to determine radiation source positions from radiographic images; and (v) 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.
011.12(B) APPLICATOR POSITION INDICATORS. The position indicators in the applicator must be compared to the actual position of the source or planned dwell positions, as appropriate, at the time of commissioning.
011.12(C) INDEPENDENT VERIFICATION. Prior to each patient treatment regimen, the parameters for the treatment must be evaluated and approved by the user and the radiological medical physicist for accuracy through means independent of that used for the determination of the parameters.
011.13 TRAINING. The requirements for training are as follows.
011.13(A) TRAINING ON OPERATING PROCEDURES. A registrant must 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 180 NAC 20-011.08. If the interval between patients exceeds one year, retraining of the individuals must be provided.
011.13(B) DEVICE SPECIFIC TRAINING. In addition to the requirements of 180 NAC 20-003.03 for therapeutic radiation machine users and 180 NAC 20-003.04 for radiological medical physicists, these individuals must also receive device specific instruction initially from the manufacturer, and annually from either the manufacturer or other qualified trainer. The training must 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 must be followed. The training must include, but not be limited to:
(i) Device-specific radiation safety requirements; (ii) Device operation; (iii) Clinical use for the types of use approved by the U.S. Food and Drug Administration (FDA); (iv) Emergency procedures, including an emergency drill; and (v) The registrant’s quality assurance program.
011.13(C) RECORDS. A registrant must retain a record of individuals receiving instruction required by 180 NAC 20-011.13(A) and (B) for three years. The record must include:
(i) A list of the topics covered; (ii) The date of the instruction; (iii) The name or names of the attendee or attendees; and (iv) The name or names of the individual or individuals who provided the instruction.
011.14 MOBILE ELECTRONIC BRACHYTHERAPY SERVICE. This section addresses the requirements for registrants providing mobile electronic brachytherapy service.
011.14(A) SURVEY INSTRUMENT FUNCTION CHECK. All survey instruments must be checked before medical use at each address of use or on each day-of-use, whichever is more restrictive.
011.14(B) ACCOUNT FOR ELECTRONIC BRACHYTHERAPY SOURCE BEFORE DEPARTURE. Each electronic brachytherapy source must be accounted for in the electronic brachytherapy device before departure from the client’s address.
011.14(C) QUALITY ASSURANCE CHECKS. At each location on each day-of-use, all of the required quality assurance checks specified in 180 NAC 20-011.11 must be performed to assure proper operation of the device.
012. OTHER USES OF ELECTRONICALLY PRODUCED RADIATION TO DELIVER THERAPEUTIC RADIATION DOSAGE . A person must not utilize any device which is designed to electrically generate a source of ionizing radiation to deliver therapeutic radiation dosage, and which is not regulated under any existing category of therapeutic radiation machine, until the following requirements have been met.
012.01 SUBMISSION REQUIREMENTS. The applicant or registrant must submit:
(A) A detailed description of the device and its intended application or applications; (B) Facility design requirements, including shielding and access control; (C) Documentation of appropriate training for users and radiological medical physicist or physicists; (D) Methodology for measurement of dosages to be administered to patients or human research subjects; (E) Documentation regarding calibration, maintenance, and repair of the device, as well as instruments and equipment necessary for radiation safety (F) Radiation safety precautions and instructions; and (G) Other information requested by the Department in its review of the application.
012.02 WRITTEN APPROVAL. The applicant or registrant must receive written approval from the Department to utilize a device specified in 180 NAC 20-012. The device may be used only as specified in this chapter and specific conditions the Department considers necessary for the medical use of the device.
APPENDIX 20-A
INFORMATION ON RADIATION SHIELDING REQUIRED FOR PLAN REVIEWS
I. ALL THERAPEUTIC RADIATION MACHINES MUST SUBMIT THE FOLLOWING INFORMATION:
(A) Basic information including: name and telephone number of the individual responsible for preparation of the shielding plan; name and telephone number of the supervisor at the registrant’s facility; and the street address, including room number of the therapeutic radiation machine. The plan should also indicate whether this is a new structure or a modification to existing structure or structures; (B) All wall, floor, and ceiling areas struck by the useful beam must have primary barriers; and (C) Secondary barriers must be provided in all wall, floor, and ceiling areas not having primary barriers.
II. THERAPEUTIC RADIATION MACHINES UP TO 150 KILOVOLTS (KV) - PHOTONS ONLY. In addition to the information listed in Section I, registrants using therapeutic radiation machines that produce only photons with a maximum energy less than or equal to 150 kilovolts (kV) must submit shielding plans which contain, at a minimum, the following additional information:
(A) Equipment specifications, including the manufacturer and model number of the therapeutic radiation machine, as well as the maximum technique factors; (B) Maximum design workload for the machine including total weekly radiation output, expressed in gray or rad, or air kerma at 1 meter, total beam-on time per day or week, the average treatment time per patient, along with the anticipated number of patients to be treated per day or week; (C) A facility blueprint or drawing indicating: scale, 0.25 inch = 1 foot is typical; direction of North; normal location of the therapeutic radiation machine's radiation port or ports; the port's travel and traverse limits; general direction or directions of the useful beam; locations of any windows and doors; and the location of the therapeutic radiation machine control panel. If the control panel is located inside the therapeutic radiation machine treatment room, the location of the operator's booth must be noted on the plan and the operator's station at the control panel must be behind a protective barrier sufficient to ensure compliance with 180 NAC 4-005; (D) The structural composition and thickness or lead or concrete equivalent of all walls, doors, partitions, floor, and ceiling of the room or rooms concerned; (E) The type of occupancy of all adjacent areas inclusive of space above and below the room or rooms concerned. If there is an exterior wall, show distance to the closest area or areas where it is likely that individuals may be present; and (F) At least one example calculation which shows the methodology used to determine the amount of shielding required for each physical condition, primary and secondary or leakage barriers, restricted and unrestricted areas, entry door or doors and shielding material in the facility:
(i) If commercial software is used to generate shielding requirements, also identify the software used and the version or revision date. (ii) Submit quality control sample calculations to verify the result obtained with the software.
III. THERAPEUTIC RADIATION MACHINES OVER 150 KILOVOLTS (KV). In addition to the information listed in Section I, registrants using therapeutic radiation machines that produce photons with a maximum energy in excess of 150 kilovolts (kV) or electrons must submit shielding plans which contain, as a minimum, the following additional information:
(A) Equipment specifications including the manufacturer and model number of the therapeutic radiation machine, and gray (rad) at the isocenter and the energy or energies and type or types of radiation produced, photon or electron. The target to isocenter distance must be specified; (B) Maximum design workload for the machine including total weekly radiation output, expressed in gray or rad at 1 meter, total beam-on time per day or week, the average treatment time per patient, along with the anticipated number of patients to be treated per day or week; (C) Facility blueprint or drawing [including both floor plan and elevation views] indicating relative orientation of the therapeutic radiation machine, scale, 0.25 inch = 1 foot is the typical scale, type or types, thickness and minimum density of shielding material or materials, direction of North, the locations and size of all penetrations through each shielding barrier, ceiling, walls and floor, as well as details of the door or doors and maze; (D) The structural composition and thickness or concrete equivalent of all walls, doors, partitions, floor, and ceiling of the room or rooms concerned; (E) The type of occupancy of all adjacent areas inclusive of space above and below the room or rooms concerned. If there is an exterior wall, show distance to the closest area or areas where it is likely that individuals may be present; (F) Description of all assumptions that were in shielding calculations including, but not limited to, design energy, room may be designed for 6 megavolt (MV) unit although only a 4 megavolt (MV) unit is currently proposed, work load, presence of integral beam stop in unit, occupancy and use or uses of adjacent areas, fraction of time that useful beam will intercept each permanent barrier, walls, floor and ceiling, and expected radiation exposure in both restricted and unrestricted areas; and (G) At least one example calculation which shows the methodology used to determine the amount of shielding required for each physical condition, primary and secondary or leakage barriers, restricted and unrestricted areas, small angle scatter, entry door or doors and maze, and shielding material in the facility:
(i) If commercial software is used to generate shielding requirements, also identify the software used and the version or revision date; and (ii) If the software used to generate shielding requirements is not in the open literature, also submit quality control sample calculations to verify the result obtained with the software.
IV. NEUTRON SHIELDING. In addition to the information listed in Section III, registrants using therapeutic radiation machines that are capable of operating above 10 megavolts (MV) must submit shielding plans which contain, as a minimum, the following additional information:
(A) The structural composition, thickness, minimum density and location of all neutron shielding material; (B) Description of all assumptions that were used in neutron shielding calculations including, but not limited to, neutron spectra as a function of energy, neutron fluence rate, absorbed dose and dose equivalent, due to neutrons, in both restricted and unrestricted areas; (C) At least one example calculation which shows the methodology used to determine the amount of neutron shielding required for each physical condition, restricted and unrestricted areas, entry door or doors and maze, and neutron shielding material utilized in the facility:
(i) If commercial software is used to generate shielding requirements, also identify the software used and the version or revision date; and (ii) If the software used to generate shielding requirements is not in the open literature, also submit quality control sample calculations to verify the results obtained with the software; and
(D) The method or methods and instrumentation that will be used to verify the adequacy of all neutron shielding installed in the facility.
V. REFERENCES. References for shielding designs are as follows and are available for viewing at the Department of Health and Human Services, Division of Public Health, Office of Radiological Health, 301 Centennial Mall South, 3rd Floor, Lincoln, Nebraska 68509:
(A) NCRP Report 49, "Structural Shielding Design and Evaluation for Medical Use of X-Rays and Gamma Rays of Energies Up to 10 MeV" (1976). (B) NCRP Report 79, "Neutron Contamination from Medical Electron Accelerators" (1984). (C) NCRP Report 144, "Radiation Protection for Particle Accelerator Facilities" (2003). (D) NCRP Report 151, “Structural Shielding Design and Evaluation for Megavoltage X and Gamma-Ray Radiotherapy Facilities. (2006).
History
- Effective 2020-11-21
Chapter 22 Shipping of High Level Radioactive or Transuranic Waste
Neb. Admin. Code tit. 180, ch. 22 Shipping of High Level Radioactive or Transuranic Waste {#sec-180-nac-22 omnilex-key=us-ne-regs-official--title-180--180 NAC 22}
Effective Date: 11/25/2020
001. SCOPE AND AUTHORITY . These regulations establish fees for shipment of high-level waste and transuranic waste. The regulations are authorized by Nebraska Revised Statute (Neb. Rev. Stat.) §§ 71-3523 to 71-3528.
002. FEE PER CASK . The fee for each cask of high-level radioactive waste or transuranic waste is $3,100.
History
- Effective 2020-11-25
Chapter 23 Fluoroscopic Education and Training for Certified Registered Nurse Anesthetists
Neb. Admin. Code tit. 180, ch. 23 Fluoroscopic Education and Training for Certified Registered Nurse Anesthetists {#sec-180-nac-23 omnilex-key=us-ne-regs-official--title-180--180 NAC 23}
Effective Date: 11/25/2020
001. SCOPE AND AUTHORITY . This chapter establishes the minimum education and training requirements for certified registered nurse anesthetists performing fluoroscopy. The regulations are authorized by and implement the Radiation Control Act, Nebraska Revised Statute (Neb. Rev. Stat.) § 71-3508 and the Certified Registered Nurse Anesthetist Practice Act, Neb. Rev. Stat. § 38-711. Upon successful completion of the approved education and training the certified registered nurse anesthetist may use fluoroscopy in conjunction with a licensed medical radiographer to perform authorized duties and functions.
002. DEFINITIONS . The following definitions apply to this chapter:
002.01 APPROVED EDUCATION PROGRAM. The University of Nebraska Medical Center’s “Fluoroscopy Radiation Safety Training for UNMC/The Nebraska Medical Center” or equivalent course as approved jointly by the Department and the Advanced Practice Registered Nursing Board is an approved educational program.
002.02 FLUOROSCOPY. An imaging technique used to obtain real-time moving images of the internal structures of a patient through the use of a fluoroscope is fluoroscopy.
003. GENERAL REQUIREMENTS . Documentation of completion of required education and training must be maintained at each facility where a Certified Registered Nurse Anesthetist performs fluoroscopy.
004. ADMINISTRATIVE CONTROLS . Prior to the use of fluoroscopic equipment by a certified registered nurse anesthetist the registrant must ensure that:
(A) The certified registered nurse anesthetist has successfully completed an approved educational program in fluoroscopy and received hands-on training in the use of a fluoroscope by completing at least three fluoroscopic procedures under the direct supervision of and in the physical presence of a physician or a person meeting the requirements of 180 NAC 23; and (B) The requirements of Neb. Rev. Stat. § 38-711 (3) are met.
History
- Effective 2020-11-25
Chapter 24 Physical Protection of Radioactive Material
Neb. Admin. Code tit. 180, ch. 24 Physical Protection of Radioactive Material {#sec-180-nac-24 omnilex-key=us-ne-regs-official--title-180--180 NAC 24}
Effective Date: 11/2/2022
001. SCOPE AND AUTHORITY . 180 Nebraska Administrative Code (NAC) 24 has been established to provide the requirements for the physical protection program for any licensee that possesses an aggregated category 1 or category 2 quantity of radioactive material listed in Appendix 24-A of 180 NAC 24. These requirements provide reasonable assurance of the security of category 1 or category 2 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 180 NAC 24 authorizes possession of licensed material.
001.01 APPLICABILITY. 180 NAC 24-004 through 24-019 apply to any person who, under 180 NAC 24, possesses or uses at any site, an aggregated category 1 or category 2 quantity of radioactive material.
001.02 TRANSPORT. 180 NAC 24-020 through 24-025 applies to any person who:
(A) Transports or delivers to a carrier for transport in a single shipment, a category 1 or category 2 quantity of radioactive material; or (B) Imports or exports a category 1 or category 2 quantity of radioactive material; the provisions only apply to the domestic portion of the transport.
002. DEFINITIONS . For purposes of 180 NAC 24 the following definitions apply:
002.01 ACCESS CONTROL. 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.
002.02 AGGREGATED. 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 2 quantity of radioactive material.
002.03 APPROVED INDIVIDUAL. An individual whom the licensee has determined to be trustworthy and reliable for unescorted access in accordance with 180 NAC 24-004 through 24-010 and who has completed the training required by 180 NAC 24-012.03.
002.04 BACKGROUND INVESTIGATION. An investigation conducted by a licensee or applicant to support the determination of trustworthiness and reliability.
002.05 CATEGORY 1 QUANTITY OF RADIOACTIVE MATERIAL. The quantity of radioactive material meeting or exceeding the category 1 threshold in Table 1 of Appendix 24-A in 180 NAC 24. This is determined by calculating the ratio of the total activity of each radionuclide to the category 1 threshold for that radionuclide and adding the ratios together. If the sum is equal to or exceeds 1, the quantity would be considered a category 1 quantity. Category 1 quantities of radioactive material do not include the radioactive material contained in any fuel assembly, subassembly, fuel rod, or fuel pellet.
002.06 CATEGORY 2 QUANTITY OF RADIOACTIVE MATERIAL. The quantity of radioactive material meeting or exceeding the category 2 threshold but less than the category 1 threshold in Table 1 of Appendix 24-A in 180 NAC 24. This is determined by calculating the ratio of the total activity of each radionuclide to the category 2 threshold for that radionuclide and adding the ratios together. If the sum is equal to or exceeds 1, the quantity would be considered a category 2 quantity. Category 2 quantities of radioactive material do not include the radioactive material contained in any fuel assembly, subassembly, fuel rod, or fuel pellet.
002.07 DIVERSION. Unauthorized movement of radioactive material subject to 180 NAC 24 to a location different from the material's authorized destination inside or outside of the site at which the material is used or stored.
002.08 ESCORTED ACCESS. 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.
002.09 FINGERPRINT ORDERS. Orders issued by the U.S. Nuclear Regulatory Commission (NRC) or the legally binding requirements issued by the Department or Agreement States that require fingerprints and criminal history records checks for individuals with unescorted access to category 1 and category 2 quantities of radioactive material or safeguards information-modified handling.
002.10 LICENSE ISSUING AUTHORITY. A licensing agency that issued the license, such as the Department, the NRC or the appropriate agency of an Agreement State.
002.11 LOCAL LAW ENFORCEMENT AGENCY (LLEA). 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 1 or category 2 quantity of radioactive material is used, stored, or transported.
002.12 MOBILE DEVICE. 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.
002.13 MOVEMENT CONTROL CENTER. 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.
002.14 NO-LATER-THAN ARRIVAL TIME. 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 6 hours after the estimated arrival time for shipments of category 2 quantities of radioactive material.
002.15 REVIEWING OFFICIAL. An individual who must 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 1 or category 2 quantities of radioactive materials that are possessed by the licensee.
002.16 SABOTAGE. Deliberate damage, with malevolent intent, to a category 1 or category 2 quantity of radioactive material, a device that contains a category 1 or category 2 quantity of radioactive material, or the components of the security system.
002.17 SAFE HAVEN. 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.
002.18 SECURITY ZONE. Any temporary or permanent area determined and established by the licensee for the physical protection of category 1 or category 2 quantities of radioactive material.
002.19 STATE. 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.
002.20 TELEMETRIC POSITION MONITORING SYSTEM. A data transfer system that captures information by instrumentation or measuring devices about the location and status of a transport vehicle or package between the departure and destination locations.
002.21 TRUSTWORTHINESS AND RELIABILITY. Characteristics of an individual considered dependable in judgment, character, and performance, such that unescorted access to category 1 or category 2 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.
002.22 UNESCORTED ACCESS. Solitary access to an aggregated category 1 or category 2 quantity of radioactive material or the devices that contain the material.
002.23 UNITED STATES. The United States when used in a geographical sense, includes Puerto Rico and all territories and possessions of the United States.
003. SPECIFIC EXEMPTIONS . A licensee that possesses radioactive waste containing category 1 or category 2 quantities of radioactive material is exempt from the requirements 180 NAC 24 24-004 through 25-025. Except that any radioactive waste that contains discrete sources, ion-exchange resins, or activated material that weighs less than 4,409 pounds (2,000 kg) is not exempt from the requirements 180 NAC 24. To secure radioactive waste licensees must:
(A) Use continuous physical barriers that allow access to the radioactive waste only through established access control points; (B) Use a locked door or gate with monitored alarm at the access control point; (C) Assess and respond to each actual or attempted unauthorized access to determine whether an actual or attempted theft, sabotage, or diversion occurred; and (D) Immediately notify the 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 1 or category 2 quantities of radioactive material.
004. PERSONNEL ACCESS AUTHORIZATION REQUIREMENTS FOR CATEGORY 1 OR CATEGORY 2 QUANTITIES OF RADIOACTIVE MATERIAL .
004.01 GENERAL.
004.01(A) ACCESS AUTHORIZATION PROGRAM. Each licensee that possesses an aggregated quantity of radioactive material at or above the category 2 threshold must establish, implement, and maintain its access authorization program in accordance with the requirements of 180 NAC 24-004 through 24-010.
004.01(B) NEW LICENSE OR LICENSE AMENDMENT. An applicant for a new license and each licensee that would become newly subject to the requirements of 180 NAC 24-004 through 24-010 upon application for modification of its license must implement the requirements of 180 NAC 24-004 through 24.010, as appropriate, before taking possession of an aggregated category 1 or category 2 quantity of radioactive material.
004.01(C) SECURITY ORDERS. Any licensee that has not previously implemented the Security Orders or been subject to the provisions of 180 NAC 24-004 through 24-010 must implement the provisions of 180 NAC 24-004 through 24-010 before aggregating radioactive material to a quantity that equals or exceeds the category 2 threshold.
004.02 GENERAL PERFORMANCE OBJECTIVE. The licensee’s access authorization program must ensure that the individuals specified in 180 NAC 24-004.03(A) are trustworthy and reliable.
004.03 APPLICABILITY.
(A) Licensees must subject the following individuals to an access authorization program:
(i) Any individual whose assigned duties require unescorted access to category 1 or category 2 quantities of radioactive material or to any device that contains the radioactive material; and (ii) Reviewing officials.
(B) Licensees need not subject the categories of individuals listed in 180 NAC 24-008.01(A) through (M) to the investigation elements of the access authorization program. (C) Licensees must approve for unescorted access to category 1 or category 2 quantities of radioactive material only those individuals with job duties that require unescorted access to category 1 or category 2 quantities of radioactive material. (D) Licensees may include individuals needing access to safeguards information-modified handling under 10 CFR 73 in the access authorization program under 180 NAC 24-004 through 24-010.
005. ACCESS AUTHORIZATION PROGRAM REQUIREMENTS .
005.01 GRANTING UNESCORTED ACCESS AUTHORIZATION. Requirements for granting unescorted access authorization are:
(A) Licensees must implement the requirements of 180 NAC 24-004 through 24-010 for granting initial or reinstated unescorted access authorization; and (B) Individuals who have been determined to be trustworthy and reliable must also complete the security training required by 180 NAC 24-012.03 before being allowed unescorted access to category 1 or category 2 quantities of radioactive material.
005.02 REVIEWING OFFICIALS.
005.02(A) TRUSTWORTHINESS AND RELIABILITY DETERMINATIONS. Reviewing officials are the only individuals who may make trustworthiness and reliability determinations that allow individuals to have unescorted access to category 1 or category 2 quantities of radioactive materials possessed by the licensee.
005.02(B) REVIEWING OFFICIAL APPOINTMENT. Each licensee must name one or more individuals to be reviewing officials. After completing the background investigation on the reviewing official, the licensee must 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 Department, ATTN: Radioactive Materials Program. 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 must recertify that the reviewing official is deemed trustworthy and reliable every ten years in accordance with 180 NAC 24-006.03.
005.02(C) UNESCORTED ACCESS. Reviewing officials must be permitted to have unescorted access to category 1 or category 2 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.
005.02(D) LIMITATION. Reviewing officials cannot approve other individuals to act as reviewing officials.
005.02(E) EXCEPTION. A reviewing official does not need to undergo a new background investigation before being named by the licensee as the reviewing official if:
(i) The individual has undergone a background investigation that included fingerprinting and an FBI criminal history records check and has been determined to be trustworthy and reliable by the licensee; or (ii) The individual is subject to a category listed in 180 NAC 24-008.01.
005.03 INFORMED CONSENT. Licensees may not initiate a background investigation without the informed and signed consent of the subject individual.
005.03(A) CONSENT. 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 must provide the individual with an opportunity to correct any inaccurate or incomplete information developed during the background investigation. Licensees do not need to obtain signed consent from those individuals that meet the requirements of 180 NAC 24-006.02. A signed consent must be obtained prior to any reinvestigation.
005.03(B) CONSENT WITHDRAWL. The subject individual may withdraw their consent at any time. Licensees must inform the individual that:
(i) If an individual withdraws their consent, the licensee may not initiate any elements of the background investigation that were not in progress at the time the individual withdrew their consent; and (ii) The withdrawal of consent for the background investigation is sufficient cause for denial or termination of unescorted access authorization.
005.04 PERSONAL HISTORY DISCLOSURE. Any individual applying for unescorted access authorization must disclose the personal history information 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 180 NAC 24.004 through 24-010 is sufficient cause for denial or termination of unescorted access.
005.05 DETERMINATION BASIS. Requirements for making a determination for unescorted access are:
(A) The reviewing official must 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 180 NAC 24-004 through 24-010; (B) 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 180 NAC 24-004 through 24-010 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; (C) The licensee must document the basis for concluding whether there is reasonable assurance that an individual is trustworthy and reliable; (D) 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 granted unescorted access authorization; and (E) Licensees must 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 must 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.
005.06 PROCEDURES. Licensees must develop, implement, and maintain written procedures for implementing the access authorization program. The procedures must:
(A) Include provisions for the notification of individuals who are denied unescorted access; (B) Include provisions for the review, at the request of the affected individual, of a denial or termination of unescorted access authorization; and (C) 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.
005.07 RIGHT TO CORRECT AND COMPLETE INFORMATION.
005.07(A) NOTIFICATION OF RIGHTS. Prior to any final adverse determination, licensees must provide each individual subject to 180 NAC 24-004 through 24-010 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.
005.07(B) CHALLENGE PROCEDURE INITIATION. 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 set forth in 28 CFR 16.30 through 16.34. 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 their 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.
005.08 RECORDS. The licensee must retain:
(A) Documentation regarding the trustworthiness and reliability of individual employees for three years from the date the individual no longer requires unescorted access to category 1 or category 2 quantities of radioactive material; (B) 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 must retain the superseded material for three years after the record is superseded; and (C) The list of persons approved for unescorted access authorization for three years after the list is superseded or replaced.
006. BACKGROUND INVESTIGATIONS .
006.01 INITIAL INVESTIGATION. Before allowing an individual unescorted access to category 1 or category 2 quantities of radioactive material or to the devices that contain the material, licensees must 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:
(A) Fingerprinting and an FBI identification and criminal history records check as required by 180 NAC 24-007; (B) Licensees must verify the true identity of the individual who is applying for unescorted access authorization to ensure that the applicant is who they claim to be. A licensee must review official identification documents and compare the documents to personal information data provided by the individual to identify any discrepancy in the information. Official document types include: driver’s license; passport; government identification; or certificate of birth issued by the state, province, or country of birth. Licensees must document the type, expiration, and identification number of the identification document, or maintain a photocopy of identifying documents on file in accordance with 180 NAC 24-009. Licensees must certify in writing that the identification was properly reviewed, and must maintain the certification and all related documents for review upon inspection; (C) Licensees must complete an employment history verification, including military history. Licensees must verify the individual’s employment with each previous employer for the most recent seven years before the date of application; (D) Licensees must verify the individual participated in the education process during the claimed period; (E) Licensees must 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 180 NAC 24-004 through 24-010 must be limited to whether the individual has been and continues to be trustworthy and reliable; (F) The licensee must also, to the extent possible, obtain independent information to corroborate that provided by the individual; and (G) 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 must document the refusal, unwillingness, or inability in the record of investigation; and attempt to obtain the information from an alternate source.
006.02 GRANDFATHERING. The following individuals must be subject to the reinvestigation requirement.
006.02(A) TRUSTWORTHY AND RELIABLE UNDER FINGERPRINT ORDERS. Individuals who have been determined to be trustworthy and reliable for unescorted access to category 1 or category 2 quantities of radioactive material under the Fingerprint Orders may continue to have unescorted access to category 1 and category 2 quantities of radioactive material without further investigation.
006.02(B) TRUSTWORTHY AND RELIABLE UNDER 10 CFR 73 OR SECURITY ORDERS. Individuals who have been determined to be trustworthy and reliable under the provisions of 10 CFR 73 or the security orders for access to safeguards information, safeguards information-modified handling, or risk-significant material may have unescorted access to category 1 and category 2 quantities of radioactive material without further investigation. The licensee must 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 NRC that required fingerprints and an 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.
006.03 REINVESTIGATIONS. Licensees must conduct a reinvestigation every ten years for any individual with unescorted access to category 1 or category 2 quantities of radioactive material. The reinvestigation must consist of fingerprinting and an FBI identification and criminal history records check in accordance with 180 NAC 24-007. The reinvestigations must be completed within ten years of the date on which these elements were last completed.
007. REQUIREMENTS FOR CRIMINAL HISTORY RECORDS CHECKS OF INDIVIDIUAL GRANTED UNESCORTED ACCESS TO CATEGORY 1 OR CATEGORY 2 QUANTITIES OF RADIOACTIVE MATERIALS .
007.01 GENERAL PERFORMANCE OBJECTIVE AND REQUIREMENTS. Licensees must ensure individuals granted unescorted access to category 1 or category 2 quantities of radioactive materials meet the requirements for criminal history records checks.
007.01(A) FINGERPRINTING. Except for those individuals listed in 180 NAC 24-008 and those individuals grandfathered under 180 NAC 24-006.02, each licensee subject to the provisions of this 180 NAC 24-004 through 24-010 must fingerprint each individual who is to be permitted unescorted access to category 1 or category 2 quantities of radioactive material. Licensees must transmit all collected fingerprints to the NRC for transmission to the FBI. The licensee must 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 1 or category 2 quantities of radioactive materials for that individual.
007.01(B) NOTIFICATION. The licensee must notify each affected individual that their fingerprints will be used to secure a review of their criminal history record, and must inform the individual of the procedures for revising the record or adding explanations to the record.
007.01(C) REINSTATEMENT. Fingerprinting is not required if a licensee is reinstating an individual’s unescorted access authorization to category 1 or category 2 quantities of radioactive materials if:
(i) The individual returns to the same facility that granted unescorted access authorization within 365 days of the termination of their unescorted access authorization; and (ii) The previous access was terminated under favorable conditions.
007.01(D) EXCEPTION. 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 1 or category 2 quantities of radioactive material, access to safeguards information, or safeguards information-modified handling by another licensee, based upon a background investigation conducted under 180 NAC 24-004 through 24-010, the Fingerprint Orders, or 10 CFR 73. An existing criminal history records check file may be transferred to the licensee asked to grant unescorted access in accordance with the provisions of 180 NAC 24-009.03.
007.01(E) LIMITATION. Licensees must 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 1 or category 2 quantities of radioactive materials, access to safeguards information, or safeguards information-modified handling.
007.02 PROHIBITIONS. Licensees may not:
(A) Base a final determination to deny an individual unescorted access authorization to category 1 or category 2 quantities of radioactive material solely on the basis of information received from the FBI involving:
(i) An arrest more than one year old for which there is no information of the disposition of the case; or (ii) An arrest that resulted in dismissal of the charge or an acquittal.
(B) Use information received from a criminal history records check obtained under 180 NAC 24-004 through 24-010 in a manner that would infringe upon the rights of any individual under the First Amendment to the Constitution of the United States, nor must licensees use the information in any way that would discriminate among individuals on the basis of race, religion, national origin, gender, or age.
007.03 FINGERPRINT CHECK PROCESSING PROCEDURES.
007.03(A) SUBMISSION. For the purpose of complying with 180 NAC 24-004 through 24-010, licensees must use an appropriate method listed in 10 CFR 37.7 to 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 1 or category 2 quantities of radioactive material. Copies of these forms may be obtained by e-mailing MAILSVS.Resource@nrc.gov. Guidance on submitting electronic fingerprints can be found at http://www.nrc.gov/security/chp.html.
007.03(B) FEES. Fees for the processing of fingerprint checks are due upon application. Licensees must 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 NRC publishes the amount of the fingerprint check application fee on the NRC’s public website. To find the current fee amount, go to the Licensee Criminal History Records Checks and Firearms Background Check information page at http://www.nrc.gov/security/chp.html and see the link for “How do I determine how much to pay for the request?”.
007.03(C) RESULTS. The NRC will forward to the submitting licensee all data received from the FBI as a result of the licensee’s application or applications for criminal history records checks.
008. RELIEF FROM FINGERPRINTING IDENTIFICATION, AND CRIMINAL HISTORY RECORDS CHECK AND OTHER ELEMENTS OF BACKGROUND INVESTIGATIONS FOR DESIGNATED CATEGORIES OF INDIVIDUALS PERMITTED UNESCORTED ACCESS TO CERTAIN RADIOACTIVE MATERIAL .
008.01 EXCEPTED INDIVIDUALS. Fingerprinting, and the identification and criminal history records checks required by section 149 of the Atomic Energy Act of 1954, as amended, and other elements of the background investigation are not required for the following individuals prior to granting unescorted access to category 1 or category 2 quantities of radioactive materials:
(A) An employee of the NRC or of the Executive Branch of the U.S. Government who has undergone fingerprinting for a prior U.S. Government criminal history records check; (B) A member of Congress; (C) An employee of a member of Congress or Congressional committee who has undergone fingerprinting for a prior U.S. Government criminal history records check; (D) The Governor of a State or his or her designated State employee representative; (E) Federal, State, or local law enforcement personnel; (F) State Radiation Control Program Directors and State Homeland Security Advisors or their designated State employee representatives; (G) Agreement State employees conducting security inspections on behalf of the NRC under an agreement executed under section 274.i. of the Atomic Energy Act; (H) Representatives of the International Atomic Energy Agency engaged in activities associated with the U.S. International Atomic Energy Agency Safeguards Agreement who have been certified by the NRC; (I) Emergency response personnel who are responding to an emergency; (J) Commercial vehicle drivers for road shipments of category 1 and category 2 quantities of radioactive material; (K) Package handlers at transportation facilities such as freight terminals and railroad yards; (L) Any individual who has an active Federal security clearance, provided that the individual makes available the appropriate documentation. Written confirmation from the agency or employer that granted the Federal security clearance or reviewed the criminal history records check must be provided to the licensee. The licensee must retain this documentation for a period of three years from the date the individual no longer requires unescorted access to category 1 or category 2 quantities of radioactive material; and (M) 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 1 or category 2 quantities of radioactive material. Written verification from the service provider must be provided to the licensee. The licensee must retain the documentation for a period of three years from the date the individual no longer requires unescorted access to category 1 or category 2 quantities of radioactive material.
008.02 COMPARABLE U.S. GOVERNMENT CRIMINAL HISTORY RECORDS CHECK. Fingerprinting, and the identification and criminal history records checks required by section 149 of the Atomic Energy Act of 1954, 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 the individual makes available the appropriate documentation. Written confirmation from the agency or employer that reviewed the criminal history records check must be provided to the licensee. The licensee must retain this documentation for a period of three years from the date the individual no longer requires unescorted access to category 1 or category 2 quantities of radioactive material. These programs include, but are not limited to:
(A) National Agency Check; (B) Transportation Worker Identification Credentials (TWIC) under 49 CFR part 1572; (C) Bureau of Alcohol, Tobacco, Firearms, and Explosives background check and clearances under 27 CFR part 555; (D) Health and Human Services security risk assessments for possession and use of select agents and toxins under 42 CFR part 73; (E) Hazardous Material security threat assessment for hazardous material endorsement to commercial driver’s license under 49 CFR part 1572; and (F) Customs and Border Protection’s Free and Secure Trade (FAST) Program.
009. PROTECTION OF INFORMATION .
009.01 FILING SYSTEM AND WRITTEN PROCEDURES. Each licensee who obtains background information on an individual under 180 NAC 24-004 through 24-010 must establish and maintain a system of files and written procedures for protection of the record and the personal information from unauthorized disclosure.
009.02 NON-DISCLOSURE. The licensee may not disclose the record or personal information collected and maintained to persons other than the subject individual, their 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 1 or category 2 quantities of radioactive material, safeguards information, or safeguards information-modified handling. 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.
009.03 SHARING OF PERSONAL INFORMATION. The personal information obtained on an individual from a background investigation may be provided to another licensee:
(A) Upon the individual’s written request to the licensee holding the data to disseminate the information contained in his or her file; and (B) The recipient licensee verifies information such as name, date of birth, social security number, gender, and other applicable physical characteristics.
009.04 AVAILABILITY. The licensee must make background investigation records obtained under 180 NAC 24-004 through 24-010 available for examination by an authorized representative of the Department to determine compliance with the regulations and laws.
009.05 RECORDS. The licensee must 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 1 or category 2 quantities of radioactive material.
010. ACCESS AUTHORIZATION PROGRAM REVIEW .
010.01 PROGRAM EVALUATION. Each licensee must be responsible for the continuing effectiveness of the access authorization program. Each licensee must ensure that access authorization programs are reviewed to confirm compliance with the requirements of 180 NAC 24-004 through 24-010 and that comprehensive actions are taken to correct any noncompliance that is identified. The review program must evaluate all program performance objectives and requirements. Each licensee must periodically, at least annually, review the access program content and implementation.
010.02 DOCUMENTATION OF RESULTS. 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 must review the findings and take any additional corrective actions necessary to preclude repetition of the condition, including reassessment of the deficient areas where indicated.
010.03 RECORDS. Review records must be maintained for three years.
011. SECURITY PROGRAM .
011.01 APPLICABILITY.
011.01(A) PROGRAM ESTABLISHMENT. Each licensee that possesses an aggregated category 1 or category 2 quantity of radioactive material must establish, implement, and maintain a security program in accordance with the requirements of 180 NAC 24-011 through 24-019.
011.01(B) IMPLEMENTATION. An applicant for a new license and each licensee that would become newly subject to the requirements of 180 NAC 24-011 through 24-019 upon application for modification of its license must implement the requirements of 180 NAC 24-011 through 24-019, as appropriate, before taking possession of an aggregated category 1 or category 2 quantity of radioactive material.
011.01(C) NOTIFICATION. Any licensee that has not previously implemented the Security Orders or been subject to the provisions of 180 NAC 24-011 through 24-019 must provide written notification to the Department in accordance with 180 NAC 1-012 at least 90 days before aggregating radioactive material to a quantity that equals or exceeds the category 2 threshold.
011.02 GENERAL PERFORMANCE OBJECTIVE. Each licensee must establish, implement, and maintain a security program designed to monitor and, without delay, detect, assess, and respond to an actual or attempted unauthorized access to category 1 or category 2 quantities of radioactive material.
011.03 PROGRAM FEATURES. Each licensee’s security program must include the program features, as appropriate, described in 180 NAC 24-012 through 24-018.
012. GENERAL SECURITY PROGRAM REQUIREMENTS .
012.01 SECURITY PLAN.
012.01(A) DEVELOPMENT AND PURPOSE. Each licensee identified in 180 NAC 24-011 must 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 180 NAC 24-011 through 24-019. The security plan must, at a minimum:
(i) Describe the measures and strategies used to implement the requirements of 180 NAC 24-011 through 24-019; and (ii) Identify the security resources, equipment, and technology used to satisfy the requirements of 180 NAC 24-011 through 24-019.
012.01(B) REVIEW AND APPROVAL. The security plan must be reviewed and approved by the individual with overall responsibility for the security program. A licensee must make revisions as necessary to ensure the effective implementation of Department requirements. The licensee must ensure:
(i) The revision has been reviewed and approved by the individual with overall responsibility for the security program; and (ii) The affected individuals are instructed on the revised plan before the changes are implemented.
012.01(C) RECORDS. The licensee must 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 must retain the superseded material for three years after the record is superseded.
012.02 IMPLEMENTING PROCEDURES. The licensee must:
(A) Develop and maintain written procedures that document how the requirements of 180 NAC 24-011 through 24-019 and the security plan will be met; (B) Approve, in writing by the individual with overall responsibility for the program, the implementing procedures and revisions to these procedures; and (C) 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.
012.03 TRAINING. Each licensee must 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.
012.03(A) REQUIREMENTS. The training must include instruction in:
(i) The licensee’s security program and procedures to secure category 1 or category 2 quantities of radioactive material, and in the purposes and functions of the security measures employed; (ii) The responsibility to report promptly to the licensee any condition that causes or may cause a violation of Department requirements; (iii) The responsibility of the licensee to report promptly to the local law enforcement agency and licensee any actual or attempted theft, sabotage, or diversion of category 1 or category 2 quantities of radioactive material; and (iv) The appropriate response to security alarms.
012.03(B) DETERMINATION. In determining those individuals who must be trained on the security program, the licensee must consider each individual’s assigned activities during authorized use and response to potential situations involving actual or attempted theft, diversion, or sabotage of category 1 or category 2 quantities of radioactive material. The extent of the training must correspond with the individual’s potential involvement in the security of category 1 or category 2 quantities of radioactive material.
012.03(C) REFRESHER TRAINING. Refresher training must be provided at a frequency not to exceed 12 months and when significant changes have been made to the security program. This training must include:
(i) Review of the training requirements of 180 NAC 24-012.03 and any changes made to the security program since the last training; (ii) Reports on any relevant security issues, problems, and lessons learned; (iii) Relevant results of Department inspections; and (iv) Relevant results of the licensee’s program review and testing and maintenance.
012.03(D) RECORDS. The licensee must 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.
012.04 PROTECTION OF INFORMATION. Information must be protected as follows:
(A) Licensees authorized to possess category 1 or category 2 quantities of radioactive material must limit access to and unauthorized disclosure of their security plan, implementing procedures, and the list of individuals that have been approved for unescorted access; (B) Efforts to limit access must 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; (C) Before granting an individual access to the security plan, implementing procedures, or the list of individuals that have been approved for unescorted access, licensees must:
(i) 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 (ii) If the individual has not been authorized for unescorted access to category 1 or category 2 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 must be conducted by the reviewing official and must include the background investigation elements contained in 180 NAC 24-006.01(B) through 24-006.01(G);
(D) Licensees need not subject the following individuals to the background investigation elements for protection of information:
(i) The categories of individuals listed in 180 NAC 24-008.01, (A) through (M); or (ii) Security service provider employees, provided written verification that the employee has been determined to be trustworthy and reliable, by the required background investigation in 180 NAC 24-006.01(B) through 24-006.01(G), has been provided by the security service provider;
(E) The licensee must 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; (F) Licensees must 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 must 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; (G) When not in use, the licensee must 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; and (H) The licensee must retain as a record for three years after the document is no longer needed:
(i) A copy of the information protection procedures; and (ii) 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.
013. LLEA COORDINATION . A licensee subject to 180 NAC 24-011 through 24-019 must coordinate, to the extent practicable, with a LLEA for responding to threats to the licensee’s facility, including any necessary armed response. The information provided to the LLEA must include:
(A) A description of the facilities and the category 1 and category 2 quantities of radioactive materials along with a description of the licensee’s security measures that have been implemented to comply with 180 NAC 24-011 through 24-019; and (B) 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 1 or category 2 quantities of material.
013.01 NOTIFICATION. The licensee must notify the Department within three business days if the LLEA:
(A) Has not responded to the request for coordination within 60 days of the coordination request; or (B) Notifies the licensee that the LLEA does not plan to participate in coordination activities.
013.02 DOCUMENTATION. The licensee must document its efforts to coordinate with the LLEA. The documentation must be kept for three years.
013.03 COORDINATION FREQUENCY. The licensee must coordinate with the LLEA at least every 12 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.
014. SECURITY ZONES .
014.01 USE AND STORAGE. Licensees must ensure that all aggregated category 1 and category 2 quantities of radioactive material are used or stored within licensee-established security zones. Security zones may be permanent or temporary.
014.02 TEMPORARY SECURITY ZONES. 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.
014.03 UNESCORTED ACCESS. Security zones must, at a minimum, allow unescorted access only to approved individuals through:
(A) Isolation of category 1 and category 2 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 1 or category 2 quantities of radioactive material within a security zone; (B) Direct control of the security zone by approved individuals at all times; or (C) A combination of continuous physical barriers and direct control.
014.04 CONTINUOUS SURVEILLANCE. For category 1 quantities of radioactive material during periods of maintenance, source receipt, preparation for shipment, installation, or source removal or exchange, the licensee must, 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.
014.05 ESCORT FOR INDIVIDUALS NOT APPROVED FOR UNESCORTED ACCESS. Individuals not approved for unescorted access to category 1 or category 2 quantities of radioactive material must be escorted by an approved individual when in a security zone.
015. MONITORING, DETECTION AND ASSESSMENT .
015.01 MONITORING AND DETECTION.
(A) Licensees must establish and maintain the capability to continuously monitor and detect without delay all unauthorized entries into its security zones. Licensees must 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. (B) Monitoring and detection must be performed by:
(i) A monitored intrusion detection system linked to an onsite or offsite central monitoring facility; (ii) Electronic devices for intrusion detection alarms that will alert nearby facility personnel; (iii) A monitored video surveillance system; (iv) Direct visual surveillance by approved individuals located within the security zone; or (v) Direct visual surveillance by a licensee designated individual located outside the security zone.
(C) A licensee subject to 180 NAC 24-011 through 24-019 must also have a means to detect unauthorized removal of the radioactive material from the security zone. This detection capability must provide:
(i) For category 1 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:
(1) Electronic sensors linked to an alarm; (2) Continuous monitored video surveillance; or (3) Direct visual surveillance.
(ii) For category 2 quantities of radioactive material, weekly verification through physical checks, tamper indicating devices, use, or other means to ensure that the radioactive material is present.
015.02 ASSESSMENT. Licensees must 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.
015.03 PERSONNEL COMMUNICATIONS AND DATA TRANSMISSION. For personnel and automated or electronic systems supporting the licensee’s monitoring, detection, and assessment systems, licensees must:
(A) Maintain continuous capability for personnel communication and electronic data transmission and processing among site security systems; and (B) 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.
015.04 RESPONSE. Licensees must immediately respond to any actual or attempted unauthorized access to the security zones, or actual or attempted theft, sabotage, or diversion of category 1 or category 2 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 1 or category 2 quantities of radioactive material, the licensee’s response must include requesting, without delay, an armed response from the LLEA.
016. MAINTENANCE AND TESTING . Each licensee subject to 180 NAC 24-011 through 24-019 must 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.
016.01 FREQUENCY. 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 manufacturer’s suggested frequency, the testing must be performed at least annually, not to exceed 12 months.
016.02 RECORDS. The licensee must maintain records on the maintenance and testing activities for three years.
017. REQUIREMENTS FOR MOBILE DEVICES . Each licensee that possesses mobile devices containing category 1 or category 2 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) Utilize a method to disable the vehicle or trailer when not under direct control and constant surveillance by the licensee for devices in or on a vehicle or trailer, unless the health and safety requirements for a site prohibit the disabling of the vehicle. Licensees must not rely on the removal of an ignition key to meet this requirement.
018. SECURITY PROGRAM REVIEW .
018.01 CONTINUING EFFECTIVENESS. Each licensee must be responsible for the continuing effectiveness of the security program. Each licensee must ensure the security program is reviewed to confirm compliance with the requirements of 180 NAC 24-011 through 24-019 and 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 must periodically, at least annually, review the security program content and implementation.
018.02 RESULTS AND RECOMMENDATIONS. 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 or conditions, and when appropriate, recommend corrective actions, and corrective actions taken. The licensee must review the findings and take any additional corrective actions necessary to preclude repetition of the condition, including reassessment of the deficient areas where indicated.
018.03 RECORDS. The licensee must maintain the review documentation for three years.
019. REPORTING OF EVENTS .
019.01 IMMEDIATE NOTIFICATION. The licensee must immediately notify the LLEA after determining that an unauthorized entry resulted in an actual or attempted theft, sabotage, or diversion of a category 1 or category 2 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 must notify the Office of Radiological Health at (402) 471-2168 during business hours or (402) 479-4921 after business hours. In no case must the notification to the Department be later than 4 hours after the discovery of any attempted or actual theft, sabotage, or diversion.
019.02 SUSPICIOUS ACTIVITY ASSESSMENT. The licensee must assess any suspicious activity related to possible theft, sabotage, or diversion of category 1 or category 2 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 must notify the notify the Department at (402) 471-2168 during business hours or (402) 479-4921 after business hours.
019.03 WRITTEN NOTIFICATION. Initial telephonic notification required by 180 NAC 24-019.01 must be followed within a period of 30 days by a written report submitted to the Department in accordance with 180 NAC 1-012. The report must include sufficient information for Department analysis and evaluation, including identification of any necessary corrective actions to prevent future instances.
020. ADDITIONAL REQUIREMENTS FOR TRANSFER OF CATEGORY 1 AND CATEGORY 2 QUANTITIES OF RADIOACTIVE MATERIAL . A licensee transferring a category 1 or category 2 quantity of radioactive material to a licensee of the Department, NRC or an Agreement State must meet the license verification provisions listed below instead of those listed in 180 NAC 3-025.04.
020.01 CATEGORY 1 QUANTITIES. Any licensee transferring category 1 quantities of radioactive material to a licensee of the Department, NRC or an Agreement State, prior to conducting such transfer, must verify with the NRC’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 must document the verification. For transfers within the same organization, the licensee does not need to verify the transfer.
020.02 CATEGORY 2 QUANTITIES. Any licensee transferring category 2 quantities of radioactive material to a licensee of the Department, NRC or an Agreement State, prior to conducting such transfer, must verify with the NRC’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 must document the verification. For transfers within the same organization, the licensee does not need to verify the transfer.
020.03 EMERGENCY WRITTEN CERTIFICATION. 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 1 shipment the authorized address. The licensee must keep a copy of the certification. The certification must be confirmed by use of the NRC’s license verification system or by contacting the license issuing authority by the end of the next business day.
020.04 RECORDS. The transferor must keep a copy of the verification documentation as a record for three years.
021. APPLICABILITY OF PHYSICAL PROTECTION OF CATEGORY 1 AND CATEGORY 2 QUANTITIES OF RADIOACTIVE MATERIAL DURING TRANSIT .
021.01 CATEGORY 1 QUANTITIES. For shipments of category 1 quantities of radioactive material, each shipping licensee must comply with the requirements for physical protection contained in 180 NAC 24-022.01 and 24-022.05; 180 NAC 24-023; 24-024.01(A), 24-024.02(A), 24-024.03, and 24-025.01, 24-025.03, 24-025.05, 24-025.07 and 24-025.08.
021.02 CATEGORY 2 QUANTITIES. For shipments of category 2 quantities of radioactive material, each shipping licensee must comply with the requirements for physical protection contained in 180 NAC 24-022.02 through 24-022.05; 24-024.01(B), 24-024.01(C), 24-024.02(B), and 24-024.03; and 24-025.02, 24-025.04, 24-025.06, 24-025.07 and 24-025.08. For those shipments of category 2 quantities of radioactive material that meet the criteria of 180 NAC 13-020.02, the shipping licensee must also comply with the advance notification provisions of 180 NAC 13-020.
021.03 SHIPPING LICENSEE. The shipping licensee must be responsible for meeting the requirements of this 180 NAC 24-020 through 24-025 unless the receiving licensee has agreed in writing to arrange for the in-transit physical protection required under 180 NAC 24-020 through 24-025.
021.04 IMPORT OR EXPORT OF CATEGORY 1 QUANTITIES. Each licensee that imports or exports category 1 quantities of radioactive material must comply with the requirements for physical protection during transit contained in 24-022.01(B) and 24-022.05; 24-023, and 24-024.01(A), 24-024.02(A), and 24-024.03; and 24-025.01, 24-025.03, 24-025.05, 24-025.07 and 24-025.08 for the domestic portion of the shipment.
021.05 IMPORT OR EXPORT OF CATEGORY 2 QUANTITIES. Each licensee that imports or exports category 2 quantities of radioactive material must comply with the requirements for physical protection during transit contained in 180 NAC 24-024.01(B). 24-024.01(C) and 24-024.02(B), and 180 NAC 24-025.02, 24-025.04, 24-025.06, 24-025.07 and 24-025.08 for the domestic portion of the shipment.
022. PREPLANNING AND COORDINATION OF SHIPMENT OF CATEGORY 1 OR CATEGORY 2 QUANTITIES OF RADIOACTIVE MATERIAL .
022.01 PREPLANNING. Each licensee that plans to transport, or deliver to a carrier for transport, licensed material that is a category 1 quantity of radioactive material outside the confines of the licensee’s facility or other place of use or storage must:
(A) Preplan and coordinate shipment arrival and departure times with the receiving licensee; (B) Preplan and coordinate shipment information with the governor or the governor’s designee of any State through which the shipment will pass to:
(i) Discuss the State’s intention to provide law enforcement escorts; and (ii) Identify safe havens; and
(C) Document the preplanning and coordination activities.
022.02 SHIPMENT COORDINATION. Each licensee that plans to transport, or deliver to a carrier for transport, licensed material that is a category 2 quantity of radioactive material outside the confines of the licensee’s facility or other place of use or storage must coordinate the shipment no-later-than arrival time and the expected shipment arrival with the receiving licensee. The licensee must document the coordination activities.
022.03 CONFIRMATION OF RECEIPT. Each licensee who receives a shipment of a category 2 quantity of radioactive material must confirm receipt of the shipment with the originator. If the shipment has not arrived by the no-later-than arrival time, the receiving licensee must notify the originator.
022.04 NEW NO-LATER-THAN ARRIVAL TIME NOTIFICATION. Each licensee, who transports or plans to transport a shipment of a category 2 quantity of radioactive material, and determines that the shipment will arrive after the no-later-than arrival time provided according to 180 NAC 24-022.02, must promptly notify the receiving licensee of the new no-later-than arrival time.
022.05 RECORDS. The licensee must retain a copy of the documentation for preplanning and coordination and any revision thereof, as a record for three years.
023. ADVANCE NOTIFICATION OF SHIPMENT OF CATEGORY 1 QUANTITIES OF RADIOACTIVE MATERIAL . As specified in 180 NAC 24-023.01 and 24-023.02, each licensee must provide advance notification to the NRC, the Department, and the governor of a state, or the governor’s designee, of the shipment of licensed material in a category 1 quantity, through or across the boundary of the state, before the transport, or delivery to a carrier for transport of the licensed material outside the confines of the licensee’s facility or other place of use or storage.
023.01 PROCEDURES FOR SUBMITTING ADVANCE NOTIFICATION.
(A) Notification must be made to the NRC, the Department, and 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’s Web site at https://scp.nrc.gov/special/designee.pdf. A list of the contact information is also available upon request from the Director, Division of Materials Safety, Security, State, and Tribal Programs, Office of Nuclear Material Safety and Safeguards, U.S. Nuclear Regulatory Commission, Washington, DC 20555–0001. Notifications to the NRC must be to the NRC Director, Office of Nuclear Security and Incident Response, U.S. Nuclear Regulatory Commission, Washington, DC 20555–0001. The notification to the NRC may be made by email to RAMQC_SHIPMENTS@nrc.gov or by fax to 301–816–5151. (B) Notification delivered by mail must be postmarked at least seven days before transport of the shipment commences at the shipping facility. (C) Notification delivered by any means other than mail must reach the Department at least 4 days before the transport of the shipment commences and must reach the office of the governor or the governor’s designee at least 4 days before transport of a shipment within or through the State.
023.02 INFORMATION TO BE FURNISHED IN ADVANCE NOTIFICATION OF SHIPMENT. Each advance notification of shipment of category 1 quantities of radioactive material must contain the following information, if available at the time of notification:
(A) Name, address, and telephone number of the shipper, carrier, and receiver of the category 1 radioactive material; (B) License numbers of the shipper and receiver; (C) Description of the radioactive material contained in the shipment, including the radionuclides and quantity; (D) Point of origin of the shipment and the estimated time and date that shipment will commence; (E) Estimated time and date that the shipment is expected to enter each state along the route; (F) Estimated time and date of arrival of the shipment at the destination; and (G) Point of contact, with a telephone number, for current shipment information.
023.03 REVISION NOTICE. The licensee must:
(A) 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 Department, the governor of the State or the governor’s designee and to the NRC’s Director, Office of Nuclear Security and Incident Response, U.S. Nuclear Regulatory Commission, Washington, DC 20555–0001; and (B) Promptly notify the NRC, the Department, the governor of the state or the governor’s designee of any changes to the information provided in accordance with 180 NAC 24-023.02 and 24-023.03(A).
023.04 CANCELLATION NOTICE. Each licensee who cancels a shipment for which advance notification has been sent must send a cancellation notice to the Department, the governor of each State or to the governor’s designee previously notified and to the NRC Director, Office of Nuclear Security and Incident Response, U.S. Nuclear Regulatory Commission, Washington, DC 20555–0001. The licensee must send the cancellation notice before the shipment would have commenced or as soon thereafter as possible. The licensee must state in the notice that it is a cancellation and identify the advance notification being cancelled.
023.05 RECORDS. The licensee must retain a copy of the advance notification and any revision and cancellation notices as a record for three years.
023.06 PROTECTION OF INFORMATION. State officials, state employees, and other individuals, whether or not licensees of the NRC or an Agreement State, who receive schedule information of the kind specified in 24-023.02 must protect that information against unauthorized disclosure as specified in 24-012.04.
024. REQUIREMENTS FOR PHYSICAL PROTECTION OF CATEGORY 1 AND CATEGORY 2 QUANTITIES OF RADIOACTIVE MATERIAL DURING SHIPMENT .
024.01 SHIPMENT BY ROAD. Requirements for shipment by road are as follows.
024.01(A) CATEGORY 1 SINGLE SHIPMENT. Each licensee who transports, or delivers to a carrier for transport, in a single shipment, a category 1 quantity of radioactive material must:
(i) Ensure movement control centers are established that maintain position information from a remote location. These control centers must monitor shipments 24 hours a day, seven days a week, and have the ability to communicate immediately, in an emergency, with the appropriate law enforcement agencies; (ii) Ensure 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; (iii) Ensure 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; (iv) Provide an individual to accompany the driver for those highway shipments with a driving time period greater than the maximum number of allowable hours of service in a 24 hour duty day as established by the Department of Transportation Federal Motor Carrier Safety Administration. The accompanying individual may be another driver; (v) Develop written normal and contingency procedures to address:
(1) Notifications to the communication center and law enforcement agencies; (2) 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; (3) Loss of communications; and (4) Responses to an actual or attempted theft or diversion of a shipment; and
(vi) Ensure drivers, accompanying personnel, and movement control center personnel have access to the normal and contingency procedures for each licensee who makes arrangements for the shipment of category 1 quantities of radioactive material.
024.01(B) CONSTANT CONTROL OF CATEGORY 2 MATERIAL. Each licensee that transports category 2 quantities of radioactive material must maintain constant control or surveillance during transit and have the capability for immediate communication to summon appropriate response or assistance.
024.01(C) CATEGORY 2 SINGLE SHIPMENT. Each licensee who delivers to a carrier for transport, in a single shipment, a category 2 quantity of radioactive material must use carriers that:
(i) Have an established packaged tracking system, which 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 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; (ii) Maintain constant control or surveillance during transit and have the capability for immediate communication to summon appropriate response or assistance; and (iii) Have established tracking systems that require an authorized signature prior to releasing the package for delivery or return.
024.02 SHIPMENT BY RAIL. Requirements for shipment by rail are as follows.
024.02(A) CATEGORY 1 SINGLE SHIPMENT. Each licensee who transports, or delivers to a carrier for transport, in a single shipment, a category 1 quantity of radioactive material must ensure:
(i) 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 must provide positive confirmation of the location of the shipment and its status. The communications center must 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; and (ii) Periodic reports to the communications center are made at preset intervals.
024.02(B) CATEGORY 2 SINGLE SHIPMENT. Each licensee who transports, or delivers to a carrier for transport, in a single shipment, a category 2 quantity of radioactive material must use carriers that:
(i) 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 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; (ii) Maintain constant control or surveillance during transit and have the capability for immediate communication to summon appropriate response or assistance; and (iii) Have established tracking systems that require an authorized signature prior to releasing the package for delivery or return.
024.03 INVESTIGATIONS. Each licensee who makes arrangements for the shipment of category 1 quantities of radioactive material must immediately conduct an investigation upon the discovery that a category 1 shipment is lost or missing. Each licensee who makes arrangements for the shipment of category 2 quantities of radioactive material must 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.
025. REPORTING OF EVENTS .
025.01 CATEGORY 1 IMMEDIATE NOTIFICATION OF LOSS. The shipping licensee must notify the appropriate LLEA and the licensee must notify the Department at (402) 471-2168 during business hours or (402) 479-4921 after business hours within one hour of its determination that a shipment of category 1 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 180 NAC 24-024.03, the shipping licensee will provide agreed upon updates to the Department on the status of the investigation.
025.02 CATEGORY 2 IMMEDIATE NOTIFICATION OF LOSS. The shipping licensee must notify the Department at (402) 471-2168 during business hours or (402) 479-4921 after business hours within four hours of its determination that a shipment of category 2 quantities of radioactive material is lost or missing. If, after 24 hours of its determination that the shipment is lost or missing, the radioactive material has not been located and secured, the licensee must immediately notify the Department.
025.03 CATEGORY 1 NOTIFICATION OF THEFT OR DIVERSION. The shipping licensee must 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 1 quantity of radioactive material. As soon as possible after notifying the LLEA, the licensee must notify the Department upon discovery of any actual or attempted theft or diversion of a shipment, or any suspicious activity related to the shipment of category 1 radioactive material.
025.04 CATEGORY 2 NOTIFICATION OF THEFT OR DIVERSION. The shipping licensee must notify the Department at (402) 471-2168 during business hours or (402) 479-4921 after business hours 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 2 quantity of radioactive material.
025.05 CATEGORY 1 NOTIFICATION OF RECOVERY. The shipping licensee must notify the Department at (402) 471-2168 during business hours or (402) 479-4921 after business hours and the LLEA as soon as possible upon recovery of any lost or missing category 1 quantities of radioactive material.
025.06 CATEGORY 2 NOTIFICATION OF RECOVERY. The shipping licensee must notify the Department at (402) 471-2168 during business hours or (402) 479-4921 after business hours as soon as possible upon recovery of any lost or missing category 2 quantities of radioactive material.
025.07 SUBMISSION OF WRITTEN REPORT. The initial telephonic notification required by 180 NAC 24-025.01 through 24-025.04 must be followed within a period of 30 days by a written report submitted to the Department in accordance with 180 NAC 1-012. A written report is not required for notifications on suspicious activities required by 180 NAC 24-025.03 and 24-025.04. The report must include the following information:
(A) Description of the licensed material involved, including kind, quantity, and chemical and physical form; (B) Description of the circumstances under which the loss or theft occurred; (C) Statement of disposition, or probable disposition, of the licensed material involved; (D) Actions that have been taken, or will be taken, to recover the material; and (E) Procedures or measures that have been, or will be, adopted to ensure against a recurrence of the loss or theft of licensed material.
025.08 REPORT OF ADDITIONAL SUBSTANTIVE INFORMATION. Subsequent to filing the written report, the licensee must also report any additional substantive information on the loss or theft within 30 days after the licensee learns of such information.
026. FORM OF RECORDS . Each record required by 180 NAC 24 must be an original or reproduced copy, or microform or electronic media, capable of producing legible, accurate, and complete records authenticated by authorized personnel throughout the retention period specified by Title 180. Records such as letters, drawings, and specifications, must include all pertinent information such as stamps, initials, and signatures. The licensee must maintain adequate safeguards against tampering with and loss of records.
027. RECORD RETENTION . Licensees must maintain records required by 180 NAC 24 for the period specified by the appropriate regulation. If a retention period is not otherwise specified, these records must be retained until the Department terminates the facility’s license. All records related to 180 NAC 24 may be destroyed upon Department termination of the facility license.
APPENDIX 24-A
Table 1 – Category 1 and Category 2 Threshold
The terabecquerel (TBq) values are the regulatory standard. The curie (Ci) values specified are obtained by converting from the TBq value. The curie values are provided for practical usefulness only.
| Radioactive material | Category 1 (TBq) | Category 1 (Ci) | Category 2 (TBq) | Category 2 (Ci) | | --- | --- | --- | --- | --- | | Americium-241 | 60 | 1,620 | 0.6 | 16.2 | | Americium-241/Be | 60 | 1,620 | 0.6 | 16.2 | | Californium-252 | 20 | 540 | 0.2 | 5.40 | | Cobalt-60 | 30 | 810 | 0.3 | 8.10 | | Curium-244 | 50 | 1,350 | 0.5 | 13.5 | | Cesium-137 | 100 | 2,700 | 1 | 27.0 | | Gadolinium-153 | 1,000 | 27,000 | 10 | 270 | | Iridium-192 | 80 | 2,160 | 0.8 | 21.6 | | Plutonium-238 | 60 | 1,620 | 0.6 | 16.2 | | Plutonium-239/Be | 60 | 1,620 | 0.6 | 16.2 | | Promethium-147 | 40,000 | 1,080,000 | 400 | 10,800 | | Radium-226 | 40 | 1,080 | 0.4 | 10.8 | | Selenium-75 | 200 | 5,400 | 2 | 54.0 | | Strontium-90 | 1,000 | 27,000 | 10 | 270 | | Thulium-170 | 20,000 | 540,000 | 200 | 5,400 | | Ytterbium-169 | 300 | 8,100 | 3 | 81.0 |
Note: Calculations Concerning Multiple Sources or Multiple Radionuclides
The “sum of fractions” methodology for evaluating combinations of multiple sources or multiple radionuclides is to be used in determining whether a location meets or exceeds the threshold and is thus subject to the requirements of this part.
I. If multiple sources of the same radionuclide and/or multiple radionuclides are aggregated at a location, the sum of the ratios of the total activity of each of the radionuclides must be determined to verify whether the activity at the location is less than the category 1 or category 2 thresholds of Table 1, as appropriate. If the calculated sum of the ratios, using the equation below, is greater than or equal to 1.0, then the applicable requirements of this part apply.
II. First determine the total activity for each radionuclide from Table 1 of Appendix 24-A. This is done by adding the activity of each individual source, material in any device, and any loose or bulk material that contains the radionuclide. Then use the equation below to calculate the sum of the ratios by inserting the total activity of the applicable radionuclides from Table 1 of Appendix 24-A in the numerator of the equation and the corresponding threshold activity from Table 1 in the denominator of the equation. Calculations must be performed in metric values (i.e., TBq) and the numerator and denominator values must be in the same units.
R1 = total activity for radionuclide 1 R2 = total activity for radionuclide 2 Rn = total activity for radionuclide n AR1 = activity threshold for radionuclide 1 AR2 = activity threshold for radionuclide 2 ARn = activity threshold for radionuclide n
History
- Effective 2022-11-02
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